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Syllabus Food Contact Materials 2011 96 03 T HIS TRAINING IS IMPLEMENTED BY THE T RAIN S AFER F OOD CONSORTIUM .
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Syllabus
Food Contact Materials
2011 96 03
T H I S T R A I N I N G I S I M P L E M E N T E D B Y T H E T R A I N S A F E R F O O D C O N S O R T I U M .
Table of contents
Preface 4
1. Introduction 5
2. Content of the courses 7
3. Abstracts of the presentations. 8
3.1 Legislation....................................................................................................................9
3.1.1 FCM, the legal framework and survey of specific regulations..........................9
3.1.2 Watch your deadlines! The legal process and guidance in a Member State,
interaction with the Commission and other MS.......................................................11
3.2 Food contact materials, - technical information.....................................................12
3.2.1 Technical introduction to FCM - what is it?.....................................................12
3.2.2 Plastic polymers.................................................................................................13
3.2.3 Printing inks.......................................................................................................20
3.3 Risk assessment, - safety assessment of food contact materials...........................22
3.3.1 General requirements in safety assessment of FCM.......................................22
3.3.2 EFSA Risk Assessment regime as support to control of non-harmonised FCM
.......................................................................................................................................23
3.3.3 The EU RASFF system........................................................................................25
3.4 Good manufacturing practise and quality assurance.............................................27
3.4.1 Italian guidance on GMP - cooperation between authorities and industry for
a common guidance.....................................................................................................27
3.4.2 QA documentation in practice...........................................................................28
3.5 Migration testing and laboratory support..............................................................30
3.5.1 Can your Reference laboratory be of any help to administrators?................30
3.5.2 Sampling and migration testing of plastic according to current EU regulation
.......................................................................................................................................31
3.5.3 Migration testing according to current EU regulation....................................33
3.5.4 Supporting documentation to DoC...................................................................36
3.5.5 Role of private consultants and laboratories...................................................37
3.6 Official control of Food Contact Materials...............................................................38
3.6.1 How to develop and prioritise in drafting the yearly control plan................38
3.6.2 Planning of control- some tools to base it on!.................................................40
3.6.3 Inspection on FCM premises.............................................................................44
3.6.4 Registration and practical inspection of FCM premises.................................46
3.6.5 Guidance to control of critical points in the printing process and
documentation for use of printing inks.....................................................................48
3.6.6 Campaign on plasticiser migration from gaskets into oily food in glass jars49
3.6.7 Organoleptic testing as a tool in FCM control..................................................51
3.2.7 FCM - a challenge for the public analytical control and administration........52
3.2.8 Plastic Kitchenware 284/2011 (Chinese kitchen utensils)............................54
4. Workshops – learning by doing! 58
4.1 Inspection/evaluation of declaration of compliance and supporting
documentation for food contact materials....................................................................58
4.2 Organoleptic testing..............................................................................................59
4.3 Inspection of GMP and critical control points in food contact materials
production....................................................................................................................62
5. Visits to production sites of food contact materials. 62
6. Networking for improving control in the European Union 64
7. Other information, links and references 64
PrefaceThis Syllabus covers the 7 training courses on Food Contact Material in the frame of the
‘Better Training for Safer Food. The training courses was organised and implemented by the
European Training Platform for Safer Food (TrainSaferFood).
The courses have taken place from September 2012 until May 2013. Jens Højslev Petersen
and Gitte Alsing Petersen, Technical University of Denmark and Bente Fabech and Mette
Holm, Danish Veterinary and Food Administration were the training coordinators for these
training courses.
Speakers at the courses were invited due to their special skills and expertise within a specific
topic and in communication of it. They came from in total 13 countries in the European Union,
including some of the European Professional Organisations. The participants acknowledged
the pallet of different nationalities as this contributed to the understanding and the need for
networking in this field, in order to achieve a more uniform control and administration of the
harmonised legislation in the European Union.
The participants at the courses were working at competent authorities in their home
countries, as food inspectors, administrators and policy officers.
Participants were from almost all EU Member States and some third countries. Their
motivation was high, as the subject of food contact materials is regarded as very complex and
huge, and it was highly appreciated that the Commission offered these courses.
The following tutors and training coordinators have contributed to this syllabus:
Bente Fabech and Mette Holm, Danish Veterinary and Food Administration (DVFA)
Jens Højslev Petersen and Gitte Alsing Pedersen, Technical University of Denmark (DTU)
Rhodri Evans and Bernard Hegarty, Food Authority of Ireland
Ester Enning, Import control coordinator, Netherlands
Viviana Golja, NRL, Slovenia
Konrad Grob and Gregor McCombie, Food Authorities in Zürich, Switzerland
Antje Harling, CVUA, Stuttgart, Germany
Rüdinger Helling, Food Control, Germany
Pirkko Kostamo, EVIRA, Finland
Mette Damgaard Kristensen, Eurofins, Denmark
Maria Rosaria Milana, Institutio Superiori de Sanita, Italy
Carina Mørkhøj, Jan Petersen and Kim Vandrup Sigsgaard, Danish Veterinary and Food
Administration (DVFA)
Karl-Erwin Piejko and Sue Ward, Plastics Europe
Maria Fatima de Pocas, NRL Portugal
Milada Sycova, The Food Authority of Slovakia
Chris Whitehead and Paul Hunt, Eupia
Detlef Woelfle, BfR, Germany
The tutors are acknowledge for their willingness to share their knowledge and to involve
themselves in the training, and the European Commission is thanked for enable such training.
The company visits were at LietPak, Vilnius, Lithuania; TetraPak, Berlin, Germany;
Progelcone, Lisbon, Portugal and Grafobal, Vilnius, Lithuania.
They are all thanked for facilitating a practical knowledge of production of food contact
materials.
All the participants were active and positive, and created a fruitful atmosphere of networking
1. IntroductionThe aim of the BTSF courses in Food Contact Materials was to provide the participants with an
in-depth understanding of the control and to keep them up-to-date on relevant aspects of EU
legislation in order to facilitate a more uniform and efficient control in the EU Member States
and invited third countries.
The courses were divided into 4 types of courses:
Administrators basic and advanced
Inspectors basic and advanced
At the basic courses non-experienced staff was offered a general introduction to the area of
FCM, the harmonised EU legislation with a focus on plastic and the control obligations. At the
advanced courses experiences staff would have the opportunity to go more into details in the
different subjects.
The courses offered activities including presentations, discussions of cases in groups, field
visits to production sites, poster sessions and social interaction (networking) with colleagues.
A three days course can cover the core issues of food contact materials, like for the basic
courses, the EU plastic regulation, but not all types of materials. The focus areas were selected
in order to give specific as well as general knowledge, and to encourage the participants to
continue and develop their skills in other areas of food contact materials.
Food contact materials were demonstrated in nature and organoleptic testing was part of the
exercises.
The programs for the courses were overlapping in some extent, as even participants with
several years of working experience have not necessary knowledge in all areas.
In this syllabus, the abstracts for all four courses are listed thematically in order to give the
reader and easy overview and access to the different subjects that were presented in the
training courses.
For each abstract, the speakers name and affiliation is mentioned together with information
on which courses had the speech on the agenda.
Workshops and company visits are described in Chapter 4 and 5.
2. Content of the courses
Food contact materials consist of many different materials and have many types of use areas.
Food administrators and inspectors do not need to have knowledge on all details like the
chemistry and production procedures for e.g. plastics and printing inks, but need to have
some basic understanding and knowledge.
Materials like plastics and printing inks are potentially composed of many thousands of
chemicals, and all of them might migrate into the food depending of their chemical/physical
properties. In the production processes are in some cases several critical control point, in
other cases like for wooden chopping boards, only few. When administrating or inspecting for
compliance with the EU regulation on Good Manufacturing Practice (GMP) or the positive list
for plastics, knowledge is needed on both chemical composition of the materials and on
critical control point in the production.
Testing of migration and evaluation of declaration of compliance and occasionally supporting
documentation are also based on knowledge, including knowledge on where to ask for
technical guidance like at the national reference laboratories.
The training courses for both food inspectors and administrators aimed to keep participants
up-to-date on relevant aspects of EU legislation in order to facilitate a more uniform and
efficient control in MS. This is important both for the authorities planning control and for the
practical control by the inspectors in order to reduce the number of non-compliant FCM.
Training the assessment of compliance documentation and better knowledge of the testing
rules for plastics was included in the training as this are important steps in improving the
skills of inspectors.
Learning objectives for the training courses for inspectors
It was the aim that at the end of the basic level course participants would be familiar with
and updated on:
The EU legislation with focus on GMP and the Plastics regulation (EU)10/2011
Finding useful FCM information on the internet, including knowledge of materials
Checklists for inspection on FCM premises
Legal requirements to compliance documentation
Critical assessment of supporting documentation
The role of private consultants
The role of National and EU Reference laboratories (NRL/EURL)
Participants at the advanced course would furthermore have more in-depth knowledge
about:
testing rules for plastic
assessment of compliance documentation
Learning objectives for the training course for administrators.
It was the aim that at the end of the basic level course participants would be familiar with
and updated on:
The EU legislation with focus on the Plastics regulation (EU)10/2011
Principles for risk assessment of substances used by EFSA
Finding useful FCM information on the internet, including knowledge of materials
Legal requirements to compliance documentation (declaration of compliance and
supporting documents)
The role of private consultants
The role of National and EU reference laboratories
Participants at the advanced course would furthermore have more in-depth knowledge how
to:
influence new EU legislation
prepare checklists for inspectors
3. Abstracts of the presentations.
The abstracts for all four courses are listed thematically order to give the reader and overview
of the content of the training courses and the different speeches covering a subject.
For each abstract, the speakers name and affiliation is mentioned together with information
on which courses had the speech on the agenda.
Workshops and company visits are described in chapter 4 and 5.
3.1 Legislation
3.1.1 FCM, the legal framework and survey of specific regulations
Bernard Hegarty and Rhodri Evans the Food Authority of Ireland
Administrators basis and advanced, Inspectors basic and advanced.
The aim of these presentations was to give the participants an overview of the EU
legislation on food contact materials (FCM).
Food contact materials and articles are regulated by:
The framework Regulation (EC) 1935/2004, which sets up general requirements for all
FCM
Regulation (EC) No 2023/2006 on Good Manufacturing Practices (GMP) for all FCMs
Specific Directives/Regulations which cover some of the particular materials and articles
listed in the Framework Regulation
Directives/Regulations on individual substances or groups of substances used in the
manufacture of FCM.
The underlying principle of the FCM legislation is that materials in contact with food must
not contaminate the food with substances that may migrate from the FCM into the food. The
legislation deal with the importation and sale of materials intended to come into contact
with food, the descriptions which must accompany them and specify labelling requirements
when materials and articles are sold for food contact use but are not already in contact with
food.
Regulation (EC) No 1935/2004 applies to materials and articles, including active and
intelligent food contact materials and articles, which in their finished state:
1. Are intended to be brought into contact with food; or
2. Are already in contact with food and were intended for that purpose; or
3. Can reasonably be expected to be brought into contact with food or to transfer their
constituents to food under normal or foreseeable conditions of use.
Regulation (EC) No 1935/2004 requires that materials and articles are manufactured in
compliance with good manufacturing practice so that, under normal or foreseeable
conditions of use, they do not transfer their constituents to food in quantities which could:
1. Endanger human health; or
2. Bring about an unacceptable change in the composition of the food; or
3. Bring about a deterioration in the organoleptic characteristics thereof (i.e., taint the food).
Regulation (EC) 1935/2004 also takes into account types of materials and articles designed
to actively maintain or improve the condition of the food (active FCM) which are not inert
by their design as well as other types of new materials which are designed to monitor the
condition of the food (intelligent FCM).
The labelling, advertising and presentation of a material or article must not mislead the
consumers. Article 15 of Regulation (EC) No 1935/2004 sets out specific labelling
requirements for materials and articles which are not yet in contact with food when placed
on the market. It requires that they must be accompanied by:
1. the words ‘for food contact’, or a specific indication as to their use, such as coffee machine,
wine bottle, soup spoon, or the symbol reproduced in Annex II of Regulation (EC) No
1935/2004; and
2. If necessary, special instructions to be observed for safe and appropriate use; and
3. the name or trade name and, in either case, the address or registered office of the
manufacturer, processor, or seller responsible for placing on the market established within
the Community; and
4. adequate labelling or identification to ensure traceability of the material or article, as
described in Article 17 of Regulation (EC) No 1935/2004; and
5. in the case of active materials and articles, information on the permitted use or uses and
other relevant information such as the name and quantity of the substances released by the
active component so as to enable food business operators who use these materials and
articles to comply with any other relevant Community provisions or, in their absence,
national provisions applicable to food, including the provisions on food labelling.
