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GUIDE TO GOOD HYGIENE PRACTICES FOR

MANUFACTURERS OF PLASTIC PACKAGING

FOR USE IN THE BEAUTY PRODUCTS INDUSTRY

CHAMBRE SYNDICALE DES EMBALLAGES EN MATIERE PLASTIQUE

Indexofcontents Preamble p. 1

AIM AND SCOPE OF THE GUIDE p. 2

1 - Aim p. 2

2 - Scope

2.1 - Products Covered in this Guide p. 2

2.2 - Production Processes Covered in this Guide p. 2

2.3 - Dangers p. 3

OVERALL STRUCTURE OF THE MANUFACTURING PROCESS p. 4

GOOD PRACTICES / COMPLIANCE WITH REQUIREMENTS FOR PACKAGING

IN CONTACT WITH PRODUCT p. 5

1 - The Requirements Laid Down By Regulations p. 5

2 - Special Regulations p. 5

3 - Attestation / Certificate of Materials’ Compliance p. 5

4 - Requirements Regarding Compatibility of Packaging p. 5

GENERAL HYGIENE PROVISIONS p. 6

1 - Introduction p. 6

1.1 - Definitions p. 6

1.2 - Traceability p. 6

2 - Building Location and Surrounding Areas p. 6

3 - Production Buildings / General Layout Of Buildings p. 6

4 - Machines and Equipment p. 8

5 - Staff and Visitors p. 9

6 - Production Materials p. 9

7 - Milled Plastic p. 9

8 - Storage of Material and Products During Manufacturing p. 10

9 - Transportation of Finished Products and of Semi-Finished Products p. 11

10 - Purchasing p. 11

10.1 - Raw Materials and Packaging p. 11

10.2 - Sub-Contractors and Service Suppliers p. 11

11 - Contaminated Products and Components p. 11

SPECIFIC HYGIENE PROVISIONS – PACKAGING AND PACKAGING ITEMS p. 12

1 - Prevention of Physical Hazards p. 12

2 - Prevention of Chemical Hazards p. 13

3 - Prevention of Microbiological Hazards p. 13

4 - For Contamination of All Types p. 14

5 - Special Provisions for Filling Activities p. 14

ARRANGEMENTS FOR UPDATING THIS GUIDE p. 14

APPENDICES p. 15

Appendix I: Glossary p. 15

Appendix II: Examples of Analysis Methods Used to Test

for Microbiological Hazards p. 18

Appendix III: Bibliography and Useful Addresses p. 19

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I

This guide applies to packagingused 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 accor-

dance 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.

Preamble1

2

AIM AND SCOPE OF THE GUIDE

OBJECTIVE

The aim of this guide is to recommend measuresfor implementing good cleanliness practice tomanufacturers of packaging made mainly of plasticfor the beauty products industry.

It lists the cleanliness measures that it would bedesirable that manufacturers of packaging madefrom plastic materials implement.

What implementation of such measures means

for packaging end-users is that, one, packagingmanufacturing companies that have implementedthese measures have demonstrated their ability tomanage cleanliness issues, and two, that suchcompanies have complied with legal and regulato-ry requirements and do not expose end-users tophysical, chemical, or biological hazards.

SCOPE

PRODUCTS COVERED IN THIS GUIDEPlastic packaging products used in the beauty prod-ucts industry, whether or not such products containother substances.

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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

LIST OF THE TYPES OF PRODUCTS COVERED (NOT A COMPREHENSIVE LIST)

PRODUCTION PROCESSES COVERED IN THIS GUIDE (NOT A COMPREHENSIVE LIST)2.2

• 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 thermo-forming, controlled atmospherepackaging (CAP), etc.)

• Paper-based composite flexiblepackaging

• Sponges• Mounts• Plastic Film• Flasks / Vials• Flock-hips

• Outer Packaging• Membrane Seals• Make-Up Brushes• Filling Pumps• Pots• Springs• Bags and Sachets (made from film, composites, paper, etc.)

• Sticks• Tubes• Valves

* Decorative printing: lacquering – varnishing – serigraphy – galvanisation – offset – hot stamping – metallisation under sleeves

– pad printing – laser stamping.

Other process: packaging.

• Wood

• Head hair – body hair

• Fibres

• Twine

• Grease – Stains

• Metal – Staples – Shavings - Burrs

• Food

• Vermin (animals, etc.)

• Personal belongings (jewellery, etc.)

• Wound dressings, syringes, etc.

• Paperboard

• Plastic

• Dust

• Tobacco

• Glass

• Debris falling from light bulbs

• Other

DANGERSDangers may be of a physical, chemical or biolog-ical nature.

This guide covers the three aforementioned cate-gories of dangers.

The following list of dangers will enable each indi-vidual manufacturer to identify the dangers that itsproduction business is exposed to.

