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"
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.
The registrants appealed the decision on six grounds, including that the study was disproportionate and unnecessary, because existing data shows that reproductive toxicity only occurs at very high levels of exposure and that sufficient measures are already in place to ensure human health protection. Exposure to carbon tetrachloride is very limited and controlled and exposure is limited to workers, which means that there is no consumer risk or exposure to the general population.
Further, ECHA is also under a duty to ensure that testing on vertebrate animals is undertaken only as a last resort. Eogrts is "overkill" in terms of the number of animals sacrificed and the costs involved, and there was uncertainty over whether commissioning it without sufficient scientific justification would cause regulatory problems in the future.
One of the reasons for ECHA to request the Eogrts study was that the dossier of the registrant with the highest tonnage band was missing a particular study, part of the standard information required by REACH for that tonnage band. The registrant had provided a waiver which ECHA found to be inadequate. The registrants argued this was not a sufficient justification to require all of them to produce the Eogrts test.
The BoA found that the requested study was not compatible with the principle of proportionality. Significantly, it set out a three-tier test that ECHA must satisfy before it can request additional information under substance evaluation:
- firstly, it must be able to show that there is a potential environmental or health risk – and that such a risk should be one that “occurs in reality and not only theoretically”;
- secondly, it must prove that the potential risk needs to be clarified; and
- thirdly, it must show that the information requested has a realistic possibility of leading to improved risk management measures.
Use of carbon tetrachloride is already subject to extensive risk management measures and ECHA could not show that they were inadequate. ECHA's assertion that there was a concern over reproductive toxicity was considered as not sufficient since it did not demonstrate that the study would lead to any improvement to risk management. Therefore, the BoA concluded that ECHA had not met these criteria.
Regarding the missing study issue, the BoA found that this check should have been done during the dossier compliance check. The BoA noted that whilst ECHA is required to conduct a compliance check on at least 5% of the total number of dossiers received for each tonnage band, one of the prioritisation criteria for selecting dossiers is that the substance is on the CoRAP list. This means that the compliance check should be performed by ECHA before the substance evaluation and that the objectives of dossier and substance evaluation are different.
Dossier adaption, such as the use of the waiver, was found to be specific to a registration and thus was not in itself sufficient justification for an information request imposed on five other registrants as part of substance evaluation. The BoA considered that this was disproportionate and could lead to significant costs for smaller registrants. The substance evaluation procedure should not be used to fill data gaps in place of a compliance check.
The case has potentially wide implications since ECHA will now be required to justify its information requests in substance evaluations according to the three-tier "necessity test".
For more information and quesitons please contact Claudio Mereu