European Chemical Agency Rapped on Compliance Letter

(CN) – The European General Court chided regulators on Tuesday for shirking formal action in favor of a letter when they found that a French chemical company had not complied with the law.

Established in 2006 through the passage of the REACH Act, short for the Registration, Evaluation, Authorization and Restriction of Chemicals, the European Chemicals Agency is required to perform compliance checks for companies that manufacture or import at least 1 ton of a substance annually.

Esso Raffinage in France thus sought registration in 2010 for a chemical it markets for industrial products.

Two years later, it received word that the registration did not comply. The European Chemicals Agency required Esso Raffinage to provide more information on 10 issues, but two of the points demanded a prenatal developmental toxicity study in rabbits as well as long-term toxicity testing to sediment organisms.

When Esso Raffinage replied in 2013, however, it explained its viewpoint that carrying out a second species prenatal developmental toxicity study would be unnecessary.

The agency in turn sent a letter to French ecology authorities, copying Esso Raffinage, that urged them to take enforcement action because the company’s registration was noncompliant.

On Tuesday, the fifth chamber of the European General Court found such letter deviated from legal procedures.

Once Esso Raffinage relayed its input on the study, according to the ruling out of Luxembourg, the European Chemicals Agency was procedurally required to examine that information and draft an appropriate decision.

“Contrary to the submissions made by ECHA and the interveners, Article 126 of Regulation No 1907/2006 cannot be interpreted as meaning that it is for member states to assess whether the registrant has complied with the requirements imposed under the first decision requiring it to bring its registration dossier into compliance,” the ruling states. “Such an interpretation would call into question Article 42(1) of Regulation No 1907/2006 which provides that it is for ECHA to examine any information submitted in consequence of a decision taken under Article 41 of the same regulation. That latter provision reflects the reality that the compliance check of registrations in the context of the evaluation of the dossiers is a single procedure which may include the adoption of a decision requiring the registrant to bring the dossier into compliance. Article 126 of Regulation No 1907/2006, read in conjunction with Article 42(1) of the same regulation, means, in such a context, that it is for Member States to impose appropriate sanctions on registrants who have been held, in accordance with the latter provision, to have infringed their obligations. It must be added in that respect that, even if, as ECHA and the interveners submit, a registrant may always bring its dossier into compliance after the adoption of a decision finding that it did not comply, pursuant to Article 42(1) of Regulation No 1907/2006, the role of the Member States under Article 126 of the same regulation is to assess whether it is necessary, having regard to the facts of each case, to impose sanctions that are effective, proportionate and dissuasive for the period during which the registrant was in breach of its obligations under Article 41(4) of Regulation No 1907/2006.”

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