Ban on bisphenol A (BPA) in food packaging

Draft Commission Regulation on the use of bisphenol A (BPA) and other bisphenols and their derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food, amending Regulation (EU) No 10/2011, amending Regulation (EC) No 1895/2005 and repealing Regulation (EU) 2018/213

Annex

Update

The EU is preparing to tighten its rules on the use of bisphenol A (BPA) and related chemicals in food contact materials. This is due to health concerns about the presence of BPA in food. The proposed changes will include a ban on the use of BPA in the manufacture of plastic food contact materials and other materials, including varnishes and coatings, printing inks, and adhesives. There are also proposed restrictions or specific requirements on the use of disodium salt of BPA and other bisphenols. A limited exception is proposed for the use of bisphenol-A diglycidyl ether (BADGE).

Recognising that a ban would have a major impact on manufacturers of food contact materials, transition periods are being discussed to avoid disrupting the food supply. Suppliers of packaged fruit, vegetables, and fishery products are likely to face particular challenges.

Feedback on this proposal via the EU's Have your Say website closed on 8 March 2024.

Impacted Products

All food packaged or stored in materials that may contain BPA (e.g. metal food packaging such as cans, tins, and jar lids; plastic packaging including polycarbonate and polysulfone)

What is changing?

Key points of the Commission’s published draft Regulation

Prohibition of BPA (Arts. 3, 9, Annex): The use of BPA in the manufacture of food contact varnishes/coatings, printing inks, adhesives, ion-exchange resins, and rubbers will be prohibited. BPA (4,4’-isopropylidenediphenol) will also be prohibited in plastic food contact materials (removed from the list of authorised substances in Annex I of Regulation (EU) 10/2011).

Exception for BADGE (Arts. 3, 8): Bisphenol-A diglycidyl ether (BADGE) is used in the manufacture of coatings for large containers (e.g. tanks, metal drums) used for processing, storing, and transporting food (e.g. wine, beer, oils, dairy, and grains). The use of BADGE will still be permitted, but only for containers with a capacity >250 litres, and provided any release of BADGE does not exceed the levels set out in the Annex I to Regulation 1895/2005.

Specific requirements for bisphenols/bisphenol derivatives (Art. 4): Substances similar to BPA that have been identified as hazardous for human health (listed in Annex VI, part 3 of Regulation 1272/2008) will not be permitted in food contact varnishes/coatings, printing inks, adhesives, ion-exchange resins, and rubbers, except where a specific application to authorise its use has been submitted (under Regulation 1935/2004).

Restrictions on disodium salt of BPA (Annex): The use of this substance will be permitted, but only in the manufacture of polysulphone resins for plastic food contact membranes, and provided that no residues can be detected in food (disodium 4,4’-isopropylidene diphenolate will be added to the list of authorised substances in Regulation (EU) 10/2011).

Declaration of compliance (Art. 7): For foods in contact with relevant materials (plastics, varnishes/coatings, printing inks, adhesives, ion-exchange resins, rubbers), businesses at all stages in the supply chain must have a written declaration that the materials are compliant. This declaration of compliance will contain:

• identity/address of the business operator issuing the declaration
• identity/address of the business operator that manufactures or imports the food contact material or article
• identity of the intermediate food contact material or final food contact article (including packaged food)
• date of the declaration
• confirmation that the intermediate food contact material or article, or final food contact article, complies with the restrictions laid down in this Regulation and in Arts 3, 15, and 17 of Regulation 1935/2004.

Transitional periods (Art. 10): The Commission proposes an 18-month time period after the Regulation enters into force,to allow packaging manufacturers to adjust to the new requirements. Longer transitional periods are foreseen in relation to specific materials, including 36 months for single-use cans of processed fruits, vegetables, and fish products; and for single-use articles on which a varnish or coating has been applied specifically to the exterior metal surface.

Why?

Following a review, EFSA (2023) found that even minimal BPA migration could exceed established tolerable daily intake (TDI) levels. To protect consumer health, the use of BPA in food contact materials must be minimised.

Where BADGE is used in large containers, the exposure of food is limited, leaving very low or negligible residues.

