Food contact materials: Legislation and official controls in Ireland Dr Bernard Hegarty Food Safety Authority of Ireland 16 November 2010
Overview The Irish legislation on FCMs Control points for legal compliance Official controls Future controls 2
EU Harmonised laws Framework Regulation (EC) No 1935/2004 General requirements for all FCM + Mandate for specific measures Ceramics GMP Regulation (EC) No 2023/2006 SPECIFIC MEASURES Materials Regenerated cellulose film Plastics Recycled plastics Active and intelligent Materials Substances Vinyl chloride monomer Nitrosamines BADGE, BFDGE & NOGE 3
Legislation on Food Contact Materials European Communities (Plastics and Other Materials) (Contact with Food) Regulations 2007 [S.I. No. 587 of 2007] Amended by SI No 88 of 2009, No 463 of 2009 & No 301 of 2010, to include latest legislation Gives effect to all the EU legislation on food contact materials Defines offences and penalties Defines powers of authorised officers in official agencies NO ADDITIONAL REQUIREMENTS Signposts the relevant requirements 4
Example of sign-posting EU Regs (1) A person who, by act or omission contravenes a) Article 3, 4, 15, 16(1) (subject to Article 27) or 17 of the Framework Regulation, b)article 4, 5, 6, 9, 10, 11, 12 or 13 of the active and intelligent material Regulation, subject to Article 14 of that Regulation, c) Article 4, 5, 6, or 7 of the GMP Regulation, d)article 2, 3, 4 or 5 of the Epoxy Derivatives Regulation, e) Article 2, 3, 4, 5, 7, 8, 10(3), 11, 12, 13 or 14 of the Recycled Plastic Regulation, subject to Articles 14 and 16 of that Regulation, or f) Regulation 3, 4, 5, 6, 7 or 13 of these Regulations, commits an offence and is liable on conviction to a fine not exceeding 5,000 or to imprisonment for a period not exceeding 6 months or to both. 5
Example of sign-posting a Directive 5. (2) From 1 January 2010, a person shall not manufacture or import a plastic material or article intended to come into contact with a foodstuff unless the additive used therein is listed in Annex III to the Plastics Directive or the provisional list referred to in Article 1 of Commission Directive No. 2008/39/EC of 6 March 2008 in accordance with the restrictions specified in that Annex or the provisional list. (3) Paragraph (2) does not apply to the use of an additive permitted by Articles 4c, 4d or 7a of the Plastics Directive. 6
FCM official controls
Irish FCM checks to date: end of chain Primary manufacturers (raw materials) Manufacturers (raw material to FCM ) Converters ( FCM into articles) Food industry (Use articles to package food) IMPORTERS OF FCMs Sampling and inspection by food inspectors Retailers of articles Final consumer 8
Checks in food businesses and retailers Main control: documentation provided by FCM supplier Complies with legal format for particular material? Inclusion of FCM in Hazard Assessment? (Regulation 852/2004, Article 5: HACCP) May involve testing by food business FCM used correctly? These checks are increasing 9
Effects on migration Increased temperature Increased contact time Increased contact area Increased % fat in food FSAI Retail Forum, 20 October 2009 10
Irish FCM checks 2011: the whole chain Primary manufacturers (raw materials) Manufacturers (raw material to FCM ) Checks by NSAI for FSAI IMPORTERS OF FCMs Converters ( FCM into articles) Food industry (Use articles to package food) Retailers of articles Final consumer 11
What will the inspectors be checking? 12
Scope of Regulation (EC) No 1935/2004 Primary manufacturers (raw materials) Manufacturers (raw material to FCM ) 1935/2004 IMPORTERS OF FCMs Converters ( FCM into articles) Food industry (Use articles to package food) Retailers of articles Final consumer 13
1935/2004 official checks Labelling in compliance with Art. 15? Traceability system, for suppliers and business customers? (Art. 17) Safety and effects on food assessed? (Art. 3) Composition, processing & use of FCM Migration tests or modelling Risk assessments, to ensure safe use of FCM Other regulatory approvals EU importer assumes responsibility for compliance [If relevant: requirements for active and intelligent FCMs met? Art. 4] 14
Scope of Regulation (EC) No 2023/2006 Primary manufacturers (raw materials) Manufacturers (raw material to FCM ) 2023/2006 on GMP IMPORTERS OF FCMs Converters ( FCM into articles) Food industry (Use articles to package food) Retailers of articles Final consumer 15
2023/2006 official checks Quality assurance system effective? Considers personnel, their knowledge and skills and organisation of premises and equipment? Specifications for starting materials? Operations done under written instructions and procedures? Quality control system effective? Monitoring GMP? Corrective actions for GMP failures, implemented and documented? Documentation available (paper / electronic)? Specifications, manufacturing formulae and processing Records on manufacturing operations for safety and the QC system If relevant, specific rules for printing inks and plastics recycling met? 16
