The Food Safety Authority of Ireland

Transcription

The Labelling of
Food in Ireland 2007
The Labelling of
Food in Ireland 2007
Published by:
Food Safety Authority of Ireland
Abbey Court
Lower Abbey Street
Dublin 1
Advice Line: 1890 33 66 77
Tel: 01 817 1300
Fax: 01 817 1301
Email: [email protected]
Website:www.fsai.ie
© 2007
ISBN 1-904465-52-8
1
CONTENTS
FOREWORD
3
SECTION 1: INTRODUCTION
4
1.1
Introduction to the Labelling Legislation
1.2
Review of the Horizontal Foodstuffs
Labelling Legislation
SECTION 2: HORIZONTAL
LABELLING LEGISLATION
6
8
Labelling, Presentation and Advertising of Food:
8
Directive 2000/13/EC and Related Directives
2.2
Batch Identification: Council Directive
89/396/EEC
2.4
70
Part A: Compositional Standards
70
4.1
Cocoa and Chocolate Products
70
4.2
Coffee and Chicory Extracts
71
4.3
Fruit Juices and Fruit Nectars
72
4.4
Caseins and Caseinates
73
4.5
Honey
74
4.6
Sugars
75
4.7
Dehydrated Preserved Milk
75
4.8
Fruit Jams, Jellies, Marmalades
and Sweetened Chestnut Purée
76
Natural Mineral Waters, Spring Waters
and Other Bottled Waters
77
4
2.1
2.3
SECTION 4: VERTICAL LEGISLATION
32
4.9
Nutrition Labelling: Council Directive
90/496/EEC
33
Nutrition and Health Claims:
Regulation (EC) No.1924/2006
37
Part B: Common Marketing Standards
80
4.10 Beef and Beef Products
(including minced beef)
80
SECTION 3: SEMI HORIZONTAL LEGISLATION
42
4.11 Spreadable Fats
83
3.1
Food Supplements
42
4.12 Milk and Milk Products
84
3.2
Foods for Particular Nutritional Uses
(Dietetic Foods)
44
3.3
Infant Formulae and Follow-On Formulae
46
3.4
Processed Cereal-Based Foods and Baby
Foods for Infants and Young Children
3.5
Dietary Foods for Special Medical Purposes
3.6
Foods Intended for Use in Energy-Restricted
Diets for Weight Reduction
3.7
(a) Protection of reserved names
84
(b) Drinking milk
85
4.13 Quick Frozen Foods
86
49
4.14 Eggs
87
51
4.15 Wine
90
4.16 Aromatised Wines
92
52
4.17 Spirit Drinks
93
Foodstuffs Treated with Ionising Irradiation
54
4.18 Olive Oil
95
3.8
Novel Foods and Novel Food Ingredients
55
4.19 Fishery and Aquaculture Products
96
3.9
Foods with Added Phytosterols
56
4.20 Poultrymeat
99
3.10 Genetically Modified Food
57
4.21 Fresh Fruit and Vegetables
100
3.11 Food with Added Vitamins
and Minerals (Fortified Foods)
59
Part C: Quality Schemes
102
4.22 Organic Food
102
3.12 Additives, Colours and Sweeteners
in Foodstuffs
60
4.23 Protection of Geographical Indications
104
3.13 Flavourings for Use in Foodstuffs
for Human Consumption
64
SECTION 5: OTHER MISCELLANEOUS
106
3.14 Material and Articles Intended to Come
into Contact with Foodstuffs
5.1
General Food Law
106
67
5.2
Hygiene Legislation
106
2
FOOD SAFETY AUTHORITY OF IRELAND THE LABELLING OF FOOD IN IRELAND 2007
APPENDICES
108
Appendix I:
108
Legislation providing for food-related information
Appendix II:
109
List of categories of ingredients which may
be designated by the name of the category
rather than the specific name (as per Directive
2000/13/EC as amended)
Appendix III:
111
Categories of ingredients which must
be designated by the name of their category
followed by their specific name or EC number
Appendix IV:
111
Allergenic ingredients
Appendix V:
112
Food ingredients and substances provisionally
exempt from labelling as allergenic (as per
Commission Directive 2005/26/EC and 2005/63/EC)
Appendix VI:
113
E numbers in numerical order
Appendix VII:
122
E numbers in alphabetical order
Appendix VIII:
131
Nutrition claims and conditions applying to them
Appendix IX:
133
Catch areas (according to Commission
Regulation (EC) No. 2065/2001)
Appendix X:
134
EU Regulations regarding the marketing
standards for fresh fruit and vegetables
Appendix XI:
Competent authorities contact details
136
3
FOREWORD
The principal function of food labelling is to inform
consumers of the properties of pre-packaged food.
The fundamental rule of the labelling of foodstuffs is that
consumers should not be misled. Detailed labelling of a
product educates consumers as to the exact nature and
characteristics of the foodstuff and enables them to make
a more informed choice.
In addition, hygiene requirements for food products such
as fresh meat, fish and milk are not outlined in this Report.
However, reference is made to the ‘Hygiene Package’
and European Food Law Regulation (EC) No. 178/2002
including certain traceability requirements in so far
as the provisions may affect labelling (Section 5).
Disclaimer
Further to the publication of the Labelling of Food in
Ireland Report 2002, it proved necessary to produce an
addendum in 2003 and a revised addendum in 2004 as
a result of changes to the labelling legislation. In order to
consolidate and further update these legislative changes,
the Labelling of Food in Ireland Report has been revised
in its totality.
The aim of this 2007 report is to outline the labelling
requirements for pre-packaged food up to and including
April 2007. It also outlines or references the labelling
provisions for un-packaged food or food sold loose
where they exist.
The European Communities (Labelling, Presentation
and Advertising of Foodstuffs) Regulations, 2002 (S.I. No.
483 of 2002) and its amendments is the main piece of
legislation in Ireland that regulates the general labelling of
pre-packaged foodstuffs for sale to consumers and also for
sale to the catering industry. These Regulations implement
the provisions of the European Directive 2000/13/EC and
its amendments on labelling (as well as a number of other
related Directives). The Labelling Directive 2000/13/EC
consolidates and repeals the previous Directive 79/112/EEC
and some of its amendments. Depending on the food
product in question, other pieces of legislation containing
labelling provisions of a more specific nature may
also apply.
This document attempts to consolidate all the information
on the labelling of foods in Ireland. It is designed to be of
benefit to consumers, manufacturers and the regulatory
authorities alike to act as a guideline on the labelling
of foods.
Omitted from this document are labelling requirements
which were considered beyond the ‘food safety’ scope
and which were not confined strictly to food products
such as declarations on price indication, some weights
and measures provisions and merchandise markings.
This publication is intended to provide a summary
of the subject matter covered. It does not purport
to be comprehensive or to constitute legal or other
professional advice.
This document presents the position of the labelling
requirements for pre-packaged food up to and including
April 2007. Changes to the labelling legislation are
expected in the future that will necessitate the update
of this publication.
4
SECTION 1 – INTRODUCTION
TO THE LABELLING LEGISLATION
1.1
WHERE CAN I FIND THE RULES
ON LABELLING?
Community legislation on the labelling of foodstuffs
to be delivered to the consumer can be broadly broken
down into the following categories:
1.
Horizontal labelling legislation
This legislation solely governs labelling and
is applicable to all pre-packaged foods intended
for the ultimate consumer.
2.
Semi horizontal legislation with labelling
provisions
This legislation is applicable to foods that are used for
a particular purpose and contains labelling provisions
applicable only to that particular food such as food
intended for weight reduction.
3.
Vertical legislation with labelling provisions
Vertical legislation governs specific food products,
such as beef or chocolate, and contains some
labelling provisions applicable to that food.
4.
Other miscellaneous
There are other Community rules that contain labelling
requirements which are not confined strictly to food
products such as declarations on price indication,
some weights and measures provisions and
merchandise markings. These labelling requirements
are outside the scope of this document but some are
briefly referenced in Section 2.1.5.4.
In addition, the hygiene rules regarding the
production and placing on the market of certain food
products such as fresh meat, are also outside the
scope of this Report. However, reference is made to
these requirements where their provisions affect the
food label (see Section 5).
Appendix I details the legislation providing for all food
related information on food products.
The labelling provisions contained in the first category,
horizontal legislation, apply to all pre-packaged food across
the board. Additional labelling provisions may also apply
from category two and/or three depending on the food.
For example, the labelling information on a bar of
chocolate must comply with the general labelling
requirements provided in the horizontal legislation
that is applicable to all foods as well as the specific
labelling provisions for chocolate as laid out in the
vertical legislation.
1.
Horizontal labelling legislation
Council Directive 2000/13/EC and its amendments on
labelling, presentation and advertising of food to the final
consumer is the main piece of EU legislation regarding the
labelling of food. This Directive is based upon the principle
of functional labelling. Its aim is to ensure that the
consumer gets all the essential information as regards the
composition of the product, methods of storage and
preparation, etc. These requirements are applicable to all
pre-packaged food. Producers and manufacturers may
provide additional information if they wish, provided that it
is accurate and does not mislead the consumer.
The system for the labelling, presentation and advertising of
food products throughout the European Union ensures that
one standard exists for all Member States so that producers
are protected against unfair competition and consumers
protected against misleading products and advertising.
In addition to Directive 2000/13/EC and its amendments,
there are also a number of related Directives that require
the provision of important information regarding the
composition of a food, such as declaring the presence of
caffeine and quinine flavouring on food labels (Directive
2002/67/EC).
Other Directives also apply to all pre-packaged food and
are thus similarly classed as horizontal legislation: Directive
89/396/EEC on batch identification, Directive 90/496/EC
on nutrition labelling and Regulation (EC) No. 1924/2006
on nutrition and health claims.
SECTION 1 INTRODUCTION TO THE LABELLING LEGISLATION
2.
Semi horizontal legislation
Semi horizontal legislation governs foods that are used for
a particular purpose such as baby foods (Directive 96/5/EC
and its amendments Section 3.4) and contains some extra
labelling provisions applicable to these foods in order to
inform the consumer regarding their composition and
intended use, e.g, a baby food must declare the age from
which the food is suitable, e.g. from four months, in
addition to the more general labelling provisions of
the horizontal legislation.
3.
Vertical legislation
Vertical legislation or specific commodity legislation similarly
contains mandatory labelling provisions for specific
products such as beef (Regulation (EC) No. 1760/2000),
fishery products (Regulation (EC) No. 104/2000 and
2065/2001) and fruit jams and jellies (Directive
2001/113/EC) in addition to the requirements of the
horizontal labelling legislation.
The vertical rules can be further broken down into the
following categories depending on the nature of the
legislation:
•
Compositional standards: These Directives set down
precise compositional criteria for specific products such
as fruit juice (Directive 2001/112/EC)
•
Common marketing standards: These Regulations
set out legal requirements for placing specific foods on
the market where the labelling requirements are linked
to trade such as eggs (Regulation (EC) No. 1907/90)
and
•
Quality schemes: Regulations containing additional
voluntary requirements for specific products for quality
rather than safety reasons such as organic food
(Regulation (EC) No. 2092/91).
All of the above categories contain labelling provisions
relevant to that particular food.
5
The Codex Alimentarius Commission
In the absence of national or European legislation in
a particular area, guidance is taken from the Codex
Alimentarius Standards. The Codex Alimentarius
Commission (CAC) was established in 1962 as a subsidiary
body of the Food and Agriculture Organisation of the
United Nations (FAO) and the World Health Organisation
(WHO) to implement the Joint FAO/WHO Food Standards
Programme. It is the body responsible for compiling
international food codes such as standards, codes of
practice and guidelines with the principal objective of
protecting the health of consumers and facilitating fair
practices in the food trade.
The Codex Alimentarius is the collection of international
food standards that have been adopted by the Codex
Alimentarius Commission. Codex standards concern all
aspects of the hygienic and nutritional quality of food,
from raw to processed foods. Codex has also produced
standards on labelling such as the ‘General standard
for the labelling of pre-packaged food’ (available
www.codexalimentarius.net/web/index_en.jsp).
1
6
1.2
REVIEW OF THE HORIZONTAL
FOODSTUFFS LABELLING
LEGISLATION
Currently, the pieces of horizontal food labelling legislation
for review are:
•
General food labelling is harmonised through Directive
2000/13/EC, a codified version of a Directive adopted in
1979, which lays down the labelling requirements that are
applicable to all foodstuffs intended for the ultimate
consumer, and to foodstuffs supplied to restaurants
and mass caterers.
Directive 2000/13/EC relating to the labelling,
presentation and advertising of foodstuffs
(i.e. the General Labelling Directive) and
–
The general labelling legislation has been completed
through additional provisions laying down further labelling
requirements, such as the Quantity of Ingredient
Declaration (QUID). Though it has been amended and
completed, the general labelling legislation is still designed
as it was originally in 1978. Therefore, the European
Commission and the Member States have undertaken a
review of the horizontal labelling legislation with a view to
updating it as consumers want to be more, but above all,
better informed on the increasingly numerous and
innovative foodstuffs supplied on the market.
its 1st Amendment: Directive 2001/101/EC
relating to the labelling, presentation and
advertising of foodstuffs (i.e. the new definition
of meat) and
•
–
its 2nd Amendment: Directive 2003/89/EC
regarding the indication of ingredients present in
foodstuffs (i.e. declaration of all allergens) and
•
Labelling legislation under review
The food labelling legislation is perceived as complex,
spread over many pieces of legislation, and sometimes
contradictory, and the structure of that legislation is
questioned for these reasons. (Appendix I outlines the
legislation providing for food related information on food
products). However, this does not mean that a modification
of the overall structure of the Community legislation on
labelling would be realistic and appropriate.
Therefore, the objective of the review shall be to recast and
modernise the horizontal provisions, applicable to all
foodstuffs, contained in Directive 2000/13/EC and other
related texts, and, if possible to eliminate any inconsistency
with other pieces of legislation. The Nutrition Labelling
Legislation will be revised in tandem in a co-ordinated way
to ensure both pieces of legislation coincide in order to
avoid repetitive changes. Semi horizontal as well as
vertical legislation are outside the scope of the
Commission’s review.
its amendment Directive 2002/86/EC as
regards the date from which trade in products
not in conformity are prohibited and
its amendment Directive 2005/26/EC
establishing a list of food ingredients or
substances provisionally excluded from Annex
IIIa of Directive 2000/13/EC (i.e. provisionally
exempting certain ingredients from being
considered as allergens) and
°
•
•
(correcting 2005/26/EC)
its amendment Directive 2006/142/EC adding
lupin and molluscs to the list of allergens
and four related Directives
–
Directive 87/250/EEC on the indication of
alcoholic strength by volume on alcoholic beverages
–
Directive 94/54/EC concerning the compulsory
indication of certain particulars (i.e. declaration
of packaging gases)
•
its 1st amendment Directive 96/21/EC
concerning the compulsory indication of certain
particulars (i.e. declaration of sweeteners, sugars
and sweeteners, aspartame and polyols)
•
it’s 2nd amendment Directive 2004/77/EC
as regards the labelling of certain foods
containing glycyrrhizinic acid and its ammonium
salt (i.e. extracts from the liquorice plant)
–
Directive 1999/10/EC providing certain
derogations as regards quantitative ingredient
declarations
–
Directive 2002/67/EC on the labelling of food
containing quinine and of food containing
of caffeine.
SECTION 1 INTRODUCTION TO THE LABELLING LEGISLATION
7
Workplan for revising the Horizontal Labelling
Legislation
The Health and Consumer Protection Directorate General
of the European Commission (DG SANCO) commissioned
an evaluation of the food labelling legislation with a view
to its simplification and modernisation in 2003. The aim
of the evaluation was to allow the Community to reassess
its policy on food labelling and to potentially identify if
legislative changes are needed in order to meet demands
from consumers. The Report on “The Evaluation of the
Food Labelling Legislation” commissioned by DG SANCO
was published in 2003 (available at www.europa.eu.int).
Amongst other findings, the Report concluded that
the overall policy objective of the legislation i.e. the right
of the consumer to be informed, was not being met due
to the number of cases of non or partial application of the
Directive i.e. the number of exemptions from the labelling
requirements.
Further to this evaluation, a European wide consultation
has being carried out by DG SANCO on the revision of the
labelling legislation. The Food Safety Authority of Ireland
(FSAI) has carried out a national consultation based on that
of DG SANCO and reported to the Department of Health
and Children. On foot of the comments received and
following the finalisation of the impact assessment, DG
SANCO is due to draft a new legislative proposal before the
end of 2007 on food labelling. A legislative proposal on
nutritional labelling will be produced in tandem, according
to the consumer needs as identified. This will require the
revision of “The Labelling of Food in Ireland 2007” in
due course.
1
8
SECTION 2 – HORIZONTAL
LABELLING LEGISLATION
2.1
LABELLING, PRESENTATION AND
ADVERTISING OF FOOD: DIRECTIVE
2000/13/EC AND RELATED
DIRECTIVES
•
Commission Directive 1999/10/EC providing certain
derogations from quantitative ingredient declarations
•
Commission Directive 2002/67/EC on the labelling
of food containing quinine and/or caffeine flavouring.
2.1.1 Legislation
European legislation
Community legislation governing the general provisions for
the labelling of food is laid out in European Parliament
and Council Directive 2000/13/EC on the labelling,
presentation and advertising of food and has been
amended by:
•
These general labelling requirements are controlled in
Ireland under the European Communities (Labelling,
Presentation and Advertising of Foodstuffs) Regulations,
2002 (S.I. No. 483 of 2002) and its amendments:
•
European Communities (Labelling, Presentation and
Advertising of Foodstuffs) (Amendment) Regulations,
2003 (S.I. No. 257 of 2003)
•
Advertising of Foodstuffs) (Amendment) (No.2)
Regulations, 2003 (S.I. No. 451 of 2003)
•
•
Advertising of Foodstuffs) (Amendment) Regulations,
2005 (S.I. No. 228 of 2005)
•
•
Advertising of Foodstuffs) (Amendment) (No. 3)
Regulations, 2005 (S.I. No. 647 of 2005).
Commission Directive 2001/101/EC regarding
the new definition of meat in meat products
–
•
National legislation
its amendment Commission Directive
2002/86/EC changing the date of implementation
Commission Directive 2003/89/EC regarding the
declaration of allergenic ingredients
–
2005/26/EC provisionally exempting certain
ingredients from being considered as allergens
•
–
correcting Commission Directive 2005/26/EC
2006/142/EC adding lupin and molluscs to the list
of allergens.
There are also a number of related Directives which
specifically contain labelling provisions in order to further
inform the consumer on the composition and/or properties
of certain foods:
•
Commission Directive 87/250/EEC on the indication
of alcoholic strength by volume on alcoholic beverages
•
Commission Directive 94/54/EC requiring the
presence of packaging gases to be declared
–
–
its 1st amendment Council Directive 96/21/EC
requiring certain declarations due the presence of
sweeteners, sugars and sweeteners, aspartame
and polyols
it’s 2nd amendment Commission Directive
2004/77/EC requiring the labelling of certain foods
containing glycyrrhizinic acid
Advertising of Foodstuffs) Regulations, 2002 to 2005
implement the provisions of the European Directives above
specifically:
•
(S.I. No. 483 of 2002) gives effect to:
–
Council Directive 2000/13/EC
–
Commission Directive 87/250/EEC
–
Commission Directive 94/54/EC
–
Council Directive 96/21/EC
–
Commission Directive 1999/10/EC.
9
SECTION 2 HORIZONTAL LABELLING LEGISLATION
•
(S.I. No. 257 of 2003) gives effect to Commission
Directive 2001/101/EC and applies only to products
which contain meat as an ingredient.
•
(S.I. No. 451 of 2003) extends the exemption for
sugar confectionary products to cocoa and chocolate
products, whereby products with a net weight less
than 50 grams do not have to declare the net quantity.
•
Directive 2002/67/EC on the labelling of food
containing caffeine and quinine.
•
•
•
Directive 2003/89/EC regarding the declaration
of allergens.
Directive 2004/77/EC regarding the labelling of foods
containing glycyrrhizinic acid and its ammonium salt.
Directive 2005/26/EC and Commission Directive
2005/63/EC provisionally exempting certain
ingredients from being considered as allergens.
The intention of placing information on the label is to
inform the consumer about the food being purchased.
These Regulations apply to the labelling of pre-packaged
foodstuffs for sale to the ultimate consumer i.e. at retail
level as well for supply to mass caterers (such as
restaurants, hospitals, canteens etc.). The supply of food,
otherwise than by sale, from any food premises such as
special offers, promotions and give-aways, are also covered
by the Regulations
These labelling rules do not apply to food sold in
restaurants and generally not to food sold loose although
there are some exceptions (see Section 2.1.5.8 on origin
and Section 2.1.6 on exemptions to the labelling rules).
2.1.2 Definitions
The definitions of ‘labelling’, ‘pre-packaged’, ‘presentation’,
‘advertise’, ‘sell’ and ‘food’ are provided for under
European and National legislation.
According to the Labelling Directive 2000/13/EC:
‘Labelling’ shall mean any words, particulars, trade marks,
brand name, pictorial matter or symbol relating to a
foodstuff and placed on any packaging, document, notice,
label, ring or collar accompanying or referring to such
foodstuffs.
‘Pre-packaged foodstuff’ shall mean any single item for
presentation as such to the ultimate consumer and to mass
caterers, consisting of a foodstuff and the packaging into
which it was put before being offered for sale, whether
such packaging encloses the foodstuff completely or only
partially, but in any case in such a way that the contents
cannot be altered without opening or changing the
packaging.
‘Presentation’ of foodstuffs refers in particular to their
shape, appearance or packaging, the packaging materials
used, the way in which they are arranged and the setting
in which they are displayed.
According to the Labelling Regulations, 2002 (S.I. No. 483
of 2002):
‘Advertise’ includes every form of advertising, whether in
a publication, by video, sound broadcasting, television,
electronic communication or radio, by display of notices,
signs, labels, showcards or goods, by distribution of
samples, circulars, catalogues, price lists or other material,
by exhibition of pictures, photographs, models or films, or
in any other way.
‘Sell’ includes an agreement or offer to sell, or displaying
for sale, or inviting an offer to buy, and cognate words shall
be construed accordingly.
According to Regulation (EC) No. 178/2002 laying down
the general principles and requirements of food law,
establishing the European Food Safety Authority (EFSA)
and laying down procedures in matters of food safety:
‘Food’ means any substance or product, whether
processed, partially processed or unprocessed, intended to
be, or reasonably expected to be ingested by humans. Food
includes drink, chewing gum and any substance, including
water, intentionally incorporated into the food during its
manufacture, preparation or treatment (it includes water
after the point of compliance as defined in Article 6 of
Directive 98/83/EC on the quality of water for human
consumption).
2
10
2.1.3 When do the labelling rules apply?
Certain criteria must be adhered to regarding the labelling,
presentation and advertising of foodstuffs where the foods
are:
•
pre-packaged (i.e. packaged before sale)
and
•
available for sale to consumers and/or for supply to
mass caterers.
However, there is a derogation from the labelling
requirements (Section 2.1.5) where a pre-packaged food is:
•
for supply only to mass caterers (for preparation,
processing, cutting etc) or
•
intended for the ultimate consumer but marketed prior
to sale to the ultimate consumer and where sale to
mass caterers is not involved at that stage, e.g. food
sold to or from wholesalers or via an intermediary.
For example, it is not permitted to state that a food is
‘free from….’ or ‘without…’ something where all similar
foodstuffs have similar properties. Such expressions may
not be used either where a substance is not normally
present in a certain type of foodstuff or where the use
of a certain additive is not permitted.
Information provided on the label of a food must not be
false or misleading to the consumer. The onus is on the
manufacturer/packager of a food to be able to demonstrate
that all the information provided on a label (whether
compulsory or provided voluntarily) is true.
Current legislation enables the general public or
competitors to take action against advertising deemed
misleading and covers all products and services. The
Regulation (EC) No. 1924/2006 on nutrition and health
claims (Section 2.4) aims to prevent misleading labelling
and advertising regarding nutritional and health properties
of foods, before it is used and then possibly contested.
In such cases, the labelling information (i.e. the compulsory
requirements under Section 2.1.5) need only appear on the
commercial documents referring to the consignment of
food such as a delivery docket. The commercial documents
containing the labelling information can either accompany
the food to which they refer or be sent before the delivery
of the food.
2.1.4.2 Size of information
However, certain essential information must also appear on
the external packaging of the foodstuff, i.e. the name of
the food, date of minimum durability and the name and
address of the manufacturer or packager, or seller in the
EU. If the food is a beverage with greater than 1.2% by
volume of alcohol, the actual alcoholic strength by volume
must also appear on the external packaging.
The size of the text must not be too small in relation to
other information and decorations and the text should be
in contrast to the background. There is no prescribed font
or text size under the legislation but this issue is being
considered under the review of the labelling legislation.
2.1.4 General requirements
2.1.4.1 Labelling must not mislead the consumer
The principle underlying the labelling of food is that the
purchaser must not be misled. The information on the
label must be clear and unambiguous and must not be
such as could mislead the consumer to a material degree:
•
as to the characteristics of the foodstuff and, in
particular, as to its nature, identity, properties,
composition, quantity, durability, origin or provenance,
method of manufacture or production
•
by attributing to the foodstuff, effects or properties
which it does not possess
•
by suggesting that the foodstuff possesses special
characteristics when in fact all similar foodstuffs possess
such characteristics.
The compulsory labelling information below (Section 2.1.5)
must be easy to understand, marked in a conspicuous place
in such a way as to be easily visible, clearly legible and
indelible. It cannot be hidden, obscured or interrupted by
other written or pictorial matter or by price labels, sealing
tapes etc.
2.1.4.3 Language
The general labelling requirements in Ireland are that foods
must be labelled in English or in Irish and English. The food
may also be labelled in other languages but only in addition
to English (or in addition to Irish and English).
Where the address of the food business on the label of a
product is within a Gaeltacht area, the legal status of the
address in Irish should be taken into account and it is
acceptable for food business addresses to be in Irish only.
Our national Health (Country of Origin of Beef) Regulations,
2006 (S.I. No. 307 of 2006) as amended, allows for the
country or countries of origin of beef on advertisements,
menus or other presentations to be in Irish, English or both
languages (see also Section 2.1.4.8 on origin).
11
2.1.4.4 Claims
Functional food claims
Nutrition and health claims on food are now tightly
regulated according to the provisions of Regulation (EC) No.
1924/2006 (Section 2.4). Under these rules a claim is
defined as:
‘Functional food’ is an emerging category of foods which
are generally presented as possessing characteristics that
can help achieve or maintain good health. Although
functional foods are not specifically regulated for in their
own right, the legal requirements regarding food safety and
labelling, including any claims made, apply to such foods as
well as to food in general. Therefore the provisions of the
horizontal labelling rules (Section 2) will apply including
claims.
“any message or representation, which is not
mandatory under Community or national
legislation, including pictorial, graphic or symbolic
representation, in any form, which states, suggests
or implies that a food has particular characteristics.”
In addition, the Labelling Directive 2000/13/EC sets out the
fundamental rules regarding claims in general. Claims on a
food must not be false or misleading to the consumer
(Section 2.1.4.1) and medicinal claims are prohibited.
Meaningless claims such as ‘added vitality’, ‘wholesome”,
‘healthful’ and ‘sound’ and claims as to good hygienic
practice, such as ‘hygienically produced’ may be misleading.
There are specific rules in force that allow for the use of
some health claims under certain conditions for particular
foods and these are provided under the following:
•
•
•
•
the European Communities (Foodstuffs Intended for
Particular Nutritional Uses) Regulations, 2005 (S.I. No.
66 of 2005) regulating specially manufactured foods
that claim to provide particular nutritional requirements
for certain groups of individuals such as for infants or
persons with digestive disorders (see Section 3.2)
the European Communities (Natural Mineral Waters,
Spring Waters and Other Waters in Bottles or
Containers) Regulations, (S.I. No. 79 of 2005) which
prohibits bottled waters from making claims that they
are natural mineral waters unless they meet certain
compositional requirements (see Section 4.9) and
the European Communities (Dietary Foods for Special
Medical Purposes) Regulations, 2001 (S.I. No. 64 of
2001) regulating specially processed foods intended to
provide particular nutritional requirements for the
dietary management of patients under medical
supervision such as patients with an impaired capacity
to metabolise food (see Section 3.5)
Commission Directive 2006/141/EC on infant formulae
and follow-on formulae permits the labelling of infant
formulae to bear specific nutrition and health claims in
accordance with the appropriate conditions for their
use (see Section 3.3).
The FSAI has produced a leaflet ‘Functional Food’ which
gives a broad guide to functional food detailing the relevant
legislation regulating such foods. This leaflet is available at
www.fsai.ie/publications and should be consulted for
further information.
Medicinal claims
In order to be permitted to make a medicinal claim,
a product must be classed as a medicine in accordance
with the Community code relating to medicinal products
for human use. The manufacture, importation, distribution
and supply of medicinal products for human use in Ireland
are regulated by the Irish Medicines Board (IMB). Further
information is available from the IMB at www.imb.ie.
2.1.5 Compulsory labelling
The following mandatory information must appear on the
packaging of a pre-packaged food or on a label attached:
•
the name under which the product is sold*
(Section 2.1.5.1)
•
the list of ingredients (Section 2.1.5.2)
•
the quantity of certain ingredients (Section 2.1.5.3)
•
the net quantity* (Section 2.1.5.4)
•
the date of minimum durability* (Section 2.1.5.5)
•
any special storage instructions or conditions of use
(Section 2.1.5.6)
•
the name or business name and address of the
manufacturer or packager, or of a seller within the
European Union (Section 2.1.5.7)
•
place of origin of the foodstuff if its absence might
mislead the consumer to a material degree (Section
2.1.5.8)
•
instructions for use where necessary (Section 2.1.5.9)
•
beverages with more than 1.2% alcohol by volume
must declare their actual alcoholic strength* (Section
2.1.5.10).
* Field of Vision
The name of the foodstuff, the date of minimum durability and the net quantity must appear on the label “in the same field of vision”. If the product is an
alcoholic beverage greater than 1.2% alcohol by volume, its actual alcoholic strength by volume must also appear in this field of vision. The intention is that
all the information can easily be seen at the same time under normal purchasing conditions.
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2.1.5.1 Name under which the product is sold
The name of the foodstuff must be stated in order to
inform the purchaser of the true nature of the product.
The legal name of the food must be used where one exists.
In its absence its customary name or a description of the
foodstuff may be given.
Legal name
The name under which a foodstuff is sold must be
the name provided for in Community legislation. The
legal name of a food is the name specified in legislation
for a product meeting particular specifications, e.g.
compositional criteria are detailed in the Vertical Directives
for butter, jam, fruit juice, sugar, chocolate, coffee, whiskey,
natural mineral waters etc. (see Section 4).
Customary name
In the absence of a legal name, a name customary in the
Member State where the product is sold to the ultimate
consumer may be used. The customary name of a food is
a name that has come to be accepted by consumers as the
name of a food without needing further explanation such
as fish fingers, spaghetti and muesli. However, a description
of the product may be warranted and its intended use
detailed in order to indicate the true nature of the product
and to distinguish it from other foods, which might
otherwise confuse the consumer (note the product name
‘Chicken and Vegetable Pie’ accompanied by a description
of the product following).
Sales name
The use of a sales name as the name of a food is permitted
in all Member States where the food has been legally
manufactured and marketed in the Member State of
production. However, the sales name shall be accompanied
by a product description in proximity to the sales name
where the labelling information provided would not enable
consumers in the Member State of marketing to know the
true nature of the food and to distinguish it from food with
which they could confuse it.
In exceptional circumstances the sales name of the Member
State of production may not be used as the name of the
food in the Member State of marketing. This provision is to
protect consumers where the composition or manufacture
of the food is so different from the food known under that
name even where a product description is given (see below
the brand name ‘Reggio’ accompanying the customary
name ‘spaghetti’).
13
Trade mark/brand names
2.1.5.2 Ingredients
The use of a trade mark, brand name, or fancy name is
permitted in addition to the name of the food. However,
such names cannot appear instead of the legal or
customary name, as it does not provide sufficient
information for consumers.
An ‘ingredient’ is defined as any substance, including
additives, used in the manufacture or preparation of a
foodstuff and still present in the finished product even if
in an altered form. If an ingredient of a foodstuff is made
up of a number of other ingredients, the latter (i.e. the
individual ingredients of the compound ingredient) is
regarded as the ingredients of the foodstuff in question.
Details of physical condition
Details of the physical condition of the foodstuff or
processes it has undergone must accompany the legal
name of the food such as powdered, freeze-dried, deepfrozen, concentrated, sterilised and smoked. Foodstuffs that
have been frozen and that are retailed without further
processing should be labelled as frozen products.
However, it is important to ensure that an accurate
indication of the processes or treatment to which the food
has been subjected is indicated on the label. Food which is
sold fresh but has been previously frozen should be labelled
as 'previously frozen' and if applicable ‘not suitable for
home freezing’ so the consumer is aware of the true nature
of the product. A further example is a product that contains
a smoked flavour but that has not been smoked but treated
with a solution which imparts a smoked flavour and colour
(see also Section 3.13 on flavourings).
Additional considerations include minced or pressed
products, such as contained in breaded scampi and fish
fingers. These foods would need to carry an appropriate
indication on the label in cases where the consumer is likely
to be misled by the general appearance of the food or
its labelling.
Substances not regarded as ingredients
The following are not considered as ingredients:
•
•
additives serving no technological function in the final
food where their presence in food is only because they
were contained in one or more of the ingredients of
that foodstuff. For example, sulphur dioxide used as a
preservative in dried fruit such as raisins (to prevent
them browning) will have no function when the dried
fruit is added to a cake mix* (see also sub section (b)
on additives)
•
additives used purely as processing aids such as
enzymes, alcohols and acids. For example, alcohols
used to speed up the reactions of certain additives
or enzymes such as rennet used in cheese production.
However, if they leave residues and perform a
technological function they must be considered as
additives and fall under the definition of an ingredient*
•
substances only used in quantities required as solvents
or media for the functioning of additives or flavourings.
For example, diethyl ether which is used in the
preparation of flavourings from natural flavouring
materials*
•
substances which are not additives but are used
in the same way and with the same purpose as
processing aids and are still present in the finished
product, even if in altered form*
Fruit and vegetables which have simply been cut in portions
such as sliced melon and which are sold to the consumer in
transparent packaging are exempt and need not indicate
this treatment unless they are otherwise further processed
such as shredded cabbage.
Irradiated products
the constituents of an ingredient which have been
temporarily separated during manufacturing, which
are later added to a foodstuff but not in excess of their
original quantity. For example, the yolk and white of an
egg need not be considered as separate ingredients and
identified separately in the ingredients list if they are
separated during manufacture. The ingredients list of
the final food would simply need to declare ‘egg’
as the ingredient, provided they are not in excess
of the original amounts
Any food which has been treated with ionising radiation
must declare ‘irradiated’ or ‘treated with ionising radiation’
(see also Section 3.7 on foods treated with ionising
radiation).
* These exemptions do not apply to additives, processing aids and other substances which have been derived from allergenic ingredients listed in Appendix IV.
As such additives, processing aids and other substances derived from allergenic ingredients are considered as ingredients and must always be declared in the
list of ingredients (Directive 2003/89/EC as amended by Directive 2005/26/EC and Directive 2005/63/EC, amending Directive 2000/13/EC as regards the
indication of ingredients present in foodstuffs).
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14
List of ingredients
•
where fruit, vegetables or mushrooms, none of which
significantly predominates in terms of weight and which
are used in proportions that are likely to vary, are used
in a mixture as ingredients of a foodstuff, they may be
grouped together in the list of ingredients under the
designation “fruit”, “vegetables” or “mushrooms”
followed by the phrase “in varying proportions”,
immediately followed by a list of the fruit, vegetables or
mushrooms present; in such cases, the mixture shall be
included in the list of ingredients in descending order
of weight on the basis of the total weight of the fruit,
vegetables or mushrooms present*
•
in the case of mixtures of herbs and spices, where none
significantly predominate, those ingredients may be
listed in another order provided it is accompanied by an
expression such as ‘in variable proportion’
•
ingredients constituting less than 2% of the finished
product may be listed in a different order after the
other ingredients and *
•
where ingredients which are similar or mutually
substitutable are likely to be used in the manufacture
or preparation of a foodstuff without altering its
composition, its nature or its perceived value, and in
so far as they constitute less than 2% of the finished
product, they may be referred to in the list of
ingredients by means of the phrase “contains …
and/or …”, where at least one of no more than two
ingredients is present in the finished product. This
provision shall not apply to additives or to ingredients
listed in Appendix IV as allergenic ingredients*.
There must be a list of all the ingredients in descending
order of weight as recorded during the manufacturing of
the foodstuff often referred to as “the mixing bowl stage”.
The list must start with a heading that includes the word
‘ingredients’.
The list of ingredients must be easy to understand by the
consumer and such that similar products can be easily
distinguished from each other depending on the
ingredients, e.g, consumers must be able to readily
distinguish between a ‘strawberry’ or ‘raspberry’ fruit
yoghurt.
There are some additional requirements when listing the
ingredients on the label:
•
added water and volatile ingredients (i.e. substances
that quickly evaporate such as alcohol), shall be listed in
the list of ingredients by their weight in the final
product and not their weight as added at the mixing
bowl stage. The amount of water added as an
ingredient is calculated by subtracting the total weight
of other ingredients from the weight of the finished
product. However, the amount of added water need
not be listed as an ingredient if it does not exceed 5%
by weight of the finished product (see also sub section
on declaration of water content below)
(In addition water need not be declared in the list
of ingredients if it is added to frozen or quick frozen
chicken carcasses in accordance with Commission
Regulation (EC) No. 1906/90 (as implemented by
Regulation (EC) No. 1538/91 as amended) on certain
marketing standards for poultry (see Section 4.20 on
poultrymeat)
•
concentrated or dried ingredients that are reconstituted
at the time of manufacture may be listed according to
their weight before their original concentration or
dehydration such as milk powder
•
in the case of concentrated or dried foods which
are to be reconstituted by the addition of water
by the consumer, such as powdered soup or sauces,
the ingredients may be listed by the order of their
proportion after the reconstitution of the product
provided that this is indicated, e.g. ‘ingredients of
the reconstituted product’ or ‘ingredients of the
ready-to-use product’
* As set out in Directive 2003/89/EC as amended, amending Directive 2000/13/EC as regards the indication of ingredients present in foodstuffs.
15
Foodstuffs that do not require a list of ingredients
Name of ingredients
The following foodstuffs are not required to indicate a list
of their ingredients:
The names used for ingredients should be their legal name,
in the absence of a legal name, a customary name or a
description of the ingredient must be given (as per the
requirements for the ‘name of the food’ Section 2.1.5.1).
In other words, the name of an ingredient must be
sufficiently specific to describe the ingredient.
•
fresh fruit and vegetables including potatoes
(unless they have been somehow processed,
e.g. peeled or chopped)
•
carbonated water provided that it can be understood
from the name that carbon dioxide has been added
to the water for example ‘sparkling’ water
•
fermentation vinegars derived from a single basic
product (where no other ingredient has been added)
•
cheese, other than fresh or processed cheese, where
no other ingredient has been added except those that
are required for its manufacture (i.e. salt, lactic acid
products, enzymes and microorganism cultures) such
as cheddar and edam cheese
•
butter, fermented milk and fermented cream where no
other ingredient has been added (except for lactic acid
products, enzymes and microorganism cultures essential
to their manufacture)
•
products comprising a single ingredient where the trade
name is the same as the ingredient name, or the trade
name enables the nature of the ingredient to be clearly
defined, for example, pepper
•
Where the ingredient ‘starch’ (or modified starch) originates
from a source that contains gluten such as starch from
wheat, oats, barley or rye, the source of its cereal origin
must always be given, e.g. wheat starch. See below a dried
soup declaring ‘Corn Starch’ and a readymeal declaring
‘Modified Maize Starch’ in their lists of ingredients)
INGREDIENTS:
Corn Starch, Sugar, Onion Powder, Skimmed
Milk Powder, Whey Protein Concentrate, Beef
Fat, Dried Potato, Dried Leeks Salt, Flavour
Enhancers (Monosodium Glutamate, Disodium
5‘ Ribanuceotides), Wheat Flour, Flavourings,
Dried Glucose Syrup, Herbs, Spices
INGREDIENTS
Cooked noodles, Soy Sauce, Red
Pepper, Pineapple, Sugar, Chinese
Mushrooms, Water, Chicken, Bamboo
Shoots, Modified Maize Starch, Spices,
Garlic Puree, Salt, Sesame Oil,
Ginger Puree.
beverages that contain more then 1.2% volume of
alcohol (see also Section 2.1.5.10 on alcoholic
beverages).
Declaration of water content
The amount of added water need not be listed as an
ingredient if it does not exceed 5% by weight of the
finished.
In addition, the water content need not be indicated
where:
•
the water is used during the manufacturing process
purely for the reconstitution of an ingredient that is
used in a concentrated or dehydrated form or
•
where the water is a liquid medium that is not usually
consumed such as kidney beans in salted water.
Categories of ingredients
Ingredients of a foodstuff that belong to a certain
category of ingredients as listed in Appendix II need only
be indicated by their designated category rather than their
specific name. For example, where fish is an ingredient of a
foodstuff all species of fish may be indicated simply as the
category ‘fish’ in the list of ingredients provided the label
does not refer to a specific species of fish.
Directive 2003/89/EC, amending Directive 2000/13/EC,
deleted the following ingredient categories from
Appendix II:
•
‘Crystallised fruit’ and
•
‘Vegetables’.
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16
See below ‘Original Beef Lasagne’ where the category of
ingredient ‘cheese’ need only be declared as such in the list
of ingredients because a particular type of cheese is not
specified in the product description.
In addition, Guidance Note 17:The Labelling of Meat
provides guidance on the documentation, labelling and
traceability information required for all meats throughout
the marketing chain. Both Guidance Notes are available at
www.fsai.ie/publications.
(b) Additives
Ingredients of a foodstuff which belong to one of the
categories of additives as listed in Appendix III must be
named in the list of ingredients by:
(a) Definition of meat
Commission Directive 2001/101/EC, amending Directive
2000/13/EC for the first time, added the category ‘meat’
to the list of categories of ingredients in Appendix II.
The aim of the new requirements is to improve consumer
information on pre-packaged meat products such as
cooked meats, prepared dishes and canned meat. The new
definition of ‘meat’ brings the legislation in line with what
consumers generally perceive meat to be i.e. muscle-meat
not fat or offal.
The labelling provisions outlined below apply to all food
products that contain meat as an ingredient
(including all products previously defined as ‘meat products’
and ‘meat preparations’ now falling under EC (Food and
Feed Hygiene) Regulations, 2005 (S.I. No. 910 of 2005)
Section 5). However, raw meat cuts sold without further
processing are excluded such as a sirloin steak. In addition,
sandwiches, rolls, soups, pizza and similar products
containing meat ingredients are also excluded from
these labelling requirements.
The new definition of meat (as set out in Appendix II)
defines ‘meat’ as the skeletal attached muscles i.e. muscle
meat only and other parts of the animals such as fat and
offal, e.g. the heart, liver and kidneys, are excluded and
must be declared separately in the list of ingredients.
Secondly, the species from which the meat came from must
also be indicated in the list of ingredients such as ‘bovine
meat’ or ‘beef meat’ or simply ‘beef’. This information is
very important for consumers to help them make an
informed choice on the basis of their personal preferences.
A separate Guidance Note has been produced on these
meat products labelling requirements - Guidance Note 14:
The application of Commission Directive 2001/101/EC as
amended by Commission Directive 2002/86/EC on the
Definition of Meat. The intention of this Guidance Note is
to enable those involved in the manufacturing, packaging
and selling of meat products to better understand the new
labelling requirements.
•
the name of the category of additive and
•
its specific name or it’s designated E number.
For example, sulphur dioxide which is a preservative
commonly used in sausages must be listed in the list of
ingredients as ‘Preservative: Sulphur Dioxide’ or
‘Preservative: E220’. If the additive belongs to more than
one category (as listed in Appendix III) the category name
given shall correspond to its main function in that particular
food. Additives which perform the same function in a food
could be grouped together for ingredient listing purposes,
e.g. Colours: E110, E120 or Colours: Sunset Yellow,
Cochineal (see also Section 3.12 on additives, colours and
sweeteners). See below an indication of the additives
present in the ingredients list of a packet of sausage rolls.
INGREDIENTS
Pork, Rusk, Salt, Milk Proteins, Soya Protein
Isolate, Spices, Stabiliser: E450, Flavour
Enhancer: E621, Dextrose, Modified Starch,
Colours: E160, E128, Water, Preservative: E223,
Hydrolysed Vegetable Protein, Wheat
Flour, Margarine (with Emulsifier E471,
Flavouring), Antioxidants: E301, E331, Herbs.
Minimum 20% Meat.
Every additive is given a number for identification purposes
and most have an ‘E’ prefix before the number which
means it has been approved by the European Community
as safe for use at specified levels in certain foods. There are
approximately 400 approved additives for use in foods in
Europe. However, some additives do not have an E number.
