Best hygiene practices applying to Beauty sector manufacturers

E
D
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MANUFACTURERS OF PLASTIC PACKAGING
FOR USE IN THE BEAUTY PRODUCTS INDUSTRY
CHAMBRE SYNDICALE DES EMBALLAGES EN MATIERE PLASTIQUE
G
G UIDE TO GOOD HYGIENE PRACTICES FOR
Index of contents
Preamble
I
AIM AND SCOPE OF THE GUIDE
1 - Aim
2 - Scope
2.1 - Products Covered in this Guide
2.2 - Production Processes Covered in this Guide
2.3 - Dangers
II OVERALL STRUCTURE OF THE MANUFACTURING PROCESS
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III GOOD PRACTICES / COMPLIANCE WITH REQUIREMENTS FOR PACKAGING
IN CONTACT WITH PRODUCT
1 - The Requirements Laid Down By Regulations
2 - Special Regulations
3 - Attestation / Certificate of Materials’ Compliance
4 - Requirements Regarding Compatibility of Packaging
IV GENERAL HYGIENE PROVISIONS
1 - Introduction
1.1 - Definitions
1.2 - Traceability
2 - Building Location and Surrounding Areas
3 - Production Buildings / General Layout Of Buildings
4 - Machines and Equipment
5 - Staff and Visitors
6 - Production Materials
7 - Milled Plastic
8 - Storage of Material and Products During Manufacturing
9 - Transportation of Finished Products and of Semi-Finished Products
10 - Purchasing
10.1 - Raw Materials and Packaging
10.2 - Sub-Contractors and Service Suppliers
11 - Contaminated Products and Components
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V
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VI ARRANGEMENTS FOR UPDATING THIS GUIDE
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SPECIFIC HYGIENE PROVISIONS – PACKAGING AND PACKAGING ITEMS
1 - Prevention of Physical Hazards
2 - Prevention of Chemical Hazards
3 - Prevention of Microbiological Hazards
4 - For Contamination of All Types
5 - Special Provisions for Filling Activities
APPENDICES
Appendix I: Glossary
Appendix II: Examples of Analysis Methods Used to Test
for Microbiological Hazards
Appendix III: Bibliography and Useful Addresses
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This guide applies to packaging
used in the beauty products industry, and which, as
such, must comply with cleanliness imperatives during the
production process.
“Beauty products” includes cosmetics and perfume products, as specified in
the 76/768/CEE Cosmetics Directive.
What French packaging manufacturers want to achieve is to address the legitimate
concerns of the end-users of packaging, for whom cleanliness is one of the main
requirements as regards the products they use.
This guide contains a description of general provisions for cleanliness and hygiene.
The way in which certain parts of this guide have been written is deliberately unspecific.
Our objective is to mobilise businesses to draw up specific formal procedures in accordance with their particular needs.
This guide is a document that will evolve in the coming years, the key aim of which
is to incite manufacturers of plastic packaging for the beauty products industry
to develop their cleanliness policies.
This guide will be reviewed when required, when companies
deem it necessary to do so, or if any changes are made
to regulations governing our industry.
Preamble
1
I AIM AND SCOPE OF THE GUIDE
for packaging end-users is that, one, packaging
manufacturing companies that have implemented
these measures have demonstrated their ability to
manage cleanliness issues, and two, that such
companies have complied with legal and regulatory requirements and do not expose end-users to
physical, chemical, or biological hazards.
1 OBJECTIVE
The aim of this guide is to recommend measures
for implementing good cleanliness practice to
manufacturers of packaging made mainly of plastic
for the beauty products industry.
2 SCOPE
2.1 PRODUCTS COVERED IN THIS GUIDE
Plastic packaging products used in the beauty products industry, whether or not such products contain
other substances.
It lists the cleanliness measures that it would be
desirable that manufacturers of packaging made
from plastic materials implement.
What implementation of such measures means
LIST OF THE TYPES OF PRODUCTS COVERED (NOT A COMPREHENSIVE LIST)
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•
•
•
•
•
•
Applicators
Logs
Blister packs
Boxes / Cases
Caps / Closures
Individual Brushes
Covers / Caps
Lids
Aluminium-based composite (i.e.
more than one layer) flexible
packaging
• Film-based composite flexible
packaging (for use in thermoforming, controlled atmosphere
packaging (CAP), etc.)
• Paper-based composite flexible
packaging
• Sponges
• Mounts
• Plastic Film
• Flasks / Vials
• Flock-hips
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•
•
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Outer Packaging
Membrane Seals
Make-Up Brushes
Filling Pumps
Pots
Springs
Bags and Sachets (made from
film, composites, paper, etc.)
• Sticks
• Tubes
• Valves
2.2 PRODUCTION PROCESSES COVERED IN THIS GUIDE (NOT A COMPREHENSIVE LIST)
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•
•
•
•
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Assembly
Compositing
Gluing
Cutting
Coating
Embossing
•
•
•
•
•
•
Extrusion and Coextrusion
Blow Extrusion and Coextrusion
Extrusion and Coextrusion
Lamination
Finishing
Blind Blocking
•
•
•
•
•
Decorative printing*
Injection and Co-injection
Injection Blowing
Welding
Thermoforming
* Decorative printing: lacquering – varnishing – serigraphy – galvanisation – offset – hot stamping – metallisation under sleeves
– pad printing – laser stamping.
Other process: packaging.
2
2.3 DANGERS
Dangers may be of a physical, chemical or biological nature.
The following list of dangers will enable each individual manufacturer to identify the dangers that its
production business is exposed to.
This guide covers the three aforementioned categories of dangers.
PHYSICAL DANGERS (NOT A COMPREHENSIVE LIST)
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Wood
Head hair – body hair
Fibres
Twine
Grease – Stains
Metal – Staples – Shavings - Burrs
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Food
Vermin (animals, etc.)
Personal belongings (jewellery, etc.)
Wound dressings, syringes, etc.
