Presentation
EU regulation no. 10/2011 on plastics intended for contact with food appeared in the Official Journal on 15/01/2011. This regulation repealed Directive no. 2002/72/EC as well as Directives no. 80/766/EEC and 81/432/EEC. Compared with the regulatory provisions previously in force, the main changes are as follows:
- The scope of the European legislation is extended to multimaterials with a plastic layer, as well as to printed, coated or adhesive-containing plastics;
- The list of authorized substances has been extended to form an exhaustive list for monomers and additives (positive list), and the status of certain other ingredients has been clarified (Polymerization aid substances, colorants, solvents, unintentionally added substances known as "NIAS", nanoparticles, dual-use additives);
- Terms for checking the conformity of materials and articles have been modified, completed and clarified (List of simulants, migration test conditions);
- Lists of monomers, starting substances, additives, polymer production aids and macromolecules obtained by microbial fermentation, authorized in the manufacture of plastics;
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Exemptions applicable to substances not on the list of authorized substances;
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Specific migration limits applicable to certain authorized substances (in mg/kg of food);
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Overall migration limit applicable to materials made solely of single- or multi-layer plastics (10 mg/dm² of material except for materials in contact with children's food, for which the limit is 60 mg/kg of food);
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Written declaration of conformity to be drawn up at stages other than retail sale;
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Supporting documentation to demonstrate compliance with legal requirements;
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Rules for checking compliance with migration limits.
A provisional list of additives to be re-evaluated by EFSA supplements the list of substances in Annex I of the regulation.
Regulation (EU) No. 10/2011 has been the subject of 16 amendments.
AMENDMENTS
Regulation (EU) n° 321/2011 of 01/04/2011 concerns the ban on bisphenol A in polycarbonate baby bottles. This text follows the publication of Directive n°2011/8/EC, on 29/01/2011, which had already amended Directive n°2002/72/EC along these lines.
Regulation (EU) No 1282/2011 of 28/11/2011 concerns the modification of the SML of 2,4,6-triamino-1,3,5-triazine (melamine) to 2.5 mg/kg feed.
Regulation (EU) n° 1183/2012 of 30/11/2012 concerns the reintroduction into Regulation (EU) n° 10/2011 of CAS number 0025265-71-8 referring to dipropylene glycol. In addition, the note on conformity control bearing No. 4 in table 3 of annex 1 of the same regulation has been amended by replacing simulant D with D2.
Regulation (EU) No 202/2014 of 03/03/2014 specifically concerns the addition of two substances (2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine and 1,3-bis(isocyanatomethyl)benzene) to the positive list of Table 1 (MCDA Nos 872 and 988) of Regulation (EU) No 10/2011.
Regulation (EU) n°865/2014 of 08/08/2014 corrects the Spanish version.
Regulation (EU) No 2015/174 concerns the addition of new substances to the positive list of the Plastics Regulation, the amendment or correction of certain SMLs or the extension of the use of certain substances.
The main aims of Regulation (EU) No 2016/1416 are to correct errors or incomplete provisions concerning authorized substances, to add new substances to the EU list, to amend or supplement the control rules in the Regulation's annexes, etc.
Regulation (EU) n° 2017/752 concerns in particular the authorization of several substances, clarification of the text corresponding to point 4 of Annex III and point 8 iii) of Annex IV of the regulation.
Regulation (EU) No 2018/79 of 18/01/2018 concerns the authorization of new substances in the EU list of the Plastics Regulation.
Regulation (EU) No 2018/213 of 12/02/2018 relates to the use of bisphenol A (BPA) in varnishes, coatings and in plastic materials and articles intended to come into contact with food.
Regulation (EU) No 2018/831 of 5/06/2018 concerns the amendment and authorization of new substances in the EU list of the Plastics Regulation.
Regulation (EU) No 2019/37 of 10/01/2019 concerns the amendment and authorization of new substances in the EU list of the Plastics Regulation.
Regulation (EU) n° 2019/988 of 17/06/2019 rectifies the French version.
Regulation (EU) No 2019/1338 of 08/08/2019 amends the restrictions on the use of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) listed in Annex I to Regulation (EU) No 10/2011.
Regulation (EU) No. 2020/1245 of September 02, 2020 carries numerous amendments and rectifications concerning the articles and Annexes I , II, IV and V of Regulation (EU) No. 10/2011.
Regulation (EU) No. 2023/1442 of July 11, 2023 amends the list of authorized substances in Annex I of the Plastics Regulation. It modifies certain substance authorizations (e.g. deletion of wood flour) and adds new substances. In particular, it modifies the specific migration limits (SMLs) for 5 phthalates (BBP, DBP, DEHP, DIDP and DINP).