However, the information referred to in (1) above is not obligatory for any articles (for
example, cutlery) which, because of their characteristics, are clearly intended to come into
contact with food.
Regulation (EC) No 2023/2006 as amended lays down the rules on good manufacturing
practice (GMP) for FCM. It applies to all sectors and to all stages of manufacture, processing
and distribution of materials and articles, excluding the production of starting substances.
Regulation (EC) No. 282/2008 covers recycled plastics. These must be made from authorised
processes, when the legislation is fully in effect.
Directive 84/500/EEC as amended covers ceramic FCMs. The main restriction is on
migration of lead and ceramic. A declaration of compliance is required at stages of marketing
up to retail.
Directive 2007/42/EC covers regenerated cellulose film. Its composition is restricted to
listed substances. If used, plastic coatings must comply with the plastics Regulation
(10/2011).
Regulation (EC) No 450/2009 covers active and intelligent materials. These must be made
using active components that are authorised by the Commission, when the authorisation
phase of the legislation is in effect.
Certain substances originating from FCM are regulated by:
Directive 93/11/EEC on nitrosamines’ in teats and soothers
Regulation (EC) No 1895/2005 on epoxy substances (BADGE, BFDGE and NOGE)
Regulation (EU) No 10/2011, as amended, on plastic FCM came into force from 1st May 2011.
The scope includes plastic coatings and gaskets on metal lids and plastic layers in multi-
material multilayer FCMs. This Regulation repeals Directive 2002/72/EC and replaces it and
its six amendments. It has a positive list of monomers and starting substances and additives.
These lists include for some substances restrictions on their migration (Specific Migration
Limits, SML), the concentration used in the FCM, or their purity or permitted use (e.g. not
permitted for plastics in contact with fatty foods). An overall migration limit (OML) of 10
mg/dm2 (or in certain cases, 60 mg/kg food) is specified. Regulation 10/2011 requires that
a declaration of compliance (DoC) is supplied for plastic materials and articles at the non-
retail stages and the information required to be supplied in the DoC is set out in an Annex to
the Regulation
Where a specific measure has not yet been introduced for a given FCM, then it must comply
with the general provisions of the Framework and GMP Regulations.
3.1.2 Watch your deadlines! The legal process and guidance in a Member
State, interaction with the Commission and other MS.
Bente Fabech /Mette Holm, Danish Veterinary and Food Administration
Administrators, advanced
The EU Member States has an important role both in the European legal process and in the
national process. In both cases, it is highly important to prioritise the timing and watch the
deadlines.
European legislation is an important tool in harmonisation of the legal requirements, and this
is especially important in the area of food contact materials, as they are traded widely within
in EU and internationally with third countries.
Harmonised legislation in this area is developed in corporation with EU’s Member States and
gathered information and comments from professional organisations. This shall first of all
ensure food safety, but also technical possibilities and control measures, which need to
function in practise.
Member States need to involve themselves in the process to get as many details as possible
taken into account. Furthermore, the national legal process has to be started in due time for
elaborating a mandate for voting.
3.2 Food contact materials, - technical information
3.2.1 Technical introduction to FCM - what is it?
Jens Højslev Petersen, DTU National Food Institute, Denmark
Administrators, basic
The most important categories of food contact materials (FCM) can be arranged in the
following families, according to which types of starting substances or materials they
are produced from:
plastic and elastomers (including synthetic and natural rubbers)
glass and ceramics (silica-based)
paper, board, wood and regenerated cellulose
metals
In most cases such materials are combined with layers of printing inks, adhesives,
coatings etc. to form the final food contact material.
Materials used for direct food contact can be produced in different qualities, which are
suitable as food packaging as well as for food production equipment. The mechanical
properties of the final FCM of plastics and elastomer can be varied dramatically by
proper choice of monomer, of polymerisation process and of additives.
Most of the paper and board is basically produced from wood by pulping and
bleaching of the fibers and adding of additives. In many cases a certain proportion of
recycled fibers will be added during the process. Adhesives are used to strengthen the
board (e.g to compensate for recycled fibers being shorter) and for surface sizing.
Issues important for food safety is, that the final material must fit to the intended
purpose with respect to: Type of food (fatty, aqueous, acidic..), contact time (seconds,
days, years) and contact temperature (freezer, room temperature, oven). Properties
for different plastics are covered more in details in the next section.
Plastic used for packaging’s can also be combined with layers of e.g. aluminum and
paperboard to improve stability and decrease permeability to oxygen and water and
increase the shelf life of the packed foodstuff. In other cases it can be necessary to
include a functional barrier, which reduces the migration of non-authorized
substances present in outer layers (e.g. recycled board) to the food to a minimum.
Such substances must comply with the general 10 µg/kg migration limit. However
special attention is given to (a) substances classified as ‘mutagenic’, ‘carcinogenic’ or
‘toxic to reproduction’ and (b) substances in nano-form which should not be present.
Production of food contact materials are industrial processes that utilizes heavy
equipment which is different from what is used in the food industry. It can therefore
be difficult for the inexperienced food inspector to point out the critical control points.
However, after having visited such production plants a few times it becomes easier to
overlook. In this course the principles for film extrusion and thermoforming of plastic
trays was explained. Furthermore all participants visited a production premises
(chapter 5).
3.2.2 Plastic polymers
Karl-Erwin Piejko and Sue Ward, Plastics Europe
Administrators, advanced and Inspectors basic
FOOD CONTACT PLASTICS
Introducing Plastics
• Many materials we use every day are made of polymers. These are large, long molecules
(macromolecules) constructed of smaller, shorter molecules, called ‘monomers’
• Polymers can be ‘natural’ or ‘synthetic’
• Natural polymers are common in animals and plants; proteins in animals (wool,
leather, silk); carbohydrates in plants (wood, rubber, and cotton, flax). These
were already used by mankind for weapons, clothing, buildings, machines…
• Synthetic polymers are today mainly made from fossil fuel raw materials, with an
increasing use of bio-mass as raw materials
Two types of plastics:
Thermoplastics - can be heated and formed, then heated and formed again and again. The
shape of the polymer molecules is generally linear or slightly branched. This means that the
molecules can flow under pressure when heated above their softening/melting point.
Examples: polyethylene, polypropylene, polystyrene, polyvinylchloride, polyethylene
terephthalate, polycarbonate, polyamide, etc
Thermosets - undergo a chemical change when they are heated, creating a three-dimensional
network. After they are heated and formed, these molecules cannot be re-heated and re-
formed.
Why are there so many different types of Plastics?
• All plastics are different, no one plastic has the same properties as another
• Plastics can be hard, soft, tough, durable, brittle, flexible, rigid, heat resistant, weather
resistant, insulators, etc.
• Not all plastics can be made into the same shape or form
Plastics to come into contact with food
To be used in contact with foodstuffs, all plastics (and bio-plastics and bio-based plastics)
must fully comply with the food contact legislation (see links at the end of this Chapter). All
additives and monomers used in their production and processing must be on the relevant
positive lists.
Major classes of food contact plastics
Polyethylene (PE)
• Low Density Polyethylene (LDPE)
• Linear Low Density Polyethylene (LLDPE)
Properties:
• Low water vapour permeability
• Relatively permeable for O2, CO2 and flavouring agents
• Resistant to acids and bases
• Swells slightly in prolonged contact with fats and oils
• Transparent
• Welds easily
Applications:
• Films, bags, tubes, nets for the packaging of meat, milk, vegetables, fruit, confectionary,
pastries, bread, sugar;
• as „sealing layer“ in the manufacture of composite materials with cardboard (one-way
packaging, e. g. by Tetrapak)
• in adhesively bonded („laminated“) or coextruded composite films with aluminium,
PA, PET for long-term storage packaging of cheese, sausage and ham, coffee, snacks
• complex composite materials with up to seven layers, i.e. ethylene vinyl alcohol
copolymer (EVOH) as gas barrier layer
• biaxially stretched blowfilm as shrink film for fresh meat and poultry
High Density Polyethylene (HDPE)
Properties:
• Compared with LDPE and LLDPE – more viscous and better cold resistance
• Less permeable for water vapour and gases
• Better resistance to chemicals and higher temperatures
Applications:
• Manufacture of bottles, containers; closures for milk and vinegar; transport packaging
– in the form of boxes/crates – for meat, bakery products, beer and wine
Polypropylene (PP)
Properties:
• High mechanical strength
• Low permeability for gases, water vapour and aromatic substances
• Resistant to higher temperatures (140°C short-term) and, therefore, suitable for hot
fillling of foods, possibly sterilization in packaging
• Welds easily
Applications:
• Boil-in-bag films, films for pastries, milling industry products and bread;
• microwave dishes, drinking cups;
• pre-formed packaging (e.g. containers with lids for dairy products, crystal-clear
bottles with screw cap for hot-fill drinks such as tea, fruit juice or milk – and
packaging material for milk powder, nuts, dried fruit, soy sauce, vinegar etc);
• highly transparent, thin films – in the form of „biaxially-oriented PPs“ (BOPP) to
package meat products and cheese
Polyvinyl chloride (PVC)
Properties:
• High chemical resistance to acids, bases, fats and oils
• Low permeability for water vapour and gases
• High resistance to UV radiation
• Good aroma tightness
• Low heat resistance (70–75°C – thus no sterilisation in packaging)
Applications of rigid PVC - films for pre-portioned packaging; pre-formed packaging
(bottles for vinegar, edible oils, wine, beer; trays for milk and dairy products, mayonnaise,
fats, salads etc. and inserts for chocolate boxes)
Applications of soft and semi-rigid PVC - cling film for the packaging of food products (PVC
used for this purpose is vapour and oxygen permeable)
Applications of soft PVC - beverage hoses; sealing material for screw caps and crown corks
Polyvinylidene chloride (PVdC)
Properties:
• Very good barrier properties against gases, flavouring agents, water, water vapour,
oils and fats
Applications:
• Films and packaging composites with various carriers (paper, plastic and aluminium
films) for the packaging of foods (poultry, meat, sausage, cheese); Can be used in
multi-layer structures for better a package with better barrier properties
Polystyrene (PS)
Properties:
• High permeability for water vapour and gases
• Hot filling possible with limitations
• Can be converted into high impact PS (HIPS) by way of adding polybutadiene rubber
or in the form of the styrene-butadiene block copolymer
Applications:
• Thin-walled ice cream tubs and drinking cups; disposable cutlery
Applications of high impact PS/HIPS - cups and other containers for the packaging of milk
and milk products, soft cheese, honey, butter, coffee cream (portion pack), confectionary,
pastries
Applications of foam PS - insulated packaging for hot and cold drinks and foodstuffs. Egg
boxes
Polyamide (PA)
Properties:
• High mechanical strength and viscosity
• Transparency
• Dimensionally stable under heat up to over 100°C (allowing PA sterilization)
• Low permeability for gases and aromatic substances, high permeability for water
vapour
• Outstanding resistance to chemicals, fats and oils
Applications:
• Use as boil-proof film (oven bag); In combination with PE: as deep-drawing composite
film for vacuum packaging or packaging in inert gas atmosphere of cheese, sausage
and meat products, bacon and fish
Polyester (PET)
Properties:
• High mechanical strength
• Transparency
• Dimensionally stable under heat (allowing sterilization)
• Very low permeability for O2, CO2 and aromatic substances
• Good resistance to chemical impacts
• Difficult to weld
Applications:
• One-way and returnable bottles for carbonated drinks and
mineral water, edible oils, sauces, mustard, syrup and salad dressing;
• As material for trays and „boil-in-bag“ films where pre-cooked meals are heated up in
a microwave or in an oven;
• When used in composite films with PE as sealing layer: for the packaging of bread,
cheese, fowl, ready-made meals, coffee – also in the form of vacuum packaging and for
„boil-in-the bag“
• PET is the most recycled packaging polymer
Polycarbonate (PC)
Properties:
• Outstanding mechanical strength and viscosity
• Good dimensional stability under heat (therefore easy to sterilise)
• Transparency
• Largely resistant to chemicals
Applications:
• Returnable milk bottles in the USA, in Germany and the Netherlands; 20 litre
returnable bottles for drinking and table water; Higher-quality tableware
Bioplastics
The term “bioplastics” is not only used for polymers made with bio-based monomers but also
includes biodegradable and non-biodegradable plastics which are either based on fossil or on
renewable material (or both).
