European Commission has published Regulation 2018/213 to approve the restrictions on the use of bisphenol A (BPA) as food contacting varnishes and coatings and as a component of plastic food contact materials and articles (FCM) under Regulation (EU) No 10/2011. The restrictions shall apply from 6 September 2018. The affected products that were lawfully placed on the market before the date may remain on the market until stock exhaustion.

Amendments to Regulation (EU) No 10/2011

1.The SML of BPA in plastic FCM under the “union list of authorised monomers” in Annex I to Regulation No 10/2011 shall be lowered to 0.05 mg/kg.

2.The BPA prohibition under Regulation No 10/2011 shall be extended from polycarbonate infant feeding bottles to polycarbonate drinking cups or bottles with spill proof characteristics for infants and young children.

New BPA restrictions on food contact varnishes and coatings

1.The specific migration limit (SML) of BPA from varnishes or coatings applied to FCM shall be 0.05 mg/kg of food. However, no migration shall be permitted from varnishes and coatings applied to materials and articles specifically intended to come into contact with the following food for infants and young children as referred to in Regulation (EU) No 609/2013:

   • Infant formula

   • Follow-on formula

   • Processed cereal-based food

   • Baby food

   • Food for special medical purposes developed to satisfy nutritional requirements of infants and young children

   • Milk-based drinks and similar products specifically intended for young children

2.The rules for compliance testing of the SML shall be referred to Regulation No 10/2011.

3.Varnished or coated FCM shall be accompanied by a written declaration of compliance, which shall be available at all stages of manufacture, processing and distribution other than the retail stage. Upon request of a national competent authority, appropriate supporting documentation to demonstrate compliance with the written declaration shall be provided not later than 10 days following the receipt of the request.

4.The written declaration shall contain the following information:

a. Identity and address of the business operator issuing the declaration of compliance;

b. Identity and address of the business operator which manufactures or imports the coated material or article;

c. Identity of the varnished or coated material or article;

d. Date of the declaration;

e. Confirmation that the varnish or coating applied to the material or article meets the SML for BPA and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;

f. Specifications on the use of the coated material or article, such as:

  Type or types of food with which it is intended to be put into contact;

  Time and temperature of treatment and storage in contact with food;

  The highest food contact surface area to volume ratio for which compliance has been verified in accordance with Articles 17 and 18 of Regulation (EU) No 10/2011 or equivalent information.