A group of 35 EU-based companies have asked Echa’s Board of Appeal to overrule the agency’s decision to make silicon dioxide subject to evaluation under REACH because of initial grounds for concern, relating to “the substance characterisation, nanoparticles and toxicity of different forms of the substance”.
The case has wider importance for nanomaterials. If the contested Decision is allowed to stand, it could set precedents for the evaluation of other nano substances, such as silver and titanium dioxide, which are also subject to evaluation.
The firms argue that none of these grounds are criteria for inclusion of a substance on the Community Rolling Action Plan (Corap) of substances for evaluation. As a result, they say, Echa’s decision to include it was adopted in breach of the REACH Regulation (Article 44).
They have also asked the board to annul the contested Decision, sent to the companies by the evaluating competent authority earlier this year. They say that since the decision to include the substance in the Corap was illegal, the contested Decision lacks a legal basis.
Furthermore, they say Echa has no powers under the REACH Regulation to seek information on “forms” of substances.
The evaluation, says the Board of Appeal, “was targeted to the characterisation of the substance, human health hazard assessment in relation to the inhalation route and exposure assessment of the registered synthetic amorphous silica (SAS).”
According to a 2013 report by the European Commission's Joint Research Centre (JRC), nano SAS is "widely used as an additive in a broad variety of final products, for example, as a functional filler in polymers, and to add strength to rubber (for example, in car tyres), paint and varnishes. Other examples are addition to paper to create different paper qualities, and to food as an anti-lumping agent." The report quotes SRI Consulting as saying precipitated SAS "is the most abundant nanomaterial on the market in terms of quantity".
Echa's contested Decision asks for the following information, by March 2017:
- information on seven physico-chemical properties of each individual SAS form;
- a sub-chronic toxicity study in rats via the inhalation route, using four specific forms;
- information on the uses of each individual form of SAS;
- information on each of eight physico-chemical properties of “each individual surface treated SAS form”; and
- “all toxicological information on surface-treated SAS as manufactured, imported and/or placed on the market as available to the registrant(s)”, and a scientific justification that substantiates if and why the toxicological information on untreated SAS can be used for assessing the safety of surface-treated SAS.
In a separate case, two companies, Grace GmbH & Co KG and Advanced Refining Technologies GmbH, have asked the Board of appeal to annul the same contested Decision.
One of their arguments is that Echa is not empowered to classify SAS as a nanomaterial.