Properties:
Alongside conventional polymers based on fossil raw materials, bio-based plastics are
manufactured on the basis of renewable resources
Applications:
• fruit and vegetables are packed in water vapour-permeable films from polyactide
(PLA); biodegradable bin liners for organic waste, so that the bin liners and their
content can be composted together
Additives
Additives can contribute significantly to the enhancement of the plastics’ function in their
specific use
Use of Additives in Polymers
Manufacture of Basic Polymer - Antioxidants - protect polymer in use; Stabilisers - protect
polymer in use; Performance Additives - tougheners, stiffeners, UV protection, barrier
Conversion of Polymer to Article - Colours - Transparent, solid, metallic colours; Performance
Additives - Slip, anti-fog, UV protection, barrier; Blowing agents - Density reduction;
Alterations to Final Article - Coatings, Printing
Why do we use additives in plastics?
Anti-oxidants - Help prevent oxidation. Oxidation can cause loss of impact strength, surface
cracks, discoloration and overall loss of mechanical properties
Heat stabilisers - Protect polymers during high temperature applications e.g. hot water pipes
Plasticisers - Used to make polymers more flexible and softer
Fillers - Substances used to improve strength e.g. glass fibres, or chalk in garden furniture to
reduce polymer usage. Usually mineral based for PVC
Biodegradable plasticisers - Enhance the degradability of the plastics
Blowing agents - Form gas to produce a foamed, lightweight polymer
External lubricants - Prevent polymer adhesion during processing and use
Pigments - Give colour to the plastics
Processing aids - Improve processability of plastics during conversion
Stabilisers - Prevent decomposition of the polymer during processing; improve the working
life of the polymer in the environment
Plasticisers - A family of molecules, usually esters, added to polymers at the formulating stage
to control physical properties such as flexibility and softness
Compliance – Resin Manufacture
• All monomers, co-monomers and additives are food contact approved
• Purchasing specifications for all monomers and other raw materials;
• Analysis sheet with every delivery
• Manual and procedures for all materials storage and handling
• FULL TRACEABILITY FOR RAW MATERIALS
• Manual and procedures for all plant processes
• Process for effluent management and treatment or disposal (and spillage management)
• Continuous analysis of resin with retention of samples
• Sales and delivery procedures with SDS and documentation with each load
• All to ISO standard
• Regular ISO inspections
• FULL TRACEABILITY FOR RESIN
For further information on plastics and food contact:
www.plasticseurope.org
www.cpme-pet.org
www.petcore.org
3.2.3 Printing inks
Chris Whitehead and Paul Hunt, EuPIA
Administrators, advanced and inspectors, advanced
Printing Inks are encountered in many ways in everyday life, from newspapers and
magazines, to packaging of all sorts. They play a significant part in the industrial part of
Europe, both in personnel involved in their development and manufacture, through to all the
printers who use the products. There are a number of ways in which can be printed and dried
or cured, and much of their chemistry depends on this factor.
The basic ingredients of an ink are: colorant (pigment or dye), resin (or binder), solvent,
additives (such as wax, plasticiser, antifoam etc.).
Some further background reading is available from the Royal Society of Chemistry website,
and/or the British Coatings Federation websites:
http://www.rsc.org/chemistryworld/issues/2003/march/inkchemistry.asp
http://www.coatings.org.uk/Sectors/printing-inks--interesting-facts.aspx
Manufacture of printing inks essentially consists of grinding (dispersing) the pigment into a
resin solution so as to break down the pigments particles thus developing the colour strength.
After this stage, other resins and additives may be blended in to give the final ink the desired
properties for ease of printing, as well as ensuring that the final print meets its desired
characteristics in terms of adhesion and resistance to handling etc. for the anticipated life of
the printed article.
With regard to food packaging, whilst inks are currently not specifically legislated in the EU,
members of the European Printing Ink Association – EuPIA – are committed to ensuring that
their products are suitable for use on the non-contact side of primary food packaging, through
obedience to Association Guidelines, and the supplying of relevant adequate information to
the printers so as to allow them to meet their obligations under the Framework Regulation
(1935/2004).
The only legislation in place in Europe currently is the Swiss Ordinance which sets out Raw
Materials which may be used for the manufacture of inks for application to the non-contact
side of food packaging. Since ink manufacturers do not make specific inks only for use on food
packaging, the majority of inks being used on food packaging in Member States will also be
made from these Raw Materials. This Ordinance was developed in conjunction with EuPIA,
and whilst making compliant inks are not particularly easy, it is feasible, and there is concern
that other proposed legislation may not be as workable, if indeed it will be possible to make
inks at all which will be compliant.
Many of the guidelines, together with other documents which set out the legal situation of
inks being used for food packaging, and FAQ’s etc. are available on the public sector of the
Trade Association web site – www.eupia.org
3.3 Risk assessment, - safety assessment of food contact materials
3.3.1 General requirements in safety assessment of FCM
Detlef Wölfle, Federal Institute for Risk Assessment (BfR), Berlin, Germany
Administrators basic
Before a substance is authorised to be used in FCM (e.g. in plastics) and is included in a
positive list by the EU Commission (Regulation 10/2011) EFSA´s opinion on its safety is
required. EFSA adopts scientific opinions and provides scientific advice for risk managers on
the safety of substances used or intended to be used to manufacture FCMs as well as the safety
of related processes (e.g. recycling of plastics).
This risk assessment is carried out by the Panel on food contact materials, enzymes,
flavourings and processing aids (CEF). The Panel’s work is based on reviewing scientific
information and data usually submitted by industry. EFSA has published a guidance document
for the presentation of an application for the safety evaluation of substances intended to be
used in FCM (Note for Guidance: http://www.efsa.europa.eu/en/scdocs/doc/21r.pdf).
According to a procedure laid down in the Regulation (EC) No. 1935/2004 the industry
submits applications to the Member States competent Authorities which in their turn transmit
the applications to EFSA for their evaluation.
The data for EFSA´s evaluation usually comprise non-toxicity data (identity of substance;
physical and chemical properties; intended use; migration; residual content of the substance
in FCM) and toxicity data. Toxicity data requirements are dependent on the degree of
migration of the substance into food: up to 0.05 mg/kg food only genotoxicity data
(mutagenicity and chromosome aberration) are needed; at higher migration subchronic
studies (up to 5 mg/kg food) and chronic toxicity/carcinogenicity,
reproduction/developmental and toxicokinetic studies are requested (>5mg/kg food). Based
on results from the repeated dose studies a no observable adverse effect level (NOAEL) is
derived. Applying adequate uncertainty factors for interspecies extrapolation and
interindividual variability a tolerable daily intake (TDI) can be established. In case of low TDI
values (< 1 mg/kg body weight per day) specific migration levels (SML) are calculated using a
default assumption for exposure (1 kg food consumed daily by a person weighing 60 kg body
weight). Restrictions for migrations can also be set based on limited data submitted by the
applicant (e.g. 0.05 mg/kg food based on negative genotoxicity findings only).
During the manufacture and use of plastic materials and articles, reaction and degradation
products may be formed. If such products migrate into food this has to be considered in the
safety evaluations. In addition, also impurities of intentionally substances including
oligomeric fractions of the substance under evaluation are considered in the risk assessment
as non-intentionally added substances (NIAS); however no authorisation is needed for NIAS.
Nevertheless, NIAS should be included, if necessary, in the specifications and/or restrictions
of a substance. For this reason, the applicant should provide sufficient information on
potential NIAS to enable a toxicological assessment to be undertaken, in particular
information regarding genotoxicity.
In case of non-plastic FCM (e.g. paper and board, printing inks, adhesives, coatings, silicones,
rubber, metals and alloys) information on the appropriate use can be retrieved from the
following sources: inventory list of the ESCO WG (EFSA 2010-2011), Council of Europe’s
Resolutions or national evaluations, e.g. BfR’s recommendation on FCM.
As future challenges in the risk assessment of FCM the evaluations of endocrine disruptors, e.g. bisphenol A, and mixtures of substances, e.g. phthalates, have to be further addressed by EFSA.
3.3.2 EFSA Risk Assessment regime as support to control of non-
harmonised FCM
Detlef Wölfle, Federal Institute for Risk Assessment (BfR), Berlin, Germany
Inspectors advanced
The general requirements for non-harmonised FCM (e.g. paper and board, printing inks,
adhesives, coatings, silicones, rubber, metals and alloys) are laid down in the framework
Regulation (EC) No 1935/2004. As tools to assess the safety of substances from those
materials more specifically the following information can be used:
data on the substance according to EFSA´s Note for Guidance
(http://www.efsa.europa.eu/en/scdocs/doc/21r.pdf),
safety evaluations mentioned in the inventory lists of the ESCO WG
(http://www.efsa.europa.eu/en/supporting/pub/139e.htm),
Council of Europe´s Resolutions or
national evaluations, e.g. BfR´s recommendation on FCM.
EFSA has published the “Note for Guidance” to inform petitioners which data are needed for
the safety evaluation of substances intended to be used in FCM. This procedure can also be
used e.g. by national authorities to evaluate non-toxicological and toxicological data submitted
by industry or from other sources. According to this document toxicity data requirements are
dependent on the degree of migration of the substance into food: up to 0.05 mg/kg food only
genotoxicity data (mutagenicity and chromosome aberration) are needed; at higher migration
subchronic studies (up to 5 mg/kg food) and chronic toxicity/carcinogenicity, reproduction/
developmental and toxicokinetic studies are requested (>5mg/kg food) are requested. Based
on results from the repeated dose studies a no observable adverse effect level (NOAEL) can be
derived. To establish a tolerable daily intake (TDI) an adequate uncertainty factor for
interspecies extrapolation and interindividual variability has to be applied to the lowest
NOAEL from the long-term studies. In case of low TDI values (< 1 mg/kg body weight per day)
specific migration levels (SML) are calculated using a default assumption for exposure (1 kg
food consumed daily by a person weighing 60 kg body weight). Restrictions for migrations
can also be set based on limited data submitted by the applicant (e.g. 0.05 mg/kg food based
on negative genotoxicity findings only).
Safety evaluations of FCM substances performed by EU Member States (MS) were listed and
classified by EFSA´s ESCO WG according to the date when the first version of the SCF
guidelines was published (1991). As an example for evaluations of substances from non-
plastic materials (e.g., paper and board) the recommendations issued by the German Federal
Institute for Risk Assessment (BfR) can be mentioned. The BfR recommendations are based
on evaluations performed or updated according to the EFSA´s Note for Guidance and
published on the internet (http://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsp).
The results of international (e.g. EFSA, JECFA/WHO) and national (MS) substance evaluations
in the area of non-plastic FCM are also reflected in the Council of Europe Resolutions.
Representatives from the MS, from the EU Commission and EFSA are working in the
Committee of Experts on packaging materials for food and pharmaceutical products (P-SC-
EMB). A current activity is e.g. the Resolution on metals and alloys which identifies specific
limits for the release of metal ions (SRL).
Substances for which no specific toxicological data are available can be (partly) evaluated by
new methods, e.g. “read across” from toxicological evaluated substances with similar chemical
structures and common metabolism. Additionally, for substances, which have not to be
authorized, the concept of “Threshold of Toxicological Concern” (TTC), can be applied if the
chemical structure is known and assuming that the human exposure is presumably very low
(e.g., for non-intentionally added substances, NIAS). The exposure thresholds in this concept
are based on a decision tree approach according to the Cramer classification depending on the
presence or absence of a structural alert for genotoxicity and general toxicity: Exposure below
such levels would indicate a low probability of health risk for the consumer
(http://www.efsa.europa.eu/en/efsajournal/doc/2750.pdf).
3.3.3 The EU RASFF system
Kim Vandrup Sigsgaard, Danish Veterinary and Food Administration, Denmark
Administrators, basic
The lecture was a review of the Rapid Alert System for Food and Feed (RASFF) starting with a
review of the legislation in place: Reg. 178/2002 and Reg. 16/2011. Article 50 in 178/2002
states that a system for the exchange of information between competent authorities in EU
member states should be in place and it should be a fully formalized system for handling of
Food and Feed. The reg. 16/2011 states the requirements for the RASFF system and how to
handle in the daily work.
The benefits of the system are that it is actually being used. It is well established. It is quick
and functional. It has a clear defined scope. And it is valid and credible.
The preliminary annual report 2011 was reviewed. 3812 original notifications has been send.
