US Chemical Firms Eyeing Europe for new Launches?
The Society of Chemical Manufacturers and Affiliates (SOCMA) has let it be known that US specialty chemicals producers are “strongly considering" launching their new products first on the European market, as the REACh review process, administered by the European Chemicals Agency (ECHA) works better than the US equivalent Toxic Substances Control Act (TSCA).
SOCMA said its companies were dismayed to read the Environmental Protection Agency’s (EPA) recent inspector general report saying that the fees they pay for safety reviews are not adequate to cover the agency’s costs and may have to be doubled.
The EPA now is proposing to charge $45,000 for filing a pre-manufacture notice (PMN), while at the same time narrowing exemptions and changing how companies divide fees for existing chemical reviews.
With higher TSCA fees in sight and new chemical reviews already stretching months beyond statutory deadlines, there will be a "greater focus" on European research & development and manufacture, a SOCMA official told the environmental trade journal Chemical Watch.
Many specialty chemical manufacturers, the trade group said, are assessing how they bring new chemicals to market. Going through the REACh process for new chemicals as well using Europe as the base for global distribution and compliance is looking increasingly attractive, because “REACh is more consistent.”
The main driver of the EPA’s tighter approach to reviewing chemicals is said to be amendments to the TSCA rules passed in 2016, which require the agency to make an affirmative safety determination for every substance it evaluates. This is seen as having considerably lengthened the time needed to review submissions.
Beyond this, the Biden administration has introduced new regulatory measures designed to protect workers. In this sense, the EPA has announced that it will need to increase its reliance on TSCA orders to address potential risks posed by new substances.
According to reports, US authorities nodded off on only a fraction of the PMNs received during the 2022 fiscal year, apart from a handful marked as invalid.
Author: Dede Williams, Freelance Journalist