Additives lacking the ‘E’ prefix have undergone a safety
evaluation in one or more Member States but are still
awaiting EU wide approval.
17
Appendix VI and VII provide a list of all additives and
their designated E numbers currently in use in the EU,
in numerical and alphabetical order respectively as listed in
the additives register in the Additives Directives (see Section
3.12). The following are the most recent changes in the
register of additives:
•
E233 Thiabendazole metabisulpihte has been
deleted from the register
•
E180 Litholrubine BK the spelling has been amended
from Latolrubine BK
•
E230 Biphenyl, diphenyl is to be deleted and
transferred to the pesticides register
•
E231 Orthophenyl phenol is to be deleted and
transferred to the pesticides register
•
E232 Sodium orthophenyl phenol is to be deleted
and transferred to the pesticides register.
In addition, the following additives have been added
to the register:
The European Commission has adopted a new package of
legislative proposals regarding additives, flavourings and
food enzymes, see Sections 3.12 and 3.13 in this regard.
Additives carried over from other ingredients
Some additives may be present in a food because
they were contained in one of the ingredients. They
need only be indicated in the list of ingredients if they
perform a significant technological function in the final
food (see previous sub-section on substances not regarded
as ingredients). Whether or not the additive performs a
technological function in the final product will depend both
on the ingredient containing the additive and the food to
which it is added. For example, preservatives used in fruit
puree will not necessarily be performing the same function
when the fruit is added to a heat-treated yoghurt.
However, carry-over additives that are derived from
allergenic ingredients (i.e. those listed in Appendix IV but
excluding those listed in Appendix V) are considered as
ingredients and must always be declared in the list of
ingredients (see also sub-section (e) on allergens).
•
E650 Zinc acetate
•
E907 Hydrogenated poly-1-decene
(c) Flavourings
•
E955 Sucralose
•
E962 Salt of aspartame-acesulfame
•
E1517 Glyceryl diacetate (diacetin)
•
E1519 Benzyl alcohol.
‘Flavourings’ are used in or on foodstuffs to impart a taste
and/or odour. Flavourings must be indicated in the list of
ingredients by the word “flavouring(s)” or by a more
specific name or description, for example, ‘Flavouring:
vanilla’. See Section 3.13 detailing the specific rules on
flavourings including the new package of legislative
proposals regarding additives, flavourings and food
enzymes.
Although some ingredients may have additive functions
in food, acting as sweeteners, colours etc. (such as sugar,
coffee, salt, concentrated fruit juice) they are not additives
as defined according to the additives legislation (Directive
89/107/EEC and its amendments) and do not need to be
listed as such.
It should be noted that only substances listed in Appendix
III are recognised as categories of additives for labelling
purposes such as antioxidants that are used to extend the
shelf life of foods and protect them against rancidity.
Flavourings are not considered as additives as they do not
perform a technological function in the food and are
regulated separately to additives (see Section 2.1.5.2 subsection (c) and 3.13 on flavourings).
For detailed information on food additives please
refer to the report by the FSAI on “Legislation, intake
and usage of food additives in Ireland” available at
Caffeine and quinine flavouring
Commission Directive 2002/67/EC on the labelling
of foodstuffs containing quinine, and of foodstuffs
containing caffeine however, requires more detailed
information on the label. The Directive requires that
where quinine or caffeine are used as a flavouring in
the production or preparation of a foodstuff, such as
in soft drinks they must always be declared in the list
of ingredients immediately after the term ‘flavouring’,
such as ‘flavouring: quinine’.
Quinine and caffeine may cause hypersensitivity or
temporary behavioural changes in certain individuals.
As current labelling rules do not require the specific
naming of flavourings in ingredient lists, caffeine or
quinine used as a flavouring, might not therefore be listed.
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18
In addition, drinks containing caffeine in excess of 150mg/l
such as high energy drinks must also provide a warning
message on the label followed by an indication of the
caffeine content such that:
•
‘High caffeine content (Xmg/100ml)’.
These provisions do not apply to beverages based on
coffee, tea or coffee or tea extract.
In the case of high contents of glycyrrhizinic acid or its
ammonium salt in these products, the consumers, and in
particular those suffering from hypertension, should in
addition be informed that excessive intake should be
avoided. To ensure a good understanding of the labelling
information by the consumer, the term ‘liquorice extracts’
should be used.
•
For confectionery or beverages containing glycyrrhizinic
acid or its ammonium salt at a concentration of
100mg/kg or 10mg/l or above, the statement
‘contains liquorice’ must be added immediately after
the list of ingredients, unless the term ‘liquorice’ is
already included in the list of ingredients or in the name
under which the product is sold. In the absence of an
ingredients list, the statement should appear near the
name under which the product is sold.
•
For confectionery containing glycyrrhizinic acid or its
ammonium salt at concentrations of 4g/kg or above,
the statement ‘contains liquorice – people
suffering from hypertension should avoid
excessive consumption’ must be added after the list
of ingredients. In the absence of an ingredients list the
statement must appear near the name under which the
product is sold.
•
For beverages containing glycyrrhizinic acid or its
ammonium salt at concentrations of 50mg/l or above,
or of 300mg/l or above in the case of beverages
containing more than 1.2% by volume of alcohol, the
statement ‘contains liquorice – people suffering
from hypertension should avoid excessive
consumption’ must appear after the list of ingredients.
In the absence of a list of ingredients a statement
should appear near the name under which the product
is sold.
Natural flavouring
Detailed rules on the use of the term ‘natural’ with regard
to flavourings are provided in the European Communities
(Flavourings for use in Foodstuffs for Human Consumption)
Regulations, 1992 (S.I. No. 22 of 1992) (see Section 3.13).
Smoke flavourings
See Section 3.13 on flavourings.
Liquorice flavouring (Glycyrrhizinic Acid)
Commission Directive 2004/77/EC amends Directive
94/54/EC as regards the labelling of certain foods
containing glycyrrhizinic acid and its ammonium salt.
This Directive provides for additional labelling of
confectionery and beverages containing glycyrrhizinic acid
or its ammonium salt above certain limits because of the
possibility that these flavourings can give rise to
hypertension.
Glycyrrhizinic acid naturally occurs in the liquorice plant
Glycyrrhiza glabra while its ammonium salt is manufactured
from aqueous extracts of the liquorice plant. Glycyrrhizinic
acid and its ammonium salt are included in the Community
register of flavouring substances (Commission Decision
1999/217/EC see Section 3.13).
Exposure to glycyrrhizinic acid and its ammonium salt occur
mostly via consumption of liquorice confectionery, including
chewing gum, herbal teas and other beverages. An upper
limit of 100 mg/day for regular ingestion is regarded as
providing a sufficient level of protection for the majority
of the population. Consumption above this level may
give rise to hypertension.
These levels apply to the products ready for consumption
or as re-constituted according to the instructions of the
manufacturer.
However, it is recognised that within the human population
there are subgroups for which this upper limit might not
offer sufficient protection. These subgroups comprise of
people with medical conditions related to ‘disturbed water
and electrolyte homeostasis’. As flavourings are not
normally required to be specifically named in the list of
ingredients (Directive 2000/13/EC) it is necessary to provide
labelling which gives the consumers clear information on
the presence of glycyrrhizinic acid or its ammonium salt in
confectionery and beverages as detailed below.
(d) Compound ingredients
These requirements came into force on 20th May 2005.
Trade in products not in compliance with these provisions
is prohibited from 20th May 2006.
The rules for the labelling of compound ingredients have
changed under Directive 2003/89/EC. The aim of this
amendment is to achieve a high level of health protection
for consumers and to guarantee their right to information
by ensuring they are appropriately informed of the
composition of food.
19
It is now obligatory to include the list of all ingredients and
other substances present in a food, however, some minor
exemptions will be permitted (see below). In addition, it has
also become mandatory to include on the label of a food as
well as alcoholic beverages, all ingredients with allergenic
effect (see sub-section (e) below on allergens).
A compound ingredient is an ingredient which is itself
made up of several other ingredients, such as jam in a
biscuit. A compound ingredient can be included in the list
of ingredients under its own specific name provided it is
followed immediately by a list of its ingredients, e.g. jam
(fruit, water, sugar etc.). Alternatively, the ingredients
of the compound ingredient may be shown in the list
of ingredients without making reference to the name
of the compound ingredient, e.g. ....fruit, water, sugar.
Below is the list of ingredients of a vegetarian lasagne
where the compound ingredient ‘textured wheat and pea
protein’ is given under its own specific name followed by
a list of its ingredients.
INGREDIENTS: Water, Tomato, Textured Wheat and Pea Protein (contains:
Wheatflour, Wheatfibre, Yeast Extract, Malt Extract, Emulsifier; E471), Onion,
Vegetarian Cheddar Cheese, Basil, Garlic, Puree, SUgar, Milk, Cooked Fresh Free
Range Egg Pasta, Tomato Puree, Carrot, Wheatflour, Vegetarian Flavourings, Double
Cream, Modified Starch, Vegetable Oil, Salt, Oregano, Paprika, Pepper, Nutmeg.
However, listing the ingredients of a compound ingredient
is not required:
a) where the composition of the compound ingredient is
defined in current Community legislation (such as in the
Vertical Directives Section 3, e.g. fruit jams and jellies)
and where the compound ingredient constitutes less
than 2% of the finished product. However, this
provision does not apply to additives
(b) for compound ingredients consisting of mixtures of
spices and/or herbs that constitute less than 2% of the
finished product, with the exception of additives, and
(c) where the compound ingredient is a foodstuff for
which a list of ingredients is not required under
Community legislation (such as alcoholic beverages).
(e) Allergens
European Directive 2003/89/EC which came into force on
25th November 2004 recognises that certain ingredients,
additives, processing aids and other substances can cause
allergies or intolerances in consumers. Thus, it sets out
labelling rules to assist consumers who have allergies or
intolerances by providing them with more comprehensible
information on the composition of foods.
The objective of Directive 2003/89/EC is to ensure that all
allergenic ingredients or substances will appear on the label
of a food. The allergens required to be indicated are listed
in Appendix IV such as eggs and fish. Lupin and molluscs
were most recently added to this list (as per Directive
2006/142/EC). These allergenic ingredients must be
declared on the label with a clear reference to the name
under which the allergen is known, so that consumers
suffering from an allergy or intolerance shall be able to
identify the ingredient they are sensitive to.
The European Commission has drawn up “Guidelines
for implementing Article 6 paragraph 10 of Directive
2000/13/EC as amended by Directive 2003/89/EC”. These
guidelines offer informal guidance on the interpretation and
implementation of some of the labelling requirements for
allergenic ingredients. (This document is available at Europa
- the European Union On-Line www.europa.eu.int ).
Appendix V lists the ingredients or substances that are
provisionally excluded from being labelled as allergens (as
per Directive 2005/26/EC and Directive 2005/63/EC). To this
end businesses had to notify the Commission of the studies
being conducted to establish whether certain ingredients
or substances under specific circumstances are not likely to
trigger adverse reactions. Businesses seeking a permanent
extension to this exemption from labelling beyond
November 2007, must submit a request to the
Commission containing the final results of the
scientific studies carried out.
Only the derivatives that are listed (Appendix V) are
provisionally exempt from labelling as allergenic pending
further scientific evaluation. All other allergenic derivatives
must be labelled appropriately.
Twenty one requests for permanent exemptions from
allergen labelling were received by the European Food
Safety Authority (EFSA) (nine have EFSA opinions, ten have
draft opinions and two are pending). The Commission
foresees that a new Directive will be published before
November 2007 (within the permitted time frame) which
will provide permanent exemptions from allergen labelling
for some substances.
The FSAI has also produced an information leaflet on
allergens and is available at:
www.fsai.ie/publications/index.asp#leaflets
2
20
Indication of allergenic ingredients
There still exist some minor possible derogations
from labelling ingredients in pre-packaged foods:
1. foods for which no ingredient list is required
(Section 2.1.5.2)
2. sub ingredients of certain compound ingredients
(Section 2.1.5.2 (d)) and
3. ingredients which belong to defined categories
(Section 2.1.5.2).
However, despite these exemptions from ingredients
labelling, where an ingredient is a known allergen listed in
Appendix IV or originates from an ingredient in that list, the
derogations no longer apply and the allergenic ingredients
must be clearly labelled.
However, any substance including additives and processing
aids which are used in the production of a food and still
present in the finished product even if in an altered form
and originates from the allergenic ingredients listed in
Appendix IV, is considered as an ingredient and must be
indicated on the label with a clear reference to the name of
the ingredient from which it originates, e.g. ‘….additive A
from wheat…’ could appear in the list of ingredients.
The exemption whereby the declaration of the allergenic
ingredient can appear in the sales name of the food only
does not extend to allergenic ‘substances’ such as carry
over additives or processing aids. Substances originating
from allergenic ingredients must be declared somewhere on
the label such as in the list of ingredients but not solely in
the sales name.
Name under which food is sold
Therefore, any ingredient that is used in the production
of a food and still present in the finished product even if
in altered form and is listed in Appendix IV as an allergenic
ingredient or originates from an ingredient in this list, must
be indicated on the label with a clear reference to the
name under which the allergen is known. For example,
where the ingredient of a food is a cereal which contains
gluten, such as wheat, the ingredient name ‘wheat’ must
appear clearly on the label.
However, the declaration ‘wheat’ is not required elsewhere
on the label if the name under which the food is sold
clearly refers to this ingredient such as “Wheat bread”.
Therefore, any declaration on the label indicating the
presence of the allergen can be considered as fulfilling
the requirements of the Directive whether the allergenic
ingredient is declared in the list of ingredients, the sales
names or somewhere else on the label provided it is
clearly stated.
Similarly a product called ‘cake with almonds’ is considered
as declaring the allergenic ingredient ‘almonds’ in the sales
name. Thus the allergenic ingredient ‘almonds’ does not
have to be repeated or declared elsewhere on the label to
fulfil the requirements under this Directive. The declaration
of the category name ‘flavour’ alone in the list of
ingredients is acceptable even where the flavour
has been made with the use of almond extracts.
Indication of allergenic substances
There is a derogation from the labelling of certain
substances in pre-packaged foods where certain substances
are not regarded as ingredients such as carry-over additives
and thus do not have to be declared on the label (Section
2.1.5.2).
Normally if the sales name of a food declares the
allergenic ingredient in the name of the food, e.g. ‘cake
with almonds’, the allergenic ingredient does not have to
be declared elsewhere or repeated on the label (except for
allergenic substances above). Milk-based products (cheese,
butter, fermented milk and cream) are particularly
concerned by this provision as they are exempted
from ingredient listing.
The trade names of certain dairy products such as cheese,
butter and yoghurt are considered as referring to the
allergenic ingredient ‘milk’ by normally informed consumers
and thus are not required to declare the allergenic
ingredient elsewhere on the label. However, the name of
some products may not imply the presence of an allergen
such as cheese sold under a trade name or appellation
which does not refer explicitly to milk. In such cases, any
supplement to the name of the product which implies a
reference to the allergenic ingredient is acceptable such
as adding ‘cheese’ to the sales name.
Repetition of allergens
Allergenic ingredients and substances need only be declared
once, it is not necessary for the allergens to be repeated on
the label. Any presentation making clear that different
ingredients or substances in a food originate from a single
allergenic ingredient or substance is acceptable such as by
way of a footnote to the list of ingredients.
SO2
Sulphur dioxide and sulphite shall appear on the label under
its full name, where it is present at levels exceeding
10mg/kg or 10mg/l as consumed or as reconstituted
according to the manufacturers instructions.
21
Definition of ‘products thereof”
Appendix IV lists the known allergenic ingredients
which must comply with the labelling requirements.
In listing the allergenic ingredients, ‘products thereof’
are also considered as being allergenic and subject to the
labelling requirements such as ‘fish and products thereof’.
Due to different wordings in other official languages the
scope of this definition has been questioned.
“Products thereof” include all products derived from an
allergenic ingredient after one or more processing stages.
Microorganisms that have been fed substrates are not
considered as ‘derived’ from these substrates. However,
where these substrates contain allergenic ingredients and
a food is prepared with microorganisms that are likely to
contaminate a food, manufacturers will have to decide if
labelling, precautionary or other wise, is required (although
precautionary labelling is not normally advised). The scope
of the Directive applies only to ingredients voluntarily used
for manufacturing food and not to involuntary
contamination.
List of allergenic ingredients
The current list of allergenic ingredients (Appendix IV)
contains the most common food allergens. This list will be
systematically re-examined and, where necessary, updated
on the basis of the most recent scientific knowledge.
It is possible for ingredients to be deleted from this list
where it has been scientifically established that it is not
possible for certain derivatives of these allergens to cause
adverse reactions. To this end, provision was made for
interested parties to notify the Commission of studies being
conducted to establish whether ingredients that are derived
from allergenic ingredients are not likely to trigger adverse
reactions (as outlined above).
Currently the derivatives that are listed in Appendix V are
provisionally exempt from labelling as allergenic pending
further scientific evaluation. All other allergenic derivatives
must be labelled appropriately.
2.1.5.3 Quantitative Ingredient Declaration (QUID)
In certain circumstances it is necessary to state on the
label the quantity, in percentage terms, of an ingredient or
category of ingredients (as listed in Appendix II) used in the
manufacture or preparation of a foodstuff. The percentage
quantity should be in or next to the name of the food or
be in the list of ingredients.
The QUID requirement applies to all foods, including
beverages, with more than one ingredient unless specially
exempt. QUID will also apply to products exempt from
ingredients listing (see Section 2.1.5.2). For these products,
the ingredient quantity will have to be indicated in or
immediately next to the name under which the product
is sold unless a list of ingredients is voluntarily indicated
on the label.
The European Commission has produced a document with
the aim of providing informal advice on the implementation
of QUID entitled ‘General guidelines for implementing
Quantitative Ingredient Declaration (QUID) 1998’. It is
advisable to consult this document in conjunction with
Directive 2000/13/EC for a more detailed explanation
of the QUID rules. (This guide is available at the European
Union On-Line www.europa.eu.int).
In addition, the Food and Drink Federation of the Irish
Business and Employers Confederation (IBEC) have
developed ‘Guidance Notes on Quantitative Declaration
of Ingredients (QUID)’, February 2000. This guideline was
drawn up to provide guidance to manufacturers and
suppliers on the introduction of QUID in Ireland.
When a Quantitative Ingredient Declaration (QUID)
is required
It is necessary to state the quantity as a percentage on
the label where the ingredient or category of ingredient is:
•
included in the name of the food, e.g. a ‘ham
and mushroom pizza’, would need to have the ham
and the mushroom quantified
•
usually associated with the name of the food
(most likely when a food is described by it’s customary
name, e.g. Chilli con carne would need to have the
minced beef quantified)
•
emphasised on the label in words, pictures or
graphics, e.g. a food emphasising “with butter”
would need to have the butter quantified
•
essential to characterise and distinguish the food
from products with which it might be confused because
of its name or appearance, e.g. the composition of
marzipan, with respect to its almond content, may vary
between Member States although it is still marketed
under the same name. Marzipan should therefore have
the ‘almond’ ingredient quantified.
2
22
See below the list of ingredients for a ‘cheese and onion
quiche’ where the cheese and onion are quantified.
•
an ingredient or category of ingredient is in the name
of a food, but is in such a small quantity so as not to
affect consumers’ purchasing decisions, such as ‘malt’
in malt whiskey
•
the quantity of an ingredient or category of ingredient
is determined by Community provisions. No such
provisions exist at present
•
no ingredient or category of ingredient significantly
predominates by weight such as in a mixture of fruit
or vegetables.
INGREDIENTS:
Pasteurised Egg, Whole Milk, Wheat Flour,
Full Fat Hard Cheese (13%), Onion (12%),
Vegetable Oil and Hydrogenated Vegetable
Oil, Modified Maize Starch, Flour Treatment
Agent (L-Cysteine Hydrochloride), Salt,
Dextrose.
See below the list of ingredients for a ‘traditional
bolognese’ where the beef, pasta and tomato are
quantified as they are associated with the name
of the food.
See below the list of ingredients for cheese flavoured
nachos where the quid declaration for ‘nacho cheese
flavour’ is given as it is a flavouring present at levels
greater than 2%.
INGREDIENTS
INGREDIENTS
Beef 20%, Water, Tomato 10%, Tomato Puree,
Onion, Carrot, Celery, Modified Starch, Cooked Pasta
(Durum Wheat Semolina), Salt, Sugar, Garlic,
Oregano, Pepper, Basil
When a Quantitative Ingredient Declaration is not
required
Ingredients or categories of ingredients need not be
quantified where:
•
a solid foodstuff is presented in a liquid medium where
the liquid medium is in addition to the essential
elements of the food such as kidney beans in salt water.
In such cases, the drained net weight as well as the net
weight must be declared (see Section 2.1.5.4 on
drained net weight) and the quantity of ingredient can
be calculated from the weight indications already given
•
existing legislation already requires the quantity of an
ingredient or category of ingredients in question to be
indicated on the label. For example, Council Directive
2001/112/EC on Fruit Juices and certain similar products
requires the fruit content of a fruit nectar to be
declared such that ‘fruit content: X % minimum’
(Section 4.3 on fruit juices)
•
a small quantity of an ingredient or category of
ingredient, 2% or less at the mixing bowl stage,
is used for flavouring such as garlic in garlic bread
Maize Flour (68%) • Vegetable Oil • Nacho Cheese
Flavour (7%) (Dried Cheese • Salt • Dried Onion •
Dextrose • Dried Garlic • Acids • Tomato • Dried Yeast
• Sugar • White Pepper • Yeast Extract • Anti-Caking
Agent: E551 • Flavouring • Colours: E160(c), E100
A pictorial representation of the food as a “serving
suggestion” would not normally be regarded as giving
special emphasis and hence not require a QUID.
Serving
Suggestion
23
QUID does not apply to constituents naturally present in
foods that have not been added as ingredients such as
caffeine in coffee. In addition, QUID does not apply where
the declaration ‘with sweetener(s)’ or with ‘sugar and
sweetener(s)’ accompanies the name of a food in
accordance with Directive 96/21/EC (Section 2.1.5.11).
Similarly, no declaration of quantity is required where
vitamins and minerals are added to a food and are subject
to nutrition labelling (Section 2.3).
The quantities indicated on labelling designate the average
quantity of the ingredient or category of ingredients to be
mentioned. Average quantity means the quantity of
ingredient or category of ingredients obtained by complying
with the recipe and good manufacturing practice, allowing
for the producer’s normal manufacturing variations. The
stated quantity of an ingredient should generally be
expressed as a percentage that has been rounded to the
nearest whole number or to the nearest 0.5 decimal place
in those cases where it is below 5%.
Expression of quantity
The quantity of an ingredient is calculated on the basis of
the recipe at the moment the ingredients are added i.e. the
same method as is used for determining the order of the
list of ingredients - at the mixing bowl stage. However,
where a food has lost moisture following treatment such
as cooking, the QUID declaration should correspond to the
quantity of the ingredient in the finished product. In such
cases where the quantity of an ingredient or the total
quantity of all ingredients exceeds 100%, the QUID
declaration should be replaced by the weight of the
ingredient used to prepare 100g of finished product.
The quantity of volatile ingredients should be indicated
on the basis of their proportion by weight in the finished
product. The quantity of ingredients used in concentrated
or dehydrated form and reconstituted during manufacture
may be indicated on the basis of their proportion by weight
as recorded before their concentration or dehydration. In
the case of concentrated or dehydrated foods which are
intended to be reconstituted by the addition of water, the
quantity of the ingredients may be indicated on the basis
of their proportion by weight in the reconstituted product.
QUID declarations should relate to the ingredients as
identified in the list of ingredients. Therefore, some
ingredients will be required to be quantified in the raw
state as their names give no indication of processing and
thus imply the basic food has been used such as ‘chicken’
and ‘egg’. Other ingredients that are identified by names
that indicate they have been somehow processed should
also be quantified as used such as ‘cooked pasta’ and ‘roast
chicken’. Declarations of processed ingredients may be
supplemented with “raw equivalent” declarations, since this
would help consumers compare similar products which
have used ingredients in different forms.
2.1.5.4 Net quantity
All pre-packaged foodstuffs must be labelled with
information on the net quantity of the foodstuff i.e. its
weight or volume, which does not include the packaging
material. The net quantity must be expressed using the
metric system i.e. litres or millilitres for liquids or kilograms
or grams for solids. The use of imperial units (i.e. pounds
and ounces) in brackets and with less prominence is
permitted in addition to the net quantity in metric until
December 2009. However, imperial units must not appear
instead of the quantity in metric. Viscous foodstuffs such
as honey may be labelled by either weight or volume.
The indication of a certain type of quantity such as
minimum quantity, average quantity and nominal quantity is
required under other Community provisions. The detailed
requirements under these rules are outside the scope of this
document although a brief overview has been outlined
below.
Declaration of quantity
The quantity declaration is governed by very specific
weights and measures legislation enforced by the Legal
Metrology Service, a division of the National Standards
Authority of Ireland (NSAI). The Legal Metrology Service
is a statutory body and it exercises it functions according
to the Metrology Acts, 1980 to 1998.
The legislation governing quantity declaration is:
•
packaged Goods (Quantity Control) Act, 1980 and
•
packaged Goods (Quantity Control) Regulations,
1981 (S.I. No. 39 of 1981).
All goods sold by quantity whether pre-packaged or loose
must comply with legal requirements. A Guidance Manual
for Packers and Importers has also been produced by the
Legal Metrology Service containing detailed instructions for
implementing a suitable packing system. The guide is
available at www.nsai.ie under Legal Metrology Service.
2
Products sold in pre-packaged constant quantities, require
representative samples of a production batch to be tested
to confirm compliance with the legal requirements. The
legislation allows that the nominal quantity declared on the
package remains within certain limits.
Slight differences in tolerances are allowed depending on
whether the package is a once off (i.e. catchweight) or
produced as a result of small to large production runs of
the same declared value. The e-mark (see below), which
often follows the quantity declaration, is placed on prepackaged goods to indicate conformance to the EU
Directives regulating the average system (i.e. the contents
of each pre-package in a batch must on average be equal
to the indication on the package). The mark which consists
of a small 'e', at least 3mm high, is placed on a package in
the same field of vision as the indication of nominal
quantity and must have the form and dimensions specified
in the Regulations.
Range of sizes for pre-packaged goods
Specific requirements for the size of pre-packaged goods
(including food products) and the notices/labels to be
attached are set out in the Merchandise Marks legislation
and regulated by the Office of the Director of Consumer
Affairs (ODCA). The range of products falling under this
legislation is set out in the Principal Act (No. 10 of 1970).
Common Position (EC) No. 34/2006 has been published
with a view to adopting a Directive laying down new rules
on nominal quantities for pre-packed products. The
proposal is to abolish nominal quantities of pack sizes for
most sectors. It is, however, recognised that nominal
quantities will still need to be maintained for a limited
number of sectors and products (including wine, spirits,
coffee and white sugar). This proposal concerns only the
legislation of “ranges of sizes/quantities” and not the
metrological requirements which will be the subject of a
later Commission proposal.
For further information contact the Department of
Enterprise, Trade and Employment website www.entemp.ie
or The European Union On-Line www.europa.eu.int.
0.9
0.025
6
0.8
46
0.08
0.0
13
0.183
0.263
24
0.183
1
The e-mark, permitted under certain circumstances by this
legislation, has the effect of allowing free movement of
packages as regards quantity across the EU. Prior to
applying the e-mark packers must notify the Legal
Metrology Service.
Multipacks
The rule for weight indications on multipacks of foodstuffs
depends on whether or not the items being sold can be
sold in individual units.
Multipacks of items that can be sold individually
For multipacks containing two or more individual packs of
the same product, with the same net quantity and where
the items can be sold individually, the net quantity shall be
expressed as:
•
the net quantity of each individual pack and
•
the total number of such packs.
For example, the net quantity of a multipack containing six
of the same products weighing 125g each and where each
product may be sold individually can be expressed as ‘6 x
125g’ on the outside of the packaging. However, an
indication of these particulars is not necessary where:
Goods that are not sold in pre-packaged constant
quantities and are sold using a measuring instrument such
as fruit and vegetables must contain or have delivered the
minimum quantity stated. All offences committed through
breaches of the Acts or Regulations may be prosecuted by
the Director of Legal Metrology. Further information is
available on NSAI website www.nsai.ie under Legal
Metrology Service/Legislation.
•
the number of items in the pack and
•
at least one net quantity for one item
can be clearly seen from the outside, e.g. through clear
plastic packaging.
25
Multipacks of items not for individual sale
For multipacks containing two or more individual inner
packs that are not sold individually, the net quantity shall be
expressed as:
•
the total net quantity of the contents of the entire
package and
•
the total number of individual packs
e.g. a package containing 10 packets of crisps could be
expressed by ‘Total weight 300g. Contains 10 packs’.
10 x 27g, 270g
There are exceptions for multipacks that are not sold
individually. An indication of the total number of individual
packs is not required for:
•
two or more individually wrapped slices of cheese or
•
two or more individually wrapped pieces of sugar
confectionery, e.g. sweets
where they are required only to state the total weight
of the entire package.
Drained net weight
Where a solid food is in a liquid medium (such as
water, salt solution, sugar solution, brine, vinegar, fruit
or vegetable juices, mixtures of these or where frozen
or quick frozen) the drained net weight of the foodstuff
must be provided in addition to the net quantity. This
requirement only applies to foodstuffs that are placed in
a liquid medium where the liquid medium is in addition
to the essential elements of the foodstuff and is not the
main reason for the purchase, e.g. red kidney beans in
salted water.
However, foods placed in other mixtures such as oil, sauce
or jelly may be the reason for the purchase and as such are
not regarded as liquid media. Such mixtures do not need to
declare their drained net weight, an indication of the overall
net quantity will suffice such as sardines in tomato sauce.
2.1.5.5 Date of minimum durability
The date of minimum durability of a foodstuff is defined in
Directive 2000/13/EC as the date until which a foodstuff
retains its specific properties when properly stored. All
foods must be date marked unless exempt in legislation.
There are two types of date markings, a ‘best-before’
and a ‘use-by’ date:
•
a ‘best-before’ date is not defined under the Directive
but can be described as the date up until which the
foodstuff can reasonably be expected to retain its
optimum condition i.e. the specific properties that are
normally associated with that foodstuff. Most foods fall
into this category
•
a ‘use-by’ date is defined in the Directive is required for
foods which from a microbiological point of view are
highly perishable and are therefore likely after a short
period to constitute an immediate danger to human
health.
Exemptions from indicating the net quantity
on the label
It is not necessary to indicate the net quantity in the
case of:
•
foodstuffs that are normally sold by number, such as a
tray of apples, provided the number of items can clearly
be seen and easily counted or it is written on the label
•
foodstuffs which are less than 5gm or 5ml in weight
(except herbs and spices) and
•
foodstuffs that are subject to considerable losses in
their weight and which are sold by number (or are
weighed in the presence of the purchaser).
Sugar, cocoa and chocolate confectionery products less
than 50gm in weight are exempt from declaring the net
quantity on the label however, the remaining general
labelling rules apply (as per European Communities
(Labelling, Presentation and Advertising of Foodstuffs)
(Amendment) (No.2) Regulations, 2003 (S.I. No. 451
of 2003)).
The ‘use-by’ date declaration should only be applied to
particular foods which fulfil both criteria of being highly
perishable as well as after a short period of time pose a
danger to human health. Generally, foods that require
refrigeration to maintain their safety rather than their
quality and that have a relatively short shelf life after
manufacture would require a ‘use-by’ date. Such products
may be ready-to-eat foods or foods requiring cooking
or reheating such as meat, fish, poultry and some
dairy products.
2
26
Certain perishable food products such as margarine and
butter which do not support the growth of food poisoning
organisms would not require a ‘use-by’ date but a ‘bestbefore’ date. In addition, frozen food products require a
‘best-before’ date. However, where scientific evidence
shows that pathogens can grow in certain foods such as
E. coli O157 in apple and orange juice, such products
would require a ‘use-by’ date.
Foods that are vacuum packed or packaged in a modified
atmosphere, such as cooked ham slices that must be kept
at refrigeration temperatures for safety reasons, should
carry a ‘use-by’ date and storage instructions (see
following). In addition, pre-packaged fresh poultry meat is
required to carry a ‘use-by’ date under Council Regulation
(EC) No. 1906/90 on marketing standards for poultry meat
(Section 4.20).
The ‘use-by’ date is the date up to which the food may be
used safely i.e. consumed, cooked or processed, once it has
been stored correctly. A product with a ‘use-by’ date of the
4th August can be used safely up to midnight on the 4th
August.
The ‘use-by’ date only applies to the product in the state
in which it is purchased. For example, a ready-to-eat food
such as cooked ham should be eaten by the ‘use-by’ date.
However, certain foodstuffs require treatment by the
consumer before consumption, such as cooking fresh
poultry. In such cases, the ’use-by’ date means process or
cook by the date declared. Therefore, food should be sold
in the physical state intended by the manufacturer as this is
the physical condition of the food to which the ‘use-by’
date applies i.e. a chilled product should be sold chilled
and not frozen and vice versa.
The date of minimum durability for fresh eggs (Section
4.14) must not be more than 28 days after laying.
An indication of the date of minimum durability
is not required for:
•
fresh fruit and vegetables including potatoes which
have not been peeled, cut, treated or processed (except
for sprouting seeds and similar products such as bean
sprouts which do require a date of minimum durability)
•
wines, liqueur wines, sparkling wines, aromatised wines
and similar products obtained from fruits other than
grapes, and beverages falling within CN codes* 2206
00 91, 2206 0093 and 2206 00 99 and manufactured
grapes or grape musts
•
beverages with greater than 10% volume of alcohol
•
soft drinks, fruit juices, fruit nectars and alcoholic
beverages in individual containers greater than five litres
intended to supply mass caterers only
•
bakery products which are normally consumed
within 24 hours of manufacture such as baguettes
and cream buns
•
vinegar (including wine vinegar)
•
cooking salt (mineral and herbal salts are not included)
•
solid sugar (sucrose). This exemption does not apply
to fructose or sweeteners or mixtures of sugars
•
confectionery products consisting of mostly flavoured
or coloured sugars such as hard sweets. Toffee,
winegums and fruit jellies are not exempt
•
chewing gums or similar products
•
individual portions of ice-cream.
However, “Guidance Note 18: Determination of Product
Shelf-Life” produced by the FSAI and available at
www.fsai.ie, recommends that best practice should be the
inclusion of a date of minimum durability on the labels of
all these food products.
The date declaration
Any form of expressing the date that can be understood by
the consumer is acceptable provided that the date is shown
in the order required, the day, month and year where
appropriate, e.g. 23.09.07 or 23rd September 2007 etc.
The actual date can be separate from the terms ‘bestbefore’ and ‘use-by’, providing that the words are followed
by an indication of the location of the date stamp, e.g.
‘best-before: see lid’. However, it should be noted that the
name of the food, the date of minimum durability and the
net quantity must all appear in the same field of vision
(Section 2.1.5.1).
For ‘best-before’ declarations, the actual date of minimum
durability should be preceded by the words ‘best-before’
where the day is indicated, otherwise ‘Best-before end’
can be declared where the month or year is indicated.
* The CN (Combined Nomenclature) Code is the tariff classification system used by customs for goods within the EU.
27
The date declared depends whether the product has a short
shelf-life or a long shelf-life:
•
foods that will not keep for more than three months,
an indication of the day and month is sufficient,
e.g. ‘Best-before: 23rd January’.
•
foods that will keep for more than three months but
not more than 18 months, an indication of the month
and year is sufficient, e.g. ‘Best-before end: March
2007’ and
•
foods that will keep for more than 18 months, an
indication of the year is sufficient, e.g. ‘Best-before’
end: 2008’.
For ‘use-by’ declarations, the date of minimum durability
should be indicated by the day, month and optionally the
year, e.g. ‘Use-by 24th December’.
Any storage conditions, which need to be observed in order
for the food to retain its specific properties until the date
shown must follow the ‘use-by’ date and should follow the
‘best-before’ date if need be, e.g. keep refrigerated. These
storage conditions should be simple and clear and if strict
storage temperatures are required to maintain the products
safety, as in highly perishable foods, a maximum
temperature should be indicated so that the unopened
food lasts until the date specified, e.g. store at 3oC. If the
product is suitable for freezing, a star marking panel
(below) may be included on the label.
STORAGE INSTRUCTIONS
FOOD FREEZER
until best before date*
STAR MARKED
FROZEN FOOD
COMPARTMENT
until best before date*
1 month
1 week
ICE MAKING
COMPARTMENT
3 days
REFRIGERATOR
24 hours
* Should be -18OC or colder
Do not re-freeze after defrosting
Additional special storage instructions (Section 2.1.5.6)
and instructions for use (Section 2.1.5.9) concerning certain
practices once the packaging of the food has been opened
may also be required.
The date of minimum durability of a product depends on a
number of variables - its composition, processing method,
packaging, storage temperature, handling etc. The decision
whether a ‘best-before’ or ‘use-by’ date is required and
what that date should be is the responsibility of those
labelling the product, usually the manufacturer or packer, as
they are in the best position to assess the properties of the
food in question. “Guidance Note 18: Determination of
Product Shelf-Life” produced by the FSAI should be
consulted for further information.
There is no legal requirement against packaged foodstuffs
being offered for sale on or after their ‘best-before’ date
provided that the foodstuff still is in a fully acceptable
condition (an exception to this is fresh eggs which must be
delivered to the consumer within a maximum time limit of
21 days of laying i.e. at least seven days before their ‘bestbefore’ date). However, if out of date stock is to be sold to
the consumer, it is strongly advisable to indicate that the
foodstuffs are past their ‘best-before’ date. This may assist
in ensuring that the consumer is not misled as to the true
nature of the product which is an offence.
Foodstuffs with a ‘use-by’ date must not be offered for sale
after this date due to the possible deterioration of these
highly perishable products and the associated risk of illness
if they are consumed. Regulation (EC) No. 178/2002 sets
down general food safety requirements, according to
which, food must not be placed on the market if it is
unsafe (i.e. injurious to health or unfit for human
consumption) see Section 5.
Once labelled, pre-packaged foods must not be re-labelled
with an altered ‘use-by’ or ‘best-before’ date or re-wrapped
other than by the manufacturer.
2.1.5.6 Special storage instructions or conditions of use
The label should outline any special storage conditions to
enable the consumer to maintain the quality of the
product. Details on how the product should be stored once
the packaging is opened should be outlined such as
refrigerate after opening, store in a cool dry place. Other
options for the storage of the food can also be detailed in
order to maintain the specific properties of the opened
food such as suitable for freezing.
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28
2.1.5.7 Name and address
The label must declare the name or business name and
address of the manufacturer or packager, or of a seller
established within the Community. Following a court case
in September 1997 (the Dega Case C-83/96*) the European
Court clarified exactly what way this was to be interpreted.
The European Courts judgement declared that the
expression “established within the Community” refers only
to the seller. In other words, as regards manufacturers and
packagers, the label on the packaging may indicate details
of either one or the other, whether established within the
Community or outside the Community; and as regards the
seller, the label may only indicate details of a trader
established within the Community.
The provision of information detailing the manufacturer,
packager or seller on the label is to enable the consumer to
contact a person responsible for the foodstuffs with a view
to expressing any positive or negative criticism about the
product purchased.
This can only be achieved if the ultimate consumer can
easily identify the person responsible for the product. In
that respect, producers and packagers differ from sellers.
The former are generally established, easily identifiable
traders, meaning that the fact that they might be situated
outside the Community does not present a problem. In
contrast, sellers are generally much smaller traders and,
consequently, more difficult to identify, particularly if they
are established outside the Community.
That is why the Community legislature, for the purposes
of the rules on labelling of foodstuffs, laid down different
rules in relation to traders depending on whether they are
manufacturers or packagers, on the one hand, or sellers,
on the other.
The contact details of the manufacturer, packager or seller
must be precise enough to enable a complainant to contact
the named agent where necessary i.e. a full postal address.
A web address is not an acceptable address on its own but
could be provided in addition to the postal address.
2.1.5.8 Origin
On the label an indication of the place of origin or
provenance of the foodstuff is required only where its
absence might mislead the consumer to a material degree
as to the true origin or provenance of the foodstuff. In
other words the requirement to provide details on the place
of origin, not necessarily the country, should be indicated
where the consumer might be otherwise misled.
Consumers could be misled through pictorial
representations, such as a flag or a map of a country other
than the one in which it was produced. Consumers could
also be misled where the name given to a food or its brand
name includes a reference to a place that could imply that
the food comes from or has been made in a particular area
such as American beef burgers that were made in Ireland.
In such instances, the true place or origin should be made
clear i.e. ‘made in Ireland’. In addition, Brie cheese made in
Tipperary would have to indicate its place of origin as it is a
product normally associated with France and consumers
might be misled to believe the product comes from France
and not Ireland unless otherwise stated. In addition, the
omission of the place of origin may mislead the consumer
to a material degree where the label as a whole suggests a
food comes from another place.
The country or place of origin of a foodstuff could be
considered as the place in which it last underwent a
substantial change i.e. the country of manufacture where
processing or treatment takes place and not where the
food is grown. For example, potatoes grown in Cyprus but
processed into crisps in Ireland could bear the indication
‘Made in Ireland’.
* Judgement of 17/09/1997, Provincia autonoma di Trento and Ufficio del medico provinciale di Trento v Dega di Depretto Gino SNC (see the European Court
Reports 1997, p.1-5001)
29
Many of the rules regulating specific food commodities (i.e.
the Vertical Directives, Section 4) contain specific rules on
origin marking such as those for wine (Section 4.15), beef
(Section 4.10) and eggs (Section 4.14) and take precedence
over the general labelling rules.
With regard to the question of whether it is permissible to
use the term “Irish” or “Ireland” in respect of products
originating in Northern Ireland, this would be legitimate
because Northern Ireland is considered part of the ‘Island of
Ireland’. Therefore, it would be unrealistic to preclude the
use of the terms “Irish” and “Product of Ireland” in respect
of general products not subject to specific controls which
originate in Northern Ireland. This situation is without
prejudice to any product specific labelling requirements
which may require more detailed information such as the
beef labelling rules (Section 4.10).
There is national legislation, Health (Country of Origin of
Beef) Regulations, 2006 (S.I. No. 307 of 2006) as amended
which extend the existing beef labelling rules (Section 4.10)
to caterers. Caterers are required to provide information on
the origin of the beef served or supplied to the consumer at
the point of choice by way of clearly displayed information
on a menu, poster, blackboard or other point of sale
material.
The information required under these rules include all
countries from which the premises is sourcing its beef and
the statements of origin information must be verifiable and
be capable of linkage with the delivery records to the
establishment. The FSAI has produced an information
leaflet for caterers on these country of origin labelling
requirements and is available at
www.fsai.ie/publications/index.asp#leaflets
See below ‘American Style Burgers’ indicating ‘Produced in
Ireland’.
2.1.5.9 Instructions for use
The label must contain instructions on how to use the
product if it is necessary so the consumer can make
appropriate use of the food, e.g. cook, reheat, mix, not
suitable for frying (see following, the instructions indicated
for a packet of dried soup).
COOKING INSTRUCTIONS:
Empty the contents of this packet into a saucepan
and gradually add 850 ml (11⁄2 pints) of cold water,
stirring until blended. Bring to the boil, stirring
continuously; partially cover and simmer for
10 minutes, stirring occasionally.
The FSAI issued voluntary advice in September 1999 to
major retailers for the indication of appropriate instructions
for the cooking of pre-packaged raw minced beef and
minced beef products as a result of the risk of E .coli from
these products (see an example below).
Cook with Care
Value Stores Select provides you with very real
assurances in terms of food safety. However this
meat product may contain bacteria that could
potentially cause illness if not cooked thoroughly.
For your safety, please follow
these simple instructions
1. Store in refrigerator or freezer. Thaw in fridge
or microwave.
2. Always make sure that raw products do not
come into contact with ready to eat or cooked
products. Wash all work surfaces and utensils
thoroughly after preparing raw food.
3. Be sure to cook thoroughly until the juices
run clear.
4. Ensure hot foods are kept hot. Refrigerate
leftovers immediately.
2
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2.1.5.10 Alcoholic beverages
The labelling of alcoholic beverages containing more than
1.2% by volume of alcohol must indicate the actual
alcoholic strength by volume on the label where it is for
sale to the ultimate consumer. Commission Directive
87/250/EEC sets down the rules for the indication of
alcoholic strength as follows:
The figure of alcoholic strength should be given to not
more than one decimal place followed by the symbol ‘%
vol.’ and may be preceded by the word ‘alcohol’ or the
abbreviation ‘alc’. For example a bottle of beer could
indicate ‘alc 4.5% vol’.
Derogation from listing ingredients
Beverages that contain more then 1.2% volume of alcohol
are not required to declare their ingredients. The derogation
from the labelling of ingredients in alcoholic beverages was
set out in the original labelling Directive in 1979. This was
intended to be a temporary derogation and that rules to
this effect were to be determined at a later date. No such
rules have been prescribed to date.
