11/12 November 2020
On August 23, 2017, the European Commission (EC) published a revised draft regulation “Bisphenol A in varnishes and coatings and plastics intended to come into contact with food,” with a feedback period open until September 20, 2017.
The previously notified draft was published in March 2016 with a deadline for comments until May 13, 2016. BPA is, for example, commonly used as a starting substance for inner coatings (epoxy resins) of aluminium tubes and cans for aerosols. Currently, varnishes and coatings are not covered by the "Plastics Regulation" 10/2011.
As reported before, the draft regulation establishes a new specific migration limit of 0.05 mg/kg food for bisphenol A (BPA) migrating from varnishes or coatings applied to materials or articles intended for food contact (currently 0.6 mg/kg). Additionally, no BPA migration is permitted from plastic materials and articles contacting infants’ and toddlers’ food. A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.
The food contact plastics Regulation (EU) No 10/2011 is to be amended accordingly. Compliance can be verified according to the rules laid down in Regulation (EU) No 10/2011, and should be recorded in a written declaration of compliance that should contain the information specified in the Annex to the draft BPA regulation.
While the draft is concerned with foodstuff packaging, it indirectly also affects packaging materials used for oral and topical medicinal products - since for these packaging materials compliance with foodstuff regulations is required (e.g. by the European guideline on plastic immediate packaging materials).
More information can be found on the EC website.