EFSA would like your feedback on the draft approach for its next re-evaluation of the toxicity of bisphenol A (BPA), a chemical widely used in food contact materials. The draft is laid down in a “scientific protocol” that defines upfront the scope, methodology and information needs before the assessment starts in 2018.
EFSA completed a comprehensive safety review of BPA in 2015. At the time, EFSA’s scientific experts set a temporary tolerable daily intake (t-TDI) for BPA and committed to re-evaluate its toxicity when the results of extensive studies in the USA became available. The new data will help to further assess possible effects on humans identified in EFSA’s previous work on BPA. EFSA’s review will also include other relevant studies published since the December 2012 cut-off point for EFSA’s last review of BPA safety.
Anna Castoldi, the EFSA scientist leading the protocol development, said: “This is the first public consultation EFSA has done on a scientific protocol. We’re giving specialists and members of the public an opportunity to inform an EFSA scientific assessment before work starts. We are looking forward to receiving comments, insights and suggestions that will help us improve the transparency and completeness of this future work.”
Those interested in EFSA’s work on BPA have until 3 September to submit written feedback on the proposals via the online form. EFSA will hold a follow-up meeting with contributors to the consultation on 14 September in Brussels, to discuss and consolidate their feedback and any additional comments that may be brought at this time. Details about the meeting will follow in the coming weeks.
Blueprint for next year’s evaluation
The draft protocol lays down the blueprint for next year’s evaluation and describes, among others:
- The potential health effects (e.g. reproduction, mammary, nervous system) and the specific questions to address for each type of effect
- Methods for gathering evidence – how to perform a literature search, which information sources to include
- Methods for selecting studies – screening of databases, eligibility of studies, criteria for inclusion/exclusion of studies, types of studies (e.g. human, animal)
- Methods for collecting data from studies (e.g. ensuring data quality, avoiding bias)
- Specific approaches for weighing and integrating evidence, establishing a full TDI for BPA and assessing uncertainties.
Who developed the draft protocol?
An EFSA international working group developed the draft protocol under the guidance of EFSA’s expert Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). The CEF Panel will carry out the BPA re-evaluation scheduled to start in 2018. Experts from Denmark, France, Germany, the Netherlands, Norway, Sweden and Switzerland were appointed by their governments to take part in the protocol working group as well as four independent scientists appointed by EFSA. Before launching this public consultation the draft protocol was reviewed and endorsed by the CEF Panel.