Of these 1952 market notifications, 635 alert, 1317 information, 1860 border rejections ,
20 news notifications (with 120 follow-ups), 5345 follow-up notifications and 67
notifications were rejected.
Then a review of the structure of the RASFF and the work with the system was given. The
procedures of notifying and the definition of the different notification types were added. The
types are Alert notifications Information notifications, News notifications and Border
Rejections. Member State shall immediately notify when the test result indicates that a
Community food safety criterion or national criterion is exceeded. Exceeding of limits:
Agricultural/environmental/industrial contaminates, radioactive contamination, residues of
veterinary medicinal products, additives, and pesticides, undesirable substance in feed,
materials in contact with food, irradiated food. The Member States shall immediately notify
the Commission, when they are restricting the placing on the market or forcing the
withdrawal from the market or the recall of food or feed in order to protect human health and
requiring rapid action.
The confidentiality of the RASFF was discussed. Members of the network shall take steps to
ensure that members of their staff are required not to disclose information obtained for the
purposes of this Section which by its nature is covered by professional secrecy in duly
justified cases. Civil servants are restricted to keep information confidential and RASFF is a
system for the exchange of information between competent authorities in EU member states.
This means that we must assume that all we notify are kept confidential in the system. This is
very important information for our companies as they may have to reveal company secrets to
the system. It is possible to ask for extra confidentiality on the notification for information
like: costumers, recipes, etc.
The weakness of the RASFF could be that Notification need to be fast and sometimes it is hard
to get the facts in time. There are over 9000 notifications/year so it is difficult to overlook.
The RASFF is very popular but the system relays on that every MS notifies hazards.
The lecture was finished with a case. An information notification of food contact material was
discussed. Migration and cadmium and of lead from glass cup from China.
3.4 Good manufacturing practise and quality assurance
3.4.1 Italian guidance on GMP - cooperation between authorities and
industry for a common guidance
Maria Rosaria, Istituto Superiore di Sanità, Italy
Inspectors basic and advanced
Regulation EC 2023/2006 on Good Manufacturing Practice is a “horizontal” tool that covers
the whole sector of FCM and in the meantime a “vertical” tool that links all the “rings” of the
supply chain, from the raw materials to the finished products. General and fundamental
principles are given and except for specific rules for printing inks and recycled plastics no
specific indications are provided on the way to ensure compliance in practice. An approach to
this issue is illustrated in the “Guidelines on the application of Reg.2023/2006/EC to the chain
of materials and articles for food contact” a tool proposed by Italian CAST Project. The
Guidelines were developed under the Scientific Responsibility of the National Institute for
Health ( ISS, Italy) in cooperation between the stakeholders involved in food safety , that
are Public Bodies ,Supply Chains of Food Packaging Producers and Food Industry . It was an
experiment for cooperation between public and private parts, in the light of the integrated
approach to food safety in line with the White Paper on Food Safety, EU 2000. The Guidelines
are structured in a first section for general application and in a second section for specific
application; in particular the chains of aluminium, paper and boards, flexible packaging,
plastics, coated and not-coated metals and alloys, wood, cork, glass. In the first section there
is a commented description of what is required to comply with the GMP Regulation from the
general point of view and it is generally applicable. The business operators have to set up and
maintain at least a Quality Assurance System and a Quality Control System both seeing to the
drawing up of the relative documentation; the archive of the operative and recorded
documents is required, too. The Guideline suggests as “minimum requirement” list, a series
of points to be considered under procedures/instructions that should be always
implemented.
Therefore, the Business should have in place, but in the meantime the Public Inspectors
should expect to find, at least the “minimum requirement”- list of procedures implemented.
The Guideline does not give the content of these procedures, but the points to be covered by
the procedures. The technical content remains responsibility of the Business, it is subject to
verification and it has to be demonstrated that it is fit for purpose. The documentation on
Traceability, the Declaration of Compliance and its supporting documentation are relevant to
demonstrate conformity to GMP Regulation, too. In the Second section there are the
implementations that the above mentioned packaging chains should have in place as
“minimum requirements” to guarantee conformity to the requisites of the Regulation (EC)
2023/2006. The description is divided into separate and independent chapters for each chain,
in order to reflect and respect the peculiarities of the same. The structure of the chapters is
the same: a) the production process, both in graphic diagram and in a summary description;
b) the applicable legislation; c) the fulfilments, specific for the chain and the position in the
chain, deriving from the application of the GMP Regulation; d) a technical glossary. Where
necessary a section of frequent questions and answers has been included along with a useful
list of bibliographic references.
To perform GMP Audit with the help of the CAST Guidelines it is suggested to
know/study the process of the business ( within the considered chain)
identify the critical steps/ control points through the help of the CAST Guidelines and
through the discussion with the Business
examine the operative documents
evaluate the examined documents
prepare the audit report and the evaluation
Example of Sheets, still under refinement in CAST 2 Project, are made available to compare
the GMP requirements with the documentation available in the business
The full text of the CAST GMP Guidelines is freely downloadable at the web address:
http://www.iss.it/binary/publ/cont/11_37_web.pdf
3.4.2 QA documentation in practice
Maria Rosaria Milana, Istituto Superiore di Sanità, Italy
Administrators, basic
Regulation EC 2023/2006 on Good Manufacturing Practice is a “horizontal” tool that
covers the whole sector of FCM and in the meantime a “vertical” tool that links all the
“rings” of the supply chain, from the raw materials to the finished products. General
and fundamental principles are given and except for specific rules for printing inks
and recycled plastics no specific indications are provided on the way to ensure
compliance in practice. An approach to this issue is illustrated in the “Guidelines on
the application of Reg.2023/2006/EC to the chain of materials and articles for food
contact” a tool proposed by Italian CAST Project. The Guidelines were developed
under the Scientific Responsibility of the National Institute for Health ( ISS, Italy) in
cooperation between the stakeholders involved in food safety , that are Public
Bodies ,Supply Chains of Food Packaging Producers and Food Industry . It was an
experiment for cooperation between public and private parts, in the light of the
integrated approach to food safety in line with the White Paper on Food Safety, EU
2000. The Guidelines are structured in a first section for general application and in a
second section for specific applications; in particular the chains of aluminium, paper
and boards, flexible packaging, plastics, coated and not-coated metals and alloys,
wood, cork, glass. In the first section there is a commented description of what is
required to comply with the GMP Regulation from the general point of view and it is
generally applicable. The business operators have to set up and maintain at least a
Quality Assurance System and a Quality Control System both seeing to the drawing up
of the relative documentation; the archive of the operative and recorded documents is
required, too.
The Guideline suggests as “minimum requirement” list, a series of points to be
considered under procedures/instructions that should be always implemented.
Therefore, the Business should have in place, but in the meantime the Public
Inspectors should expect to find, at least the “minimum requirement”- list of
procedures implemented. The Guideline does not give the content of these
procedures, but the points to be covered by the procedures. The technical content
remains responsibility of the Business, it is subject to verification and it has to be
demonstrated that it is fit for purpose. The documentation on Traceability, the
Declaration of Compliance and its supporting documentation are relevant to
demonstrate conformity to GMP Regulation, too. In the Second section there are the
implementations that the above mentioned packaging chains should have in place as
“minimum requirements” to guarantee conformity to the requisites of the Regulation
(EC) 2023/2006. The description is divided into separate and independent chapters
for each chain, in order to reflect and respect the peculiarities of the same. The
structure of the chapters is the same: a) the production process, both in graphic
diagram and in a summary description; b) the applicable legislation; c) the
fulfilments, specific for the chain and the position in the chain, deriving from the
application of the GMP Regulation; d) a technical glossary. Where necessary a section
of frequent questions and answers has been included along with a useful list of
bibliographic references.
The full text of the CAST GMP Guidelines is freely downloadable at the web address:
http://www.iss.it/binary/publ/cont/11_37_web.pdf
3.5 Migration testing and laboratory support
3.5.1 Can your Reference laboratory be of any help to administrators?
Viviana Golja National Reference laboratory, Slovenia and Fátima Poças, National Reference
laboratory, Portugal.
Administrators, basic
According to article 33 of REGULATION (EC) No 882/2004 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 29 April 2004 on official controls performed to verify compliance
with feed and food law, animal health and animal welfare rules, member states have
designated national reference laboratories (NRLs) for food contact materials (FCM). These
laboratories are working together with European reference laboratory (EURL) in the network.
Cooperation with (NRLs) can be beneficial to member states competent authorities (CA).
. NRLs are well experienced in testing of food contact materials and improve their
knowledge in collaboration with the EURL and other NRLs. At regular meetings of the
network, exchange of information is taking place not only about testing of food contact
materials, but also about interpretation of rules for testing according to the legislation.
Therefore, NRLs play an important role in assuring high quality and uniformity of analytical
results in the field of food contact materials. NRLs have access to collection of standard
substances, take part in training actions, proficiency testing and interlaboratory comparisons
organised by the European reference laboratory. Together with the EURL, the network
produces different guidance documents (e.g. Guidelines on testing conditions for articles in
contact with foodstuffs). National reference laboratories tasks in their member states include
coordinating activities of other official control national laboratories dealing with food contact
materials. They may organise (where appropriate) comparative tests for official national
laboratories and disseminate information about food contact materials that EURL supplies.
National reference laboratory can assist national competent authorities with technical issues
on food contact materials. They can advise food inspectors on collecting samples for
laboratory testing at the market and in the production chain, as well as on procedures for
handling and preserving the samples. They can also assist member states competent
authorities on assessing declarations of compliance and especially supporting documentation
about migration testing, modelling etc, discuss different issues and results of campaigns.
National reference laboratories can be of great help to administrators.
List of National reference laboratories (with contact persons and emails) can be found on web
site:
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m/european-network/FCM%20EURL
%20Contacts%20NRLs%20Summary%202012_July%20updated-1.pdf
Information about European reference laboratory can be found on the web site :
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m
(Or just Google EURL FCM)
3.5.2 Sampling and migration testing of plastic according to current EU
regulation
Viviana Golja National Referene laboratory, Slovenia and Fátima Poças, National Reference
laboratory, Portugal.
Inspectors basic
When a plastic is in contact with foodstuffs, mass transfer of different substances into food
may occur. Such mass transfer is called migration. Migrated substances should not endanger
human health, bring about an unacceptable change in the composition of the food, or bring
about deterioration in the organoleptic characteristics of the food. In order to determine the
amount of migrated substances, sampling followed by analysis of food already in contact with
plastics, or migration testing of plastics not yet in contact with food is performed.
Sampling can be performed over samples already on the market or over packaging samples
not yet released into the market (inside industry premises). Appropriate sampling is essential
for obtaining correct results. To obtain a representative sample, attention should be paid to
proper selection of sampling points, to procedures for samples collection handling and
preservation and to the necessary amount of sample.
Determination of substances migrated into foodstuffs may be a very complex task. It is also
time consuming, because concentration should be determined at the end of the shelf life of the
foodstuff. For that reason, compliance testing of plastic materials is mostly performed on
materials not yet in contact with foodstuffs using food simulants at contacting conditions that
are thought to simulate the migration up to the end of shelf life. Food simulants A (10 %
ethanol), B (3 % acetic acid) and C (20 % ethanol) are assigned for foods that have a
hydrophilic character and are able to extract hydrophilic substances, according to the product
pH and alcohol content. Food simulants D1 (50 % ethanol) and D2 (vegetable oil) are assigned
for foods that have a lipophilic character and are able to extract lipophilic substances. Food
simulant D1 is used for alcoholic foods with an alcohol content of above 20 % and for oil in
water emulsions. Food simulant D2 is used for foods which contain free fats at the surface.
Food simulant E (poly (2,6-dihenyl-p-phenylene oxide) or Tenax® is assigned for testing
specific migration into dry foods. The material to be tested is firstly exposed to simulant(s)
for a certain time, temperature and surface to volume ratio in order to mimic migration into
foodstuffs. After exposure overall or/and specific migration is determined. Overall migration
is means the amount of non-volatile substances released from a material or article into food
simulants.. Specific migration is the amount of a given substance released from a material or
article into food or food simulants. It is determined by use of appropriate analytical technique
(e.g. gas chromatography or liquid chromatography with appropriate detectors, ICP MS etc.).
For determination of specific migration worst case testing conditions should be selected from
the tables listed in Regulation 10/2011/EC. For determination of overall migration there are
nine standardised test conditions listed in Regulation 10/2011/EC. Compliance assessment
can be performed by more severe screening approaches in replacement of verification
procedures described above. For example, overall migration potential can be calculated based
on complete extraction or substitute food simulants known to overestimate overall migration
compared to the regulated food simulants. Specific migration potential can be estimated
based on the residual content of the substance in the material and assuming complete
migration. Migration modelling can also be used substituting migration experiments using
validated mathematical models. If a material or article fails to comply with the migration
limits in the screening approach a conclusion of non-compliance has to be confirmed by
verification procedure.
