EUROPEAN COMMISSION
HE ALTH AND CONSUME RS DIRE CTORATE-GENERAL
Safety of the Food chain
Innovation and sustainability
Brusls, 21.02.2014
Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact
with food
TABLE OF CONTENTS
1INTRODUCTION (4)
1.1Purpo of the Guidance document (4)
wlfl2CHAPTER I – GENERAL PROVISIONS (4)
2.1Subject matter and scope (4)
2.2Definitions (7)
2.3Placing on the market of plastic materials and articles (11)
3CHAPTER II - COMPOSITIONAL REQUIREMENTS (11)
3.1Union list of authorid substances (11)
3.1.1Union list (11)
3.1.2Addition of new substances to the Union list (13)
3.2Derogations for substances not included in the Union list (13)
体育课3.2.1Polymer production aids (PPA) (14)
贴春联的来历
3.2.2Salts of authorid acids, alcohols and phenols (14)
3.2.3Mixtures (14)
3.2.4Polymeric additives (14)
3.2.5Polymeric starting substances (14)
3.3Substances not included in the Union list (14)
3.3.1Aids to polymerisation (15)
3.3.2Non-intentionally added substances (NIAS) (17)
3.3.3Stabilirs in monomers, starting substances and additives (17)
3.3.4Coatings, printing inks and adhesives (17)
3.3.5Colorants (18)
除水垢的方法哪种最有效3.3.6Solvents (18)
3.4The status of antimicrobial substances (18)
3.5Establishment and management of the provisional list of additives (19)
3.6General requirements on substances (20)
3.6.1Specifications and restrictions for substances, materials and articles (20)
3.6.2Specific migration limits (SMLs) (22)
3.6.3Dual-u additives (22)
3.6.4Overall migration limit (OML) (27)
4CHAPTER III - SPECIFIC PROVISIONS FOR CERTAIN MATERIALS AND ARTICLES (28)
4.1Plastic multi-layer materials or articles (28)
4.2Multi-material multi-layer materials or articles (29)
4.3Set-off in the ca of multi-layer materials or articles (29)
5CHAPTER IV - DECLARATION OF COMPLIANCE AND DOCUMENTATION (30)
5.1Declaration of compliance (DoC) (30)
5.2Supporting documentation (31)
6CHAPTER V - COMPLIANCE (31)
6.1Expression of migration test results (31)
6.2Testing of migration (32)
6.3Asssment of substances not included in the Union list (32)
7CHAPTER VI - FINAL PROVISIONS (33)
7.1Amendments of EU acts (33)
7.2Repeal of EU acts (33)
7.3Application and transitional provisions (34)
8ANNEX I - SUBSTANCES (40)
西汉丞相8.1Union List of authorid monomers, other starting substances, macromolecules obtained from microbial fermentation, additives, and polymer production aids (Table 1) . 40 8.2Group restriction of substances (Table 2) (42)尽道
8.3Notes on verification of compliance (Table 3) (42)
8.4Detailed specification on a substance (Table 4) (43)
9ANNEX II - RESTRICTIONS ON MATERIALS AND ARTICLES (43)
10ANNEX III - FOOD SIMULANTS (43)
11ANNEX IV - DECLARATION OF COMPLIANCE (44)
12ANNEX V - COMPLIANCE TESTING (44)
13ABBREVIATIONS (44)
1Introduction
lol官方助手
1.1 Purpo of the Guidance document
This Guidance document is part of a ries of documents to provide guidance on application of Regulation (EU) No 10/20111 on plastic materials and articles intended to come into contact with food (the "Plastics Regulation"). The ries covers the prent general guidance, guidance on migration testing (in preparation), guidance on migration modelling2 and guidance on information in the supply chain3.
This Guidance document covers general aspects of the Plastics Regulation. It is structured in the same manner as the Plastics Regulation itlf. It contains in particular:
∙explanations on what is covered by the Plastics Regulation and what is not,
∙definitions of terms that relevant in the context of food contact materials and articles, ∙function categories of additives and polymer production aids,
∙explanations which substances are included in the Union list,
∙explanations why substances are exempted from inclusion in the Union list and applicable provisions for the substances,
∙status of biocides in plastic food contact materials and articles,
∙explanations on dual u additives and an indicative list of dual u additives,
∙explanations on the transitional provisions.
