2. Food Contact Materials
Mervyn Briggs Food Standards Agency Northern Ireland

3. Overview on presentation
Aims of EU legislation
Core EU Framework Regulations
Specific or EU harmonised measures
Enforcement

4. A Schematic view of EU Food Contact Material Law
General requirement for all contact materials
Regulation (EC) No. 1935/2004
Good Manufacturing Practice Regulation (EC) No. 2023/2006
Specific measures for 3 groups of materials
Organic
Food Contact Plastics Regulation (EU) 10/2011
Fibrous
Regenerated cellulose film Directive 2007/42
Inorganic
Ceramics
Directive 84/500 as amended
The heavy green box contains the two Horizontal regulations. The first is Regulation EC No /2004 which lays down main principles that food contact materials and articles must be manufactured using GMP so as not to allow constituents to migrate into food at levels that would cause harm to human health or affect the nature or quality of food.
The Regulation applies across the EU and to all food contact materials.
The second Regulation EC No. 2023/2006 examines in detail the principles in Good Manufacturing Practice.
Below these Horizontal measures there are a number of vertical directives that cover
3 Groups of contact materials . Organic, fibrous and inorganic.
Plastics
RCF and
Ceramics
Under the plastics heading we have further subdivision relating to specific substances and their control in food contact materials.
There are over 15 sets of EC directives dealing with plastics. The subjects covered include,Migration testing,Use of simulants, Suspension of AZODICARBONAMIDE
Plasticizers,VCM,N-Nitrosamines and N-nitrosatable substances in rubber teats
Epoxy derivatives ( BFDGE,NOGE and BADGE)
I will not be covering all of these today but I will touch on some key provisions and give you sufficient information and web links to enable you to read further at your leisure.
The Commission are gathering information regarding proposed amendments to Council Directive 84/500/EEC for the release of lead and cadmium into food. New limits are proposed for the release of lead, 10 ppb (part per billion) and for cadmium, 5 ppb.
A useful site to obtain copies of EU rules is
Controls on individual substances
VCM Directive 78/142
Vinyl chloride monomer
Nitrosamines Directive 93/11
Epoxy Derivatives Regulation (EC) 1895/2005

5. Materials not yet covered by specific directives
Varnishes and coatings
Paper and board
Metals and alloys
Textile products
Elastomers and rubber
Glass
Wood ( including cork)
Paraffin waxes and
Micro crystalline waxes
General requirements
of 1935/2004 apply.
The list provided on this slide includes a range of substances for which there are no current specific directives regulating their use in food contact materials and articles, but it must be borne in mind that EC Regulation 1935/2004 main provision do apply and if these materials are used in the manufacture of food contact items then
they must be made under good manufacturing practice and not allow constituent to migrate into foods at levels that would harm human health or affect the nature or quality of the food.

6. Application of Regulation (EC) No. 1935/2004
The rule applies to materials and articles in their
finished state
intended to come into contact with food
reasonably expected to come into contact with food
e.g. Inside surfaces of refrigerators and
there is a reasonable expectation of the transfer of
constituents into food e.g. Print inks or adhesive labels
The rule applies to materials and articles in their finished state that are
intended to come into contact with food
reasonably expected to come into contact with food
e.g. Inside surfaces of refrigerators and
there is a reasonable expectation of the transfer of
constituents into food e.g. Print inks or adhesive labels
The regulations do not apply to
Antiques
Covering or coating materials such as materials covering cheese rind,prepared meat products or fruit which form part of the food and may be consumed. Nor do they apply to
Fixed public or private water supply equipment.

7. What are Food Contact Materials?
These are not defined in the regulations but clearly include all elements that make up
Food Packaging/wrapping
Cookware
Cutlery
Tableware
Work surfaces
Food contact parts of processing machinery and equipment
To my knowledge there is no one directive or regulation that defines what food contact materials are but by implication they include
Food Packaging/wrapping
Cookware
Cutlery
Tableware
Work surfaces
Food contact parts of processing machinery and equipment and
Disposable plastic cups and plates.

