- Filling knowledge gaps on potential adverse effects on human health of BPA substitutes.
- Supporting the development of a science-based hazard assessment of BPA alternatives.
- Leading the way for regulation standards of BPA substitutes.
Key messages
- Closing critical data gaps on BPA alternatives for hazard assessment across five key toxicological endpoints.
- Providing regulatory agencies with data to support safer substitutions and regulatory decisions.
- Utilising advanced methods and multi-institution collaboration to ensure reliable results.
Overview
Bisphenol A (BPA) ↗ is a chemical which is mainly used in the production of various plastics for the manufacturing of consumer goods. It is a widely used and studied chemical that has been proven to be harmful to human health. Thus, over the course of the decade, there has been an increase of restrictions on the use of BPA, which in turn led to an introduction of several chemical substitutes ↗.
Since their introduction, chemical substitutes to BPA have already been found in humans and the environment, raising concerns about their safety of use. For most BPA alternatives, information on potential effects on human and environmental health is either missing or too limited, restricting a sound hazard assessment or characterisation.
With further restrictions on BPA in the coming years, the use of BPA alternatives is projected to significantly increase, giving the scientific assessment of these substances great significance.
The project will fill knowledge gaps on the effects of eight prioritised BPA substitutions on human health following five toxicological endpoints:
- Endocrine disruptors, also referred to as hormonally active agents;
- Developmental neurotoxicity, meaning toxic substances influencing the development of nervous systems;
- Immunotoxicity, regarding toxic agents effecting the immune system;
- Non-genotoxic carcinogenicity, as tumour inducing substances; and
- Metabolism, meaning chemical reactions in the human body.
Another contribution of this project will be the identification of molecular biomarkers in order to develop a method to rapidly predict potential effects of BPA alternatives on human health. Identifying these biomarkers will help determine the mechanism(s) through which BPA alternatives act, revealing their adverse health effects.
Achievements & Results
A collaborative workshop with key stakeholders, including the European Chemicals Agency (ECHA ↗) and the European Food Safety Authority (EFSA ↗), successfully prioritized eight alternatives to bisphenol A (BPA) for detailed toxicological assessment. A list of the prioritised alternatives and the methods used for prioritisation are documented in an additional deliverable on the hazard assessment activities. Early toxicological evaluations of these BPA alternatives suggest that some may have potential adverse effects, highlighting the importance of thorough assessments to prevent regrettable substitutions. The project has also fostered stronger partnerships among the 13 project participating institutions across Europe, promoting interdisciplinary collaboration and addressing critical data gaps in chemical safety research.
Policy relevance
Filling data gaps for the hazard assessment for BPA alternatives, that will be useful in avoiding adverse effects of substitutions.
Related Publications
Bisphenol A (BPA) alternatives currently used in consumer products require stricter pre-market safety assessments to avoid substituting one hazardous chemical for another.
Significant gaps in knowledge about BPA alternatives, including their effects on metabolism, neurodevelopment, endocrine, and immune systems, must be addressed to inform effective EU-wide chemical regulations.
Encouraging research that identifies mechanisms of toxicity and develops predictive tools for immunotoxicity and endocrine disruption is critical to advancing safer chemical substitutes.
Future safety testing of BPA alternatives should simulate realistic human exposures, integrate biokinetics, and assess the impacts of chemical metabolites to support robust risk assessments.
Clear communication of risks from BPA substitutes is necessary to protect vulnerable populations and maintain public trust in chemical safety initiatives.
Emerging evidence on BPA substitutes, such as their systemic bioavailability and endocrine-disrupting properties, necessitates swift updates to safety thresholds and a new generation risk assessment approach.
Bisphenol A (BPA), a synthetic chemical widely used in the production of polycarbonate plastic and epoxy resins, has been associated with a variety of adverse effects in humans including metabolic, immunological, reproductive, and neurodevelopmental effects, raising concern about its health impact. In the EU, it has been classified as toxic to reproduction and as an endocrine disruptor and was thus included in the candidate list of substances of very high concern (SVHC). On this basis, its use has
been banned or restricted in some products. As a consequence, industries turned to bisphenol alternatives, such as bisphenol S (BPS) and bisphenol F (BPF), which are now found in various consumer products, as well as in human matrices at a global scale. However, due to their toxicity, these two bisphenols are in the process of being regulated. Other BPA alternatives, whose potential toxicity remains largely unknown due to a knowledge gap, have also started to be used in manufacturing processes. The gradual restriction of the use of BPA underscores the importance of understanding the potential risks associated with its alternatives to avoid regrettable substitutions. This review aims to summarize the current knowledge on the potential hazards related to BPA alternatives prioritized by European Regulatory Agencies based on their regulatory relevance and selected to be studied under the European Partnership for the Assessment of Risks from Chemicals (PARC): BPE, BPAP, BPP, BPZ, BPS-MAE, and TCBPA. The focus is on data related to toxicokinetic, endocrine disruption, immunotoxicity, developmental neurotoxicity, and genotoxicity/carcinogenicity, which were considered the most relevant endpoints to assess the hazard related to those substances. The goal here is to identify the data gaps in BPA alternatives toxicology and hence formulate the future directions that will be taken in the frame of the PARC project, which seeks also to enhance chemical risk assessment methodologies using new approach methodologies (NAMs).