The Plastics Regulation is a specific measure for plastic food contact materials and articles adopted pursuant Article 5 of Regulation (EC) No 1935/20044 on materials and articles intended to come into contact with food (the “Framework Regulation”). It consolidates the previous Directives on plastic food contact materials and articles into one Regulation and simplifies the rules applicable to them.
2Chapter I – General provisions
2.1 Subject matter and scope
The Plastics Regulation applies to plastic materials and articles as t out in the scope. Plastic materials and articles include the following types of products:
∙plastic intermediate materials (e.g. resins and films for further conversion) and tho which already have their final composition, but still require mechanical re-shaping to reach their final article shape, without any modification of the formulation (e.g.
thermo-formable sheets and bottle pre-forms);
1 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).
2 "Applicability of generally recognid diffusion models for the estimation of specific migration in support of Directive 2002/72/EC" uropa.eu/our_labs/eurl_food_c_m/guidance-documents.手足的成语
3"Union Guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain" ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/guidance_reg-10-2011_en.pdf.
4 Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
∙final plastic food contact material or article ready to come into contact with food (e.g.
packaging material, food storage container, kitchenware or utensil, plastic part in food-processing m
achinery, food preparation surface, inner surface of fridge, baking trays);
∙finished plastic components of the final food contact material or article which only need to be brought together or asmbled, either during packing/filling o r before, to make the final article (e.g. bottle and cap, tray and lid, parts of kitchenware or food processing machinery);
∙plastic layers inside a finished multi-material multi-layer.
Plastic materials covered by the scope of the Plastics Regulation are bad on synthetic polymers and synthetic or natural polymers that have been chemically modified. Natural polymers that have not been chemically modified are not covered by the scope of the Plastics Regulation. The Plastics Regulation also covers plastics bad on polymers manufactured by microbial fermentation.
The Plastics Regulation covers bio-bad and bio-degradable plastics if they are manufactured with synthetic polymers, chemically modified natural or synthetic polymers or polymers manufactured by microbial fermentation. For example, a material bad on modified starch is covered by the scope of the Plastics Regulation, while a material bad on natural macromolecule that is not chemically modified, such as non-modified starch, is not covered by the scope of the Plastics Regulation. Adding an additive to a natural macromolecule is not a chemical modification. The chemical modifica
tion has to occur to the macromolecule itlf. Plastics manufactured with the u of monomers or oligomers obtained by the so-called “chemical recycling" process and manufactured with the u of production scraps are also covered by the Plastics Regulation. Plastics manufactured with recycled plastics from mechanical recycling process are also covered by Regulation (EC) No 282/20085 on recycled plastic materials and articles intended to come into contact with foods, with the exception of tho parated from food by a functional barrier layer.
The definition of plastics6 in Article 3 (2) of the Plastics Regulation is quite broad. Following this definition, in principle rubber, silicones and ion exchange resins would be within the scope of the Plastics Regulation. However, as the provisions t out for plastics are not necessarily applicable to the materials and they may, in time, be covered by other specific measures, tho other materials mentioned above are in Article 2 (2) explicitly excluded from the scope of the Plastics Regulation.
Plastic materials and articles are covered by the scope of the Plastics Regulation when they are coated with an organic or inorganic coating or when they are printed. Plastic materials are covered by the scope of the Plastics Regulation when they consist of veral plastic layers which are bound together by adhesives. However, the rules t o ut in the Plastics Regulation for printing inks, adhesives and coatings ud in plastics are only tho with regard to their contribution to the migrati
on from the plastic material and article. The Plastics Regulation does not t compositional requirements to printing inks, adhesives and coatings7. Rules for 5 Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended t come into contact with foods and amending Regulation (EC) No 2023/2006, (OJ L 86, 28.3.2008, p.9).
6 "Plastic" means polymer to which additives or other substances may have been added, which is capable of functioning as a main structural component of the final materials and articles.
7 Except for tho coatings which form gaskets in caps and closures that are explicitly listed in Article 2 (1) (d)
as falling within the scope of the Plastics Regulation.