8. Some examples

9. Some more examples

10. Main provisions of Regulation (EC) No. 1935/2004
General protective requirement (Article 3)
Active and intelligent materials and articles (Article 4)
Specific measures
European Food Safety Authority (EFSA)and Substance authorisations (Article 11)
5. Labelling (Article 15)
6. Compliance declarations ( Article 16)
7. Traceability (Article 17)
There are 28 articles but for the purposes of today's talk I will focus only on 7 of them which are listed on the slide.

11. General protective requirement of Regulation (EC) No 1935/2004
Food Contact materials including active and intelligent materials and articles ;
Must be made under good manufacturing practice (GMP)
Must not transfer constituents in quantities that
will harm human health
cause unacceptable changes to the composition of food
cause deterioration to organoleptic character of food
Labelling, advertising etc., must not mislead consumers
The general protective requirement asks that Food Contact materials
Must be made under good manufacturing practice (GMP). GMP is referred to in 1935/2004 but it is further elaborated upon in Regulation 2023/2006.
Food contact materials and articles
Must not transfer constituents in quantities that
will harm human health
cause unacceptable changes to the composition of food or
cause deterioration to taste,texture, odour or appearance of food
Labelling, advertising etc., must not mislead consumers
The general protective requirement applies traditionally to adventitious migration of substances from Food Contact Materials but it also serves as a Fail Safe provision where intended migration arises from ACTIVE contact materials ( e.g. Additives)

12. Active and intelligent materials and articles
Must comply with the EU rules on food (e.g. Food additives)
Must be authorised and according to EU rules on food.
Released substances are treated as ingredients
Must not change the nature or quality of food to mislead consumers
Properly labelled
Identify non-edible parts “Do not eat”
Identify material as active or intelligent
Identify nature of released active component
Information on permitted use of active systems
By way of explanation what are active and intelligent materials and articles?
Active materials: Could release substances into food to increase shelf life or improve condition.
Active materials : Might absorb substances from the environment of the food e.g. Gas scavengers or might absorb for example liquid from a packaged meat cut.
Intelligent materials: These would monitor the condition of food e.g. Change packaging colour if the temperature or food environment change. The intelligent materials might also indicate if the use by date of a food had expired.
Such active and intelligent materials and articles must (Refer to slide)
Regulation (EC) No. 450/2009 (Specific measures)

13. Specific Measures Active and intelligent materials and articles
Adhesives
Ceramics
Cork
Rubber
Glass
Ion-exchange resins
Metals and alloys
Paper and board
10. Plastics (virgin & recycled)
11. Printing inks
12. RCF
13. Silicones
14. Textiles
15. Varnishes and coatings
16. Waxes
17. Wood
The parent Regulation makes provision for specific measures. There are 17 classes of material listed in Regulation (EC) 1935/2004 for which specific measures can be produced.
Specific measures typically include
Registers of substances
Limits on migration
Purity standards
Quality standards for processes
Checking compliance (sampling and analysis)
Traceability, Record keeping and labelling
Commission is preparing an impact assessment to decide on a way forward for the non-harmonised areas of FCM legislation, which may warrant sector specific, harmonised legislation.

14. European Food Safety Authority
Provisions liable to affect public health must be adopted after
consulting EFSA
Substance authorisation:
EFSA will give an opinion within 6 months of an application
being made based on the intended conditions of use of the
material or article in which it is used. The substance must comply
with the safety criteria ( Article 3 and 4).
EFSA web address:
Who is EFSA? The European Food Safety Authority (EFSA) is an independent European agency funded by the EU budget that operates separately from the European Commission, European Parliament and EU Member States.
What is EFSA Role in contact materials? The Panel on food contact materials, enzymes, flavourings and processing aids (CEF) deals with questions on the safety of use of materials in contact with food, and with questions related to the safety of processes.
EFSA is at the centre of European authorisation procedures providing the necessary risk assessments for the Commission and MS who will take account when developing EC legislation relating to contact material.
Provisions liable to affect public health must be adopted after
consulting EFSA
Substance authorisation:
EFSA will give an opinion within 6 months of an application
being made based on the intended conditions of use of the
material or article in which it is used. The substance must comply
with the safety criteria ( Article 3 and 4).

