The Board of Appeal has annulled a decision of the European Chemicals Agency, taken under the REACH Regulation, by which the Agency required extensive and onerous additional testing to be conducted by chemicals companies on synthetic amorphous silica (SAS). The Board of Appeal’s decision is of major significance to companies subject to the REACH Regulation and of broader importance in the context of the European Union’s regulation of nanomaterials.
SAS is a synthetic form of silicon dioxide which has been manufactured for over a century. It has a wide variety of applications, including as an anti-caking agent, free flow agent, whitening agent, and thickening agent, and is found in many food, cosmetic, pharmaceutical and industrial products. The Appellant, WR Grace, is a leading US-based chemicals corporation with a substantial EU presence. It produces three types of SAS: precipitated, colloidal and gel. It is registered as a manufacturer of SAS under the REACH Regulation.
Relying on a single scientific study from 1991, purportedly showing concerns about inhalation of a type of SAS (pyrogenic) not manufactured by the Appellant, the European Chemicals Agency issued a substance evaluation decision in 2015 requiring the Appellant to carry out a costly battery of tests on all forms of SAS placed on the market in the EU.
WR Grace appealed against the decision, arguing that the Agency had failed to substantiate its suspicion of risk in relation to the three types of SAS manufactured by WR Grace. Following an extensive pleading process, lasting over two years, and a hearing held in Helsinki, the Board of Appeal agreed, annulling the decision insofar as it required testing on precipitated, colloidal and gel SAS and ordering that the Appellant’s appeal fee be refunded.
The Board of Appeal also agreed with the Appellant that the Agency’s abstract concerns about the safety of nanomaterials did not justify the decision; it endorsed the Appellant’s submission that the fact that a substance is a nanomaterial does not imply that it presents any specific risk of hazard.
The Board of Appeal’s decision is available here.
David Scannell and Andrew McIntyre represented WR Grace, becoming the first British barristers to appear before the ECHA Board of Appeal.