Paperboard
Plastic
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Dust
Tobacco
Glass
Debris falling from light bulbs
Other
CHEMICAL DANGERS (NOT A COMPREHENSIVE LIST)
• Components (additives)
- Additives
- Colouring Agents
- Millings
- Process Solvents
• Components (printing)
- Inks
- Lacquers
- Varnishes
• Contaminants
- Cleaning Solvents
- Cleaning Products
- Lubricants
- Pest- and Vermin-Control Products
• Water Treatment Products
MICROBIOLOGICAL DANGERS (NOT A COMPREHENSIVE LIST)
• Pathogenic micro-organisms
• Active micro-organisms, including yeast and mould
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II OVERALL STRUCTURE OF THE MANUFACTURING PROCESS
SUPPLIES IN
CHECKS
STORAGE
PRODUCTION & ASSEMBLY
FILLING
CHECKS
CHECKS
PACKING PRIOR TO DISPATCH
WASTE DISPOSAL
CHECKS
STORAGE
DISPATCH
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III GOOD PRACTICES / COMPLIANCE
WITH REQUIREMENTS FOR PACKAGING IN CONTACT WITH PRODUCT
provisions in relation to the selling and usage of certain
dangerous substances and mixes.
• Directive 67/548/EEC dated 27th June 1967 regarding
harmonisation of legislative, regulatory and civil service
provisions in relation to the classifying, packaging and
labelling of dangerous substances.
1 THE REQUIREMENTS LAID DOWN
BY REGULATIONS
2 SPECIAL REGULATIONS
The main set of regulations regarding cosmetics is
Directive 76/768/EEC known as the “Cosmetics
Directive” issued on the 27th of July 1976 regarding
harmonisation of [EEC, as it was then, now EU]
Member States’ legislation in the area of cosmetic
products. As of May 2005 this directive had undergone seven amendments, notable among them
being the 2003 amendment, enacted through
Directive 2003/15/EEC, dated 27th of February 2003.
Regulations regarding materials in contact with food
do not necessarily apply to packaging used in the
beauty products industry. However, if you receive a
specific request from a client, as a company that manufactures packaging for beauty products you may
find your company in the position of having to apply
regulations regarding materials in contact with food.
This legislation specifically includes Directive
2002/72/EEC and the various legal texts reprinted in
brochure 1227, published by La Direction des
Journaux Officiels [the Office of Official (French)
Government Publications, very broadly similar to the
UK’s HMSO].
You should pay heed to the following Directives and
government orders:
• Directive 2003/1/CE dated 06/01/2003: Update of
appendix 2 of Directive 76/768/EEC, to cater for technical
advances made. Specifies the list of substances that
cosmetic products may not contain.
These regulations specifically include the “positive
list” of materials that are authorised and are based
on two criteria: the material in question must be
inert, and must also be harmless.
• Directive 2003/80/CE dated 05/09/2003: Specifies the
symbol to be used for cosmetic products’ best before
dates.
Directive 2004/12/EEC, which is an update to
Directive 94/62/EEC, lays down requirements as
regards the design and manufacture of packaging
and the environment and also addresses how packaging is to be dealt with downstream of end-users.
Specifically, manufacturers of plastic packaging
materials for beauty products must comply with
upper legal limits for heavy metal content and with
regulations regarding the unintentional introduction
of dangerous substances into the environment.
• Decision 96/335/CE dated 08/05/1996: Provides an
inventory of the standard names of ingredients used in
cosmetics.
• Directive 95/32/CE dated 07/07/1995: Specifies testing
methods to be used to analyse what cosmetics contain.
Notable government orders amongst the legislation transposing this Directive i.e. Dir. 76/768/EEC
into French Law are as follows:
• The government order dated 17/11/2004, which
updates the government orders dated 22/01/2003 and
06/02/01, and which gives a list of substances that cosmetic products may not contain.
3 ATTESTATION / CERTIFICATE OF
MATERIALS COMPLIANCE
• The government order dated 06/02/2001, which gives a
list of colourings that cosmetic products may contain.
A compliance certificate will be requested from suppliers for all materials used to manufacture packaging, which will attest that the regulations described
above have been complied with.
• The government order dated 06/02/2001, which gives a
list of preservatives that cosmetic products may contain.
• The government order dated 27/12/2000, which sets
the content of applications for waivers for one or more
ingredients on cosmetic products’ labels.
4 REQUIREMENTS REGARDING
COMPATIBILITY OF PACKAGING
• The government order dated 30/06/2000, which gives
a list of legal categories for cosmetic products.
Please also review:
• Directive 76/769/EEC dated 27th July 1976 regarding
harmonisation of [EEC as it was then, now EU]
Member States’ legislative, regulatory and civil service
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The compatibility of packaging with the product it
contains that is chosen and proposed to clients by
suppliers or the packaging that is specified by the
former absolutely must be validated by means of
appropriate testing of it by the client, for which
clients are liable. Specifically clients must verify the
compatibility of packaging with the product it contains
should the product being packaged be modified, or
should the contents or the end-usage of the product
be modified, or should the circumstances in which
the material or the packaging is used be modified.
2 BUILDING LOCATION AND
SURROUNDING AREAS
2.1 BUILDING LOCATION
Factories should be as far away as possible from
external sources of pollution.
There should not be stagnant water in the enclosed
area of the site.
Water storage facilities – to supply fire safety
systems – should not present any threat whatsoever
to health.
However, we recommend that packaging manufacturing companies should check that compatibility
testing has indeed been carried out successfully by
their clients.
IV GENERAL HYGIENE PROVISIONS
2.2 ENCLOSURES
The factory lot must be enclosed and enclosures
must be maintained in a good state of repair.
1 INTRODUCTION
Cleanliness is first and foremost a mindset, a part of
company’s culture.
2.3 VEGETATION
Natural areas must be serviced regularly.
All direct contact between all or parts of packaging
must be avoided.
Compliance of employees with simple, general
instructions, is, alone, likely to guard a company
against a whole range of contamination hazards
from all types of sources.
1.1 DEFINITIONS
In the text below the term “production premises”
designates the parts of a site on which products are
manufactured and the parts of such sites on which
products are in contact with ambient air.
The term “factory” is used to designate the whole of
sites.
The word “must” clearly designates basic provisions.
The terms “should” and “endeavour to” designate
measures that it is recommended that companies
take. Should a business not implement such measures, it is their responsibility to ensure that the cleanliness of its products is nevertheless satisfactory.
2.4 ROADS, PATHS, AND PAVEMENTS
Roads, paths and pavements must be coated or
tarmacked.
A water drainage system is in place and maintained
in such a way as to avoid any stagnation of water.