Food products whose durability has been extended by
means of packaging gases must declare ‘packaged in
a protective atmosphere’ on the label (see below the
declaration ‘packaged in a protective atmosphere’
near the list of ingredients for ham slices in modified
atmosphere packaging).
Keep refrigerated. Eat within 48 hours of
opening. Packed in a protective atmosphere.
‘Modified atmosphere packing’ (MAP) is a packaging
process that is used as a food preservation method
generally for chilled products. The normal gas environment
of the food product in the packaging is altered, which
reduces the rate of respiration of fresh foods as well as the
growth of bacteria thus extending the shelf-life of the
product.
Established products packaged under MAP include many
fresh products such as red meats, pasta, ready meals, fruit
and vegetables. Packaging gases are authorised under
Council Directive 89/107/EC and its amendment Directive
95/2/EC (i.e. Additives Directives Section 3.12).
Declaration of allergens
Where an allergenic ingredient is present in an alcoholic
beverage (i.e. beverages containing more than 1.2% by
volume of alcohol) the allergenic ingredient must be
declared on the label such that ‘contains (name of
allergenic ingredient)’. This is necessary as alcoholic
beverages are not required to list their ingredients.
However, where the ingredient concerned is already
included in the list of ingredients (if given) or in the name
under which the beverage is sold such as ‘Wheat Beer’ the
declaration ‘contains (name of allergenic ingredient)’ is not
required.
2.1.5.11 Other compulsory labelling requirements
Packaging gases
Commission Directive 94/54/EEC regarding the compulsory
indication on the label of certain particulars, requires that
packaging gases that are used in the packaging of a food
must be indicated on the label so consumers understand
that the shelf-life of the product has been extended. This
enables consumers to understand why the food has a
longer shelf-life than similar products packaged differently.
Sweeteners
Foodstuffs containing a sweetener or sweeteners
(as authorised by Directive 94/35/EC) must be labelled
“with sweeteners(s)” near the name of the food
(as per Directive 96/21/EC amending Directive 94/54/EC)
(see also Section 3.12 on sweeteners).
Sugars and sweeteners
Foodstuffs containing both an added sugar or sugars and a
sweetener or sweeteners (as authorised by Directive
94/35/EC) must be labelled “with sugar(s) and
sweeteners(s)” near the name of the food (as per
Directive 96/21/EC amending Directive 94/54/EC) (see also
Section 3.12 on sweeteners).
Aspartame
Aspartame is a low-calorie sweetener used to sweeten
a wide variety of reduced-calorie foods and beverages,
including low-calorie tabletop sweeteners. Aspartame
contains phenylalanine, an essential amino acid which is
also found naturally in protein containing foods. Certain
individuals are sensitive to phenylalanine, a rare inherited
metabolic disease known as Phenylketonuria (PKU).
Foodstuffs containing aspartame must be labelled
“contains a source of phenylalanine” (as per Directive
96/21/EC amending Directive 94/54/EC) (see also Section
3.12 on sweeteners).
31
Polyols
Polyols also called sugar alcohols, are a group of low
calorie, carbohydrate-based sweeteners. Polyols have the
taste and texture of sugar with half the calories. They are
used as a food ingredient in many sugar-free and lowcalorie foods such as chewing gums and ice-cream. Foods
containing polyols have high amounts of low-digestible
carbohydrates and as such should be consumed in
moderation. Over consumption of polyol containing foods
may cause laxative effects similar to prunes, beans or
certain high-fibre foods.
Foodstuffs containing more than 10% added polyols must
be labelled “excessive consumption may produce
laxative effects” (as per Directive 96/21/EC amending
Directive 94/54/EC) (see also Section 3.12 on sweeteners).
2.1.6 Exemptions to the general labelling rules
Food for sale without pre-packaging
Each Member State can set their own rules regarding the
labelling of food for sale without pre-packaging i.e. sold
loose, packaged food for direct sale or food packaged on
the sales premises at the consumers request. In Ireland, as
in most Member States, non pre-packaged food, does not
to have comply with the labelling requirements in their
entirety.
The labelling provisions set out below for food sold without
pre-packaging are the current minimum legal requirements.
In light of the revision by the European Commission of the
labelling legislation which may prescribe tighter rules for
un-packaged food in the future and to ensure consumers
receive adequate information, the FSAI recommends
additional information be provided where foods are sold
without pre-packaging. The FSAI recommends that food
sold without pre-packaging should also detail the date of
minimum durability (Section 2.1.5.5), the presence of any
allergenic ingredients (2.1.5.2. (e)) and the species of
animal and meat content for meat products (Section
2.1.5.2 (a)).
It should be noted that other labelling requirements falling
under the Vertical Directives (Section 4) may also apply,
e.g. fresh fish sold loose over the counter need only declare
the name of the food such as Cod, on a notice nearby
according to horizontal labelling legislation. However, the
vertical legislation for fish also requires certain information
to be declared on a label or notice nearby regarding origin
(Section 4.19).
(b) Food pre-packaged for direct sale
Pre-packaged food that is packaged by a person who sells
them for retail sale on the same premises (or from a vehicle
used by that person) need only indicate the name of the
food on the label, e.g. coleslaw pre-packed into containers
on the premises need only declare the name ‘coleslaw’ on
the label.
However, where the person packaging the food sells it from
another premises owned by him/her, or onto another
business, the exemption no longer applies and the food
must be labelled in full.
(c) Pre-packaged flour confectionery for direct sale
Pre-packaged flour confectionery for sale on the premises
from which they are produced, need only indicate the
name of the food on the label, e.g. a pre-packaged
Madeira Cake baked on the premises from which it is sold
need only indicate ‘Madeira Cake’ on the label.
(d) Food pre-packaged on the sales premises at the
consumers request
Food packed on the premises at the request of the
consumer or mass caterer such as sandwiches made up at
the consumers request, need only indicate the name of the
food either on the label or displayed on a notice near the
food. This notice and the information displayed on it must
be visible, legible, indelible and not obscured in any way.
Sandwiches, rolls, soups, pizza and similar products
containing a meat ingredients are not required to declare
the species and percentage meat (see Section 2.1.5.2 (a)).
(a) Un-packaged food
(e) Other exemptions
Food without pre-packaging for sale to consumers or mass
caterers need only indicate the name of the food either on
the label or displayed on a notice near the food. This notice
and the information displayed on it must be visible, legible,
indelible and not obscured in any way. For example, fresh
cheese sold loose at a deli counter.
Individually wrapped fancy confectionery
Individually wrapped fancy confectionery not enclosed
in any further packaging and intended for sale as a single
item need only indicate the name of the product and the
name and address of the manufacturer, packer or seller on
the label. Fancy confectionery is taken to mean a product in
the form of a figure, an animal, egg etc. or in any other
fancy form.
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32
Milk in reusable glass bottles
Milk and milk products in glass bottles intended for re-use
only require the name of food, the net quantity, the date of
minimum durability and the name or business name and
address of the manufacturer or packager, or of the seller
established within the Community.
Small packages
Packaging or containers where the largest surface is less
then 10cm2 only require the name of the food, the net
quantity and the date of minimum durability. The European
Commission recommends that labelling information on
allergens should be provided on such small food packages
in addition.
Butter
Butter produced at a national level for the domestic market
need only indicate either the manufacturer, packer or seller
on the label or the creamery number.
When these Regulations do not apply
These Regulations do not apply to foods for export to
another country other than a Member State of the
European Union.
2.1.8 Competent authority
The policy functions in relation to the Directive on the
Labelling, Presentation and Advertising of Foodstuffs are
the responsibility of the Department of Health and Children.
The FSAI has the overall responsibility for the enforcement
of the European and national Regulations on labelling in
collaboration with the official agencies that work under
service contract to the FSAI according to the Food Safety
Authority of Ireland Act, 1998 (No. 29 of 1998) as
amended.
The agencies currently responsible for enforcing the
labelling requirements under the European Communities
(Labelling, Presentation and Advertising of Foodstuffs)
Regulations, 2002 to 2005 on behalf of the FSAI are:
•
Department of Agriculture, Fisheries and Food
•
Sea-Fisheries Protection Authority
•
Health Service Executive
•
Local Authorities and
•
Office of the Director of Consumer Affairs (ODCA)*.
2.2
BATCH IDENTIFICATION:
COUNCIL DIRECTIVE 89/396/EEC
2.2.1 Legislation
•
Council Directive 89/396/EEC regulates the indications
or marks identifying the lot to which a foodstuff
belongs
Amended by:
Council Directive 91/238/EEC and Council Directive
92/11/EEC.
•
European Communities (Identification of Foodstuff Lot)
2.2.2 Introduction to batch identification
This legislation sets down horizontal labelling requirements
applicable to all foods in order to establish a common lot
identification system. It’s purpose is to facilitate the
withdrawal of food from the market where the food may
constitute a health hazard to consumers.
Regulation (EC) No. 178/2002 laying down the general
principles and requirements of food law, establishing
the European Food Safety Authority and laying down
procedures in matters of food safety (see Section 5)
also sets out some traceability requirements. The FSAI
has produced ‘Guidance Note 10: Product Recall and
Traceability’ in this regard. Guidance Note 10 addresses
the main issues concerning the traceability of foodstuffs
and outlines the key considerations for a traceability
system. The guide is available at www.fsai.ie/publications
2.2.3 Labelling requirements
These regulations require an indication or mark identifying
the manufacturing lot or batch to which a foodstuff
belongs. The letter ‘L’ must precede the lot mark except
in cases where it is clearly distinguishable from the other
indications on the label.
The lot identification should appear on the label of a prepackaged food. Food that is sold without pre-packaging,
the lot number can appear on the packaging or on the
container or, failing that, on the relevant commercial
documents. The lot identification must be easily visible,
clearly legible and indelible.
* The ODCA is part of the National Consumer Agency. For further details see www.nca.ie
33
It is the responsibility of the producer, manufacturer
or packager (or the first seller established within the
Community) to determine the lot and affix the
corresponding indication. The concept of a lot implies
that several sales units of a food have almost identical
production, manufacture or packaging characteristics.
The requirements therefore do not apply to bulk products
or products which due to their diverse nature are not
considered as forming an identical batch.
The durability date can double up as a lot mark provided
it is sufficiently precise to identify a particular batch i.e. the
day and the month. An indication merely of the month
and year would not be sufficient.
2.3
NUTRITION LABELLING:
COUNCIL DIRECTIVE 90/496/EEC
2.3.1 Legislation
•
Council Directive 90/496/EEC regarding nutrition
labelling
Amended by:
Commission Directive 2003/120/EC.
•
European Communities (Nutrition Labelling For
Foodstuffs) Regulations, 2005 (S.I. No. 65 of 2005).
See below the lot ‘L 0200A’ indicated on pre-packaged tea.
2.3.2 Introduction to nutrition labelling
JUL 2002 L0200A
08.0557
These requirements do not apply to:
a) agricultural products intended for storage, preparation
or packaging stations; transported to producers'
organisations or collected for immediate integration
into an operational preparation or processing system
b) food without pre-packaging, food packaged at the
request of the purchaser or food pre-packaged for
immediate sale
c) packaging or containers, the largest side of which has
an area of less than 10cm2 or
d) to individual portions of ice cream where the indication
enabling the lot to be identified can appear on the
combined package.
Consumer awareness and interest in diet and health issues
has increased dramatically over recent years. There is a
greater demand for ‘healthy alternatives’ to certain foods as
consumers are encouraged to become more aware in what
they are eating to combat many health problems such as
obesity and heart disease.
Consumers are no longer contented with purely accepting
the food that is presented for sale, they want to know the
exact properties of the food they are purchasing and how
it was produced. Provision of nutrition information on the
label enables consumers to make more informed choices
with regard to the nutrition characteristics of the foodstuff.
Nutrition labelling is voluntary but is compulsory where
a nutrition claim is made on the label. However, if a label
carries nutrition labelling, even when it is not required,
it must comply with the Regulations.
Revision of the Nutrition Labelling Directive
The policy functions in relation to the Regulations on lot
marking are the responsibility of the Consumer Protection
Unit, Department of Enterprise, Trade and Employment.
These Regulations are enforced by the FSAI and the
Environmental Health Department of the Health Service
Executive pursuant to its service contract with the FSAI,
for the purposes of ensuring compliance with these
Regulations
Officers of the Office of the Director of Consumer Affairs
are also authorised under the Regulations to enforce its
provisions.
In 2003 the Health and Consumer Protection Directorate
General of the European Commission launched a survey, in
the form of a questionnaire, on the application of Directive
90/496/EEC on nutrition labelling and on the desirability
of revising it. The Commission prepared a report on the
application of Directive 90/496/EEC on nutrition labelling
based on the responses from the various Member States
(available at the European Union Online www.europa.eu.int
under Food Safety). The responses show that overall
Member States and stakeholders welcome a revision
of the Nutrition Labelling Directive and that the focus
should be on the simplification of nutrition labelling
legislation in order to better serve consumers.
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34
In light of this Report, the Commission pursued its
consultation on nutrition labelling on the basis of more
targeted considerations in 2004. The overall objective
for the revision will be the improvement of the existing
nutrition labelling rules in order to facilitate consumer
understanding and informed choice. The need for full
mandatory nutritional labelling is just one of the areas
being considered under this revision.
claims made on foods (see Section 2.4) specifies the
conditions for the use of nutrition and health claims and
ensures that only nutrition and health claims that are in
conformity with the labelling, presentation and advertising
requirements will be allowed on the market. To this end
only nutrition claims fulfilling specific criteria that are listed
in Appendix VIII are permitted.
In order to facilitate this revision a study has been carried
out for DG SANCO of the European Commission on the
potential impact of the introduction of mandatory nutrition
labelling for pre-packaged food products across the EU.
Work has been divided into three areas: the impact of
mandatory nutrition labelling on consumers, the food
industry and the control authorities who have the
responsibility for enforcing legislation (the report is available
at the European Union Online www.europa.eu.int under
Food Safety).
TABLE A – Vitamins and minerals which may be
declared on the label and their Recommended Daily
Allowances (RDA)
The impact assessments numerous conclusions included
that the introduction of nutrition labelling on all prepackaged foodstuffs is a potentially important element
in the overall strategy to combat obesity and noncommunicable diseases. Improving the level of information
available to consumers has (in conjunction with a spectrum
of other nutrition-related initiatives) the potential to
improve consumer understanding of different foods which
in turn would stimulate changes in patterns of food choice
and ultimately improve consumer health.
The Commission initially reviewed the technical issues in the
Directive (such as tolerances, conversion factors, definitions,
reference values etc.) in 2006 and will draft a Commission
Proposal before the end of 2007. The revision of the
nutrition labelling legislation is being carried out in tandem
with the revision of the horizontal labelling legislation (see
Section 1.2).
2.3.3 Labelling
Nutrition claims
A nutrition claim is one that states, suggests or implies that
a foodstuff has particular nutrition properties due to the
energy (i.e. the amount of calories) and/or the nutrients
(such as protein or fat) that it does or does not provide at
increased or reduced rates. Nutrition claims include the
declaration ‘low fat’ and ‘high fibre’ provided certain
conditions are met.
Vitamin/Mineral
RDA
Vitamin A
800µg
Vitamin B6
2mg
Vitamin B12
1µg
Vitamin C
60mg
Vitamin D
5µg
Vitamin E
10mg
Pantothenic Acid
6mg
Calcium
800mg
Biotin
0.15mg
Thiamin
1.4mg
Phosphorus
800mg
Riboflavin
1.6mg
Iron
14mg
Niacin
18mg
Magnesium
300mg
Zinc
15mg
Folacin
200µg
Iodine
150µg
Nutrition information
The type of nutrition claim made dictates the information
that must be given on the label. Nutrition information must
be presented in one of two formats, Group 1 or Group 2
Format, depending on the nutrient that is the subject of the
claim. All nutrient values must be stated per 100g or 100ml
of the foodstuff. Values per serving or per portion may also
be declared provided that the number of servings or
portions per packet is specified.
35
Nutrition labelling in Group 1 format must declare the
following where a nutrition claim is made for one or more
of these nutrients:
•
NUTRITION LABELLING IN GROUP 2 FORMAT
Energy value (specified numerically in kilo joules and
kilo calories)
•
Amount of protein, carbohydrate and fat (specified
numerically in grams).
NUTRITION LABELLING IN GROUP 1 FORMAT
Nutrition Information
Average Values per 100g
Energy
170kJ/40kcal
Protein
4.0g
Carbohydrate
5.3g
Fat
1.2g
See below nutrition information given in Group 1 format on
a packet of dried sauce mix.
NUTRITION INFORMATION
PER 100G
PER 190ML
SERVING
Energy
1557 kj
369 kcal
255 kj
60 kcal
Protein
9.6 g
1.6 g
Carbohydrate
62.0 g
10.2 g
Fat
9.2 g
1.5 g
Group 2 format requires nutrition information to be given
on a more extensive list of eight nutrients where a nutrition
claim is made for sugars, saturates, fibre or sodium.
Nutrition labelling in Group 2 format must declare
the following:
•
energy value (specified numerically in kilo joules and
kilo calories)
•
amount of protein, carbohydrate, sugars, fat,
saturates, fibre and sodium (specified numerically
in grams).
Per 100g
Energy
1150kJ/270kcal
Protein
13g
Carbohydrate
(of which sugars)
46g
(18g)
Fat
(of which sugars)
3.5g
(0.6g)
Fibre
29g
Sodium
0.9g
In addition, where sugar and/or polyols and/or starch
are declared the nutrient declared must be shown as a
component of carbohydrate in the nutrition table such as:
•
Carbohydrate
of which
g
•
Sugars
g
•
Polyols
g
•
Starch
g
Fatty acids are the basic units of fats and are broken into
three main categories: saturates, monounsaturates and
polyunsaturates. Where the amount of mono-unsaturates
and/or polyunsaturates and/or the cholesterol rate is given,
the total amount of saturates shall also be given.
In addition, where the amount and/or type of fatty acids
and/or cholesterol rate is declared the nutrient declared
must be shown as a component of total fats in the
nutrition table such as:
•
Fat
of which
g
•
Saturates
g
•
Monounsaturates
g
•
Polyunsaturates
g
•
Cholesterol
mg
2
36
Additional information may also be provided on the label
for amounts of one or more of the following (but the
declaration must include the nutrient which is the subject
of the nutrition claim):
•
Starch (specified numerically in grams)
•
Polyols (specified numerically in grams)
•
Monounsaturates (specified numerically in grams)
•
Polyunsaturates (specified numerically in grams)
•
Cholesterol (specified numerically in milligrams)
•
Vitamins and minerals (specified numerically in the units
indicated in Table A).
See below the nutrition information for brown sliced bread
where sugars are indicated as a component of
carbohydrate and saturates, monounsaturates and
polyunsaturates as a component of fat.
NUTRITION INFORMATION
Typical Analysis Composition per 100g, (2 Slices approx.)
Energy
Protein
Carbohydrate
of which sugars
Fat
of which saturates
mono-unsaturates
polyunsaturates
Sodium
Fibre
826kJ
8.70g
39.40g
0.32g
1.30g
0.74g
0.35g
0.21g
0.60g
5.70g
(194kcal)
Table B shows an example where nutrition information is
given on a label in Group 2 Format. In addition to the legal
requirements, additional voluntary nutrition information is
also given on vitamins, minerals and and per 40g serving.
TABLE B – Nutrition labelling in Group 2 Format
with additional non-compulsory information
Per 100g
Per serving (40g)
Energy
Protein
Carbohydrate
(of which sugars)
1150kJ/4270kcal
13g
46g
(18g)
700kJ/170kcal
9g
25g
(14g)
Fat
(of which saturates)
Fibre
Sodium
Vitamins
Vitamin D
Thiamin (B1)
Minerals
Calcium
Iron
3.5g
(0.6g)
29g
0.9g
3.5g
(1.5g)
12g
0.4g
(%RDA)
3.1µg (65)
0.9mg (65)
(%RDA)
1.3µg (25)
0.4mg (30)
340mg (45)
8.8mg (65)
300mg (45)
3.6mg (65)
Recommended Daily Allowances (RDAs) are the level
of intake of nutrients that, on the basis of scientific
knowledge, are judged to be adequate to meet the known
nutrient needs of practically all healthy people. RDAs are
generally assessed and prepared by nutritionists in individual
countries depending on the type of foods that are eaten
and subsequently the nutrients that are obtained from
these foods in individual sections of the community or the
country as a whole.
The RDA's in Table A originated from the European Council
Directive 90/496/EEC on nutrition labelling and are based
on the European population. However, in 1999, the FSAI
published “Recommended Dietary Allowances for Ireland”
based on the health of the population specifically in Ireland.
Although there are only minute differences between the
European and Irish RDA's, the RDA's contained in Table A
according to Directive 90/496/EEC must be used for
nutrition labelling purposes.
Energy value
Where nutrition information regarding the vitamin and
mineral content of a food is given on the label (whether
voluntary or a result of a claim being made) the following
information must also be provided on the label in addition
to the declaration of their quantity:
•
an indication of the percentage of the Recommended
Daily Allowance (RDA) that the vitamins and/or minerals
provide (as listed in Table A) and
•
there should be at least 15% of this RDA present in
either 100g or 100ml of the product (or 15% of this
RDA present per packet of the foodstuff where the
packet only contains a single portion).
The energy value of a food that is to be declared can be
calculated by using the conversion factors in Table C as
detailed in the Nutritional Labelling Regulations. The
conversion factor is the amount of energy (which is
measured in either kilo calories or kilo joules) obtained per
gram of the specified nutrient. For example, you get four
kilo calories of energy per gram of carbohydrate in food
whereas you get 9 kilo calories of energy per gram of fat
in food. The energy value of a nutrient is calculated by
multiplying the amount of the nutrient (in grams) present
in a food by its energy value i.e. the conversion factor.
37
Commission Directive 2003/120/EC amending Directive
90/496/EEC on nutrition labelling adds ‘salatrims 6kcal/g –
25kj/g’ to the table of conversion factors for the calculation
of energy value (Table C). Salatrims are a type of reducedcalorie fats and have been approved for use as novel food
ingredients in energy-reduced bakery products and
confectionery.
TABLE C – Nutrient Conversion Factors
kcal/g or
Carbohydrate (except polyols)
kJ/g
4
17
Polyols
2.4
10
Protein
4
17
Fat
9
37
Alcohol (ethanol)
7
29
Organic acid
3
13
Salatrims
6
25
The policy functions in relation to nutrition labelling are the
responsibility of the Food Unit, Department of Health and
Children.
Executive, pursuant to its service contract with the FSAI,
Regulations.
The Health Promotion Unit of the Department of Health
and Children has produced leaflets and further information
on nutrition and healthy eating.
2.4
NUTRITION AND HEALTH CLAIMS:
REGULATION (EC) NO. 1924/2006
2.4.1 Legislation
General requirements
In general, nutrition information on the nutrient content
of a food relates to the foodstuff before preparation
or cooking i.e. as purchased. It may, however, relate
to the product after preparation provided that sufficient
preparation instructions are given and the label clearly
states that the information relates to the food as prepared
for consumption.
The information, if space permits, must be presented
together in one place in tabular form with the numbers
aligned. If, however, there is insufficient space on the label
the information may be presented in linear form. The
labelling must be legible, indelible, in a conspicuous
location and written in English. The information may appear
in other languages, including Irish, in addition to the
English declaration if desired.
The supply of food otherwise than by sale from any
food premises, such as special offers, promotions and
give-aways, are covered by the Regulations.
Exemptions from the Nutrition Regulations
Nutrition Labelling does not apply to the following:
•
natural mineral waters (which are regulated under
EC (Natural Mineral Waters, Spring Waters and Other
Waters in Bottles or Containers) Regulations, 2005
(S.I. No. 79 of 2005) Section 4.9) and
•
food supplements (Section 3.1).
•
Corrigendum to Regulation (EC) No. 1924/2006 on
nutrition and health claims made on foods.
2.4.2 Introduction to nutrition and health claims
This Regulation was produced in response to the
proliferation of the number and type of nutrition and health
claims appearing on food labels within the Community, and
due to the divergent national measures introduced by some
Member States, to regulate their use.
The Regulation applies to all nutrition and health claims
made in commercial communications, whether in the
labelling, presentation or advertising of foods to be
delivered as such to the final consumer. It covers such
claims made on all foods, including foods for particular
nutritional uses (PARNUTS), natural mineral waters, water
intended for human consumption and food supplements.
Foods intended for supply to mass caterers (such as
restaurants, canteens etc.), unpackaged food and trade
marks construed as a nutrition or health claim also fall
under the terms of the Regulation with some exceptions
(see Section 2.4.5).
2
38
The Regulation aims to ensure that consumers receive
accurate and meaningful information while food producers
will be able to use serious and scientifically substantiated
claims as a marketing tool. According to the rules, nutrition
and health claims must not:
(a) be false, ambiguous or misleading;
(b) give rise to doubt about the safety and/or the
nutritional adequacy of other foods;
(c) encourage or condone excess consumption of a food;
(d) state, suggest or imply that a balanced and varied diet
cannot provide appropriate quantities of nutrients in
general;
(e) refer to changes in bodily functions which could give
rise to or exploit fear in the consumer, either textually
or through pictorial, graphic or symbolic
representations.
The Regulation also specifies the conditions for the use of
nutrition and health claims and ensures that only nutrition
and health claims that are in conformity with the labelling,
presentation and advertising requirements will be allowed
on the market. To this end, only nutrition claims that are
listed in Appendix VIII are permitted and all health claims
must undergo an approval and authorisation process at
European level, appear on a Community authorised list and
adhere to conditions necessary for their use.
Foods or certain categories of foods must comply with
specific nutrient profiles in order to bear nutrition or health
claims. These nutrient profiles are to be established by the
Commission by 19th January 2009 at the latest. Nutrient
profiles will particularly take account of:
•
the fat, saturated fat, trans fat, sugar and salt/sodium
content of foods bearing claims
•
the role and importance of the food and the
contribution to the diet of the general population or
certain risk groups
•
the overall composition of the food and the presence
of nutrients that have been scientifically recognised
as having an effect on health.
In general, foods placed on the market or labelled prior to
1st July 2007 which do not comply with the requirements
of this Regulation may be marketed until their expiry date
but not later than 31st July 2009. In addition, health claims
describing or referring to the role of a nutrient or other
substance in the growth, development and the functions
of the body may be made until the adoption of the
Community approved list of health claims provided that
they comply with the Regulation.
For further details on nutrition and health claims including
transition times, the authorisation process and how to
submit a claim for authorisation is available at
www.fsai.ie/industry/hn_claims/hn_intro.asp.
2.4.3 Notification of health claims
All health claims must undergo an approval and
authorisation process at European level, appear on a
Community authorised list and adhere to conditions
necessary for their use.
The authorisation procedure and the subsequent inclusion
of a health claim on a Community permitted list is
dependent upon the type of health claim being made:
a) food business operators making ‘reduction of disease
risk claims’ and ‘claims referring to children's
development and health’ are required to submit a
detailed dossier (including copies of scientific studies
that are relevant to the claim), to the FSAI for
assessment by the European Food Safety Authority
(EFSA);
b) food business operators making health claims
describing or referring:
•
to the role of a nutrient or other substance in
growth, development and the functions of the
body; or
•
to psychological and behavioural functions; or
•
slimming or weight control or reduction in the
sense of hunger or an increase in the sense of
satiety or to the reduction of the available energy
from the diet
can be authorised for inclusion on a Community
list of permitted claims under alternative procedures
where the submission of a full dossier is not required.
However, these claims must be based on generally
accepted scientific evidence and well understood by the
average consumer. Submissions can be made to the
FSAI for assessment by EFSA via the European
Commission;
39
c) the addition of claims to the Community list of
permitted claims (fulfilling the requirements for health
claims in (b) above) which are based on newly
developed scientific evidence and/or applications which
include a request for the protection of proprietary data,
shall be required to adhere to a similar but separate
approval procedure. Submissions can be made to the
FSAI for assessment by EFSA.
However, all claims referring to children’s development
and health shall be authorised in accordance with (a)
above.
2.4.5 Labelling
Nutrition and health claims are only permitted where they
adhere to certain general conditions for use, e.g. the
substance in respect of which the claim is made, must have
been shown to have beneficial nutritional or physiological
effect, as established by generally accepted scientific
evidence.
Nutrition claims
A ‘nutrition claim’ is any claim which states, suggests or
implies that a food has particular beneficial nutritional
properties due to the energy and/or the nutrients or other
substances that it does or does not provide/contain at a
reduced or increased rate.
Nutrition claims are only permitted if they are listed in
Appendix VIII. Where a nutrition claim is made, nutrition
information must be provided on the label in accordance
with Directive 90/496/EC on Nutrition Labelling (Section
2.3).
Comparative nutrition claims
A comparison may only be made between foods of the
same category, e.g. cheese, taking into consideration a
range of foods in that category. The comparison must
relate to the same quantity of food and the label must
state:
•
the difference in the quantity of a nutrient and/or
•
the energy value.
Comparative nutrition claims must compare the
composition of the food in question with a range of foods
of the same category, which do not have a composition
which allows them to bear a claim, including foods of
other brands.
Health claims
A ‘health claim’ is any claim that states, suggests or implies
that a relationship exists between a food category, a food
or one of its constituents and health. Health claims are
prohibited unless they are authorised and included in a
Community list of permitted claims and comply with the
prescribed general and specific requirements (the latter are
detailed below).
Where a health claim is made on foods (with the exception
of generic advertising) nutrition information must be
provided on the label in a ‘Group 2’ format in accordance
with Directive 90/496/EC on Nutrition Labelling (Section
2.3).
A ‘Group 2’ format requires nutrition information to be
given on the following eight nutrients (see table below):
•
energy value (specified numerically in kilo joules and
kilo calories)
•
amount of protein, carbohydrate, sugars, fat,
saturates, fibre and sodium (specified numerically
in grams).
Nutrition information
Per 100g
Energy
X KJ
X Kcal
Protein
Xg
Carbohydrate
of which sugars
Xg
Xg
Fat
of which saturates
Xg
Xg
Fibre
Xg
Sodium
Xg
2
40
Additional information may also be provided voluntarily in
this table on certain other specified nutrients (Section
2.3.3).
There are a number of restrictions on the use of certain
health claims. The following health claims are not
permitted:
However, where the amount of a substance to which a
claim relates cannot appear in the nutrition information,
according to Nutrition Labelling Directive 90/496/EC, it
must appear in the same field of vision of this nutrition
information panel respecting the requirements of the
Directive, e.g. quantities are expressed per 100g and
apply to the food as sold etc.
(a) claims which suggest that health could be affected
by not consuming the food
(b) claims which make reference to the rate or amount
of weight loss
Health claims are only permitted if the following
information is included in the labelling, or if no such
labelling exists, in the presentation and advertising:
(c) claims which make reference to recommendations of
individual doctors or health professionals and other
associations (not including recommendations of or
endorsements by national associations of medical,
nutrition or dietetic professionals and health-related
charities).
a) a statement indicating the importance of a varied and
balanced diet and a healthy lifestyle
Trade marks
b) the quantity of the food and pattern of consumption
required to obtain the claimed beneficial effect
c) where appropriate, a statement addressed to persons
who should avoid using the food, and
d) an appropriate warning for products that are likely to
present a health risk if consumed to excess.
Reference to general, non-specific benefits of the nutrient
or food for overall good health or health-related well-being
may only be made if accompanied by a specific health claim
included in one of the Community lists of authorised claims.
Trade marks, brand names etc. used in the labelling,
presentation or advertising of a food which may be
construed as a nutrition or health claim may be used
without undergoing the authorisation procedures provided
that it is accompanied by a related nutrition or health claim
in the labelling in accordance with the Regulation.
Products bearing trade marks or brand names existing
before 1st January 2005 which do not comply with this
Regulation may continue to be marketed until 19th January
2022 after which time the provisions of the Regulation will
apply.
Generic descriptors which have traditionally been used to
indicate a particular class of food or beverage such as
‘digestive’ or ‘cough drop’ which could imply an effect on
human health, may apply for a derogation from the above.
The Commission will adopt and make public, the rules
according to which such applications shall be made, so as
to ensure that the application is dealt with transparently
and within a reasonable time.
41
Unpackaged food
Food sold loose (such as fresh fruit, vegetables and bread)
to the final consumer or to mass caterers, food packed at
the point of sale at the request of the purchaser or prepackaged with a view to immediate sale must adhere to
the provisions of the Regulation with some exceptions.
However, where a health claim is made, such foods are not
required to declare nutrition information or comply with all
the specific labelling conditions.
Alcoholic beverages
Beverages containing more than 1.2% by volume of alcohol
cannot bear health claims and only the following nutrition
claims are permitted:
•
nutrition claims referring to low alcohol levels
•
the reduction of the alcohol content
•
the reduction of the energy content.
The policy functions in relation to the Regulation on
nutrition and health claims will be the responsibility
of the Food Unit, Department of Health and Children.
The Regulations will be enforced by the FSAI along with
any of named agencies pursuant to their service contract
with the FSAI the purposes of ensuring compliance with
these Regulations.
2
42
SECTION 3 – SEMI HORIZONTAL LEGISLATION
SEMI HORIZONTAL LABELLING RULES
The provisions of the horizontal labelling rules for prepackaged foodstuffs (Section 2) apply to the foodstuffs
outlined in this chapter in addition to the specific
requirements detailed in the various pieces of legislation
below unless stated otherwise.
3.1
FOOD SUPPLEMENTS
3.1.1 Legislation
•
Directive 2002/46/EC regulates food supplements
Amended by:
Directive 2006/37/EC amending Annex II to Directive
2002/46/EC as regards the inclusion of certain
substances.
•
European Communities (Food Supplements)
3.1.2 Introduction to food supplements
Food supplements are considered as foods which contain
concentrated sources of nutrients or other substances with
a nutritional or physiological effect whose purpose is to
supplement the normal diet. Food supplements falling
under these rules must be pre-packaged for sale to the
ultimate consumer and marketed in dose form such as pills,
tablets, capsules, liquids in measured doses etc.
Directive 2002/46/EC on food supplements which was
applicable from 1st August 2005 establishes harmonised
rules for the labelling of food supplements and introduces
specific rules on vitamins and minerals in food
supplements. The aim of the Directive is to harmonise the
legislation and to ensure that these products are safe and
appropriately labelled so that consumers can make
informed choices.
An adequate and varied diet can, under normal
circumstances, provide all the necessary nutrients for
normal development and maintenance of a healthy life.
However, surveys show that this ideal situation is not
being achieved for all nutrients and by all groups of the
population across the Community. In order to ensure a
high level of protection for consumers and facilitate their
choice, food supplements put on to the market must be
safe and bear adequate and appropriate labelling.
Food supplements may contain a wide range of nutrients
(i.e. vitamins and minerals) as well as other ingredients such
as amino acids, essential fatty acids, fibre and various
plants and herbal extracts. However, only certain permitted
vitamin or mineral preparations, listed in Annex II of the
Directive, may be used for the manufacture of food
supplements. The Amendment Directive 2006/37/EC
includes in this Annex, certain vitamin and mineral
substances that have been evaluated by EFSA and have
received a favourable scientific evaluation. In addition, this
amendment replaces the category heading ‘folic acid’ in
Annex II in order to take account of the inclusion of other
forms of folate. Specific rules regarding other ingredients of
food supplements will be laid down at a later stage based
on scientific data.
The trade of products containing vitamins and minerals not
listed in Annex II was prohibited from the 1st of August
2005. However, vitamin and mineral substances may be
considered for inclusion in the permitted lists in the
Directive following the evaluation of an appropriate
scientific dossier concerning the safety and bioavailability
of the individual substance. Detailed guidance on this
procedure is available at the European Union On-line
www.europa.eu.int/comm/food/food/labellingnutrition/sup
plements/index_en.htm.
Member States may, however, from 1st August 2005 until
31st December 2009 provide derogations for vitamins and
minerals and their forms not included in the Directive. Thus
ingredients not included in the Annexes to the Directive
may stay on the market if the product containing that
ingredient was on sale before 12th July 2002 and a safety
dossier on it was submitted to the European Commission
through Member States by the 12th of July 2005.
Petitioners should contact the competent authorities in the
individual Member States if they wish to obtain such
derogations (details are available at the European Union
On-line www.europa.eu.int).
Ireland will grant derogations until 31st December 2009 for
ingredients and ingredient sources on application to the
FSAI as long as they do not pose a risk to public health in
Ireland. This occurs only where a safety dossier has been
submitted to the FSAI (or to the relevant authority of
another EU Member State) and this dossier has been
forwarded to EFSA.
43
SECTION 3 SEMI HORIZONTAL LEGISLATION
The FSAI has granted derogations for a number of
ingredient sources to date thus allowing them to continue
to be used in food supplements. These ingredients (used by
any operator) are allowed to remain on the market until
31st December 2009 providing EFSA has not given an
unfavourable opinion. (Further information on ingredient
dossiers is available at www.fsai.ie/legislation/food_supp).
Food supplement or a medicine?
Under certain circumstances a product containing vitamins
and/or minerals can come within the terms of medicinal
product legislation by virtue of its composition,
concentration, labelling, presentation and/or medicinal
claims (see Section 2.1.4.4). ‘Medicinal’ products fall under
the jurisdiction of the Irish Medicines Board (IMB) and
hence Directive 2002/46/EC on food supplements will not
apply (see also www.imb.ie). Similarly, Directive 2002/46/EC
will not apply to products falling under definitions in other
food categories such as foods for particular nutritional uses
(Section 3.2) and foods for special medical purposes
(Section 3.5).
3.1.3 Labelling
‘Food supplement’ is the prescribed name for products sold
under this Directive. The labelling, presentation and
advertising must not attribute to food supplements the
property of preventing, treating or curing a human disease,
or refer to such properties (i.e. making a medicinal claim).
In addition to the labelling requirements of Directive
2000/13/EC (Section 2.1), the label of a ‘food supplement’
must declare:
(a) the names of the categories of nutrients or substances
that characterise the product or an indication of the
nature of those nutrients or substances
(b) the portion of the product recommended for daily
consumption
(c) a warning not to exceed the stated recommended daily
dose
(d) a statement to the effect that food supplements should
not be used as a substitute for a varied diet
(e) a statement to the effect that the products should be
stored out of the reach of young children.
The labelling, presentation and advertising of food
supplements must not state or imply that a balanced and
varied diet cannot provide appropriate quantities of
nutrients in general.
The amount of the nutrients or substances with a
nutritional or physiological effect present in the product
must be declared on the labelling in numerical form (the
units to be used for vitamins and minerals are specified in
Annex I of the Directive). The amounts of the nutrients
or other substances shall be declared per portion of the
product as recommended for daily consumption on the
labelling. These declared values are the average values
based on the manufacturers’ analysis of the product.
In addition, the percentage of the Recommended Daily
Allowance (RDA) shall also be declared for vitamins and
minerals as per the Nutrition Labelling Directive 90/496/EEC
(Section 2.3). However, the Nutrition Labelling Directive
90/496/EC itself does not apply to food supplements.
This percentage may also be given in graphical form.
Notification of food supplements
To facilitate efficient monitoring of food supplements,
Member States may require the manufacturer or the person
placing the product on the market to notify the competent
authority in their territory. In Ireland, the FSAI must be
notified where food supplements are manufactured in or
are imported into Ireland and are being placed on the Irish
market for the first time. The provision of supplementary
material, such as the labelling of the product, marketing
material and certificates proving the products/ingredients
are fit for human consumption may also be required.
Reformulated products must also be notified.
The FSAI has developed a form that manufacturers
and importers may use to help them with their notification
and is available on the FSAI website
www.fsai.ie/legislation/notif_forms/food_supp_not_form.pdf.
The policy functions in relation to the Regulations on food
supplements are the responsibility of the Food Unit,
Department of Health and Children.
Regulations.
3
44
3.2
FOODS FOR PARTICULAR
NUTRITIONAL USES
(DIETETIC FOODS)
Framework Directive and its daughter Directives
3.2.1 Legislation
The Framework Directive 89/398/EEC and its amendments
lists the following groups of dietary foods for which specific
rules shall be set out by Commission Directives:
•
Council Directive 89/398/EEC regarding food intended
for particular nutritional uses
infant formulae and follow-on formulae (Commission
Directive 2006/141/EC, see Section 3.3)
•
Amended by:
Directive 96/84/EC, Directive 1999/41/EC and
Regulation (EC) No. 1882/2003.
processed cereal-based foods and baby foods for
infants and young children (Commission Directive
2006/125/EC, see Section 3.4)
•
Commission Directive 2001/15/EC on substances that
may be added for specific nutritional purposes in foods
for particular nutritional uses
food intended for use in energy-restricted diets for
weight reduction (Commission Directive 96/8/EC,
see Section 3.6)
•
dietary foods for special medical purposes (Commission
Directive 1999/21/EC, see Section 3.5)
•
foods intended to meet the expenditure of intense
muscular effort, especially for sports people*.
•
•
Amended by:
Directive 2004/5/EC, Directive 2004/6/EC and Directive
2006/34/EC.
•
European Communities (Foodstuffs Intended for
Particular Nutritional Uses) Regulations, 2005
(S.I. No. 66 of 2005).
3.2.2 Introduction to dietetic foods
Foodstuffs intended to satisfy particular nutritional
requirements of specific groups of the population are called
"foods for particular nutritional uses", "dietetic foods" or
"dietary foods”. Directive 89/398/EEC and its amendments
sets out a framework of rules for the composition,
marketing and labelling requirements of dietetic foods,
including measures to ensure the appropriate use of such
foods and to exclude any risk to human health.
Foods intended for particular nutritional uses are clearly
distinguishable from foods for normal consumption owing
to their special composition or manufacturing process
which are suitable for their claimed nutritional purposes
and which are marketed in such a way as to indicate their
suitability. Such foods are only permitted for retail sale in
pre-packaged form where the packaging completely covers
the food. Foods for particular nutritional uses must comply
with the provisions applicable to foods for normal
consumption in addition to the provisions of these
Regulations.
The 2005 Regulations gives effect to all of the above
Directives and revokes the European Communities
(Foodstuffs Intended for Particular Nutritional Uses)
Regulations 2002 (S.I. No. 379 of 2002) and its amendment
(S.I. No. 441 of 2002).
These specific Directives (commonly called the daughter
Directives) detail specific provisions including certain
labelling requirements for each group of food for particular
nutritional uses.
It is intended that a specific Directive be laid down to
detail specific provisions for foods intended to meet the
expenditure of intense muscular effort, especially for sports
people. There is a wide range of products marketed
as foods for sports people. Those products range from
products intended for competition athletes to consumers
making occasional intense muscular effort through sport
and other related activities. A Commission proposal has
been produced and includes definitions, specific labelling
rules and where necessary and scientifically possible,
compositional criteria. The former Scientific Committee
for Food adopted a report on the subject (available at
www.europa.eu.int) which forms the basis for the
technical provisions in the proposal.
Substances added to foods for particular
nutritional uses
The nutritional substances that can be added to foods for
particular nutritional uses are controlled through positive
lists included in Commission Directive 2001/15/EC and its
amendments. These lists were based on the scientific advice
of the former Scientific Committee for Food (SCF) and apply
to all dietary food groups that are covered by the
Framework Directive 89/398/EEC.
*Foods intended to meet the expenditure of intense muscular effort, especially for sports people.
45
The chemical substances which may be used in the
manufacture of foodstuffs for particular nutritional uses
includes vitamins, minerals, amino acids, carnitine, taurine,
nucleotides, choline and inositol. These chemical substances
have been selected on the basis of their safety, their
availability for use by humans and their organoleptic
and technological properties.
The specific daughter Directives, such as dietary foods for
special medical purposes, details the specific labelling
requirements for that particular category of food. In
addition to the labelling requirements under their own
specific legislation and the general labelling legislation
(Section 2.1) these foods must also detail the following
on the label:
The specific daughter Directives such as infant formulae,
follow-on formulae and weaning foods also include lists
of nutritional substances that may be added to these
particular foods.
1. Products fulfilling the nutritional requirements of
individuals in classes 1 and 2 must declare:
Additional substances may be considered for inclusion
in these lists based on the evaluation of an appropriate
scientific dossier concerning the safety and bioavailability
of the individual substance. Further details are available
at the European Union On-line www.europa.eu.int.
3.2.3 Labelling
Foods for particular nutritional uses must fulfil the particular
nutritional requirements for the following classes of
individuals:
In addition, the labelling, presentation and advertising
of foods for particular nutritional uses must not attribute
properties for the prevention, treatment or cure of human
disease or imply such properties.
•
an indication of its particular characteristics.
•
the designation under which the product is sold and
•
a reference to the purpose for which it is intended.
Foods that have no specific Directives governing them
(but are specifically manufactured for individuals in class
1 or 2) must detail the following provisions on the label:
•
the composition or special manufacturing process
of the foodstuff that enables it to fulfil its particular
nutritional purpose
•
the amount of carbohydrate, protein and fat (per 100g
or 100ml) of the food as marketed and where
appropriate, as consumed and
•
the available energy value (in kilo joules or kilocalories
per 100g or 100ml) of the food as marketed and where
appropriate, as consumed.
3. infants or young children in good health.