15. Labelling Materials and articles must be accompanied by
1. “For food contact” or a symbol indicating their use
2. Instructions for safe use.
3. Details of manufacturer, processor or seller responsible for first placing on the market.
4. Traceability information
5. Information of the permitted use of active materials
When materials and articles are not in contact with food
when placed on the market they must be accompanied by
The term “For food contact” or bear a symbol indicating their use if it is not already obvious. The symbol top right of slide is shown in 1935/2004.
2. Instructions for safe and appropriate use where necessary. E.g material might be a cling film that is not suitable for microwave use
3. The name or trade name and address or registered office of
manufacturer, processor or seller responsible for first placing
on the market.
4. Traceability information
5. Information of the permitted use of active materials
including the name and quantity of the substance
released
This information must be in a language easily understood, conspicuous, legible and indelible

16. Compliance declarations
A written declaration indicating that the material or article complies with EU rules
Documentation must be available to demonstrate compliance and available to authorities on demand.
In the absence of specific measures the rules do not prevent Member States from retaining or adopting National provisions for declarations of compliance.
FSA Guidance: Guide to UK legal compliance
and good practice for business documentation June 2009
1935/2004 requires that the specific measures on materials and articles in contact with food include provisions that they be accompanied by a written declaration of compliance.
Note Declaration and documentation have specific meaning.
Documentation must be available to demonstrate how the declaration of compliance has been achieved. This documentation must be made available to authorities on demand.
In the absence of specific measures the rules do not prevent Member States from retaining or adopting National provisions for declarations of compliance.
The FSA in consultation with stakeholders has prepared specific guidance covering the subject of compliance declarations and also GMP.
Details are given in the slide on where to find the download.
There are specific requirements for Declarations of compliance in
450/2009- Active and intelligent materails and articles.
10/2011- Plastic materials and articles.
84/500 Ceramic articles in contact with food

17. Typical information required in a Declaration of Compliance:
Name/Address of producer/manufacturer/importer
Material Description/Identification
Date of Declaration
Test Results
Statement of compliance including relevant Directive/Regulations
Specifications on components/materials.
Information for downstream use
Specification restricting types of food and intended conditions of use
Statement regarding use of functional barrier
You will need to refer to the specific pieces of legislation to get the exact details required for the Declaration of compliance.
450/2009- Active and intelligent materials and articles.
10/2011- Plastic materials and articles.
84/500 Ceramic articles in contact with food

18. Traceability
Traceability must be ensured at all stages for the control and
recall of defective products, consumer information and
Attribution of responsibility
Where feasible businesses must have systems and procedures
to identify businesses they supply and receive from.
Goods placed on EU market must be identifiable in a way
that allows their traceability by means of labelling/
Documentation/Information.
Traceability must be ensured at all stages for the control and
recall of defective products, consumer information and
Attribution of responsibility. Incidentally “All stages” means manufacture, processing and distribution”
Where feasible businesses must have systems and procedures
to identify businesses they supply and receive from. (Sometimes referred to as the one up and one down approach)
Goods placed on EU market must be identifiable in a way
that allows their traceability by means of labelling/
Documentation/Information.
This information must be made available to the competent authority.

19. Good Manufacturing Practice (GMP)
EC Regulation 2023/2006 (GMP Regulation)
Elaborates on GMP in (1935/2004)
Defines GMP, QA, QC and other key terms
Requires Business operators to
Establish documented QA and QC procedures relating to compliance and safety of finished products
Document records of manufacturing
Make available documents to Competent authority
FSA Guidance: Guide to UK legal compliance
and good practice for business documentation June 2009
Whilst GMP is mentioned in the main EC Regulation 1935/2004 more specific details are contained in EC Regulation 2023/ It applies to all sectors and stages of manufacture, processing and distribution
Elaborates on GMP in (1935/2004)
Defines GMP, QA, QC and other key terms
Requires Business operators to
To Establish documented QA and QC procedures relating to compliance and safety of finished products
To Document records of manufacturing and
To Make available documents to Competent authority
Annex in the Regulation requires
Print inks on non food contact surfaces to be applied in a way that they do not transfer to the food contact side in levels contrary to Art 3 Regulation 1935/2004
Printed materials and articles must be handled and stored in their finished or semi finished state such that substances on the printed side do not transfer to the food contact side in levels contrary to Art 3 Reg 1935/2004
Printed surfaces must not come in direct contact with the food
The FSA Guidance document goes into the subject of GMP in more detail and deals with typical production issues. It can be downloaded from the Agency web site.

