food contact materials
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Food Contact Materials
Mervyn Briggs
Food Standards AgencyNorthern 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
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/eu_legisl_en.htm
General requirement for all contact materialsRegulation (EC) No. 1935/2004
Good Manufacturing Practice Regulation (EC) No. 2023/2006
Specific measures for 3 groups of materials
OrganicFood Contact Plastics Regulation (EU) 10/2011
FibrousRegenerated cellulose film Directive 2007/42
InorganicCeramicsDirective 84/500 as amended
Controls on individual substances
VCM Directive 78/142Vinyl 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 theirfinished 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 measures4. 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. Adhesives3. Ceramics4. Cork5. Rubber6. Glass7. Ion-exchange resins8. Metals and alloys9. Paper and board
10. Plastics (virgin & recycled)
11. Printing inks12. RCF13. Silicones14. Textiles15. Varnishes and
coatings16. Waxes17. Wood
European Food Safety AuthorityProvisions liable to affect public health must be adopted afterconsulting EFSA
Substance authorisation:EFSA will give an opinion within 6 months of an applicationbeing made based on the intended conditions of use of thematerial or article in which it is used. The substance must complywith the safety criteria ( Article 3 and 4).
EFSA web address: http://www.efsa.europa.eu/
Labelling
Materials and articles must be accompanied by1. “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 information5. 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/legalcompliancefoodpackaging
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 proceduresto identify businesses they supply and receive from.
• Goods placed on EU market must be identifiable in a waythat 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/legalcompliancefoodpackaging
Specific EU measures
• Vinyl Chloride monomer (VCM)
• Plastics
• Active and Intelligent materials and articles
• Ceramics
• Regenerated cellulose film
Regulation (EU) 10/2011Council 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.
Vinyl Chloride Monomer (VCM)
Regulation (EU) 10/2011 on plastic materials and articles
intended to come into contact with food
Specific EU Measure on Plastics
Covers plastic materials and articles and their parts
a. Consisting exclusively of plastic orb. 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 comeinto contact with food and are intended for that purpose.
Regulation (EU) 10/2011 Article 2
Plastics Overall Migration Limits(OML)
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.
Regulation (EU) 10/2011 Article 12
Specific Migration Limit (SML)
Where there is no specific migration limit or restriction in Annex 1 the limit is 60 mg/kg
Regulation (EU) 10/2011 Article 11
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
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
Primary legislation• Food Safety (NI) Order 1991
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) 2012. (Currently being made and proposed coming into operation on 20th 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?
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