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French Agency for Food, Environmental and Occupational Health & Safety

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Published on 21/01/2015

Bisphenol A: EFSA recommends lowering the Total Daily Intake (TDI) while considering that current exposure levels are without risk for human health

In 2014, following its large-scale study, EFSA submitted for consultation an interim report on the health risks of bisphenol A (BPA). ANSES contributed to the consultation by emphasising the extensive work conducted by the European authority while pointing out certain divergences in the evaluation of how uncertainties were accounted for, as well as differences of interpretation in the analysis of available studies. Today, the European Food Safety Authority (EFSA) published the results of its work, recommending a significant reduction in the Total Daily Intake (TDI) of bisphenol A, while indicating that the current exposure levels to bisphenol A are too low to pose any risk to human health. In addition, while evaluation differences still exist in this report, EFSA and ANSES continue to pursue their collaboration on this topic, and new studies will soon be issued on the effects of low doses of BPA on health.

 

For several years now, bisphenol A has been the subject of numerous scientific investigations into its effects on health, due in particular to the fact that it is a suspected endocrine disruptor and that it is found in a large number of marketed items and products.

In this context, ANSES has launched several expert assessments on the topic since 2008. In April 2013, the Agency published the results of an assessment of the health risks of bisphenol A. In its conclusion to this study, ANSES recommended reducing exposure to bisphenol A and set a major objective: preventing exposure by the most vulnerable populations (infants, young children and pregnant or breastfeeding women). 

EFSA then launched a comprehensive re-evaluation of the health effects of bisphenol A.

In January 2014, EFSA published for consultation its draft opinion on the health risks of BPA and proposed lowering the Total Daily Intake, established on a temporary basis, in order to prevent risks that it considered to be low with regard to consumer exposure. ANSES contributed to this consultation in the form of an opinion in which it emphasised the extensive work conducted by the European authority, while pointing out certain divergences in the evaluation of how uncertainties were accounted for, as well as differences of interpretation in analysis of the available studies.

The French and European agencies have met several times in order to examine these areas of divergence. In its final report published today, EFSA concludes that BPA does not present any risk for consumer health at the current exposure levels (via diet, as well as thermal paper and cosmetics), but nonetheless recommends significant reductions in the Total Daily Intake for bisphenol A.ANSES is pleased with the quality of communication between the two agencies, especially with regard to how uncertainties were accounted for, and while evaluation differences remain, EFSA and ANSES are pursuing their collaboration in order to harmonise methodology.

Since publications on the health effects of BPA are issued frequently and in abundance, and the state of scientific knowledge is constantly evolving, ANSES will continue its monitoring efforts and its work to improve knowledge of this substance.

In 2012, ANSES proposed a tougher classification of bisphenol A, which would list it as toxic for reproduction in the framework of the CLP(1) regulation. Following a favourable opinion issued in March 2014 by the European Chemicals Agency (ECHA) in response to this proposal, the European Commission is expected to integrate this revised harmonised classification shortly via an amendment to annex VI of the CLP regulation. Classification in category 1B (“substance presumed to have reprotoxic potential for humans”) will directly require the application of more stringent regulatory measures, with the obligation to implement strengthened preventive measures for occupational uses of bisphenol A (primarily its substitution), and a ban on marketing authorisations for substances and mixtures intended for use by consumers which contain over 0.3% of bisphenol A.

Lastly, a dossier prepared by ANSES in the framework of the REACh regulation which aims to obtain a restriction of BPA use in thermal paper is currently being examined by ECHA. The latter is expected to issue its opinion on the subject in the coming weeks.

 

(1)CLP: Classification, Labelling, Packaging

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