understanding the eu legislation on food contact materials

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Understanding the EU Legislation on Food Contact Materials

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Today’s Presenters

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James CalderAssent ComplianceDirector, Compliance Programs







INTRODUCTION







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Lists

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Feature PresentationFood Contact Materials in the EU







EU Food Contact Regulations Focus on the Framework Regulation creating a general mandate for all food contact materials (FCM) and other specific measures related to FCMs.

This is known as the Framework Regulation No 1935/2004.

The principle underlying this regulation is that any material or article intended to come into contact with food, directly or indirectly, must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health, or to bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties

Organoleptic - Organoleptic properties are the aspects of food, water or other substances that an individual experiences via the senses — including taste, sight, smell, and touch.

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What Is a Food Contact Material?

Food Contact Materials

Materials with direct and indirect contact with food

⬥ Containers for transporting food⬥ Machinery to process food⬥ Packaging materials⬥ Kitchenware and tableware

The term does not cover fixed public or private water supply equipment.

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Legal Structure

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Framework Regulation (EC) No. 1935/2004

(GMP) Regulation (EC) No. 2023/2006

Specific measuresNational Consumer Goods Ordinance

Materials

• Ceramics• Regenerated cellulose• Plastic• Recycled plastic• Active and intelligent materials

• Nitrosamines• BADGE, BFDGE & NOGE• Bisphenol A

Including:• Adhesives• Gums• Glass• Metals & alloys• Ion exchange resins• Paper & boards• Printing inks• Wood• Textiles• Lacquers/coatings• Waxes

*no specific regulation

Substances Materials *







Framework Regulation (EC) No 1935/2004⬥ For special rules on active and intelligent materials

(they are by their design not inert)

⬥ Powers to enact additional EU measures for specific materials (e.g. for plastics)

⬥ The procedure to perform safety assessments of substances used to manufacture FCMs involving the European Food Safety Authority

⬥ Rules on labelling including an indication for use (e.g. as a coffee machine, a wine bottle, or a soup spoon) or by reproducing the appropriate symbol. For more information, please refer to the following document on Symbols for labelling food contact materials.

⬥ For compliance documentation and traceability

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http://www.efsa.europa.eu/en/topics/topic/foodcontactmaterials

http://www.efsa.europa.eu/en/topics/topic/foodcontactmaterials

https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_legis_fcm-symbols.doc

https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_legis_fcm-symbols.doc


Regulation on Good Manufacturing ProcessesRegulation (EC) No 2023/2006 ensures the manufacturing process is well controlled so the specifications for FCMs remain in conformity with the legislation:

⬥ Premises fit for purpose and staff awareness of critical production stages

⬥ Documented quality assurance and quality control systems maintained at the premises

⬥ Selection of suitable starting materials for the manufacturing process with a view to the safety and inertness of the final articles

⬥ Good manufacturing rules apply to all stages in the manufacturing chain of food contact materials, although the production of starting materials is covered by other legislation

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http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R2023-20080417


Legislation on Specific Materials

Ceramics

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Plastic Materials Active & Intelligent Materials

Recycled Plastic Materials

Regenerated Cellulose Film







Plastic MaterialsRegulation No 10/2011⬥ Ensures the safety of plastic materials is the use of migration limits⬥ These limits specify the maximum amount of substances allowed to migrate to food⬥ For the substances on the Union list the regulation sets out 'Specific Migration Limits' (SML)

These are established by the European Food Safety Authority (EFSA) on the basis of toxicity data of each specific substance. To ensure the overall quality of the plastic, the overall migration to a food of all substances together may not exceed the Overall Migration Limit (OML) of 60mg/kg food, or 10 mg/dm2 of the contact material

A 'Declaration of Compliance’ (DoC) needs to be provided.

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The DoC is based on supporting documentation which documents the reasoning on the safety of a plastic food contact material, and which must be provided to enforcement authorities on their request. The supporting documentation also provides an important link to the manufacturer's responsibility under GMP (Regulation (EC) No 2023/2006).






http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32006R2023


Active & Intelligent MaterialsActive and intelligent materials extend the shelf-life of food by maintaining or improving the condition of packaged food. To accomplish this, they release or absorb substances to or from the food or its surrounding environment.

As a result, these substances are exempted from the general inertness rule in Regulation (EC) No 1935/2004. The specific rules in Regulation (EC) No 450/2009 apply to address their specific purpose, e.g.:⬥ absorption of substances from food packaging interior such as liquid and oxygen⬥ release of substances, such as preservatives, into the food⬥ indicate expiry of food through labelling that changes colour when maximum shelf-life or storage

temperature is exceeded

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Active materials do not include systems that absorb substances entering from the atmosphere, such as active oxygen barriers.

