The European Commission Announces Intention to Adopt Further Measures Regarding BPA in FCMs
The European Commission (EC) has announced that it is working on a measure to further restrict the intentional use of bisphenol A (BPA) in food contact materials (FCMs). The EC hosted a webinar on July 18, 2023, to outline what may be included in forthcoming BPA legislation. The EC also published a supplemental Q&A on August 4, 2023, to provide clarity on certain points raised by stakeholders during the webinar and to provide additional insight into the Commission’s current thinking on the matter. The EC has not yet set forth any formal proposal regarding the use of BPA in FCMs beyond those already in place.
BPA is currently authorized under the Plastics Regulation (EU) 10/2011 for use as a monomer in the manufacture of plastic FCMs, except in the manufacture of polycarbonate bottles and feeding cups intended for infants or small children, subject to a specific migration limit (SML) of 0.05 mg/kg foodstuff. The same SML applies to the use of BPA in varnishes and coatings intended to contact food, except an SML of non-detect applies to varnishes and coatings in contact with food intended for consumption by infants or small children. In June of this year, the EC announced its plan to prohibit the intentional use of BPA in all food contact plastics, varnishes and coatings, inks, adhesives, and rubber. The forthcoming prohibition would include the intentional use of BPA in housewares (e.g., kitchen and tableware) and in food processing equipment.
The Commission’s initiative follows the European Food Safety Authority’s (EFSA) re-evaluation of all available scientific data on BPA, which was published on April 19, 2023, and established a new tolerable daily intake (TDI) for BPA of 0.2 nanograms per kilogram of body weight (bw) per day. EFSA had previously established a temporary TDI for BPA of 4 micrograms per kilogram bw, which translates to a 20,000-fold decrease in the TDI following the most recent EFSA evaluation. During the July 18 webinar, the Commission noted that the option of establishing a new, lower SML for BPA in light of EFSA’s revised TDI would be neither practical nor enforceable due to analytical limitations.
The Commission considers that compliance with the prohibition on the intentional use of BPA in all food contact plastics, varnishes and coatings, inks, adhesives, and rubber can primarily be verified through a Declaration of Compliance issued by business operators in the supply chain.
The unintentional presence of BPA would not be subject to the prohibition, although the Commission acknowledges in its Q&A that BPA traces may be present in FCMs (e.g., in recycled materials or as a non-intentionally added substance (NIAS) in other plastics). The EC is evaluating appropriate measures to address this issue, including possible maximum levels of contamination.
Notably, while the EFSA opinion and the EC’s initiative are focused specifically on BPA, the Q&A notes that a ban on the intentional use of BPA prompts the need to consider alternatives, particularly with respect to its use in varnishes and coatings. The EC advises that the use of other bisphenols with the same or similar risk potential should be avoided, consistent with the Commission’s commitment as part of the EU’s Chemicals Strategy for Sustainability to eliminate harmful chemicals from use in FCMs, unless the use is deemed essential and the risk can be controlled.
With respect to use of BPA in materials applied to the non-food-contact surface of the packaging (e.g., on the exterior of metal food or beverage cans), the EC has noted that certain scenarios could still result in the transfer of BPA to the direct food-contact surface of the article and potential migration of BPA to food. As such, the EC notes in the Q&A that business operators should deploy good manufacturing practices (GMP) to avoid such scenarios and eventually consider replacing BPA used on the exterior, non-food-contact surface of FCMs.
According to the webinar, a fixed 18-month transition period is foreseen after entry into force of the prohibition. The estimated timeline for publication of the final legislation is Spring 2024, so the application of the ban would likely take effect in late 2025/early 2026. The Commission is inviting comments from stakeholders specifically on the proposed transitional measures and timeline until September 15, 2023.
Publication of the full text of the proposed ban is expected at the end of September 2023, and a four-week public consultation is envisioned.