Food Contact Materials
Mervyn Briggs
Food Standards Agency
Northern Ireland

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

A Schematic view of EU Food
Contact Material Law
General requirement for all Good Manufacturing Practice contact materials Regulation (EC) No. 2023/2006
Regulation (EC) No. 1935/2004 http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm
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
Controls on individual substances
VCM Directive 78/142
Vinyl chloride monomer
Nitrosamines
Directive 93/11
Epoxy Derivatives
Regulation (EC) 1895/2005

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.

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

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

Some examples

Some more examples

Main provisions of Regulation
(EC) No. 1935/2004
1. General protective requirement (Article 3)
2. Active and intelligent materials and articles
(Article 4)
3. Specific measures
4. European Food Safety Authority (EFSA)and
Substance authorisations (Article 11)
5. Labelling (Article 15)
6. Compliance declarations ( Article 16)
7. Traceability (Article 17)

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

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
Regulation (EC) No. 450/2009 (Specific measures)

Specific Measures
1. Active and intelligent materials and articles
2. Adhesives
3. Ceramics
4. Cork
5. Rubber
6. Glass
7. Ion-exchange resins
8. Metals and alloys
9. Paper and board
10.
Plastics (virgin & recycled)
11. Printing inks
12. RCF
13. Silicones
14. Textiles
15. Varnishes and coatings
16. Waxes
17. Wood

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: http://www.efsa.europa.eu/

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

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 http://www.food.gov.uk/foodlabelling/foodcontactmaterials2/legalcompliancefoodpackagi ng

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

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.

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 http://www.food.gov.uk/foodlabelling/foodcontactmaterials2/le galcompliancefoodpackaging

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

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.

Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food

Specific EU Measure on Plastics
Regulation (EU) 10/2011 Article 2
Covers plastic materials and articles and their parts a. Consisting exclusively of plastic or b. 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.

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.

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

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

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

The Plastic Kitchenware (Conditions of Import from China) Regulations (Northern Ireland)
2011
• Primary aromatic amines
• Formaldehyde.
• Enforced by
District Councils

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

Changes to legislation
• 12 week Consultation started on 20 th
January 2012.
• Consolidation of the food contact materials legislation
• The Materials and Articles in Contact with
Food Regulations (NI) 2012. (Currently being made and proposed coming into operation on 20 th November 2012)

Enforcement of legislation
• Food Standards Agency
• District Council EHOs

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.

END
Any Questions?