EU Designates Bisphenol A an Endocrine Disruptor

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By Stephen Gardner

The widely used chemical bisphenol A will be categorized as an endocrine disruptor for the purposes of the European Union’s REACH regulation, the European Chemicals Agency said June 16.

Bisphenol A is already considered under REACH to be a “substance of very high concern” (SVHC) because it is toxic to reproduction. But a regulatory committee of representatives from the EU’s 28 countries unanimously agreed at a June 12-16 meeting that it should also be designated an endocrine disruptor, or a substance that could damage the hormone system, the chemicals agency said.

The additional designation has no immediate impact but could come into play if a decision is made to ban bisphenol A from use in the EU. Under REACH (Regulation No. 1907/2006 on the registration, evaluation and authorization of chemicals), SVHCs can be prioritized for phaseout, meaning their use would be prohibited in the EU unless companies obtain usage-specific authorizations.

To obtain an authorization, applicants must prove banned substances can be used safely and cannot be replaced by safer alternatives. Proving the safe use of an endocrine disruptor would be difficult because it is assumed there is no safe exposure level, unless the applicant for an authorization can prove such a level exists.

Natacha Cingotti, a policy officer with advocacy group the Health and Environment Alliance, said in a statement June 16 that the designation of bisphenol A as an endocrine disruptor was “long overdue and of crucial importance so that measures to reduce people’s exposure to the substance can be introduced in the future.”

SVHC Updates

Bisphenol A is manufactured in or imported into the EU in annual volumes of up to 10 million metric tons, according to European Chemicals Agency data. Most of that volume is used in the manufacture of polycarbonate plastic, which leaves only traces of bisphenol A in the finished product and would not be affected by a potential future phaseout decision on the substance.

Other uses of bisphenol A, such as in brake fluids, tires and adhesives and in the manufacture of polyvinyl chloride (PVC), could be affected if a decision is taken to phase out the substance. In such an eventuality, companies would require authorizations to continue using the substance in these applications.

The European Chemicals Agency said it would formalize the additional designation of bisphenol A by the end of June.

The agency added that the regulatory committee of EU national representatives had also agreed to identify the substance perfluorohexane-1-sulphonic acid and its salts as an SVHC because of its persistence in the environment and because it bioaccumulates in organisms.

The addition of the substance brings the number of SVHCs under REACH to 174. So far, decisions on phaseout have been taken for 43 of those substances.

To contact the reporter on this story: Stephen Gardner in Brussels at correspondents@bna.com

To contact the editor responsible for this story: Greg Henderson at ghenderson@bna.com

For More Information

The European Chemicals Agency list of SVHCs is available at https://echa.europa.eu/candidate-list-table.

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