Pavements adjoining buildings are maintained.
3 PRODUCTION BUILDINGS /
GENERAL LAYOUT OF BULIDINGS
3.1 SET-UP OF FLOWS
Buildings’ general layouts should be designed in
such a way as to enable linear production flows, with
no crossing of materials or u-turns. If this is not currently the case, safeguards will have to be put in
place to handle this situation correctly.
The general lay-out of buildings must enable separation of areas that are used for air-exposed raw
materials, semi-finished products, and packaging
from other areas of the factory and from the outside
of the factory.
1.2 1.2. TRACEABILITY
Depending on contractual requirements, businesses
are obligated to implement appropriate measures to
ensure product traceability.
Suppliers of raw materials and packaging should
either hold ISO 9000 standards certification or have
an audited quality control system in place which is
sufficiently strict to ensure that satisfactory safety
levels are met. If not, appropriate checking and testing measures should be taken before products are
used by end-users.
Semi-finished products and component products
with unproven traceability that do not comply with
regulations regarding packaging in contact with
products will not be used in the production process.
3.2 GENERAL CONSTRUCTION
GUIDELINES FOR BUILDINGS
Avoid nooks and crannies and dead (acute) angles.
Walls must be impermeable and cleanable and
resistant to abrasion and other types of impact.
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Floors must have an impermeable covering, be
cleanable and resistant to abrasion, and if possible
be light-coloured and non-skid.
Repairs that are needed are to be carried out at least
once a year.
Endeavour to avoid having stairs, platforms, ladders
and footbridges that are made from open worked
sheet metal if this is likely to affect product quality;
also to be avoided are tubular structures. Block up
the ends of any existing tubular structures.
Bare construction frames and H-beams, lighting
equipment, insect traps, and other bare fittings must
be accessible and cleanable.
The location of insect traps must be chosen in such
a way as to avoid damage to product quality.
The use of wood must, as far as possible, be avoided. Existing structures made from wood should
have a paint or varnish covering and be maintained
in a good state of repair.
Production premises should have no direct contact
with the outside, except via emergency exits that are
kept closed except in case of emergency. Premises,
and specifically production premises must be
equipped with an appropriate ventilation system. Air
flows must be arranged in such a way as to avoid air
circulating from a contaminated area towards production premises.
It is preferable that production premises be kept
pressurised. This measure may constitute a basic
measure for certain parts of the site (c.f. hazard
analysis).
Openings that are inevitably required should have
anti-insect grills or nets.
Natural and/or artificial lighting must supply sufficient light to enable employees to see products
properly in production areas.
Doors giving access to production areas must be
equipped with mechanisms that ensure that they are
kept closed when not in use.
Windows should not have ledges, they should be
intact, and their opening devices should be disabled
as far as possible, and be equipped – if required –
with anti-insect curtains if they are not disabled.
Walls and roofing should be maintained and repaired
in such a way as to ensure that the impermeability of
the building is maintained during bad weather.
Staples and thumbtacks should not be used on notice
boards in the production premises, and such notice
boards should not be closed. General overall measures will be implemented to ensure that required
maintenance and repairs are carried out.
3.3 NETWORKS
Make sure that there are no waste-water and rainwater distribution networks in the production premises generally, unless they are needed for production
processes.
Ensure that dead areas are minimised.
The paths of electric cabling should be cleanable,
and if possible vertical.
Electricity and water distribution networks should
be impermeable, clearly identified, cleanable and
cleaned regularly.
Cooling water distribution pipes must be heat insulated so as to avoid condensation in the production
premises.
Le Guide de choix et d’utilisation des lubrifiants dans
les industries agroalimentaires [Guide to Selecting
and Using Lubricants in the Food Industry], issued by
CNRS-CNERNA (Centre National de Recherche
Scientifique, the National Centre for Scientific
Research - Centre National d'Etudes et Recherches
en Nutrition Appliquée, the National Centre for
Applied Nutrition Research) and published by
Editions Lavoisier in 1992) is the reference work as
regards areas to be lubricated and the specific lubricant to be used. (See Appendix III).
3.4 FLUIDS
Water that comes into direct contact with products
should be fit for human consumption. Facilities used
for producing, treating, and distributing water for
human consumption must have been manufactured
in accordance with the provisions of the government
order dated 29th May 1997 (published in the Journal
Officiel on the 1st of June 1997), an updated version of
a previous government order.
Compressed air must be filtered, have any oil
removed from it, and dehumidified.
Oil distribution systems and in particular hydraulic
oil distribution systems must be impermeable and
maintained in a perfect state of repair.
3.5 COMMUNAL AREAS
Changing rooms and washroom facilities should not
give direct access to production premises but rather
enable them to be accessed without leaving the
building.
Each staff member must have his or her own clothes
locker – included in this are temporary employees,
employees on temporary contracts, and individuals
on work placements.
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Lockers should be emptied, cleaned and disinfected
at least once a year.
Raw material or products that fall onto the floor will
be discarded in bins.
Enough washroom facilities should be provided for
staff and should be cleaned daily.
The way in which machines are laid out will enable
easy cleaning.
Taps should preferably not be hand-operated.
The use of devices that use compressed air should
be kept to a minimum. If vacuum machines are used,
checks will be carried out to ensure that their filters
are designed in such a way to prevent dust from
being blown back out of them.
Disposable paper towels should be provided for the
drying of hands. Hand-dryers that use hot air are not
recommended.
Enough bins should be provided.
Consumables used – cleaning cloths, solvents, etc. –
for cleaning will be placed in appropriate containers
when discarded.
A special area set apart from production premises
should be provided, in which drinks and meals can
be consumed. A smoking room, also set apart,
should also be provided for employees.
4.3 MAINTENANCE
Parts of machines that come into contact with products and equipment that distribute all types of fluid
must be cleaned regularly. Cleaning products, and,
taking a wider view, all substances that are not used
in the manufacture of products must be subject to
internal procedures, which will confirm that they are
used and detail how and where they are used (these
details will be recorded on Safety Sheets).
Cleaning products must comply with the requirements laid out in Section III.
Steps will be taken to ensure that as little as possible of each cleaning product is used and employees
will ensure that machines are dry after cleaning.
Employees will ensure that all leakages in water
and/or oil distribution systems that occur are
repaired.
