Richard E. Engler, Ph.D., Quoted by Chemical Watch in Article “US speciality chemical firms considering shifting R&D to EU”
On January 17, 2023, Chemical Watch quoted Richard E. Engler, Ph.D., Director of Chemistry, The Acta Group (Acta®) regarding an annoucement by the Society of Chemical Manufacturers and Affiliates (Socma) that U.S. speciality chemicals companies are “strongly considering” introducing new chemicals into the European market due to the consistency of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) review process relative to that of the Toxic Substances Control Act (TSCA).
Rich Engler, director of chemistry with law firm Bergeson & Campbell, also flagged disparities between the two jurisdictions.
“Many of our clients have successfully registered substances under REACH and yet the same substances, supported by the required REACH data set, languish” under TSCA, he said. Moreover, PMNs “nearly always” face a consent order restricting their use in the US, he said.
“Companies are already avoiding the TSCA market due to delays, uncertainty and overregulation,” said Dr Engler. “Increasing the cost without concomitant improvement in EPA’s new chemicals review will only further disincentivise commercialisation under TSCA.”
The EPA plans to increase the cost of filing a PMN to $45,000 and an exemption notice to $13,200. This would put TSCA’s rates at the top end of the global spectrum.
In Canada, for example, new substance notification fees range from only a few hundred dollars to under US$3,000. Australia, meanwhile, has fees that top out around the US-equivalent of $25,000. The EU’s highest tonnage band carries a registration cost of €33,699.
“EPA’s proposed fee is much higher than elsewhere,” said Dr Engler. However, he noted the costs associated with bringing new chemicals to market around the global “are difficult to compare”.
In the EU, for example, the cost “is largely due to the testing burden, not the registration fee”, he said.
See – https://chemicalwatch.com/654186/us-speciality-chemical-firms-considering-shifting-rd-to-eu (subscription required)