The term ‘dietetic’ and ‘dietary’ may be used in the
labelling, advertising or presentation of foods to describe
foodstuffs for groups of individuals in classes 1 and 2
above. However, the use of these terms or other similar
words is prohibited where the foods are for normal
consumption i.e. where they have not been specifically
manufactured for the individuals needs.
the designation under which the product is sold and
2. Products fulfilling the nutritional requirements of
individuals in class 3 must declare:
1. persons where their digestive metabolism is disturbed
or
2. persons with special physiological conditions requiring
controlled consumption of certain substances or
•
However, if the energy value of the food is less than 50kJ
(12kcals) per 100g or 100ml these particulars may be
replaced by the statement ‘energy value less than 50kJ
(or 12kcals) per 100g (or 100ml)’.
Notification of foods for particular nutritional uses
The FSAI must be notified before a food for a particular
nutritional use is placed on the Irish market for the first
time. The duty to notify falls on the manufacturer if the
product is manufactured in Ireland and on the importer
if the product is imported into Ireland. The notification
process requires that a notification form be completed
and a sample label of the product along with any
associated documentation supporting the use of this
product be submitted to the FSAI. The notification form can
be found at www.fsai.ie/legislation/notif_forms/index.asp
3
46
The policy functions in relation to the Regulations on foods
intended for particular nutritional uses are the responsibility
Executive, pursuant to its service contract with the FSAI
Regulations.
3.3
INFANT FORMULAE AND
FOLLOW-ON FORMULAE
3.3.1 Legislation
•
and follow-on formulae.
•
European Communities (Infant Formulae and Follow-on
Formulae) Regulations, 2004 (S.I. No. 242 of 2004)
•
European Communities (Infant Formulae and Follow-On
Formulae) (Amendment) Regulations, 2007 (S.I. No. 242
of 2007).
3.3.2 Introduction to infant formulae
and follow-on formulae
Infant formulae are breast milk substitutes suitable for use
by infants during the first months of life as the sole source
of nourishment. Follow-on formulae are products which
may be used when complementary feeding is introduced
and constitute the principal liquid element of a
progressively diversified diet.
Directive 2006/141/EC on infant formulae and follow-on
formulae is a daughter Directive to Council Directive
89/398/EEC on foodstuffs intended for particular nutritional
uses (Section 3.2). Directive 2006/141/EC sets out
compositional, labelling and some presentation and
advertising requirements for infant formulae and follow-on
formulae intended for infants in good health. Commission
Directive 2006/141/EC on infant formulae and follow-on
formulae repeals and replaces the previous Directive
91/321/EEC and its many amendments from 1st January
2008 in the interests of clarity.
The recast Directive 2006/141/EC also takes account
of the latest scientific advice on compositional requirements
for infant formulae and follow-on formulae as well as
international developments, such as within Codex
Alimentarius, in relation to the timing of the introduction
of complementary foods into the diet of infants. In
addition, in order to provide better protection for the
health of infants, the rules on composition, labelling and
advertising give due regard to the principals and the aims
of the International Code of Marketing of Breast milk
Substitutes.
Commission Directive 2006/141/EC also amends
Commission Directive 1999/21/EC on dietary foods for
special medical purposes as regards as regards the
minimum level of manganese in foods intended for infants
(Section 3.5).
The Annexes of the Directive set criteria for the composition
of infant formulae and follow-on formulae (such as protein,
carbohydrate, fat) including, where necessary, minimum
and maximum levels.
Infant formulae and follow-on formulae must be labelled
in such a way that it enables consumers to make a clear
distinction between these products so as to avoid any
risk of confusion between infant formulae and follow-on
formulae. The FSAI has produced a leaflet on the
‘Marketing of Infant Formulae and Follow-on Formulae’
and is available at www.fsai.ie/publications.
3.3.3 Labelling: infant formulae
The labelling of infant formulae shall be designed to
provide the necessary information about the appropriate
use of the products so as not to discourage breast-feeding.
The use of the terms ‘humanised’, ‘maternalised’, ‘adapted’
or similar terms are prohibited.
The labelling should not include pictures of infants or other
pictures or text which may idealise the use of the product.
It may however, have graphic representations for easy
identification of the product and for illustrating methods of
preparation.
The designated name under which the products are sold
shall be ‘infant formula’. Where the products are
manufactured entirely from cows milk proteins the name
under which the products are sold shall be ‘infant milk’.
47
In addition to the labelling requirements for foodstuffs
intended for particular nutritional uses (Section 3.2) the
following information must appear on the label of infant
formulae:
•
a statement to the effect that the product is suitable
for particular nutritional use by infants from birth when
they are not breastfed
•
the energy value (in kJ and kcal) per 100ml of the
product ready for use
•
the content of proteins, carbohydrate and fat
expressed in numerical form per 100ml of the
•
the average quantity of each vitamin and mineral
expressed in numerical form per 100ml of the product
ready for use
•
the average quantity of choline, inositol and carnitine
expressed in numerical form per 100ml of the product
ready for use where applicable
•
instructions for appropriate preparation, storage and
disposal of the product
•
a warning regarding the health hazards of inappropriate
preparation and storage
•
a statement preceded by the words ‘Important Notice’
regarding:
(i) the superiority of breastfeeding and
(ii) a recommendation that the product be used only
on the advice of independent persons having
qualifications in medicine, pharmacy, nutrition
or similar.
The labelling of infant formulae may bear nutrition and
health claims outlined below in accordance with the
appropriate conditions for their use.
Nutrition and health claims for infant formulae
and conditions warranting a corresponding claim:
1. Nutrition Claims
Nutrition claim
related to:
Conditions warranting
the nutrition claim:
Lactose only
Lactose is the only
carbohydrate present.
Lactose free
Lactose content is not
greater than 2.5mg/100kJ
(10mg/100kcal).
Added LCP or an
equivalent nutrition claim
related to the addition
of docosahexaenoic acid
The docosahexaenoic
acid content is not less
than 0.2% of the total fatty
acid content.
Nutrition claims on the
addition of the following
optional ingredients:
Taurine
Voluntarily added at a level
that would be appropriate
for the intended particular
use by infants and in
accordance with the
conditions set out in Annex I
of Directive 2006/141/EC.
Fructo-oligosaccharides and As above
galacto-oligosaccharides
Nucleotides
As above
3
48
2. Health claims (including reduction
of disease risk claims)
Nutrition claim
related to:
Conditions warranting
the health claim:
Reduction of risk to allergy (a) objective and scientifically
to milk proteins. This health
verified data as proof
claim may include terms
to the claimed properties
referring to reduced
must be available
allergen or reduced
antigen properties.
(b) the infant formulae
shall satisfy the provisions
set out in point 2.2 of
Annex I of the Directive
and the amount of
immunoreactive protein
measured with methods
generally acceptable as
appropriate shall be less
than 1% of nitrogen
containing substances in
the formulae
(c) the label shall indicate
that the product must not
be consumed by infants
allergic to the intact
proteins from which it is
manufactured unless
generally accepted clinical
tests provide proof of the
infant formulae’s
tolerance in more than
90% of infants
(confidence interval 95%)
hypersensitive to proteins
from which the
hydrolysate is
manufactured
(d) the infant formulae
administered orally must
not induce sensitisation,
in animals, to the intact
proteins from which the
infant formulae are
manufactured.
In addition, the label may bear an indication of the average
quantity of certain nutrients listed in Annex III of the
Directive (not already declared) expressed in numerical
form, per 100ml of the product ready for use.
The following requirements, as outlined above, also apply
to the presentation of the products concerned (such as
their shape, appearance, packaging, display) and to
advertising:
•
information about the appropriate use of the products
so as not to discourage breastfeeding
•
the prohibition regarding the use of the terms
‘humanised’, ‘maternalised’, ‘adapted’ or similar terms
•
the requirements detailed under the ‘Important Notice’
•
graphics or text which may idealise the use of the
product
•
nutrition and health claims and their condition for use
and
•
the labelling of infant formulae and follow-on formulae
in such a way as to enable consumers to make a clear
distinction between the products.
3.3.4 Labelling: follow-on formulae
The labelling of follow-on formulae shall be designed to
provide the necessary information about the appropriate
use of the products so as not to discourage breastfeeding.
The use of the terms ‘humanised’, ‘maternalised’, ‘adapted’
or similar terms are prohibited.
The designated name under which the products are sold
shall be ‘follow-on formula’. Where the products are
manufactured entirely from cows milk proteins the name
under which the products are sold shall be ‘follow-on
milk’.
intended for particular nutritional uses (Section 3.2),
the following information must appear on the label of
follow-on formulae:
•
a statement that:
–
the product is suitable only for particular nutritional
use by infants over the age of six months
–
it should form only part of a diversified diet
–
it is not to be used as a substitute for breast milk
during the first six months of life
–
the decision to begin complementary feeding,
including any exception to six months of age,
should be made only on the advice of independent
persons having suitable qualifications based on the
individual infants specific needs.
49
•
the energy value (in kJ or kcal) per 100ml of the
•
the content of proteins, carbohydrate and fat in
numerical form per 100ml of the product as ready
for use
3.4
PROCESSED CEREAL-BASED FOODS
AND BABY FOODS FOR INFANTS
AND YOUNG CHILDREN
3.4.1 Legislation
•
•
the average quantity of each vitamin and mineral in
numerical form per 100ml of the product as ready
for use
the average quantity of choline, inositol and carnitine in
numerical form, in 100ml of the product ready for use,
where applicable
•
instructions for appropriate preparation, storage and
disposal of the product
•
a warning regarding the health hazards of inappropriate
preparation and storage.
In addition, the label may bear an indication of:
•
the average quantity of certain nutrients listed in Annex
III of the Directive (not already declared) expressed in
numerical form, per 100ml of the product ready for
use and
•
in addition to numerical information, information on
vitamins and minerals included in Annex VII of the
Directive, expressed as a percentage of the reference
values per 100 ml of the product ready for use.
The policy functions in relation to the Regulations on infant
formulae and follow-on formulae are the responsibility of
the Food Unit, Department of Health and Children.
following agencies, pursuant to its service contract with the
FSAI, for the purposes of ensuring compliance with these
Regulations:
•
Executive
•
Department of Agriculture, Fisheries and Food.
•
Commission Directive 2006/125/EC on processed cerealbased foods and baby foods for infants and young
children.
•
European Communities (Processed cereal-based foods
and baby foods for infants and young children)
3.4.1 Introduction to baby foods and weaning foods
Processed cereal-based foods and other baby foods are
specifically intended for infants and young children as they
progress onto a mixed family diet. Cereal-based foods and
baby foods for infants and young children are used as part
of a diversified diet and do not constitute the sole source of
nourishment of infants and young children. The essential
composition of the products must be appropriate for the
nutritional requirements of infants and young children in
good health.
Directive 2006/125/EC is a daughter Directive to Council
Directive 89/398/EEC on foodstuffs intended for particular
nutritional uses (Section 3.2). Commission Directive
2006/125/EC sets rules on the composition and labelling
of processed-cereal based foods and other baby foods. The
Annexes to the Directive set criteria for the composition of
weaning foods including, where necessary, minimum and
maximum levels following relevant scientific advice.
Commission Directive 2006/125/EC on processed cerealbased foods and baby foods for infants and young children
repeals and replaces the previous Directive 96/5/EC and its
many amendments in the interests of clarity and rationality.
The 2004 Regulation gives effect to the previous Directive
96/5/EC and its amendments and will be replaced in due
course in order to implement the terms of the new
Directive 2006/141/EC.
3
50
These rules cover foodstuffs that are intended for use by
infants while they are being weaned, by young children as
a supplement to their diet as well as for their progressive
adaptation to ordinary food. Such foodstuffs are divided
into the following groups:
•
the available energy value (in kilojoules and kilocalories)
and the protein, carbohydrate and fat content
expressed in numerical form per 100g or 100ml of the
product as sold and where appropriate as consumed
•
the average quantity of each of the specified vitamins
and minerals as listed Annex I and Annex II of the
Directive, in numerical form per 100g or 100ml of the
product as sold and where appropriate as consumed
and
•
instructions for the appropriate preparation of the
product when necessary and a statement regarding the
importance of following those instructions.
a) processed cereal-based foods:
•
simple cereals (which are reconstituted using milk or
other nutritious liquids)
•
cereals with an added high protein food (which are
reconstituted using water or other protein free
liquids)
•
pastas (for use after cooking in boiling water or
other appropriate liquids)
•
rusks and biscuits (which are used directly or
pulverised after the addition of suitable liquids) and
In addition, the label may declare:
•
the average quantity of certain nutrients listed in Annex
IV of the Directive (not already declared) in numerical
form per 100g or 100ml of the product as sold and
where appropriate as consumed and
•
in addition to numerical information, information on
vitamins and minerals listed in Annex V of the Directive
expressed as a percentage of their reference values per
100g or 100ml of the product as sold and where
appropriate as consumed, provided that the quantities
present are at least equal to 15% of the reference
values.
b) baby foods.
The rules relate to products such as cereals and
preparations including meat, poultry, fish, vegetables and
fruits that may be introduced as part of the weaning diet of
the infant and young child. The composition and labelling
of these products are tightly regulated. The Directive does
not apply to milks intended for young children.
Under the Regulations infants are children under the age of
12 months and young children are children aged between
one and three years.
The Annexes of the Directive set criteria for the composition
of processed cereal-based foods and baby foods (such as
protein, carbohydrate, fat) including, where necessary,
minimum and maximum levels.
3.4.2 Labelling
In addition to the requirements for foodstuffs intended for
particular nutritional uses (Section 3.2) the label must state
the following:
•
a statement regarding the appropriate age from which
the product may be used depending on its properties
however, this must not be less than four months for
any product. Products recommended for use from the
age of four months may indicate that they are suitable
from that age unless advised otherwise by a relevant
professional
•
the presence or absence of gluten if the specified age
from which the product may be used is less than six
months
The policy functions in relation to the Regulations on
processed cereal-based foods and baby foods for infants
and young children are the responsibility of the Food Unit,
Executive, pursuant to its service contract with the FSAI, for
the purposes of ensuring compliance with these
Regulations.
51
3.5
DIETARY FOODS FOR SPECIAL
MEDICAL PURPOSES
3.5.1 Legislation
3.5.3 Labelling
The prescribed name under which a dietary food for special
medical purposes is sold is ‘Food(s) for special medical
purposes’.
•
Commission Directive 1999/21/EC on dietary foods for
special medical purposes
Amended by:
and follow-on formulae.
following must appear on the label of dietary foods for
special medical purposes:
•
the energy value (in kJ and kcal) and the protein,
carbohydrate and fat content in numerical form per
100g or 100ml of the product as sold and where
appropriate as ready for use in accordance with the
manufacturers instructions. This information may be
provided per serving in addition provided the number
of servings is also indicated on the label
•
the quantity of each vitamin and mineral (as listed in
the Annex of the Directive) in numerical form per 100g
or 100ml of the product as sold and where appropriate
as ready for use in accordance with the manufacturers
instructions. This information may be provided per
serving in addition provided the number of servings
is also indicated on the label
•
European Communities (Dietary Foods for Special
2001)
•
European Communities (Dietary Foods for Special
Medical Purposes) (Amendment) Regulations, 2007 (S.I.
No. 241 of 2007).
3.5.2 Introduction to dietary foods for special
medical purposes
Dietary foods for special medical purposes are specially
formulated processed foods intended for the dietary
management of diseases, disorders or medical conditions
of individuals who are being treated under medical
supervision. Directive 1999/21/EC is a daughter Directive
of Council Directive 89/398/EEC on foodstuffs intended
for particular nutritional uses and lays down compositional
and labelling provisions for dietary foods for special medical
purposes. Commission Directive 2001/15/EC as amended,
sets out detailed rules on the sources of certain nutritional
substances that may be used in foods for special medical
purposes (Section 3.2).
Dietary foods for special medical purposes are specifically
defined in the Regulations and can only be marketed as
such if they comply with rules such as the compositional
requirements laid down in the Annex to the Directive.
and follow-on formulae amends Commission Directive
1999/21/EC as regards as regards the minimum level of
manganese in foods intended for infants (Section 3.3).
•
the content of components of protein (such as amino
acids), carbohydrate (such as starch or fibre), fat (such
as saturates) and/or other nutrients where their
declaration is necessary for the appropriate intended
use of the product. Where appropriate this information
should be declared in numerical form per 100g or
100ml of the product as sold and where appropriate
as ready for use in accordance with the manufacturers
instructions. This information may be provided per
serving in addition provided the number of servings
is also indicated on the label
•
information on the osmolarity (i.e. the measure
of the osmotic pressure) or osmolality (i.e. the solute
concentration) of the product where appropriate and
•
information on the origin and the nature of the proteins
in the product where appropriate.
3
52
The label shall also declare the following preceded by the
words ‘important notice’:
•
a statement that the product must be used under
medical supervision
•
a statement whether the product is suitable for use as
the sole source of nourishment
•
a statement that the product is intended for a specific
age group and
•
a statement that the product poses a health hazard
when consumed by persons who do not have the
disease, disorders or medical conditions for which
the product is intended.
The label shall also declare the following:
•
•
the words ‘For the dietary management of ………’
where the disease, disorders or medical conditions for
which the product is intended should be inserted
a statement concerning adequate precautions and
contra-indications
•
a description of the properties and/or characteristics
that make the product useful such as the nutrients
that have been increased, reduced or eliminated and
•
a warning that the product is not for parenteral
(intravenous) use where appropriate.
The label must also provide instructions for the preparation,
the use and the storage of the product after the opening
of the container.
Notification of Dietary Foods for Special Medical
Purposes
Notification of dietary foods for special medical purposes is
a statutory requirement under the Directive. The FSAI must
be notified where a food for special medical purposes is
placed on the Irish market. The duty to notify falls on the
manufacturer if the product is manufactured in Ireland and
on the importer if the product is imported into Ireland.
The FSAI has produced Guidance Note 19: The
Notification of Dietary Foods for Special Medical Purposes
under the European Communities (Foods for Special
2001). This guide and the notification forms are available
on the FSAI’s website www.fsai.ie.
The policy functions in relation to the Regulations on foods
for special medical purposes are the responsibility of the
Food Unit, Department of Health and Children.
Regulations.
3.6
FOODS INTENDED FOR USE IN
ENERGY-RESTRICTED DIETS FOR
WEIGHT REDUCTION
3.6.1 Legislation
•
Commission Directive 96/8/EC on foods intended for
use in energy-restricted diets for weight reduction.
•
European Communities (Foods Intended for Use in
Energy-Restricted Diets for Weight Reduction)
3.6.2 Introduction to foods intended for use in
energy-restricted diets for weight reduction
Directive 96/8/EC is a daughter Directive to the Framework
Directive 89/398/EEC on foodstuffs intended for particular
nutritional uses (Section 3.2) and specifies compositional
and labelling requirements for foods specially manufactured
for energy restricted diets intended to replace part or whole
of the daily diet. The compositional criteria include energy,
protein quantity and quality, fat quantity and type,
minimum and maximum levels for dietary fibre and
minimum levels for certain vitamins and minerals based on
the advice of the former Scientific Committee for Food. The
sources of nutritional substances that can be used in these
products are given in Commission Directive 2001/15/EC
(Section 3.2).
These specially formulated energy reduced foods are
divided into two categories:
•
products to replace the whole daily diet and
•
products to replace one or more meals of the daily diet.
53
3.6.3 Labelling
label must bear the following indications:
•
•
•
•
•
•
2. For products replacing one or more meals of the daily
diet, the label must contain:
the name under which the product is sold. For products
replacing the whole daily diet, the specified name is
‘Total diet replacement for weight control’ and
for products replacing one or more meals a day the
specified name is ‘Meal replacement for weight
control’,
the energy value (in kJ and kcals) and the quantity
of protein, carbohydrate and fat in numerical form,
per specified quantity of the product ready for use as
proposed for consumption
the average quantity of the vitamins and minerals listed
in the Regulations, in numerical form, per specified
quantity of the product ready for use as proposed for
consumption
instructions for the appropriate preparation
of the product and where necessary a statement
as to the importance of following those instructions
if the product provides a daily intake of polyols
greater than 20g per day when used according to
the manufacturers instructions, a statement shall be
provided that the food may have a laxative effect and
a statement regarding the importance of maintaining
an adequate daily fluid intake.
In addition to the labelling requirements above:
1. Products replacing the whole daily diet must be
contained in the same package and the label must
contain a statement that the product:
•
provides adequate amounts of all essential nutrients
for the day and
•
should not be used for more than three weeks
without medical advice.
•
a statement that the products are useful for the
intended use only as part of an energy-restricted
diet
•
a statement that other foodstuffs are necessary as
part of the diet and
•
the quantity of certain vitamins and minerals listed
in the Regulations expressed as a percentage of
their reference values (or RDA) (as given in Directive
90/496/EC on nutritional labelling Section 2.3).
The labelling, advertising and presentation of the products
concerned shall not make any reference to:
•
the rate or amount of weight loss that may result from
their use or
•
to a reduction in the sense of hunger or
•
an increase in the sense of satiety.
foods for use in energy restricted diets are the responsibility
Regulations.
3
54
3.7
FOODSTUFFS TREATED
WITH IONISING IRRADIATION
3.7.1 Legislation
•
Council Directive 1999/2/EC concerning foods and food
ingredients treated with ionising radiation
•
Council Directive 1999/3/EC establishing a Community
list of food and food ingredients treated with ionising
radiation.
•
European Communities (Foodstuffs Treated with
Ionising Irradiation) Regulations, 2000 (S.I. No. 297
of 2000).
3.7.2 Introduction to ionising radiation
Irradiation is a physical treatment of food with high-energy
ionising radiation. It can be used to prolong the shelf-life of
food products and/or to reduce health hazards associated
with certain foods due to contamination with pests or
pathogenic microorganisms. The legislation applies to the
manufacture, marketing and importation of food and food
ingredients treated with ionising radiation.
Directive 1999/2/EC is the Framework Directive and covers
the general and technical aspects for carrying out the
irradiation process, labelling of irradiated foods and
conditions for authorising food irradiation. The Directive
stipulates that the treatment with ionising radiation
of a specific food item may only be authorised if:
•
there is a reasonable technological need
•
it presents no health hazard and is carried out under
the conditions proposed
•
it is of benefit to the consumer
•
it is not used as a substitute for hygiene and health
practices or for good manufacturing or agricultural
practice.
Directive 1999/3/EC is the implementing Directive and
specifically provides an EU list of foodstuffs that may be
treated with ionising radiation and the maximum dose
allowed. To date, only a single food category is listed on
this EU-wide positive list for irradiation treatment: ‘dried
aromatic herbs, spices and vegetable seasonings’. The
permitted maximum overall average absorbed dose is
10kiloGray (kGy).
However, Member States may continue to irradiate
particular foods that had national authorisations prior to
implementation of this Directive. For example, the UK had
authorised that potatoes can be treated with ionising
radiation up to maximum of 0.2kGy. Member States may
also retain existing restrictions or bans on irradiated foods
not on the EU-authorised list.
A requirement was introduced in Directive 1999/2/EC
that the Commission should forward a proposal to
complete this Community positive list of foodstuffs
authorised for irradiation. Before preparing a proposal for a
Community positive list, the Commission services launched
an open discussion with consumer organisations, industry
organisations and other interested parties in 2000 on the
strategy for drawing up the positive list. A consultation
paper outlining a strategy was launched, inviting
comments.
The comments revealed strong views, both in favour
and against. Some arguments were to the effect that
the conditions for authorisation, especially technological
need, benefit to the consumers and no substitute for good
hygiene are subject to a wide range of interpretations. As a
result of the comments received on the consultation paper,
the Commission adopted a Communication on food and
food ingredients authorised for treatment with ionising
radiation in the Community. In essence, the Communication
concludes that given the complexity of the issue, a broader
debate is opportune at this stage. A positive opinion from
EFSA would be needed to place a specific food item on the
EU-wide list of products authorised for irradiation.
There are no authorised food irradiation facilities in Ireland
and therefore any irradiated foodstuffs or food ingredients
on the Irish market are imported. Ireland does not ban or
restrict the import of any of the foods irradiated by other
Member States.
The FSAI has produced a leaflet on irradiated food and is
available at www.fsai.ie/publications/index.asp.
55
3.7.3 Labelling
Products that are intended for sale to the ultimate
consumer or mass caterers must indicate the words
‘irradiated’ or ‘treated with ionising radiation’ as follows:
The policy functions in relation to the Regulations
on ionising radiation are the responsibility of the Food
Unit, Department of Health and Children whereas the
Radiological Protection Institute of Ireland (RPII) is the
body responsible for irradiation facilities in Ireland.
(i) Irradiated foodstuffs
•
•
For individual irradiated food items, these words
must appear on the label of the product.
For irradiated products sold in bulk, the words must
accompany the name of the product either on a
display or notice above or adjacent to the container
in which the products are placed.
(ii) Irradiated ingredients
•
•
For individual non-irradiated food items containing
irradiated ingredients, these words must accompany
the name of the irradiated ingredient in the list of
ingredients.
For non-irradiated products containing irradiated
ingredients sold in bulk, these words must
accompany the name of the product either on a
display or notice above or adjacent to the container
in which the products are placed.
Regulations.
Two Public Analyst Laboratories in Cork and Galway have
been identified as 'designated' laboratories for the purpose
of food analysis in accordance with the legislation.
3.8
3.8.1 Legislation
•
Irradiated ingredients used in a compound
ingredient of a foodstuff (which itself is not
irradiated) must also indicate these words.
•
Irradiated foodstuffs and non-irradiated foodstuffs
containing irradiated ingredients not intended for sale to
the ultimate consumer and mass caterers such as sale to
wholesalers must indicate the following:
•
the words ‘irradiated’ or ‘treated with ionising radiation’
•
the identity and address of the irradiation facility or its
reference number.
An indication of the treatment shall be given in all cases on
the documents that accompany the irradiated foodstuff. In
addition, materials used for packaging foodstuffs to be
irradiated must be suitable for the purpose.
Irradiated foods imported from third countries must also
comply with the conditions set out in the Directive. The
third country irradiation facility must be approved by the
Community and appear on a list of authorised facilities.
Foods irradiated in third countries must be accompanied
by documents showing the name and address of the
facility that carried out the irradiation treatment.
Regulation (EC) No. 258/97 concerning novel foods and
novel food ingredients
Amended by:
Regulation (EC) No. 1829/2003 on genetically modified
food and feed.
(iii) Irradiated compound ingredients
•
NOVEL FOODS AND NOVEL
FOOD INGREDIENTS
The EU Regulations concerning food have yet to be
transposed into Irish legislation (see also Section
3.10.1).
3.8.2 Introduction to novel foods
Regulation (EC) No. 258/97 governs novel foods and novel
food ingredients which are defined as foods and food
ingredients that have not been used for human
consumption to a significant degree within the European
Community prior to May 15th 1997. Food and food
ingredients within the scope of this Regulation must not
present a danger for, mislead, or be nutritionally
disadvantageous for the consumer. The Regulation is not
applicable to food additives, flavourings or extraction
solvents.
Regulation (EC) No. 258/97 has been amended by
Regulation (EC) No. 1829/2003 which now governs the
authorisation and labelling of genetically modified (GM)
food and feed (see Section 3.10).
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56
Before being placed on the market, novel foods and novel
food ingredients must undergo a Community safety
assessment procedure following which an authorisation
decision may be taken. The authorisation decision defines
the scope of the authorisation and specifies the conditions
of use, the designation of the food or food ingredient, its
specification and any specific labelling requirements.
3.9
FOODS WITH ADDED PHYTOSTEROLS
3.9.1 Legislation
•
Commission Regulation (EC) No. 608/2004 regulates
the labelling of foods and food ingredients with added
phytosterols, phytosterol esters, phytostanols and/or
phytostanol esters.
The FSAI has produced a leaflet on novel foods. This leaflet
and further information on novel foods is available at
www.fsai.ie.
3.8.3 Labelling
•
Regulation (EC) No. 258/97 provides specific labelling
requirements for novel foods in order to ensure that the
final consumer is informed of:
•
any characteristics such as its composition, nutritional
value and the intended use of the food which renders
it no longer equivalent to existing foods
•
the presence of materials which may have implications
for the health of certain sections of the population and
•
the presence of materials which may gives rise to
ethical concerns.
The list of foods authorised within the EU under the novel
food Regulation is available at the European Union Online:
http://europa.eu.int/comm/food/food/biotechnology/novelfo
od/authorisations_en.htm.
The policy functions in relation to Regulation (EC) No.
258/1997 on novel foods are the responsibility of the Food
Unit, Department of Health and Children.
Executive, pursuant to its service contract with the FSAI, for
the purposes of ensuring compliance with these
Regulations (see also Section 3.10.5 regarding genetically
modified food).
The EU Regulations have yet to be transposed into Irish
legislation.
3.9.2 Introduction to phyosterols
Phytosterols or plant sterols are naturally occurring
compounds that are structurally related to cholesterol.
Some of these substances have been proven to reduce
serum cholesterol levels and have therefore been approved
for use as novel food ingredients under Commission
Regulation (EC) No. 258/97 concerning novel foods
and novel food ingredients (Section 3.8). The labelling
requirements under the Novel Foods Regulations must be
complied with as well as the specific labelling provisions
outlined below.
A number of food manufacturers have sought and received
authorisation for the placing of specific food products on
the market with some of these added substances under
specific Decisions.
In its opinion regarding the effects of consumption
of phytosterols, phytosterol esters, phytostanols and
phytostanol esters from multiple sources, the former SCF
confirmed the need to label these substances in order to
allow consumers to restrict their consumption of these
substances to a maximum of 3g/day. The SCF also indicated
that there was no evidence of additional benefits at intakes
higher than 3g/day and that high intakes might induce
undesirable effects. Therefore, plant sterol intakes
exceeding 3g/day should be avoided.
3.9.3 Labelling
In order to facilitate consumer understanding the word
‘phyto’ on the label should be replaced with the word
‘plant’. Therefore, for labelling purposes, phytosterol,
phytosterol ester, phytostanol and phytostanol ester shall be
designated respectively by the terms ‘plant sterol’, ‘plant
sterol ester’, ‘plant stanol’ or ‘plant stanol ester’ or
their plural form, as appropriate.
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The labelling of foods or food ingredients with added
phytosterols, phytosterol esters, phytostanols or phytostanol
esters shall contain the following:
•
the words ‘with added plant sterols/plant stanols’
shall appear, easily visible and legible in the same field
of vision as the name under which the product is sold
•
the amount of added phytosterols, phytosterol esters,
phytostanols or phytostanol esters content shall be
stated in the list of ingredients (expressed in % or as
grams of free plant sterols/plant stanols per 100g or
100ml of the food)
•
a statement that the product is intended exclusively for
people who want to lower their blood cholesterol level
and in the same field of vision a statement that the
consumption of more than 3g/day of added plant
sterols/plant stanols should be avoided
•
a statement that patients on cholesterol lowering
medication should only consume the product under
medical supervision
•
an easily visible and legible statement that the product
may not be nutritionally appropriate for pregnant and
breastfeeding women and children under the age of
five years
•
advice shall be included that the product is to be used
as part of a balanced and varied diet, including regular
consumption of fruit and vegetables to help maintain
carotenoid levels and
•
there shall be a definition of a portion of the food or
food ingredient concerned (preferably in g or ml) with
a statement of the plant sterol/plant stanol amount
that each portion contains.
Commission Decision 2004/333/EC, Commission Decision
2004/334/EC, Commission Decision 2004/335/EC and
Commission Decision 2004/336/EC also contain some
presentation requirements that are applicable only to the
products and companies to whom the Decisions are
addressed.
phytosterols are the responsibility of the Food Unit,
These Regulations are enforced by the FSAI for the
purposes of ensuring compliance with these Regulations.
3.10 GENETICALLY MODIFIED FOOD
3.10.1 Legislation
•
Regulation (EC) No. 1829/2003 regulates genetically
modified food and feed
Implemented by:
Commission Regulation (EC) No. 641/2004 setting out
detailed rules for the implementation of Regulation (EC)
No. 1829/2003
•
Regulation (EC) No. 1830/2003 concerning the
traceability and labelling of genetically modified
organisms and the traceability of food and feed
products produced from genetically modified
organisms.
•
The EU Regulations concerning food have yet to be
transposed into Irish legislation.
The Department of Health and Children and the
Department of Agriculture, Fisheries and Food are
responsible for the policy functions in relation to
Regulation (EC) No. 1829/2003 and Regulation (EC) No.
1830/2003 regarding genetically modified food and
feed respectively. The Department of Agriculture,
Fisheries and Food has transposed the relevant
provisions regarding genetically modified ‘feed’.
3.10.2 Introduction to genetically modified food
Genetically modified organisms (GMOs) are organisms in
which the genetic material (DNA) has been altered in a way
that does not occur naturally. The most common types of
GMO’s that have been developed and commercialised are
genetically modified plant species such as maize, soya bean,
oilseed rape and cotton varieties. These plants have been
genetically modified in order to provide resistance to certain
insect pests and/or to certain herbicides.
Until April 2004, genetically modified (GM) food was
regulated as a novel food under Regulation (EC) No.
258/1997 (Section 3.8). Under these rules food derived
from 18 GM events were approved for use. However, the
entire body of GMO legislation has been amended in 2004,
leading to the creation of a new legal framework.
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58
Since April 2004, GM food and feed are regulated in the
European Community under Regulation (EC) No. 1829/2003
on genetically modified food and feed. Regulation (EC) No.
1829/2003 also repeals Regulation (EC) No. 1139/98,
49/2000 and 50/2000. This new Regulation provides for a
single Community procedure for the authorisation of all
GM food and feed i.e. food and feed consisting of,
containing or produced from genetically modified
organisms. For example, a frozen ready meal containing
GM maize powder falls under the Regulation. Although the
Regulation covers food containing material derived from a
genetically modified source there are some exceptions such
as processing aids which are not normally considered as
ingredients. The authorisations granted under the new
framework are entered in the Community Register of GM
Food and Feed.
Commission Regulation (EC) No. 641/2004 sets out
detailed rules for the implementation of Regulation (EC) No.
1829/2003 with regard to the preparation and submission
of food applications, the notification of existing products
and adventitious or technically unavoidable presence of
genetically modified material which has benefited from
a favourable risk evaluation.
Directive 2001/18/EC on the deliberate release into the
environment of GMOs regulates both the experimental
release of GMOs into the environment and the placing on
the market of live GMOs. Regulation (EC) No. 1830/2003
amends Directive 2001/18/EC in relation to the traceability
and labelling of genetically modified organisms and the
traceability of food and feed products produced from
genetically modified organisms.
Regulation (EC) No. 1830/2003 covers all live GMOs and
food and feed products derived from GMOs. It establishes
a traceability and labelling system for GMOs and food
produced from GMO’s whereby operators retain, for
a period of five years, information pertaining to the
immediate receipt and distribution of GM ingredients.
GMOs and food products produced from GMOs that are
placed on the market must satisfy labelling and traceability
conditions under Regulations (EC) No. 1829/2003 and
3.10.3 Labelling: Regulation (EC) No. 1830/2003
Regulation (EC) No. 1830/2003 provides a framework for
the traceability and labelling of products containing,
consisting of or produced from GMOs.
Traceability
From the first stage of placing on the market, foods or
ingredients containing or consisting of GMOs must be
accompanied by the following documented information:
•
that the product contains or consists of a GMO
•
the unique indentifier number assigned to the GMO.
Operators must retain information on each food or
ingredient for a period of five years.
From the first stage of placing on the market, foods or
ingredients produced from GMOs must carry an indication
of each of the ingredients produced from a GMO. Where
identification systems such as lot numbering exist and is
clearly visible on the packaging, operators may instead
retain the lot number information which will include
information on the GM ingredients.
Traceability applies only to foods or ingredients where
greater than 0.9% contain, consist of or were produced
from GMOs.
Labelling
Clear labelling of GMO’s enables consumers to make
informed choices and avoids potentially misleading
consumers regarding the method of manufacture or
production. Generally speaking, in the case of pre-packaged
products ‘consisting’ of or ‘containing’ GMOs, Regulation
(EC) No. 1830/2003 requires operators to state on a label
that “This product contains genetically modified
organisms”. In the case of non-pre-packaged products
offered to the final consumer, these words must appear on,
or adjacent to the product display.
Food products containing, or consisting of GMOs,
produced from or containing ingredients produced from
GMOs to be delivered as such to the final consumer or to
mass caterers (restaurants etc.) must follow specific labelling
requirements. These labelling provisions, as set out in
Regulation (EC) No. 1829/2003, apply even where the final
product does not contain detectable DNA or protein from
GM source such as for highly refined foods like oil from GM
maize or cotton seed.
(a) Where the food consists of more than one ingredient,
the words ‘genetically modified’ or ‘produced from
genetically modified (name of the ingredient)’
shall appear in the list of ingredients in parentheses
immediately following the ingredient concerned.
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(b) Where the ingredient is designated by the name of a
category, the words ‘contains genetically modified
(name of organism)’ or ‘contains (name of
ingredient) produced from genetically modified
(name of organism)’ shall appear in the list of
ingredients.
(c) Where there is no list of ingredients, the words
‘genetically modified’ or ‘produced from
genetically modified (name of organism)’ shall
appear clearly on the labelling.
(d) The indications referred to in (a) and (b) may appear
in a footnote to the list of ingredients. In this case they
shall be printed in a font of at least the same size as the
list of ingredients. Where there is no list of ingredients,
they shall appear clearly on the labelling.
(e) Where the food is offered for sale to the final consumer
as non-pre-packaged food, or as pre-packaged food in
small containers of which the largest surface has an
area of less than 10cm2, the information required under
this paragraph must be permanently and visibly
displayed either on the food display or immediately
next to it, or on the packaging material, in a font
sufficiently large for it to be easily identified and read.
The policy functions in relation to Regulation (EC) No.
1829/2003 and Regulation (EC) No. 1830/2003 is the
responsibility of the Food Unit, Department of Health
and Children and the Department of Agriculture, Fisheries
and Food regarding genetically modified food and feed
respectively.
The food related provisions of both these Regulations
are enforced by the FSAI and the Environmental Health
Department of the Health Service Executive, pursuant to its
service contract with the FSAI, for the purposes of ensuring
compliance with these Regulations. The Department of
Agriculture, Fisheries and Food enforces the feed related
provisions of Regulation (EC) No. 1829/2003.
The Environmental Protection Agency (EPA) is the
competent authority for Directive 2001/18/EC on the
deliberate release into the environment of genetically
modified organisms while the Department of the
Environment, Heritage and Local Government is responsible
for policy matters.
3.11 FOOD WITH ADDED VITAMINS
AND MINERALS (FORTIFIED FOODS)
In addition, the labelling shall also mention any
characteristic or property where the food:
3.11.1 Legislation
•
is different from its conventional counterpart as regards
its composition; nutritional value or nutritional effects;
intended use of the food; implications for the health
of certain sections of the population;
•
•
may give rise to ethical or religious concerns.
•
GM labelling threshold
Foods or ingredients that have a GM content of no greater
than 0.9% (of authorised GM material) do not require
specific GM labelling provided the operator can
demonstrate that the GM presence is due to adventitious or
technically unavoidable mixing that can occur during
harvesting, storage, transport or processing.
Adventitious or technically unavoidable traces of
unauthorised GM material at no greater than 0.5% are
tolerated in food until April 2007 provided they have
benefited from a favourable opinion from a Community
Scientific Committee or EFSA, the application for its
authorisation has not been rejected and detection methods
are publicly available.
Regulation (EC) No. 1925/2006 on the addition of
vitamins and minerals and of certain other substances
to foods.
legislation.
3.11.2 Introduction to fortified foods
Fortified foods are ordinary foods to which nutrients such
as vitamins, minerals, amino acids and essential fatty acids,
are voluntarily added. Nutrients may have been added to
foods for a number of reasons such as the replacement
of nutrients lost during manufacture, the equivalence
of products and fortification.
The Regulation sets out harmonised EU rules for adding
vitamins and minerals and certain other substances to
foods. It lists the vitamins and minerals which can be added
to foods and, establishes the criteria for setting minimum
and maximum levels for such nutrients on the basis of
scientific advice.
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60
The Regulation also applies to foods for particular
nutritional uses (Section 3.2) novel foods and novel food
ingredients (Section 3.8), genetically modified food (Section
3.10) and food additives and flavourings (Sections 3.12 and
3.13 respectively). However, the Regulation does not apply
to food supplements, such as vitamin pills, which are clearly
sold as concentrated sources of nutrients and are not
considered as fortified foods (Section 3.1).
The Regulation prohibits the fortification of unprocessed
foodstuffs, such as fruit, vegetables or meat that should be
preserved in their natural state, and alcoholic beverages.
The addition of certain vitamins or minerals to some foods
is mandatory in some Member States such as adding the
mineral iodine to salt to prevent iodine deficiency diseases.
National Regulations will be produced to give effect to the
Regulation in due course.
The policy functions in relation to Regulation on foods
with added vitamins and minerals are the responsibility
In due course the Regulations will be enforced by the FSAI
along with any named agencies pursuant to their service
contract with the FSAI, for the purposes of ensuring
compliance with these Regulations.
3.12 ADDITIVES, COLOURS AND
SWEETENERS IN FOODSTUFFS
3.12.1 Legislation
•
3.11.3 Labelling
Fortified foods must respect the labelling rules set for food
in general such as the horizontal labelling rules (Section 2)
including any labelling provisions outlined in the Regulation
(EC) No. 1924/2006 on nutrition and health claims (Section
2.4).
The labelling, presentation and advertising of foods to
which vitamins and minerals have been added shall not:
•
include any mention stating or implying that a balanced
and varied diet cannot provide appropriate quantities
of nutrients
•
mislead or deceive the consumer as to the nutritional
merit of a food that may result from the addition of
these nutrients.
Directive 89/107/EEC concerning food additives
authorised for use in foodstuffs intended for human
consumption
Amended by:
Directive 94/34/EC.
•
European Communities (Additives, Colours and
Sweeteners in Foodstuffs) Regulations, 2000
(S.I. No. 437 of 2000)
Amended by:
(S.I. No. 342 of 2001), (S.I. No. 344 of 2002),
(S.I. No. 380 of 2002), (S.I. No. 61 of 2005)
(S.I. No. 192 of 2005) and (S.I. No. 193 of 2005).
3.12.2 Introduction to additives, colours and
sweeteners package of legislative proposals
Community legislation
Nutrition labelling must be provided where vitamins and
minerals have been added to a food under this Regulation.
The nutrition information must be provided in a ‘Group 2’
Format according to Directive 90/496/EEC on nutrition
labelling (Section 2.3) and the total amounts of vitamins
and minerals present must be declared.
The labelling of products to which vitamins and minerals
have been added may bear a statement indicating this
addition under the conditions set out in Regulation (EC)
No. 1924/2006 on nutrition and health claims (Section 2.4).
The Community legislation on food additives is governed by
the Framework Directive 89/107/EEC and is based on the
principle that only authorised additives may be used in the
manufacture or preparation of foodstuffs. Prior to their
authorisation, food additives are evaluated for their safety
by EFSA. Prior to EFSA’s role in evaluating food additives
which began in 2003, the evaluations were carried out
by the Scientific Committee on Food (SCF).
61
In effect, a 'positive list' of approved additives has been
developed. Specific conditions for the use of the food
additive may include the foodstuff to which it can be
added, the conditions under which it may be added and
the maximum permitted levels of use. Most food additives
may only be used in limited quantities in certain foodstuffs.
The FSAI has produced a report ‘Legislation, intake and
usage of food additives in Ireland’. This report and further
information on food additives is available at www.fsai.ie.
The following are not considered as additives and are not
governed by the Framework Directive 89/107/EC:
In addition, to the general criteria for food additives, the
Framework Directive recommends that the detailed
provisions, depending on the category of food additive, be
included in separate Directives. Three technical Directives
have addressed the use of the following:
•
Council Directive 94/35/EC on sweeteners for use in
foodstuffs
•
Directive 94/36/EC on colours for use in foodstuffs
•
Directive 95/2/EC all other additives i.e. food additives
other than colours and sweeteners also known as
'miscellaneous additives' Directive.
These Directives list the individual permitted additives and
the general and specific food categories in which each
additive is permitted. Furthermore, these Directives also lay
down any necessary maximum levels of use.
Our national Regulations (S.I. No. 437 of 2000) and its
amendments give effect to most of the European Directives
governing additives, colours and sweeteners in food
including the Framework Directive 89/107/EEC, Council
Directive 94/35/EC on sweeteners and Directive 94/36/EC
on colours and their various amendments. The
Miscellaneous Additives Directive 95/2/EC and its
amendments is implemented by European Communities
(Food Additives other than Colours and Sweeteners)
Regulations, 2004 (S.I. No. 58 of 2004) and its amendment
(S.I. No. 369 of 2005).
Additives are defined in the Framework Directive 89/107/EC
as:
‘any substance not normally consumed as a food in
itself and not normally used as a characteristic
ingredient of a food whether or not it has nutritive
value, the intentional addition of which to food for a
technological purpose in the manufacture, processing,
preparation, treatment, packaging, transport or storage
of such food results, or may be reasonably expected to
result, in it or its by-products becoming directly or
indirectly a component of such foods’.
