Importing pre-packaged foodstuffs

Importing pre-packaged foodstuffs
Information for you who want to import or trade foodstuffs within the EU
Starting your business
If you import or trade pre-packed foodstuffs within
the EU you can find information in this brochure that
is important for you and your business.
Importing or trading within the EU?
Import means purchasing from countries that are not
members of the EU. Trading within the EU means, in
most cases, free trade between Member States.
You are responsible for the food being safe
Everyone serving or selling food is responsible for
the food being safe to eat. It must not entail a risk
to people’s health. This applies to both hygiene and
labelling.
It is also the responsibility of anyone selling prepackaged food that the labelling is correct and does not
mislead the consumer.
An example of when labelling is important for
consumer safety is if the foodstuff contains allergens,
that is substances which can trigger an allergic reaction
in someone who is allergic.
Registering your business
When you start a business which involves importing
or trading foodstuffs, you must be registered at the
control authority. This is usually the environmental
service at your local municipality authority. Contact the
environmental health service at your local authority.
You must be registered even if you do not have storage
facilities of your own for your goods, but only an office.
However, if your business is very limited it may be the
case that it does not need to be registered. Examples
of such businesses can be found in The National Food
Agency’s approval and registration guide (in Swedish).
It is the control authority that decides.
Irrespective of whether the business needs to be
registered or not, you are responsible for the foodstuffs
you sell being safe for the consumer.
N.B. Not all the rules are included here. The contents
are intended to give an overview of the legislation that
affects you. There are also references to further rules
that you may be obliged to keep track of.
3
This is what you need to include in your registration
application:
• Name and address of the food business operator.
• Corporate identity number, personal identity number
or coordination number.
• Premises, space or place where the business is to be run.
• A description of the nature and scope of the business.
• Any other information that the control authority
requests.
Registration forms are available at your local authority.
Find out what rules apply
The rules exist to protect the consumer
The food legislation has two main purposes:
- to protect the consumer from food that is unfit for
human consumption or has negative health effects and
- to ensure that labelling provides the consumer with
sufficient information to enable him or her to make
independent and safe choices. Labelling, advertising
and presentation of food must not mislead the
consumer.
The local authority charges a fee
The local authority charges a fee for registration and
inspections. The size of your inspection fee depends
on how great the need is to inspect your business.
The local authority assesses the need and gives you
a decision about the inspection time. Every local
4
authority decides on an hourly rate for food business
inspections in the municipality. Your annual inspection
fee is calculated by multiplying the inspection time by
the hourly rate. For example, 2 hours x 1,000 Swedish
crowns = an annual inspection fee of 2,000 Swedish
crowns.
Even if the fee is paid annually, it is not certain that
the local authority will visit you each year. The time
you have been given in your decision is the time that
the local authority needs to inspect your business. The
time covers preparation, the actual visit as well as any
follow up work at the local authority offices. Travelling
time is, however, not included in the inspection time.
This applies to all food businesses
• Responsibility – As a food business operator, you
are responsible for the food that you manufacture,
transport, store or sell. For example, you must
follow the rules concerning safety and labelling.
• Traceability “one step forward and one step back”–
A supplier and a batch must be able to be identified
rapidly.
• Openness – You must immediately inform the
competent authorities and consumers if there is
reason to suspect that a foodstuff is not safe.
• Preventive – You must regularly review critical
control points in your business and ensure that they
are checked.
• Control – You must have your own controls so that
the business meets the objectives of the legislation.
Labelling gives the consumer
important information
The labelling rules exist to make it easier for the
consumer to make informed and safe choices with
regard to food.
The information in this brochure is not comprehensive.
There may be other rules that you must take into
account depending on the foodstuff. This section takes
up only certain mandatory labelling information and
not all the special requirements. You may also need to
know about other rules.
Irrespective of whether you run a food business or not,
all prepackaged food must be correctly labelled. This
also applies if foodstuffs are given away free of charge.
What is pre-packaged food?
Food is pre-packaged if it was placed in a package
before it reached the consumer. The packaging should
completely or partially cover the food. It should not
be possible to change the contents without opening
or changing the packaging. However, food that is
packaged at the time it is sold, for example cheese that
is packed at the customer’s request and sold over the
counter, does not count as pre-packaged. There are
more examples in the labelling regulations guide in
Swedish.
How should labelling be done?
