Experiences of food contact legislation and regulation in … · Bernard Hegarty Created Date:...

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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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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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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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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


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




Final consumer



IMPORTERS OF FCMs


Checks by NSAI for FSAI

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What will the inspectors be checking?


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Scope of Regulation (EC) No 1935/2004




Final consumer



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


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Scope of Regulation (EC) No 2023/2006




Final consumer



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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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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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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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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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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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 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


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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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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


Experiences of food contact legislation and regulation in … · Bernard Hegarty Created Date:...

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