Guidance documents on testing conditions can be found on web sites:
http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/8793/1/guidelines
%20test%20conditions_final_ed2009.pdf
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m/publications/FCM%20EURL
%20LBNA24815ENN_Guidelines%20kitchenware%20PAAs-FA_2011_06_online.pdf
3.5.3 Migration testing according to current EU regulation
Gitte Alsing Pedersen, DTU National Food Institute, Denmark
Inspectors advanced
Migration testing is part of the supporting documentation. To ensure that the documentation
rely on valid data the following 4 items must be respected: Testing of representative
material(s), selecting of appropriate test conditions, use of an appropriate and well
performance analytical methods and proper calculation and reporting of the final test result.
In case of plastic food contact materials the regulation specifies the technical rules on how to
perform the testing. From January 1, 2013 until January 1, 2016 industry documentation can
be based on compliance testing performed according to EU directive 82/711 or (more
appropriate for new tests) to Regulation (EU) 10/2011. For enforcement compliance testing
of plastic FCM, Regulation EU 10/2011 apply from January 1, 2013.
A. The migration of a given sample shall comply with qualitative restrictions as: 1)
Confirm that starting substances are authorised and used as specified (monomers,
additives and/or production aids) in Annex 1 of EU 10/2011, 2) identify if any NIAS
and 3) in case a functional barrier is used then evaluate the use of specific non-
autorised substances behind the barrier.
B. The migration shall comply with the quantitative restrictions as:
Specific migration limits, SML: 0.01 – 60 mg/kg
Residual content in final product: QM (mg/kg) og QMA = (0.01 mg/6dm2)
Restrictions on trace elements (Ba, Co, Cu, Fe, Li, Mn and Zn)
Specification on primary aromatic amines, PAA: LOD = 0.01 mg/kg (sum of PAA’s)
C. Overall migration limits: 10 mg/dm2, however always 60 mg/kg for infants and young
children
Rules for compliance testing according to Regulation EU 10/2011 is separated into two parts:
1. Test conditions for specific migration and 2. Test conditions for overall migration. This is
given in Annex V of the regulation.
When doing specific migration testing of a FCM already in contact with food special
attention shall be on potential contamination of the food from other sources that the FCM. In
particular this should be taken into account for phthalates.
Documentation of compliance for specific migration of a FCM not yet in contact with food can
be done by a) screening tests or by b) verification test using food simulants or food. Screening
testing is performed either by calculations (assuming that all of a given substance migrate),
diffusion modelling, extraction testing or by measuring overall migration of non-volatiles into
food simulants. Screening testing takes less resources and is cheaper that verification testing.
However, if the FCM is not in compliance based on the screening approach, test for
verification of compliance need to be done to confirm the conclusion of non-compliance.
Verification of compliance into food or food simulants shall be performed using test conditions
of time and temperature representing the worst foreseeable conditions of use. In case of
contact times above 30 days at room temperature and below testing shall be performed at
accelerated test conditions using elevated test temperature up to 60 C for max 10 days. A ⁰spreadsheet for calculation of which exposure time and temperature to be used in the
accelerated compliance testing are designed by the European Reference Laboratory
(EURL)for food contact materials.
According to regulation (EU) 10/2011 the food simulants are as follows: 10 % ethanol, 3 %
acetic acid, 20 % ethanol, 50% ethanol, vegetable oil and modified polyphenylene oxide
(MPPO)/Tenax. In comparison to directive EU 82/711, water is no longer a food simulant, 20
% ethanol is a new food simulant assigned for alcoholic food and for hydrophilic food with
lipofilic ingrediens, food simulant D2 (vegetable oil) is no longer restricted to olive oil and
food simulant E (MPPO/Tenax) is assigned for testing into dry food. In support of selecting
the appropriate test conditions, a guideline on test conditions EUR 23814, EN 2009
(Guidelines on testing conditions for articles in contact with food) is given by the EU-
reference laboratory (EURL) at the EURL web site
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m/publications.
The migration testing shall only include parts of the FCM that are intended for contact with
food. Surface/volume ratio of contact shall be selected according to the most severe as in real
use e.g. small containers have a higher surface/volume ratio than containers of a larger size.
For repeated use articles, testing is performed 3 times on the same sample with new portions
of food simulant. The portion of food simulant used in the 3th test shall be in compliance.
However, for substances with SML=non-detectable as for PAA or for non-authorised
substances behind a functional barrier the migration of 1th shall comply.
In every determination of migration, an appropriate and well performing method of analysis
shall be used according to Regulation EU 882/2004. Guidance and performance criteria for
analytical methods are given by the EURL guideline EUR 24105, 2009 (Guidelines for
performance criteria and validation procedures of analytical methods used in control of food
contact materials) on the EURL web site. Standard methods for overall and specific migration
testing are published as European standards from CEN.
A specific migration results is expressed in mg/kg. The calculation is based on either 1: Real
surface-volume ratio in use: M (mg/kg) = (m (mg) x Surface area in use)/(Surface area in test
x V (kg)) or 2: For containers < 500 ml or > 10 l, or FCM where it is not possible to estimate
the surface-volume ratio the migration is calculated as: M (mg/kg) =M (mg/dm2) * 6 dm2/kg.
Results of specific migration into food simulants prevail over test results obtained by
screening and test results of specific migration into food prevail over test results into food
simulants.
Overall migration testing is performed according to 9 standard testing conditions given in
EU 10/2011. Conclusion of non-compliance for overall migration shall be based on these
verifications tests.
For plastic multi-layer materials with a functional barrier the compliance testing shall ensure
that: The substances behind the functional barrier do not belong to substances classified as
mutagenic, carcinogenic, toxic to reproduction (CRM) or to a substances in nanoform.
Migration must not exceed 0.01 mg/kg. Guidance for evaluation of a functional barrier in
multi-layer materials is given by the EURL guideline: EUR 25112 EN (Guidance document on
fat reduction factor, functional barrier concept, phthalates and primary aromatic amines) on
the EURL web site.
3.5.4 Supporting documentation to DoC
Viviana Golja National Referene laboratory, Slovenia and Fátima Poças, National Reference
laboratory, Portugal.
Inspectors advanced
Article 16(1) of Regulation (EC) No 1935/2004 indicates that materials and articles covered
by specific measures should be accompanied by a written declaration compliance (DOC).
Coatings, printing inks and adhesives are not yet subject to the DOC but adequate information
should be provided to the manufacturer of the final plastic article to ensure compliance.
At each stage of manufacture, supporting documentation (DOC support) should be available
for the enforcement authority on request. The requirements (content) of the support DOC
depends on whether applies to a substance, products from intermediate stages or finalised
articles. In the first case, specifications on composition, purity and toxicological information
(as support for risk assessment) are required. For finalised materials or articles complete
information on migration testing and other analysis (when applicable), and scientific evidence
or reasoning on the safety demonstrating compliance are required.
Information on migration comprises the migration results and complete information of the
conditions of testing. Migration may be based on experiments (verification tests) or based on
other approaches such, extraction tests and calculations (modelling). These are also
admissible if they are as severe as the migration testing (e.g. replacing specific migration by
overall migration, for non-volatile substances). They are called screening tests.
Results and reasonings described in the DoC and supporting documentations are valid while
formulations and processing conditions remain constant as part of a quality assurance system.
These documents need to be updated when substantial changes in the production bring about
changes in the migration or when new scientific data are available. The documentation should
easily identify the material it corresponds to and should be issued by the business operator.
The supporting documentation includes, most of the times, migration reports. These should
include the conditions of test, namely
- the food simulant(s) used,
- the time/temperature conditions and
- the ratio of materials surface to food contact volume (S/V); there are cases where the real
S/V is applied, others where a standardised S/V= 6dm2/kg is applied;
Migration results are presented in mg/kg food for specific migration and in mg/dm2 for
overall migration. Results for caps, gaskets and stoppers are to be presented in mg/dm 2 with
total contact surface (cap contact surface plus container surface whatever the material of the
container) or in mg/article if the intended use of the closure is unknown.
Before comparing specific or overall migration results with the legal limits correction factors
should be applied. A fat reduction factor (FRF) is applied to testing migration of lipophilic
substances intended to be in contact with foods that have a fat content of 20% or higher. The
experimental result should be divided by the FRF. This is to account for the fact that
consumers typically do not eat 1 kg of fat per day. Furthermore, for certain types of food and
when using simulant D2, the experimental result should be divided by a reduction factor
(DRF) before comparing with the legal limit. This factor is to account for the fact that simulant
D2 tends to overestimate migration of some substances as compared to real foods.
For further details the national reference laboratory can be contacted.
3.5.5 Role of private consultants and laboratories
Mette Damgaard, Consultant MSc. Eurofins Product Testing, Denmark.
Inspectors, advanced
The food contact legislation is extensive and complex – and it can be difficult for
manufacturers and importers to know which requirements their products must comply with.
Which information must be delivered by the various part of the supply chain – and how does
each company ensure that they have all relevant information for a given product for food
contact?
Which tests should be conducted – and what should a Declaration of Compliance contain? The
range of questions is vast and differs from one part of the supply chain to another.
The type of questions asked by the industry typically reflects the size of the company. Large
companies often have their own Regulatory Affairs Department who takes care of the
legislative requirements – while small and medium sized enterprises find it hard to allocate
resources to keep up to date with the current legislation on food contact materials.
Inspectors typically do not have sufficient time and resources to help the industry with their
questions on specific products. Thus they can advise the industry to take contact to a private
consultant for assistance.
Private consultants and laboratories can help all parts of the supply chain to comply with the
legal requirements for their particular product. Some companies need help to get information
from raw material suppliers in order to set up a test program and have their product tested –
others need help to make a declaration of compliance – and yet others need help to evaluate
the information they have received from their suppliers. The private consultant is also capable
of making tailor made trainings to suit the need of the specific company so they can ask the
right questions to their suppliers and answer to customer demands.
An increasing number of manufacturers do not wish to pass on detailed information on their
material through the supply chain. They will however give it to a consultant or testing
institute for compliance testing if a confidentiality agreement is signed. In such cases the
private consultant can be the key to ensuring compliance.
The legislation on plastic for food contact materials is very clear as described in Regulation
10/2011/EC as amended – but when it comes to materials that are not regulated by material
specific legislation it is difficult for the manufacturers and importers to know which questions
to ask and which information is needed to ensure compliance with Regulation 1935/2004/EC
and Regulation 2023/2006/EC.
How is compliance with Regulation 1935/2004/EC ensured for materials like silicone, rubber,
textiles, wood, coatings etc.
The private consultant can help the industry by advising on which recommendations or
national legislation the products should comply with. The consultant can furthermore help to
gather information on the raw materials, set up test programs, conduct tests, and ensure that
the correct information is delivered in the supply chain.
To sum up – the private consultant works with all kinds of companies and all types of
materials and can help the industry in a tailor made solution to ensure compliance for the
products in question.
3.6 Official control of Food Contact Materials
3.6.1 How to develop and prioritise in drafting the yearly control plan
Milada Syčová, Public Health Authority, Slovak republic
Caroline de Prater, Food Authority of Belgium (equivalent speech, with Belgium in focus)
Administrators basic, Inspectors basic and Inspectors advanced
The yearly plan is part of the MANCP and requirements are set up in Regulation (EC) No.
882/2004. General aims of the yearly plan are :
• to ensure compliance with certain rules or to contain certain risk
• has to contain minimum level of mandatory controls in specific areas
Perfect yearly plan which could provide 100% safety of FCM means to control all scope of
materials and articles, all FCM producers in EU, all importers to EU, all FCM users - food
industry and also control declaration of compliance, supporting documentation and good
manufacturing practice.
The yearly plan has to be flexible and it´s necessary to answer following questions: what to
control? (articles/materials), where to control? what to control? (Substances, DoC, GMP...) and
how to control?
What are necessary to taken into account when the yearly control plan is prepared? First of all
requirements of EU legislation, specific limits for some substances, DoC, supporting
documentations, labelling, traceability and GMP; requirements of national legislation (specific
limits for some substances); RASFF information; information from food inspection, industry
and trade; FVO recommendations; research studies; information from EURL and DG SANCO –
FCM meetings; inputs from consumers; media information; results from previous inspection;
number of inspectors and their knowledge’s; number of staff in NRL and at last but not at least
laboratory capacity in NRL.
