Ziram is registered under the REACH regulation at a tonnage band of 100-1000 tonnes per annum, covering the manufacture, formulation and industrial use as a vulcanisation agent in rubber and latex production in the EU. As part of the process for evaluating Ziram under REACH with respect to identified concerns for developmental neurotoxicity and parkinsonian disorders, ECHA requested further information from the Appellants in the form of a combined Developmental Neurotoxicity study and Neurotoxicity study in rats.
The Appellants contested the decision on five grounds, including ECHA's failure to meet the required legal standard for requesting information for substance evaluation under Article 46 of REACH. They argued that ECHA had failed to satisfy any of the criteria established by the BoA in its three-tier test for requesting information under substance evaluation:
- ECHA must firstly show that the substance presents a potential risk to the environment or to human health;
- it must also demonstrate that the potential risk needs to be clarified; and
- it must show that the requested information has a realistic possibility of leading to improved risk management measures.
Regarding the concern for developmental neurotoxicity, the BoA took into consideration its annulment of the first part of the combined study. Accordingly, if it were to uphold the request for the second part of the study, this would entail an amendment of ECHA's decision and the adoption of its own decision ordering the Appellants to perform the developmental neurotoxicity study. However, in examining the available evidence concerning this part of ECHA's decision, the BoA concluded that it did not provide sufficient information for it to be able to decide whether the requested developmental neurotoxicity study, when performed without the neurotoxicity study, would provide additional information to that already in the Appellants' dossier, and that it was therefore unable to replace ECHA's decision with its own decision requesting such study.
The BoA therefore annulled ECHA's decision in its entirety and remitted it to ECHA for further action regarding the developmental neurotoxicity study.
It should also be noted that the BoA rejected the Appellants' initial claim that ECHA had failed to identify a 'real risk' of parkinsonian disorders caused by exposure to Ziram, considering that this threshold was too high in light of REACH's human health and environmental protection aims. The BoA confirmed that ECHA's obligation under the three-tier test is to establish a 'potential risk' - albeit not a purely hypothetical one - and not an 'actual risk', and then proceeded to examine whether a 'potential risk' had been established, as claimed by ECHA.
The BoA's decision clearly sharpens the standard of precision that ECHA must meet when seeking to justify a request for further information at substance evaluation with the demonstration of a potential risk.
Furthermore, with regard to ECHA's conclusions in the contested decision that certain studies in the Appellants' dossier "cannot be used to negate" the parkinsonian disorder concern, the BoA recalled that the burden of proof under the substance evaluation process rests on ECHA to demonstrate that a request for information is necessary, and not on a registrant to prove that there is no concern.
The Appellants were represented by Claudio Mereu and Simon Englebert of Fieldfisher's EU Regulatory team
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