•
processing aids
•
substances used in the protection of plants and plant
products in conformity with Community rules relating
to plant health
•
flavourings for use in foodstuffs (as regulated by
Council Directive 88/388/EEC see Section 3.13) and
•
substances added to foodstuffs as nutrients such as
vitamins and mineral.
Additives can be sold either directly to the ultimate
consumer or to manufacturers for use in food. Sweeteners
are used to impart a sweet taste to foodstuffs or used as
a table-top sweetener and can be for sold to the ultimate
consumer or for use in the manufacture of foodstuffs.
Council Directive 94/35/EC and its amendments Directives
96/83/EC, 2003/115/EC and 2006/52/EC regulating
sweeteners for use in foodstuffs, outlines what sweeteners
are permitted in particular foods and at what level. For
example, aspartame (E951) is permitted in energy-reduced
soups at a maximum usable dose of 110mg/l.
Council Directive 95/2/EC (miscellaneous additives) and its
amendments (including most recently Directive 2006/52/EC)
specifically regulate food additives other than colours and
sweeteners and outlines what additives are permitted in
particular foods and at what level. For example, citric acid
(E330) is permitted in fruit juices at a maximum level
of 3g/l.
3.12.3 Labelling
The provisions for labelling the presence of an additive,
where it is an ingredient in a food, are contained in
Directive 2000/13/EC (horizontal labelling legislation,
Section 2.1). The Framework Directive 89/107/EEC on food
additives sets out specific labelling provisions for food
additives sold direct to food producers and consumers.
Directive 94/35/EC sets out labelling requirements for tabletop sweeteners and Directive 96/21/EC provides additional
labelling provisions concerning the details that must appear
on the label of a food containing a sweetener (see also
Section 2.1.5.11). All these requirements are outlined
below.
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62
Directive 2003/114/EC an amendment to the Miscellaneous
Additives Directive 95/2/EC does not set out labelling
requirements but contains labelling related provisions that
impact on the declaration of additives present in flavourings
(see also Section 3.13). Where an additive is from a
genetically modified source it must also adhere to the
labelling requirements of Regulation (EC) No. 1829/2003/EC
and 1830/2003/EC for genetically modified food and feed
(Section 3.10).
Food additives not intended for sale to the ultimate
consumer may be marketed only if their packaging or
containers bear the following information, which must
be conspicuous, clearly legible and indelible:
•
name and E number of each food additive, whether
sold singly or mixed together, in descending order of
weight (and the name and E number of any substances
or additives incorporated into the additives in
descending order of weight*)
Labelling: additives
•
one of the following statements: ‘for use in food’ or
‘restricted use in food’ or a more specific reference
to its intended food use
•
special conditions of storage and use where necessary
•
directions for use where necessary*
Food additives for sale to the ultimate consumer may
be marketed only if their packaging or containers bear the
following information, which must be conspicuous, clearly
legible and indelible:
•
a lot or batch number*
•
manufacturer or packager, or of a seller established
within the Community*
•
name under which the product is sold and it’s E
number (see also section 2.1.5.2 (b) on E numbers
and Appendix VI and VIII)
•
an indication of the percentage of any component
which is subject to a quantitative limitation in a food*
and
•
name and E number of each food additive, whether
sold singly or mixed together, in descending order of
weight and the name and E number of any substances
or additives incorporated into the additives in
descending order of weight
•
the net quantity.
The Framework Directive 89/107/EEC outlines the labelling
requirements for food additives for sale to the ultimate
consumer and food additives not intended for sale to
the ultimate consumer i.e. to food producers.
•
one of the following statements: ‘for use in food’
or ‘restricted use in food’ or a more specific
reference to its intended food use
•
special conditions of storage and use where necessary
•
directions for use where necessary
•
a lot or batch number
•
within the Community
•
the net quantity and
•
the date of minimum durability.
Labelling: additives other than colours and sweeteners
The use of additives is sometimes necessary to ensure the
safety and quality of flavourings and to facilitate their
storage. If the presence of an additive in a foodstuff, due to
the use of a flavouring, is generally low and the additive
does not have a technological function in the foodstuff, it is
then not considered as an ingredient (Section 2.1.5.2). The
additive in question is therefore not required to be listed in
the ingredients list.
However, if under certain circumstances, the additive does
have a technological function in the compound foodstuff,
it should be considered as an additive of the compound
foodstuff and not as an additive of the flavouring. Hence
the additive is considered as an ingredient of the food and
should be declared in the list of ingredients. Other relevant
rules relating to the additive in the particular food will
also apply.
* These indications need only appear on the commercial documents accompanying the consignment provided “intended for the manufacture of foodstuffs
and not for retail sale” appears as a conspicuous part of the packaging or container of the product in question.
63
Labelling: sweeteners
Council Directive 94/35/EC on sweeteners for use
in foodstuffs outlines the labelling requirements for
sweeteners. Sweeteners are a category of food additive
which are used to impart a sweet taste to foods or used
a table-top sweetener.
These rules also make it compulsory to declare the
following information on the label of a table-top
sweetener:
•
the term ‘…….- based table-top sweetener’ to be
added to the sales description where the name(s) of the
sweetening substances used in its composition should
be inserted
•
the words ‘excessive consumption may induce
laxative effects’ where the sweetener contains polyols
•
the words ‘contains a source of phenylalaine’
where the sweetener contains aspartame and
•
the words ‘contains a source of phenylalaine’
where the sweetener contains salt of aspartame and
acesulfame (Directive 2003/115/EC amending Directive
94/35/EC).
Directive 96/21/EC amending Directive 94/54/EC on the
compulsory indication of particulars on the labelling of
certain foodstuffs provides additional labelling provisions
concerning the details that must appear on the label of
a food containing a sweetener to makes its presence
clear as follows (Section 2.1.5.11):
•
foodstuffs containing a sweetener or sweeteners
(as authorised by Directive 94/35/EC) must be labelled
“with sweeteners(s)” near the name of the food
•
foodstuffs containing both an added sugar or sugars
and a sweetener or sweeteners (as authorised by
Directive 94/35/EC) must be labelled “with sugar(s)
and sweeteners(s)” near the name of the food
•
foodstuffs containing aspartame must be labelled
“contains a source of phenylalanine” and
•
foodstuffs containing more than 10% added polyols
must be labelled “excessive consumption may produce
laxative effects.”
The European Commission has adopted a package of
legislative proposals which upgrades current rules for
flavourings and additives and will introduce harmonised EU
legislation on food enzymes for the first time. The texts aim
to clarify and update current legislation in this area and to
create a simplified common approval procedure for food
additives, flavourings and enzymes, based on scientific
opinions from EFSA.
For additives and flavourings which are already covered by
EU legislation, the proposals bring the rules into line with
the latest scientific and technological developments and will
improve the clarity of the legislation. With regard to food
enzymes, the draft Regulation proposes replacing divergent
national legislation with new, harmonised EU rules. Further
details are available at
http://ec.europa.eu/food/food/chemicalsafety/additives/prop
_leg_en.htm. At the time of print these legislative proposals
were not yet completed therefore, the current legislation as
outlined above still applies.
The policy functions in relation to Regulations on additives
are the responsibility of the Food Unit, Department of
Health and Children pursuant to their service contract with
the FSAI, for the purposes of ensuring compliance
with these Regulations:
•
Executive
•
Local Authorities
•
Department of Communications, Energy and Natural
Resources.
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64
3.13 FLAVOURINGS FOR USE IN
FOODSTUFFS FOR HUMAN
CONSUMPTION
3.13.1
Legislation
•
Council Directive 88/388/EEC relating to flavourings for
use in foodstuffs
Completed by:
Commission Directive 91/71/EEC.
With respect to flavouring substances, a major initiative
is underway to develop a list of flavouring substances
approved for the use in foodstuffs. Council Regulation
2232/96/EC, sets out procedures for the use of these
substances in or on foodstuffs in the EU. Subsequently
Commission Decision 1999/217/EC as amended by
2000/489/EC, 2002/113/EC, 2004/357/EC, 2005/389/EC
and 2006/252/EC adopted an EU Register of flavouring
substances used in or on foodstuffs which will form the
basis of an evaluation programme of these flavouring
substances. It is envisaged that all flavouring substances
will be evaluated and the list completed by 2008.
•
European Communities (Flavourings for use in
Foodstuffs for Human Consumption) Regulations,
1992 (S.I. No. 22 of 1992).
3.13.2 Introduction to flavourings
Community legislation
Flavourings are used in or on foodstuffs in order to impart
odour and/or taste. Flavourings mean flavouring substances
(i.e. a defined chemical substance with flavouring
properties, obtained by a variety of means), flavouring
preparations (i.e. flavourings containing more than one
flavouring substance), process flavourings (flavourings
obtained during manufacturing to a temperature not
exceeding 180oC for a period not exceeding 15 minutes)
and smoke flavourings (a smoke extract used in traditional
foodstuff smoking processes).
The Framework Directive 88/388/EEC sets out the
definitions for the different types of flavourings, such as
natural, nature-identical or artificial flavouring substances.
General rules for their use and labelling requirements are
also given. Use of flavourings must not result in the
presence in foodstuffs of undesirable substances in
quantities greater than those specified in the Directive.
The following are not considered flavourings and are
therefore not governed by the current Framework Directive
88/388/EEC:
•
edible substances and products intended to be
consumed as such, with or without reconstitution
•
substances which have exclusively a sweet, sour or salt
taste
•
material of vegetable or animal origin, having inherent
flavouring properties, where they are not used as
flavouring sources.
3.13.3 Labelling
The labelling requirements for flavourings depend on
whether or not they are intended for sale to the final
consumer. Commission Directive 91/71/EEC amends the
Framework Directive on Flavourings, to prescribe labelling
requirements for flavourings sold as such to the final
consumer.
Flavourings intended for sale to the final consumer
may not be marketed unless their labels indicate the
following information, which should be easily visible,
clearly legible and indelible:
1) the word ‘flavouring’ or a more specific name or
description of the flavouring
2) the words ‘for foodstuffs’ or a more specific reference
to the foodstuff for which the flavouring is intended
3) the date of minimum durability
4) special conditions for storage and use of the flavour
where necessary
5) instructions for use if its omission would prevent the
appropriate use of the flavouring
6) the net quantity expressed in units of mass or volume
7) the name and business name and address of the
manufacturer or packer, or of a seller established within
the Community
8) an indication or mark identifying the batch (see also
Council Directive 89/396/EC Section 2.2) and
9) in the case of a mixture of flavourings with other
substances a list in descending order of weight of the
categories of flavourings and the names of each of the
other substances (or where appropriate their 'E' number
see Section 2.1.5.2 (b)) as contained in the mixture.
65
Flavourings not intended for sale to the final
consumer may not be marketed unless their packages
bear the following information, which should be easily
visible, clearly legible and indelible:
1) the name and business name and address of the
manufacturer or packer, or of a seller established
within the Community
2) the sales description: either the word ‘flavouring’ or
a more specific name or description of the flavouring
3) the statement ‘for foodstuffs’ or a more specific
reference to the food for which the flavouring is
intended
4) a list in descending order of weight of the categories
of flavouring substances and flavouring preparations
classified as natural flavouring substances, naturalidentical flavouring substances, artificial flavouring
substances and smoke flavourings etc.*
5) in the case of a mixture of flavourings with:
•
additives necessary for the storage and use of
flavourings or
•
products used for dissolving or diluting flavourings
a list in descending order of weight of the categories
of flavourings and the names of each of the other
substances (or where appropriate their ‘E’ numbers)
as contained in the mixture*
6) an indication of the maximum quantity of each
flavouring component*
7) an indication identifying the consignment and
8) the nominal quantity expressed in units of mass
or volume.
Natural flavourings
On a label the word ‘natural’ applying to a flavour or any
word having substantially the same meaning, e.g. pure,
may only be used where the flavouring component
is derived from
•
flavouring substances or
•
flavouring preparations
Acceptable ‘natural’ processing methods to obtain
flavouring compounds may be achieved by physical,
enzymatic or microbiological processes such as freezing,
concentration, drying, distillation, traditional cooking
processes and pasteurisation. Foods could be described as
‘made from natural flavourings’ and unflavoured products
as ‘natural’ only if these criteria are met.
Foodstuffs containing flavourings obtained by ‘artificial’
methods would not be permitted to use the word ‘natural’
on the product, e.g. flavourings obtained by chemical
means, heating processes and smoking are excluded such
as bleaching, hydrogenation and smoking with chemicals.
If the name of the flavouring contains a reference to the
source of the flavouring such as its vegetable or animal
origin, as in ‘natural chicken flavour’ then the word
‘natural’ may only be used if the flavour was obtained
purely from a chicken source by ‘natural processes’. If
however, as above, the flavour was obtained through any
chemical or similar artificial process then the term ‘natural’
may not be used.
Similarly, the wording ‘natural apple flavour’ for a foodstuff
may only be used where the actual apple flavour was
obtained solely from apples by natural processing methods
as above. The term natural would have to be omitted and
the words ‘apple flavour’ only permitted where the apple
flavour was obtained by artificial means. In addition, the
word ‘natural flavour’ may be used where the flavour was
obtained naturally but not solely from apples.
Directive 2003/89/EC, an amendment to the general
labelling Directive 2001/13/EC (see Section 2.1.5.2 (e) on
allergens), requires that if a flavouring or processing aid is
derived from one of the allergenic sources listed by the
Directive, the name of the source must be declared clearly
by name in the ingredient list.
Smoke Flavourings
Regulation (EC) No. 2065/2003 regulates smoke flavourings
used or intended for use in or on foods. This Regulation
establishes a procedure for the safety assessment and
authorisation of smoke condensates to be carried out by
EFSA, which will result in a positive list of primary products
and specific conditions of use in, or on, foods.
to which nothing has been added and which have been
subjected only to such processing as to render them
suitable for human consumption.
* Points 4), 5) and 6) above need only appear on the trade documents relating to the consignment which are to be supplied with or prior to delivery.
However, the indication ‘intended for the manufacture of foodstuffs and not for retail’ must appear in a conspicuous part of the packaging
of the product.
3
66
Smoke flavourings do not have to be specifically declared in
the list of ingredients the name ‘flavouring(s)’ is sufficient
(Section 2.1.5.2 (c) on flavouring). However, details of the
physical condition of the foodstuff or processes it has
undergone must accompany the legal name of the food
such as ‘smoked’ (Section 2.1.5.1). It should be noted that
a product being sold as having undergone a smoking
process such as ‘smoked chicken’ would be misleading to
the consumer where in fact it was treated with a smoked
flavouring. In this case, the name of the food should
declare ‘chicken with smoked flavourings’ so the consumer
is informed of the true nature of the product.
Quinine and caffeine flavourings
Commission Directive 2002/67/EC on the labelling of
foodstuffs containing quinine and of foodstuffs containing
caffeine requires that, where caffeine or quinine are used as
a flavouring in the production or preparation of the food,
they should be declared by name in the ingredients list,
immediately after the term ‘flavouring’(Section 2.1.5.2)
Package of legislative proposals
The European Commission has adopted a package of
legislative proposals which would upgrade current rules
for flavourings and additives and introduce harmonised EU
legislation on food enzymes for the first time. The texts aim
to clarify and update current legislation in this area and to
create a simplified common approval procedure for food
additives, flavourings and enzymes, based on scientific
opinions from EFSA.
For additives and flavourings, which are already covered by
EU legislation, the proposals bring the rules into line with
the latest scientific and technological developments and will
improve the clarity of the legislation. With regard to food
enzymes, the draft Regulation proposes replacing divergent
national legislation with new, harmonised EU rules. Further
details are available at
http://ec.europa.eu/food/food/chemicalsafety/additives/prop
_leg_en.htm. At the time of print, these new legislative
proposals were not yet completed therefore, the current
legislation as outlined above still applies.
Additives, diluents and carriers
Directive 2003/114/EC amends for the fifth time
Directive 95/2/EC on food additives other that colours
and sweeteners and introduces new provisions relating
to the use of additives in flavourings. A new carry-over
provision has been inserted specifically for foods containing
flavourings. The presence of a food additive in a foodstuff
is permissible in a foodstuff where a flavouring has been
added, to the extent to which the food additive is
permitted in the flavouring in compliance with this
Directive and has been carried over to the foodstuff
via the flavouring, provided the food additive has
no technological function in the final food.
The level of additives in flavourings shall be limited to
the minimum necessary to guarantee the safety and quality
of the flavourings and to facilitate storage. Furthermore,
the presence of additives in flavourings must not mislead
the consumer or present a hazard to their health. If the
presence of an additive in a foodstuff, as a consequence
of adding flavourings, has a technological function in the
foodstuff, it shall be considered as an additive of the
foodstuff and not as an additive of the flavouring.
flavourings for use in foodstuffs are the responsibility
following agencies, pursuant to their service contract with
the FSAI, for the purposes of ensuring compliance with
these Regulations:
•
Environmental Health Department of the Health
Service Executive
•
Resources.
The FSAI has been nominated as the competent authority
for receiving dossiers on smoke flavourings in accordance
with Regulation (EC) No. 2065/2003.
67
3.14 MATERIAL AND ARTICLES INTENDED
TO COME INTO CONTACT WITH
FOODSTUFFS
There are also Directives on individual substances or groups
of substances used in the manufacture of materials and
articles intended for food contact:
3.14.1 Legislation
•
Materials Containing Vinyl Chloride Monomer (Council
Directive 78/142/EEC and its implementing measures
Commission Directive 80/766/EEC and Commission
Directive 81/432/EEC)
•
Elastomers or Rubber Teats and Soothers: Release
of N-nitrosamines and N-nitrosable Substances
(Commission Directive 93/11/EEC)
•
Materials Containing Certain Epoxy Derivatives
(Commission Regulation (EC) No. 1895/2005).
•
Regulation (EC) No. 1935/2004 on materials and articles
intended to come into contact with food.
•
European Communities (Plastics and other materials)
(Contact with food) Regulations, 2006 (S.I. No. 139
of 2006).
3.14.2 Introduction to materials and articles
intended to come into contact with food
The underlying principle of the legislation is that any
material or article intended to come into contact with food,
directly or indirectly, must be sufficiently inert to preclude
substances from being transferred to food in quantities
large enough to endanger human health. In addition, the
possible migration of substances to the food must not bring
about an unacceptable change in the composition of the
food or a deterioration in its organoleptic properties.
The Framework Regulation (EC) No. 1935/2004 sets general
requirements for all food contact materials and repeals the
Framework Directive 89/109/EEC and Directive 80/590/EEC.
The new framework Regulation takes into account new
types of materials and articles designed to actively maintain
or improve the condition of the food (active food contact
materials and articles) as well as other types of new
materials which are designed to monitor the condition of
the food (intelligent food contact materials and articles).
Specific Directives have also been drawn up which cover
some of the particular materials and articles listed in the
Framework Regulation:
•
Ceramic Articles (Council Directive 84/500/EEC amended
by Commission Directive 2005/31/EC)
•
Plastic Material (Commission Directive 2002/72/EC
amended by Commission Directive 2004/1/EC,
Commission Directive 2004/19/EC and Commission
Directive 2005/79/EC)
•
Regenerated Cellulose Film (Commission Directive
93/10/EEC amended by Commission Directive
1993/111/EC and Commission Directive 2004/14/EC).
Where a specific Directive has not yet been introduced for a
given food contact material or article, then it must comply
with the general provisions of the Framework Directive. In
due course, it is proposed to introduce Directives on paper
and board, glass, metal and alloys, wood including cork,
textile products and microcrystalline waxes.
Our national 2006 Regulations give full effect to Regulation
(EC) No. 1935/2004 and Commission Regulation (EC)
No.1895/2005 on certain epoxy substances from food
contact materials. It also transposes the specific Directives
on plastics, regenerated cellulose film, ceramics, vinyl
chloride monomer and elastomer or rubber teats. These
Regulations consolidate and repeal the previous national
rules on food contact materials (i.e. S.I. No. 307 of 1991
and its amendments).
The Regulations deal with the importation and sale of
materials intended to come into contact with food, the
descriptions which must accompany them and specifies
labelling requirements for when materials and articles are
sold for food contact use but are not already in contact
with food.
3
68
The legislation controls the use of materials and articles for
use in contact with foodstuffs, specifically with regard to
the control of the potential contamination that can occur
through the migration of substances from the contact
material to the foodstuff. The contamination can affect the
appearance, taste or odour of the foodstuff or can cause
toxicological effects depending on the degree and nature
of the contaminants.
The legislation applies to all materials and articles “which in
their finished state are intended to come into contact with
food or water”, including cutlery, coffee machines, etc.
However, the main focus of concern is food-packaging
materials where there is greater potential for contamination
to occur as a foodstuff spends most time in contact with
the packaging.
3.14.3 Labelling
The Framework Regulation requires that materials and
articles (intended for food contact use) which are not yet
in contact with food when placed on the market, must
be accompanied by the following information:
(a) the words “for food contact”, or a specific indication
as to their use, such as coffee machine, wine bottle,
soup spoon, or the following symbol
All of this information must be conspicuous, clearly legible
and indelible. In addition, retail trade in materials and
articles shall be prohibited if the information required under
(a), (b) and (e) is not given in a language easily understood
by purchasers.
At the retail stage, this information shall be displayed either
on the materials and articles themselves, the packaging,
or on the labelling. This information may also appear on
a notice in the immediate vicinity of the materials and
articles provided it is clearly visible to purchasers. However,
information regarding (c) above may only appear on a
notice where for technical reasons, that information or
a label bearing it cannot be affixed to the materials and
articles at either the manufacturing or the marketing stage.
At the marketing stages other than the retail stage,
the information required above can be displayed on
the accompanying documents, the labels, the packaging
or the materials and articles themselves.
The Framework Regulation also requires that:
•
the labelling, advertising and presentation
of a material or article shall not mislead consumers
•
intelligent materials and articles shall not give
information about the condition of the food which
could mislead consumers
•
active and intelligent materials and articles already
brought into contact with food, e.g. filled food
packaging, shall be adequately labelled to allow
identification by the consumer of non-edible parts,
e.g. sachets contained in the package with the food
•
active and intelligent materials and articles shall be
adequately labelled to indicate that the materials
or articles are active and/or intelligent.
This information is not obligatory for any articles which,
because of their characteristics, are clearly intended to
come into contact with food.
(b) special instructions to be observed for safe and
appropriate use where necessary
(c) the name/trade name and the address or registered
office of the manufacturer, processor, or seller
responsible for placing the material or article
on the market established within the Community
(d) adequate labelling or identification to ensure traceability
of the material (required from 27th October 2006)
(e) in the case of active materials and articles, information
on the permitted use or uses and other relevant
information such as the name and quantity of the
substances released by the active component so as to
enable food business operators who use these materials
and articles to comply with any other relevant legislative
provisions such as food labelling (Directive 2000/13/EC,
Section 2.1).
Additionally, the specific measures on particular materials
may specify additional labelling requirements and the
accompaniment of materials and articles by written
declarations of compliance with the legislation.
69
materials and articles to come in contact with food are the
responsibility of the Department of Agriculture, Fisheries
and Food.
these Regulations:
•
Executive
•
Local Authorities
•
Resources.
3
70
SECTION 4 – VERTICAL LEGISLATION
VERTICAL LABELLING RULES
4.1.3 Labelling
The provisions of the horizontal labelling rules for prepackaged foodstuffs (Section 2) apply to the foodstuffs
outlined in this chapter in addition to the specific
requirements detailed in the various pieces of legislation
below unless stated otherwise.
The labelling requirements for cocoa and chocolate
products are as follows:
PART A: COMPOSITIONAL
STANDARDS
4.1
COCOA AND CHOCOLATE PRODUCTS
4.1.1 Legislation
•
the prescribed names for cocoa and chocolate
products as listed and defined in the Directive must be
used in trade as their sales names such as ‘chocolate’,
‘milk chocolate’, ‘drinking chocolate’, ‘couverture
chocolate’, ‘plain chocolate’, ‘cocoa butter’,
‘cocoa powder’, ‘filled chocolate’ etc.
However, these names can be used for other products in
accordance with custom provided these other products
cannot be confused with the products defined in the
Directive such as ‘chocolate’ cakes.
•
•
the labelling of chocolate products which contain
vegetable fats other than cocoa butter must be
supplemented by the statement ‘contains vegetable
fat in addition to cocoa butter’. This statement
must be conspicuous, clearly legible and in the same
field of vision as the list of ingredients and clearly
separated from this list. This statement must be in
lettering at least as large and in bold with the sales
name nearby (the sales name of the product may also
appear elsewhere on the label)
•
where certain chocolate products are sold in
assortments the sales name may be replaced by
‘assorted chocolates’ or ‘assorted filled
chocolates’. In this case, there may be a single list
of ingredients for all the products in the assortment
•
for specific products (such as powered chocolate,
drinking chocolate, chocolate, milk chocolate, family
milk chocolate, chocolate a la taza and chocolate
familiar a la taza) an indication of the total dry cocoa
content must be given by a declaration ‘cocoa solids
......% minimum’
•
fat-reduced cocoa and sweetened cocoa/drinking
chocolate must indicate the cocoa butter content
Directive 2000/36/EC relating to cocoa and chocolate
products intended for human consumption.
•
European Communities (Marketing of Cocoa and
Chocolate Products) Regulations, 2003 (S.I. No. 236
of 2003).
4.1.2 Introduction to cocoa and chocolate products
Directive 2000/36/EC repealed Council Directive 73/241/EEC
and was introduced to simplify Community provisions. The
Directive lays down rules for the composition and labelling
of cocoa and chocolate products and defines different
categories of chocolate products including chocolate, milk
chocolate, family milk chocolate, white chocolate and filled
chocolate.
The new rules were required in order to take account of
technolocigal progress and changes in consumer tastes and
to be brought in line with general Community legislation on
labelling, sweetners, additives, flavourings etc. Cocoa and
chocolate products may not be marketed in the Community
unless they conform to the definitions and rules laid down
in the Directive.
71
SECTION 4 VERTICAL LEGISLATION
•
the sales names ‘chocolate’, ‘milk chocolate’ and
‘couverture chocolate’ may be supplemented by
declarations or adjectives relating to quality provided
the product contains the following:
–
chocolate: not less than 43% total dry
–
milk chocolate: not less than 30% total dry cocoa
solids and not less than 18% dry milk solids
obtained by partly or wholly dehydrating whole
milk, semi- or full-skimmed milk, cream, or from
partly or wholly dehydrated cream, butter or milk
fat, including not less than 4.5% milk fat
–
couverture chocolate: not less than 16 % of dry
non-fat cocoa solids.
4.2.2 Introduction to coffee and chicory extracts
Directive 1999/4/EC repealed Directive 77/436/EEC on
coffee and chicory extracts in order for the legislation to
be brought in line with general Community legislation on
foodstuffs, particularly labelling and methods of analysis.
The legislation prescribes standards for the composition
and labelling of coffee extracts and chicory extracts.
4.2.3 Labelling
The following labelling provisions apply to coffee and
chicory extracts:
•
In Ireland and the UK, the sales name ‘milk chocolate’ may
be used to describe ‘Family Milk Chocolate’ provided the
amount of dry milk solids is indicated by the declaration
‘milk solids ……%’.
These names must be supplemented by the words
‘paste’ or ‘in paste form’ or ‘liquid’ or ‘in liquid
form’ as appropriate. The names may also be
supplemented by the term ‘concentrated’ as follows:
The policy functions in relation to the Regulations on cocoa
and chocolate products are the responsibility of the Food
Division, Department of Agriculture, Fisheries and Food.
these Regulations:
•
Executive
•
4.2
(a) liquid coffee extract: the coffee based dry matter
content is more than 25% by weight or
(b) the liquid chicory extract: the chicory based dry
matter content is more than 45% by weight
•
the labelling must include the term ‘decaffeinated’
if the product meets the specified requirements. This
information must be written within the same field of
vision as the sales description
•
for particular products with added sugars (such as
liquid coffee extract and liquid chicory extract) the
labels must include the terms ‘with....’, ‘preserved
with....’, ‘with added....’ or ‘roasted with....’
followed by the name of the types of sugar(s) used.
This information must also appear within the same
field of vision as the sales description
•
the dry matter content must be expressed as a
percentage by weight of the finished product in the
case of dried coffee extract, coffee extract paste,
dried chicory extract and chicory extract paste.
COFFEE AND CHICORY EXTRACTS
4.2.1 Legislation
•
Directive 1999/4/EC regulates coffee extracts and
chicory extracts.
•
European Communities (Marketing of Coffee Extracts
and Chicory Extracts) Regulations, 2000 (S.I. No. 281
of 2000).
the product names ‘coffee extract’, ‘soluble
coffee extract’, ‘soluble coffee’ or ‘instant coffee’,
or in the case of chicory extracts, ‘chicory extract’,
‘soluble chicory’ or ‘instant chicory’ apply only
to the products defined in the Directive and must
be used in trade to designate them.
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72
4.3.3 Labelling
The policy functions in relation to the Regulations on coffee
and chicory extracts are the responsibility of the Food
The following labelling provisions apply to fruit juices
and similar products intended for consumption:
•
Department of Agriculture, Fisheries and Food pursuant to
its service contract with the FSAI, for purposes of ensuring
compliance with these Regulations.
Officers authorised under these Regulations by the Health
Service Executive and the Office of the Director of
Consumer Affairs may also enforce these provisions.
4.3
FRUIT JUICES AND FRUIT NECTARS
Where the product comes from a single kind of fruit,
the name of the fruit must be substituted for the word
‘fruit’ such as ‘orange’ juice. For products manufactured
from two or more fruits the product names shall be
supplemented by a list of the fruits used, in descending
order of the volume of the fruit juices or purées
included. However, in the case of products
manufactured from three or more fruits, the indication
of the fruits used may be replaced by the words
‘several fruits’ or a similar wording, or by the
number of fruits used
4.3.1 Legislation
•
Directive 2001/112/EC relating to fruit juices and certain
similar products intended for human consumption.
•
European Communities (Marketing of Fruit Juice and
Certain Similar Products) Regulations, 2003 (S.I. No.
240 of 2003).
•
fruit juices which have been sweetened by the
addition of sugars, the sales name shall include the
word ‘sweetened’ or ‘with added sugar’, followed
by an indication of the maximum quantity of sugar
added, calculated as dry matter and expressed in
grams per litre
•
the restoration of fruit juices and similar products to
their original state, by means of the substances strictly
necessary for this operation, shall not entail an
obligation to enter on the labels a list of the ingredients
used for this purpose. However, the addition to fruit
juice of extra pulp or cells shall be indicated on the
labelling
•
without prejudice to QUID requirements (Directive
2000/13/EC, Section 2.1.5.3), for mixtures of fruit juice
and fruit juice from concentrate, and for fruit nectar
obtained entirely or partly from one or more
concentrated products, the labelling shall bear the
words ‘made with concentrate(s)’ or ‘partially
made with concentrate(s)’, as appropriate. That
information shall be entered close to the product name,
standing out well from any background, in clearly visible
characters
4.3.2 Introduction to fruit juices
Directive 2001/112/EC repealed Directive 93/77/EEC and
prescribes and harmonises within the European Union,
standards for the composition and labelling of fruit juices
and certain similar products. The Community provisions
regarding fruit juices were recast in order to make the rules
on manufacturing and marketing conditions for fruit juices
and similar products more accessible and in line with
general Community legislation on foodstuffs, particularly
legislation on labelling, colouring matter, sweeteners and
other authorised additives.
One of the main changes introduced by the new legislation
is the fact that ‘fruit juice from concentrate’ must be called
as such now under its sales name (rather than the
declaration “made from concentrate”). This provision will
help consumers to differentiate between fruit juice and fruit
juice from concentrate and therefore inform them of the
true nature of their purchase
The Department of Agriculture, Fisheries and Food in
conjunction with the FSAI has produced a guide on the
“Labelling of Fruit Juices and Related Products” and should
be consulted for a more detailed guide to the legislation.
It is available at www.fsai.ie/publications.
the prescribed names for fruit juices and similar
products as listed and defined in the Directive must
be used in trade as the name of the product such as
‘fruit juice’, ‘fruit juice from concentrate’, ‘fruit
nectar’ etc. However, by way of derogation, certain
designations have been recognised as the product
name in the language and under the conditions laid
down such as ‘vruchtendrank’ for fruit nectars
in German
As ‘fruit juice’ and ‘fruit juice from concentrate’ are
considered two separate products (having their own
legal names) where they are ingredients in a composite
product, they must appear in the list of ingredients
under their own designation.
73
•
•
for fruit nectars, the labelling shall indicate the
minimum content of fruit juice, fruit purée or any
mixture of those ingredients, by the declaration ‘fruit
content: … % minimum’. That information shall be
located in the same field of vision as the product name
the labelling of concentrated fruit juice not intended for
delivery to the final consumer shall bear a reference
indicating the presence and quantity of added sugars,
or added lemon juice or acidifying agents (as permitted
by Directive 95/2/EC on food additives other than
colours and sweeteners). This reference shall appear
on the packaging, on a label attached to the packaging
or on an accompanying document.
Ireland permits the addition of vitamins and minerals
to fruit juices and similar products defined above in
accordance with Directive 90/496/EEC on nutrition
labelling (Section 2.3).
on fruit juices are the responsibility of the Food Division,
4.4.2 Introduction to caseins and caseinates
Caseins are the principal protein of milk and caseinates
are the products obtained by drying caseins treated with
neutralizing agents. These rules regulate the composition
and manufacturing characteristics of caseins and caseinates
intended for human consumption either as such or
incorporated in another foodstuff and the labelling and
marking of edible caseins, caseinates and mixtures of these.
4.4.3 Labelling
The product names ‘edible acid casein’, ‘edible rennet
casein’ and ‘edible caseinates’ are reserved for the
products defined in the Directive. These names must be
used in trade as the name of the product. It is unlawful to
use them for any product unless it complies with the
prescribed heat-treatment process and technological
adjuvants and bacterial cultures.
Casein and caseinates must delare the following on the
package, containers or label:
a) the reserved name as above and in the case of
caseinates an indication of the cation or cations.
b) products marketed as mixtures:
following agencies, pursuant to their service contract
with the FSAI, for the purposes of ensuring compliance
•
Executive
•
4.4
CASEINS AND CASEINATES
4.4.1 Legislation
•
Council Directive 83/417/EEC relating to certain
lactoproteins (caseins and caseinates) intended for
human consumption.
•
the words ‘mixture of …….’ followed by the
names of the different products which make
up the mixture, in decreasing order of weight,
•
an indication of the cation or cations in the case
of caseinate(s),
•
the protein content in the case of mixtures
containing caseinates.
c) the quanity in metric (or where specifically authorised
in imperial units until December 2009)
d) the name or business name and the address of the
within the Community. In the case of national
production Member States may maintain national
provisions requiring details of the manufacturing or
packaging establishment to be mentioned.
e) country of origin where the products have been
imported from third countries
•
f)
European Communities (Caseins and Caseinates)
the date of manufacture or similar marking to identify
the batch.
Certain particulars a), b), e) and f) must be in language
easily understood by the purchaser. In addition, certain
particulars need only appear on the accompanying
documents. Further derogations are also provided for
products transported in bulk.
All of the labelling requirements must be clearly visible,
easily legible and in indelible characters.
4
74
casein and caseinates are the responsibility of Milk Policy,
The following information must appear on the package,
container or label of honey and the information must be
conspicuous, clearly legible and indelible:
•
These Regulations are enforced by the FSAI. Officers
authorised under these Regulations by the Minister of
Agriculture, Fisheries and Food may also enforce these
provisions.
the prescribed names as listed and defined in the
Directive such as ‘blossom honey’ must be used in
trade to designate the product or the simple product
name ‘honey’ may replace the prescribed name (except
in the case of ‘filtered honey’, ‘comb honey’, ‘chunk
honey’ or ‘cut comb in honey’ and ‘baker's honey’)
4.5
–
for baker's honey, the words ‘intended for cooking
only’ shall appear on the label in close proximity to
the product name
–
for filtered honey and baker's honey, under certain
circumstances the product names may be
supplemented by information on:
HONEY
4.5.1 Legislation
•
Directive 2001/110/EC relating to honey
Corrected by:
Corrigendum to Council Directive 2001/110/EC of 20
December 2001 relating to honey.
•
European Communities (Marketing of Honey)
Products can only be marketed as ‘honey’ if they comply
with the definition and compositional requirements as set
out in the Directive.
°
regional, territorial or topographical origin,
°
specific quality criteria.
where baker's honey has been used as an ingredient in
a compound foodstuff, the term ‘honey’ may be used
in the product name only of the compound food
instead of the term ‘baker's honey’ (however, this
exemption does not apply to the list of ingredients)
•
the country or countries of origin where the honey has
been harvested shall be indicated on the label.
However, if the honey originates in more than one
Member State or third country, that indication may be
replaced with one of the following, as appropriate:
These rules prescribe standards for the composition and
labelling of honey. Compositional criteria are laid down in
respect of sugar content, fructose and glucose content,
moisture content, water-insoluble content, electrical
conductivity and free acid.
4.5.3 Labelling requirements
its floral or vegetable origin,
•
4.5.2 Introduction to honey
Directive 2001/110/EC on honey repeals and replaces
Directive 74/409/EEC. European Communities (Marketing of
Honey) Regulations, 2003 revokes the previous Regulations
and implements the Directive 2001/110/EC.
°
–
‘blend of EC honeys’
–
‘blend of non-EC honeys’
–
‘blend of EC and non-EC honeys’.
on honey are the responsibility of the Horticulture
•
•
Environmental Health Department of the Health
Service Executive.
75
4.6
SUGARS
•
4.6.1 Legislation
•
Directive 2001/111/EC relating to certain sugars
intended for human consumption.
•
European Communities (Marketing of Sugar Products)
4.6.2 Introduction to sugars
Directive 2001/111/EC repeals and replaces Council
Directive 73/437/EEC. European Communities (Marketing
of Sugar Products) Regulations, 2003 revokes the previous
Food Standards (Certain Sugars) Regulations, 1975 and
1981 and implements the Directive.
This legislation defines several kinds of sugar such as white
sugar, glucose syrup and fructose and sets down rules for
their labelling and packing. These provisions however, do
not apply when the products take the form of icing sugars,
candy sugars or sugars in loaf form.
4.6.3 Labelling
where glucose syrup or dried glucose syrup contain
fructose in proportions greater than 5% on a dry matter
basis, they shall, in respect of their product name and
as ingredients, be labelled as ‘glucose-fructose syrup’
or ‘fructose-glucose syrup’ and ‘dried glucose-fructose
syrup’ or ‘dried fructose-glucose syrup’, respectively, to
reflect whether the glucose component or the fructose
component is in greater proportion.
The policy functions in relation to the Regulations on sugars
are the responsibility of the Crops Policy and State Bodies
these Regulations:
•
•
Executive.
4.7
DEHYDRATED PRESERVED MILK
4.7.1 Legislation
The following labelling provisions apply to sugars:
•
the prescribed names as listed and defined in the
Directive such as ‘semi-white sugar’ must be used in
trade to designate the products. The prescribed name
‘sugar’ or ‘white sugar’ can also be used as the name
for ‘extra-white sugar’.
•
Qualifying terms that are commonly used are also
permitted in addition to the compulsory products name.
In addition, the prescribed names may also be used in
product names made up to designate other products,
in accordance with custom. In both cases, the ‘names’
must not be liable to mislead the consumer.
•
•
pre-packaged products weighing less than 20g are not
required to declare net weight.
The following information must also appear on the label:
•
•
the dry matter and invert sugar content of sugar
solution, invert sugar solution and invert sugar syrup
the qualifying term ‘crystallised’ for invert sugar syrup
incorporating crystals in the solution
Council Directive 2001/114/EC relating to certain partly
or wholly dehydrated preserved milk for human
consumption.
European Communities (Dehydrated Preserved Milk)
4.7.2 Introduction to dehydrated preserved milk
Council Directive 2001/114/EC repeals and replaces Council
Directive 76/118/EEC relating to certain partly or wholly
dehydrated preserved milk for human consumption.
European Communities (Dehydrated Preserved Milk)
Regulations, 2003 (S.I. No. 298 of 2003) gives effect to
Directive 2001/114/EC and revokes the previous Dehydrated
Preserved Milk Regulations, 1980 to 1990.
The new requirements bring Directive 2001/114/EC into
line with general Community legislation on foodstuffs,
particularly legislation on labelling, authorised additives,
hygiene and health rules. The rules relating to partly or
wholly dehydrated preserved milk for human consumption
detail the compositional requirements for different types
of dehydrated milk, the use of reserved descriptions,
manufacturing specifications and the labelling of products.
4
76
4.7.3 Labelling
The prescribed names as listed and defined in the Directive
such as ‘condensed milk’ and ‘whole milk powder’
must be used in trade to designate the products. However,
a number of other prescribed names have been permitted
for use as trade names across the various Member States.
For labelling in English:
dehydrated preserved milk are the responsibility of the
Milk Policy Division, Department of Agriculture, Fisheries
and Food.
•
the term ‘evaporated milk’ denotes the product
‘condensed milk’ where it contains, by weight, at least
9% fat and 31% total milk solids
•
the term ‘evaported semi-skimmed milk’ denotes
the product ‘condensed partly skimmed milk’ where it
contains, by weight, between 4% and 4.5% fat and not
less than 24% total solids
•
the term ‘semi-skimmed milk powder’ or ‘dried
semi-skimmed milk’ denotes the product ‘dried partly
skimmed milk’ with a fat content of between 13% and
26%.
•
•
Executive.
4.8
FRUIT JAMS, JELLIES, MARMALADES
AND SWEETENED CHESNUT PURÉE
4.8.1 Legislation
The labelling must state the percentage of milk fat,
expressed by weight in relation to the finished product.
This requirement is not applicable to unsweetened and
sweetened condensed skimmed milk and skimmed milk
powder. The percentage fat-free dried milk extract must
also be given for partly dehydrated milk products. Both
of these labelling particulars must be appear near the
trade name.
Directive 2001/113/EC relating to fruit jams, jellies and
marmalades and sweetened chestnut puree intended for
human consumption.
Totally dehydrated milk products must state:
4.8.2 Introduction to fruit jams
•
the recommendations as to the method of dilution
or reconstitution, including details of the fat content
of the product when diluted or reconstituted
•
that the product is ‘not intended as a food for
infants under 12 months’.
Directive 2001/113/EC revokes and replaces Directive
79/693/EEC on fruit jams, jellies and marmalades and
sweetened chestnut puree. The Marketing of Fruit Jams
Regulations, 2003 revokes the previous 1982 Regulations
and gives legal effect to Directive 2001/113/EC.
Products weighing less than 20kg per unit that are
packaged in outer packaging, the mandatory particulars
above need only appear on the outer package except for
the reserved name.
European Communities (Marketing of Fruit Jams, Jellies,
Marmalades and Sweetened Chestnut Puree) Regulations,
2003 (S.I. No. 294 of 2003).
The legislation prescribes and harmonises, within the
European Union, standards for the composition and
labelling of fruit jams, jellies, marmalades and sweetened
chestnut puree products. The provisions do not apply to
products intended for the manufacture of fine bakery
wares, pastries or biscuits. For the purposes of this
Directive, tomatoes, the edible parts of rhubarb stalks,
carrots, sweet potatoes, cucumbers, pumpkins, melons
and watermelons are considered as fruit.
The Department of Agriculture, Fisheries and Food, in
conjunction with the FSAI, has produced a comprehensive
leaflet on the “Labelling of Jams, Jellies and Marmalades
and should be consulted for further information. It is
available at www.fsai.ie/publications.
77
4.8.3 Labelling
The prescribed names as listed and defined in the Directive
such as ‘jam’ and ‘marmalade’ must be used in trade to
designate the products. Products cannot be marketed
unless they comply with the definitions for these products.
However, these prescribed product names may be used to
designate other products in accordance with custom such
as ‘jelly’ provided it cannot be confused with ‘jelly’ as
defined in the Directive.
The product names shall be supplemented by an
indication of the fruit or fruits used, in descending order
of weight of the raw materials used. However, for products
manufactured from three or more fruits, the indication of
the fruits used may be replaced by the words ‘mixed fruit’
or a similar wording, or by the number of fruits used.
The following must also appear on the label:
•
•
•
the fruit content* by including the words ‘prepared
with … g of fruit per 100g’ of the finished product,
after deduction of the weight of water used in
preparing the aqueous extracts, if appropriate
the total sugar content* by the words ‘total sugar
content … g per 100g’, the figure indicated
representing the value determined by refractometer at
20°C for the finished product, subject to a tolerance of
±3 refractometric degrees. The sugar content need not,
however, be indicated where a nutrition claim is made
for sugars on the labelling pursuant to Directive
90/496/EEC on nutrition labelling (Section 2.3)
where the residual content of sulphur dioxide is more
than 10mg/kg, its presence shall be indicated on the list
of ingredients.
The policy functions in relation to the Regulations on fruit
jams are the responsibility of the Food Division, Department
of Agriculture, Fisheries and Food.
these Regulations:
•
•
Executive.