The use of disodium salt of BPA in separation membranes is important to ensure that a wide range of foods are safe for consumers. Good manufacturing practice can reduce residues of BPA to negligible amounts, and there are currently no alternatives available that can provide the mechanical strength and chemical stability of the substance. Therefore its use is proposed to be permitted with restrictions.

Timeline

Feedback on this proposal via the EU's Have your Say website closed on 8 March 2024.

What are the major implications for exporting countries?

The ban on BPA marks a major change from traditional practices used for decades in making food contact materials, especially in metal packaging coatings. Given the widespread use of BPA-based products in the EU, transitioning away from BPA will require careful planning to prevent supply chain disruptions. Many businesses have already started adapting to BPA-free manufacturing processes in response to demand. The Commission’s proposed transition periods aim to take into account the challenge of finding alternative solutions.

The proposed changes are recognised to be a particular challenge for foods associated with high acidity which are aggressive to food packaging, including fruit and vegetables such as tomatoes. The seasonal nature of certain foods and fish products, and high demand on packaging in peak periods, is recognised by the Commission’s suggestion of an extended 36-month period for these products. It is also acknowledged that a 36-month period may be required to transition to BPA-free varnishes and coatings, which can transfer to the interior surfaces of metal packaging.

Recommended Actions

All suppliers of packaged foods to the EU market (and particularly of fruit, vegetable, and fish products) are recommended to alert their packaging suppliers to the proposed EU ban of BPA, and evaluate strategies for a transition away from the use of BPA.

Background

BPA is commonly used in varnishes/coatings applied to surfaces of food packaging, such as cans, tins, or jar lids. It can be also used in materials such as printing inks and adhesives. BPA can migrate from food packaging into food.

BPA can currently be used in the manufacture of plastic food contact materials, provided a specific migration limit of 0.05 mg/kg of food is respected. The use of BPA in drinking bottles for children is already prohibited (Regulation 2018/213).

Regulation (EU) 10/2011 lays down rules on plastic food contact materials. It is one of a series of regulations relating to specific food contact materials. It reinforces Regulation 1935/2004, which sets out the EU’s overall approach to food contact materials. For further information see Food contact materials explained.

Regulation 2023/2006 sets out general rules on good manufacturing practice related to quality assurance systems, quality control systems, and documentation. It also sets out specific rules on printing inks and quality assurance systems for plastic recycling processes.

Resources

Sources

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Regulation

Draft Commission Regulation on the use of bisphenol A (BPA) and other bisphenols and their derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food

Annex

What is changing and why?

The European Food Safety Authority (EFSA) has identified health risks from levels of bisphenol A (BPA) in food. The EU therefore plans to:

• Prohibit use of BPA in the manufacture of food contact materials including plastics, varnishes/coatings, printing inks, adhesives, ion-exchange resins, and rubbers.
• Allow exceptional use of bisphenol-A diglycidyl ether (BADGE), used in the manufacture of coatings for large containers, only for containers with a capacity >250 litres and provided any release of BADGE is minimal.
• Prohibit the use of bisphenols/bisphenol derivatives identified as hazardous for human health infood contact varnishes/coatings, printing inks, adhesives, ion-exchange resins, and rubbers except where a specific application to authorise its use has been submitted.
• Limit use of disodium salt of BPA to the manufacture of polysulphone resins for use in plastic membranes.
• Require businesses to possess a compliance declaration confirming compliance with the BPA Regulation for all relevant packaged food placed on the EU market.
• Establish transitional measures that provide manufacturers of food contact materials a period of time (18–36 months after the Regulation enters into force) to develop alternative solutions to the use of BPA in food contact materials.

The Commission aims to safeguard consumer health by minimising exposure to BPA and raising safety standards in the production of food contact materials.

Actions

All suppliers of packaged foods to the EU market (and particularly of fruit, vegetable, and fish products) are recommended to alert their packaging suppliers to the proposed EU ban of BPA, and evaluate strategies for a transition away from the use of BPA.

Timeline

Feedback on this proposal via the EU's Have your Say website closed on 8 March 2024.

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