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FCM: 12th Amendment to Regulation EU/10/2011

On January 11th, 2019 Regulation EU/2019/37 was published in the Official Journal of the European Union. It concerns the 12th amendment of Regulation EU/10/2011 on plastics for food contact. The amendments reflect the scientific findings previously published by EFSA and concern several adjustments to annex I and annex III of the Regulation.

Regarding Annex I, five changes are made to Table 1, the so-called positive list. On the one hand it concerns an adaptation of four previously authorized substances (FCM 467, FCM 974, FCM 1066 and FCM 1068), on the other hand there are also three new substances added to the list (FCM 1059, FCM 1067 and FCM 1069).

In addition, table 2 is also adjusted by the addition of group restriction N° 35 for the substances FCM 467, 744 and 1059.

A new note (27) was also added regarding the verification of compliance (table 3) and for substance FCM 744, the detailed specifications in table 4 were adapted.

Finally, an adjustment has also been made in point 4 of annex III, in which food simulants are assigned to different food categories for demonstrating compliance with the overall migration limit. This list was already converted itself into a tabular form by regulation EU/2017/752 (table 3). Originally there was, on the one hand, the food category "all aqueous and alcoholic foods and milk products" (row 3) with simulant D1 to perform the testing and, on the other hand, the food category “all aqueous, acidic and alcoholic foods and milk products" (row 4) with simulants D1 and B to perform the testing. This is now adjusted by adding a PH limit and the categories now read as follows:

  • all aqueous and alcoholic foods and milk products with a pH ≥ 4,5 for which category simulant D1 must be used to perform the testing
  • all aqueous and alcoholic foods and milk products with a pH < 4,5 for which category simulants D1 and B must be used to perform the testing.

This Regulation shall enter into force on 31 January 2019.

Plastic materials and articles complying with Regulation EU/10/2011 as applicable before the entry into force of this Regulation may be placed on the market until 31 January 2020 and may remain on the market until exhaustion of stocks.

IBE-BVI members can obtain on simple request Regulation EU/2019/37.