ECHA Board of Appeal annuls ECHA's decision on substance evaluation
On 25 September 2018, the Board of Appeal of the European Chemicals Agency (''ECHA'') ruled in case A-008-2017, annulling the Agency’s decision of 23 March 2017 on the substance evaluation of 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol pursuant to Article 46 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals ("the REACH Regulation").
The Appellants, represented by Fieldfisher, challenged this decision in so far as it required providing information on an extended one-generation reproductive toxicity study ("EOGRTS") in rats (oral route) and a soil simulation test.
The Appellants submitted that the Agency failed to fulfil the conditions for imposing further information requirements under Article 46 of the REACH Regulation and failed to provide an adequate statement of reasons, in particular regarding the potential risk perceived by the Agency. In addition, the Appellants claimed that the Agency failed to provide information or explanations on how the information required in the Contested Decision would lead to an improvement of the risk management measures in place.
Moreover, the Appellants claimed that the requirement to conduct an EOGRTS was based on an error of assessment, and there was insufficient weight-of-evidence to justify the request for information. In their view, whilst two high quality and reliable studies showed either no adverse effects or reversible effects, the Agency chose to rely on four old studies of poor or unreliable quality to support its finding of the possibility of adverse effects.
The Appellants further argued that the Contested Decision should be partially annulled also in relation to the Agency's request to conduct a soil simulation study with use of strong extraction techniques, detection of degraded metabolites at 0.1% w/w and parallel testing at different temperatures (20 °C and 12 °C).
As regards the requirement to conduct an EOGRTS, the Board of Appeal took the view of the Appellants that the Agency had made no evaluation whatsoever of whether the available information showed 'serious concerns about the potential for adverse effects on fertility or development' within the meaning of Column 2 of Section 8.7.1. of Annex VIII of the REACH Regulation.
According to the Board of Appeal, the rights of the registrants were adversely affected by the Agency's failure to assess whether there were 'serious concerns about the potential for adverse effects on fertility or development' and therefore whether the EOGRTS was an information requirement for some or all registrants, some of which registered the substance at a lower tonnage band.
The Board of Appeal further noted that, as the Agency did not carry out an assessment of which registrants would be required to provide the EOGRTS, it is not known which of the registrants should pay a share of the costs relating to the performance of that test. As the Agency failed to assess all the relevant factors and circumstances of this case, the Board of Appeal followed the Appellants' claim and annulled the requirement to perform an EOGRTS.
As regards the requirement to provide information on the soil simulation test, however, the Board of Appeal dismissed the appeal with the exception of the requirement to use 20 °C during the test for the identification of potential metabolites which is annulled. Indeed, the kinetic and metabolite identification parts of the soil simulation testing should both be performed at 12 °C. The Board of Appeal set the new deadline for submitting the information on soil simulation testing on 4 January 2021.
For more information and questions please contact Claudio Mereu.