You can find the rules for food labelling in the National
Food Agency’s regulations LIVSFS 2004:27 concerning
the labelling and presentation of food (the labelling
regulations). This regulation is in Swedish only but
the rules are based on EU-directive 2000/13/EC that
can be found in English. The National Food Agency’s
labelling regulations guide (also in Swedish) helps you
with how the requirements of the legislation should be
5
A new EU regulation for labelling, Regulation (EU) No 1169/2011 on the provision of food information
to consumers (the so-called food information regulation), was adopted on November 22, 2011. Some
of the new rules are as follows: allergens in particular shall be given prominence in the labelling,
a smallest text size has been determined, a nutrition declaration must be present for the great majority
of foods and it shall include the amount of salt. More information can be found on the European commission website.
interpreted. In the appendix to the guide you will find
a list of certain other provisions concerning labelling.
Some examples are dietary supplements, cocoa and
chocolate goods, honey, olive oil, fruit juice and fruit
nectar, natural mineral water and spring water, veal,
and products containing caffeine or which are specially
made for consumers with an intolerance.
There are also rules governing certain information on
prepackaged food, for example nutrition labelling,
claims that the food is nutritional or healthy and the
keyhole. You will find a complete and up-to-date list of
the legislation on the National Food Agency’s website.
Labelling should be easy to read
and understand
The main rule is that labelling should be in Swedish,
but it is possible to use another language if there is no
significant difference in spelling (see the example in the
guide). The labelling information may be given in several
languages at the same time as long as the text is not too
difficult to read. The rules also say that the text should
be clearly legible and not be hidden by some other text
or pictures. In order to increase legibility, a requirement
concerning a smallest font size of 1.2 mm (0.9 mm on
small packages) has been introduced in the new rules,
which will begin to apply on December 13, 2014.
What information must be present
on the packaging?
Depending on what type of food you want to sell,
there are requirements that all or some of the following
labelling information is given:
• The name of the food (§§ 17–21 of the National Food
Agency’s labelling regulations) shall be present on the
labelling. The food’s brand name may not replace the
name of the food, but may be used in combination
with the name, for example “Kalasknyten –
kanelbullar” (cinnamon buns). The name should
give a clear description of the food and not mislead
the consumer. An example of a misleading name is
if an ingredient is given prominence without being
of special importance for the food, that is not to be
found in the food in any large quantities or does not
give the food a particular character. It is sometimes
necessary in connection with the name to state how
the food has been treated so that the consumer can
get a good understanding of what the article is, for
example “rökt skinka”, (“smoked ham”).
A list of ingredients (§§ 22–39) shall be present in
most cases when the food contains more than one
ingredient, but there are certain exceptions (§§ 23–24).
The ingredients shall be given in descending order of
weight, that is to say that the ingredient that weighed
the most at the time of manufacture of the food shall be
stated first. The main rule is that all ingredients must be
stated. Even the ingredients in a compound ingredient
must be stated, but in some cases a category name may
be used (§ 35). Before the list there should be a heading
that contains the word “ingrediens” (ingredient).
Example: “Ingredienser: mjölk, vete, ägg, socker”.
(Which means; ingredients: milk, wheat, egg, sugar).
Ingredients that may cause allergy or intolerance (allergens)
shall always be stated in the list of ingredients. For
further information, see the above-mentioned guide. This
requirement also applies to ingredients and substances
WHEN YOU GIVE THE FOOD A NAME
1. Begin by finding out if there is a name that you must use according to joint EU or national rules.
You can find more information on the National Food Agency’s website.
2. If there is no such name you should decide if the food has a generally accepted name.
3. The third option is for you yourself to describe the food using a descriptive name. The description should
be such that it describes the food as fairly as possible. See the labelling regulations.
6
that are used in the manufacture of a food, for example
additives, processing aids, flavourings or enzymes, which
have been extracted from any of the allergens.
Example: If modified starch has its origin in wheat, this
shall be stated. For example, you can write “modifierad
vetestärkelse” or “modifierad stärkelse (från vete) wich
means “modified wheat starch” or “modified starch
(from wheat)”.
Example: If the name of the food is “Skagen röra”
(a Swedish dish containing prawns), the quantity of
prawns must be stated, as it is implicitly understood
that the ingredient is included.
• the ingredient is particularly prominent in the
labelling (for example in a picture) or
• it is necessary to avoid that the food is confused with
another food.