20. Specific EU measures Vinyl Chloride monomer (VCM) Plastics
Active and Intelligent materials and articles
Ceramics
Regenerated cellulose film

21. Vinyl Chloride Monomer (VCM)
Regulation (EU) 10/2011
Council Directive 78/ 142
The maximum VCM level in a material or article intended to come into contact with food is
1 mg/kg in the final contact material product
VCM should not be detectable in
Foodstuffs in excess of 0.01 mg/kg.

22. Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food
Published January 2011 by EU
48 recitals setting out the reasoning behind the EU Regulations
23 Articles or rules
Articles of particular interest
Subject matter Article 1 (Purpose)
Scope of the rules Article 2 (What do they apply to ) Whats exempt?
Definitions of terms used throughout Article (3)
Requirements for placing on the market (Article 4)
Compositional requirements for plastics Articles 5- 7
Restrictions OML/SML Articles 8-12
Multi layers 13 &14
Declarations of compliance & supporting documents
Assessing compliance 17-19
Remainder are administrative provisions
6 Annexes
1 Substances and their restrictions
2 Restrictions on materials and articles
3 Food simulants
4 Declarations of compliance
5 Compliance testing
6 Correlation tables

23. Specific EU Measure on Plastics
Regulation (EU) 10/2011 Article 2
Covers plastic materials and articles and their parts
Consisting exclusively of plastic or
Composed of two or more layers of materials each
consisting exclusively of plastic, bound together by
adhesives or other means.
When in the finished product state are intended to come
into contact with food and are intended for that
purpose.
1. This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:
materials and articles and parts thereof consisting exclusively of plastics;
(b) plastic multi-layer materials and articles held together by adhesives or by other means;
(c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating;
(d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
(e) Plastic layers in multi-material multi-layer materials and articles.
Does not apply in respect of
(a) ion exchange resins;
(b) rubber;
(c) silicones.

24. Plastics Overall Migration Limits(OML)
Regulation (EU) 10/2011 Article 12
Outlines the amount of a constituent of plastic contact material that is allowed to migrate out of the contact material.
The standard is 10 milligrams per square decimetre of surface
area or in the case of materials in contact with infant food not more than 60 milligrams per kilogram released into a food simulant.
Article 12
Overall migration limit
1. Plastic materials and articles must not transfer their constituents to food simulants in quantities exceeding 10 milligrams of total constituents released per dm 2 of food contact surface.
2. However plastic materials and articles intended to be brought into contact with food intended for infants and young children, as defined by Commission Directives 2006/141/EC ( 1 ) and 2006/125/EC ( 2 ), must not transfer their constituents to food simulants in quantities exceeding 60 milligrams of total of constituents released per kg of food simulant.

25. Specific Migration Limit (SML)
Regulation (EU) 10/2011 Article 11
Where there is no specific migration limit or restriction in Annex 1 the limit is 60 mg/kg
Article 11
Specific migration limits
1. Plastic materials and articles shall not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I. Those specific migration limits (SML) are expressed in mg of substance per kg of food (mg/kg).
2. For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.
3. By derogation from paragraphs 1 and 2, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:
(a) exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or
(b) exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.

26. BADGE/BFDGE/NOGE in coatings
Regulation (EC) No 1895/2005
Applicable to plastics, surface coatings and adhesives
BADGE SML 9 mg/Kg
Badge-chlorohydrin adducts SML 1 mg/Kg
BFDGE and NOGE prohibited
Declaration of compliance and supporting
documentation required
BADGE/BFDGE/NOGE in coatings
Applicable to plastics, surface coatings and adhesives
BADGE SML 9 mg/Kg or 9 mg/ 6 square decimetres for containers with capacity <0.5 litres or >10 litres
Badge-chlorohydrin adducts SML 1 mg/Kg or 1 mg/ 6 square decimetres for containers with capacity <0.5 litres or >10 litres
BFDGE and NOGE prohibited
Declaration of compliance and supporting
documentation required
BADGE: 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether
BFDGE: bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers
NOGE: novolac glycidyl ethers

