EC Proposes to Ban BPA in Food-Contact Materials
The European Commission (EC) published a draft regulation on February 9, 2024, that would prohibit the use of bisphenol-A (BPA) in the manufacture of food-contact plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, and rubber. This initiative follows the European Food Safety Authority’s (EFSA) re-evaluation of all available scientific data on BPA, which was published in April 2023 and established a new tolerable daily intake (TDI) for BPA of 0.2 nanograms per kilogram of body weight (bw) per day.
The draft regulation would amend Regulation (EU) No 10/2011 (the Plastics Regulation) to prohibit the use of BPA in the manufacture of plastic food-contact materials (FCMs). There would be an 18-month transition period for most applications that, according to the EC, would allow “time to identify and ensure the technical feasibility of alternatives at scale for the whole of the Union market.” A 36-month transition period would be allowed for certain applications including: single-use final food-contact articles for processed fruit, vegetables, and fish products; single-use final food contact articles on which a varnish or coating has been applied specifically to the exterior metal surface; and repeat use final food contact articles used as components in professional food production equipment, such as seals, pumps, and gauges.
The draft regulation proposes an exception for the use of the disodium salt of BPA in the manufacture of polysulfone resins for use in filtration membranes, provided that its migration to food in non-detect (detection limit = 0.01 mg/kg). Additionally, the draft regulation would amend Regulation (EC) No 1895/2005 to prohibit the use of bisphenol-A diglycidyl ether (BADGE) and its derivatives in the manufacture of varnishes and coatings, with the exception of those applied to large capacity tanks over 250 liters (so-called “heavy duty coatings and varnishes”) as well as pipelines belonging or connected to them. Specific conditions would also apply to the use of BADGE based heavy duty coatings and varnishes.
Finally, with respect to other bisphenols and bisphenol derivatives, those listed in Annex VI, Part 3 of the EU’s CLP Regulation[1] would, in principle, also be prohibited for the manufacture of food-contact varnishes and coatings, printing inks, adhesives, ion-exchange resins, and rubber due to their classification as category 1A or 1B ‘mutagenic,’ ‘carcinogenic,’ ‘toxic to reproduction,’ or category 1 ‘endocrine disrupting’ for human health. However, they could potentially still be used subject to strict conditions including, notably, the submission of a petition dossier for the bisphenol substance in question to the EFSA via a competent authority within a limited timeframe.
Comments on the initiative are due by March 8, 2024.
[1] Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.