Read more
Read about how additives should be stated in the list
of ingredients under the section “If food additives or
flavourings are included”.
The quantitative ingredient declaration may either
be stated next to the name of the food or in the list
of ingredients in connection with the ingredient in
question. The quantity should be given as a percentage.
It is your responsibility to ensure that the list of
ingredients is drawn up in accordance with the
requirements of the legislation.
Read more about when a quantitative ingredient
declaration is necessary and see more examples in the
guide.
• Net quantity (§§ 45–51) – must be stated on all prepackaged food with the few exceptions to be found
in § 51. How the net quantity should be stated
depends on the form of the food. Liquids should be
given in volume and other foods in weight, see
§ 46. Dietary supplements in the form of tablets and
capsules or the like may instead be labelled with
information about the number of tablets, capsules
or the like.
• Best before or use by date (§§ 52-54) – should be
stated on all prepackaged food with the exception of
The quantity of certain ingredients or categories of
ingredients (§§ 40–44), is required if:
• the ingredient or category of ingredients is included
in the name of the food,
Example: If the name of the food is blåbärspaj
(“Blueberry pie”), the quantity of blueberries must
be stated.
• the ingredient or category of ingredients is usually
associated with the name of the food without being
included in the name of the food.
7
•
•
•
•
•
•
the products listed in § 52. Information on the use
by date must be given for perishable foods that are
easily spoiled by e.g. microorganisms. For further
information, see the guide.
Special directions for storage or use (§§ 55-56) –
must be present on food that is labelled with a use
by date or if how the food is stored is of importance
for durability. It is also important that you as a
food business operator store the food in the way
described in the labelling information.
Contact details (§ 57) in the form of your
company’s name and address should be present on
the labelling. Instead of an address you can write
your Swedish telephone number. However, the
National Food Agency does not consider only an
e-mail address and internet address to be sufficient.
Origin (§ 58) – required if it is necessary for the
consumer not to be misled. If for example there is a
picture on the packaging that gives the impression
that the product is manufactured in a special
country or in a certain place, the origin needs to
be stated. Read more about origin in the labelling
guide. Indication of origin is required for certain
other foods, such as beef and veal, fish, honey and
olive oil.
Instructions for use (§ 59) – must be included on
the labelling if it is necessary for the consumer to
understand how the food is to be used. Examples of
instructions for use are how squash drinks are to be
diluted and how deep-frozen fish is to be thawed.
Actual alcoholic strength (§ 60) – must be stated
for beverages containing more than 1.2 percent by
volume of alcohol.
Nutrition labelling – describes how much energy
and nutrients the food contains, for example fat,
protein and carbohydrates. It does not always
have to be included, but is mandatory, e.g. on
food packages with nutritional claims, that is a
claim about the particular nutritional properties
of a food. Examples of nutritional claims are “low
energy content”, “low fat level” and “high protein
content”.
Nutrition labelling is also mandatory if a foodstuff has
been enriched with vitamins or minerals. The nutrition
labelling rules state how the labelling must be laid out,
and it is not permitted to do it in any other way.
8
Important to know if the product contains
allergens
Allergens are substances, usually proteins, that can
cause an allergic reaction in anyone who is allergic.
Small amounts are often enough. The symptoms
can vary from itching to more severe symptoms, for
example anaphylactic shock.
In the worst case the symptoms are so severe that they can
lead to death. It is therefore very important to know the
composition of the foodstuff you are importing or trading,
and to ensure that all allergens have been correctly
included in the labelling. For further information, see
What information should be on the packaging?
If food additives or flavourings are included
Food additives
Food additives are substances added to foodstuffs for
technical reasons, for example to affect consistency,
taste or colour.
If you import or trading food in Sweden, it is your
responsibility that the additives included in the
foodstuffs have been approved here. Legislation
concerning food additives may be different in countries
outside the EU.
The rules on what additives may be used in food are
common to the entire EU. The rules on what additives
may be used in food are common to the entire EU and
can be found in Regulation (EC) No 1333/2008 on
food additives.
The fact that an additive has been approved does not
necessary mean that it may be used in all food. What
additives are permitted in what foodstuffs and on what
conditions, for example permitted quantity, can be found
in the EU Regultaions about food additives.
If you want to find out whether a certain additive is
permitted in a certain food, you can search in the pdf
versions of the EU Regulations about food additives. It
can be found on the National Food Agency’s website.
