On the 29th of April 2017 the European Commission published Regulation (EU) 2017/752[1] amending Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food. (EU) 2017/752 updates the list of authorized Substances in Annex I of (EU) 10/2011 adding a restriction on nickel, and adjusts the food simulant assignment for testing overall migration into table form. (EU) 2017/752 shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The restriction on nickel shall apply from the 19th of May 2019.
The main amendment
(1). The authorized Substances list in Annex I of (EU) 10/2011 is amended as follows:
(a) in point 1, Table 1 is amended as follows: (i) in column 11 as regards the entries for the substances with FCM substance numbers 142, 168, 202, 387, 462, 467, 481, 502, 662 and 779, the reference to note ‘(1)’ is deleted; (ii) inserted six substances in numerical order of the FCM substance numbers
(b) in point 3, in Table 3, the following entry is added:
| ‘(24) | The substance or its hydrolysis products are authorised food additives and compliance with Article 11(3) shall be verified’; |
(2). in point 1 of Annex II, the following line is inserted after Manganese:
‘Nickel = 0,02 mg/kg food or food simulant.’;
(3). in Annex III, point 4 is replaced by the following:
4. Food simulant assignment for testing overall migration
For tests to demonstrate compliance with the overall migration limit food simulants shall be chosen as set out in Table 3:
Table 3
Food simulant assignment for demonstrating compliance with the overall migration limit
| Foods covered | Food simulants in which testing shall be performed |
| all types of food | 1. distilled water or water of equivalent quality or food simulant A (Ethanol 10 % (v/v)); 2. food simulant B (Acetic acid 3 % (w/v)); and 3. food simulant D2 (Vegetable oil ). |
| all types of food except for acidic foods | 1. distilled water or water of equivalent quality or food simulant A (Ethanol 10 % (v/v)); and 2. food simulant D2 (Vegetable oil ). |
| all aqueous and alcoholic foods and milk products | food simulant D1 (Ethanol 50 % (v/v)) |
| all aqueous, acidic and alcoholic foods and milk products | 1. food simulant D1 (Ethanol 50 % (v/v)); and 2. food simulant B (Acetic acid 3 % (w/v)) |
| all aqueous foods and alcoholic foods up to an alcohol content of 20 % | food simulant C (Ethanol 20 % (v/v)) |
| all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 % | 1. food simulant C (Ethanol 20 % (v/v)); and 2. food simulant B (Acetic acid 3 % (w/v)).’ |
(4). in Annex IV, point 8(iii) is replaced by the following:
‘(iii) the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Article 17 and 18 or equivalent information;’
Implementation time and transition period
(1) (EU) 2017/752 shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(2) The restriction of nickel shall apply from 19 May 2019.
(3) Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 19 May 2018 and may remain on the market until exhaustion of stocks.
Suggestion：
(EU) 10/2011 has been revised 8 times since it was issued in 2011. The first six amendment focus on the authorized substances in Annex 1. The seventh amendment (EU) 2016/1416 published on august 2016 has greater impact. (EU) 2016/1416 revised the authorized substances in Annex 1 clarified and corrected some definitions; re- restricted the migration of heavy metals and adjusted the test conditions of specific migration.