Esso Raffinage Appeals Developmental Toxicity Study On Second Species

“Appeal lodged with European Court just published.
Esso Raffinage has asked the European Court to annul a statement of non-compliance (Sonc) issued by Echa.

The Sonc was adopted in April, but details of the company’s appeal were only published in the EU Official journal on 28 September.

The company’s second plea says Echa breached REACH Article 42(1). This says the agency shall examine any information submitted in consequence of a decision taken under Articles 40 (examination of testing proposals) or 41 (compliance check of registrations).

More specifically it relates to a request by Echa for the company to conduct a prenatal developmental toxicity study on a second species. The appeal notice says Echa committed an error in interpreting the information requirements regarding Annex X, section 8(7)(2) as there is no de facto requirement to conduct such a study.

In May Echa announced that to meet prenatal developmental toxicity information requirements for high volume substances (as set out in Annex X), registrants would have to provide data on two species from 1 September, but should avoid unnecessary animal testing.”

Article by Geraint Roberts
Appeal notice :

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