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© FSAI
Food contact materials: Legislation and official controls in Ireland
Dr Bernard HegartyFood Safety Authority of Ireland16 November 2010
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Overview
The Irish legislation on FCMs
Control points for legal compliance
Official controls
Future controls
Food Contact Materials Seminar, 16 November 20102
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Framework Regulation (EC) No 1935/2004
General requirements for all FCM + Mandate for specific measures
SPECIFIC MEASURES
Materials
Substances Ceramics
Regenerated cellulose film
Plastics
Recycled plastics
Active and intelligent Materials
Vinyl chloride monomer
Nitrosamines
BADGE, BFDGE & NOGE
GMP Regulation (EC) No 2023/2006
EU Harmonised laws
3Food Contact Materials Seminar, 16 November 2010
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Food Contact Materials Seminar, 16 November 20104
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
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Food Contact Materials Seminar, 16 November 20105
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.
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Food Contact Materials Seminar, 16 November 20106
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.’
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FCM official controls
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Irish FCM checks to date: end of chain
Primary manufacturers (raw materials)
Manufacturers(raw material to ‘FCM’)
Food industry(Use articles to package food)
Final consumer
Retailers of articles
Converters(‘FCM’ into articles)
IMPORTERS OF FCMs
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Sampling and inspection by food inspectors
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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
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FSAI Retail Forum, 20 October 200910
Effects on migration
Increased temperature Increased contact time Increased contact area Increased % fat in food
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Irish FCM checks 2011: the whole chain
Primary manufacturers (raw materials)
Manufacturers(raw material to ‘FCM’)
Food industry(Use articles to package food)
Final consumer
Retailers of articles
Converters(‘FCM’ into articles)
IMPORTERS OF FCMs
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Checks by NSAI for FSAI
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What will the inspectors be checking?
Food Contact Materials Seminar, 16 November 201012
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Scope of Regulation (EC) No 1935/2004
Primary manufacturers (raw materials)
Manufacturers(raw material to ‘FCM’)
Food industry(Use articles to package food)
Final consumer
Retailers of articles
Converters(‘FCM’ into articles)
IMPORTERS OF FCMs
1935/2004
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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
Food Contact Materials Seminar, 16 November 2010
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Scope of Regulation (EC) No 2023/2006
Primary manufacturers (raw materials)
Manufacturers(raw material to ‘FCM’)
Food industry(Use articles to package food)
Final consumer
Retailers of articles
Converters(‘FCM’ into articles)
IMPORTERS OF FCMs
2023/2006 on GMP
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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 systemIf relevant, specific rules for printing inks and
plastics recycling met? 16Food Contact Materials Seminar, 16 November 2010
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Food Contact Materials Seminar, 16 November 201017
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?
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Food Contact Materials Seminar, 16 November 201018
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 substances3. Date of declaration4. Confirm that FCM complies with Dir 2002/72 & Reg
1935/20045. Information on any substances used for which there are
restrictions under Dir 2002/72 to allow users to comply6. Information on any substances used for which there are
restrictions under food law, to allow users to comply7. 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
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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
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Other specific laws on:
Vinyl chloride monomerDirective 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?
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Food Contact Materials Seminar, 16 November 201021
Other specific laws on:
Certain epoxy chemicalsRegulation (EC) 1895/2005
• Covers plastics, coatings & adhesives
No use of BFDGE or NOGE?Migration of BADGE &
derivatives < SML?Nitrosamines in teats & soothersDir 93/11/EC
• Limits release of N-nitrosamines
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Food Contact Materials Seminar, 16 November 201022
Other specific laws on:
Ceramics Directive 84/500/EECMigration of lead and cadmium
within set limits?Declaration of compliance?
Regenerated Cellulose FilmDirective 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?
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Official controls on FCMs
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Enforcement by Member States
Regulation (EC) 178/2002 requires it for foodRegulation (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
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National Food Control Programme
SFPA HSE
DAFFLocal
Author-ities
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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
Food Contact Materials Seminar, 16 November 201026
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Regulation (EC) No 882/2004 on official controls
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Regulation 882/2004 on official controlsGrants competent authorities rights of access, to
industry’s:• Documentation• Information• Samples
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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 non-
compliance
Account will be taken of extent to which existing voluntary schemes meet FCM law requirements
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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
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Competent authority responsibilities
• Effective official controls• Freedom from conflicts of interest• Adequate staff resources• Appropriate facilities and equipment• Legal powers for enforcement
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Controls on controls
Own checks by FCM industry
Checks by food industry
MS Official Controls
FVO checks
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Summary
Producing safe FCM is an industry responsibilityOfficial controls to ensure it is safe are the
responsibility of the competent authoritiesOfficial 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 toolNSAI will be checking compliance with the
legislation in FCM suppliers
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