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The European Commission adopted legislation on 12 February 2018 that establishes a new specific migration limit (SML) for bisphenol A (BPA) used in varnishes and coatings for food contact (FC) applications and significantly reduces the existing migration limit in the entry for BPA in the Food Contact Plastics Regulation (2011/10/EU).
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Published in the EU Official Journal on 14 February 2018, Regulation 2018/213/EU establishes several requirements for placing on the market FC products treated with varnishes or coatings containing 2,2-bis(4-hydroxyphenyl)propane, or BPA. Specifically, the migration of BPA into or onto food from varnishes or coatings applied to materials and articles is not allowed to exceed the SML of 0.05 milligram per kilogram of food (mg/kg).
For products intended to come in contact with food for infants, babies and young children, the migration of BPA to the food is banned altogether.
The new legislation also stipulates:
- Testing requirements to verify such FC products are in compliance;
- The format of written declarations of compliance accompanying the FC products;
- How the declarations must be documented; and
- Relevant supporting documentation on compliance must be made available to relevant competent authorities upon request.
Additionally, the regulation amends the general entry for BPA in Annex I, the Union list of authorized substances, to Regulation 2011/10/EU, reducing the existing SML from 0.6 mg/kg to 0.05 mg/kg. Also added to the entry is a restriction that excludes the use of BPA for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants and young children.
Companies have until 6 September 2018 to adjust their manufacturing processes to comply with the new restrictions.
Varnished or coated materials and articles and plastic materials and articles duly placed on the market before 6 September 2018 may remain on the market until exhaustion of stocks.