EFSA Bisphenol Safety Assessment Guidance
The European Food Safety Authority (EFSA) has published its guidance on safety assessment data requirements for bisphenols other than bisphenol A (BPA) and their derivatives, clarifying the evidence needed to assess their use in food contact materials.
The guidance addresses bisphenols with specified hazardous properties and recommends the same assessment framework for bisphenols and derivatives that have not been classified as hazardous. The aim is to avoid replacing BPA with substances that may pose similar health risks.
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Explore the guidance scope, safety data requirements and implications for food contact applications.
Regulatory Background: Regulation (EU) 2024/3190
In December 2024, the EU published Regulation (EU) 2024/3190, which generally prohibits the use of BPA in food contact materials and restricts other bisphenols and bisphenol derivatives with specified harmonized hazard classifications.
For bisphenols and derivatives with a harmonized classification under the EU Classification, Labelling and Packaging (CLP) Regulation as category 1A or 1B carcinogens, mutagens or reproductive toxicants, or category 1 endocrine disruptors for human health, businesses seeking to use them in specific food contact applications must apply for the relevant authorization.
EFSA developed the guidance to support these applications by specifying the scientific evidence and toxicological data applicants should provide.
Broader Safety Assessment of BPA Alternatives
The guidance covers bisphenols with the hazard classifications described above. It also recommends that applicants follow the same data requirements when seeking food contact authorization for bisphenols and derivatives that are not currently classified as hazardous.
This approach reflects the EU's concern about the safety of BPA alternatives. The absence of a hazardous classification does not, by itself, establish that a substitute is safe.
More Extensive Toxicological Data at Low Migration Levels
Food contact safety assessments traditionally use migration levels to determine the toxicological data required. However, BPA and some structurally related substances may cause health effects at low exposure levels. The guidance therefore sets out more extensive data requirements for bisphenols.
Even where migration is below 0.05 mg/kg food, applicants are expected to provide data addressing immunotoxicity, developmental and reproductive toxicity, metabolic effects and toxicokinetics. For substances migrating at levels above 5 mg/kg food, the data package should also include long-term toxicity and carcinogenicity studies.
EFSA recommends an extended one-generation reproductive toxicity study based on OECD Test Guideline 443, together with in vivo and in vitro toxicokinetic studies, to support a more complete safety assessment.
For bisphenols with existing toxicological data, applicants may use a weight-of-evidence approach, integrating animal studies, in vitro studies, computational toxicology and read-across to support the safety assessment.
Where sufficient scientific justification is available, applicants may also justify omitting data that are not relevant to the specific case, helping to avoid unnecessary repeat testing.
Implications for Polycarbonate, Epoxy Resin and Coating Manufacturers
For manufacturers using bisphenols in polycarbonates, epoxy resins, food packaging coatings and related materials, the guidance raises expectations for the safety evidence supporting BPA alternatives.
Low migration alone no longer provides a basis for substantially reducing the toxicological data package. Applicants seeking EU food contact authorization for the bisphenols concerned need to assess key endpoints, including immunotoxicity, developmental and reproductive toxicity, and metabolic effects. These more extensive studies raise the evidentiary burden for authorization applications.
Bisphenols with existing food contact authorizations may also be affected. If a future change in hazard classification brings a substance within the restrictions of Regulation (EU) 2024/3190, businesses may need to prepare safety data in accordance with the guidance to support an application for a specific use.
What the Guidance Means for Future Applications
The guidance extends the EU's focus beyond restrictions on BPA toward a broader safety assessment of other bisphenols and their derivatives.
It is a technical safety assessment document, not a blanket ban on all BPA alternatives. It also does not create a new mandatory authorization requirement for every bisphenol that has not been classified as hazardous.
For businesses planning to enter the EU food contact materials market and seeking authorization for new uses involving these substances, early identification of applicable requirements, development of an adequate safety data package and careful planning of alternatives can help reduce compliance risks.
Preparing Safety Data for a Bisphenol Application?
Explore the EU application process and dossier requirements, or contact REACH24H to discuss your substance, intended food contact use and available safety data.
