Reinforced Restriction on Bisphenol A in Food Contact Materials and Articles

The European Commission published regulations to strengthen the restriction of bisphenol A (BPA) in plastic food contacting materials and articles.

On 14 February 2018, the European Commission has published Regulation (EU) No 2018/213 to strengthen the restriction of bisphenol A (BPA) in plastic food contacting materials and articles as well as to restrict the use of BPA as food contacting varnishes and coatings 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. 

Major changes for BPA Requirement are highlighted as below:

1. Lowered Specific Migration Limit for BPA

• The Specific Migration Limit of BPA in plastic food contact material under the Annex I is lowered from 0.6 mg/kg to 0.05 mg/kg.

2. New prohibition of BPA in polycarbonate(PC) drinking cups or bottles

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

3. New BPA requirements on food contact varnishes and coatings

• The Specific Migration Limit (SML) of BPA from varnishes and coatings intended to come into contact with food is 0.05 mg/kg.
• Referred to in Regulation (EU) No 609/2013, no migration of BPA shall be permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements and milk-based drinks and similar products specifically intended for young children. 
• A written declaration of compliance is required for varnished or coated materials and articles shall be available at all stages of manufacture, processing and distribution other than the retail stage. Supporting documentation and written declaration shall be provided not later than 10 days upon request.

The written declaration shall contain the following information:

1. Identity and address of the business operator issuing the declaration of compliance;
2. Identity and address of the business operator which manufactures or imports the coated material or article;
3. Identity of the varnished or coated material or article;
4. Date of the declaration;
5. Confirmation that the food contact varnish or coating meets the SML for BPA and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;
6. 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