EFSA prepares for BPA toxicity assessment

A ‘scientific protocol’ that details the scope, methodology and information needs before the assessment starts has been published​​ with the outcome of an external consultation.​

The protocol outlines inclusion or exclusion of certain studies with cross-sectional and single measurement human studies being included in the review. It also clarifies how evidence will be weighed, confidence in results of the studies estimated and likelihood of effects expressed.

Experts from Denmark, France, Germany, the Netherlands, Norway, Sweden and Switzerland helped develop it.

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

Prof Ursula Gundert-Remy, who chaired the 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.”​

The European Commission banned BPA in manufacture of packaging for 0-3 years earlier this year with regulation adopted next year.

A specific migration limit (SML) of 0.05 mg/kg food for BPA migrating from varnishes or coatings applies to materials or articles intended for food contact. Current levels allow an SML of 0.6 mg of BPA per kg of food (mg/kg).

The panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) gave the go-ahead for the next phase of the assessment.

EFSA will set up a working group in 2018 and start collecting scientific papers and data. The agency last evaluated the substance in 2015 saying it posed no health risk.

This will include the report of the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) two-year core study on rodents and academic studies from the CLARITY study, when they become available.

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

The draft NTP research report with results of the CLARITY-BPA core study will be peer-reviewed by an expert panel in 2018. The meeting details and draft report will be available early next year.