For performing the official control following tools can be used: audit, inspection, monitoring,
sampling, analysis, documentary check which are defined in Art. 2 Regulation (EC) 882/2004.
How to control? Two types of control can be performed: documentary check which means
control of declaration of compliance and supporting documentation and physical check which
means analysis of individual or group of substances for which SMLs are set up.
Where to control? Priorities for controls are following: border, FCM producers, FCM
importers, FCM users – food industry, wholesale, retail, distribution chain, internet shops and
other kind of selling e.g. doorstep selling. What to control? Group of materials and articles in
1935/2004 according EU legislation only: ceramics, plastics, regenerated cellulose, active and
intelligent, recycled plastics for other – national requirements applied.
The control plan in Slovakia: proposal of the yearly plan is prepared by NRL for food contact
materials on the regional level in cooperation with central level – Public Health Authority,
proposal is presented on annual meeting regarding official controls to which inspectors from
the 36 regional offices are invited all inspectors can comment the proposal and after adoption
is sent to all health offices.
The yearly control plan in Slovak republic is divided as follows: official controls with
sampling, official controls without sampling (DoC, supporting, documentation, labelling,
GMP), special campaign (ceramics sell in toys shops, PS catering packaging).
Useful links: Regulation (EC) No. 882/2004
Web site: www.ruvzpp.sk ; www.uvzsr.sk
Email contact: [email protected]
3.6.2 Planning of control- some tools to base it on!
Bente Fabech, Danish Veterinary and Food Administration, Denmark.
Administrators, advanced
When planning the official control on food contact materials, there are several questions to
consider, like: Which goals should be achieved? In which link in the supply chain should the
control take place? The expertise to be used in planning? Strategy and priorities on materials?
- And whether the control includes analysis and/or documentation etc.?
The overall goal for the official control is that FCM shall comply with the legal requirements,
compliance shall be documented, instructions of use shall be followed, - by all users and
knowledge on FCM, including legislation shall be updated in industry and trade.
The area of FCM is including starting substances, intermediates, final food contact materials
and users of food contact materials in the food production and at the retailers. Compliance can
be controlled in all these links. There are benefits/disadvantages that need to be considered,
when deciding on where the control takes place. At FCM producers and importers the correct
composition of the materials should be available together with instruction of use etc.
Furthermore, GMP in production facilities can be checked. At the food producers and retailers
with/without production the actual use can be controlled and sampling is faster.
Control principles in Denmark (EU Member State) are that the control sites should be as close
to the production/importer as possible (at FCM producers or importers). The public
inspection includes control of documents, physical check and analytical and organoleptic
control. In addition to this, industry/trade are obliged to have in-house control,
documentation and analytical control
National control plans for FCM is elaborated after identification of possible problems based on
knowledge: research, toxicology and chemistry, literature, exposure and use of materials,
Rapid Alerts, information from food inspection/administration, industry and trade, EU
colleagues, including FVO inspections and politics/media. The decision on which types of FCM
materials to priorities, also the following questions are addressed: Potential uses, food contact
(type of food, contact time + temperature etc.), complexity (many/few chemicals),
specific/general legislation and risk assessments as basis.
For 2005-08, the Danish Food Administration formulated a strategy on FCM with priorities on
materials. Some examples are given here:
Materials Control/research
priority
Comment
Surface coatings 1 Used much, only general requirements
Printing inks 2 Used much, only general requirements
Silicones 3 Used in many household FCM, only general
requirements
Paper and board, recycled 4 Unknown raw materials
Adhesives 5 Used much, only general requirements
Plastics 6 Used very much, but spec. regulation
Ceramics, glass, porcelain * Limited use
RASFF messages is also taken into account, and there included, e.g. metals, formaldehyde,
primary aromatic amines and phthalates, but only information on chemicals, which other
countries has controlled, not on all potential problems! This raises the question, if the balance
in the planning gives priority to the Rapid Alerts, then all member states would analysis of the
same chemicals as others, and it this a good idea?
A few examples of the public control in Denmark were mentioned:
a. FCM and control at food producers, including retailers (2009: 1500 inspections).
Focus: Documentation, traceability and instructions of use, and the conclusions were that we
noted lack of knowledge (traceability, DoC, FCM) and need for improvement of DoC
b. Declaration of compliance and control.
Test results from analytical control are often part of the declaration of compliance. The
evaluation of such results needs to include evaluation of the test conditions. The example
illustrate problems in the analytical control was found as a company had a good in in-house
documentation, but the results of analysis differed due to the choice of test parameters. For
plastics utensils there are many test conditions, which have to be correctly chosen to come to
the correct results. A comparison of the results below lists the different parameters and
differences in analysis made by four different laboratories.
Danish NRL Consultant no. 1 Consultant no. 2 Consultant no. 3
Test/
standards
EN 13130-1
(specific migration)
EU 82/711, 85/572,
2002/72, incl.
amendments
EN 1186-1 (testing)
EN 13130
EN 1186
EU 82/711, 85/572,
2002/72, including
amendments
EN 1186
Number of
samples tested
3 pieces 1 piece 2 pieces 3 pieces
Simulant 3% acetic acid 3% acetic acid 3% acetic acid 3% acetic acid
Temperature 100ºC 100ºC 100ºC 100ºC
Time 3 x 4 hours 3 x 2 hours 1 3 x 2 hours and
3 x 4 hours
3 x 2 hours and
3 x 4 hours
Real contact
area
0,25 dm2 Contact area is not
given in the result
0,66 dm2 0,7 dm2
Contact volume
of simulant
100 mL 900 mL 210 mL No information given
Calculation
(Area/kg
relationship
used for
calculation)
6 dm2/kg
(this figure is used if
the amount of food
in contact is not
known)
6 dm2/kg Contact: 1 ”item”,
e.g.. a) one piece of
1,3 dm2
b) one sample of 0,66
dm2 in contact with
500 g food
corresponding to
a) 2,6dm2/kg
b) 1,3 dm2/kg
6 dm2/kg
Since 2005, the Danish authorities have focused on documentation as a corner stone
in the public control. This includes cooperation with industry and trade, updating of
food inspectors, European corporation (like e.g. the Nordic network) and more
control. However, a clear need for joint EU activities on this area is needed.
1
In conclusion, planning of the control of food contact materials is a task, where many
parameters have to be considered.
3.6.3 Inspection on FCM premises
Pirkko Kostamo, Finnish Food Safety Authority Evira, Finland
Inspectors, advanced
Food contact materials (FCM) are always present in the food chain! All the food is in contact
with many kinds of FCMs during the production chain, starting from primary production and
slaughterhouses ending in food producing premises, catering and home kitchens. That is why
they play an important role in food chain. It is a question about preventing chemical
contamination.
In the legislation there are over ten paragraphs which give obligations to national authorities
concerning the general control of FCMs and their production chain. The most remarkable one
is the so called frame work regulation (EU) No 1935/2004. Further on regulations (EU) No
882/2004 and (EU) No 178/2002 include basic obligations for control procedure and
measures. The so called GMP regulation (EU) 2023/2006 gives detailed responsibilities and
rules to the FCM operators for a documented quality management system.
In order to perform control measures a crucial point is to know all the inspection sites in the
country. A practical way is to create a register on the operators and operations. That is the key
element in unifying control procedures and equality of operators. There are different means
in building a register: using general trade and industry registers, searching operators from the
lists of professional organization or issuing national legislation including obligation on
registration.
The starting point for the control visits lies on multiannual national control plans (MANCP) as
a consequence of regulation (EU) No 882/2004. Each member state (MS) should include also
FCM inspections into their MANCP and determine the inspection frequency. It is good to
prioritize inspection objects risk based like in the food sector.
When starting to plan a control visit to a FCM establishment it is useful to ask for the GMP
quality management system in advance to be studied. Find and study also the internet pages
of the company in order to get familiar with the operation and special vocabulary. Then fix the
date in order to meet the responsible persons. It is useful to make an action plan for the
inspection to see what risk based and important in this particular operation is. Carry the
inspection out along the process starting from the end, if possible. This gives you a possibility
to take an example product for which to ask for supporting documents and traceability
information. The operator has to be able to prove the details and show you the relevant
documents.
The guidelines issued by either MSs, the EU or professional organizations are very much
recommended to use in performing inspections. The four Nordic countries have in
cooperation issued four guidelines on different topics which also include check lists. The EU
Commission will soon issue three guidelines concerning the plastics regulation (EU) No
10/2011. The control methods of the regulation (EU) No 882/2004 are also applicable to
FCMs: visual inspection, examination of written material, sampling and analysis, taking
enforcement measures in the case of non-compliance and drawing up records. A lot of useful
information is available on the internet pages of different operators (pls. see the annex).
In order to assess the functioning of the GMP system check specifically: the knowledge and
skills of the operator, the contents of the quality management system (quality assurance,
process flow charts, risk assessment, traceability). Also check that relevant analysis for the
quality assurance is performed (supporting documents) and declarations of compliance for
the next step operators are carefully compiled and adequate. If the situation is not satisfactory
measures should be taken.
Usefull links
Results of the official co-operation between authorities and operators in the Nordic region –
publications of NCM (Nordic Council of Ministers)
• Food contact materials – in-house documentation and traceability Nordic check lists to
industry and trade http://www.norden.org/en/publications/publikationer/2008-517
• Food contact materials - short version In-house documentation: Nordic check lists to
industry and trade http://www.norden.org/en/publications/publikationer/2008-709
• Paper and board in food contact materials 2008-515
http://www.norden.org/en/publications/publikationer/2008-515
• Food contact materials and articles: Printing Inks Check lists for compliance in industry
and trade and control by food inspection
http://www.norden.org/en/publications/publikationer/2012-521
Other useful links
• German BfR internetpages http://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsp?
filter=clear
• The USA FDA internetpages
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/
RegulatoryStatusFoodContactMaterial/default.htm
• EFSA: http://www.efsa.europa.eu/en/news.htm
• Resolutions of the European Council (CoE) recommendation concerning FCMs (c. 10
different materials)
www.coe.int/t/e/social_cohesion/soc-sp/public_health/food_contact/
• The list of European FCM professional organisations – through which to contact special
organisations and their GMPs eg. Paper and board, metals and alloys
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/euro_contact_points_en.pdf
• Industry guideline for the Compliance of Paper & Board Materials and Articles for Food
Contact: Issue 2
http://www.cepi.org/topics/foodcontact/publications/Industryguidelineissue2
• EuPIA documents related to the manufacture and supply of food packaging inks
http://www.eupia.org/uploads/tx_edm/2011-11-
14_EuPIA_Guideline_for_Food_Packaging_Inks_-_November_2011__corr_July_2012.pdf
3.6.4 Registration and practical inspection of FCM premises
Jan Petersen/Carina Mørkhøj, Danish Veterinary and Food Administration, Denmark
Administrators, basic
Documentation of compliance, traceability and GMP – inspections in practice
A focus on use of FCM including information of correct use of especially plastic materials at
the food producers, when performing audits at the food producer, showed in general poor
documentation and lack of information about limitations in use. Often the glass and fork-
symbol was considered a “food approval”.
Registration of FCM premises is essential to make control inspections of theses. In Denmark,
there is a requirement for all importers and producers of food contact materials (FCM) to be
registered. The authority, Danish Veterinary and Food administration (DVFA) inspect all FCM
companies with a frequency depending on their activities, normally every year or every
second year. Registration of all FCM establishments was mandatory since 2008 due to the
GMP-regulation 2023/2006 and coming into force in 2008.
Audit at a FCM establishment is focused on activities (import, producer), sort of materials and
documentation. Hygiene, including physical and microbiological hazards, is not part of the
audit.
The most relevant legislation is: Article 3, 15, 16 and 17 in the Regulation for food contact
materials 1935/2004 and GMP-regulation 2023/2006. This legislation is relevant for all sort
of materials mentioned in annex 1 in 1935/2004. Specific legislation is relevant to plastic (the
plastic Regulation 10/2011), ceramics and some imported plastic materials.
FCM as specified in Regulation 1935/2004 includes packaging materials, containers and
process equipment used during process and all other equipment that makes contact to food.
Therefore a declaration of compliance (DoC) should be available for all equipment stating
suitability for food contact and specifying details about limitations of use. For plastic
materials, specific requirements are laid down in annex 4 in the plastic Regulation 10/2011,
including requirements for information about substances with specific migration and dual use
additives, and very important, the specifications on the use of the material.
