News Details
EU Launches Consultation on BPA and Other Bisphenols in Food Contact Materials
On 9 February 2024, the European Commission announced a four-week consultation on a draft regulation aimed at strengthening the restriction of bisphenol A (BPA) in food contact materials (FCMs) and articles. The proposed legislation also covers other bisphenols and bisphenol derivatives, with provisions for derogations and transition periods for businesses. Stakeholders and the public are invited to submit their comments on the proposed regulations by 8 March 2024.
Bisphenol A
The substance 4,4'-isopropylidenediphenol, commonly known as bisphenol A (BPA) (CAS number 80-05-7), is used in the production of certain food contact materials and articles. Its main applications include the manufacture of epoxy resins for varnishes and coatings on metal food packaging such as cans, tins, and jar lids. BPA is also found in certain types of plastic used in food storage and processing equipment. Its versatile chemical properties can extend its use to materials such as printing inks, adhesives, ion exchange resins, and rubbers in finished food contact articles. Concerns arise because BPA can migrate from the materials or articles it comes into contact with into food, exposing consumers to this substance.
The use of bisphenol A (BPA) in plastic food contact materials is authorised by EU Regulation 10/2011, with a specific migration limit of 0.05 mg/kg of food set by Regulation (EU) 2018/213. This limit is based on the opinion of the European Food Safety Authority (EFSA). The regulation also bans BPA in polycarbonate drinking cups or bottles for babies and young children. In addition, there is a ban on its use in varnishes or coatings for materials intended to come into contact with certain childcare articles, reinforcing the existing ban in Commission Regulation (EU) No 321/2011 on polycarbonate feeding bottles and cups for young children.
In 2023, the EFSA published an updated opinion on BPA, identifying adverse effects, including effects on the immune system, based on new scientific data.
Content of the draft regulation
Highlights of the draft regulation include:
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Article 3: Prohibition of the use of BPA |
1. Prohibits the use of BPA in food contact varnishes, coatings, inks, adhesives, ion-exchange resins, and rubbers, as well as the sale of finished articles containing BPA. 2. Allows the use of BPA as a precursor for BADGE (bisphenol-A diglycidyl ether)-based heavy-duty varnishes with specific restrictions, including migration limits and prevention of BPA presence in final products. |
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Article 4: Specific requirements on the use of other bisphenols and bisphenol derivatives |
1. Prohibits certain bisphenols and derivatives in food contact materials due to health concerns. 2. Allows their use under certain conditions, including prior authorisation, submission of relevant information, and compliance with the intended conditions of use. |
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Article 5: Monitoring and reporting of results |
1. Requires the monitoring of BPA in specific materials and articles. 2. Specifies rules for compliance, random sampling, and reduction of monitoring where BPA is not detected. 3. Requires investigation and reporting to authorities if BPA is found, along with planned remedial actions. |
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Article 6: Methodologies for verification of compliance |
1. Applies specific rules for the verification of BPA migration from BADGE-based varnishes. 2. Specifies the duration of testing under continuous flow conditions and expression of monitoring results. |
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Article 7: Written declaration of compliance and supporting documentation |
1. Requires a written declaration of compliance for materials covered by the regulation. 2. Specifies the information to be included in the declaration and emphasises the availability of documentation for competent authorities. |
If the draft Regulation is implemented the following transitional provisions will apply for final food contact articles:
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Final food contact articles made of plastics, varnishes, coatings, inks, adhesives, ion exchange resins, and rubbers complying with pre-existing rules can be placed on the market until 18 months after the entry into force.
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Certain articles (single-use for certain food types, varnished metal surface articles, and repeat-use articles in professional food production equipment) complying with pre-existing rules can be marketed until 36 months after entry into force.
Timeline
The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union. Upon entry into force Regulation (EU) 2018/213 will be repealed.
We acknowledge that the above information has been compiled from European Commission.
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