The new EU regulation on food contact materials (EU) no 2018 / 213 reduces BPA restrictions

Last year, a draft regulation on the use of bisphenol A varnishes and coatings in food contact was published, and regulation (EU) No 10 / 2011 on the use of bisphenol A 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. The regulation further limits the use of bisphenol A (BPA) in some food contact materials. In plastics regulation 10 / 2011, the specific migration limit (SML) of BPA in varnishes and coatings and the SML of BPA are revised.
Although the regulation applies to food packaging, it also indirectly affects packaging materials for oral and topical drugs - because these packaging materials need to comply with food regulations (e.g. European guidelines for direct plastic packaging materials). For example, BPA is usually used as the starting material for inner coating of aluminum pipe (epoxy resin) and aerosol tank. So far, plastics regulation 10 / 2011 does not apply to varnishes and coatings. Specifically, regulation No. 2018 / 213 stipulates that the SML of varnish and coating per kilogram of food (or food simulant) is 0.05 mg BPA. BPA migration (detection limit = 0.01 mg / kg), infant food or food with special medical requirements for infants and young children is not allowed for varnishes and coatings intended for materials and articles in contact with infant formula, follow-up formula and processed cereal food. With regard to "plastics regulation" 10 / 2011, the new BPA regulation reduces the SML of BPA from 0.6 mg / kg to 0.05 mg / kg, and expands the prohibition of using BPA to manufacture polycarbonate baby bottles to polycarbonate drinking cups or bottles. Due to its anti overflow characteristics, it is applicable to infants and young children.
The regulation also provides that operators shall ensure that painted or coated materials / articles are accompanied by a written declaration of compliance (DOC), which is available at all stages of manufacturing, processing and distribution other than the retail stage.



The doc contains the following specific information specified in Annex I to the regulation:
1. The identity and address of the operator issuing the doc;
2. Identity and address of the operator who manufactures or imports coating materials / products
3. Characteristics of painting or coating materials / products;
4. Date of announcement;
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. Application specification of coating materials / products (i.e. the type of food in contact with it, the processing and storage time and temperature in contact with food, the relationship between the maximum food contact surface area and volume ratio), which compliance has been verified).
It is prohibited to dissolve BPA in the layer. The types of food involved include infant food, growth formula, food for special medical purposes, infant formula, dairy drinks, cereal processed food and similar foods for children mentioned above. In addition, Doc "shall allow easy identification of the paint materials and articles they are painting. It shall be updated to reflect any changes in the migration level of varnish or coating applied to materials and articles." At the request of the competent national authority, the operator shall provide appropriate supporting documents. Such supporting documents shall be provided immediately (no later than 10 days after receipt of the request).