Relevant for: Hardlines, Toys & children's products
On 23 August 2017, the European Commission (EC) opened a comment period on draft Regulation1 to tighten the bisphenol A (BPA) (CAS No. 80-50-7) limits in varnishes, coatings and plastics that come into contact with food. The consultation opens until 20 September 2017. EC allows 6-months transition period for this new amendments and the materials or articles cam remain on the market until exhaustion of stocks.
The draft Regulation creates a new specific migration limit (SML) of 0.05 mg/kg food for BPA migrating from varnishes and coatings applied to materials or articles intended for food contact. Current levels allow an SML of 0.6 mg of BPA per kg of food (mg/kg).
Further, BPA migration is NOT permitted from plastic materials and articles specifically intended to come into contact with food for infants’ and young children (i.e. infant formula, follow-up formula, processed cereal-based food, baby food or nutritional food for medical purposes).
The food contact plastics Regulation (EU) No. 10/20112 should therefore be amended accordingly. Business operators should ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance (DoC) according to the rules laid down in Annex I to the Regulation, and make it available at all stages of manufacture, processing and distribution other than the retail stage. Upon request of national surveillance authorities, all supporting documentation to demonstrate compliance should be provided within 10 days.
According to the draft Regulation, the written declaration should contain the following information:
- the identity and address of the business operator issuing the DoC;
- the identity and address of the business operator which manufactures or imports the coated material or articles;
- the identity of the laboratory responsible for testing;
- the identity of the varnished or coated materials or articles;
- the date of the declaration;
- confirmation that the varnish or coating applied to the material or articles meets the restrictions laid down in Article 2 of Regulation (EU) No. 10/2011 and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No. 1935/2004; and
- specifications on the use of the coated materials or articles, such as:
- the type or types of food with which it is intended to be put into contact;
- the 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.
BPA is used in the manufacture of certain materials and articles intended to come into contact with food, such as polycarbonate (PC) plastic and epoxy resins used in varnishes and coatings. Due to its high exposure to human and the reproductive toxicity, besides food contact materials, BPA is also regulated in other consumer products like thermal paper, toys and children’s products in the EU and US.