4.9
NATURAL MINERAL WATERS,
SPRING WATERS AND OTHER
BOTTLED WATERS
4.9.1 Legislation
•
Council Directive 80/777/EEC regarding the exploitation
and marketing of natural mineral waters
Amended by:
Council Directive 96/70/EC.
•
Commission Directive 2003/40/EC on establishing the
list, concentration limits and labelling requirements for
the constituents of natural mineral waters and the
conditions for using ozone-enriched air for the
treatment of natural mineral waters and spring waters
•
Council Directive 98/83/EC on the quality of water
•
European Communities (Natural Mineral Waters, Spring
Waters and Other Waters in Bottles or Containers)
4.9.2 Introduction to natural mineral waters,
spring waters and other bottled waters
Council Directive 80/777/EEC and its amendment set rules
regarding the exploitation and marketing of natural mineral
waters. Commission Directive 2003/40/EC establishes the
list of constituents of natural mineral waters which may
present a risk to public health as well as labelling
requirements for certain constituents. It also defines the
conditions for using ozone-enriched air for separating
certain compounds and appropriate labelling provisions.
The 2007 Regulations repeal and replace the 2005
Regulations and implements the European Directives above
as well Council Directive 98/83/EC on the quality of water
intended for human consumption which relate to "other
waters in bottles or containers".
There are three types of water which can be bottled:
•
natural mineral water
•
spring water
•
all other waters.
* The declaration of fruit content and total sugar content must appear in clearly visible characters and the same visual field as the product name.
4
78
Natural mineral water
Under the Directive, a natural mineral water is defined
as a ‘microbiologically wholesome water originating in an
underground water table or deposit and emerging from a
spring tapped at one or more natural bore exits’. It is clearly
distinguished from ordinary drinking water by its nature as
a result of its mineral content, its constituents and its
original state. Natural mineral waters must not be subjected
to any treatment or addition although there are some
exemptions such as the introduction of carbon dioxide
under special conditions.
A natural mineral water may only be exploited subject to
permission from the responsible authority of the country
where the water has been extracted. In Ireland the
responsible authority is the National Standards Authority of
Ireland (NSAI). The NSAI has produced an Irish Standard
432:2005 on Packaged Water which covers water that is
placed in a sealed container or package and is offered for
sale, or supply for human consumption. Compliance with
this standard is voluntary on the part of producers (Further
information is available at www.nsai.ie).
The natural mineral water rules apply to water extracted
from the ground in any Member State of the EU as well as
to 3rd country imports. A list of all approved natural
mineral waters is published in the Official Journal of the
European Communities (available at www.europa.eu.int
and www.fsai.ie).
The natural mineral water rules do not effect the use
of natural mineral waters and spring waters in the
manufacture of soft drinks. The rules also do not apply to:
•
waters which are medicinal products (according to
European Directive 2001/83/EC as amended on the
Community code relating to medicinal products for
human use see Section 2.1.4.4)
•
natural mineral waters used at source for curative
purposes in thermal or hydromineral establishments or
•
natural mineral waters for export to countries outside
the European Union.
4.9.3 Labelling: natural mineral waters
The packaging or container of a natural mineral water must
be fitted with closures designed to avoid adulteration and
contamination.
The label of a natural mineral water must state the
following:
(i) the label must declare the sales description ‘natural
mineral water’ as defined in the Directive or for
effervescent natural mineral waters the sales names:
•
‘naturally carbonated natural mineral water’
i.e. any water whose carbon dioxide content is the
same from the spring after decanting and bottling
as it is at source or
•
‘natural mineral water fortified with gas from
the spring’ i.e. any water whose carbon dioxide
content from the spring after decanting and
bottling is greater than that at source or
•
‘carbonated natural mineral water’ i.e. any
water to which carbon dioxide has been added
other then the spring from which the water comes.
Spring water
‘Spring Water’ is a description reserved for water which is
intended for consumption in its natural state, comes from
an underground source, protected from all risk of pollution
and is bottled at source. Only very limited treatments are
permitted. Water which does not meet the requirements of
a natural mineral water but is a spring water must comply
with the natural mineral waters legislation above and with
the rules on drinking water.
All other water in bottles and containers
Water which is intended for human consumption and is not
a natural mineral water or a spring water and is placed on
the market in either bottles or containers must be free from
any micro-organism and parasites and from any substances
which in numbers or concentrations, constitute a potential
danger to human health. 'Other waters' must meet the
minimum requirements set out in the legislation.
Natural mineral waters which have undergone total or
partial elimination of free carbon dioxide exclusively by
physical methods must supplement the sales description
with the words ‘fully de-carbonated’ or ‘partially
de-carbonated’ as appropriate.
(ii) a statement of the analytical composition detailing the
characteristic constituents of the natural mineral water
79
(iii) the place where the spring is exploited and the name of
the spring. The place where the natural mineral water
spring is exploited or the name of the locality may
appear in the trade description provided the spring is
exploited at that place and this does not mislead the
consumer with regard to the place of exploitation of
the spring.
Where the trade description is different from the name
of the spring or its place of exploitation, the name of
the spring on the label or anywhere during its
advertisement must be one and half times the height
and width of the letters of the trade description.
4.9.4 Labelling: spring waters
The term ‘spring water’ is reserved for water that
is intended for human consumption in its natural state
and bottled at source. It must adhere to certain conditions
of exploitation, microbiological requirements, labelling
provisions and a limited number of permitted treatments
(according to Directives 80/777/EEC as amended). However,
spring waters must also comply with the provisions of
Directive 80/778/EC relating to the quality of water
Labels of spring water must detail the following:
(iv) details of certain permitted treatments undergone.
(i) the place where the spring is exploited and the name
of the spring.
It is not permitted for labels, packaging or advertising of
natural mineral waters to use designations, proprietary
names, trade marks, brand names, illustrations etc. which
suggest the natural mineral water has characteristics which
the water does not possess especially regarding its origin,
date of authorisation of exploitation, results of analysis or
guarantees of authenticity.
The place where the spring is exploited or the name of the
locality may appear in the trade description provided the
spring is exploited at that place and this does not mislead
the consumer with regard to the place of exploitation
of the spring.
It is prohibited to market more than one natural mineral
water from the same source under a different trade
description.
In addition, and in accordance with Directive 2003/40/EC
the label of a natural mineral water with a fluoride
concentration exceeding 1.5mg/l must declare:
•
the words ‘contains more than 1.5mg/l of fluoride:
not suitable for regular consumption by infants
and children under 7 years of age’. This
information must be in the immediate proximity to the
trade name in clearly visible characters and
•
the actual fluoride content in relation to the physicochemical composition in terms of its essential
constituents (as per point (ii) above).
The labelling of natural mineral waters which have been
treated with ozone-enriched air shall bear the words
‘water subjected to an authorised ozone-enriched
air oxidation technique’ in proximity to the analytical
composition of characteristic constituents.
Where the trade description is different from the name
of the spring or its place of exploitation the name of the
spring on the label or anywhere during its advertisement
must be one and half times the height and width of the
letters of the trade description.
(ii) details of certain permitted treatments undergone.
The packaging, labels or advertising of spring waters
must not use designations, proprietary names, trade
marks, brand names, illustrations or other signs whether
emblematic or not, which are liable to cause confusion
with natural mineral waters, in particular the description
‘mineral water’.
It is prohibited to market more than one spring water from
the same source under a different trade description.
In addition, and in accordance with Directive 2003/40/EC
the labelling of spring waters which have been treated with
ozone-enriched air shall bear the words ‘water subjected
to an authorised ozone-enriched air oxidation
technique’ in proximity to the analytical composition
of characteristic constituents.
4
80
4.9.5 Labelling: other waters in bottles
and containers
National provisions not derived from European
legislation
The packaging, labels or advertising of other waters
must not use designations, proprietary names, trade
marks, brand names, illustrations or other signs whether
emblematic or not, which are liable to cause confusion
with natural mineral waters, in particular the description
‘mineral water’.
•
natural mineral waters, spring waters and other waters are
the responsibility of the Food Unit, Department of Health
and Children.
these Regulations:
•
National Standards Authority of Ireland (NSAI)
•
Executive.
Health (Country of Origin of Beef) Regulations 2006
(S.I. No. 307 of 2006).
4.10.2 Introduction to beef and beef products
The Regulations require a mandatory traceability system
for all E.U. bovines from farms to slaughterhouses and a
mandatory system of traceability and origin labelling for
beef from slaughterhouses to end consumers. This labelling
system for beef consists of two elements, a compulsory
beef labelling system and a voluntary beef labelling system,
with the objective of providing maximum transparency
during the marketing of beef.
The requirements apply to all fresh or frozen beef, either
carcasses, de-boned meat, cut meat or minced meat, which
are marketed in the E.U. The information required under
the Beef Labelling Regulations should be applied to or
attached to individual pieces of meat or to their packaging
material. Where beef is not wrapped, the information is
required to be provided in a written and visible form to the
consumer at point of sale.
Two guides have recently been published by the FSAI:
PART B: COMMON
MARKETING STANDARDS
•
“Guidance on beef labelling” which outlines in detail
the requirements for the labelling of beef (available at
www.fsai.ie/industry) and
4.10 BEEF AND BEEF PRODUCTS
(INCLUDING MINCED BEEF)
•
“Guidance Note 17: The labelling of meat” which
provides an overview of the legislative requirements for
the documentation and labelling of all meats including
beef (available at www.fsai.ie/publications).
4.10.1 Legislation
•
Council Regulation (EC) No. 1760/2000 establishes
a system of identification and registration of bovine
animals and the labelling of beef and beef products
•
Commission Regulation (EC) No. 1825/2000 laying
down detailed rules for the application of Regulation
(EC) No. 1760/2000 as regards the labelling of beef
and beef products
Amended by:
Commission Regulation (EC) No. 275/2007 as regards
the labelling of beef and beef products.
•
European Communities (Labelling of Beef and Beef
Products) Regulations, 2000 (S.I. No. 435 of 2000)
Amended by:
European Communities (Labelling of Beef and Beef
Products) Regulations, 2002 (S.I. No. 485 of 2002).
These guides should be consulted for a more detailed
account of the labelling of meat including beef.
4.10.3 Labelling: compulsory beef labelling system
Compulsory beef labelling requires operators or
organisations to label beef with specific information
at all stages of marketing up to and including the point
of sale to the consumer. It should be noted that where
the ‘name of country’ is required on the label this means
that either the name of the Member State or the name
of the third country (a country outside the European Union)
must be provided.
81
Operators or organisations are required to label beef with
the following information:
1) the reference number or code of the animal or group
of animals from which the beef was derived
2) the country of the slaughterhouse and approval
number. The indication should read:- ‘Slaughtered in
(name of country) (approval number)’.
3) the country of the cutting hall and approval
number. The indication should read:- ‘Cutting in
(name of country) (approval number)’.
Minced meat
There is an exception to the compulsory beef labelling
system for minced beef. An operator or organisation
preparing minced beef can indicate on the label:
•
‘prepared in (name of country)’ depending on
where the meat was prepared
•
‘origin (name of country)’ where the country or
countries of origin are not the same as the country
of preparation
•
a reference number or reference code ensuring the
link between the meat and the animal or group of
animals and
•
the name of the country where the animal was
slaughtered.
4) Origin of the beef.
(i) If the beef is derived from animals born, raised and
slaughtered in the same country, the indication on
the label may be given as “Origin: (name of
country)”.For example, ‘Origin: Ireland’
(ii) If the beef is derived from animals from different
countries the label must indicate:
•
country of birth
•
country (or countries) of fattening
•
country of slaughter
e.g. ‘Born in France’‘Reared in France’ ‘Slaughtered
in Ireland’.
In addition, an operator or organisation preparing minced
beef may add the following to the label:
•
one or more of the compulsory indications above for
beef if they wish, such as where fattening took place
and
•
the date on which it was prepared.
Operators and organisations involved in the production and
marketing of beef, when implementing the requirements of
the compulsory beef labelling system should ensure that a
system is in place to guarantee the accuracy of the
information on the labels.
Trimmings and cut meats
As a result of problems encountered by producers of cut
meats and trimmings and producers of minced meat in the
practical application of the Regulations on the labelling of
beef and beef products, Commission Regulation (EC) No.
275/2007 was adopted. In order to resolve the vast
majority of these issues, Regulation (EC) No. 275/2007
redefines the size and composition of an animal group
while ensuring traceability.
Experience has also shown that operators often have
difficulties in applying the labelling provisions in outlets
for the sale of non pre-packaged cut meats to the final
consumer. In this respect, the Regulation (EC) No. 275/2007
sets out additional labelling requirements for trimmings,
pre-packaged cut meat and non pre-packaged cut meat.
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Beef from third countries
By way of derogation, beef imported into the Community
for which not all the information referred to above is
available, shall be labelled with the words:
•
‘Origin: non-EC’; ‘Slaughtered in (name of third
country).
Labelling where information is not available
Approval by the Department of Agriculture, Fisheries and
Food of the information to be provided on the label will
depend on the application submitted by the operator or
organisation indicating:
•
the information to be included on the label
•
the measures to be taken by the operator or
organisation to ensure the accuracy of the information
•
the control system to be applied at all stages from
production through to the point of sale including
checks to be carried out by an independent control
body designated by the applicant for this purpose.
These bodies must comply with the criteria set out in
European Standard EN/45011.
Meat derived from animals born in the Community before
1st January 1998, where there is no information regarding
the place of birth and/or the place of rearing, the label
should state:
•
‘Born before 1st January 1998’.
Meat derived from animals imported live into the
Community where there is no information regarding the
place of birth and/or the place of rearing, the label should
state:
For example, labels wishing to contain the following type of
information, relating to the animals from which the beef
was produced, must be approved:
•
method of fattening
•
information on slaughtering, e.g. age at slaughter or
date of slaughter, sex
•
method or length of maturation of beef
Simplification of the indication or origin
•
breed
Beef derived from animals that have been reared for
30 days or less in the country of birth or the country
of slaughter, are not required to have this country on
the label provided that the animal has been reared for
a period longer than 30 days in another country (i.e. the
country where the animal spent the longest period
of time appears on the label).
•
other information not easily checked at point of sale.
•
‘Live import into the EU’ or ‘Live import from
(name of 3rd country).
4.10.4 Labelling: voluntary beef labelling system
Council Regulation (EC) No. 1760/2000 permits operators
to put additional information on labels. Operators wishing
to place information on the label additional to the
requirements of the compulsory labelling system must
first submit an application for approval to the competent
authority where the sale or production of the beef takes
place. In Ireland it is the responsibility of the Department
The competent authority is obliged to examine the
application thoroughly, particularly to ensure that the
traceability system is capable of verifying the information on
the label. The costs of the controls carried out by an
independent control body must be borne by the operators.
4.10.5 County of origin of beef for caterers
The Department of Health and Children introduced national
legislation to better inform consumers on the origin of beef
sold to consumers by the service sector (restaurants,
canteens and similar premises). The Health (Country of
Origin of Beef) Regulations, 2006 (S.I. No. 307 of 2006)
as amended, require caterers serving beef to clearly identify
the country or countries of origin of the beef on any
advertisement, menu or other presentation used.
The FSAI has produced an information leaflet entitled
“Advice for Caterers on the Country of Origin Beef
Labelling Requirements” and is available at
www.fsai.ie/publications/index.asp#leaflets.
beef labelling are the responsibility of the Meat Policy
and Meat Hygiene Divisions, Department of Agriculture,
Fisheries and Food.
83
these Regulations:
•
•
Executive
•
4.11.3 Labelling
Only milk fats, fats and fats composed of plant and/or
animal products adhering to the prescribed compositional
requirements are covered by this Regulation. The
spreadable fats must declare the following information
in the labelling and presentation of the products:
•
Local Authorities.
Derogations to the sales descriptions for spreadable
fats are permitted for traditional products or where
the designations are used to describe characteristic
qualities of a product, including the following English
language terms:
4.11 SPREADABLE FATS
4.11.1 Legislation
•
‘Brandy butter’, ‘sherry butter’ or ‘rum butter’: for
a sweetened alcoholic product with a minimum
milk-fat content of 20%; and
Council Regulation (EC) No. 2991/94 laying down the
standards for spreadable fats
Implemented by:
Commission Regulation (EC) No. 445/2007 laying down
certain detailed rules for the application of Council
Regulation (EC) No. 2991/94 laying down standards for
spreadable fats and of Council Regulation (EEC) No.
1898/87 on the protection of designations used in the
marketing of milk and milk products - Codified version.
‘Buttercream’: for a sweetened product with a
minimum milk-fat content of 22.5%.
•
the total percentage fat content by weight at the time
of production (the average fat content must be
declared without the use of decimals),
•
the vegetable, milk or other animal fat content in
decreasing order of weighted importance as a
percentage by total weight at the time of production
for compound fats composed of plant and/or animal
products and
•
the percentage salt content in a legible manner in the
list of ingredients.
•
legislation.
4.11.2 Introduction to spreadable fats
Regulation (EC) No. 2991/94 sets compositional
requirements for a wide range of spreadable fats, from
dairy fats, to the more diverse mixtures of dairy and
vegetable fats. Detailed rules for its application are set in
Commission Regulation (EC) No. 445/2007.
Regulation (EC) No. 445/2007 is a codified version of
previous rules and was adopted in order to ensure the
consistency between Community legislation, namely
Regulation (EC) No. 2991/94 and (EEC) No. 1898/87
(Section 4.12). The aim of the latter two Regulations is
essentially the same, namely to avoid any confusion in the
mind of the consumer as to the true nature of the products
in question. Therefore, the use of the designation ‘butter’
should be regulated in a single text.
the sales description as defined in the Regulation such
as ‘Butter’, ‘Margarine’ and ‘Dairy Spread X%’
The information provided on the label must be easy to
understand and marked in a conspicuous place in such
a way as to be easily visible, clearly legible and indelible.
The following may be provided on the label in addition to
the mandatory requirements:
•
the sales description may be used in conjunction with
one or more terms to define the plant and/or animal
species from which the product originates, or the
intended use of the product or the production methods
used as long as these terms are not in contradiction
with other Community provisions such as Protected
Geographical Indication (see Section 4.23)
•
the term ‘vegetable’ may be used in addition to
the sales description of certain fats provided that the
product contains only fat of vegetable origin with
a tolerance of 2% of the fat content of animal fats
•
the sales description ‘minarine’ or ‘halvarine’ may be
used for half-fat margarine products
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84
•
•
the term ‘reduced fat’ may be used to replace the
term ‘three-quarter-fat’ or used for products where
the fat content is between 41% and 62% and
4.12 MILK AND MILK PRODUCTS
the term ‘low fat’ or ‘light’ may be used to replace
the term ‘half-fat’ or used for products where the fat
content is less than 41%.
4.12.1 Legislation
(a) Protection of reserved names
•
Butter
The designation ‘butter’ may be used for composite
products of which an essential part is butter if the end
product contains at least 75% milk fat and has been
manufactured solely from butter and the other added
ingredients mentioned in the description.
Council Regulation (EEC) No. 1898/1987 on the
protection of designations used in marketing of milk
and milk products
Amended by:
Commission Regulation (EEC) No. 222/1988.
Implemented by:
Commission Regulation (EC) No. 445/2007 laying down
certain detailed rules for the application of Council
Regulation (EC) No. 2991/94 laying down standards for
spreadable fats and of Council Regulation (EEC) No
1898/87 on the protection of designations used in the
marketing of milk and milk products - Codified version.
The designation ‘butter’ may also be used for composite
products containing less than 75% butter but at least 62%
milk fat if the other specified requirements are met and if
the product designation includes the term ‘butter
preparation’.
The designation ‘butter’ may be used in association with
a word or words to designate ‘Alcoholic butter’ (butter
containing alcoholic beverages and sugar) where it contains
at least 34% milk fat.
Where the designation ‘butter’ is used in composite
products the milk fat content and the total fat contents
(if the other added ingredients contain fat) must be
indicated in the labelling and presentation of the product in
a conspicuous place and be easily visible and clearly legible.
4.12.2 Introduction to reserved names for milk
and milk products
spreadable fats are the responsibility of the Milk Policy
these Regulations:
•
•
legislation.
Milk is defined as the normal mammary secretion obtained
from one or more milkings without either addition thereto
or extraction therefrom. Milk products are defined as
products derived exclusively from milk. Substances
necessary for their manufacture may be added provided
that the substances are not used for replacing any milk
constituents in part or whole.
Council Regulation (EEC) No. 1898/1987 as amended
regulates the protection of designations used in the
marketing of milk and milk products. This Regulation
defines milk and milk products and designates reserved
names exclusively for milk products. The intention of the
Regulation is to detail the difference between milk products
and other food products including those consisting partly of
milk components. (See Section 4.11 regarding Regulation
(EC) No. 445/2007).
85
4.12.3 Labelling
(b) Drinking milk
The term ‘milk’ can only be used in marketing where:
4.12.4 Legislation
•
milk is treated without altering its composition or has
undergone fat standardisation
•
the term is used in association with words used to
describe the milk in relation to its type, grade, origin
and/or intended use or to describe the physical
treatment or the modification in composition to which
it has been subjected provided that the modification is
restricted to an addition or removal of natural milk
constituents.
•
The following terms are reserved exclusively for milk
products:
•
the designations: whey, cream, butter, buttermilk,
butteroil, caseins, anhydrous milkfat (AMF),
cheese, yoghurt, kephir, and koumiss and
•
designations or names used for milk products according
to the Labelling Directive 2000/13/EC (see Appendix II).
However, this provision does not apply to the designation
of products the exact nature of which is clear from
traditional usage and/or when the designations are clearly
used to describe a characteristic quality of the product.
The term ‘milk’ and and the designations used for milk
products may also be used in association with other words
to describe composite products where the milk constituents
are not replaced and where milk or milk products form an
essential part of the product (in terms of quantity or
characterization of the product).
The origin of milk and milk products must be stated
if it is not from a bovine source such as ‘goats milk’.
Products other than milk and the reserved designations
above may not claim, imply or suggest in the labelling,
advertising or presentation of a product that it is a dairy
product. However, in the case of a product containing
milk or a milk product, the name ‘milk’ or the reserved
designations above may only be used to describe the raw
materials as would be listed in the list of ingredients.
Council Regulation (EC) No. 2597/1997 lays down
additional rules on the common organisation of the
market in milk and milk products for drinking milk
Amended by:
Council Regulation (EC) No. 1602/1999 laying down
additional rules on the common organisation of the
market in milk and milk products for drinking milk.
4.12.5 Introduction to drinking milk
This Regulation ensures that milk products contain at least
the natural protein content of milk and to permit
enrichment of drinking milk with milk proteins, mineral salts
or vitamins or the reduction of its lactose content. It also
lays down requirements concerning the composition of
drinking milk.
The European Regulations were implemented by the
European Communities (Hygienic Production and Placing on
the Market of Raw Milk, Heat-Treated Milk and Milk-Based
Products) Regulations, 1996 (S.I. No. 9 of 1996). However,
the 1996 Regulations have now been repealed by European
Communities (Food and Feed) Regulations, 2005 (S.I. No.
910 of 2005) see Section 5.
4.12.6 Labelling
The following sales descriptions shall be used for drinking
milk, which is intended for delivery to the consumer
without further processing:
•
‘Raw milk’ – milk that is not heated at above 40°C
or treated otherwise but having an equivalent effect
•
‘Whole milk’ – heat treated milk which is either
(a) fat standardised whole milk with a minimum 3.5%
milk fat or
(b) non fat standardised whole milk with a minimum
3.5% milk fat where the milk fat content has not
been altered since the milking stage
•
‘Semi-skimmed milk’ – heat treated milk with its fat
content reduced to a minimum of 1.5% and a
maximum 1.8%
•
‘Skimmed milk’ – heat treated milk with a fat content
reduced to a maximum of 0.5%.
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86
The following modifications to drinking milk are permitted:
4.13.2 Introduction to quick frozen food
a) modification of the natural fat content by the addition
or removal of cream or the addition of whole, semiskimmed or skimmed milk in order to meet the milk fat
criteria set out above
Quick freezing is a rapid freezing process designed to
preserve the characteristics of foodstuffs by ensuring a
temperature of –18oC or lower is reached at all points of
the product. At this temperature all microbiological activity
likely to impair the quality of a foodstuff is suspended.
However, it is necessary to maintain at least that
temperature during the storage and distribution of the
quick-frozen foodstuffs until sale to the ultimate consumer.
Certain temperature increases are inevitable and may be
tolerated provided the tolerances do not exceed 3°C and
provided they do not harm the quality of the products. Air,
nitrogen and carbon dioxide are the only cryogenic
(freezing) media permitted.
b) enrichment of the milk with milk proteins, mineral salts
or vitamins and
c) reduction of the lactose content by conversion to
glucose and galactose.
Modifications to drinking milk according to b) and c) above
are only permitted if the modification is indelibly indicated
on the packing of the product so it can be easily seen and
read.
It should be noted that the provisions of Directive
90/496/EEC on nutrition labelling apply along with the
provisions of the general labelling Directive 2000/13/EC,
where milk or milk products are enriched and/or make a
nutrition claim (see Section 2).
According to the Directive ‘quick-frozen foodstuffs’ are
defined as foodstuffs:
•
which have undergone a freezing process known as
‘quick-freezing’ whereby the zone of maximum
crystalisation is crossed as rapidly as possible depending
on the type of product and where the resultant
temperature of the product (after thermal stabalisation)
is continuously maintained at –18oC or lower at all
points and
•
which are marketed in such a way as to indicate that
they possess this characteristic (such as ‘quick-frozen’).
The policy functions in relation to the EU Regulations
on reserved names for milk and drinking milk are the
responsibility of the Milk Policy Division, Department
•
Products cannot be marketed as ‘quick-frozen’ unless they
comply with the definition above.
The requirements of the Directive do not apply to icecream and other edible ices.
4.13.3 Labelling
4.13 QUICK FROZEN FOODS
4.13.1 Legislation
EU Legislation
•
Council Directive 89/108/EEC relating to quick-frozen
foodstuffs for human consumption.
•
Foods intended for sale to the ultimate consumer or
mass caterer
The following must appear on the label of quick-frozen
foods intended to supply without further processing the
consumer, restaurants, hotels, mass caterers, etc:
•
the term ‘quick-frozen’ added to the sales name
•
the date of minimum durability (defined as the period
during which quick-frozen products may be stored by
the purchaser), the storage temperature and/or the type
of storage equipment required
•
a reference number or an equivalent mark in order to
the identify a batch and
•
a clear declaration: ‘do not refreeze after
defrosting’.
European Communities (Quick-Frozen Foodstuffs)
Regulations 1992 (S.I. No. 290 of 1992)
Amended by:
European Communities (Monitoring of Temperature in
the means of Transport, Warehousing and Storage of
Quick-Frozen Foodstuffs and Sampling Procedure and
Methods of Analysis for Control of the Temperatures of
Quick-Frozen foods intended for human consumption)
87
Quick frozen foodstuffs intended for supply to the ultimate
consumer must be packed by the manufacturer or packer in
suitable pre-packaging which protects them from microbial
or other external contamination and against drying.
4.14 EGGS
Foods not intended for sale to the ultimate consumer
or mass caterer
•
Less restrictive requirements apply where the product is not
intended for sale to the final consumer, restaurants,
hospitals, canteens and other similar mass caterers. The
following shall appear on the label, packaging, container or
wrapping of the products not intended for sale to the
ultimate consumer or mass caterer:
•
the term ‘quick-frozen’ added to the sales name
•
the net quantity in units of mass
•
a reference number or an equivalent mark in order to
the identify a batch and
•
manufacturer, packager or seller established within the
European Union.
This information can appear on the packaging, container,
wrapping or label.
The policy functions in relation to the Regulations on quick
frozen food are the responsibility of the Food Division,
these Regulations:
•
•
•
Resources
•
Local Authorities
•
Office of the Director of Consumer Affairs (authorised
under legislation).
4.14.1 Legislation
EU Legislation
Council Regulation (EC) No. 1028/2006 on marketing
standards for eggs
Implemented by:
Commission Regulation (EC) No. 557/2007 on
marketing standards for eggs.
•
European Communities (Marketing Standards for Eggs)
4.14.2 Introduction to eggs
Regulation (EC) No. 1028/2006 lays down the conditions
for marketing eggs within the Community. It applies to
both eggs produced in the Community and imported from
third countries. The marketing conditions also apply to eggs
for export outside the Community. Regulation (EC) No.
1028/2006 repeals and replaces the previous Regulation
(EEC) No. 1907/1990 from 1st July 2007.
A new implementing Regulation (EC) No. 557/2007 has
recently also been published which sets detailed rules to
implement Regulation (EC) No. 1028/2006, including
detailed labelling requirements and repeal the previous
implementing rules (i.e. Regulation (EC) No. 2295/2003).
Our national Regulations will be required to be amended
accordingly.
The Regulations do not apply to eggs sold directly to the
final consumer by the producer on the production site or
in a local public market or by door-to-door selling in the
region of production. However, such eggs must be marked
with the producer’s distinguishing code (see Section
4.14.3).
Eggs are graded by quality (depending on certain
characteristics such as shell and cuticle shape) into one
of two categories:
•
Class A or ‘fresh’ or
•
Class B.
Class A eggs are also graded by weight as follows.
(a) XL-very large: weight ≥ 73g;
(b) L-large: weight ≥ 63g and < 73g;
(c) M-medium: weight ≥ 53g and < 63g;
(d) S-small: weight < 53g.
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88
4.14.3 Labelling
Marking of eggs
Class A eggs must be marked with the producer code.
Class B eggs must be marked with the producer code
and/or with another indication. Member States may exempt
Class B eggs from this requirement where those eggs are
marketed exclusively on their territory. The marking of eggs
must take place at the production site or at the first
packing centre to which the eggs are delivered.
Other additional indications may also be used, provided
that such indications are not likely to be mistaken for the
weight grading letters or terms and they comply with the
general labelling Directive 2000/13/EC (see Section 2.1).
Where Class A eggs of different sizes are packed together
in the same pack, the minimum net weight of the eggs
shall be given in grams and the indication ‘Eggs of
different sizes’ or equivalent terms shall appear
on the outer surface of the pack.
Marking of eggs delivered directly to the food industry
Eggs sold by the producer to the final consumer on a local
public market in the region of production must be marked
with the producer’s distinguishing code. However, Member
States may be exempt from this requirement for producers
with up to 50 laying hens, provided that the name and
address of the producer are indicated at the point of sale.
It is the responsibility of packing centers to grade and pack
eggs and label their packs.
The producer code (as detailed in the Annex to Directive
2002/4/EC on the registration of establishments keeping
laying hens) must be easily visible and clearly legible and
be at least 2mm high. Where it is not possible for technical
reasons to mark cracked or soiled eggs, marking with the
producer code shall not be compulsory.
Indications on Class B eggs
The marking requirements on eggs shall not apply to eggs
produced in the Community, collected by the food industry
operator for processing until 30th June 2008. Subsequently,
from 1st July 2008, Member States may exempt operators
at their request from the marking of eggs where eggs are
delivered directly from the production site to the food
industry.
Marking of egg packs
Packs containing Class A eggs shall bear on the outer
surface in easily visible and clearly legible type:
(a) the packing centre code
(b) the quality grading: packs shall be identified either
by the words ‘Class A’ or the letter ‘A’ whether alone
or in combination with the word ‘fresh’
The markings on Class B eggs shall be a circle at least
12mm in diameter around the letter ‘B’ at least 5mm high,
or an easily visible colour spot of at least 5mm in diameter.
(c) the weight
Packs marked as ‘extra’
(f) the following special storage condition: an indication
advising consumers to keep eggs chilled after purchase.
The words ‘extra’ or ‘extra fresh’ may be used as an
additional quality indication on packs containing Class A
eggs until the ninth day after laying of the eggs. However,
the laying date and the time limit of nine days shall be
shown on the pack in such a way as to be easily visible
and clearly legible.
(d) the date of minimum durability
(e) the wording ‘washed eggs’ where appropriate
In addition, packs containing Class A eggs shall indicate:
•
For the identification of the farming method, only the
terms listed in Annex I of Regulation (EC) No. 557/2007
are permitted in accordance with specific conditions.
Terms for organic production are also permitted in
accordance with Council Regulation (EEC) No. 2092/91
on organic production (Section 4.22)
Time limits
Eggs must be graded, marked and packed within ten days
of laying. ‘Extra’ or ‘extra fresh’ Class A eggs must be
graded, marked and packed within four days of laying.
The farming method may be complemented by one
of the indications listed in Annex I of Regulation (EC)
No. 557/2007 in accordance with certain requirements
Weight grading
The weight grading shall be indicated by the corresponding
letters or terms as detailed above or by a combination of
both, which may be supplemented by the corresponding
weight ranges, e.g. XL-very large: weight ≥ 73g.
the farming method on the outer surface which must
be easily visible and clearly legible
•
the meaning of the producer code shall be explained
on or inside the pack.
89
Packs containing Class B eggs shall bear on the outer
surface in easily visible and clearly legible type:
(a) the packing centre code
(b) the quality grading: packs shall be identified either
by the words ‘Class B’ or the letter ‘B’
(c) the packing date.
Member States may require, for packs of eggs produced
on their territory, that the labels be affixed in such a way
so as to be broken when opening the packs.
Indication of the date of minimum durability
The date of minimum durability is set at not more than 28
days after laying. Where the period of laying is indicated,
the date of minimum durability shall be determined from
the first day of that period.
Information to be displayed for loose egg sales
For loose egg sales, the following information shall be
given in such a manner as to be easily visible and clearly
legible to the consumer:
(a) the quality gradings
(b) the weight grading
(c) an indication of the farming method
(d) an explanation of the meaning of the producer code
(e) the date of minimum durability.
Industrial eggs
Industrial eggs shall be marketed in packaging containers
with a red band or label.
Those bands and labels shall show:
(a) the name and address of the operator for whom the
eggs are intended
(b) the name and address of the operator who has
dispatched the eggs
(c) the words ‘industrial eggs’ in capital letters 2cm high,
and the words ‘unsuitable for human consumption’
in letters at least 8mm high.
Information displayed on transport packaging
At the production site, each transport packaging containing
eggs shall be identified by the producer by:
(a) the producer’s name and address
(b) the producer code
(c) the number of eggs and/or their weight
(d) the laying date or period
(e) the date of dispatch.
Marking of eggs for cross-border delivery
Eggs delivered from a production site to a collector, a
packing centre or non-food industry situated in another
Member State shall be marked with the producer code
before leaving the production site.
Import of eggs
In accordance with the equivalence of rules (including
regarding marking and labelling, farming methods and
controls), eggs imported from third countries may be
marked with a distinguishing number equivalent to the
producer code. If sufficient controls are not provided,
imported eggs from the third country concerned must bear
a code permitting the identification of the country of origin
and the indication that the farming method is
‘unspecified’.
The policy functions in relation to the Regulations on eggs
are the responsibility of the Department of Agriculture,
Fisheries and Food.
Department of Agriculture, Fisheries and Food, pursuant
to their service contract with the FSAI, for the purposes
of ensuring compliance with these Regulations.
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4.15 WINE
4.15.1 Legislation
EU Legislation
•
Council Regulation (EC) No. 1493/1999 on the common
organisation of the market in wine and its many
amendments
Implemented by:
Commission Regulation (EC) No. 1622/2000 on the
common organisation of the market in wine and
establishing a Community code of oenological
practices and processes and its amendments
–
Amended by
Commission Regulation (EC) No. 389/2007
Application:
Commission Regulation (EC) No. 753/2002 as
regards the description, designation, presentation
and protection of certain wine sector products
and its amendments
–
Quality wines produced in specified regions, known as
“quality wines psr”, are wines that comply with certain
criteria and come from certain areas. Only certain products
are suitable for yielding a quality wine psr and a number
of production rules must be respected. Each Member State
must notify the European Commission of quality wines psr
in their area. The list of quality wines psr is published in the
Official Journal of the European Union. ‘Table wines’ are
generally wines other than quality wines psr where certain
conditions such as vine varieties and alcoholic strength
are met.
Regulation (EC) No. 1493/1999 contains eight Annexes
detailing exactly how wine should be produced and
marketed:
•
Annex I defines product names such as wine, table
wine, liqueur wine and sparkling wine
•
Annex II defines alcoholic strengths such as ‘actual’,
‘potential’, ‘total’ and ‘natural’ alcoholic strength
•
Annex III details approved wine-growing zones, such
as the wine-growing zone C II which in Spain includes
the area under vines in the province of La Rioja
•
Annex IV lists authorised oenological processes and
practices, such as acidification, and sweetening for the
purpose of ensuring the proper refinement of the
product,
•
Annex V sets limits and conditions for certain
oenological practices, such as a total sulphur dioxide
content of 160mg and 210mg for red and white wine
respectively (with exceptions)
•
Annex VI details provisions for quality wines produced
from specified regions
•
Annex VII details the description, designation,
presentation and protection of certain products other
than sparkling wine and
•
Annex VIII details the description, designation,
presentation and protection of sparkling wine.
Amended by:
Commission Regulation (EC) No. 382/2007.
There are also a number of other related Regulations.
•
legislation.
4.15.2 Introduction to wine
Council Regulation (EC) No. 1493/1999 as amended
regulates the marketing of wine. Numerous implementing
measures and related Regulations have also been published
which are not detailed in this guide.
The common organisation of the market in wine comprises
of rules governing wine-production potential, market
mechanisms, producer organisations and sectoral
organisations, oenological practices and processes,
description, designation, presentation and protection,
quality wine psr and trade with third countries. These rules
apply to many different products such as wine of fresh
grapes (including fortified wines) and wine vinegar.
The Regulation defines various types of wine such as wine,
table wine, sparkling wine, semi-sparkling wine, liqueur
wine and quality wines produced in specified regions. The
two main categories of wine are however ‘quality wines
produced in specified regions’ and ‘table wines’.
Specifically Title V, Chapter II and Annex VII and VIII of the
Regulation set out the rules for the description, designation
and presentation of wine including some labelling
requirements.
The description, designation and presentation of products
covered by this Regulation can significantly effect their
marketability. Therefore, this Regulation lays down rules
which take into account the legitimate interests of
consumers and producers and promotes the smooth
operation of the internal market and the production
of quality products.
91
The fundamental principles of these rules is to provide for
the obligatory use of certain terms so as to identify the
product and provide consumers with certain important
items of information and the optional use of other
information.
The rules include provisions on the prevention of fraudulent
practices, penalties at Community level to be applied in the
event of improper labelling, use of languages, in particular
when different alphabets are involved, and the use of brand
names, especially when these could cause confusion
amongst consumers.
In view of the differences between products covered
by this Regulation and their markets, and the expectations
of consumers and traditional practices, the rules are
differentiated according to the products concerned. Rules
are also applied to the labelling of imported products, in
particular to clarify their origin and to avoid any confusion
with Community products. In addition, the use of
geographical indications and other traditional terms
is permitted.
Table wines, table wines with geographical indication and
quality wines psr, and wines originating in third countries
must also include on the label:
•
The sales description must also be provided on the label for
the various types of wine as follows:
A. Table wines
• the words ‘table wine’
•
where wine is produced in one Member State from
grapes harvested in another, the declaration “wine
obtained in…….from grapes harvested in….”,
•
•
the name of the geographical unit such as the locality
or wine growing region
•
under certain conditions the term ‘regional wine’, in
which case the words ‘table wine’ will not be required.
C. Quality wines psr
• the production area or specified region of origin,
•
•
the sales designation of the product such as ‘liqueur
wine’ or the name of the product (as defined in the
Regulation)
•
the nominal (average) volume
•
the actual alcoholic strength by volume
•
the lot number (see also Section 2.2 on the
identification of foodstuffs lot).
the words ‘retsina’ and ‘vino tinto de mezcla’
for certain table wines.
B. Table wines with geographical indications
• the words ‘table wine’
Compulsory labelling
The following mandatory information must appear
on the label of table wines, table wines with geographical
indication and quality wines psr, wines originating in third
countries, liqueur wines, semi-sparkling wines and aerated
semi-sparkling wines:
the Member State of origin
or where the wine is a mixture of products from a
number of Member States, the declaration “mixture
of wines from different countries of the
European Community” or
4.15.3 Labelling
The requirements relating to the description, designation,
presentation and protection of wine as set out in Council
Regulation (EC) No. 1493/1999 are very detailed. The
following is a summary of the main provisions, however,
the Regulation should be read in conjunction with this
section for a full list of the labelling and presentation
requirements.
the name or corporate name of the bottler, the local
administrative area and the Member State or, for
containers with a nominal volume of more than 60
litres, the consignor, for imported wines, the importer
or, when bottling took place in the Community, the
bottler.
the words ‘quality wine produced in a specified
region’ or
‘quality liqueur wine psr’ or ‘quality semisparkling wine psr’ as appropriate.
D. Imported wine
• the word “wine” must be provided in addition to the
name of the country of origin or in addition to the
name of the geographical area if the wine is designated
with a geographical indication.
E. Other wines
• The names ‘liqueur wine’, ‘semi-sparkling wine’
or ‘aerated semi-sparkling wine’ as appropriate.
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92
Language
Quality wines psr may also:
All information on the label must be given in one or more
of the official languages of the Community so that the final
consumer can easily understand the items on the label.
However, the following must be given solely in the official
language of the Member State where the product was
prepared:
•
reference geographical areas in certain circumstances
in order to specify the origin of the wine
•
provide information to the effect that bottling took
place in the specified region, provided that such
information is traditional and customary in the specified
region concerned.
•
the name of the specified region
•
the name of another geographical unit
•
the traditional specific terms and the additional
traditional particulars
The policy functions in relation to the EU Regulations on
wine are the responsibility of the Food Division, Department
•
the name of the vineyards or their associations
and bottling particulars.
Brand names
The description, presentation and advertising of the various
wine products may be supplemented by brand names.
However, such brand names may not contain any words,
parts of words, signs or illustrations which are likely to
cause confusion or mislead the consumer.
4.16 AROMATISED WINES
4.16.1 Legislation
EU legislation
•
Table wines, table wines with geographical indication and
quality wines psr may declare the following on the label in
addition to the mandatory provisions above:
•
the names, titles and addresses of the persons that took
part in the marketing
•
the type of product
•
a particular colour in accordance with the rules
laid down by the Member State of production.
Table wines with geographical indications and quality wines
psr may also declare:
Council Regulation (EEC) No. 1601/1991 laying down
general rules on the definition, description and
presentation of aromatised wines, aromatised winebased drinks and aromatised wine-product cocktails
Amended by:
Council Regulation (EC) No. 3279/1992, Council
Regulation (EEC) No. 3378/1994, Council Regulation
(EC) No. 2061/1996, Regulation (EC) No. 1882/2003.
•
European Communities (Definition, Description and
Presentation of Aromatised Wines, Aromatised WineBased Drinks and Aromatised Wine-Product Cocktails)
•
the vintage year
•
the name of one or more vine varieties
4.16.2 Introduction to aromatised wines
•
an award, medal or competitive achievement
•
indications concerning the means used to obtain the
product or methods used in its manufacture
•
other traditional terms in accordance with the
provisions laid down by the Member State of
production
•
the name of a vineyard
The Regulations lay down the general rules on the
definition, description and presentation of aromatised
wines, e.g. Vermouth, aromatised wine-based drinks,
e.g. Sangria and Glühwein, and aromatised wine-product
cocktails. The rules on ‘aromatised drinks’ ensure
consumers receive more detailed information on the
labelling of these products in view of the nature of the
drinks in question.
•
a term indicating where the wine was bottled
such as on the estate or by a group of vineyards.
93
4.16.3 Labelling
‘Aromatised wines’, ‘aromatised wine-based drinks’ and
‘aromatised wine-product cocktails’ are defined in the
Regulations and these reserved sales descriptions must be
used in trade to designate them. Products not falling under
the Regulations are not permitted to use these names.
A description of a particular category of ‘aromatised wine’
as detailed in the Regulations may replace the words
‘aromatised wine’ on the label. In addition, the description
‘aromatised wine’ may be replaced by ‘wine-based aperitif’
(the use of the term ‘aperitif’ is without prejudice to the use
of the term to define products which do not fall within the
scope of this Regulation).
A description of a particular category of ‘aromatised
wine-based drinks’ or ‘aromatised wine-product cocktails’
as detailed in the Regulations, may replace the sales
description in the Member State of production or maybe
used to supplement these words in the other Member
States.
The reserved names ‘aromatised wine’ and ‘aromatised
wine-based drink’ or their permitted descriptions may also
include the following particulars under certain
circumstances:
Where the alcohol used in the manufacture of the
drinks covered by this Regulation comes from one sole
raw material (for example, solely wine alcohol, molasses
alcohol or grain alcohol), the nature of the alcohol may be
indicated on the label. However, where the alcohol comes
from several raw materials, no special indication relating to
the nature of the alcohol can appear on the label.
The labelling must be in one or more official languages
of the Community in such a way that the final consumer
can readily understand each item, unless purchasers are
provided with the information by other means. In the case
of drinks originating in the Community and intended for
export, the labelling particulars may be repeated in another
language.
aromatised wines are responsibility of the Food Division,
these Regulations:
•
•
Health Service Executive.