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3

• 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

CHEMICAL DANGERS (NOT A COMPREHENSIVE LIST)

• Pathogenic micro-organisms• Active micro-organisms, including yeast and mould

MICROBIOLOGICAL DANGERS (NOT A COMPREHENSIVE LIST)

PHYSICAL DANGERS (NOT A COMPREHENSIVE LIST)

OVERALL STRUCTURE OF THE MANUFACTURING PROCESSII

4

SUPPLIES IN

WASTE DISPOSAL

STORAGE

FILLING

STORAGE

DISPATCH

PRODUCTION & ASSEMBLY

CHECKS

CHECKS

CHECKS

PACKING PRIOR TO DISPATCH

CHECKS

5

GOOD PRACTICES / COMPLIANCE

WITH REQUIREMENTS FOR PACK-

AGING IN CONTACT WITH PRODUCT

THE REQUIREMENTS LAID DOWNBY REGULATIONSThe main set of regulations regarding cosmetics isDirective 76/768/EEC known as the “CosmeticsDirective” issued on the 27th of July 1976 regardingharmonisation of [EEC, as it was then, now EU]Member States’ legislation in the area of cosmeticproducts. As of May 2005 this directive had under-gone seven amendments, notable among thembeing the 2003 amendment, enacted throughDirective 2003/15/EEC, dated 27th of February 2003.

You should pay heed to the following Directives andgovernment 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.

• Directive 2003/80/CE dated 05/09/2003: Specifies the

symbol to be used for cosmetic products’ best before

dates.

• 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 legisla-tion transposing this Directive i.e. Dir. 76/768/EECinto French Law are as follows:

• The government order dated 17/11/2004, whichupdates the government orders dated 22/01/2003 and06/02/01, and which gives a list of substances that cos-metic products may not contain.

• The government order dated 06/02/2001,which gives alist of colourings that cosmetic products may contain.

• The government order dated 06/02/2001, which gives alist of preservatives that cosmetic products may contain.

• The government order dated 27/12/2000, which setsthe content of applications for waivers for one or moreingredients on cosmetic products’ labels.

• The government order dated 30/06/2000, which givesa list of legal categories for cosmetic products.

Please also review:

• Directive 76/769/EEC dated 27th July 1976 regardingharmonisation of [EEC as it was then, now EU]Member States’ legislative, regulatory and civil service

provisions in relation to the selling and usage of certaindangerous substances and mixes.

• Directive 67/548/EEC dated 27th June 1967 regardingharmonisation of legislative, regulatory and civil serviceprovisions in relation to the classifying, packaging andlabelling of dangerous substances.

SPECIAL REGULATIONSRegulations regarding materials in contact with fooddo not necessarily apply to packaging used in thebeauty products industry. However, if you receive aspecific request from a client, as a company that manu-factures packaging for beauty products you mayfind your company in the position of having to applyregulations regarding materials in contact with food.This legislation specifically includes Directive2002/72/EEC and the various legal texts reprinted inbrochure 1227, published by La Direction desJournaux Officiels [the Office of Official (French)Government Publications, very broadly similar to theUK’s HMSO].

These regulations specifically include the “positivelist” of materials that are authorised and are basedon two criteria: the material in question must beinert, and must also be harmless.

Directive 2004/12/EEC, which is an update toDirective 94/62/EEC, lays down requirements asregards the design and manufacture of packagingand the environment and also addresses how pack-aging is to be dealt with downstream of end-users.Specifically, manufacturers of plastic packagingmaterials for beauty products must comply withupper legal limits for heavy metal content and withregulations regarding the unintentional introductionof dangerous substances into the environment.

ATTESTATION / CERTIFICATE OFMATERIALS COMPLIANCE

A compliance certificate will be requested from sup-pliers for all materials used to manufacture packag-ing, which will attest that the regulations describedabove have been complied with.

REQUIREMENTS REGARDINGCOMPATIBILITY OF PACKAGINGThe compatibility of packaging with the product itcontains that is chosen and proposed to clients bysuppliers or the packaging that is specified by theformer absolutely must be validated by means ofappropriate testing of it by the client, for which

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clients are liable. Specifically clients must verify thecompatibility of packaging with the product it containsshould the product being packaged be modified, orshould the contents or the end-usage of the productbe modified, or should the circumstances in whichthe material or the packaging is used be modified.

However, we recommend that packaging manufac-turing companies should check that compatibilitytesting has indeed been carried out successfully bytheir clients.

GENERAL HYGIENE PROVISIONS

INTRODUCTIONCleanliness is first and foremost a mindset, a part ofcompany’s culture.

Compliance of employees with simple, generalinstructions, is, alone, likely to guard a companyagainst a whole range of contamination hazardsfrom all types of sources.

DEFINITIONSIn the text below the term “production premises”designates the parts of a site on which products aremanufactured and the parts of such sites on whichproducts are in contact with ambient air.

The term “factory” is used to designate the whole ofsites.

The word “must” clearly designates basic provisions.

The terms “should” and “endeavour to” designatemeasures that it is recommended that companiestake. Should a business not implement such meas-ures, it is their responsibility to ensure that the clean-liness of its products is nevertheless satisfactory.

1.2. TRACEABILITYDepending on contractual requirements, businessesare obligated to implement appropriate measures toensure product traceability.

Suppliers of raw materials and packaging shouldeither hold ISO 9000 standards certification or havean audited quality control system in place which issufficiently strict to ensure that satisfactory safetylevels are met. If not, appropriate checking and test-ing measures should be taken before products areused by end-users.

Semi-finished products and component productswith unproven traceability that do not comply withregulations regarding packaging in contact withproducts will not be used in the production process.

BUILDING LOCATION AND SURROUNDING AREAS

BUILDING LOCATIONFactories should be as far away as possible fromexternal sources of pollution.There should not be stagnant water in the enclosedarea of the site.Water storage facilities – to supply fire safety systems – should not present any threat whatsoeverto health.

ENCLOSURESThe factory lot must be enclosed and enclosuresmust be maintained in a good state of repair.

