EU Regulation (EU) No 2018/213 on food contact materials reduces BPA restrictions

Last year, a draft regulation on the use of bisphenol A varnish and coatings in food contact was published, and the regulation (EU) No 10/2011 on the use of this substance in plastic food contact materials was revised. Now, the European Commission (EC) published its final Commission Regulation (EU) 2018/213 in the Official Gazette on February 14, 2018. This regulation further restricts the use of bisphenol A (BPA) in certain food contact materials. In the "Plastic Regulation" 10/2011, specific migration limits (SML) for BPA in varnishes and coatings were established, and the SML for BPA was revised.

Although this regulation applies to food packaging, it also indirectly affects packaging materials used for oral and topical medicines - as these packaging materials need to comply with food regulations (such as the European Guidelines for Plastic Direct Packaging Materials). For example, BPA is commonly used as a starting material for aluminum tube inner coatings (epoxy resins) and aerosol cans. So far, the "Plastic Regulations" of 10/2011 have not been applicable to varnishes and coatings. Specifically, Regulation No. 2018/213 stipulates that the SML of varnish and coating per kilogram of food (or food simulants) is 0.05 mg BPA. For paints and coatings intended specifically for use in contact with infant formula, subsequent formula, processed grain foods, BPA migration is not allowed (detection limit=0.01 mg/kg), infant food, or food with special medical requirements for infants and young children. Regarding the "Plastic Regulation" on 10/2011, the new BPA regulation reduces the SML of BPA from 0.6 mg/kg to 0.05 mg/kg and expands the ban on using BPA to manufacture polycarbonate baby bottles to polycarbonate drinking cups or bottles, which are suitable for infants and young children due to their spill proof properties.
The regulation also stipulates that operators should ensure that painted or coated materials/items are accompanied by a written Declaration of Compliance (DoC), which is available at all stages of manufacturing, processing, and distribution beyond the retail stage.


The DoC contains the following specific information as specified in Annex I of the regulations:

1. The identity and address of the operator issuing the DoC;
2. The identity and address of the operator who manufactures or imports coating materials/products
3. Characteristics of painting or coating materials/products;
4. Announce the date;
5. Confirm that the varnish or coating applied to the material/product complies with the restrictions specified in this regulation and the requirements of EU Regulation 1935/2004;
6. The compliance of the usage specifications for coating materials/products (i.e. the type of food in contact with them, the time and temperature of handling and storage in contact with food, and the relationship between the maximum food contact surface area and volume ratio) has been verified.

BPA dissolution is prohibited in the layer, involving food types such as baby food, growth formula milk powder, special medical use food, infant formula milk powder, dairy beverages, processed cereal foods, and similar foods suitable for children mentioned above. In addition, DoC should allow easy identification of the painted materials and products. It should be updated to reflect any changes in the migration level of varnish or coating applied to materials and products At the request of the national regulatory authorities, operators should provide appropriate supporting documents. Such proof documents should be provided immediately (no later than 10 days after receiving the request).