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 contact materials Regulation (EC) No. 1935/2004 Good Manufacturing Practice Regulation (EC) No. 2023/2006 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 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?