VEGETATIONNatural areas must be serviced regularly.

All direct contact between all or parts of packagingmust be avoided.

ROADS, PATHS, AND PAVEMENTSRoads, paths and pavements must be coated or tarmacked.

A water drainage system is in place and maintainedin such a way as to avoid any stagnation of water.

Pavements adjoining buildings are maintained.

PRODUCTION BUILDINGS / GENERAL LAYOUT OF BULIDINGS

SET-UP OF FLOWSBuildings’ general layouts should be designed insuch a way as to enable linear production flows, withno crossing of materials or u-turns. If this is not cur-rently the case, safeguards will have to be put inplace to handle this situation correctly.

The general lay-out of buildings must enable sepa-ration of areas that are used for air-exposed rawmaterials, semi-finished products, and packagingfrom other areas of the factory and from the outsideof the factory.

GENERAL CONSTRUCTIONGUIDELINES FOR BUILDINGSAvoid nooks and crannies and dead (acute) angles.

Walls must be impermeable and cleanable andresistant to abrasion and other types of impact.

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2.4

2.3

2.2

2.1

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1.2

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Floors must have an impermeable covering, becleanable and resistant to abrasion, and if possiblebe light-coloured and non-skid.

Repairs that are needed are to be carried out at leastonce a year.

Endeavour to avoid having stairs, platforms, laddersand footbridges that are made from open workedsheet metal if this is likely to affect product quality;also to be avoided are tubular structures. Block upthe ends of any existing tubular structures.

Bare construction frames and H-beams, lightingequipment, insect traps, and other bare fittings mustbe accessible and cleanable.

The location of insect traps must be chosen in sucha way as to avoid damage to product quality.

The use of wood must, as far as possible, be avoid-ed. Existing structures made from wood shouldhave a paint or varnish covering and be maintainedin a good state of repair.

Production premises should have no direct contactwith the outside, except via emergency exits that arekept closed except in case of emergency. Premises,and specifically production premises must beequipped with an appropriate ventilation system. Airflows must be arranged in such a way as to avoid aircirculating from a contaminated area towards pro-duction premises.

It is preferable that production premises be kept pressurised. This measure may constitute a basicmeasure for certain parts of the site (c.f. hazardanalysis).

Openings that are inevitably required should haveanti-insect grills or nets.

Natural and/or artificial lighting must supply suffi-cient light to enable employees to see productsproperly in production areas.

Doors giving access to production areas must beequipped with mechanisms that ensure that they arekept closed when not in use.

Windows should not have ledges, they should beintact, and their opening devices should be disabledas far as possible, and be equipped – if required –with anti-insect curtains if they are not disabled.

Walls and roofing should be maintained and repairedin such a way as to ensure that the impermeability ofthe building is maintained during bad weather.

Staples and thumbtacks should not be used on noticeboards in the production premises, and such noticeboards should not be closed. General overall meas-ures will be implemented to ensure that requiredmaintenance and repairs are carried out.

NETWORKSMake sure that there are no waste-water and rain-water distribution networks in the production prem-ises generally, unless they are needed for productionprocesses.

Ensure that dead areas are minimised.

The paths of electric cabling should be cleanable,and if possible vertical.

Electricity and water distribution networks shouldbe impermeable, clearly identified, cleanable andcleaned regularly.

Cooling water distribution pipes must be heat insu-lated so as to avoid condensation in the productionpremises.

Le Guide de choix et d’utilisation des lubrifiants dansles industries agroalimentaires [Guide to Selectingand Using Lubricants in the Food Industry], issued byCNRS-CNERNA (Centre National de RechercheScientifique, the National Centre for ScientificResearch - Centre National d'Etudes et Recherchesen Nutrition Appliquée, the National Centre forApplied Nutrition Research) and published byEditions Lavoisier in 1992) is the reference work asregards areas to be lubricated and the specific lubri-cant to be used. (See Appendix III).

FLUIDSWater that comes into direct contact with productsshould be fit for human consumption. Facilities usedfor producing, treating, and distributing water forhuman consumption must have been manufacturedin accordance with the provisions of the governmentorder dated 29th May 1997 (published in the JournalOfficiel on the 1st of June 1997), an updated version ofa previous government order.

Compressed air must be filtered, have any oilremoved from it, and dehumidified.

Oil distribution systems and in particular hydraulicoil distribution systems must be impermeable andmaintained in a perfect state of repair.

COMMUNAL AREASChanging rooms and washroom facilities should notgive direct access to production premises but ratherenable them to be accessed without leaving thebuilding.

Each staff member must have his or her own clotheslocker – included in this are temporary employees,employees on temporary contracts, and individualson work placements.

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3.3

Lockers should be emptied, cleaned and disinfectedat least once a year.

Enough washroom facilities should be provided forstaff and should be cleaned daily.

Taps should preferably not be hand-operated.

Disposable paper towels should be provided for thedrying of hands. Hand-dryers that use hot air are notrecommended.

Enough bins should be provided.

A special area set apart from production premisesshould be provided, in which drinks and meals canbe consumed. A smoking room, also set apart,should also be provided for employees.

Soap provided should be anti-bacterial soap, sup-plied in one-use containers.

MAINTENANCE AND CLEANINGA maintenance and cleaning manager is appointedby management.

All of the premises are maintained in a good state ofrepair and repairs are carried out when required.