Soap provided should be anti-bacterial soap, supplied in one-use containers.
3.6 MAINTENANCE AND CLEANING
A maintenance and cleaning manager is appointed
by management.
All of the premises are maintained in a good state of
repair and repairs are carried out when required.
A Premises Cleaning Schedule is drawn up and in
place, which is implemented by trained staff.
Periodic checks that cleaning is being done properly
should be carried out.
4 MACHINES AND EQUIPMENT
4.1 DESIGN OF PRODUCTION
EQUIPMENT AND MATERIALS
4.4 CONVEYOR BELTS
Conveyor belts used for products will be protected
against foreign bodies and contaminants falling on
them and will be cleaned regularly.
When designing equipment and material it is recommended that the following cleanliness issues be
taken into account: dust, soiling, various forms of
contamination, any potential areas that would prove
difficult to clean. Design must be carried out in such
a way as to enable cleaning to be carried out easily,
effectively, and to enable it to be monitored
4.5 FASTENING SYSTEMS
Fasteners – i.e. screws, nuts and bolts, metal pins,
etc. – that could fall into the manufactured products are attached extremely securely or protective
shields are in place to prevent any risk of them
falling into the manufactured products.
4.2 CLEANABILITY
Work stations and adjacent areas must be clean and tidy.
The effectiveness and regularity of cleaning must be
evaluated.
Easy access to work stations must be provided via
passageways that are sufficiently large, so as to
facilitate cleaning of them. Workshop floor plans will
be drawn up.
4.6 LUBRICATION
The risk of products being soiled by lubricants from
machines is dealt with in section V, subsection 1.7.1.
Lubricants that might come into contact with products
must comply with the regulations laid out in section III.
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5.4 DRINKS – FOOD – SMOKING
The consumption of drinks, food, tobacco and medicine is forbidden in the production premises - apart
from drinking from a water fountain, to be located in
a sectioned-off area outside of the packing area –
but will be authorised in suitable premises, to be
separated from the production premises.
5 STAFF AND VISITORS
Personal hygiene is each individual’s responsibility.
All individuals that handle materials must have good
body hygiene.
5.1 PERSONAL HYGIENE
Staff must have hair that is clean and must cover it
as much as possible in premises in which these
measures are justified.
Staff must wash their hands at the following times at
least: before starting work, after using toilets, and
when leaving canteens.
In workshops facilities must be provided to production staff for them to wash their hands after engaging in dirty work and at regular intervals.
Injuries to staff must be treated and be covered with
dressings – coloured dressings if possible.
5.5 VISITORS
Persons visiting a company who enter the production
premises must be clearly identified by badges which
state the name of the company for which they work,
must be accompanied, and must be informed of
Internal Company Rules regarding hygiene and
cleanliness.
They should not touch products unless they have
received prior authorisation to do so.
A product that has been touched must not be put
back on the production line.
5.2 WORK CLOTHING
The aim of work clothing is to reduce the physical and
biological contamination if items handled by staff.
Work clothing must not be used for any other
purpose apart from work and must remain on the
production premises.
The use of work clothing is mandatory for employees
that are in contact with products. Suitable caps must
be used to cover hair by staff working in premises
where this measure is justified. Employees must
wear work shoes, depending on the area in which
they work.
At the start of shifts work clothing is in a satisfactory state of cleanliness.
Cleaning must be carried out sufficiently often,
depending on the type of activity – i.e. depending on
the type and extent of soiling, on temperature, and
on the work environment.
Employees change clothes at the start and end of
their shifts.
When engaged in dirty work employees will be able
to use disposable clothes.
5.6 SUB-CONTRACTORS
Sub-contractors not employed directly by the company must adhere to the same set of rules regarding
hygiene and cleanliness as site staff.
5.7 TRAINING
Depending on the hygiene issues in play in their
area, staff must be trained regarding compliance
with good hygiene practices, training which will be
based on initial induction training or specific appropriate training.
Both permanent and temporary staff will receive
such training.
Employee training records must be kept at all times.
6 PRODUCTION MATERIALS
6.1 RAW MATERIALS
The raw materials used must comply with the applicable regulations laid out in section III.
Before a new raw material can be approved for use,
a statement must be obtained from its supplier certifying that it complies with the regulations laid out in
section III. A safety data sheet must also be filled in
by the supplier.
5.3 JEWELLERY AND PERSONAL
POSSESSIONS
In the production premises, it is strongly advised that
jewellery should not be worn by staff. The wearing of
any breakable items or any items that are likely to
fall off should be forbidden.
Personal possessions should not be taken into the
production premises (each company will negotiate
the precise details of arrangements to implement
this measure with staff when drawing up Internal
Company Rules).
6.2 PACKAGING AND ACCESSORIES
Products must be packaged, stored and protected in
such a way as to prevent contamination and soiling
of them and to maintain the products’ initial hygiene
quality levels, which are the result of compliance
with the present provisions.
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6.3 WASTE MATERIAL / RUBBISH
Waste material will be stored in clearly marked,
identifiable containers, which have been designed to
handle material that is to be used for the waste
material’s ultimate use – i.e. re-use, recycling, or
elimination. The use of containers that are also used
for handling finished products is to be avoided.
7 MILLED PLASTIC
7.1 MILLING MECHANISMS ON
MACHINES
Milling mechanisms on machines will be covered to
prevent any risk of airborne debris and dust.
7.2 STORAGE AND HANDLING OF
MATERIALS TO BE MILLED
All substances that are to be milled and ultimately
used in products must be transported and stored
under conditions that prevent any possibility of contamination and of mixing.
Waste material from manufacturing processes that
is to be milled and re-used will be stored in marked
receptacles, away from the effects of bad weather
and sources of contamination.
If products have to be stocked outside in the open
air, then they will be protected from and insulated
from the ground, from the effects of bad weather,
and from dust.
All items to be milled will be protected, marked and
stored separately, in accordance with applicable regulations.
7.3 MILLING UNITS
Milling units must be located in an open area inside
the production premises and easy access to them
must be ensured. Any measures that are necessary
to prevent the risk of contamination of re-used
materials will be taken.
7.4 STORAGE OF MILLED PLASTIC
All milled plastic will be clearly marked and stocked
separately, in accordance with applicable legislation.
