As of today, September 6th 2018, the new harmonised Regulation on the use of Bisphenol A (BPA) in food contact applications applies fully across the EU. The measure defines the rules for the use of BPA in new areas such as coatings and varnishes used in cans. It also amends the existing plastics Regulation for BPA accordingly, which applies to all polycarbonate plastics in food contact applications. The text published in the Official Journal of the European Union on February 14th 2018 states “This regulation shall be binding in its entirety and directly applicable in all Member States”.
The new Regulation represents a highly protective measure with a lowered Specific Migration Limit (SML). The SML is based on the most recent European Food Safety Authority (EFSA) opinion, and it is science based and very conservative.
This is the first Regulation on Bisphenol A that covers all major food contact applications. It additionally includes precautionary elements for the protection of young children. In essence, it helps to regain consumer trust in the EU regulation and restore a proper functioning of the internal market for food contact materials containing BPA.
Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of BPA in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials
- is applicable to varnishes and coatings, and to plastics.
- defines the SML at 0.05 mg/kg food, based on the EFSA TDI. The new SML already includes an allocation factor considering other exposure routes such as dermal contact assessed in the EFSA opinion.
- allows no migration from coatings and varnishes into food for products intended for young children, as referred to in Regulation (EU) No 609/2013.
- notes in Annex II the changes applicable for plastics in food contact (the new SML 0.05 mg/kg food), and – in addition to the already existing use exception of polycarbonate for infant feeding bottles – broadening it to sippy cups.