•
‘extra-dry’
•
‘dry’
•
‘semi-dry’
4.17 SPIRIT DRINKS
•
‘semi-sweet’ and
4.17.1 Legislation
•
‘sweet’.
EU legislation
The terms ‘semi-sweet’ and ‘sweet’ may be replaced
by an indication of the sugar content, expressed in grams
of invert sugar per litre.
•
Amended by:
Council Regulation (EEC) No. 3280/1992, Regulation
(EC) No. 3378/1994 and Regulation (EC) No.
1882/2003.
The reserved sales descriptions may be supplemented
by a reference to the main flavouring used.
Certain geographical designations are permitted and may
replace the reserved descriptions or supplement them
forming composite descriptions. The permitted
geographical designations cannot not be translated.
Aromatised drinks which do not comply with this
Regulation may not be marketed for human consumption
by associating words or phrases such as ‘like’, ‘type’, ‘style’,
‘make’, ‘flavour’ or any other similar indications with any of
the descriptions mentioned in this Regulation.
Council Regulation (EEC) No. 1576/1989 laying down
general rules on the definition, description and
presentation of spirit drinks
•
Commission Regulation (EEC) No. 1014/1990 laying
down detailed implementing rules on the definition,
description and presentation of spirit drinks
Amended by:
Commission Regulation (EEC) No. 1180/1991,
Commission Regulation (EC) No. 2675/1994,
Commission Regulation (EC) No. 2626/95, Commission
Regulation (EC) No. 2523/1997 and Commission
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•
•
the ‘protected’ geographical designation reserved
exclusively for spirit drinks may supplement or replace
(in certain circumstances) the ‘reserved’ names provided
they were produced in the geographical area indicated.
For example, the geographical designation ‘Irish
Cream’ may appear on it’s own or accompanied by
its reserved name ‘liqueur’ (the list of the protected
geographical designations for spirit drinks are contained
in Annex II to Council Regulation (EC) No. 1576/89 as
amended) (see also Regulation (EEC) No. 2081/1992
Section 4.23)
•
geographical indications other than those which
are protected may supplement the ‘reserved’ names
provided they do not mislead consumers such as
‘Irish vodka’
•
the minimum alcoholic strength by volume as
prescribed for each product such as Whiskey 40%;
Rum, Gin and Vodka 37.5% and Brandy 36%
•
a reference to the place of manufacture and/or origin
and/or source of the spirit drink for certain spirit drinks.
European Communities (Definition, Description
and Presentation of Spirit Drinks) Regulations, 1995
(S.I. No. 300 of 1995)
Amended by:
European Communities (Definition, Description
and Presentation of Spirit Drinks) Regulations, 1996
(S.I. No. 60 of 1996) and Regulations, 1998
(S.I. No. 7 of 1998).
•
Irish Whiskey Act, 1980 (S.I. No. 33 of 1980).
4.17.2 Introduction to spirit drinks
Council Regulation (EC) No. 1576/1989 and its
amendments lay down the general rules on the definition,
description and presentation of spirit drinks. Further
detailed rules for its implementation are contained in
Commission Regulation (EC) No. 1014/1990 and its
amendments. Our national Regulations, 1995 to 1998,
give effect to both EU Regulations.
These rules set out the production, composition and
minimum alcoholic strengths for each product covered by
the legislation and their labelling requirements. The Irish
Whiskey Act, 1980 defines the production and labelling
requirements of Irish whiskey and blended Irish whiskey.
One or more of the following labelling requirements may
also be provided in addition to the declarations above:
•
where the labelling indicates the raw material used to
produce the ethyl alcohol of agricultural origin, each
agricultural alcohol used must be mentioned in
descending order of quantity used
•
the term ‘blend’ name may be provided in addition to
the name of the spirit drink where the product has
undergone blending and
•
the maturation period may be specified only where it
refers to the youngest alcoholic component and
provided that the product was aged under supervision.
4.17.3 Labelling
Spirit drinks are defined as alcoholic liquids intended for
human consumption, which have particular organoleptic
qualities and, have (with the exception of advocaat and
two ‘Barenfang’ products) a minimum alcoholic strength
of 15% volume.
The following mandatory information must appear on the
label of a spirit drink:
•
the reserved name of the spirit drink such as ‘whiskey’,
‘brandy’, ‘gin’, ‘vodka’, etc. Only products complying
with the specific definitions and requirements as
defined in the legislation have the exclusive use of the
reserved name such as Irish Whiskey or Irish Whisky.
Spirit drinks that do not meet the specific requirements
of the reserved names (whiskey, brandy etc.) may only
be described as ‘spirit drinks’ or ‘spirits’.
The policy functions in relation to the Regulations on spirit
drinks are the responsibility of the Food Division,
with these Regulations;
•
•
Health Service Executive.
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4.18 OLIVE OIL
4.18.1 Legislation
In addition to the trade description (as set out in Article 35
of Regulation (EC) No. 136/1966) ‘extra virgin olive oil’,
‘virgin olive oil’, ‘olive oil’ and ‘olive-pomace oil’ must
indicate, in clear and indelible lettering, the following
information on the category of oil:
EU legislation
•
Commission Regulation (EC) No.1019/2002 on the
marketing standards for olive oil
Amended by:
Commission Regulation (EC) No. 406/2004 and
Commission Regulation (EC) No. 1044/2006 on the
marketing standards for olive oil.
•
Council Regulation (EEC) No.136/1966 on the
establishment of a common organisation of the market
in oils and fats and its amendments
Implemented by:
Commission Regulation (EEC) No. 2568/1991 on the
characteristics of olive oil and olive-residue oil and on
the relevant methods of analysis and its numerous
amendments.
•
European Communities (Marketing Standards for Olive
Oil) Regulations, 2004 (S.I. No. 397 of 2004).
4.18.2 Introduction to olive oil
Commission Regulation (EC) No. 1019/2002 lays down
marketing standards for the retail-stage marketing (i.e. sale
to the final consumer) of olive oils and olive-pomace oils
presented in the natural state or incorporated in a
foodstuff. It sets rules on the labelling of different
categories of olive oil, designation of origin, packaging
requirements and optional labelling indications. Our
national Regulations 2004 implements Commission
Regulation (EC) No. 1019/2002 as amended.
The basic Regulation (EEC) No. 136/1966 is mainly a market
support Regulation. It sets out the classifications for nine
different types of olive oil and olive-pomace oils. This
Regulation has been amended many times as has its
implementing measure Commission Regulation (EEC) No.
2568/1991. It is currently being reviewed and this review
may result in changes to the classifications of olive oils in
the next few years.
Commission Regulation (EEC) No. 2568/91 further defines
these nine categories and distinguishes them from each
other and from other oils/fats. Other EU rules exist covering
the appropriate methods of analysis, measures to improve
the quality of olive oil production and controls for the
designation of extra virgin and virgin olive oil.
(a) extra virgin olive oil:
‘superior category olive oil obtained directly
from olives and solely by mechanical means’
(b) virgin olive oil:
‘olive oil obtained directly from olives and solely
by mechanical means’
(c) olive oil composed of refined olive oils and virgin olive
oils:
‘oil comprising exclusively olive oils that have
undergone refining and oils obtained directly
from olives’
(d) olive-pomace oil:
‘oil comprising exclusively oils obtained
by treating the product obtained after the
extraction of olive oil and oils obtained directly
from olives’
or
‘oil comprising exclusively oils obtained by
processing olive pomace oil and oils obtained
directly from olives.’
Only extra virgin and virgin olive oils may bear a
designation of origin (i.e. reference to a geographical area)
on the packaging or the label under certain conditions
(in accordance with Regulation (EEC) No. 2081/1992
(see Section 4.23)).
Where a designation of origin mentions a Member State or
the Community, the designation of origin must correspond
to the geographical area in which the olives concerned
were harvested or in which the mill, where the oil was
extracted from the olives, is situated.
If the olives have been harvested in a Member State or third
country other than that in which the mill where the oil was
extracted from the olives is situated, the designation of
origin shall indicate both the area where the olives were
harvested and the area where the oil was obtained using
the following wording:
‘(extra) virgin olive oil obtained in (the Community
or the name of the Member State concerned) from
olives harvested in (the Community or the name
of the Member State or country concerned)’.
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96
In the case of blends of extra virgin olive oils or virgin olive
oils in which more than 75% originated in the same
Member State or in the Community, the main origin (the
geographical area in which the olives concerned were
harvested or in which the mill, where the oil was extracted
from the olives, is situated) may be designated followed by
an indication of the minimum percentage (75% or more)
which is actually from the main place of origin.
The policy functions in relation to the Regulations on olive
oil are the responsibility of the Crops Policy Section,
these Regulations:
Extra virgin olive oil, virgin olive oil, olive oil and olivepomace oil may also indicate the following on the label as
appropriate under certain conditions:
•
•
•
‘first cold pressing’ for virgin or extra virgin olive oils
•
•
‘cold extraction’ for virgin or extra virgin olive oils
Office of the Director of Consumer Affairs (authorised
under Regulations).
•
indications of organoleptic properties
•
indication of the acidity or maximum acidity.
In a blend of olive oil (or olive-pomace oil) and other
vegetable oils where the presence of olive oils (or olivepomace oils) is highlighted on the labelling elsewhere than
in the list of ingredients, using words, images or graphics,
the blend concerned must bear the following trade
description:
•
4.19 FISHERY AND AQUACULTURE
PRODUCTS
4.19.1 Legislation
EU Legislation
•
Implemented by:
down the rules for the application of Council Regulation
(EC) No. 104/2000 as regards informing consumers
about fishery and aquaculture products.
‘Blend of vegetable oils (or the specific names of
the vegetable oils concerned) and olive oil (or olivepomace oil)’, directly followed by the percentage
of olive oil (or olive-pomace oil) in the blend.
The presence of olive oil (or olive-pomace oil) may be
highlighted by images or graphics on the labelling of a
blend only where it accounts for more than 50% of the
blend concerned.
Generally, where the presence of olive oil (or olive-pomace
oil) in a foodstuff (other than in a blend as detailed above)
is highlighted on the labelling elsewhere than in the list of
ingredients, using words, images or graphics, the trade
description of the foodstuff shall be directly followed by the
percentage of olive oil (or olive-pomace oil) relative to the
total net weight of the foodstuff.
The percentage of added olive oil (or olive-pomace oil)
relative to the total net weight of the foodstuff may be
replaced by the percentage of added olive oil (or olivepomace oil) relative to the total weight of fats, adding the
words ‘percentage of fats’.
Extra virgin olive oil, virgin olive oil, olive oil and olivepomace oil must be presented to the final consumer in
packaging of a maximum capacity of five litres. The
packaging shall be fitted with an opening system that can
no longer be sealed after the first time it is opened.
organisation of the markets in fishery and aquaculture
products.
•
European Communities (Labelling of Fishery and
Aquaculture Products) Regulations, 2003 (S.I. No.
320 of 2003).
4.19.2 Introduction to fishery and aquaculture
products
Our National Regulations 2003 give effect to Article 4 of
Council Regulation (EC) No. 104/2000 and to Commission
Regulation (EC) No. 2065/2001 laying down the conditions
for informing consumers about fishery and aquaculture
products.
The Regulations set out specific information which must
be included on the label where fishery products are sold
at retail level to consumers. In addition, for the purposes
of traceability, this information must be included on the
commercial documents for the fishery products throughout
the marketing chain, such as during processing, at
wholesale level and for use by mass caterers.
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The FSAI has published Guidance Note No. 7: “The
Labelling of Fish and Aquaculture Products according
to the European Communities (Labelling of Fishery and
Aquaculture Products) Regulations, 2003 (S.I. No. 320
of 2003) Revision 1”. The guide specifically details the
labelling and packaging requirements for fishery and
aquaculture products and should be consulted for a more
detailed guide to the legislation. The guide is available at
4.19.3 Labelling
The labelling requirements of the Regulations apply only
to raw fish and aquaculture products to which no other
ingredients have been added (except salt) and include:
•
live fish
•
fresh, chilled and frozen fish
•
fish fillets and other fish meat (whether minced or not)
•
dried, salted or brined fish
•
smoked fish (whether hot or cold smoked fish)
•
crustaceans (except those which are both cooked
and peeled)
•
molluscs (except when cooked).
Processed products such as breaded fish fillets, crab sticks,
ready-to-eat dishes or tinned fish are not covered by the
Regulations.
The fishery and aquaculture products listed above which are
offered for retail sale to the final consumer must indicate
on the label:
1) the commercial designation of the species of fish,
2) the production method, whether farmed or caught at
sea or in freshwater and
3) the catch area.
These requirements apply only to products for ‘retail sale
to the final consumer’. In other words, these rules apply
to products which are sold at retail level whether they are
pre-packaged or sold loose over the counter. Where the
products are sold loose, this information could be stated
clearly at the point of sale on a notice or sign near
the food.
These provisions do not apply to fishery products sold by
mass caterers such as in restaurants and takeaways.
However, this information must be passed throughout the
marketing chain i.e. from producer, to processor, wholesaler
and caterer, either on the labelling or packaging of the
product or on the commercial documents accompanying
the food.
These labelling requirements do not apply to small
quantities of fishery products sold directly to consumers by
either fishermen or producers provided these products do
not exceed the value of EUR 20 for each purchase. The
source of these small quantities may only be the sellers
own business.
Commercial designations
The commercial designation (or trade name) is the name
associated with the particular species of fish, e.g. the
commercial designation for Gadus morhua is Cod. The full
list of commercial designations recognised in Ireland can be
found in the schedule attached to the Regulations (S.I. No.
320 of 2003) or on the FSAI’s website – www.fsai.ie.
Member States are required to draw up and publish a list of
the commercial designations of fishery products accepted in
their territory. This list must also indicate the scientific name
for each species, its name in the official language(s) of the
Member State and any other accepted names.
Member States must however recognise the commercial
designations laid down by other EU Member States where
they are for the same species in the same language.
Therefore, commercial designations appearing in the
English, Scottish, Welsh and Northern Irish Regulations
may be applied and used in Ireland.
Manufacturers, processors and packagers selling to a
market outside Ireland must use the commercial
designation of the country/area to which they are exporting
so the final consumer of that area knows what is being
purchased. It is the responsibility of those marketing any
fishery products to obtain the necessary information to
ensure the products are accurately labelled. For further
information regarding commercial designations for fishery
products, export operators should contact Bord Iscaigh
Mhara.
The production method
The method of production i.e. the means by which the fish
have been obtained must also be indicated. In other words,
whether they have been caught either at sea or in
freshwater, or produced (farmed) by aquaculture.
The production method must be declared as follows:
•
‘caught’ where the fish were caught at sea or
•
‘caught in freshwater’ where the fish were caught
in freshwater or
•
‘cultivated’ or ‘farmed' where the fish are produced
from aquaculture.
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98
However, where it is obvious from the commercial
designation and/or the catch area (see below) that the fish
were caught at sea, then the method of production may be
omitted, e.g. cod may be described as ‘Cod - Caught in the
North East Atlantic’. Alternatively the expression ‘North East
Atlantic Cod’ would also be acceptable. Such authorisation
may not be granted if there is doubt as to the production
method such as for ‘Atlantic Salmon’.
Where fishery products are of the same species
but derived from a different production method, the
production method for each batch must be indicated.
For example, where a salmon platter contains both salmon
caught at sea and cultivated salmon, the commercial
designation ‘salmon’ must be provided, the production
method for each batch i.e. ‘caught at sea’ and ‘cultivated’
as well as the catch area.
The catch area
Where fishery products of the same species are offered
for sale but derived from a variety of catch areas or fishfarming countries, the catch area of the batch which is
most represented by quantity must be at least declared
in addition to the indication that the products come from
different catch or fish-farming areas. For example, the
indication ‘a mix of tuna from the Pacific Ocean and
other areas’ could appear on the labelling.
The catch area must be indicated as follows:
•
products caught at sea must detail the name of the
area where they were caught according to Appendix
VIII such as ‘North-East Atlantic’
This is the minimum amount of information that must
be provided. However, in addition, more detailed
information regarding these catch areas may also be
given, e.g. fish caught in the Irish Sea must declare
“North - East Atlantic” but additional information such
as “Caught off the East Coast of Ireland” may also be
declared
•
•
products caught in freshwater must reference
the Member State or third country of origin such
as ‘Irish Eel’
farmed products must reference the Member State or
third country in which the product undergoes the final
development stage, e.g. if a fish started its life in
Scotland and underwent final development in Ireland,
the labelling could state “Farmed Irish fish” or similar
Where the product is farmed in more than one Member
State or third country, the Member State where the
product is sold to the final consumer shall authorise
which Member State or third country is to be indicated.
It is recommended that as much information as is practical
is provided to the consumer, to allow them to make
informed choices about the fish they are buying.
Labelling exceptions for fishery combinations
Where different species of fishery products are for sale,
information regarding the commercial designation, the
production method and the catch area shall be given for
all species, e.g. for a seafood platter containing plaice,
monkfish and shrimps, the commercial designation,
production method and catch area must be detailed
for all three species.
As far as is practical it is recommended that batches are
composed in such a way that the fish comprising them
originate from the same production method or catch area,
and this is clearly specified on the labelling.
Traceability
The information required above i.e. the commercial
designation, the production method and the catch area,
must be available at each stage of marketing for each
species in addition to the scientific name for the purpose of
traceability. These details can be provided on the labelling
or packaging of the products or on the commercial
document accompanying the product such as an invoice
or delivery documents.
The policy functions in relation to the Regulations on fishery
and aquaculture products are the responsibility of the
Resources.
these Regulations:
•
•
Resources (authorised under Regulations)
•
Officers authorised under the Labelling Regulations.
99
4.20 POULTRYMEAT
4.20.3 Labelling
4.20.1 Legislation
The following labelling requirements apply only to
poultrymeat as defined in these Regulations and include:
EU Legislation
•
•
•
fresh
•
frozen and quick frozen cuts and carcasses of chickens
Amended by:
Council Regulation (EEC) No. 317/1993, Council
Regulation (EC) No. 3204/1993, Council Regulation (EC)
No. 1101/1998 and Council Regulation (EC) No.
1029/2006.
•
ducks
•
geese
•
turkeys
•
guinea fowl.
Commission Regulation (EEC) No. 1538/1991
introducing detailed rules for implementing Regulation
1906/1990/EEC on certain marketing standards for
poultrymeat and its numerous amendments.
The requirements do not apply to:
Council Regulation (EC) No. 1906/1990 on certain
marketing standards for poultrymeat
National Legislation
•
European Communities (Labelling and Marketing
Standards for Poultrymeat) Regulations, 2004 (S.I. No.
42 of 2004)
Amended by:
European Communities (Labelling and Marketing
Standards for Poultrymeat) (Amendment) Regulations,
2004 (S.I. No. 50 of 2004).
•
New York Dressed (NYD) Poultry (i.e. poultry which
is not eviscerated immediately after slaughter and
is sold in carcass form to the retailer or consumer)
•
poultrymeat preparations, e.g. chicken nuggets,
chicken burgers, chicken sausages.
Where poultry is packaged, the required information below
must be indicated on each pack. In the case of unpackaged
poultry, the following information must be displayed in a
notice or sign, visible to the consumer, near the product:
(a) the name under which the product is sold:
•
whole carcasses must indicate the species
(‘chicken’, ‘broiler’, ‘turkey’ etc) and the form
of presentation (‘partially eviscerated’, ‘with giblets’
or ‘without giblets’)
•
cuts of poultry must indicate the species and the cut
(‘chicken breast fillet’, ‘turkey drumstick’ etc)
4.20.2 Introduction to poultrymeat
The EU Regulations lay down marketing standards for
certain types and presentations of poultrymeat. Poultrymeat
marketed in the EU must be graded for quality and weight
and marketed, packed, labelled, transported and presented
for sale in accordance with the requirements of these
Regulations. Our National Regulations implement the EU
Regulations except for Council Regulation (EC) No.
1029/2006.
The FSAI has published “Guidance Note No. 17: The
Labelling of Meat” which provides an overview of the
legislative requirements for the documentation and labelling
of all meats including poultrymeat. This guide is available at
www.fsai.ie/publications and should be consulted for a
more detailed account of the labelling requirements for
poultrymeat.
(b) a ‘use-by’ date for fresh poultrymeat, a ‘best-before’
date for frozen poultrymeat
(c) class (poultrymeat must be graded into Class A or Class
B)
(d) in the case of fresh poultrymeat, the total price
and the price per weight unit at the retail stage
(e) condition (i.e. fresh, frozen or quick-frozen)
and recommended storage temperature
(f) approval number of the slaughterhouse or cutting
plant (as per Article 4 of Regulation (EC) No. 853/2004)
except in the case of cutting and boning at the place
of sale
(g) in the case of poultrymeat imported from third
countries, an indication of the country of origin.
It is not necessary to classify poultrymeat or to indicate the
particulars above in the case of deliveries to cutting or
processing establishments.
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100
Where claims concerning types of farming, e.g. free range,
are made on poultry labels, it is necessary that the producer
and processor of the poultry be registered for this purpose
with the Department of Agriculture, Fisheries and Food.
Regulation (EC) No. 1538/1991 as amended allows for the
use of following terms on the labelling of poultrymeat
under certain conditions as appropriate:
(a) ‘Fed with … % of …’
poultry are the responsibility of the Pigmeat/Eggs and
Poultry/Meat Hygiene Division, Department of Agriculture,
Fisheries and Food.
these Regulations:
(b) ‘Extensive indoor’ (‘Barn reared’)
(c) ‘Free range’
(d) ‘Traditional free range’
•
•
Local authorities.
(e) ‘Free range — total freedom’.
4.21 FRESH FRUIT AND VEGETABLES
These terms may be supplemented by indications referring
to the particular characteristics of the respective types of
farming.
4.21.1 Legislation
EU legislation
•
When free-range production (points c, d and e) is indicated
on the label for meat coming from ducks and geese kept
for the production of ‘foie gras’, the term ‘from foie gras
production’ shall also be indicated.
Intra-trade sales of poultrymeat (such as supply to
wholesalers) and food sold to mass caterers must indicate
the following information on the commercial documents
accompanying the food in addition to the particulars
outlined in Section 2.1.3 (in accordance with the Labelling
Directive 2000/13/EC):
•
the class of poultrymeat and
•
the condition in which the poultrymeat is marketed,
e.g. fresh, frozen, and the recommended storage
temperature.
Optional labelling
An indication of the use of one of the methods of chilling
may appear on the labelling:
•
air chilling
•
air-spray chilling
•
immersion chilling.
•
European Communities (Marketing of Fruit and
Vegetables) Regulations 1997, (S.I. No. 122 of 1997).
4.21.2 Introduction to fresh fruit and vegetables
Council Regulation No. 2200/1996 sets up the common
organisation of the market with regard to fruit and
vegetables. Under the Regulation, products (listed in Annex
I of the Regulation such as apples) which are to be supplied
fresh to the consumer are subject to certain marketing
standards.
The information particulars required by the quality
standards must be shown legibly in an obvious position on
one side of the packaging, either indelibly printed directly
onto the package or on a label which is an integral part of
or firmly affixed to the package.
Specific EC marketing standards exist for the following fruit,
vegetables, salads and nuts (also listed in Appendix I):
•
Fruit Apples (dessert), Apples (culinary), Apricots,
Avocados, Cherries, Citrus Fruit, Kiwifruit, Melons,
Nectarines, Peaches, Plums, Strawberries, Table grapes,
Watermelons
•
Vegetables Artichokes, Asparagus, Beans, Brussels
Sprouts, Cabbage, Carrots, Cauliflower, Celery,
Courgettes, Garlic, Leeks, Mushrooms, Onions, Peas,
Spinach
Small quantities
Member States may derogate from the requirements of
Regulation (EC) No. 1906/1990 in cases of direct supply of
small quantities of poultrymeat (as referred to in Article
1(3)(d) of Regulation (EC) No. 853/2004) by a producer
with an annual production of under 10,000 birds.
organisation of the market in fruit and vegetables and
its numerous amendments.
101
•
Salads Aubergines, Chicory, Cucumbers, Lettuce,
Endive, Sweet Peppers, Tomatoes
•
Nuts Walnuts in shell, Hazelnut in shell.
Appendix IX lists the EU Regulations regarding the
marketing standards for all fruit and vegetables listed
above. There are also other Regulations relating to the
marketing of fresh fruit and vegetables which are not
outlined in this guide.
For further detailed information regarding the marketing
standards of fresh fruit and vegetables please see the
information leaflet of the Department of Agriculture,
Fisheries and Food ‘European Community Marketing
Standards for Fresh Fruit and Vegetables’ available at
www.agriculture.gov.ie/crops_and_plants/marketing_standa
rds/marketing_standards.pdf.
The Regulations regarding the marketing standards for fresh
fruit and vegetables ensure that regulated produce offered
to the consumer is of acceptable quality and accurately
labelled. Produce may be offered for sale only if it conforms
to the specified standards and produce of unsatisfactory
quality is kept off the market. The standards do not apply
to processed or prepared fresh produce (example, packs of
sliced carrots).
4.21.3 Labelling
Fresh fruit and vegetables of all quality classes must be
sound, clean and of marketable quality, and that each
container or display of produce is clearly marked with the
correct information regarding quality class, origin and in
certain cases, variety.
The main requirements of the Regulations relate to quality
classification and information labelling of the produce. Only
the labelling requirements are detailed below.
The label of all fruit and vegetables are required to state the
following:
•
nature of produce (if not visible)
•
origin of produce
•
quality class
•
packer and/or dispatcher identification
•
official control marking (optional).
It is the responsibility of the retailer to ensure that produce
on display is labelled properly. The labelling information
required is usually marked on the packages in which the
fresh produce is supplied. However, if the produce is
unlabelled when received the retailer still has responsibility
to ensure the produce is labelled when put on display
for sale.
Variety-marking requirements exist for some products
such as apples, avocados and oranges classified as ‘Extra’,
‘Class I’ and ‘Class 2’. Additional information on the nature
of produce and/or commercial specification is required for
some marketing standards. The relevant Regulation should
be consulted in this regard.
Produce displayed loose
Products may be presented unpackaged, provided that the
retailer displays with the goods offered for sale, a card
showing prominently and legibly the information particulars
specified in the quality standards relating to variety, origin
of the product and class.
Produce sold in original packaging
All packages shall be labelled with all the information
required, i.e. nature of produce, origin of produce, quality
class and packer and/dispatcher identification. In the case
of packer and/dispatcher identification it is acceptable to
use either:
(i) the name and address of the packer and/or the
dispatcher or
(ii) an officially issued or accepted code representing the
packer and/or dispatcher, indicated in close connection
with “packer and/or dispatcher”.
Produce sold in pre-packs
Produce that is offered for sale in pre-packs must
display all the information required, i.e. nature of produce,
origin of produce, quality class and packer and/dispatcher
identification. In addition, the net weight or number
(if not clearly visible) must be stated.
The packer and/or dispatcher must be identified
on the pre-pack using either:
(i) the name and address of the packer and/or the
dispatcher or
(ii) the name and address of a seller established within
the Community indicated in close connection with
the mention “Packed For”.
An officially issued code representing the packer’s name
and address shall also be included.
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102
Mixed consumer packs
The same principles for labelling of original packaging
apply. If, however, products of more than one type are in
the same package, the name of each of the products/types
contained in the package must be stated. The products
contained in the mixes must be of the same commercial
class. Individual origins must be indicated (broader
descriptions like ‘Produce from various countries’ or
‘EC Produce’ are not acceptable). Varieties or commercial
type of the produce must be stated where this is required
by the relevant standard.
Single over wrapped items
Single over wrapped items, e.g. individually film wrapped
cucumbers, are not considered pre-packs and therefore do
not need to carry full labelling information. However, details
of origin, quality class and variety, if necessary, must be
indicated, in clear characters, on a show card with the
produce.
PART C: QUALITY SCHEMES
The Regulations under this section on Quality Schemes do
not specifically fall under the umbrella of food safety
legislation. However, the Regulations do contain some
labelling provisions and are thus detailed below.
4.22 ORGANIC FOOD
4.22.1 Legislation
EU legislation
•
Council Regulation (EC) No. 2092/1991 on organic
production of agricultural products and indications
referring thereto on agricultural products and foodstuffs
and its many amendments.
•
European Communities (Organic Farming) Regulations,
2004 (S.I. No. 112 of 2004).
Miniatures
Aubergines, cauliflowers, cabbages and courgettes may be
marketed in the form of miniature produce, subject to rules
on presentation and labelling. An indication of “mini” or
“baby” or other appropriate term for miniature, where
appropriate, must be given.
Where several types of miniature produce are mixed in the
same package, all products and their respective origins
must be mentioned. The size requirements shall not apply
to miniature produce. However, they must be reasonably
uniform in size.
The policy functions in relation to the Regulations on fresh
fruit and vegetables are the responsibility of the Horticulture
and Plant Health Division, Department of Agriculture,
Fisheries and Food.
These Regulations are enforced by the Department
4.22.2 Introduction to organic food
Organic food is produced in accordance with standards laid
down in Council Regulation (EC) No. 2092/1991 and its 40
amendments. Our national 2004 Regulations give effect to
Regulation (EC) No. 2092/1991 and the majority of its
amendments.
The Regulations governing the production of organic food
do not fall under the umbrella of food safety legislation.
However, the standards laid down do contain some
labelling provisions. The Department of Agriculture,
Fisheries and Food is the competent authority charged with
overall responsibility for ensuring that operators producing,
preparing, importing or marketing organic products do so
according to certain standards as laid down in the
Regulations. An organic operator must be registered with
the Department and submit their enterprise to inspection
by an approved inspection body.
There are currently three organic inspection and
certification bodies approved by the Department, Demeter
Standards Ltd, Irish Organic Farmers’ and Growers’
Association (IOFGA) and Organic Trust Ltd, certifying that
organic operators are meeting the stipulated standards for
organic food production. Further information on organic
food is available from The Department of Agriculture,
Fisheries and Food at www.agriculture.gov.ie. Also the FSAI
has produced a leaflet on Organic Food and is available at
www.fsai.ie.
103
4.22.3 Labelling
An organic product produced according to the Regulations
should bear the indication ‘organic’ in the labelling,
advertising material or commercial documents. Packaged
organic food, which must remain closed from packaging
until point of retail sale, must indicate the name and/or
code number of the organic certification body.
The words "Certified Organic" or "Organic Certification"
should appear on the product label followed by one of
the following three codes depending on which private
inspection body in Ireland is certifying the produce:
IRL-OIB1-EU
IRL-OIB2-EU
IRL-OIB3-EU
IRL-OIB1-EU is assigned to the Demeter Standards Ltd, IRLOIB2-EU is used by the Irish Organic Farmers’ and Growers’
Association (IOFGA) and IRL-OIB3-EU is used by Organic
Trust Ltd.
Whilst not required by Regulation, each of the certification
bodies may also include their own name and/or logo on the
product label:
IRL-O1B1-EU
Demeter Standards Ltd.
IRL-O1B2-EU
Irish Organic Farmers and
Growers Association
IRL-O1B3-EU
Organic Trust
The Community logo may be provided in addition on the
label indicating that products are covered by the specific
inspection scheme. The provision of the logo is voluntary
but where it is provided the technical reproduction rules
must be adhered to (such as colours, size, background etc.)
and certain conditions must be met (such as an indication
of the name and/or business name of the producer,
preparer or vendor).
The Community logo in black and white:
The provisions of the general labelling rules (Council
Directive 2000/13/EC Section 2.1) also apply to packaged
organic food. No claim may be made on the label or
advertising material that suggests to the purchaser that the
product constitutes a guarantee of superior organoleptic,
nutritional or salubrious quality.
The above labelling provisions apply to organic produce at
point of sale only. However, for intra-trade, the producers
or processors details or license number must be provided
on all ‘internal’ documentation such as delivery dockets,
invoices, etc. so that full traceability is maintained.
Organic products imported from outside the EU (i.e. third
country imports) must be produced in conformity to EU
standards. At present, the following countries are
recognised by the European Commission as having
equivalent organic production and inspection rules to those
of the European Community:
•
Argentina, Australia, Hungary, Israel, Switzerland and
the Czech Republic.
Where a third country does not have equivalence
recognition, the Department, as the competent authority,
must satisfy itself that the product being imported was
produced in accordance with production rules equivalent
to those in the EU.
Products prepared partially from ingredients of organic
origin may only make reference on the label to the organic
production method provided they adhere to the conditions
set out in Article 5 of Council Regulation (EC) No. 2092/91
as amended.
organic food are the responsibility of The Organic Unit,
Department of Agriculture, Fisheries and Food. These
Regulations are enforced by the Department of
Agriculture, Fisheries and Food.
The FSAI also has responsibility with regard to labelling
issues.
4
104
4.23 PROTECTION OF GEOGRAPHICAL
INDICATIONS
The European system for protection of food names consists
of three elements:
4.23.1 Legislation
a) Protected Designation of Origin
EU legislation
b) Protected Geographic Indication
•
c) Traditional Specialities Guaranteed.
Council Regulation (EC) No. 510/2006 on the protection
of geographical indications and designations of origin
for agricultural products and foodstuffs
Implemented by:
down detailed rules of implementation of Council
Regulation (EC) No. 510/2006 on the protection of
geographical indications and designations of origin
for agricultural products
•
Council Regulation (EC) No. 509/2006 on agricultural
products and foodstuffs as traditional specialities
guaranteed.
•
These Regulations have yet to be implemented.
4.23.2 Introduction to protected names
Under the umbrella of European Policy on quality
agricultural products, special provisions have been adopted
to allow producers to register, and in that way protect, the
names of certain agricultural products and foodstuffs.
‘Protected’ foodstuffs exhibit special characteristics derived,
in cases where the name is geographical, from the specific
area in which the product is produced, and in other cases
from a traditional composition or method of production.
These provisions also enable consumers to make a more
informed choice regarding the characteristics of a foodstuff.
These names which are protected against any direct or
indirect commercial use or exploitation, may be used only
for the registered products thus guaranteeing the consumer
consistency of quality and composition.
a) Protected Designation of Origin (PDO)
Foodstuffs and agricultural products whose names are
protected under this designation must be are produced,
processed and prepared in a given geographical area
using recognised know-how such as Imokilly Regato
Cheese produced in Cork.
b) Protected Geographic Indication (PGI)
For products bearing the name of a particular
geographical area, the geographical link must occur
in at least one of the stages of production, processing
or preparation such as Clare Island Salmon and
Timoleague Brown Pudding.
c) Traditional Specialities Guaranteed (TSG)
This type of registration does not refer to the
origin but highlights traditional character, either in the
composition or means of production such as Mozzarella
Cheese made to the traditional specification.
Regulation (EC) No. 510/2006 and 509/2006 replaces the
previous rules in this area. These new quality designation
regulations simplify the systems considerably including the
registration process.
Products which are registered are published in the Official
Journal of the European Union. Lists of all registered
products, applications for registration and Community
guidance are available at the European Union Online
www.europa.eu.int/comm/agriculture/foodqual/quali1_en.h
tm. A detailed factsheet on Euroepan Policy for Quality
Agricultural Products is also available at
http://ec.europa.eu/agriculture/publi/fact/quality/2007_en.pdf.
105
4.23.3 Labelling
The EU symbols – quality logos
Consumers and the food trade can recognise products with
a PDO, PGI or TSG status by the blue and yellow ‘sun’ logos
enclosing the EU stars (see below). In addition, in the case
of PDO and PGI, in the middle there is a symbol of the
countryside, representing through furrows the delimited
geographical area to which the registered product name
is linked.
These EU symbols provide guarantees of authenticity that
the food products concerned are made in a specific region
or use particular production methods. The symbols are
aimed partly at preventing imitators from passing their
products off as the genuine article, but they also allow
producers to increase awareness of their products. From
1st May 2009, it will be obligatory for producers or traders
to use the EU symbol, or the equivalent indication PDO, PGI
or TSG, on products that have been registered.
PDO, PGI and TSG logos
4
protected designations are the responsibility of the Food
These Regulations are also enforced by the Department
106
SECTION 5 – OTHER MISCELLANEOUS
5.1
GENERAL FOOD LAW
5.1.1 Legislation
5.1.3 Labelling
One of the principles established by the Regulation relates
to the presentation of food and misleading consumers.
Article 16 ‘Presentation’ states:
•
Regulation (EC) No. 178/2002 laying down the general
principles and requirements of food law, establishing
the European Food safety Authority and laying down
procedures in matters of food safety.
Without prejudice to more specific provisions of food
law, the labelling, advertising and presentation of
food or feed, including their shape, appearance or
packaging, the packaging materials used, the manner
in which they are arranged and the setting in which
they are displayed, and the information which is
made available about them through whatever
medium, shall not mislead consumers.
•
European Communities (Food and Feed Hygiene)
(Amendment) Regulations 2006 (S.I. No. 387 of 2006)
•
European Communities (Hygiene of Fishery Products
and Fish Feed) Regulations 2006 (S.I. No. 335 of 2006).
5.1.2 Introduction to the General Food Law
Regulation (EC) No. 178/2002 known as ‘General Food
Law’ establishes the common basis for food law in all
Member States. It sets out guiding principles to ensure a
high level of protection of human health and consumers'
interest in relation to food and also provides the framework
for the development of EU food legislation (such as the
Hygiene Package Section 5.2).
There are a range of general provisions (such as the
establishment of the European Food Safety Authority) and
specific provisions (such as the traceability requirements)
contained within the Regulation. Certain specific provisions
including those relating to misleading labelling and
advertising came into effect on 1st January, 2005.
A guidance document on the implementation of the main
requirements of General Food Law has been developed
by a working group of Member State experts and is
available at
http://ec.europa.eu/food/food/foodlaw/guidance/index_en.htm.
As the Regulation applies to all sectors of food production,
distribution and sale, the policy functions are the
responsibility of the Department of Health and Children,
the Department of Agriculture, Fisheries and Food and
the Department of Communications, Energy and
Natural Resources.
The Regulations are enforced by the FSAI and the official
agencies under the arrangements of the service contracts
with the FSAI.
5.2
HYGIENE OF FOODSTUFFS
LEGISLATION
5.2.1 Legislation
•
Regulation (EC) No. 852/2004 on the hygiene of
foodstuffs
•
Regulation (EC) No. 853/2004 laying down specific
hygiene rules for food of animal origin.
•
(Amendment) Regulations, 2006 (S.I. No. 387 of 2006)
European Communities (Hygiene of Foodstuffs)
European Communities (Hygiene of Fishery Products
and Fish Feed) Regulations, 2006 (S.I. No. 335 of 2006).
107
SECTION 5 OTHER MISCELLANEOUS
5.2.2 Introduction to the hygiene of foodstuffs
legislation
From 1st January 2006, all the European hygiene
rules which were scattered across a number of Directives
were replaced by new European Regulations (often referred
to as the Hygiene Package). These new rules apply to all
food businesses. The European Directives that have been
repealed and replaced by the ‘Hygiene Package’ are
as follows:
•
Hygiene of foodstuffs - Directive 93/43/EEC
•
Fresh meat – production and marketing - Directive
64/433/EEC
•
Fresh meat – intra community trade - Directive
72/461/EEC
•
Fresh Poultrymeat - production and marketing Directive 1/118/EEC
•
Fresh Poultrymeat - 3rd Countries - Directive
91/494/EEC
•
Pig Meat - 3rd Countries - Directive 77/96/EEC
•
Meat Products - production and marketing - Directive
77/99/EEC
•
Meat Products - intra community trade - Directive
80/215/EEC
•
Egg Products - production and marketing - Directive
87/437/EEC
•
Bivalve molluscs: production and marketing - Directive
91/492/EEC
•
Fishery products: production and marketing - Directive
91/493/EEC
•
Fishing vessels - Directive 92/48/EEC
•
Rabbit and farmed game - Directive 91/495/EEC
•
Wild Game - Directive 92/45/EEC
•
Milk Products - production and marketing - Directive
92/46/EEC
•
Milk Production - Directive 89/362/EEC
•
Minced Meat - Directive 94/65/EC.
Regulation (EC) No. 852/2004 on the hygiene of foodstuffs
lays down general hygiene requirements that food
businesses must comply with at all stages of the food
chain. Regulation (EC) No. 853/2004 laying down specific
hygiene rules for food of animal origin lays down the
hygiene requirements that food businesses handling food
of animal origin must comply with at all stages of the food
chain in addition to those specified in Regulation (EC)
No. 852/2004.
In order to assist Member States and food business
operators to better understand the new food hygiene rules,
guidance documents were prepared and are available at
www.ec.europa.eu/food/food/biosafety/hygienelegislation/g
uide_en.htm.
5.2.3 Labelling – identification and health marks
Regulation (EC) No. 853/2004 provides detailed information
about the use of identification and health marks. Although
Regulation (EC) No. 852/2004 does not contain specific
labelling provisions, this Regulation needs to be read in
conjunction with Regulation (EC) No. 853/2004 in order
to understand where there is provision for a number of
exemptions regarding the use of identification marks.
Fresh meat must still bear a health mark applied by an
official veterinarian. However, all other products of animal
origin produced in an approved establishment must be
labelled with an identification mark. The details concerning
use of identification marks are contained in Article 5 and
Annex II, Section I of Regulation (EC) No. 853/2004.
The provisions and details regarding the labelling of
products of animal origin are quite complex, but detailed
explanation of the use of identification and health marks
can be found in the European Commission’s guidance on
the Regulations (available at
www.ec.europa.eu/food/food/biosafety/hygienelegislation/g
uide_en.htm.
As the Regulations apply to all sectors of food production,
distribution and sale, the policy functions are the
responsibility of the Department of Health and Children,
the Department of Agriculture, Fisheries and Food and
the Department of Communications, Energy and Natural
Resources.
The Regulations are enforced by the FSAI and the official
agencies under the arrangements of the service contracts
with the FSAI.
5
108
APPENDIX I
LEGISLATION PROVIDING FOOD-RELATED INFORMATION
Horizontal
legislation
on labelling
Semi horizontal
legislation incl.
labelling
provisions
Directive
2000/13/EC*
as amended
Food supplements
And its related
Directives:
• Directive
87/250/EC*
(alcoholic strength)
• Directive
94/54/EEC* as
amended (specific
requirements)
• Directive
1999/10/EC* (QUID
derogations)
• Directive
2002/76/EC*
(caffeine / Quinine)
Directive 89/396/EEC
(Identification
of lot)
Directive 90/496/EC
(Nutrition Labelling)
Regulation (EC) No.
1924/2006 (Nutrition
and health claims)
Foodstuffs for particular
nutritional uses and
specific related
Directives:
• Infant formulae and
follow-on food
Vertical legislation incl. labelling provisions
Compositional
Standards
Common Marketing
Standards
Quality
Schemes
Chocolate
Coffee
Fruit juices
Caseins
Honey
Sugar
Preserved milk
Fruit jam
Mineral water
Beef
Spreadable fats
Milk
Quick frozen foods
Eggs
Wine
Aromatised wine
Spirits
Olive oil
Fish
Poultry
Fresh fruit and
vegetables
Mushrooms
Walnuts in shell
Hazelnuts in shell
Watermelons
Strawberries
Plums
Oils and fats
Beans
Preserved tuna
and bonito
Sardines
Carrots
Cauliflowers
Cabbages
Leeks
Artichokes
Garlic
Onions
Courgettes
Aubergines
Peas
Lettuces
Sweet peppers
Tomatoes
Apples
Apricots
Avocados
Cherries
Citrus fruit
Grapes
Kiwifruit
Melons
Peaches and nectarines
Pears
Organic food
• Baby food
• Food for special
medical purposes
• Food intended for
weight reduction
Irradiated food
Novel food
Phytosterols
Genetically modified
food
Fortified food
Additives
Flavourings
Materials and articles in
contact with food
Nominal quantities
Directive 98/6/EC
(Indication of prices)
Regulation (EC) No.