If containers are used for storing milled plastic, such
containers will be stored separately and protected.
8 STORAGE OF MATERIAL AND
PRODUCTS DURING MANUFACTURING
Companies that manufacture products that are not
for use in the beauty products industry must store
the various different materials they produce in clearly-defined areas.
10
The flow of the various different materials should
occur in such a way as to avoid any mixing or inappropriate usage of them.
8.1 SILOS
Silos must be made from inert weather-resistant
material – stainless steel or aluminium.
Air ducts (to take in air for pumping purposes) must
be equipped with filters.
Silos must be specialised by material i.e. must only
be used to store/be designed for storing one type of
material].
8.2 CONTAINERS
No containers should be stored outside. If so, they
should be insulated from the ground and protected by
a weatherproof and contaminant-proof mechanism.
Containers must be clean, in a good state of repair
and vandal-proof. They must be inspected and
cleaned regularly.
Containers must only be opened in the production
premises. They must be re-shut very carefully if all
of their contents are not used.
Vats, storage tanks and miscellaneous other containers must be equipped with covers. Their closing
mechanisms must be designed to deal with the risk
of condensation and the risk of foreign bodies being
deposited on their covers.
8.3 REELS
Materials delivered in reels must be packaged in such
a way as to retain the material’s properties during the
full length of the logistics chain.
Packaging must only be removed when reels are
being used.
If all or part of a reel is put back into storage, it must
be repackaged using new material or in a way that
complies with hygiene requirements.
No external storage whatsoever is permitted.
8.4 SEMI-FINISHED PRODUCTS
Semi-finished products must be stored in closed packaging, to maintain their properties until they are used.
No external storage whatsoever is permitted.
Semi-finished products must be packaged as soon
as they leave the production area.
8.5 HANDLING EQUIPMENT
Handling equipment that is used in the production
premises may only use electricity or gas and must
not be used outside.
Ensure that any vehicle or handling device that is
used outside cannot enter the production premises.
Should this set-up not be compatible with a company’s other imperatives, the company will have to
ensure that the devices are clean and in good working
order when they enter the premises.
9.3 LOADING
Loading of vehicles should not be carried out outside.
Ensure that loading bays are set up in such a way as
to protect the product batches being dispatched,
even during inclement weather.
8.6 STORAGE PREMISES
Must be separated from the production premises.
Must be cleaned regularly.
The lay-out of storage racks must allow cleaning to
be carried out.
The storage area must be maintained in a good state
of repair, be dry and well-ventilated, and be protected from the effects of bad weather.
The ground may not be natural (i.e. made of natural
materials, e.g. soil). It should be covered with
cement or otherwise paved.
Toxic substances that have to be used to enable the
business to operate must be stored in a separate and
secure area. No cross-contamination whatsoever
between storage and production areas should be
possible.
10 PURCHASING
10.1 RAW MATERIALS AND PACKAGING
Raw materials used in products and packaging that
comes into direct contact with products must comply
with the applicable regulations laid out in section III.
• 10.1.1. For each component used a company
should hold a certificate, submitted by a supplier,
which attests that the component complies with
regulations. Such certificates should be issued
regularly by each supplier.
• 10.1.2. Suppliers of these products must either
prove that they comply with ISO 9000 standards
(or hold equivalent quality control certification), or
have an audited quality control system in place
that provides satisfactory levels of safety.
Otherwise, appropriate checking should be carried out before using products.
9 TRANSPORTATION OF FINISHED
PRODUCTS AND OF SEMI-FINISHED
PRODUCTS
• 10.1.3. When it reaches your premises each delivery of goods must be suitably packaged, in good
condition, and, apart from the case of goods delivered loose, must be on pallets that are in a good
state of repair; additionally, each delivery must
come with a delivery note that gives details of the
good delivered. If not, delivery of the batch will not
be accepted.
The special provisions inherent to the transportation
of plastic packaging for use in the beauty products
industry will be established by each individual company and the individuals that need to be aware of
them – i.e. the employees of transport companies –
will be informed of them.
• 10.1.4. The inside of vehicles must be clean.
If a lorry’s condition is not satisfactory, it will either
be cleaned or turned away.
The vehicle will be in a good state of repair and, in
particular, be waterproof.
Suppliers and transport companies should be
notified of the above requirements in writing.
9.1 VEHICLES
The insides of vehicles have to be clean and contaminant-free.
If the condition of a truck is not satisfactory, then it
will be sent away or else cleaned.
They will be in a good state of repair and, in particular,
will be waterproof.
• 10.1.5. Inks, varnishes, glues and adhesives used
must comply with the applicable regulations.
9.2 PACKAGING
Before loading, packaging will be inspected, to
check that it is in good condition.
Products packed in cardboard boxes, will, if feasible,
be placed on pallets and wrapped in plastic film.
Plastic palettes, metal palettes, or wooden palettes
treated in accordance with the NOR 15 standard will
preferably be used.
• 10.1.6. Raw material packaging and packaging
bought should not contain staples.
10.2 SUB-CONTRACTORS AND SERVICE
SUPPLIERS
11
The above companies must have been approved by
your company. Otherwise it is your responsibility to
check periodically on the quality of the service sup-
plied and the way in which it is supplied and comply
with the present good cleanliness practices.
1.3 1.3 ANIMALS, PESTS AND VERMIN
• 1.3.1. Compliance with general hygiene provisions
regarding external areas and buildings will contribute to averting the dangers that arise from
pests. Please refer to these provisions (sections 1
and 2).
• 1.3.2. Airborne insects: traps or systems to repulse
airborne insects should, at least, be placed in all
areas in which products are unpacked, and should
undergo regular maintenance.
• 1.3.3. Rodents and creepy crawlies: you should
have a service contract with a specialised company.
• 1.3.4. Pets: are not allowed in the production or
storage premises.
• 1.3.5. The workshop will, insofar as possible, be
pressurised.
Should their staff work on your company’s premises
they will have to comply with all of the rules that apply
to your company’s staff. (C.f. section 4 especially).
11 CONTAMINATED PRODUCTS AND
COMPONENTS
Any component or product that has been soiled by
any type of contaminant whatsoever must be
removed from the production line and be dealt with
in a specific way.
