Skip to main content

EC Proposed BPA Ban in Food-Contact Materials Adopted

EU Flag

The Standing Committee on Plants, Animals, Food and Feed (SC-PAFF) adopted the Regulation on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonized classification for specific hazardous properties in certain materials and articles intended to come into contact with food (BPA Regulation) on June 12, 2024. The draft BPA Regulation and its Annexes can be accessed on the European Commission ('EC') website. The proposed ban was first published by the EC on February 9, 2024. (For background information, see the article, EC Proposes to Ban BPA in Food-Contact Materials noting that the text of the draft Regulation has since then been revised).
The BPA Regulation will now undergo a three-month scrutiny period before the European Parliament (EP) and the Council before being finalized, with a potential delay due to EP elections. The scheduled entry into force date is late 2024, with transitional provisions applying (i.e., for single-use final food contact articles and for repeat-use final food contact articles already on the market, respectively). 

Under this Regulation, the use of BPA and its salts will be prohibited in the manufacture of food-contact plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, silicones, and rubber with some limited exceptions listed in Annex II. These exceptions are the use of BPA and its salts as a monomer or starting substance in the manufacture of 1) polysulfone filtration membrane assemblies and 2) liquid epoxy resins to be applied on self-supporting food contact materials or articles with a capacity greater than 1000 liters. In both cases, the migration of BPA must not be detectable (ND), using 1 µg/kg (or 1 ppb) as a detection limit. Additionally, the BPA Regulation provides for each of these exceptions that the final food contact articles be cleaned and flushed prior to first being brought into contact with food.

In addition, the use of other hazardous bisphenols and hazardous bisphenol derivatives (listed in Annex VI, Part 3 of Regulation (EC) No. 1272/2008 as category 1A or 1B carcinogenic, mutagenic, toxic to reproduction or category 1 endocrine disruptor for human health) is also prohibited for the same food contact materials and articles as noted for BPA above, unless explicitly authorized. To obtain an authorization for the use of such substances in specific applications, business operators must follow the procedure set forth in the BPA Regulation (which will include the submission of a petition dossier to the European Food Safety Authority (EFSA) with a certain timeframe).
Among other changes, the BPA Regulation includes a reporting obligation for business operators using BPA or other hazardous bisphenols or hazardous bisphenol derivatives on the status of alternative substances. This information will have to be made available to the EC four years (and at the latest five years) from the date from which the use of the hazardous bisphenol or hazardous bisphenol derivative is authorised for use in the manufacture of the food contact material or article for a specific application. This information must be updated over time as long as the specific application remains in place. The BPA Regulation mandates that food contact materials and articles covered by that Regulation that are not yet in contact with food, as well as bisphenols and bisphenol derivatives intended to be used as monomers/starting substances in the manufacture of those material and articles be accompanied by a Declaration of Compliance (at all marketing stages other than the retail stage). 

Finally, it is noteworthy that the BPA Regulation also amends the Plastics Regulation by deleting BPA (FCM Substance No. 151) and 4,4-dihydroxydiphenyl sulphone or BPS (FCM Substance No. 154) from Annex I of the Plastics Regulation (instead the Plastics Regulation will contain a cross-reference to the BPA Regulation).