EU amends (EU) No 10/2011 on food contact material plastic
Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food。
The important changes are as follow：
1. ANNEX II heavy metals and primary aromatic amines (PAAs)
2. Migration rules for plastic materials or components of food processing equipment or electrical equipment.
- The restricted heavy metal elements are updated from the original 9 items (Al, Ba, Co, Cu, Fe, Li, Mn, Zn, Ni) to 24 items.
- For PAAs regulated in Article 43 of REACH ANNEX XVII and unlimited requirements in EU 10 / 2011 - Annex I, the migration of each PAA shall not exceed 0.002 mg / kg. For PAAs which are not regulated by Article 43 of REACH ANNEX XVII and unlimited in EU 10 / 2011 - Annex I, the total migration shall not exceed 0.01 mg / kg.
3. Change migration rules for reusable plastic products
- The food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and
- The migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use.
4. Update overall migration test conditions
- The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.
- The test condition of OM0 -40 ℃ for 30min is added, which is suitable for short-term contact with food at low temperature or room temperature (≤ 30min); Add "or at reflux" to OM4 test conditions.