EU Bans BPA and Other Bisphenols in Food-Contact Materials
On December 19, 2024, the European Commission (EC) adopted a ban on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives in certain food-contact materials and articles. The ban was first proposed by the EC on February 9, 2024 (an article on the original proposal can be found here). The initial draft of the BPA Regulation modified the listing for BPA under the EU Plastics Regulation (Reg. No. 10/2011) to severely restrict its use in food-contact applications but did not change the Plastic Regulation listing for 4,4’-sulphonyldiphenol, commonly known as bisphenol S (BPS). Thus, plastic materials and articles manufactured with BPS were not subject to the restrictions in the initial draft. The revised regulation adopted in December applies the restrictions to BPS and other hazardous bisphenols and has much broader implications for industry.
Under Commission Regulation (EU) 2024/3190, the use of BPA and its salts is prohibited in the manufacture of food-contact plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, silicones, and rubber. Some very limited exceptions to the prohibition on BPA are listed in Annex II. Permitted uses of BPA include the use of BPA (and its salts) as 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. Both exempted uses are subject to certain migration limits. That is, the migration of BPA must not be detectable using 1 µg/kg (or 1 ppb) as a detection limit. Additionally, the final food contact articles must be cleaned and flushed prior to first being brought into contact with food.
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) are also prohibited for use in the manufacture of food-contact materials and articles, unless explicitly authorized. Article 6 of the Regulation requires the European Food Safety Authority to publish guidelines prior to January 20, 2027, regarding information needed in a petition to seek authorization of other hazardous bisphenols/derivatives.
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.) As noted above, the proposed removal of BPS from Annex I of the Plastics Regulation was not included in the initial draft of the Regulation that was open for public consultation. Thus, industry was not provided with an opportunity to submit comments to the EC on the impact of a ban on BPS. The Regulation does not extend the exemptions for BPA (i.e., use in manufacture of polysulfone used in food processing membrane assemblies, and in certain liquid epoxy resins in high-capacity articles) to BPS. Likewise, the transition provisions in Articles 11 and 12 only reference food-contact material and articles manufactured using BPA. An unintended effect of not including BPS in Articles 11 and 12 is that plastic materials and articles manufactured with BPS could be immediately banned without any transition period.
The BPA Regulation also includes a periodic reporting obligation for business operators using BPA or other bisphenols/derivatives on the status of developing alternatives for the exempted uses of BPA. The BPA Regulation also includes a Declaration of Compliance requirement (for all marketing stages other than the retail stage).