Do as follows:
• Open the pdf document.
• Type the E number or the name of the additive in the
search box (a space is needed after the E).
• Click on search.
Food additives must be stated in the list of ingredients
together with a functional name, which describes why
the additive is used. Examples of functional names
are sweeteners, colour and stabilizers (see the list in
Appendix 3 of the National Food Agency´s labelling
regulations). After the functional name the E number
or the name of the additive should be stated (see § 36
of the National Food Agency’s labelling regulations and
the section on food additives in the labelling regulations
guide).
have a sweet, salty or sour taste, for example sugars
and salt do not, however, count as flavourings, Smoke
flavourings are a special type of flavourings that consist
of smoke extract and add a smoked taste.
The rules for flavourings and smoke flavourings are
common to the entire EU. The EU Commission has also
adopted a list of the flavouring compounds permitted
for use in or on food. On the EU Commission’s website
you will find a short list of smoke flavourings permitted
for use in food.
Sweeteners
Foods containing sweeteners must be labelled “with
sweetener(s)”. The information should be placed near
the name of the food. If the food contains more than
10 percent sugar alcohols the information “excessive
consumption may produce laxative effects” shall also
be included. Foods containing aspartame shall be
labelled “contains a source of phenylalanine”.
If you import or trade foodstuffs in Sweden it is your
responsibility that all the ingredients included are
permitted.
Read more
Read more about labelling regarding food containing
flavourings in § 37 of the National Food Agency’s
labelling regulations and in the guide to them.
Flavourings and smoke flavourings
Flavourings are substances that are added to give or
strengthen a food’s taste or smell. Substances that only
9
Checklist for LABELLING OF FOOD
Before you offer your goods for sale, go over the package’s labelling.
1. How should this particular product be labelled?
2. Has all mandatory information been included? It must be in Swedish.
3. Does the food contain any allergens? If so, make sure that they are included in the list of ingredients.
4. Are there any food additives, flavourings or smoke flavourings? Check that they are permitted in the EU and
are correctly stated in the labelling.
5. Find out whether any of the product’s ingredients contain or have been produced using GMO and need to
be labelled with information about this.
6. Are there any ingredients that can be considered to be novel foods?
7. Are there any ingredients that can entail classification as a pharmaceutical?
Genetically modified organisms – GMO
Genetic engineering is used in food production, e.g.
to produce crops that are resistant to insecticides or
have a better nutritional composition. The purpose
of the GMO legislation is to guarantee that only safe
genetically modified foods are released on to the market.
Storage space and premises
The space and premises where you are to store your
food must be easy to clean and must protect the food
from pests. If there are special directions for the storage
of your food, for example storage temperature, it must
be possible to store the food at this temperature.
There are rules for how food that consists of, contains
or has been produced using GMO shall be labelled
so that the consumer is able to make an informed
choice. An example of such labelling is “produced from
genetically modified soya”.
Traceability and recall
There are traceability requirements for all food
businesses. If all your customers are end consumers
you only need to be able to trace the food backwards.
However, if you sell your products on to another
food business operator you must also be able to
trace the foodstuff one step forward. What should be
documented are the name and address of the supplier
or customer, what has been purchased or sold, when
and how much. You can, for example, save receipts and
any delivery notes for the food that you buy.
If food contains no more than 0.9 percent of
unavoidable residues of an approved GMO product, no
information needs to be given about this.
Read more
Read more at the EU commission´s website.
Controlling your business
It is your responsibility as a food business operator to
ensure that the requirements of the legislation are met.
If you import or trade pre-packaged foodstuffs from
countries within the EU, you should check that the
labelling is correct and that the goods do not contain
anything not permitted or that may harm the consumer.
You may therefore need to check certain information
with your supplier, for example in order to be able to
give the right functional name for a food additive or
to ensure that all allergens have been included in the
labelling.
If you suspect that food that you have sold is not
safe you must inform your customers and the control
authority.
If a foodstuff must be recalled, any sources and
distribution can be found thanks to its traceability.
For certain foodstuffs, for example beef, fish and
food containing GMO there are more detailed
traceability requirements. Read more in the document
“Information to food business operators about
traceability” (in Swedish).
Certain foodstuffs are inspected at the border
Import
If you intend to import or trade dietary supplements
from other EU-countries, you should contact the the
Swedish Medical Products Agency in order to obtain an
assessment as to whether the contents of your product
may involve classification as a pharmaceutical. Read
more on the Medical Products Agency’s website.
