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January 18, 2023

Acta Webinar on Chemicals Strategy for Sustainability Quoted in Bloomberg Law Article “Chemical Law Change Ahead in EU Seen Likely to Raise Costs in US”

Bergeson & Campbell, P.C.

On January 17, 2023, Bloomberg Law quoted speakers, including Jane S. Vergnes, Ph.D., DABT®, Director of Toxicology, Bergeson & Campbell, P.C. (B&C®), from B&C affliate The Acta Group’s (Acta®) “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?” webinar.

The European Union will propose many regulatory changes this year that could substantially increase US companies’ costs and prevent exports of some chemicals or products made with them to the region, attorneys and toxicologists said Tuesday.

On Feb. 7 the European Chemicals Agency (ECHA) plans to release a proposal to restrict thousands of per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).

Expected by spring are proposed revisions to REACH regulation followed by other regulatory changes that will affect companies making batteries, electronics, pharmaceuticals, cosmetics, and veterinary medicines or exporting them to the European Economic Area (EEA), said Meglena Mihova, an attorney and managing partner with EPPA SA, a consultancy firm based in Brussels.

The EU also will release this year details on new hazard descriptions that manufacturers must use to classify and label the chemicals they make in or export to the EEA, she said during a webinar organized by the Acta Group, an affiliate of the Bergeson & Campbell PC law firm.


“I’ve never seen such complex interlinks among the different pieces of legislation,” said Mihova, who chairs the Environment Committee of the American Chamber of Commerce to the EU.

Europe’s regulatory overhauls are designed to implement its Green Deal and Chemicals Strategy for Sustainability, she said.

That means they’re intended to make regulations more protective of human health and the environment, said Jane S. Vergnes, ACTA’s vice president for scientific affairs.

But the result is to expand the hazard-based approach to classifying and overseeing chemicals, Vergnes said. That has the potential to widen Europe’s misalignment with other chemical regulations in other countries, including the US, Japan, and China, she said.

Details on many proposals are unclear, but the descriptions of them that have been floated suggest the changes could substantially increase chemical testing costs, said Thomas Petry, managing director and owner of ToxMinds BVBA, which helps chemical and pharmaceutical companies evaluate the effects of their products.

Chemical manufacturers would have to evaluate and classify their chemicals’ potential to cause new types of concerns and comply with additional information requirements that haven’t been part of the laws’ mandates, he said.

Hazards that will be new or require new information include a chemical’s ability to mimic, block, or alter hormones; its potential to persist in the environment, build up in the food chain, and move easily thorough the environment; and its potential to harm the immune, neurological, and respiratory systems, he said.

Companies making an estimated 30,000 polymers will need to provide information about those compounds, he said.

Polymers are large molecules composed of many repeating smaller chemicals. Companies making polymers in the EEA or exporting them to the region have generally been exempted from REACH’s data requirements.

Proposals to test mixtures of chemicals and to evaluate chemical risks in new ways are also expected, Petry said.

Due to testing costs, some chemicals may no longer be available, meaning companies relying on those compounds to make other products may have to redesign them, increasing their costs, he said.

The result will be a lot of animal testing despite Europe’s desire to minimize it, “high testing costs, and high uncertainties about the regulatory outcomes,” Petry said. “Regulatory uncertainty is never good from a business perspective.”

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