Plastics Directive 2002/72/EC Are the monomers & starting substances used on the positive list? Are the additives used on the positive or provisional lists? For both, what evidence is there that any Specific Migration Limits are complied with? Migration test results? In accordance with Directives on how testing should be carried out: food simulants, test duration & temperature? Calculations? What evidence is there that the Overall Migration Limit (60 mg/kg food) is complied with? Safety of other substances assessed? (catalysts, colorants, by-products, inks, ) Declaration of compliance, with all points covered? 17
Declaration of compliance for plastics 1. Name and address of EU manufacturer or importer of food contact material, or FCM substances 2. Identity of the plastic material or substances 3. Date of declaration 4. Confirm that FCM complies with Dir 2002/72 & Reg 1935/2004 5. Information on any substances used for which there are restrictions under Dir 2002/72 to allow users to comply 6. Information on any substances used for which there are restrictions under food law, to allow users to comply 7. Specifications for safe use (foods, time/temp, S/V) 8. For plastic multi-layer materials using functional barrier layers, confirmation that finished FCM complies with relevant parts of Dir 2002/72 18
Importance of documentation Danish example: Importers of nylon kitchen utensils from Third Countries Importers with adequate documentation: 10% had high migration of Primary Aromatic Amines (PAA) Importers with poor documentation: 55% had high migration of PAA 19
Other specific laws on: Vinyl chloride monomer Directive 78/142/EEC Covers all PVC FCMs Dirs. 80/766 & 81/432/EEC set test methods for official control Checks: Content of VCM < 1 mg/kg? Migration of VCM < 0.01 mg/kg? 20
Other specific laws on: Certain epoxy chemicals Regulation (EC) 1895/2005 Covers plastics, coatings & adhesives No use of BFDGE or NOGE? Migration of BADGE & derivatives < SML? Nitrosamines in teats & soothers Dir 93/11/EC Limits release of N-nitrosamines 21
Other specific laws on: Ceramics Directive 84/500/EEC Migration of lead and cadmium within set limits? Declaration of compliance? Regenerated Cellulose Film Directive 2007/42/EC Includes RCF uncoated, coated with RCF & coated with plastics Composition of RCF as described? Do any plastic coatings comply with Dir 2002/72/EC? 22
Official controls on FCMs 23
Enforcement by Member States Regulation (EC) 178/2002 requires it for food Regulation (EC) 1935/2004 requires it for FCM Regulation (EC) 882/2004 specifies how it is to be done, for laws on food and feed, including FCMs Responsibility to comply always remains with industry! Enforcement is carried out in Ireland by Official Agencies of the Food Safety Authority of Ireland 24
National Food Control Programme SFPA HSE Local Authorities DAFF
National Standards Authority of Ireland An official agency of the FSAI Service contract in place Already enforces legislation on natural mineral water From 2011, NSAI will be inspecting FCM suppliers, checking compliance with FCM legislation NSAI inspectors trained on details of EU legislation on FCMs 26
Regulation (EC) No 882/2004 on official controls
Regulation 882/2004 on official controls Grants competent authorities rights of access, to industry s: Documentation Information Samples 28
Reg 882 requires risk-based controls Official controls should take account of: Identified risks Issues in the past Reliability of own checks Any information that might indicate noncompliance Account will be taken of extent to which existing voluntary schemes meet FCM law requirements 29
Official control requirements Staff (training, and keeping up to date) Transparency and confidentiality Documented control procedures, verified Reports on the controls, to the industry Comprehensive controls 30
Competent authority responsibilities Effective official controls Freedom from conflicts of interest Adequate staff resources Appropriate facilities and equipment Legal powers for enforcement 31
Controls on controls FVO checks MS Official Controls Checks by food industry Own checks by FCM industry 32
Summary Producing safe FCM is an industry responsibility Official controls to ensure it is safe are the responsibility of the competent authorities Official controls check compliance to: Regulation (EC) No 1935/2004 Regulation (EC) No 2023/2006 on GMP Specific material and substance rules Declaration of Compliance a useful tool NSAI will be checking compliance with the legislation in FCM suppliers 33