Results of inspections in FCM establishments (and food producers) in Denmark shows:
Insufficient or lack of DoC for materials other than plastic and for plastic as well
Datasheets with technical information instead of DoC
Lack of understanding of requirements at supplier level in and outside EU
Incorrect use of FCM due to insufficient information on use of the FCM
On this background the DVFA see the following challenges in the future
Better knowledge of and compliance with the legislation in industry and trade
Education of and networking between inspectors in EU
In our opinion registration and inspection in every FCM establishment in EU can be a help to
insure better documentation and correct use of FCM in the future.
3.6.5 Guidance to control of critical points in the printing process and
documentation for use of printing inks
Bente Fabech/Mette Holm, Danish Veterinary and Food Administration, Denmark
Inspectors, advanced
Safe food contact materials (FCM) are a complicated area for printing inks, also due to the
critical control points in the printing process. It is therefore useful to have more precise check
lists on printing inks as guidance to industry and trade, both in the Nordic countries and in
EU2. The Nordic check list should contribute to the development of more uniform control and
requirements for in-house control of FCM, both for products produced in EU and for those in
third countries producing FCM for import into EU and be used as basic guidance for industry,
trade and for the food inspectors in the Nordic Countries in their work in controlling in-house
declaration of compliance of printing inks and printing processes.
2 This check list on printing inks is a supplement to the general check list for all types of FCM. Nordic report, TemaNord 2008:517 (long and short version, see http://www.norden.org/da/publikationer/publikationer/2008-517
The legal requirements in EU with relevance for FCM are found in different regulations and
directives: the Food Law, the Control regulation, the Hygiene regulation and regulation no.
1935/2004 and the GMP regulation no. 2023/2006 that covers all types of materials, and the
production of them. Printing inks used in FCM are regulated by these general requirements
and some uses are addressed more specifically, and as there is no specific legislation in the
area in EU yet, the responsibility of compliance could benefit from more guidance and risk
assessments.
With this work on printing inks, the Nordic Food Authorities have continued previous work
on elaboration of check lists with the minimum requirements for documentation, especially
the declaration of compliance needed to comply with the legal requirements for the in-house
documentation of industry and trade. The report has a short introduction to printing
processes and some of the critical points in these processes. Such knowledge is regarded as
useful in the control and quality assurance.
In-house documentation, including declarations of compliance with the legal requirements,
supporting documentation for the declaration and request of other types of information, are
based on the assumption, that each link in the chain ensures compliance. The links from
producers of chemicals for FCM to the users of the final materials in the food industry and
trade rely on each member of the supply chain taking responsibility for providing and
communicating information critical to ensuring compliance of the final, packaged foodstuffs
or the final material or article sold to the consumers. Furthermore, it is important for the food
safety aspects that food industry and also consumers follow the instruction of use on the
labels of the FCM sold directly to them.
The check lists for the control of compliance for printing inks set a specific frame with
minimum requirements to all relevant links in the chain from producers or importers of
chemicals and raw materials like additives to the users of the final FCM in the food industry
and trade, including intra-community trade in the EU and import from third countries.
The check lists are guidance with the aim to give a starting point for industry and trade when
developing their in-house documentation and declaration of compliance. It can be used in
present and future work on constructing in-house control documentation or work on
improvements of the documentation in order to ensure compliance with the requirements in
the legislation, especially the EU regulation no. 1935/2004.
3.6.6 Campaign on plasticiser migration from gaskets into oily food in
glass jars
Gregor McCombie, Kantoles Labor Zurich, Switzerland and Antje Hartling, CVUA, Stuttgard,
Germany
Administrators, basic, Inspectors, basic and Administrators, advanced
Oily food packaged in glass jars with twist-off metal lids is presented as a detailed example of
a complex food contact material and migration.
Metal vacuum closures consist of a metal lid sealed with a PVC gasket, which intends to seal
the glass tightly. The soft PVC contains about 30 % plasticizers in weight (e.g. epoxidised soy
bean oil, ESBO). In particular, low molecular weight plasticizers readily migrate into free
edible oil in the food. The plastic regulation 10/2011 [1] contains specific migration limits
(SML) for individual plasticizers, group migration limits (SML(T) 32 and 31)for the sum of
plasticizers and restrictions for some plasticizers in contact with fatty food stuffs. These
requirements must be respected at the end of the shelf life.
Further complicating the problem, it is necessary to recalculate the analytical results from
mg/kg food into in mg/dm2 with respect to the total internal surface (glass plus lids), because
in most cases the content of the food was below 500 g, for which art 17 10/2011 requires
recalculation.
In this session the students were taught an alternative, new approach to address food safety
issues in the area of FCM on a European scale. The lecture was about a pan-European
enforcement campaign, where 2 Laboratories in Switzerland and Germany, who had specific
analytical know-how, offered to analyse samples for any interested EU-Member state. The
results of the campaign were published in a peer reviewed journal:
“The results of a joint European enforcement campaign are described. The two governmental
food control laboratories in Stuttgart/Germany and Zürich/Switzerland analyzed the
migration of the plasticizers from the gaskets of lids into food in glass jars for 411 products
collected by the authorities of 21 European countries. Of these products, 308 contained free
edible oil in contact with the gasket and were considered relevant for further evaluation. In 74
of the relevant products (24 %), either non-authorized plasticizers had been used or the
migration exceeded the legal limits, in some cases for several parameters and by up to more
than a factor of 10. Most of the products were 1–4 years from the end of their shelf life. Taking
into account that migration proceeds throughout storage, sometimes even accelerates, limits
are likely to be exceeded for many more products by the end of the shelf life. Polyadipate
showed the lowest migration. Promising gaskets are either plasticized exclusively with a
polyadipate or with combinations of substances. Joint enforcement is cost-effective,
particularly when chemical analysis is demanding; accumulation of experience facilitates the
evaluation of results, and joint measures are promising to be more effective.” [2]
As the situation on the market was found to be inacceptable a follow-up campaign was
launched by the same laboratories and is scheduled to run to the end of 2013. In the current
campaign a new aspect was introduced. By means of checking the Documentation according
to the GMP regulation (2023/2006), it aims to check whether and how the chain of producers
of lids for glass jars ensure the safety of the final products - with respect to the migration of
plasticizers only. In the second campaign fewer countries are participating due to the added
complexity. For the same reason the number of samples was reduced to 3 for each
participating country. The new campaign builds on the success of the first one and keeps the
pressure on industry. Additionally, it is also a test on the enforceability of Regulation
2023/2006.
References
[1] Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and
articles intended to come into contact with food, last changed by Commission Regulation (EU)
No. 1183/2012 of November 2012 (ABl. L 338/11)
[2] Migration of plasticizers from the gaskets of lids into oily food in glass jars: a European
enforcement campaign; Gregor McCombie, Antje Harling-Vollmer, Maria Morandini, Gabriele
Schmäschke, Sylvia Pechstein, Werner Altkofer, Maurus Biedermann, Sandra Biedermann-
Brem, Michael Zurfluh, Gaby Suter, Matthias Landis, Koni Grob; Eur Food Res Technol (2012)
235:129–137
3.6.7 Organoleptic testing as a tool in FCM control
Rüdinger Helling, Food Control Laboratory, Germany
Administrators, basic and Inspectors, advanced
Organoleptic testing is an integral part of compliance assessment with regard to article 3 (1c)
reg. (EC) 1935/2004 and can as well be used as an useful screening tool for migrating
substances. Legislative requirements were introduced and typical sources for off-flavours and
taints were discussed before going into the details of testing standards and procedures.
Advantages and drawbacks were pointed out and the need for harmonized rules was worked
out.
Standards for organoleptic testing:
FCM from paper and board in indirect contact (transfer via gas phase):
Test for odour: DIN EN 1230-1 (2002)
Test for transfer of taints: DIN EN 1230-2 (2010)
Training of a sensory panel: CEN/TR 15645 1 - 3 (2007)
FCM in direct and indirect contact with food:
Test for odour: DIN 10955 (2004)
Test for aroma transfer: DIN 10955 (2004)
Colour fading: EN 646, 648 (2007)
In the courses the participants were invited to participate in an organoleptic experiment
consisting of 4 different foodstuffs. As part of the experiment they learnt, that:
FCM may affect the organoleptic properties of packaged food significantly
a large panel and trained staff is mandatory to achieve reliable results due to
differences in individual thresholds
not every off-flavour will lead to non-compliance
even very low concentrations of a substance may lead to unacceptable organoleptic
changes of the food
chemical analysis and organoleptic testing do not necessarily give identical results and
therefore both is required independently
3.2.7 FCM - a challenge for the public analytical control and
administration
Konrad Grob, Kantonales Labor Zürich
Administrators advanced
Migration from FCM is probably the largest source of food contamination (roughly 1000 times
the amount of pesticide residues, perhaps 100’000 substances) and nonetheless poorly
controlled.
Only for a fraction of the FCM the most important starting materials are regulated, and mostly
70-95 % of the migrate into food still consists of other components.
Enforcement is insufficient, which became apparent by dramatic violations of legislation. In
1996, BADGE was found at up to 50 mg/kg in canned oily fish – the legal limit at the time was
0.02 mg/kg. Industry switched to NOGE with practically the same structure and no
toxicological evaluation. It was also detected that BADGE was used as an additive (it was listed
as monomer) and since it was used as a scavenger to bind HCl from PVC in organosols, it was
largely converted to chlorohydrins, for which also not safety could be assured. Finally it was
determined that the migrate consisted of a “forest of peaks” of which hardy any had been
identified, not to mention evaluation. Scientifically untenable arguments were brought
forward, such as that the starting substances used to make the resins which were then reacted
to the coatings would “cover” the safety of the whole migrate. The question remained
unanswered why authorities do not react against such poor excuses.
Soon later it was detected that the migration of plasticizers from the gaskets of lids for glass
jars into oil foods by far exceeded the legal limits. In 2004 still often phthalates were used in
Europe. It turned out that no manufacturer was able to provide lids respecting the legal limits.
DG SANCO was compelled to introduce regulations for the protection of the failing
manufacturers. Even though a manufacturer started selling compliant lids in 2005, the larger
producers were allowed to sell non-compliant lids up to 2009. A European campaign in 2011
revealed that still a quarter of the oily products in glass jars was non-compliant.
In 1996 it was detected that printed paperboard released mineral oil into the packed food in
concentrations which by far exceeded the limit derived from the SCF opinion from 1989.
However, hardly any notice was taken by industry. It argued that the recycled paperboard
contained large amounts of mineral oil and that, therefore, printing with mineral-oil-
containing inks would change little. The paperboard industry used the opposite argument. It
took up to 2009 when Swiss legislation stopped the use of mineral-oil-based inks and
Germany announced legislation against high mineral oil migration.
Polyolefins are considered as the best regulated, safest food packaging material. However,
most of the migrate consists of saturated oligomers (POSH), mostly branched, and thus prone
to be accumulated in the human body just as the saturated mineral oil hydrocarbons (MOSH).
On the basis of the evaluation of the MOSH, the migration of the POSH had to be considered
unacceptable for many products. No toxicological data has been submitted showing the safety
of this migrate. Nonetheless no measures were taken to compel industry to show compliance
of the main migrate from polyolefins.
Much of the unsatisfactory situation is due to insufficient enforcement, supported by reactions
of the type “of course it was known that the migration from the lids exceeds the limits, but
nobody said anything…” Harsh measures are taken against small producers, bakers and cooks,
but hardly any against large companies.
Authorities, particularly those responsible for the safety of FCM, have to strongly improve
their work to fulfill their task and minimally satisfy the expectations of the consumers. They
have to be respected by industry, which means that they must be competent and strong in
taking measures. GMP is a key tool not only for enforcement, but also for the chain of
manufacturers to achieve adequate compliance work. GMP enables to specify the producer
responsible for a migrating substance. The supporting documentation records the work
performed to ensure compliance. This clarifies the roles within a complex industry and
enables enforcement to check whether each manufacturer has done his part of the compliance
work. However, effective enforcement is not feasible when each country tries to do a bit of
enforcement covering all types of FCM. To increase efficiency as well as competence,
authorities should collaborate, sharing the work among the countries. This should enable to
deepen competences, more efficiently use analytical methods and taking stronger measures.
3.2.8 Plastic Kitchenware 284/2011 (Chinese kitchen utensils)
Ester Enning, Control coordinator, The Nederlands
Administrators advanced and Inspectors advanced
The Regulation (EU) No 284/2011 aims to ensure uniform import procedures at EU level of
kitchenware made of polyamide and melamine originated or consigned in China and Hong
Kong regarding the release of primary aromatic amines (PAA) and formaldehyde.
