ECHA Board Of Appeal Ruling On Substance Evaluation Process

The BoA rejects ECHA's requirement for a particular study and sets a three-tier "necessity test"

1.    Background

On 23 September 2015 the European Chemicals Agency ("ECHA") Board of Appeal ("BoA") annulled an ECHA decision which required an additional study as part of the substance evaluation of carbon tetrachloride (case A-005-2014). Carbon tetrachloride is a substance used in closed industrial processes that is already highly regulated and subject to strict handling measures. It is included on the Community rolling action plan ("CoRAP") as a substance to be evaluated due to concerns for human health under the REACH Regulation.

As part of the evaluation process, ECHA reviewed the dossiers produced by the six registrants and requested that an additional one-generation reprotoxicity testing study ("Eogrts") be submitted to assess the reproductive properties of the substance. Such studies are expensive and involve testing on vertebrate animals.