10
Animal foodstuffs and certain vegetable foodstuffs that
are imported from countries outside the EU must be
inspected at Swedish border. You can find information
about which goods must undergo border inspection on
the National Food Agency’s website.
Food goods of animal origin must come from an EUapproved facility in the country you are importing
from, and there must be a health certificate from the
exporting facility.
Trading within EU
When goods are brought in from countries within the
EU you must be registered at your local authority.
Novel foods must be approved
There are rules for novel foods since May 15, 1997.
According to the rules, foods that were not on the
EU market before this date are to be considered
novel foods. Before a novel foods are permitted to be
placed on the market, they must be approved by the
EU Commission. Before the Commission can make a
decision, the European authority for food safety, EFSA,
must evaluate the food’s safety. It may thus be the case
that foods or ingredients that have been consumed in
countries outside the EU for a long time are not always
approved in the EU.
Read more
On the National Food Agency’s website, www.livsmedelsverket.se
• Import and export
• Goods subjected to border control
• New simpler rules for running a business – information to food
business operators (in Swedish)
On the EU Commission´s website
• Rules for novel foods
• Genetically modified food, GMO
In legislation, guides and other information
Food and hygiene
– Regulation (EC) No 178/2002 laying down the general principles and
requirements of food law. Applies to all food businesses, even those
handling food without being food business operators.
– Guidance on the implementation of Regulation (EC) No 178/2002.
– Regulation (EC) No 852/2004 on the hygiene of foodstuffs. It is
a good idea for anyone selling pre-packaged food to be familiar
with the contents of this regulation in order to know what hygienic
demands are made of subsuppliers.
– Guidance on the implementation of Regulation (EC) No 852/2004
– Regulation (EC) No 853/2004 laying down specific hygiene rules for
food of animal origin. It is a good idea for anyone selling prepackaged
animal foodstuffs to be familiar with the contents of this regulation in
order to know what hygienic demands are made of subsuppliers.
– Guidance on the implementation of Regulation (EC) No 853/2004
– The National Food Agency’s hygiene guide (in Swedish)
– The National Food Agency’s approval and registration guide (in
Swedish)
– Information to food business operators about traceability (in Swedish)
There is a list of approved novel foods on the EU
Commission’s website. Some examples are lycopene,
isomaltulose and phytosterols as ingredients in certain
foods. You can also read a description there of how the
food or ingredient may be used, for example in what
foods and in what concentrations.
As a food business operator you must find out if
your product or the ingredients contained are to
be considered novel. If your control authority asks,
you must be able to show either that the food or the
ingredient is approved as a novel food or that it was on
the EU market before May 15, 1997 and is therefore not
covered by the regulation on novel food. There are also
a number of foods and ingredients that have been tested
without being approved, for example betaine and stevia.
Read more
Read more about the rules for novel foods on the
European Commission´s website.
Labelling
– National Food Agency regulations (LIVSFS 2004:27) on the labelling
and presentation of food (in Swedish)
– National Food Agency regulations (SLVFS 1993:21) on nutrition
labelling (in Swedish)
– National Food Agency regulations (LIFSFS 2002:47) on the labelling
of certain foods (in Swedish)
– Regulation (EC) No 1924/2006 on nutrition and health claims made
on foods
– The National Food Agency’s labelling regulations guide (in Swedish)
– Directive 2000/13/EC on the approximation of the laws of the
Member States to the labelling, presentation and advertising of
foodstuff
– Directive 90/496/EEC on nutrition labelling for foodstuffs
Food Additives
– Regulation (EC) No 1333/2008 on food additives
Flavourings
– Regulation (EC) No 1334/2008 on flavourings
– Regulation (EC) No 2065/2003 on smoke flavourings
– Commission decision 1999/217/EC on adopting a register of
permitted flavouring substances
– The EU Commission’s website for smoke flavourings
Allergy
– Management and labelling of food products with reference to Allergy
and Intolerance. Swedish Food Sector Guidelines drawn up by the
Swedish Food Retailers Organization and Swedish Food Federation,
which amongst other things describe how the labelling “may contain
traces of ” should be designed and in what circumstances it may be
used. (in Swedish)
11
© Livsmedelsverket, februari 2013. Layout: Byrå 4, Uppsala.