Legal framework, guidelines
There is a legislative framework for FCM (Food Contact Materials). Besides a regulation for
the general principles, there are specific regulations such as for plastic FCMs. In addition,
there is a Regulation that concerns a more specific part of the plastic FCMs. Due to the
detected risk; there is a regulation in place for certain kitchenware coming from two non EU-
Member states: EU Regulation 284/2011. To prevent the import of none conform
consignments into the EU. In case of a non-compliancy EU Reg. 882/2004 is in place.
Scope of the EU Regulation
Polyamide and melamine plastic kitchenware, defined by customs number (CN) code 3924 10
00 which consist completely of polyamide or melamine. Or which consist of parts intended to
come into contact with food that are made of polyamide or melamine. Originated or consigned
in China or Hong Kong.
The regulation does not apply to silicone kitchenware, kitchenware such as knives that have
melamine or polyamide but not intended to come into contact with food. It neither applies to
tablecloths or serving trays.
Prior notification – documentation – documentary check
EU Regulation requires a prior notification of all consignments entering en EU MS. The prior
notification has to take place 2 working days prior to the estimated arrival at the outside EU
border. A prior notification, to be provided at the point of first introduction, has to include a
declaration (a filled out example of the Annex of Regulation284/2011) and a certificate of
analyses.
If MS decided to designate specific first points of introduction they are listed here:
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm
The CA (Competent Authority) performs a documentary check on all consignments. The prior
notification may be submitted on paper or in electronic form.
Identity and physical check
From all notified consignments, on 10% (chosen at random) an identity and physical checks
has to take place. That means a control to check whether the documents presented for a
certain consignment really does tally with the consignment it selves. And if so, followed by a
sampling for laboratory analysis. Even though the prior notification and all of the Regulation
is aimed at consignments, sampling is based on single lots: each lot of the consignments
should be sampled separately. The sample size is 3 x 5 articles (or sets)
Onward transport
After the inspection including sampling, the importer may request to transport the
consignment to its final destination, this might be in another EU MS. Pending the results of the
official control, and the importer can limit the interruption of the logistic chain.
As long as the consignment remains under continuous control of CA, the request may be
granted. The CA which has performed the official controls has to organize an arrangement
with the CA at the point of destination. The consignment should be appropriately identifiable
at the place of destination, ensuring it will not be placed on the market until the official
controls have finalized. Once the duly completed declaration is issued, the consignment can be
placed on the market.
Practical situations
In case a consignment is not accompanied by a set of documents or the documents are not
conforming, it is allowed to solve the non-compliancy within a limited timeframe.
Scope discussion
The Regulation 284/2011 in the text only speaks about kitchenware, tableware is not
mentioned. However, the CN code includes tableware.
What is a lot?
A consignment can arrive at the first point of introduction in one container, in several
containers, or only as part of one container together with other consignments. It can consist
of articles that differ in shape, size, print pattern, food contact areas and/or conditions of uses.
A lot means a stated portion of the consignment to be tested for the migration of primary
aromatic amines or formaldehyde. Plates in a different colour are different lots.
Quality of documents
The Annex of the Regulation has to be filled out for the prior notification. Handwriting can
easily be hard to read or incomplete. A digital form can be found here, downloadable in all EU
languages:
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm
Certificates of analyses have to be complete, showing what article was tested, what test has
taken place, what the testing conditions were (long enough, warm enough?) and what the
findings were.
We do not only accept certificates of analyses from China or Hong Kong but also from EU
laboratories.
If the documents are not satisfactory, a limited time frame can be allowed to solve the
problem.
Dispute
It may occur that the CA of an EU MS performs official controls and detects a non compliant
consignment. The importer may disagree. In such cases, national legislation should be taken
into account.
Aspects that may be relevant to the dispute: Why is the importer disagreeing with the official
results, based on what information? If it is based on a second analyze, on 1 of the 3 sets of
samples taken during the official control: what laboratory performed the analyses? Was the
analyses ok, the lab accredited, the method validated, etc.
Other non-compliances
It may occur that one detects that a consignment has been imported into the EU but the
consignment was not presented for official controls.
The consignment should be considered as non compliant with Reg. 284/2011. The CA should
order a recall or withdrawal and placing under official detention without delay, leading to
redispatch.
If the supporting documents do not cover all of the consignment, the CA may request further
information from the one responsible to be delivered within a limited time frame. Non
compliancy is the conclusion if the correct supporting documents cannot be presented.
For more information:
The regulation (English version):
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:077:0025:0029:en:PDF
Guidance document on testing:
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m/technical-guidelines-2011
Guidance document on import conditions and procedures:
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/20110614_guidelines_chin
a_measure_en.pdf
More documents on FCMs:
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm
4. Workshops – learning by doing!
Theoretical and practical workshops interacted in order to improve the knowledge of the
participants. It is well known that theoretical knowledge has to be activated as a practical tool
by using this knowledge in training sessions.
The workshops was including in the courses covering the following issues
1. Inspection/evaluation of declaration of compliance for FCM
2. Supporting documentation for FCM
3. Organoleptic testing
4. Inspection of GMP and critical control points in food contact materials production
5. National control plans –prioritisation and planning
4.1 Inspection/evaluation of declaration of compliance and
supporting documentation for food contact materials
The participants were divided into 6 groups with approximately 6-8 persons per group. A
coordinator was appointed and the group got 1-2 examples of declaration of compliance to
discuss and evaluate.
The documents for the discussion were found on the internet and therefore public available
real-life examples. The starting point for selection of these documents was to use some
documents of a reasonable quality. Some examples were given from food contact materials
producers, who were ask for examples of “perfect documentation”.
The skills of the participants differed quite a lot, also at the advanced courses. However, as
this issue is complicated, the groups supported themselves together with some of the tutors
and got a learning experience, also in the joint discussion afterwards in plenary.
4.2 Organoleptic testing
For this exercise, different samples were prepared by Rüdiger Hellinger, tutor on organoleptic
testing, as given below. The participants tasted samples of orange juice, chocolate and water
with and without an off taste and the they were requested to check the food samples for off-
flavours and abnormalities in odour and taste.
The results (shown in the table below) were calculated and explained by Rüdiger (below),
Tests were discussed in plenary. The results of all 4 tests comply with the requirements of the
guideline standard (German DIN 10955) because 6 or more valid results were obtained.
Table of test results:
Assay Check
for
Number of
Participants
giving a
result /
Invalid
counted
due to
wrong
Median
of
intensity
(scale 0 –
Number of
participants
outside of
the
Minimum -
Maximum
given
score
valid
results
thereof
assignment
(abnormal
sample was
not identified
correctly) 4)
permitted
tolerance to
the median
(±1.5)
(range of
results)
WaterOdour 35 / 29 2 3 4 0 – 4
Taste 34 / 22 3 2 9 0 – 4
Multifruit
Juice
Odour 36 / 27 5 1.5 4 0 – 4
Taste 36 / 22 7 2 7 0 – 4
Crisp
Bread
Odour 35 / 29 2 3 4 0 – 4
Taste 34 / 22 3 2 9 0 – 4
ChocolateOdour 37 / 31 0 2 6 0 – 4
Taste 36 / 30 0 3 6 0 – 4
The Water was spiked with 45 µg/l styrene (SML 60,000 µg/l). Despite some
participants found it strongly abnormal in odour (4) and taste (4) and other found no
difference between both samples the whole panel indicated a significant deviation in
odour (non compliance) and a different but still compliant taste. According to the test
the sample would not be compliant with the requirements of Reg. 1935/2004, article
3 (1c) with regard to odour characteristics.
The off-flavour was described as plastic, sweet, styrene, salty, sour.
The Multifruit Juice was spiked with 120 µg/l styrene (SML 60,000 µg/l). Despite
some participants found it very intensively abnormal in odour (4) and taste (4) the
whole panel indicated the sample still to be compliant with the requirements of Reg.
1935/2004, article 3 (1c).
The off-flavour was described as chemical, bitter, sweet, acetaldehyde, sharp.
Crisp Bread and Chocolate were stored in a polypropylene plastic container
releasing 4-methylbenzaldehyde. Despite some didn’t notice a difference and others
found odour and taste to be horrible and rated it 4 the panel found both samples to be
at the borderline. Chocolate would fail with regard to taste whereas the crisp bread
was assessed as non-compliant with regard to odour. In consequence the plastic
container in both cases did not comply with the requirements of Reg. 1935/2004,
article 3 (1c).
The off-flavour was described as organic, foreign, rancid, almond, bitter, oxidized
butter, weed, vanilla, and naphthalin.
Conclusion:
The sensory test with juice was obviously more demanding than the others. Many
participants failed in identifying the spiked sample and rated instead the other blank
sample. Furthermore the numbers of participants outside the permitted range is
noticeable for all experiments and illustrate the huge variability in individual
organoleptic thresholds, underlining the need of a large panel to achieve reliable
results.
4.3 Inspection of GMP and critical control points in food contact
materials production
A general requirement is the European Union regulation on good manufacturing practise. The
Italian authorities have published a guideline with information on critical control points in the
production of different types of materials. The guideline is developed in close corporation
with Italian industry organisation and subject for one of the speeches.
Participants were asked to use the guideline in order to point out some critical points in the
production of glass and plastics. For some of the participants, this is part of the daily work, for
others it is not, as some countries do not inspect in FCM production facilities. However, in
both cases, tools for such work in not available (except for Italian inspectors).
In general, the public control is widespread in many sectors, and inspection of FCM
enterprises requires special expertise and/or tools.
5. Visits to production sites of food contact materials.
Visit to a production site was for many of the participants a first time experience, and fitted in
with the theoretical training and the workshops. Especially, food inspectors are/can be in
charge of inspection of such premises, and as such premises are often very big and difficult to
get an overview of, a training visit with no other obligations that learning is a good start.
The company visits were at LietPak, Vilnius, Lithuania, TetraPak, Berlin, Germany, Progelcone,
Lisbon, Portugal and Grafobal, Vilnius, Lithuania. They are all thanked for facilitating a
practical knowledge of production of food contact materials.
LietPak is a plastic converter, producing different types of plastic food contacts materials.
Before the visit the quality manager and a colleague explained about the production facilities.
They use extruders for monolayer plastic and coextrude to form multilayers. They also
produce advanced laminated plastic films using adhesives. Also printing and coating of plastic
film was shown as well as cutting and heat sealing of bags. Participants had a quick tour along
the production line from plastic granule to final printed packaging.
TetraPak, Berlin is producing milk cartons, from paper rolls and printing on the paper using
different techniques. The quality assurance unit is a joint function for several TetraPak
production units located in Stuttgart, Germany. A representative from this unit was present to
answer questions. Such an opportunity was highly appreciated by the participants as quality
assurance is the main interest of both administrators and food inspectors.
Progelcone, Lisbon originally produced waffle cones for ice cream and other wafers for pastry.
Now the company has also produces disposable packaging for fast-food restaurants (paper
and plastic cups, disposable cutlery, burger boxes etc.). The visit to the production site was
very informative and well planned. The participants were divided into smaller groups, and the
waiting time between the guided tours around the production was spent looking at products.
There was opportunity to ask the quality control manager about documentation etc. At the
end there was time for questions to the production and documentation to the director from
the company.
Grafobal, Vilnius is a smaller print company using offset printing on card board. Visit to this
company was informative, also because they represent many of the smaller food contact
materials producers in Europe. As some waiting time was foreseen, the training coordinators
had prepared for showing films on paper production and quality assurance in the waiting
time. These films were supplied by the professional organization for paper and board, CEPI
and fitted in as information on the raw materials at Grafobal.
Before the visit, it was highlighted to the participants that they were not visiting for
inspection but for learning.
6. Networking for improving control in the European Union
During every course the participants were encouraged to network with colleagues and tutors.
This is important, both for a more harmonised approach in administration and inspection of
food contact materials, both also as many inspectors/administrators have few colleagues to
discuss with in their home countries.
In the European Union, harmonised legislation is only adopted for a minor part of the food
contact materials used. During the discussions it was pointed out by the participants that they
would like to have more harmonised legislation or guidelines in this area.
7. Other information, links and references
A 3 days program does not cover all aspects in the area of food contact materials, and in
general no one has knowledge in all details. The participants at these courses were
encouraged to from networks with colleagues, and were very active in this field.
More knowledge can be found in many places, and references and links are listed under the
abstracts.