Regulation (EC) No 450/2009 foresees the establishment of a Union list of substances permitted for the manufacture of active and intelligent materials.








Recycled Plastic MaterialsRegulation (EU) No 10/2011 sets out criteria for the composition of new plastic materials.

However, after these materials have been used, they do not comply anymore to the plastic regulation as they may have been contaminated with other substances.

Therefore, a separate regulation exists to control the recycling processes: Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods.

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http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:02011R0010-20150226




CeramicsDirective 84/500/EEC — approximating EU countries' laws on ceramic articles intended to come into contact with foods.

Concerns the possible migration of lead and cadmium from ceramic articles which, in their finished state, to FCM.

Annexes provide specific test conditions.

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http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31984L0500


Regenerated Cellulose FilmRegenerated cellulose film is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

Directive 2007/42/EC — materials and articles made of regenerated cellulose film intended to come into contact with foods.

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http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32007L0042


Legislation on Specific Substances

Certain epoxy derivatives in materials and articles intended to come into contact with food.

Release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers.

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Legislation on Specific SourcesProducts originating or consigned from China or Hong Kong.

Kitchenware made of melamine or polyamide originating or consigned from China or Hong Kong must comply with the import rules of Regulation EU No 284/2011.

⬥ Consignments must be notified to the competent authorities at the entry points at least two days prior to arrival

⬥ Consignments must have a declaration and a laboratory report on the analysis of primary aromatic amines (for polyamide) and formaldehyde (for melamine)

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https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_legis_decl-compl-284-2011_template.doc


Database of Food Contact Materials

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Declaration of ComplianceFramework Regulation, the “declaration of compliance,” is the written confirmation that the food contact materials comply with the rules applicable to them.

Such a document is obligatory as long as this has been stipulated in so-called “specific measures”, i.e. specific rules on materials.

Moreover, Article 16 states that the declarations of compliance shall be supported by appropriate documentation to demonstrate the compliance.

That documentation shall be made available to the competent authorities on demand.

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Declaration Of Compliance

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Manufacturerintermediate products/raw

materials for plastic

Manufacturerfood contact material

Traderfood contact material

Importerfood contact material

Manufacturerother intermediate products

(adhesives, printing inks, etc.)

User/packerpacked food

Retailpacked food

food contact material

Final consumer

Importerpacked food

Flow of goods for food contact materials, their intermediate products and raw materials

Declaration of compliance

Flow of goods of packed food

Information/confirmation on suitability/information on composition/status of other intermediate products not subject to the scope of Regulation (EU) No.10/2011







EU Plastics Regulation DoC

“At all marketing stages other than the retail stage, a written declaration (...) shall be made available (...).” This also applies to intermediate products and raw materials.

The declaration shall be issued by the business operator and shall contain the information laid down in Annex IV of the Regulation.

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The business operator shall make available to the national competent authorities upon request appropriate documentation (supporting documents) that demonstrate compliance (“conditions and results of testing, calculations, other analysis, and evidence on the safety or reasoning demonstrating compliance”).







TestingWithin the scope of the declaration of compliance, the issuing manufacturer must state which of the following applications are covered by the declaration based on the tests performed:⬥ goods to be packed⬥ packaging technologies⬥ food contact conditions (volume/time/temperature)

Furthermore, it should be stated that in the case of other uses,the user themself has to verify suitability.

From Jan 1st, 2016, Regulation (EU) No 10/2011 takes exclusive effect and the declaration of compliance has to be adapted accordingly.

You can no longer use guidance from Directives 82/711/EEC and 85/572/EEC.

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1JANUARY







Due DiligenceIn principle, the declaration of compliance provided by the manufacturer of a food contact material or articles does not release the downstream user from the exercise of due diligence.

The manufacturer has to guarantee the specific application complies with relevant migration limits until the expiration of the best-before date, and must verify this on a random basis, if necessary, or have it tested in agreement with the supplier.

The declaration of compliance is founded on trust in the presumption of legality but it does not cover all imaginable applications. The downstream user has to take into consideration that the declaration of compliance is only binding for the characteristics assured in the document.

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Summary

⬥ Establish if any materials, products, parts, or processes are captured within Food Contact Legislation.

⬥ Establish internal compliance requirements (testing, GMP, documentation control, etc).

⬥ Establish supply chain communication process.

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Upcoming Events: Webinars & Conferences

Learn more about Assent events:www.assentcompliance.com/events

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[Webinar] Compliance Essentials: Company & Supply Chain EducationThursday, November 3rd | 1 PM EDT

Upcoming Educational SummitsNovember 17, 2016 | BostonFebruary 8, 2017 | San Jose

Restricted Substance & Product Compliance ForumDecember 1, 2016 | Chicago






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Q&A Discussion

Questions?

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AppendixFor Reference Only







Legal Structure

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Declaration Of Compliance

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