27. Recycling Plastics – Regulation EC 282/2008
Mechanical recycling processes, not chemical ones
Authorisation for processes required, approval by EFSA
Community Register
DoC and GMP requirements
EFSA Guideline on submission of dossiers available
Until March 2008 there were no harmonised rules for the using recycled plastics in contact with food.
The Regulation deals with mechanical processes for recycling food contact plastic for further use in contact with food.
A person or company must apply for authorisation to use a specific process and the processes authorised must be managed by a quality assurance system that guarantees the reproducible quality of the recycled plastic.

28. Primary aromatic amines Formaldehyde. Enforced by District Councils
The Plastic Kitchenware (Conditions of Import from China) Regulations (Northern Ireland) 2011
Primary aromatic amines
Formaldehyde.
Enforced by District Councils
Commission Regulation (EU) No 284/2011 lays down specific conditions and detailed procedures for the import of polyamide and of melamine plastic kitchenware originating in or consigned from the People's Republic of China (China) and Hong Kong Special Administrative Region of the People's Republic of China (Hong Kong). These specific conditions include that plastic kitchenware originating in or consigned from China and Hong Kong shall be imported into the Member States only if the importer submits to the competent authority for each consignment a declaration and a laboratory report confirming that it meets the requirements concerning the release of primary aromatic amines and formaldehyde.
A temporary import control measure put in place until EU satisfied that these implements can be manufactured to comply with EU legal specifications.

29. Northern Ireland Legislation implementing EU rules
Primary legislation
Food Safety (NI) Order 1991
Secondary Legislation
Materials and Articles in Contact with Food Regulations
(NI) 2007 SR. No. 434
Materials and Articles in Contact with Food (Amendment)
Regulations (NI) 2009 SR. No. 377
Plastic Materials and Articles in Contact with Food
Regulations (NI) 2009 SR.No. 56
Ceramic Articles in contact with Food Regulations
(NI) 2006 SR. No. 217

30. Changes to legislation
12 week Consultation started on 20th January 2012.
Consolidation of the food contact materials legislation
The Materials and Articles in Contact with Food Regulations (NI) (Currently being made and proposed coming into operation on 20th November 2012)
A 12 week consultation started back in January 2012 drawing attention to plans to create a single piece of legislation after the consolidation of the plastics directives into one European Regulation. Currently FSA working through regulatory procedures and protocols with an anticipated coming into operation date of 20th November 201 for the new food contact materials legislation.

31. Enforcement of legislation
Food Standards Agency
District Council EHOs
Legislation refers to Competent Authorities
FSA is competent authority regarding Article 9 of 1935/2004 ( Authorisations of new substances.)
FSA is competent authority regarding Article 13 of 1935/2004 (Competent authority of Member State)s.
The DCs and FSA both competent authorities regarding Article 16(1) Declarations of compliance and 17(2) Traceability
The competent authority in respect of Art 6(2) 2023/2006 Quality Control Systems and 7(3) of 2023/2007 (documentation) is the District Council.
The Competent Authority for Article 13 of Reg 450/2009- Active and Intelligent Materials and Articles is FSA and DCs
The Competent authority for Ceramic materials 84/500 is the District Council.
Article 8 of 10/2011 FSA and DCs ( Composition of materials used).
Article 16 of 10/2011 Supporting documentation the FSA is the competent authority.
Epoxy derivatives Reg 6(4) 1895/2005- Identification of date of filling. DC is the competent authority.
As a rule the day to day enforcement of the food contact materials is a function of the District Councils.

32. Powers of authorised officers
Enter premises to determine compliance with the regulations (Includes GMP)
Inspect records on site e.g. traceability
Inspect GMP and associated records and documents. (Quality Assurance/Quality Control).
No offence is needed to look at records.
Take samples of materials and articles intended for use as food contact material.
Submit samples to a Public Analyst for chemical analysis.
The powers of Authorised officers is contained within The
Food Safety (NI) Order 1991
Materials and Articles in Contact with Food Regulations (NI) 2012
There are also powers regarding detention and seizure under Consumer Protection Legislation.

33. END
Any Questions?