A Premises Cleaning Schedule is drawn up and inplace, which is implemented by trained staff.Periodic checks that cleaning is being done properlyshould be carried out.

MACHINES AND EQUIPMENT

DESIGN OF PRODUCTIONEQUIPMENT AND MATERIALSWhen designing equipment and material it is recom-mended that the following cleanliness issues betaken into account: dust, soiling, various forms ofcontamination, any potential areas that would provedifficult to clean. Design must be carried out in sucha way as to enable cleaning to be carried out easily,effectively, and to enable it to be monitored

CLEANABILITYWork stations and adjacent areas must be clean and tidy.

The effectiveness and regularity of cleaning must beevaluated.

Easy access to work stations must be provided viapassageways that are sufficiently large, so as tofacilitate cleaning of them. Workshop floor plans willbe drawn up.

Raw material or products that fall onto the floor willbe discarded in bins.

The way in which machines are laid out will enableeasy cleaning.

The use of devices that use compressed air shouldbe kept to a minimum. If vacuum machines are used,checks will be carried out to ensure that their filtersare designed in such a way to prevent dust frombeing blown back out of them.

Consumables used – cleaning cloths, solvents, etc. –for cleaning will be placed in appropriate containerswhen discarded.

MAINTENANCE Parts of machines that come into contact with prod-ucts and equipment that distribute all types of fluidmust be cleaned regularly. Cleaning products, and,taking a wider view, all substances that are not usedin the manufacture of products must be subject tointernal procedures, which will confirm that they areused and detail how and where they are used (thesedetails will be recorded on Safety Sheets).

Cleaning products must comply with the require-ments laid out in Section III.

Steps will be taken to ensure that as little as possi-ble of each cleaning product is used and employeeswill ensure that machines are dry after cleaning.

Employees will ensure that all leakages in waterand/or oil distribution systems that occur arerepaired.

CONVEYOR BELTSConveyor belts used for products will be protectedagainst foreign bodies and contaminants falling onthem and will be cleaned regularly.

FASTENING SYSTEMSFasteners – i.e. screws, nuts and bolts, metal pins,

etc. – that could fall into the manufactured prod-

ucts are attached extremely securely or protective

shields are in place to prevent any risk of them

falling into the manufactured products.

LUBRICATIONThe risk of products being soiled by lubricants frommachines is dealt with in section V, subsection 1.7.1.

Lubricants that might come into contact with productsmust comply with the regulations laid out in section III.

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STAFF AND VISITORSPersonal hygiene is each individual’s responsibility.All individuals that handle materials must have goodbody hygiene.

PERSONAL HYGIENEStaff must have hair that is clean and must cover itas much as possible in premises in which thesemeasures are justified.

Staff must wash their hands at the following times atleast: before starting work, after using toilets, andwhen leaving canteens.

In workshops facilities must be provided to produc-tion staff for them to wash their hands after engag-ing in dirty work and at regular intervals.

Injuries to staff must be treated and be covered withdressings – coloured dressings if possible.

WORK CLOTHINGThe aim of work clothing is to reduce the physical andbiological contamination if items handled by staff.Work clothing must not be used for any other purpose apart from work and must remain on theproduction premises.The use of work clothing is mandatory for employeesthat are in contact with products. Suitable caps mustbe used to cover hair by staff working in premiseswhere this measure is justified. Employees mustwear work shoes, depending on the area in whichthey work.At the start of shifts work clothing is in a satisfacto-ry state of cleanliness.Cleaning must be carried out sufficiently often,depending on the type of activity – i.e. depending onthe type and extent of soiling, on temperature, andon the work environment.Employees change clothes at the start and end oftheir shifts.When engaged in dirty work employees will be ableto use disposable clothes.

JEWELLERY AND PERSONALPOSSESSIONSIn the production premises, it is strongly advised thatjewellery should not be worn by staff. The wearing ofany breakable items or any items that are likely tofall off should be forbidden.Personal possessions should not be taken into theproduction premises (each company will negotiatethe precise details of arrangements to implementthis measure with staff when drawing up InternalCompany Rules).

DRINKS – FOOD – SMOKINGThe consumption of drinks, food, tobacco and med-icine is forbidden in the production premises - apartfrom drinking from a water fountain, to be located ina sectioned-off area outside of the packing area –but will be authorised in suitable premises, to beseparated from the production premises.

VISITORSPersons visiting a company who enter the productionpremises must be clearly identified by badges whichstate the name of the company for which they work,must be accompanied, and must be informed ofInternal Company Rules regarding hygiene andcleanliness.They should not touch products unless they havereceived prior authorisation to do so.A product that has been touched must not be putback on the production line.

SUB-CONTRACTORSSub-contractors not employed directly by the com-pany must adhere to the same set of rules regardinghygiene and cleanliness as site staff.

TRAININGDepending on the hygiene issues in play in theirarea, staff must be trained regarding compliancewith good hygiene practices, training which will bebased on initial induction training or specific appro-priate training.Both permanent and temporary staff will receivesuch training.Employee training records must be kept at all times.

PRODUCTION MATERIALS

RAW MATERIALS The raw materials used must comply with the appli-cable regulations laid out in section III.

Before a new raw material can be approved for use,a statement must be obtained from its supplier cer-tifying that it complies with the regulations laid out insection III. A safety data sheet must also be filled inby the supplier.

PACKAGING AND ACCESSORIESProducts must be packaged, stored and protected insuch a way as to prevent contamination and soilingof them and to maintain the products’ initial hygienequality levels, which are the result of compliancewith the present provisions.

