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On February 14, 2018, the European Commission has published Regulation (EU) 2018/213 in the Official Journal of the EU (OJEU) which strengthens the restriction of Bisphenol A (BPA) in certain food contact materials and articles. This regulation included a new restriction of BPA in food contact varnished and coated materials and articles. In addition, the Annex I of Regulation (EU) No 10/2011 is amended by lowered the migration limit of BPA in plastic food contact materials and articles and included new prohibition of BPA in polycarbonate drinking cups or bottles intended for infant and young children. The new requirements will be applicable from September 6, 2018.
Major Changes for Bisphenol A Requirement
1. Lowered Specific Migration Limit for Bisphenol A
• Specific migration limit for BPA in plastic food contact materials and articles is lowered from 0.6 mg/kg to 0.05 mg/kg.
2. New restriction of Bisphenol A in food contact varnish or coating
• Specific migration limit for BPA in varnishes and coatings intended to come into contact with food is 0.05 mg/kg.
• No migration of BPA shall be permitted from varnishes or coatings applied to materials and articles specifically intended to come into with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/2013.
A written declaration of compliance containing the information laid down in Annex I of the regulation is required for varnished or coated materials and articles. Supporting documentation, such as test results shall be made available to demonstrate compliance with the declaration upon request by national authorities.
3. New prohibition of Bisphenol A in polycarbonate drinking cups or bottles
• BPA should not be used to manufacture polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infant and young children.
Download Bulletin PDF to view table with a summary of the BPA requirement.
Effective date of new requirement: September 6, 2018 (Food contact plastic and food contact varnished or coated materials and articles that were lawfully placed on the market before September 6, 2018 may remain on the market until exhaustion of stocks.)
Commission Regulation (EU) 2018/213
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If you have any comments and/or questions regarding these requirements, please contact your customer service representative.