The European Commission's recent draft regulation proposes significant restrictions on the use of bisphenol-A (BPA) in various food contact materials (FCMs), in response to findings from the European Food Safety Authority's (EFSA) comprehensive re-evaluation of BPA's safety. This proposed regulation would amend existing regulations, particularly Regulation (EU) No 10/2011 (the Plastics Regulation), to enforce the prohibition of BPA in plastic FCMs. The draft regulation outlines transition periods, providing time for identifying and implementing viable alternatives across the Union market.

The proposal includes exceptions for specific applications, such as single-use final food-contact articles for certain products and repeat-use final food-contact articles used in professional food production equipment. Moreover, an exception is proposed for the disodium salt of BPA in the manufacture of polysulfone resins for filtration membranes, with strict migration limits.

Furthermore, the draft regulation addresses bisphenol-A diglycidyl ether (BADGE) and its derivatives, proposing their prohibition in varnishes and coatings, except for heavy-duty coatings and varnishes applied to large capacity tanks and connected pipelines, subject to specific conditions.

Additionally, the regulation aims to restrict other bisphenols and derivatives classified as hazardous under Annex VI, Part 3 of the EU's CLP Regulation. While these substances would be generally prohibited, exceptions may be considered under strict conditions, including the submission of petition dossiers to EFSA through competent authorities within a limited timeframe.

Stakeholders and the public have until March 8, 2024, to provide comments and feedback on the proposed regulation.

IBE-BVI members advantage:

IBE-BVI members can obtain, by simple request a copy of the draft regulation and its annex: click here

 Post 04/03/2024

Federico Bassotto March 4, 2024
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