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WASTE MATERIAL / RUBBISHWaste material will be stored in clearly marked,identifiable containers, which have been designed tohandle material that is to be used for the wastematerial’s ultimate use – i.e. re-use, recycling, orelimination. The use of containers that are also usedfor handling finished products is to be avoided.

MILLED PLASTIC

MILLING MECHANISMS ONMACHINESMilling mechanisms on machines will be covered toprevent any risk of airborne debris and dust.

STORAGE AND HANDLING OFMATERIALS TO BE MILLEDAll substances that are to be milled and ultimatelyused in products must be transported and storedunder conditions that prevent any possibility of con-tamination and of mixing.

Waste material from manufacturing processes thatis to be milled and re-used will be stored in markedreceptacles, away from the effects of bad weatherand sources of contamination.

If products have to be stocked outside in the openair, then they will be protected from and insulatedfrom the ground, from the effects of bad weather,and from dust.

All items to be milled will be protected, marked andstored separately, in accordance with applicable reg-ulations.

MILLING UNITSMilling units must be located in an open area insidethe production premises and easy access to themmust be ensured. Any measures that are necessaryto prevent the risk of contamination of re-usedmaterials will be taken.

STORAGE OF MILLED PLASTICAll milled plastic will be clearly marked and stockedseparately, in accordance with applicable legislation.

If containers are used for storing milled plastic, suchcontainers will be stored separately and protected.

STORAGE OF MATERIAL AND

PRODUCTS DURING MANUFACTURINGCompanies that manufacture products that are notfor use in the beauty products industry must storethe various different materials they produce in clear-ly-defined areas.

The flow of the various different materials shouldoccur in such a way as to avoid any mixing or inap-propriate usage of them.

SILOSSilos must be made from inert weather-resistant

material – stainless steel or aluminium.

Air ducts (to take in air for pumping purposes) mustbe equipped with filters.

Silos must be specialised by material i.e. must onlybe used to store/be designed for storing one type ofmaterial].

CONTAINERSNo containers should be stored outside. If so, theyshould be insulated from the ground and protected bya weatherproof and contaminant-proof mechanism.

Containers must be clean, in a good state of repairand vandal-proof. They must be inspected andcleaned regularly.

Containers must only be opened in the productionpremises. They must be re-shut very carefully if allof their contents are not used.

Vats, storage tanks and miscellaneous other con-tainers must be equipped with covers. Their closingmechanisms must be designed to deal with the riskof condensation and the risk of foreign bodies beingdeposited on their covers.

REELSMaterials delivered in reels must be packaged in sucha way as to retain the material’s properties during thefull length of the logistics chain.

Packaging must only be removed when reels arebeing used.

If all or part of a reel is put back into storage, it mustbe repackaged using new material or in a way thatcomplies with hygiene requirements.

No external storage whatsoever is permitted.

SEMI-FINISHED PRODUCTSSemi-finished products must be stored in closed pack-aging, to maintain their properties until they are used.

No external storage whatsoever is permitted.

Semi-finished products must be packaged as soonas they leave the production area.

HANDLING EQUIPMENTHandling equipment that is used in the productionpremises may only use electricity or gas and mustnot be used outside.

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Ensure that any vehicle or handling device that isused outside cannot enter the production premises.

Should this set-up not be compatible with a compa-ny’s other imperatives, the company will have toensure that the devices are clean and in good workingorder when they enter the premises.

STORAGE PREMISESMust be separated from the production premises.

Must be cleaned regularly.

The lay-out of storage racks must allow cleaning tobe carried out.

The storage area must be maintained in a good stateof repair, be dry and well-ventilated, and be protect-ed from the effects of bad weather.

The ground may not be natural (i.e. made of naturalmaterials, e.g. soil). It should be covered withcement or otherwise paved.

Toxic substances that have to be used to enable thebusiness to operate must be stored in a separate andsecure area. No cross-contamination whatsoeverbetween storage and production areas should bepossible.

TRANSPORTATION OF FINISHEDPRODUCTS AND OF SEMI-FINISHEDPRODUCTS

The special provisions inherent to the transportationof plastic packaging for use in the beauty productsindustry will be established by each individual com-pany and the individuals that need to be aware ofthem – i.e. the employees of transport companies –will be informed of them.

VEHICLESThe insides of vehicles have to be clean and contam-inant-free.

If the condition of a truck is not satisfactory, then itwill be sent away or else cleaned.

They will be in a good state of repair and, in particular,will be waterproof.

PACKAGINGBefore loading, packaging will be inspected, tocheck 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 palettestreated in accordance with the NOR 15 standard willpreferably be used.

LOADINGLoading of vehicles should not be carried out outside.

Ensure that loading bays are set up in such a way asto protect the product batches being dispatched,even during inclement weather.

PURCHASING

RAW MATERIALS AND PACKAGINGRaw materials used in products and packaging thatcomes into direct contact with products must complywith the applicable regulations laid out in section III.

• 10.1.1. For each component used a companyshould hold a certificate, submitted by a supplier,which attests that the component complies withregulations. Such certificates should be issuedregularly by each supplier.

• 10.1.2. Suppliers of these products must eitherprove that they comply with ISO 9000 standards(or hold equivalent quality control certification), orhave an audited quality control system in placethat provides satisfactory levels of safety.Otherwise, appropriate checking should be car-ried out before using products.