178/2002
(General food law)
(Units of measurement)
(Weight of certain prepackaged products)
Protected designations
of origin and
geographical
indications
Other
Metrology
(quantity control)
Eco labelling
Traditional specialities
guaranteed
Cucumbers
Witloof chicory
Bananas
Brussel sprouts,
celery and spinach
Hygiene Legislation
Regulation No. 853/2004 on the hygiene of foodstuffs of animal origin
Commission Regulation (EC) No. 2074/2005 (laying down implementing measures for Regulation (EC) No. 853/2004,
854/2004 and 882/2004
Regulation No. 2073/2005 on microbiological criteria for foodstuffs
* Horizontal legislation and their amendments under review
109
APPENDICES
APPENDIX II
LIST OF CATEGORIES OF INGREDIENTS WHICH MAY BE
DESIGNATED BY THE NAME OF THE CATEGORY RATHER
THAN THE SPECIFIC NAME (AS PER DIRECTIVE 2000/13/EC
AS AMENDED)
Definition
Designation
Refined oils other than olive oils
“Oil”, together with either the adjective “vegetable”
or “animal”, as appropriate or an indication of their
specific vegetable or animal origin
The adjective “hydrogenated” must accompany
the indication of a hydrogenated oil
Refined fats
“Fat”, together with either the adjective “vegetable”
or “animal” as appropriate, or an indication of their
specific vegetable or animal origin
Mixtures of flour obtained from two or more cereal species
“Flour”, followed by a list of the cereals from which it
has been obtained, in descending order by weight
Starches, and starches modified by physical means or
by enzymes
“Starch”
All species of fish where the fish constitutes an ingredient
of another foodstuff and provided that the name and
presentation of such foodstuff does not refer to a specific
species of fish
“Fish”
All types of cheese where the cheese or mixture of
cheeses constitutes an ingredient of another foodstuff
and provided that the name and presentation of such
foodstuff does not refer to a specific type of cheese
“Cheese”
All spices not exceeding 2% by weight of the foodstuff
“Spice(s)” or “mixed spices”
All herbs or parts of herbs not exceeding 2% by weight
of the foodstuff
“Herb(s)” or “mixed herbs”
All types of gum preparations used in the manufacture
of gum base for chewing gum
“Gum base”
All types of crumbled baked cereal products
“Crumbs”or “rusks” as appropriate
Appendices
The adjective “hydrogenated” must accompany
the indication of a hydrogenated fat
110
Definition
Designation
All types of sucrose
“Sugar”
Anhydrous dextrose or dextrose monohydrate
“Dextrose”
Glucose syrup and anhydrose glucose syrup
“Glucose Syrup”
All types of milk protein (caseins, caseinates and whey
products) and mixtures thereof
‘Milk proteins’
Press, expeller or refined cocoa butter
‘Cocoa butter’
All types of wine as defined in Council Regulation (EC) No.
1493/1999 of 17 May 1999 on the common organisation
of the market in wine
‘Wine’
Skeletal muscles** of mammalian and bird species
recognised as fit for human consumption with naturally
included or adherent tissue, where the total fat and
connective tissue content does not exceed the values
indicated below and where the meat constitutes an
ingredient of another foodstuff. The products covered by
the Community definition of ‘mechanically recovered meat’
are excluded from this definition
“…meat” and the name(s)* of the animal species from
which it comes
Maximum fat and connective tissue content for ingredients
designated by the term “…meat”:
Connective tissue1 (%)
Species
Fat (%)
Mammals (other than rabbits and
porcines) and mixtures of species with
mammals predominating
25
25
Porcines
30
25
Birds and rabbits
15
10
If these maximum limits are exceeded, but all the other criteria for the definition of “…meat” are satisfied, the “…meat”
content must be adjusted downwards accordingly, and the list of ingredients must mention, in addition to the term
“…meat”, the presence of fat and/or connective tissue.
1
The connective tissue content is calculated on the basis of the ratio between collagen content and meat protein content. The collagen content means the
hydroxyproline content multiplied by a factor of 8.
* For labelling in English, this designation may be replaced by the generic name of the ingredient for the animal species concerned.
** The diaphragm and the masseters are part of the skeletal muscles, while the heart, tongue, the muscles of the head (other than the masseters), the muscles
of the carpus, the tarsus and the tail are excluded.
111
APPENDICES
APPENDIX III
CATEGORIES OF INGREDIENTS WHICH MUST BE DESIGNATED
BY THE NAME OF THEIR CATEGORY FOLLOWED BY THEIR
SPECIFIC NAME OR EC NUMBER
Categories of ingredients which must be designated by the name of their category followed by their specific name
or European Communities number
Acid
Colour
Gelling agent
Raising agent
Acidity regulator
Emulsifier
Glazing agent
Stabilizer
Anti-caking agent
Emulsifying salts*
Humectant
Sweetener
Anti-foaming agent
Firming agent
Modified starch**
Thickener
Antioxidant
Flavour enhancer
Preservative
Bulking agent
Flour treatment agent
Propellant gas
* The category ‘Emulsifying salts’ can only used for processed cheeses or products based on processed cheeses.
** Modified starch must contain an indication of its specific vegetable origin if it contains gluten such as Modified Corn Starch (its specific name or E number
need not be indicated).
APPENDIX IV
•
Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof
•
Crustaceans and products thereof
•
Eggs and products thereof
•
Fish and products thereof
•
Peanuts and products thereof
•
Soybeans and products thereof
•
Milk and products thereof (including lactose)
•
Nuts i. e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew
(Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa),
Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof
•
Celery and products thereof
•
Mustard and products thereof
•
Sesame seeds and products thereof
•
Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2
•
Lupin and products thereof
•
Molluscs and products thereof.
Appendices
ALLERGENIC INGREDIENTS
112
APPENDIX V
FOOD INGREDIENTS AND SUBSTANCES PROVISIONALLY
EXEMPT FROM LABELLING AS ALLERGENIC (AS PER
COMMISSION DIRECTIVE 2005/26/EC AND 2005/63/EC)
Ingredients
Products thereof provisionally excluded
Refined oils other than olive oils
•
Wheat based glucose syrups including dextrose1
•
Wheat based maltodextrins1
•
Glucose syrups based on barley
•
Cereals used in distillates for spirits
•
Lysozym (produced from egg) used in wine
•
Albumin (produced from egg) used as fining agent in wine and cider
•
Fish gelatine used as carrier for vitamin or carotenoid preparations
and flavours
•
Fish gelatine or Isinglass used as fining agent in beer, cider and wine
•
Fully refined soybean oil and fat1
•
Natural mixed tocopherols (E306), natural D-alpha tocopherol, natural
D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from
soybean sources
•
Vegetable oils derived phytosterols and phytosterol esters from soybean
sources
•
Plant stanol ester produced from vegetable oil sterols from soybean sources
•
Whey used in distillates for spirits
•
Lactitol
•
Milk (casein) products used as fining agents in cider and wines
•
Nuts used in distillates for spirits
•
Nuts (almonds, walnuts) used (as flavour) in spirits
•
Celery leaf and seed oil
•
Celery seed oleoresin
•
Mustard oil
•
Mustard seed oil
•
Mustard seed oleoresin
Eggs
Fish
Soybean
Milk
Nuts
Celery
Mustard
1
And products thereof, in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by EFSA for the relevant
product from which they originated.
113
APPENDICES
APPENDIX VI
E Number
Name
E100
Curcumin
E101
Riboflavin (ii) Riboflavin-5'-phosphate
E102
Tartrazine
E104
Quinoline Yellow
E110
Sunset Yellow FCF, Orange Yellow S
E120
Cochineal, Carminic acid, Carmines
E122
Azorubine, Carmoisine
E123
Amaranth
E124
Ponceau 4R, Cochineal Red A
E127
Erythrosine
E129
Allura Red AC
E131
Patent Blue V
E132
Indigotine, Indigo carmine
E133
Brilliant Blue FCF
E140
Chlorophylis and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins
E141
Copper complexes of chlorophylls and chlorophyllins (i) Copper complexes of chlorophylls
(ii) Copper complexes of chlorophyllins
E142
Greens S
E150a
Plain caramel
E150b
Caustic sulphite caramel
E150c
Ammonia caramel
E150d
Sulphite ammonia caramel
E151
Brilliant Black BN, Black PN
E153
Vegetable carbon
E154
Brown FK
E155
Brown HT
E160a
Carotenes: (i) Mixed carotenes (ii) Beta-carotene
E160b
Annatto, bixin, norbixin
E160c
Paprika extract, capsanthin, capsorubin
E160d
Lycopene
E160e
Beta-apo-8'-carotenal (C 30)
E160f
Ethyl ester of beta-apo-8'-carotenic acid (C 30)
E161b
Lutein
E161g
Canthaxanthin
Appendices
E NUMBERS IN NUMERICAL ORDER
114
E Number
Name
E162
Beetroot Red, betanin
E163
Anthocyanins
E170
Calcium carbonates
E171
Titanium dioxide
E172
Iron oxides and hydroxides
E173
Aluminium
E174
Silver
E175
Gold
E180
Litholrubine BK
E200
Sorbic acid
E202
Potassium sorbate
E203
Calcium sorbate
E210
Benzoic acid
E211
Sodium benzoate
E212
Potassium benzoate
E213
Calcium benzoate
E214
Ethyl p-hydroxybenzoate
E215
Sodium ethyl p-hydroxybenzoate
E216
Propyl p-hydroxybenzoate
E217
Sodium propyl p-hydroxybenzoate
E218
Methyl p-hydroxybenzoate
E219
Sodium methyl p-hydroxybenzoate
E220
Sulphur dioxide
E221
Sodium sulphite
E222
Sodium hydrogen sulphite
E224
Potassium metabisulphite
E226
Calcium sulphite
E227
Calcium hydrogen sulphite
E228
Potassium hydrogen sulphite
E230
Biphenyl, diphenyl to be deleted and transferred to the pesticides register
E231
Orthophenyl phenol to be deleted and transferred to the pesticides register
E232
Sodium orthophenyl phenol to be deleted and transferred to the pesticides register
E234
Nisin
E235
Natamycin
E239
Hexamethylene tetramine
E242
Dimethyl dicarbonate
E250
Sodium nitrite
E251
Sodium nitrate
E Number
Name
E252
Potassium nitrate
E260
Acetic acid
E261
Potassium acetate
E262
Sodium acetates (i) Sodium acetate (ii) Sodium hydrogen acetate (sodium diacetate)
E263
Calcium acetate
E270
Lactic acid
E280
Propionic acid
E281
Sodium propionate
E282
Calcium propionate
E283
Potassium propionate
E284
Boric acid
E285
Sodium tetraborate (borax) E 249 Potassium nitrite
E290
Carbon dioxide
E296
Malic acid
E297
Fumaric acid
E300
Ascorbic acid
E301
Sodium ascorbate
E302
Calcium ascorbate
E304
Fatty acid esters of ascorbic acid (i) Ascorbyl palmitate (ii) Ascorbyl stearate
E306
Tocopherol-rich extract
E307
Alpha-tocopherol
E308
Gamma-tocopherol
E309
Delta-tocopherol
E310
Propyl gallate
E311
Octyl gallate
E312
Dodecyl gallate
E315
Erythorbic acid
E316
Sodium erythorbate
E320
Butylated hydroxyanisole (BHA)
E321
Butylated hydroxytoluene (BHT)
E322
Lecithins
E325
Sodium lactate
E326
Potassium lactate
E327
Calcium lactate
E330
Citric acid
E331
Sodium citrates (i) Monosodium citrate (ii) Disodium citrate (iii) Trisodium citrate
E332
Potassium citrates (i) Monopotassium citrate (ii) Tripotassium citrate
E333
Calcium citrates (i) Monocalcium citrate (ii) Dicalcium citrate (iii) Tricalcium citrate
Appendices
115
APPENDICES
116
E Number
Name
E334
Tartaric acid (L(+)-)
E335
Sodium tartrates (i) Monosodium tartrate (ii) Disodium tartrate
E336
Potassium tartrates (i) Monopotassium tartrate (ii) Dipotassium tartrate
E337
Sodium potassium tartrate
E338
Phosphoric acid
E339
Sodium phosphates (i) Monosodium phosphate (ii) Disodium phosphate (iii) Trisodium phosphate
E340
Potassium phosphates (i) Monopotassium phosphate (ii) Dipotassium phosphate (iii) Tripotassium
phosphate
E341
Calcium phosphates (i) Monocalcium phosphate (ii) Dicalcium phosphate (iii) Tricalcium phosphate
E343
Magnesium phosphates (i) monomagnesium phosphate (ii) Dimagnesium phosphate [Note - this
additive is under discussion and may be included in a future amendment to the Directive on
miscellaneous additives]
E350
Sodium malates (i) Sodium malate (ii) Sodium hydrogen malate
E351
Potassium malate
E352
Calcium malates (i) Calcium malate (ii) Calcium hydrogen malate
E353
Metatartaric acid
E354
Calcium tartrate
E355
Adipic acid
E356
Sodium adipate
E357
Potassium adipate
E363
Succinic acid
E380
Triammonium citrate
E385
Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA)
E400
Alginic acid
E401
Sodium alginate
E402
Potassium alginate
E403
Ammonium alginate
E404
Calcium alginate
E405
Propan-1,2-diol alginate
E406
Agar
E407
Carrageenan
E407a
Processed eucheuma seaweed
E410
Locust bean gum
E412
Guar gum
E413
Tragacanth
E414
Acacia gum (gum arabic)
E415
Xanthan gum
E416
Karaya gum
E417
Tara gum
E Number
Name
E418
Gellan gum
E420
Sorbitol (i) Sorbitol (ii) Sorbitol syrup
E421
Mannitol
E422
Glycerol
E425
Konjac (i) Konjac gum (ii) Konjac glucomannane
E431
Polyoxyethylene (40) stearate
E432
Polyoxyethylene sorbitan monolaurate (polysorbate 20)
E433
Polyoxyethylene sorbitan monooleate (polysorbate 80)
E434
Polyoxyethylene sorbitan monopalmitate (polysorbate 40)
E435
Polyoxyethylene sorbitan monostearate (polysorbate 60)
E436
Polyoxyethylene sorbitan tristearate (polysorbate 65)
E440
Pectins (i) pectin (ii) amidated pectin
E442
Ammonium phosphatides
E444
Sucrose acetate isobutyrate
E445
Glycerol esters of wood rosins
E450
Diphosphates (i) Disodium diphosphate (ii) Trisodium diphosphate(iii) Tetrasodium diphosphate (iv)
Dipotassium diphosphate (v) Tetrapotassium diphosphate (vi) Dicalcium diphosphate (vii) Calcium
dihydrogen diphosphate
E451
Triphosphates (i) Pentasodium triphosphate (ii) Pentapotassium triphosphate
E452
Polyphosphates (i) Sodium polyphosphates (ii) Potassium polyphosphates (iii) Sodium calcium
polyphosphate (iv) Calcium polyphophates
E459
Beta-cyclodextrine [Note - this additive was added in October 1998 by Directive 98/72]
E460
Cellulose (i) Microcrystalline cellulose (ii) Powdered cellulose
E461
Methyl cellulose
E463
Hydroxypropyl cellulose
E464
Hydroxypropyl methyl cellulose
E465
Ethyl methyl cellulose
E466
Carboxy methyl cellulose, Sodium carboxy methyl cellulose
E468
Crosslinked sodium carboxymethyl cellulose
E469
Enzymically hydrolysed carboxy methyl cellulose
E470a
Sodium, potassium and calcium salts of fatty acids
E470b
Magnesium salts of fatty acids
E471
Mono- and diglycerides of fatty acids
E472a
Acetic acid esters of mono- and diglycerides of fatty acids
E472b
Lactic acid esters of mono- and diglycerides of fatty acids
E472c
Citric acid esters of mono- and diglycerides of fatty acids
E472d
Tartaric acid esters of mono- and diglycerides of fatty acids
E472e
Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids
E472f
Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids
Appendices
117
APPENDICES
118
E Number
Name
E473
Sucrose esters of fatty acids
E474
Sucroglycerides
E475
Polyglycerol esters of fatty acids
E476
Polyglycerol polyricinoleate
E477
Propane-1,2-diol esters of fatty acids
E479b
Thermally oxidized soya bean oil interacted with mono- and diglycerides of fatty acids
E481
Sodium stearoyl-2-lactylate
E482
Calcium stearoyl-2-lactylate
E483
Stearyl tartrate
E491
Sorbitan monostearate
E492
Sorbitan tristearate
E493
Sorbitan monolaurate
E494
Sorbitan monooleate
E495
Sorbitan monopalmitate
E500
Sodium carbonates (i) Sodium carbonate (ii) Sodium hydrogen carbonate (iii) Sodium sesquicarbonate
E501
Potassium carbonates (i) Potassium carbonate (ii) Potassium hydrogen carbonate
E503
Ammonium carbonates (i) Ammonium carbonate (ii) Ammonium hydrogen carbonate
E504
Magnesium carbonates (i) Magnesium carbonate (ii) Magnesium hydroxide carbonate (syn.
Magnesium hydrogen carbonate)
E507
Hydrochloric acid
E508
Potassium chloride
E509
Calcium chloride
E511
Magnesium chloride
E512
Stannous chloride
E513
Sulphuric acid
E514
Sodium sulphates (i) Sodium sulphate (ii) Sodium hydrogen sulphate
E515
Potassium sulphates (i) Potassium sulphate (ii) Potassium hydrogen sulphate
E516
Calcium sulphate
E517
Ammonium sulphate
E520
Aluminium sulphate
E521
Aluminium sodium sulphate
E522
Aluminium potassium sulphate
E523
Aluminium ammonium sulphate
E524
Sodium hydroxide
E525
Potassium hydroxide
E526
Calcium hydroxide
E527
Ammonium hydroxide
E528
Magnesium hydroxide
E Number
Name
E529
Calcium oxide
E530
Magnesium oxide
E535
Sodium ferrocyanide
E536
Potassium ferrocyanide
E538
Calcium ferrocyanide
E541
Sodium aluminium phosphate, acidic
E551
Silicon dioxide
E552
Calcium silicate
E553a
(i) Magnesium silicate (ii) Magnesium trisilicate
E553b
Talc
E554
Sodium aluminium silicate
E555
Potassium aluminium silicate
E556
Calcium aluminium silicate
E558
Bentonite
E559
Aluminium silicate (Kaolin)
E570
Fatty acids
E574
Gluconic acid
E575
Glucono-delta-lactone
E576
Sodium gluconate
E577
Potassium gluconate
E578
Calcium gluconate
E579
Ferrous gluconate
E585
Ferrous lactate
E620
Glutamic acid
E621
Monosodium glutamate
E622
Monopotassium glutamate
E623
Calcium diglutamate
E624
Monoammonium glutamate
E625
Magnesium diglutamate E 626 Guanylic acid
E627
Disodium guanylate
E628
Dipotassium guanylate
E629
Calcium guanylate
E630
Inosinic acid
E631
Disodium inosinate
E632
Dipotassium inosinate
E633
Calcium inosinate
E634
Calcium 5'-ribonucleotides
E635
Disodium 5'-ribonucleotides
Appendices
119
APPENDICES
120
E Number
Name
E640
Glycine and its sodium salt
E650
Zinc acetate
E900
Dimethyl polysiloxane
E901
Beeswax, white and yellow
E902
Candelilla wax
E903
Carnauba wax
E904
Shellac
E905
Microcrystalline
E907
Hydrogenated poly-1-decene
E912
Montanic acid esters
E914
Oxidized polyethylene wax
E920
L-Cysteine
E927b
Carbamide
E938
Argon
E939
Helium
E941
Nitrogen
E942
Nitrous oxide
E943a
Butane
E943b
Isobutane
E944
Propane
E948
Oxygen
E949
Hydrogen
E950
Acesulfame K
E951
Aspartame
E952
Cyclamic acid and its Na and Ca salts
E953
Isomalt
E954
Saccharin and its Na, K and Ca salts
E955
Sucralose
E957
Thaumatin
E959
Neohesperidine DC
E962
Salt of aspartame-acesulfame
E965
Maltitol (i) Maltitol (ii) Maltitol syrup
E966
Lactitol
E967
Xylitol
E999
Quillaia extract
E1103
Invertase]
E1105
Lysozyme
E1200
Polydextrose
E Number
Name
E1201
Polyvinylpyrrolidone
E1202
Polyvinylpolypyrrolidone
E1404
Oxidized starch
E1410
Monostarch phosphate
E1412
Distarch phosphate
E1413
Phosphated distarch phosphate
E1414
Acetylated distarch phosphate
E1420
Acetylated starch
E1422
Acetylated distarch adipate
E1440
Hydroxy propyl starch
E1442
Hydroxy propyl distarch phosphate
E1451
Acetylated oxidised starch
E1450
Starch sodium octenyl succinate
E1505
Triethyl citrate
E1517
Glyceryl diacetate (diacetin)
E1518
Glyceryl triacetate (triacetin)
E1519
Benzyl alcohol
E1520
Propan-1,2-diol (propylene glycol)
Appendices
121
APPENDICES
122
APPENDIX VII
E NUMBERS IN ALPHABETICAL ORDER
E Number
Name
E414
Acacia gum (gum arabic)
E950
Acesulfame K
E260
Acetic acid
E472a
Acetic acid esters of mono- and diglycerides of fatty acids
E1422
Acetylated distarch adipate
E1414
Acetylated distarch phosphate
E1451
Acetylated oxidised starch
E1420
Acetylated starch
E355
Adipic acid
E406
Agar
E400
Alginic acid
E129
Allura Red AC
E307
Alpha-tocopherol
E173
Aluminium
E523
Aluminium ammonium sulphate
E522
Aluminium potassium sulphate
E559
Aluminium silicate (Kaolin)
E521
Aluminium sodium sulphate
E520
Aluminium sulphate
E123
Amaranth
E150c
Ammonia caramel
E403
Ammonium alginate
E503
Ammonium carbonates (i) Ammonium carbonate (ii) Ammonium hydrogen carbonate
E527
Ammonium hydroxide
E442
Ammonium phosphatides
E517
Ammonium sulphate
E160b
Annatto, bixin, norbixin
E163
Anthocyanins
E938
Argon
E300
Ascorbic acid
E951
Aspartame
E122
Azorubine, Carmoisine
E901
Beeswax, white and yellow
E Number
Name
E162
Beetroot Red, betanin
E558
Bentonite
E210
Benzoic acid
E1519
Benzyl alcohol
E160e
Beta-apo-8'-carotenal (C 30)
E459
Beta-cyclodextrine [Note - this additive was added in October 1998 by Directive 98/72]
E230
Biphenyl, diphenyl to be deleted and transferred to the pesticides register
E284
Boric acid
E151
Brilliant Black BN, Black PN
E133
Brilliant Blue FCF
E154
Brown FK
E155
Brown HT
E943a
Butane
E320
Butylated hydroxyanisole (BHA)
E321
Butylated hydroxytoluene (BHT)
E634
Calcium 5'-ribonucleotides
E263
Calcium acetate
E404
Calcium alginate
E556
Calcium aluminium silicate
E302
Calcium ascorbate
E213
Calcium benzoate
E170
Calcium carbonates
E509
Calcium chloride
E333
Calcium citrates (i) Monocalcium citrate (ii) Dicalcium citrate (iii) Tricalcium citrate
E623
Calcium diglutamate
E385
Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA)
E538
Calcium ferrocyanide
E578
Calcium gluconate
E629
Calcium guanylate
E227
Calcium hydrogen sulphite
E526
Calcium hydroxide
E633
Calcium inosinate
E327
Calcium lactate
E352
Calcium malates (i) Calcium malate (ii) Calcium hydrogen malate
E529
Calcium oxide
E341
Calcium phosphates (i) Monocalcium phosphate (ii) Dicalcium phosphate (iii) Tricalcium phosphate
E282
Calcium propionate
E552
Calcium silicate
Appendices
123
APPENDICES
124
E Number
Name
E203
Calcium sorbate
E482
Calcium stearoyl-2-lactylate
E516
Calcium sulphate
E226
Calcium sulphite
E354
Calcium tartrate
E902
Candelilla wax
E161g
Canthaxanthin
E927b
Carbamide
E290
Carbon dioxide
E466
Carboxy methyl cellulose, Sodium carboxy methyl cellulose
E903
Carnauba wax
E160a
Carotenes: (i) Mixed carotenes (ii) Beta-carotene
E407
Carrageenan
E150b
Caustic sulphite caramel
E460
Cellulose (i) Microcrystalline cellulose (ii) Powdered cellulose
E140
Chlorophylis and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins
E330
Citric acid
E472c
Citric acid esters of mono- and diglycerides of fatty acids
E120
Cochineal, Carminic acid, Carmines
E141
Copper complexes of chlorophylls and chlorophyllins (i) Copper complexes of chlorophylls
(ii) Copper complexes of chlorophyllins
E468
Crosslinked sodium carboxymethyl cellulose
E100
Curcumin
E952
Cyclamic acid and its Na and Ca salts
E309
Delta-tocopherol
E242
Dimethyl dicarbonate
E900
Dimethyl polysiloxane
E450
Diphosphates (i) Disodium diphosphate (ii) Trisodium diphosphate(iii) Tetrasodium diphosphate (iv)
Dipotassium diphosphate (v) Tetrapotassium diphosphate (vi) Dicalcium diphosphate (vii) Calcium
dihydrogen diphosphate
E628
Dipotassium guanylate
E632
Dipotassium inosinate
E635
Disodium 5'-ribonucleotides
E627
Disodium guanylate
E631
Disodium inosinate
E1412
Distarch phosphate
E312
Dodecyl gallate
E469
Enzymically hydrolysed carboxy methyl cellulose
E315
Erythorbic acid
E Number
Name
E127
Erythrosine
E160f
Ethyl ester of beta-apo-8'-carotenic acid (C 30)
E465
Ethyl methyl cellulose
E214
Ethyl p-hydroxybenzoate
E304
Fatty acid esters of ascorbic acid (i) Ascorbyl palmitate (ii) Ascorbyl stearate
E570
Fatty acids
E579
Ferrous gluconate
E585
Ferrous lactate
E297
Fumaric acid
E308
Gamma-tocopherol
E418
Gellan gum
E574
Gluconic acid
E575
Glucono-delta-lactone
E620
Glutamic acid
E422
Glycerol
E445
Glycerol esters of wood rosins
E1517
Glyceryl diacetate (diacetin)
E1518
Glyceryl triacetate (triacetin)
E640
Glycine and its sodium salt
E175
Gold
E142
Greens S
E412
Guar gum
E939
Helium
E239
Hexamethylene tetramine
E507
Hydrochloric acid
E949
Hydrogen
E907
Hydrogenated poly-1-decene
E1442
Hydroxy propyl distarch phosphate
E1440
Hydroxy propyl starch
E463
Hydroxypropyl cellulose
E464
Hydroxypropyl methyl cellulose
E132
Indigotine, Indigo carmine
E630
Inosinic acid
E1103
Invertase]
E172
Iron oxides and hydroxides
E943b
Isobutane
E953
Isomalt
E416
Karaya gum
Appendices
125
APPENDICES
126
E Number
Name
E425
Konjac (i) Konjac gum (ii) Konjac glucomannane
E270
Lactic acid
E472b
Lactic acid esters of mono- and diglycerides of fatty acids
E966
Lactitol
E180
Litholrubine BK
E920
L-Cysteine
E322
Lecithins
E410
Locust bean gum
E161b
Lutein
E160d
Lycopene
E1105
Lysozyme
E504
Magnesium carbonates (i) Magnesium carbonate (ii) Magnesium hydroxide carbonate
(syn. Magnesium hydrogen carbonate)
E511
Magnesium chloride
E625
Magnesium diglutamate E 626 Guanylic acid
E528
Magnesium hydroxide
E530
Magnesium oxide
E343
Magnesium phosphates (i) monomagnesium phosphate (ii) Dimagnesium phosphate [Note - this
additive is under discussion and may be included in a future amendment to the Directive on
miscellaneous additives]
E470b
Magnesium salts of fatty acids
E553a
(i) Magnesium silicate (ii) Magnesium trisilicate
E296
Malic acid
E965
Maltitol (i) Maltitol (ii) Maltitol syrup
E421
Mannitol
E353
Metatartaric acid
E461
Methyl cellulose
E218
Methyl p-hydroxybenzoate
E905
Microcrystalline wax
E472f
Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids
E472e
Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids
E471
Mono- and diglycerides of fatty acids
E624
Monoammonium glutamate
E622
Monopotassium glutamate
E621
Monosodium glutamate
E1410
Monostarch phosphate
E912
Montanic acid esters
E235
Natamycin
E959
Neohesperidine DC
E Number
Name
E234
Nisin
E941
Nitrogen
0E942
Nitrous oxide
E311
Octyl gallate
E231
Orthophenyl phenol to be deleted and transferred to the pesticides register
E914
Oxidized polyethylene wax
E1404
Oxidized starch
E948
Oxygen
E160c
Paprika extract, capsanthin, capsorubin
E131
Patent Blue V
E440
Pectins (i) pectin (ii) amidated pectin
E1413
Phosphated distarch phosphate
E338
Phosphoric acid
E150a
Plain caramel
E1200
Polydextrose
E475
Polyglycerol esters of fatty acids
E476
Polyglycerol polyricinoleate
E431
Polyoxyethylene (40) stearate
E432
Polyoxyethylene sorbitan monolaurate (polysorbate 20)
E433
Polyoxyethylene sorbitan monooleate (polysorbate 80)
E434
Polyoxyethylene sorbitan monopalmitate (polysorbate 40)
E435
Polyoxyethylene sorbitan monostearate (polysorbate 60)
E436
Polyoxyethylene sorbitan tristearate (polysorbate 65)
E452
Polyphosphates (i) Sodium polyphosphates (ii) Potassium polyphosphates (iii) Sodium calcium
polyphosphate (iv) Calcium polyphophates
E1202
Polyvinylpolypyrrolidone
E1201
Polyvinylpyrrolidone
E124
Ponceau 4R, Cochineal Red A
E261
Potassium acetate
E357
Potassium adipate
E402
Potassium alginate
E555
Potassium aluminium silicate
E212
Potassium benzoate
E501
Potassium carbonates (i) Potassium carbonate (ii) Potassium hydrogen carbonate
E508
Potassium chloride
E332
Potassium citrates (i) Monopotassium citrate (ii) Tripotassium citrate
E536
Potassium ferrocyanide
E577
Potassium gluconate
Appendices
127
APPENDICES
128
E Number
Name
E228
Potassium hydrogen sulphite
E525
Potassium hydroxide
E326
Potassium lactate
E351
Potassium malate
E224
Potassium metabisulphite
E252
Potassium nitrate
E340
Potassium phosphates (i) Monopotassium phosphate (ii) Dipotassium phosphate (iii) Tripotassium
phosphate
E283
Potassium propionate
E202
Potassium sorbate
E515
Potassium sulphates (i) Potassium sulphate (ii) Potassium hydrogen sulphate
E336
Potassium tartrates (i) Monopotassium tartrate (ii) Dipotassium tartrate
E407a
Processed eucheuma seaweed
E1520
Propan-1,2-diol (propylene glycol)
E405
Propan-1,2-diol alginate
E944
Propane
E477
Propane-1,2-diol esters of fatty acids
E280
Propionic acid
E310
Propyl gallate
E216
Propyl p-hydroxybenzoate
E999
Quillaia extract
E104
Quinoline Yellow
E101
(i) Riboflavin (ii) Riboflavin-5'-phosphate
E954
Saccharin and its Na, K and Ca salts
E962
Salt of aspartame-acesulfame
E904
Shellac
E551
Silicon dioxide
E174
Silver
E262
Sodium acetates (i) Sodium acetate (ii) Sodium hydrogen acetate (sodium diacetate)
E356
Sodium adipate
E401
Sodium alginate
E541
Sodium aluminium phosphate, acidic
E554
Sodium aluminium silicate
E301
Sodium ascorbate
E211
Sodium benzoate
E500
Sodium carbonates (i) Sodium carbonate (ii) Sodium hydrogen carbonate (iii) Sodium sesquicarbonate
E331
Sodium citrates (i) Monosodium citrate (ii) Disodium citrate (iii) Trisodium citrate
E316
Sodium erythorbate
E Number
Name
E215
Sodium ethyl p-hydroxybenzoate
E535
Sodium ferrocyanide
E576
Sodium gluconate
E222
Sodium hydrogen sulphite
E524
Sodium hydroxide
E325
Sodium lactate
E350
Sodium malates (i) Sodium malate (ii) Sodium hydrogen malate
E219
Sodium methyl p-hydroxybenzoate
E251
Sodium nitrate
E250
Sodium nitrite
E232
Sodium orthophenyl phenol to be deleted and transferred to the pesticides register
E339
Sodium phosphates (i) Monosodium phosphate (ii) Disodium phosphate (iii) Trisodium phosphate
E337
Sodium potassium tartrate
E281
Sodium propionate
E217
Sodium propyl p-hydroxybenzoate
E481
Sodium stearoyl-2-lactylate
E514
Sodium sulphates (i) Sodium sulphate (ii) Sodium hydrogen sulphate
E221
Sodium sulphite
E335
Sodium tartrates (i) Monosodium tartrate (ii) Disodium tartrate
E285
Sodium tetraborate (borax) E 249 Potassium nitrite
E470a
Sodium, potassium and calcium salts of fatty acids
E200
Sorbic acid
E493
Sorbitan monolaurate
E494
Sorbitan monooleate
E495
Sorbitan monopalmitate
E491
Sorbitan monostearate
E492
Sorbitan tristearate
E420
Sorbitol (i) Sorbitol (ii) Sorbitol syrup
E512
Stannous chloride
E1450
Starch sodium octenyl succinate
E483
Stearyl tartrate
E363
Succinic acid
E955
Sucralose
E474
Sucroglycerides
E444
Sucrose acetate isobutyrate
E473
Sucrose esters of fatty acids
E150d
Sulphite ammonia caramel
E220
Sulphur dioxide
Appendices
129
APPENDICES
130
E Number
Name
E513
Sulphuric acid
E110
Sunset Yellow FCF, Orange Yellow S
E553b
Talc
E417
Tara gum
E334
Tartaric acid (L(+)-)
E472d
Tartaric acid esters of mono- and diglycerides of fatty acids
E102
Tartrazine
E957
Thaumatin
E479b
Thermally oxidized soya bean oil interacted with mono- and diglycerides of fatty acids
E171
Titanium dioxide
E306
Tocopherol-rich extract
E413
Tragacanth
E380
Triammonium citrate
E1505
Triethyl citrate
E451
Triphosphates (i) Pentasodium triphosphate (ii) Pentapotassium triphosphate
E153
Vegetable carbon
E415
Xanthan gum
E967
Xylitol
E650
Zinc acetate
131
APPENDICES
APPENDIX VIII
NUTRITION CLAIMS AND CONDITIONS APPLYING TO THEM
Low Energy
Saturated Fat-Free
A claim that a food is low in energy, and any claim likely
to have the same meaning for the consumer, may only
be made where the product does not contain more than
40kcal (170kJ)/100g for solids or more than 20kcal (80
kJ)/100 ml for liquids. For table-top sweeteners the limit
of 4kcal (17kJ)/portion, with equivalent sweetening
properties to 6g of sucrose (approximately 1 teaspoon
of sucrose), applies.
A claim that a food does not contain saturated fat,
and any claim likely to have the same meaning for the
consumer, may only be made where the sum of saturated
fat and trans-fatty acids does not exceed 0.1g of saturated
fat per 100g or 100ml.
A claim that a food is energy-reduced, and any claim likely
to have the same meaning for the consumer, may only be
made where the energy value is reduced by at least 30%,
with an indication of the characteristic(s) which make(s)
the food reduced in its total energy value.
Energy-Free
A claim that a food is energy-free, and any claim likely to
have the same meaning for the consumer, may only be
made where the product does not contain more than 4kcal
(17kJ)/100 ml. For table-top sweeteners the limit of 0.4kcal
(1.7kJ)/portion, with equivalent sweetening properties to 6g
of sucrose (approximately 1 teaspoon of sucrose), applies.
Low Fat
A claim that a food is low in fat, and any claim likely
be made where the product contains no more than
3g of fat per 100g for solids or 1.5g of fat per 100ml
for liquids (1.8g of fat per 100ml for semi-skimmed milk).
Fat-Free
A claim that a food is fat-free, and any claim likely to have
the same meaning for the consumer, may only be made
where the product contains no more than 0.5g of fat per
100g or 100ml. However, claims expressed as ‘X % fat-free’
shall be prohibited.
Low Saturated Fat
A claim that a food is low in saturated fat, and any claim
likely to have the same meaning for the consumer, may
only be made if the sum of saturated fatty acids and transfatty acids in the product does not exceed 1.5g per 100g
for solids or 0.75g/100ml for liquids and in either case the
sum of saturated fatty acids and trans-fatty acids must not
provide more than 10 of energy.
A claim that a food is low in sugars, and any claim likely
be made where the product contains no more than 5g
of sugars per 100g for solids or 2.5g of sugars per
100ml for liquids.
Sugars-Free
A claim that a food is sugars-free, and any claim likely
be made where the product contains no more than 0.5g
of sugars per 100g or 100ml.
With No Added Sugars
A claim stating that sugars have not been added to a food,
consumer, may only be made where the product does not
contain any added mono- or disaccharides or any other
food used for its sweetening properties. If sugars are
naturally present in the food, the following indication
should also appear on the label: ‘CONTAINS NATURALLY
OCCURRING SUGARS’.
Low Sodium/Salt
A claim that a food is low in sodium/salt, and any claim
only be made where the product contains no more than
0.12g of sodium, or the equivalent value for salt, per 100g
or per 100ml. For waters, other than natural mineral waters
falling within the scope of Directive 80/777/EEC, this value
should not exceed 2mg of sodium per 100ml.
Very Low Sodium/Salt
A claim that a food is very low in sodium/salt, and any
claim likely to have the same meaning for the consumer,
may only be made where the product contains no more
than 0.04g of sodium, or the equivalent value for salt, per
100g or per 100ml. This claim shall not be used for natural
mineral waters and other waters.
Appendices
Energy-Reduced
Low Sugars
132
Sodium-Free or Salt-Free
Contains [Name of the Nutrient or Other Substance]
A claim that a food is sodium-free or salt-free, and any
may only be made where the product contains no more
than 0.005g of sodium, or the equivalent value for salt,
per 100g.
A claim that a food contains a nutrient or another
substance, for which specific conditions are not laid down
in this Regulation, or any claim likely to have the same
meaning for the consumer, may only be made where the
product complies with all the applicable provisions of this
Regulation, and in particular Article 5. For vitamins and
minerals, the conditions of the claim ‘source of’ shall apply.
Source of Fibre
A claim that a food is a source of fibre, and any claim likely
made where the product contains at least 3g of fibre per
100g or at least 1.5 g of fibre per 100kcal.
High Fibre
A claim that a food is high in fibre, and any claim likely
made where the product contains at least 6g of fibre per
100g or at least 3g of fibre per 100kcal.
Source of Protein
A claim that a food is a source of protein, and any claim
only be made where at least 12% of the energy value
of the food is provided by protein.
High Protein
A claim that a food is high in protein, and any claim likely
made where at least 20% of the energy value of the food
is provided by protein.
Source of [Name of Vitamin/s]
and/or [Name of Mineral/s]
A claim that a food is a source of vitamins and/or minerals,
consumer, may only be made where the product contains
at least a significant amount as defined in the Annex to
Directive 90/496/EEC or an amount provided for by
derogations granted according to Article 6 of Regulation
(EC) No. 1925/2006 of the European Parliament and of the
Council of 20 December 2006 on the addition of vitamins
and minerals and of certain other substances to foods.
High [Name of Vitamin/s]
and/or [Name of Mineral/s]
A claim that a food is high in vitamins and/or minerals,
consumer, may only be made where the product contains
at least twice the value of ‘source of [NAME OF VITAMIN/S]
and/or [NAME OF MINERAL/S]’.
Increased [Name of the Nutrient]
A claim stating that the content in one or more nutrients,
other than vitamins and minerals, has been increased,
consumer, may only be made where the product meets
the conditions for the claim ‘source of’ and the increase
in content is at least 30% compared to a similar product.
Reduced [Name of the Nutrient]
A claim stating that the content in one or more nutrients
has been reduced, and any claim likely to have the same
meaning for the consumer, may only be made where the
reduction in content is at least 30% compared to a similar
product, except for micronutrients, where a 10% difference
in the reference values as set in Directive 90/496/EEC shall
be acceptable, and for sodium, or the equivalent value for
salt, where a 25% difference shall be acceptable.
Light/Lite
A claim stating that a product is ‘light’ or ‘lite’, and any
shall follow the same conditions as those set for the term
‘reduced’; the claim shall also be accompanied by an
indication of the characteristic(s) which make(s) the food
‘light’ or ‘lite’.
Naturally/Natural
Where a food naturally meets the condition(s) laid down
in this Annex for the use of a nutrition claim, the term
‘naturally/natural’ may be used as a prefix to the claim.
133
APPENDICES
APPENDIX IX
Catch area
Identification of the area1
North-West Atlantic
FAO area 21
North-East Atlantic2
FAO area 27
Baltic Sea
FAO area 27.IIId
Central-Western Atlantic
FAO area 31
Central-Eastern Atlantic
FAO area 34
South-West Atlantic
FAO area 41
South-East Atlantic
FAO area 47
Mediterranean Sea
FAO areas 37.1, 37.2 and 37.3
Black Sea
FAO area 37.4
Indian Ocean
FAO areas 51 and 57
Pacific Ocean
FAO areas 61, 67, 71, 77, 81 and 87
Antarctic
FAO areas 48, 58 and 88
1
FAO Yearbook. Fishery statistics. Catches. Vol. 86/1. 2000.
2
Excluding the Baltic Sea.
Appendices
CATCH AREAS (ACCORDING TO COMMISSION REGULATION (EC)
NO. 2065/2001)
134
APPENDIX X
EU REGULATIONS REGARDING THE MARKETING STANDARDS
FOR FRESH FRUIT AND VEGETABLES
Fruit
Regulation (EC) No.
Apples
85/2004
Apricots
851/2000
Avocados
831/1997
Bananas (green)
2257/1994
Cherries
214/2004
Kiwifruit
1673/2004
Lemons
1799/2001
Mandarins
1799/2001
Melons
1615/2001
Nectarines
1861/2004
Oranges
1799/2001
Peaches
1861/2004
Pears
86/2004
Plums
1168/1999
Citrus Fruit (e.g. Satsumas, clementines,
tangerines and similar citrus hybrids)
1799/2001
Strawberries
843/2002
Table Grapes
2789/1999
Watermelons
1862/2004
135
APPENDICES
Regulation (EC) No.
Artichokes
1466/2003
Asparagus
2377/1999
Aubergines
1292/1981
Beans (other than shelling beans)
912/2001
Brussel Sprouts
1591/1987
Cabbage
1591/1987
Carrots
730/1999
Cauliflower
963/1998
Celery
1591/1987
Chicory
2213/1983
Courgettes
1757/2003
Cucumbers
1677/1988
Endive
1543/2001
Garlic
2288/1997
Leeks
2396/2001
Lettuce
1543/2001
Mushrooms
1863/2004
Onions
1508/2001
Peas (including mangetout and sugar-snap)
2561/1999
Spinach
1591/1987
Sweet Peppers
1455/1999
Tomatoes
790/2000
Nuts
Regulation (EC) No.
Hazelnuts (in shell)
1284/2002
Walnut (shell)
175/2001
Appendices
Vegetables
Source: www.agriculture.gov.ie
136
APPENDIX XI
COMPETENT AUTHORITIES CONTACT DETAILS
Headquarters
Department of Agriculture and Food
Agriculture House, Kildare Street, Dublin 2
Tel: +353 (0)1 6072000
www.agriculture.gov.ie
The Organic Unit
Department of Agriculture and Food,
Johnstown Castle Estate, Co. Wexford
Tel: +353 (0)53 63465
Department of Communications,
Energy and Natural Resources
Headquarters
Resources, 29-31 Adelaide Road, Dublin 2
Tel: +353 (0)1 6782000
www.dcmnr.gov.ie
Department of Enterprise, Trade and Employment:
Headquarters
Department of Enterprise, Trade & Employment,
23 Kildare Street, Dublin 2
Tel: +353 (0)1 631 2121
www.entemp.ie
Department of Health and Children
Department of Health and Children
Hawkins House, Hawkins Street, Dublin 2
Tel: +353 (0)1 6354000
www.dohc.ie
Local Authorities
Contact local city or county council
Marine Institute
Marine Institute
Rinville, Oranmore, Co. Galway
Tel: +353 (0)91 387200
www.marine.ie
National Standards Authority of Ireland (NSAI)
Headquarters
Legal Metrology Service
NSAI, Dublin, Glasnevin, Dublin 9
Tel: +353 (0)1 8073807
www.nsai.ie
Office of the Director of Consumer Affairs (ODCA)*
4 Harcourt Road, Dublin 2
Tel: +353 (0)1 402 5555
www.odca.ie
The Radiological Protection Institute of Ireland
3 Clonskeagh Square, 119 Clonskeagh Road, Dublin 14
Tel: +353 (0)1 2697766
www.rpii.ie
Other:
Bord Iscaigh Mhara,
Market Development Division,
Crofton Road, Dun Laoghaire, Co. Dublin
Tel: +353 (0)1 2144100.
www.bim.ie
Abbey Court,Lower Abbey Street, Dublin 1
Tel: +353 (0)1 8171300
Advice line: 1850 33 66 77
www.fsai.ie
EPA Headquarters
PO Box 3000
Johnstown Castle Estate, Co. Wexford
Tel: +353 (0)53 9160600
www.epa.ie
Irish Medicines Board,
Earlsfort Centre, Earlsfort Terrace, Dublin 2
Tel: 353 (0)1-676 4971
www.imb.ie
Head Office
Oak House,Limetree Avenue,
Millennium Park, Naas, Co. Kildare
Tel: +353 (0)45 880400
www.hse.ie
Contact also local Environmental Health Departments
* The ODCA is part of the National Consumer Agency www.nca.ie
Advice Line: 1890 33 66 77
Telephone: 01 817 1300
Facsimile: 01 817 1301
Email: [email protected]
Website: www.fsai.ie
ISBN 1-904465-52-8
€25

The Food Safety Authority of Ireland

Transcription

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