V SPECIFIC HYGIENE PROVISIONS
PACKAGING AND PACKAGING ITEMS
1.4 METAL
• 1.4.1. On machines and on fittings, in the areas in
which products transit, nuts and bolts will be,
insofar as possible, of the captive type.
1 PREVENTION OF PHYSICAL HAZARDS
1.1 GLASS AND FRAGILE
TRANSPARENT MATERIALS
1.5 PLASTIC
• 1.5.1. Any employee that loses ear protectors must
notify a supervisor.
• 1.5.2. Use of self-adhesive tape will be minimised
– insofar as possible – in production areas.
• 1.5.3. Conveyor belts with plastic or elastomer
belts are to be avoided, insofar as possible, in production areas and when they must be used they
should be inspected regularly and maintained in a
good state of repair.
• 1.5.4. Containers and bins used for moving product
around the site will be regularly inspected and
cleaned and will be disposed of if they get broken
– even partially.
• 1.1.1. All parts of factory equipment made from
glass or fragile transparent material must be –
insofar as it is reasonably possible to do so –
replaced with an appropriate material (for example
polycarbonate or metal) in areas in which products
are unpacked or uncovered.
If replacement of the part is not a reasonable
option to take, a film of anti-shattering safety coating can be applied to the parts made from glass or
fragile plastic.
• 1.1.2. All sources of light and also anti-insect
devices must be protected against the risk of
debris being dispersed from them.
1.2 1.2 BLADES USED FOR CUTTING
• 1.2.1. The location of, checks on, and removal of
cutting blades from production lines must be correctly managed.
• 1.2.2. The use of folding blades is to be avoided.
• 1.2.3. If cutting blades are broken or lost a supervisor should be notified immediately, who will
evaluate the risk of contamination straight away
and will take preventative action, if required.
• 1.2.4. Ensure that the use of cutting blades in your
company is kept to a strict minimum and endeavour to use other cutting methods instead of blades.
1.6 FIBRES
• 1.6.1. String is to be banned from production areas.
• 1.6.2. The use of cleaning cloths and sponges for
cleaning activities must be kept to a strict minimum. Preferably use disposable paper towels for
wiping.
• 1.6.3. Brushes must have colour hairs or bristles
and must be replaced regularly. The use of wooden brushes is to be avoided. Brushes that use
disposable towelettes should be preferred.
12
1.7 LUBRICANTS
• 1.7.1. Grease that is required for the lubrication of
parts of machines that are in contact with products
must not be used to excess.
• 1.7.2. Packaging, components and products soiled
by grease should be discarded.
• 1.7.3. Where oil is used in the production premises,
appropriate means of retaining leaks should be
available.
Oil circuits will be inspected regularly.
• 1.7.4. Lubricated parts in movement in areas near
to products must – when it is technically possible
to do so – be equipped with protective guards.
2.3 USAGE OF MILLED SUBSTANCES
Companies must ensure that any milled substances
used are completely free of any form of chemical
pollution.
2.4 CONTAMINANTS
Substances designated as contaminants – i.e. cleaning products, pest control agents, etc. – must be
managed as follows:
• Check that they comply with regulations.
• Storage safety measures to be taken – to avoid all
direct contact with products.
• To be used as sparingly as possible.
1.8 PRODUCTION WASTE
All production waste and substandard products must
be destroyed.
2.5 COVERING COMPONENTS
Covering components are inks, lacquers, varnishes,
other coatings and other miscellaneous substances.
These substances must comply with the regulations
outlined above.
These substances must be used in ways that comply
strictly with common practices in the packaging
industry and with the substances’ technical properties.
Implementing such practices will enable companies
to prevent contamination of packaged products and
to guard against any potential effects on the health
of the products’ users and consumers.
2 PREVENTION OF CHEMICAL
HAZARDS
Introduction
All components, additives, substances involved in
the production process, and cleaning products have
to comply with the regulations laid out in section III.
The Safety Sheets of the above substances must be
held on file by companies.
3 PREVENTION OF MICROBIOLOGICAL
2.1 MAIN COMPONENTS
Certificates showing compliance with the regulations which apply to the relevant packaging.
HAZARDS
Plastic packaging used by the beauty products
industry does not facilitate the development of
micro-organisms.
2.2 ADDED COMPONENTS
• Additives
• Colourings
• Solvents and lubricants (that are involved in production process or used for cleaning)
For these substances the following provisions must
be applied:
1. Certificates showing compliance with technical and
legal provisions must be obtained and kept on file.
2. Safety Data Sheets must be obtained and applied
on the ground.
3. Areas in which these substances are stored must
be free from all external sources of pollution.
4. These substances must not be used after any useby dates that may apply.
After carrying out research on this issue, consulting
with representative scientific authorities in France,
and after checking the main relevant databases, we
found that no health incidents of a microbiological
nature have been reported that were directly linked
to packaging.
Even though plastic packaging does not provide a
good environment for micro-organisms to develop,
the measures taken by packaging manufacturers do
not mean that users of packaging can forego taking
the requisite measures in relation to the specific
nature of product they pack.
Should clients specifically request companies to do
so, special treatment of packaging aimed at improving
the microbiological cleanliness of products or special testing may be used.
13
It is strongly recommended that a risk analysis study
be carried out to assess and control the microbiological hazards that arise in each specific situation.
appearance, colour, odour, density, viscosity, etc.
- Instructions as to what to do with the remainder
of unpacked jus.
Periodical reviews of the provisions in place to guard
against such dangers should be carried out.
• Product Intake and Storage:
- The jus is taken in, inspected and released for
packing.
• As regards the special provisions that need to be
put in place as regards the packaging of products,
companies should avoid having an employee who
is carrying an ailment (e.g.germs) of a type that
could alter the properties and affect the integrity of
the product that is being packaged.
- Deliveries of open drums will not be accepted –
resultant doubts over hygiene and contamination.
- The premises in which the jus is stocked are
secure, and its storage conditions will comply
with the client’s recommendations.
Finally, the environment in which packaging made
from plastic materials for use in the beauty products
industry is an unfavourable one for the development
of germs that cause ailments, just so long as general
hygiene provisions are taken.
• Using the jus:
- The containers used to transport the jus enable
batch traceability to be maintained and are handled in compliance with the Safety Instructions
Sheet and the site’s hygiene requirements.