• 10.1.3. When it reaches your premises each deliv-ery of goods must be suitably packaged, in goodcondition, and, apart from the case of goods deliv-ered loose, must be on pallets that are in a goodstate of repair; additionally, each delivery mustcome with a delivery note that gives details of thegood delivered. If not, delivery of the batch will notbe accepted.

• 10.1.4. The inside of vehicles must be clean. If a lorry’s condition is not satisfactory, it will eitherbe cleaned or turned away. The vehicle will be in a good state of repair and, inparticular, be waterproof.Suppliers and transport companies should benotified of the above requirements in writing.

• 10.1.5. Inks, varnishes, glues and adhesives usedmust comply with the applicable regulations.

• 10.1.6. Raw material packaging and packagingbought should not contain staples.

SUB-CONTRACTORS AND SERVICESUPPLIERS The above companies must have been approved byyour company. Otherwise it is your responsibility tocheck periodically on the quality of the service sup-

10.2

10.1

10

9.3

9.2

9.1

9

8.6

plied and the way in which it is supplied and complywith the present good cleanliness practices.

Should their staff work on your company’s premisesthey will have to comply with all of the rules that applyto your company’s staff. (C.f. section 4 especially).

CONTAMINATED PRODUCTS ANDCOMPONENTSAny component or product that has been soiled byany type of contaminant whatsoever must beremoved from the production line and be dealt within a specific way.

SPECIFIC HYGIENE PROVISIONS

PACKAGING AND PACKAGING ITEMS

PREVENTION OF PHYSICAL HAZARDS

GLASS AND FRAGILETRANSPARENT MATERIALS• 1.1.1. All parts of factory equipment made fromglass or fragile transparent material must be –insofar as it is reasonably possible to do so –replaced with an appropriate material (for examplepolycarbonate or metal) in areas in which productsare unpacked or uncovered.

If replacement of the part is not a reasonableoption to take, a film of anti-shattering safety coat-ing can be applied to the parts made from glass orfragile plastic.

• 1.1.2. All sources of light and also anti-insectdevices must be protected against the risk ofdebris being dispersed from them.

1.2 BLADES USED FOR CUTTING• 1.2.1. The location of, checks on, and removal ofcutting blades from production lines must be cor-rectly managed.

• 1.2.2. The use of folding blades is to be avoided.

• 1.2.3. If cutting blades are broken or lost a super-visor should be notified immediately, who willevaluate the risk of contamination straight awayand will take preventative action, if required.

• 1.2.4. Ensure that the use of cutting blades in yourcompany is kept to a strict minimum and endeav-our to use other cutting methods instead of blades.

1.3 ANIMALS, PESTS AND VERMIN• 1.3.1. Compliance with general hygiene provisionsregarding external areas and buildings will con-tribute to averting the dangers that arise frompests. Please refer to these provisions (sections 1and 2).

• 1.3.2. Airborne insects: traps or systems to repulseairborne insects should, at least, be placed in allareas in which products are unpacked, and shouldundergo regular maintenance.

• 1.3.3. Rodents and creepy crawlies: you shouldhave a service contract with a specialised company.

• 1.3.4. Pets: are not allowed in the production orstorage premises.

• 1.3.5. The workshop will, insofar as possible, bepressurised.

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.

PLASTIC• 1.5.1. Any employee that loses ear protectors mustnotify 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 elastomerbelts are to be avoided, insofar as possible, in pro-duction areas and when they must be used theyshould be inspected regularly and maintained in agood state of repair.

• 1.5.4. Containers and bins used for moving productaround the site will be regularly inspected andcleaned and will be disposed of if they get broken– even partially.

FIBRES• 1.6.1. String is to be banned from production areas.

• 1.6.2. The use of cleaning cloths and sponges forcleaning activities must be kept to a strict mini-mum. Preferably use disposable paper towels forwiping.

• 1.6.3. Brushes must have colour hairs or bristlesand must be replaced regularly. The use of wood-en brushes is to be avoided. Brushes that use disposable towelettes should be preferred.

1.6

1.5

1.4

1.3

1.2

1.1

1

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11

12

13

LUBRICANTS• 1.7.1. Grease that is required for the lubrication ofparts of machines that are in contact with productsmust not be used to excess.

• 1.7.2. Packaging, components and products soiledby grease should be discarded.

• 1.7.3.Where oil is used in the production premises,appropriate means of retaining leaks should beavailable.

Oil circuits will be inspected regularly.

• 1.7.4. Lubricated parts in movement in areas nearto products must – when it is technically possibleto do so – be equipped with protective guards.

PRODUCTION WASTEAll production waste and substandard products must

be destroyed.

PREVENTION OF CHEMICAL HAZARDS

Introduction

All components, additives, substances involved inthe production process, and cleaning products haveto comply with the regulations laid out in section III.

The Safety Sheets of the above substances must beheld on file by companies.

MAIN COMPONENTSCertificates showing compliance with the regula-tions which apply to the relevant packaging.

ADDED COMPONENTS• Additives

• Colourings

• Solvents and lubricants (that are involved in pro-duction process or used for cleaning)

For these substances the following provisions mustbe applied:

1. Certificates showing compliance with technical andlegal provisions must be obtained and kept on file.

2. Safety Data Sheets must be obtained and appliedon the ground.

3. Areas in which these substances are stored mustbe free from all external sources of pollution.

4. These substances must not be used after any use-by dates that may apply.

USAGE OF MILLED SUBSTANCESCompanies must ensure that any milled substancesused are completely free of any form of chemicalpollution.

