On September 3, 2020, the Official Journal of the European Union (OJ) published an amendment (EU) No 2020/1245 to Regulation (EU) No 10/2011. The bill mainly deals with (EU) No 10/2011 Annex I, II, Important amendments have been made to IV and V. Up to now, 15 amendments have been made. The bill will come into effect on September 23, 2020. Food contact plastic materials and products that are first put on the market before March 23, 2021 and comply with the old regulations are allowed to continue to be put on the market until September 23, 2022, until the inventory is exhausted.
The important changes are as follows:
- Heavy metal migration: Annex II requirements for heavy metal migration in plastics have been increased from 9 (barium, cobalt, copper, iron, lithium, manganese, zinc, aluminum and nickel) to include the lanthanide series La (Lanthanum), Europium (Europium), and Gd (Gadolinium) , Terbium Tb (Terbium), a total of 24 metal (or corresponding salt) substances;
- Primary aromatic amines (PAAs) special migration: PAAs whose migration limits are not listed in (EU) No 10/2011 Annex I Table 1, for those regulated by Article 43 of Annex XVII of REACH, the migration amount of each PAA shall not exceed 0.002mg/ kg; for PAA that is not controlled by REACH Annex XVII Article 43, the total amount of migration shall not exceed 0.01 mg/kg.
- Compliance determination requirements: the migration test of reusable food contact plastics and products must be carried out three times, each time using a fresh simulant, and the migration result of the latter shall not be higher than the migration result of the previous one. Although the compliance of the migration is determined based on the results of the third migration test, if there is an increase in the migration results from the first migration test to the third migration test, the product compliance cannot be determined, even after the third migration The results of any one test did not exceed SML.
- The increase of the overall migration conditions: the new test number OM0 (40°C, 30 minutes) is added, which is suitable for situations where it is in contact with any food at low temperature or room temperature not exceeding 30 minutes. The word "or reflow" is added to the test conditions of OM4, which is suitable for migration tests that are technically difficult to complete at 100°C.