4 FOR CONTAMINATION OF ALL
TYPES
- Once the containers have been emptied they are
returned to the client, or destroyed if the client
so wishes, or else cleaned very carefully with a
view to re-using them.
Should contamination of products occur, a company
should have in place procedures with which to evaluate the risk (i.e. the type of hazard and its scope)
and to determine the appropriate course of action to
be taken (i.e. separate the affected products, destroy
the affected product, product recall, etc.).
After being packaged, the finished product is
checked against the Product Specification Sheet,
released and dispatched in accordance with the
client’s instructions.
5 SPECIAL PROVISIONS FOR FILLING
The jus distribution line is emptied, rinsed, cleaned
and checked – to ensure that the next time it is used
in appropriate hygiene conditions and is contamination free.
ACTIVITIES
SPECIAL REQUIREMENTS
By “filling” we mean the activity that involves filling
packaging with the active ingredient – jus [pronounced “juice”, word used in the cosmetics industry for product formula], [skin] cream, bulk, etc. –
before delivering the end product to clients in the
beauty products sector.
The amount of jus that has been used is checked.
• Surplus jus is dispatched or destroyed with the
client’s agreement.
• The finished product is packaged, handled, stored
and finally dispatched in compliance with the
hygiene and safety conditions specified by agreement with the client.
• Successful execution of filling activities requires
total control of hygiene and safety issues regarding
the active ingredient supplied by clients. In particular
the following items must be available for use by
packaging manufacturers:
VI ARRANGEMENTS FOR
- For each batch of jus supplied: A delivery note, a
product testing certificate, and the product’s useby date.
UPDATING THIS GUIDE
Each year a Committee appointed by the CSEMP
(Chambre Syndicale des Emballages en Matière
Plastique, the Plastic Packaging Trade Association)
will hold a meeting with the objective of reshaping
this guide or, if required, to update it in relation to
changes in regulations and to companies’ practices.
- A Certified jus control document and its use-by
date.
- A Safety Instructions Sheet.
- Product Specification Sheet listing the product’s
14
APPENDIX I - GLOSSARY OF TERMS
1 PRODUCTION PROCESSES
PROCESS
DEFINITION
USED FOR
Calendering
The manufacture of stiff or flexible sheets of
thermoplastic material using the movement
of several heated cylinders.
• Sheets
Compositing
An activity that consists of assembling – using various
techniques – flexible materials to obtain a structure with
several layers and/or which contains several materials.
• Composite
Used to assemble two items using water-based
adhesive, other types of adhesive, or wax.
• Paper/aluminium
Coating
An activity that consists of depositing on an item –
paper, aluminium, plastic film – a continuous even
coating of a substance in solvent phase (e.g. varnish),
in aqueous phase (e.g. PVDC/Polyvinylidene Chloride,
silicone) or in liquid phase (wax).
• Non-stick
Embossing
Used to cut out a shape or to reproduce a motif by
reshaping an item (thus creating a raised area on it).
Extrusion
Coextrusion
Used to fuse and shape plastic material using an
extruder, which is a mechanism with a heated
cylindrical barrel inside which a screw turns, which
pushes – at a consistent speed – plastic material
through a single shaping orifice called a “die”
• Sheets
Extrusion
Coating
Coextrusion
Coating
Used to deposit a continuous coating of plastic
material on an item. The plastic material is in a viscous
state and is extruded via a single die (in the case of
extrusion) or a multi-die (in the case of coextrusion).
• Paper
Flat-Die Extrusion
Flat Die
Coextrusion
Used to extrude plastic material into a sheet shape.
• Plastic
Blow Extrusion
Moulding (I)
Blow Coextrusion
Moulding
Techniques used to produce plastic film, which
consists of extruding plastic material through a ringshaped die (or through several concentric dies in the
case of coextrusion). When it comes out of the die the
plastic film is blown up and shaped into a vertical
bubble which is then wound into a sheath shape.
• Bags •
Pasting
15
for thermoforming
(generally made from PVC)
flexible
packaging
composites
paper
for thermoforming
• Tubes
/ polyethylene
• Paper / polypropylene for
bags
film (PVC,
Polypropylene, etc.)
in single sheets (extrusion)
or with several sheets
(coextrusion)
Sachets • Films
PROCESS
DEFINITION
USED FOR
Extrusion
Used to assemble two items using an extrusion of
plastic material in a continuous layer through a single
or multiple die (the latter being used in coextrusion).
•
Blow Extrusion
Moulding (II)
This is a variant of extrusion that enables very thin
products to be made. The extruder head is equipped
with a die, through which air is blown, which stretches
the material.
Finishing
Final process before packaging, which may be cutting
– spooled to the required width, to set formats of
certain dimensions, in shapes (e.g. membrane seals).
Blind Blocking
Used to change the shape of aluminium sheets,
without using heat, between two cylinders, one of
which at least has the pattern that is being embossed.
Blind blocking can either be full or in the form of a motif.
Printing
Reproduction of a motif by depositing inks on an item.
•
Packaging for consumer
goods
Injection
Entails heating plastic material so it turns liquid and can
be injected under pressure into a mould.
•
Corking Plugs • Boxes
Pots • Cases • Pumps
Blow Injection
Moulding
Produces a hollow item in two stages :
1) Manufacturing a preform
2) Blowing up the hot preform by blowing air into it.
Moulding
Expanded
Polystyrene
Expanded polystyrene (EPS) is obtained by moulding
and welding balls in a mould, with the linking between
the pre-expanded balls occurring due to the thermal
effect of water vapour.
Aluminium / paper
composites
• Multilayer Plastic Film
• Bottles • Flasks/Vials
• Plastic
jugs
• Barrels • Containers
•
•
Bottles • Flasks/Vials
Pots
•
Boxes
•
•
Thermoforming
(PVC, Expanded
Polystyrene, etc.)
Second stage of processing in which material which
has already been made into sheets, plates, tubes,
or profiles is softened using heat and shaped by
applying a simple-shaped mould.
16
Pots • Lids • Blister Packs
2 OTHER TERMS
TERMS
DEFINITION
Corrective Action
An act, the aim of which is to eliminate the causes of non-compliance, a defect
or any other current undesirable event, to prevent it re-occurring.