CONTAMINANTS Substances designated as contaminants – i.e. clean-ing products, pest control agents, etc. – must bemanaged as follows:

• Check that they comply with regulations.

• Storage safety measures to be taken – to avoid alldirect contact with products.

• To be used as sparingly as possible.

COVERING COMPONENTS Covering components are inks, lacquers, varnishes,other coatings and other miscellaneous substances.

These substances must comply with the regulationsoutlined above.

These substances must be used in ways that complystrictly with common practices in the packagingindustry and with the substances’ technical properties.Implementing such practices will enable companiesto prevent contamination of packaged products andto guard against any potential effects on the healthof the products’ users and consumers.

PREVENTION OF MICROBIOLOGICALHAZARDSPlastic packaging used by the beauty productsindustry does not facilitate the development ofmicro-organisms.

After carrying out research on this issue, consultingwith representative scientific authorities in France,and after checking the main relevant databases, wefound that no health incidents of a microbiologicalnature have been reported that were directly linkedto packaging.

Even though plastic packaging does not provide agood environment for micro-organisms to develop,the measures taken by packaging manufacturers donot mean that users of packaging can forego takingthe requisite measures in relation to the specificnature of product they pack.

Should clients specifically request companies to doso, special treatment of packaging aimed at improvingthe microbiological cleanliness of products or spe-cial testing may be used.

3

2.5

2.4

2.3

2.2

2.1

2

1.8

1.7

It is strongly recommended that a risk analysis studybe carried out to assess and control the microbiolog-ical hazards that arise in each specific situation.

Periodical reviews of the provisions in place to guardagainst such dangers should be carried out.

• As regards the special provisions that need to beput in place as regards the packaging of products,companies should avoid having an employee whois carrying an ailment (e.g.germs) of a type thatcould alter the properties and affect the integrity ofthe product that is being packaged.

Finally, the environment in which packaging madefrom plastic materials for use in the beauty productsindustry is an unfavourable one for the developmentof germs that cause ailments, just so long as generalhygiene provisions are taken.

FOR CONTAMINATION OF ALLTYPESShould contamination of products occur, a companyshould have in place procedures with which to eval-uate the risk (i.e. the type of hazard and its scope)and to determine the appropriate course of action tobe taken (i.e. separate the affected products, destroythe affected product, product recall, etc.).

SPECIAL PROVISIONS FOR FILLINGACTIVITIES

SPECIAL REQUIREMENTSBy “filling” we mean the activity that involves fillingpackaging with the active ingredient – jus [pro-nounced “juice”, word used in the cosmetics indus-try for product formula], [skin] cream, bulk, etc. –before delivering the end product to clients in thebeauty products sector.

• Successful execution of filling activities requirestotal control of hygiene and safety issues regardingthe active ingredient supplied by clients. In particularthe following items must be available for use bypackaging manufacturers:

- For each batch of jus supplied: A delivery note, aproduct testing certificate, and the product’s use-by date.

- A Certified jus control document and its use-bydate.

- A Safety Instructions Sheet.

- Product Specification Sheet listing the product’s

appearance, colour, odour, density, viscosity, etc.

- Instructions as to what to do with the remainderof unpacked jus.

• Product Intake and Storage:

- The jus is taken in, inspected and released forpacking.

- Deliveries of open drums will not be accepted –resultant doubts over hygiene and contamina-tion.

- The premises in which the jus is stocked aresecure, and its storage conditions will complywith the client’s recommendations.

• Using the jus:

- The containers used to transport the jus enablebatch traceability to be maintained and are han-dled in compliance with the Safety InstructionsSheet and the site’s hygiene requirements.

- Once the containers have been emptied they arereturned to the client, or destroyed if the clientso wishes, or else cleaned very carefully with aview to re-using them.

After being packaged, the finished product ischecked against the Product Specification Sheet,released and dispatched in accordance with theclient’s instructions.

The jus distribution line is emptied, rinsed, cleanedand checked – to ensure that the next time it is usedin appropriate hygiene conditions and is contamina-tion free.

The amount of jus that has been used is checked.

• Surplus jus is dispatched or destroyed with theclient’s agreement.

• The finished product is packaged, handled, storedand finally dispatched in compliance with thehygiene and safety conditions specified by agree-ment with the client.

ARRANGEMENTS FOR

UPDATING THIS GUIDEEach year a Committee appointed by the CSEMP(Chambre Syndicale des Emballages en MatièrePlastique, the Plastic Packaging Trade Association)will hold a meeting with the objective of reshapingthis guide or, if required, to update it in relation tochanges in regulations and to companies’ practices.

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15

APPENDIX I - GLOSSARY OF TERMS

PRODUCTION PROCESSES1

PROCESS DEFINITION

Calendering The manufacture of stiff or flexible sheets of thermoplastic material using the movement of several heated cylinders.

Compositing An activity that consists of assembling – using various techniques – flexible materials to obtain a structure withseveral layers and/or which contains several materials.

Pasting Used to assemble two items using water-based adhesive, other types of adhesive, or wax.

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).

Embossing Used to cut out a shape or to reproduce a motif by reshaping an item (thus creating a raised area on it).

Extrusion Used to fuse and shape plastic material using an Coextrusion 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”

Extrusion Used to deposit a continuous coating of plastic Coating material on an item. The plastic material is in a viscous Coextrusion state and is extruded via a single die (in the case of Coating extrusion) or a multi-die (in the case of coextrusion).

