REGULATION (EU) NO. 2020/1245 - 15th AMENDMENT OF REGULATION (EU) N. 10/2011

From 23 September 2020 become effective the Regulation (EU) No. 2020/1245, published by the European Commission on 2 September 2020, which modifies and rectifies Regulation (EU) No. 10/2011 concerning plastic materials and objects intended to come into contact with food products (MOCA).

Based on the recent scientific opinions of EFSA (European Food Safety Authority), it modifies the Annex I, II, IV and V of Regulation (EU) No. 10/2011.

The following are the main innovations introduced:
– addition of new metals with specific migration limit (SML) to the list of Annex II: Arsenic, Cadmium, Chromium, Lead, Mercury and Antimony and four lanthanides (Lanthanum, Europium, Gadolinium and Terbium); the sum of these lanthanides must not exceed the SML of 0.05 mg/kg as sum;
– for primary aromatic amines listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No. 1907/2006 the limit of detection was lowered to 0.002 mg/kg; for unlisted primary aromatic amines, the sum as specific migration must not exceed 0.01 mg/kg;
new test condition for overall migrations (OM0) for any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes).
– new approach of conformity assessment for items intended for repeated use with particular regard to the specific migrations;
– new dispositions to carry out migration tests for food processing equipment or an appliance, considering the whole machinery.

The Regulation (EU) No. 2020/1245 has a transitional period that allows companies to adapt to the new dispositions.

Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and which were first placed on the market before 23 March 2021 may continue to be placed on the market until 23 September 2022 and remain on the market until the exhaustion of stocks.

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