EU Consults Over BPA and other Bisphenols in Certain Food Contact Materials and Articles

SafeGuardSHardgoodsJuly 10, 2024

SG 107/24

The EU has informed the WTO of its draft regulation on the use of BPA and other bisphenols and bisphenol derivatives in certain food contact materials and articles. This proposal is intended to be adopted in November 2024.

In June 2024, the World Trade Organization (WTO) announced a draft regulation from the European Union (EU) on the use of BPA and other bisphenols and bisphenol derivatives with harmonized classification for specific hazardous properties in certain food contact materials (FCM) and articles.

This draft law also amends Regulation (EU) No 10/2011 on food contact plastics (consolidated version to August 2023), repeals Regulation (EU) 2018/213 in relation to BPA in varnishes and coatings intended to come into contact with food, and amends Regulation (EU) No 10/2011 on the use of that substance in food contact plastics.

Highlights of the draft regulation, attached to WTO document 24-4751, are summarized in Table 1.

Section to Draft Regulation	Highlights
Article 1 ‘Subject matter and scope’	Establishes specific requirements for BPA, its salts and other hazardous bisphenols and hazardous bisphenol derivatives in the manufacture of adhesives, ion-exchange resins, plastics, printing inks, rubber, silicones and varnishes and coatings Establishes requirements for BPA content in FCM and articles which have been produced using another bisphenol or bisphenol derivative
Article 2 ‘Definitions’	Provides several terms and their definitions, including but not limited to: ‘Bisphenol derivative’ – a substance indicated by the general structure B in Annex I, but does not include the salt form of a bisphenol ‘Hazardous bisphenol or hazardous bisphenol derivative’ – a bisphenol or bisphenol derivative listed as carcinogenic, mutagenic or toxic to reproduction (CMR) category 1A or 1B, or endocrine disrupting for human health category 1 in Regulation (EC) No. 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation)
Article 3 ‘Prohibition of the use of BPA’	Prohibits the use of BPA and its salts in the manufacture of FCM and articles other than the specified applications and specifications in Annex II (see Table 2 below)
Article 4 ‘Prohibition on the presence of BPA in FCM and articles for which other bisphenols or bisphenol derivatives are used in their manufacture	Prohibits residual BPA if another bisphenol or bisphenol derivative is used in the manufacture of FCM and articles
Article 5 ‘Prohibition of the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives’	Unless exempt, the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of FCM and articles and placing on the market of such products is prohibited
Article 6 ‘Authorization for the use of hazardous bisphenols other than BPA or hazardous bisphenol derivatives in the manufacture of FCM and articles for specific applications’	An application for authorization in accordance with Article 9 to Regulation (EC) No. 1935/2004 must be submitted for the use of such substance(s) for a specific application
Article 7 ‘Reporting obligations concerning alternatives to BPA, hazardous bisphenols and hazardous bisphenol derivatives laid down in Annex II’	Economic operators using BPA, other hazardous bisphenols or hazardous bisphenol derivatives listed in Annex II (see Table 2 below) must provide to the Commission on the status of alternative substances. This is voluntary for micro, small and medium-sized enterprises (SME)
Article 8 ‘Declaration of compliance (DoC) and supporting documentation’	A written DoC must accompany all marketing stages other than the retail stage for FCM and articles which are not yet in contact with food, as well as bisphenols and bisphenol derivatives intended to be used as monomers or other starting substances in the production of these products (see Annex III for details)
Article 9 ‘Verification of compliance with the requirements of this Regulation’	Select appropriate test methods in accordance with Article 34 to Regulation (EU) 2017/625 and other additional rules. Additional rules apply for the selection of methods used to verify a FCM or article does not contain BPA, another hazardous bisphenol or a hazardous bisphenol derivative, or does not release those substances into food above the specified detection limit (DL) or specific migration limit. These include, but are not limited to, a DL of 1 µg/kg for the method, unless a different DL has been defined under Annex II Test results and compliance with a migration limit are in accordance with Regulation (EU) No. 10/2011 on food contact plastics
Article 10 ‘Amendment to Regulation (EU) No. 10/2011	Deletes FCM substance numbers 151 (BPA) and 154 (bisphenol S, BPS)
Article 11 ‘Transitional provisions concerning single-use final food contact articles’	Single-use final products made with BPA that are compliant with rules as applicable before the entry into force of this Regulation, which do not comply with this regulation, may be placed on the market until 18 months after the date of entry into force Provides derogations for specified single-use final products
Article 12 ‘Transitional provisions concerning repeat-use final food contact articles’	Repeat-use final food contact articles made with BPA that are compliant with rules as applicable before the entry into force of this regulation, which do not comply with this regulation, may be first placed on the market until 18 months after the entry into force of this regulation Allows derogations for specified repeat-use final products
Article 13 ‘Repeal’	Repeals Regulation (EU) 2018/213

Table 1.

Substance (CAS)	Scope	Specific Application	Other Restrictions
BPA (80-05-7)	Varnishes and coatings	Monomer or starting substance in liquid epoxy resins to be applied on self-supporting FCM and articles with a capacity > 1,000 liters	Not detectable (ND) for migration into food Finished food contact articles must be cleaned and flushed prior to first being brought into food contact
BPA (80-05-7)	Plastics	Monomer or starting substance in polysulfone (PS) filtration membrane assemblies	As above

Table 2.

According to the WTO notification, the draft regulation is planned for adoption in November 2024.

The regulation will enter into force 20 days after its publication in the Official Journal of the EU (OJEU).

SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance. Contact us to know more or visit our website. In the end, it’s only trusted because it’s tested.

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