Preventative Action
An act, the aim of which is to eliminate the causes of non-compliance, a defect
or any other undesirable potential event, to prevent it from occurring.
Risk/Hazard Analysis
Procedure which consists of gathering and evaluating data regarding hazards
and factors that lead to hazards arising, so as to determine which of them present
a danger to the salubriousness of food and must therefore be detailed in the
HACCP method.
CCP
Critical Control Point
A point in a procedure at which control can be applied (and is vital) and a foodsafety hazard can be prevented, eliminated or reduced to acceptable levels.
Composite
A material made up of at least two layers, made of the same substances or
of different substances.
Hazard
A physical, chemical or biological factor or agent that is likely to have a damaging
effect on the health of individuals.
Primary Packaging
Packaging that is in direct contact with products.
HACCP
Hazard Analysis
Critical Control Point
A method of analysis which defines, evaluates and keeps hazards that threaten the
cleanliness of products under control.
Approved By
Certified compliance with certain set standard criteria.
Micro-organisms
Bacteria, yeasts and moulds.
Active
Micro-organisms
Micro-organisms that – while they are not dangerous – that are likely to make a
product unfit for human consumption (by making a product substandard, etc.).
Pathogenic
micro-organisms
Micro-organisms that are likely to cause various types of food poisoning.
Traceability
The ability to retrieve the history, usage or locale of an entity (a product or
a production process) using recorded data.
17
APPENDIX II
Examples of Analysis Methods Used to Test for Microbiological Hazards.
The Agar Slide Method Technique
Immersion Recovery Technique
• Take a sample from packaging (e.g. from a roll).
• Put a packaging sample into a Stomacher bag with
20ml – or other appropriate amount – of diluent
(EPT + 0 .2% strength Tween 80).
• Slides plus agar (e.g. plate for total flora and yeast
and mould).
• Put that into an ultrasound vat for 3 minutes.
• Swab each side of the slide for about ten seconds
against the surface you are testing and then put
the slide back in its holder.
• Now put it in a Stomacher.
• Take a 1ml sample of the liquid milieu, dilute and
inoculate in the chosen counting milieu.
• Keep in an incubator at 30°C for two or three days
• Count the number of colonies on each side of the
slide after incubation.
Recovery by Direct Seeding in an Agar Milieu
Technique (Enumeration of yeast and mould)
• Take a sample from packaging on the production
line.
• Seed the sample by filling the sample container
with specific amounts of agar with glucose and
chloramphenicol at specific temperatures.
• Spread the agar on the sides of the packaging by
rotating.
• Incubate for 7 days at 25°C.
• Enumeration by counting.
Swabbing Recovery Technique
• Take a sample from packaging.
• Rub two swabs against sample.
• Shake the swabs in a vortex-like way.
• Inoculation in any counting milieu.
18
APPENDIX III - BIBLIOGRAPHY AND USEFUL ADDRESSES
I- HYGIENE BIBLIOGRAPHY
Codex Alimentarius
FAO / WHO, Rome
Module for Companies in the Food Industry
Pasteur Institute, Lille, France
Introducing the HACCP Method
SEQUAL Agroalimentaire (01/96)
HACCP – Theory and Practice
Intervention du Professeur JOUVE (07/93)
Growth and Usage of HACCP by French Food Industry Companies Notes - Etudes de la DGCCRF (04/95)
Successfully Managing Hygiene
in the Food Business : Tools, Means, and Methods
Conférence AFNOR (20/06/95)
Internal Hygiene Testing in the Food Industry and in
ASEPT (10/96)
Associated Industries - Food Packaging and Decontamination
Cleaning and Disinfection - Hygiene Practices and Management
Guide to Good Hygiene Practice
DGAL (10/94)
Hygiene and Quality Control – 22 Questions That
Companies Need To Ask Themselves
Assemblée Générale d’ORQALI (6/04/94)
Applying Risk Analysis Studies
in the Area of Food Standards
Rapport de la consultation mixte d’experts
FAO / OMS (13-17/03/95)
“Micro-organismes pathogènes transmis par les aliments”
(Pathogenic Micro-Organisms Spread By Food)
M. GELINAS - Editions EDISEM (97)
Lubricants in the Food Sector – Guide to Choosing and
Using the Right Ones
CNRS – CNERNA – Editions Lavoisier (92)
II- USEFUL ADDRESSES
AFSSAPS (French Heath Safety Agency for
Health Products [sic])
143-147, boulevard Anatole France - 93285 - SAINT-DENIS Cédex
Tel: +33 (0)1 5587 3000
AFSSA (French Food Safety Agency)
27/31, avenue du Général Leclerc - BP 19
94701 - MAISONS-ALFORT
Tel: +33 (0)1 4977 1350 / Fax: +33 (0)1 4977 2612
DGAL (A French government food authority) 251, rue de Vaugirard - 75015 PARIS
Tel: +33 (0)1 4955 4955 / Fax: +33 (0)1 4955 5680
DGCCRF (A French government agency
responsible for overseeing fair trading,
consumer issues and fraud repression)
59, bld Vincent Auriol - 75013 PARIS
Tel: +33 (0)1 4487 1717 / Fax: +33 (0)1 4497 3043
DGS (A French government health agency)
8, avenue de Ségur - 75350 PARIS 07 SP
Tel: +33 (0)1 4056 6000
French government official publications
office, broadly similar to HMSO
26, rue Desaix - 75727 PARIS Cédex 15
Tel: +33 (0)1 4058 7600 - www.journal-officiel.gouv.fr
EC official publications office
2, rue Mercier - L-2585 LUXEMBOURG
Tel: (352) 2929-1 - http://europa.eu.int
the French Ministry of Industry
Le Bervil Digitip 2 - 12, rue Villiot - 75012 PARIS
Tel: +33 (0)1 5344 9482 / Fax: +33 (0)1 5344 9193
the French Ministry of Health
8, avenue de Ségur - 75350 PARIS 075 P
Tel: +33 (0)1 4056 6000
19
(THE FRENCH PLASTIC PACKAGING TRADE ASSOCIATION)
5, rue de Chazelles - 75017 PARIS - FRANCE
Tel: +33 (0)1 4622 3366 / Fax: +33 (0)1 4622 0235
WEBSITE : www.packplast.org
E-MAIL : [email protected]
july 2005 - M. VANHOVE
CSEMP