19/03/2014: On 12 March 2014, the ECHA’s Risk Assessment Committee (RAC) adopted an opinion proposing to reclassify bisphenol A (BPA) as reprotoxic 1 B, i.e. ‘presumed human reproductive toxicant’, under the

EU Regulation on the classification, labelling and packaging of substances and mixture (CLP). BPA is currently classified as reprotoxic 2, ‘suspected human reproductive toxicant’, under the CLP. The full RAC opinion is currently not available. The following provides an initial industry position.

 

 

Generally, for Classification & Labelling assessments, valid guideline studies are used as the primary source of data. We believe that the RAC also based their assessment on such guideline studies. The conclusion of the most relevant studies for the assessment of reproductive toxicity, two large-scale multi-generation studies on BPA, conducted according to internationally accepted guidelines, is that

BPA should not be considered a selective reproductive toxicant. Accordingly, and based on our best understanding of the spirit and principles for classification in Europe, the available data does not support a reprotoxic 1 B conclusion, even with the revised classification criteria in the recently adopted Globally Harmonized System (GHS, CLP since Dec. 2012).

 

 

Reproductive effects in guideline studies occur only at extremely high doses that are millions of times higher than typical human exposure. Neither the reported high-dose effects nor the proposed

reprotoxic 1 B classification are indicative of any risk to human health. The findings of these studies have already been incorporated into risk assessments conducted by government bodies around the

world. These assessments, including EFSA (2013, 2014) and US FDA (2013), consistently conclude that BPA is safe in its current uses. The proposed classification does not provide any new information to

change those conclusions.

 

The opinion will be forwarded to the European Commission, which will evaluate it and present a proposal for a re-classification to Member State experts. If the proposal is adopted, labelling information for handling BPA in production and converting processes will change.

 

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