The European Chemicals Agency (ECHA) has backed a proposal to strengthen the existing harmonised classification and labelling (CLH) of bisphenol A (BPA).
The Committee for Risk Assessment (RAC) has adopted an opinion that was proposed by France last year that says the chemical is a presumed human reproductive toxicant which may damage fertility.
The agency said several member states provided input during the public consultation.
BPA will be reclassified as a reprotoxic 1 B, i.e. ‘presumed human reproductive toxicant’, under the EU Regulation on the classification, labelling and packaging of substances and mixture (CLP).
It is currently a reprotoxic 2, ‘suspected human reproductive toxicant’.
Jos Mossink, head of unit classification at ECHA, told FoodQualityNews.com that the classification and labelling are important to communicate hazards of the substance and the precautions to be taken when handling them.
"Classification aims to identify the intrinsic hazardous properties of chemicals and, thus, a chemical’s hazardous property is independent of human exposure levels," he said.
"It is important to understand that ECHA’s harmonised classification and labelling (CLH) looks at the intrinsic properties of the substance and does not address risk whereas EFSA has made a risk assessment.
"Hence these are two separate processes which are based on different regulations governing different but complementary aspects of chemical safety."
The full opinion is not yet available but will be in the next few weeks and it will be found here .
The proposal is focussed on the adverse effects on sexual function and fertility only, not on developmental toxicity or other hazard classes than reproductive toxicity.
BPA ‘should not be a selective reproductive toxicant’
Valid guideline studies are generally used as the primary source of data in CLH assessments, said PlasticsEurope’s Polycarbonate/Bisphenol A group (PC/BPA) / Epoxy Resin Committee (ERC).
“We believe that the RAC also based their assessment on such guideline studies,” said Jasmin Bird, communications manager of the group.
“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… 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).”
RAC concluded that there were adverse effects on reproductive capacity (functional fertility) following oral exposure to BPA in a multi-generation guideline study in mice and in rats.
Impaired female reproductive capacity was also observed in several supplementary non-guideline studies. Toxic effects in reproductive organs were observed in several of the studies.
Human exposure levels
However, RAC said that classification focuses on the properties of the substance and does not take human exposure levels into account.
Bird said that 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,” she said.
“The findings of these studies have already been incorporated into risk assessments conducted by government bodies around the world.”
A substance evaluation of BPA was carried out in Germany in 2012 and, as a result ECHA issued a decision in December 2013 to request further data in the areas of skin absorption and environmental exposure.
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.
Mossink said based on the previous experience it may take up to two years before the substance is entered into annex VI of the CLP regulation.
The European Food Safety Authority (EFSA’s) consultation on its draft opinion on the potential health risks of BPA for consumers closed last week and the final version is expected later this year.