On 3 September 2020, the EU published in its Official Journal of the European Union new Regulation (EU) No. 2020/1245, which revised the EU Food Exposure to Plastics Regulation (EU) No. 10/2011.The regulation mainly modifies annexes I, II, IV and V of regulation (EU) No 10/2011.The rules, which take effect 20 days after publication, also give the market a cushion.We remind relevant enterprises to evaluate their products on this update as soon as possible to avoid unnecessary losses.The main amendments are as follows:
Changes about a particular migration
Table 1, "General List of Migration Limits (SMLs) of Substances transferred from Plastic Materials and Products", adds a total of 24 metallic (or corresponding salts) substances, including lanthanum, Europium, gadolinium and terbium.
For primary aromatic amines (PAAs) that are regulated by Article 43 of Appendix XVII of REACH but do not list their migration limits in (EU) No. 10/2011, the amount of PAA migration per item shall not exceed 0.002mg/kg.For PAAs not subject to the control of Article 43 of Appendix XVII of REACH, and for which (EU) No.10/2011 does not list migration limits, the total PAAs migration shall not exceed 0.01 mg/kg.
Regulations for the removal of laboratory and reusable plastics
Defines a new rule for testing the migration of plastics or components in food processing equipment or electrical appliances, that is, plastics materials or components used in food processing equipment or electrical appliances may be subjected to special migration tests in the final product to verify conformity of the product under the most adverse foreseeable conditions.
The migration test for reusable food exposure to plastics and products must be performed three times, each time using fresh simulants, and the results of the latter migration must not be higher than the results of the previous migration.Although the compliance of the migration is determined based on the results of the third migration test, if the results of the migration from the first migration test to the third migration test increase, the compliance of the product cannot be determined, even if the results of any of the three migration tests do not exceed SML.
Update on the full migration condition
The new test condition (40°C, 30 minutes) under test code OM0 is applicable to contact with any food at low temperature or room temperature for not more than 30 minutes.
The word "or reflux" has been added to the OM4 test conditions for migration tests that are technically difficult to complete at 100°C.
Conclusion:
The content of this revision and update is very much, not only the heavy metal migration projects increase, the detection limit of primary aromatic amine is reduced, the reuse product migration conditions are also more complicated.Special attention should be given to melamine materials, which are referred to as "unstable" materials in the standard. Melamine is particularly prone to dissolve formaldehyde and melamine under acidic and thermal contact conditions, and the second and third migrations are usually higher than the first.
GST reminds relevant enterprises to prepare for this update and timely collect relevant information to meet the latest legal requirements to avoid legal disputes.We have a professional technical team to track the latest development of regulations and standards for you, and help you to develop the most comprehensive and economical test plan.If you have any questions about the EU food contact material regulations or other product compliance issues, please feel free to contact us.
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