EU Consults Over Proposed Ban on BPA and Other Bisphenols in Food Contact Materials

SafeGuardSHardgoodsFebruary 15, 2024

SG 32/24

The EU has initiated a consultation on the use of BPA and other bisphenols in food contact materials and articles. Comments are being accepted until March 8, 2024.

Bisphenol A (BPA) is an industrial chemical used in the manufacture of food contact materials (FCM) and articles, including adhesives, ion-exchange resins, printing inks, rubber, epoxy resins in varnishes and coatings applied to metal packaging such as cans, tins and jar lids, as well as polycarbonate and polysulfone plastics for storage and processing equipment.

Since its publication, Regulation (EU) No. 10/2011 on food contact plastics (consolidated version to August 2023) has been revised on several occasions. These amendments were:

Regulation (EU) No. 321/2011 on the prohibition of BPA in polycarbonate (PC) infant feeding bottles
Regulation (EU) 2018/213 by expanding the scope of the BPA ban to PC drinking cups and bottles for infants and young children and revising the specific migration limit for BPA to 0.05 mg/kg. This piece of legislation also regulates BPA in food contact varnishes and coatings

In 2023, the European Food Safety Authority (the Authority) issued an updated opinion on BPA. Based on new scientific data, the Authority concluded that this substance exerts several adverse effects, including those that have an impact on the immune system.

On February 9, 2024, the European Commission announced a four-week consultation on its draft regulation to strengthen the prohibition/restriction of BPA in FCM and articles (the draft Regulation). This piece of draft legislation also regulates the use of other bisphenols and bisphenol derivatives with derogations and transitional periods for businesses.

Highlights of the draft Regulation are summarized in Table 1.

Article to Draft Regulation	Highlights
Article 3 ‘Prohibition of the use of BPA’	Prohibits BPA in all stages of manufacturing of the following FCM: Adhesives Ion-exchange resins Printing inks Rubber Varnishes and coatings Prohibits food contact articles from being placed on the market if BPA is used in the manufacture of the above mentioned FCM Permits the use of BPA in the manufacture of bisphenol-A diglycidyl ether (BADGE) and its derivatives for BADGE-based heavy-duty varnishes and coatings under certain conditions
Article 4 ‘Specific requirements on the use of other bisphenols and bisphenol derivatives’	Prohibits the use of bisphenols and bisphenol derivatives in the manufacture of the listed five types of FCM in Article 3 above if these are carcinogenic, mutagenic, toxic for reproduction (CMR) category 1A or 1B substances, or endocrine disrupting for human health category 1 under Part 3 to Annex VI of Regulation (EC) No. 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to December 2023), otherwise an application for authorization has been submitted to the competent authority
Article 5 ‘Monitoring and reporting results’	Mandates manufacturers to monitor the presence of BPA and its migration if they place the following on the market: BADGE-based heavy-duty varnishes and coatings applied to FCM and articles Polysulfone resins in filtration membranes Paper and board materials and articles containing recycled materials Directs each business operator in the point above to monitor 5% of the batch of FCM and articles that it places on the market and submit a report containing results to the Member State competent authority
Article 6 ‘Methodologies for verification of compliance’	BPA migration from BADGE-based heavy-duty varnishes and coatings applied to FCM and articles is determined according to Regulation (EU) 10/2011 on food contact plastics
Article 7 ‘Written declaration of compliance and supporting documentation’	Requires a declaration of compliance (DoC) for FCM and articles under the scope of this Regulation (Annex II)
Article 8 ‘Amendment to Regulation (EC) 1895/2005’	Prohibits BADGE in FCM and articles with a capacity of less than 250L Requires FCM and articles with a capacity between 250L and 10,000L to comply with the specific migration limits for BADGE and BADGE derivatives in Annex I (The above two points replace existing language in Article 2)
Article 9 ‘Amendment to Regulation (EU) 10/2011	Deletes FCM Substance No. 151 (BPA) on positive list (Table 1 to Annex I) Adds FCM Substance No. 1091 (disodium 4,4’-isopropylidene diphenolate, aka disodium BPA, CAS 2444-90-8) with specifications to positive list
Article 10 ‘Transitional provisions’	Finished food contact articles containing varnishes and coatings, adhesives, ion-exchange resins, plastics, printing inks and/or rubber that were compliant before the date of entry of the new law may be first placed on the market until 18 months after the date of entry of this law¹ Compliant finished food contact articles that were first placed on the market before the end of the applicable transitional period may remain on the market until stocks are exhausted¹
Article 11 ‘Repeal’	Repeals Regulation (EU) 2018/213 on BPA in varnishes and coatings, and amending Regulation (EU) 10/2011 on BPA in food contact plastics
¹ Contains derogations

Table 1

If approved, the new law will be implemented in phases from the twentieth day following its publication in the Official Journal of the European Union (OJEU).

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. Discover more on our website. In the end, it’s only trusted because it’s tested.

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