Feedback from a public consultation has helped EFSA to finalise the strategy for its next re-evaluation of the toxicity of bisphenol A (BPA). A “scientific protocol” that transparently details upfront the scope, methodology and information needs before the assessment starts has been published today together with the outcome of the external consultation EFSA held on this preparatory work.

BPA is a chemical widely used to manufacture plastics and resins. EFSA has assessed its safety for use in food contact materials several times, most recently in 2015 when it also committed to re-evaluate BPA toxicity when the results of newly performed studies by the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA project) become available.

Engaging with stakeholders helped shape final text

EFSA publicly consulted on a draft version of the protocol that sets out in advance the rules for the future re-evaluation of BPA and held a public meeting with specialists, interested members of the public and other stakeholders.

Prof Ursula Gundert-Remy who chaired the international EFSA working group that developed the protocol, said: “The consultation and especially the workshop in Brussels helped us to build an understanding with the public about the nature of the work, the information needs and the challenges for this type of assessment. Engaging with these interested parties also helped to shape the final protocol published today.”

Protocol significantly changed following feedback

The protocol has been amended in several substantial ways.

Prof Ursula Gundert-Remy said: “Important changes relate to the inclusion or exclusion of certain types of studies. Cross-sectional and single measurement human studies will be included in the review.

“We have also expanded on and clarified how we will weigh the evidence, estimate our confidence in the results of the studies and express the likelihood of effects.”

Next steps

EFSA’s expert Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) discussed and endorsed the protocol at a meeting in Parma on 30 November, giving the green light for the next phase of the preparatory work for the assessment.

EFSA will set up a new working group in 2018 and start collecting scientific papers and data. This will include the report of the CLARITY-BPA two-year core study on rodents and publications of academic studies developed from the CLARITY study, when they become available.

The CLARITY-BPA project was developed in the USA by the National Institute of Environmental Health Sciences (NIEHS) and the Food and Drug Administration (FDA) and run by the National Toxicology Program (NTP).

EFSA will continue to liaise with the European Chemicals Agency and national scientific advisory bodies in EU Member States who are also working on BPA.

Who developed EFSA’s scientific protocol?

The protocol was developed by an EFSA international working group under the guidance of the CEF Panel. 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.