Flat-Die Extrusion Used to extrude plastic material into a sheet shape.Flat Die Coextrusion

Blow Extrusion Techniques used to produce plastic film, which Moulding (I) consists of extruding plastic material through a ring-Blow Coextrusion shaped die (or through several concentric dies in the Moulding 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.

USED FOR

•Sheets for thermoforming(generally made from PVC)

•Composite flexible packaging

•Paper/aluminium composites

•Non-stick paper

•Sheets for thermoforming•Tubes

•Paper / polyethylene •Paper / polypropylene forbags

•Plastic film (PVC,Polypropylene, etc.) in single sheets (extrusion)or with several sheets (coextrusion)

•Bags • Sachets • Films

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PROCESS DEFINITION

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 This is a variant of extrusion that enables very thin Moulding (II) 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.

Injection Entails heating plastic material so it turns liquid and canbe injected under pressure into a mould.

Blow Injection Produces a hollow item in two stages :Moulding 1) Manufacturing a preform

2) Blowing up the hot preform by blowing air into it.

Moulding Expanded polystyrene (EPS) is obtained by moulding Expanded and welding balls in a mould, with the linking betweenPolystyrene the pre-expanded balls occurring due to the thermal

effect of water vapour.

Thermoforming Second stage of processing in which material which (PVC, Expanded has already been made into sheets, plates, tubes, Polystyrene, etc.) or profiles is softened using heat and shaped by

applying a simple-shaped mould.

USED FOR

• Aluminium / paper composites • Multilayer Plastic Film

•Bottles • Flasks/Vials •Plastic jugs•Barrels •Containers

• Packaging for consumergoods

• Corking Plugs • Boxes • Pots • Cases • Pumps

• Bottles • Flasks/Vials • Pots

• Boxes

•

Pots • Lids • Blister Packs

17

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 A point in a procedure at which control can be applied (and is vital) and a food-Critical Control Point safety 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 A method of analysis which defines, evaluates and keeps hazards that threaten theHazard Analysis cleanliness of products under control.Critical Control Point

Approved By Certified compliance with certain set standard criteria.

Micro-organisms Bacteria, yeasts and moulds.

Active Micro-organisms that – while they are not dangerous – that are likely to make a Micro-organisms product unfit for human consumption (by making a product substandard, etc.).

Pathogenic Micro-organisms that are likely to cause various types of food poisoning.micro-organisms

Traceability The ability to retrieve the history, usage or locale of an entity (a product or a production process) using recorded data.

2

APPENDIX IIExamples of Analysis Methods Used to Test for Microbiological Hazards.

The Agar Slide Method Technique

• Take a sample from packaging (e.g. from a roll).

• Slides plus agar (e.g. plate for total flora and yeastand mould).

• Swab each side of the slide for about ten secondsagainst the surface you are testing and then putthe slide back in its holder.

• Keep in an incubator at 30°C for two or three days

• Count the number of colonies on each side of theslide after incubation.

Recovery by Direct Seeding in an Agar MilieuTechnique (Enumeration of yeast and mould)

• Take a sample from packaging on the productionline.

• Seed the sample by filling the sample containerwith specific amounts of agar with glucose andchloramphenicol at specific temperatures.

• Spread the agar on the sides of the packaging byrotating.

• 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.

Immersion Recovery Technique

• Put a packaging sample into a Stomacher bag with20ml – or other appropriate amount – of diluent(EPT + 0 .2% strength Tween 80).

• Put that into an ultrasound vat for 3 minutes.

• Now put it in a Stomacher.

• Take a 1ml sample of the liquid milieu, dilute andinoculate in the chosen counting milieu.

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APPENDIX III -BIBLIOGRAPHY AND USEFUL ADDRESSES

I- HYGIENE BIBLIOGRAPHYCodex 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 Conférence AFNOR (20/06/95)in the Food Business : Tools, Means, and Methods

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 Assemblée Générale d’ORQALI (6/04/94)Companies Need To Ask Themselves

Applying Risk Analysis Studies Rapport de la consultation mixte d’expertsin the Area of Food Standards FAO / OMS (13-17/03/95)

“Micro-organismes pathogènes transmis par les aliments” M. GELINAS - Editions EDISEM (97)(Pathogenic Micro-Organisms Spread By Food)

Lubricants in the Food Sector – Guide to Choosing and CNRS – CNERNA – Editions Lavoisier (92)Using the Right Ones

II- USEFUL ADDRESSES AFSSAPS (French Heath Safety Agency for 143-147, boulevard Anatole France - 93285 - SAINT-DENIS CédexHealth Products [sic]) 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 PARISTel: +33 (0)1 4955 4955 / Fax: +33 (0)1 4955 5680

DGCCRF (A French government agency 59, bld Vincent Auriol - 75013 PARIS responsible for overseeing fair trading, Tel: +33 (0)1 4487 1717 / Fax: +33 (0)1 4497 3043consumer issues and fraud repression)

DGS (A French government health agency) 8, avenue de Ségur - 75350 PARIS 07 SP Tel: +33 (0)1 4056 6000

French government official publications 26, rue Desaix - 75727 PARIS Cédex 15 office, broadly similar to HMSO 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 PARISTel: +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

CSEMP(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 : infos@packplast.org july2005-M.VANHOVE