In view of the publication by the European Food Safety Authority of further scientific advice on certain substances that can be used in plastic materials and articles intended to come into contact with foodstuffs and to identify some drafting errors and of ambiguities present in the current legal text, the European Commission has modified the above mentioned Community legislation, accepting the indications of scientific opinions and correcting the errors in this text.

The European Commission, with EU Regulation of 10 January 2019 n. 37, amended the Community legislation regulating the production of plastic materials and objects intended to come into contact with food products.

The Regulations come into force on 31 January 2019.

Provisions envisaged by Regulation no. 2019/37

The Regulation in question, which became necessary in the face of:

• of the indications received from the European Food Safety Authority, concerning:

-) the publication of further scientific advice on certain substances that can be used in food contact materials (MCA), as well as on the permitted use of previously authorized substances;
-) the use of some authorized substances;

• the identification of some drafting errors and ambiguities in the text;

provides for the modification, in the regulations concerning materials and objects of plastic material intended to come into contact with food products, of the provisions concerning:

• the Union list of authorized substances that can be used in the manufacture of the products in question;
• food simulants that must be used in tests to demonstrate the conformity of plastic materials and objects not yet in contact with foodstuffs at the planned migration limits.

Information on changes to the list of authorized substances that may be used in the manufacture of MOCA plastics

The change shown:

• in the list of authorized monomers, of the other starting substances, of the macromolecules obtained by microbial fermentation, of the additives and of the adjuvants of the polymerization process, it refers:

-) for the substitution of the entries concerning MCA substances:
*) n. 467 - crotonic acid;
*) n. 744 - copolymer of 3-hydroxybutanoic acid and 3-hydroxy pentanoic acid;
*) n. 1066 - 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylate of dimethyl;
*) n. 1068 - [3- (2,3-epoxypropoxy) propyl] trimethoxysilane;
-) for the introduction of the new MCA substances:
*) n. 1059 - poly [(R) -3-hydroxybutyrate-co- (R) -3-hydroxyhexanate);
*) n. 1067 - dimethylcarbonate;
*) n. 1069 - isobutane;

• in the list of restrictions by group of substances, concerns the introduction of the references of substances with numbers 467, 744 and 1059 and providing for the total specific migration limit (relating to the sum of the substances in the group in question) of 0 , 05 mg of substance per kg of foodstuff;
• in the notes on the verification of compliance (8), refers to the introduction of the new note no. "(27)";
• in the list concerning the detailed specification of substances, refers to the replacement of the restriction line of the substance MCA n. 744 - copolymer of 3-hydroxybutanoic acid and 3-hydroxy pentanoic acid.

Indications regarding changes to the list of food simulants

The changes made to the list of food simulants to be used in tests to demonstrate the conformity of plastic materials and articles not yet in contact with foodstuffs at the migration limits (10), concerns the specification of the type of proof that it must be carried out in dairy products according to the type of pH detected (≥ or

Transitional provisions

The Regulation in question allows the materials and objects made of plastics produced according to the provisions in force up to 31 January 2019, the possibility of being able to be placed on the market until 31 January 2020 and remain on the market until the stocks are exhausted.