ECHA Says BoA Sonc Decision is Case- Specific

« Agency plans to inform registrants of dossier evaluation outcomes next year.

ECHA says it considers that a decision by its Board of Appeal (BoA), regarding a statement of non-compliance (Sonc), following a dossier evaluation decision, only applies to the specific case between the appellant and itself.

In its decision on the case – finalised in August– the BoA said the agency should have followed the decision-making procedures outlined in REACH Articles 50 and 51 when issuing the Sonc. This enables the registrant to comment before the Sonc is issued.

Speaking at Chemical Watch’s Global Enforcement Summit in Brussels, Ofelia Bercaru, head of unit in Echa’s directorate of evaluation said: “We don’t see reason to withdraw other Soncs.”

She said the agency considered the case was particular as it applied to a notified new substance (Nons) dossier submitted originally to the Belgian authorities under legislation preceding REACH.

However, she added that the agency plans to initiate a discussion with the Competent Authorities for REACH and CLP (Caracal) and the Enforcement Forum. This will be to see whether adjustments are needed to the Sonc step within the dossier evaluation process.

Ms Bercaru said the REACH evaluation process seems to work well. She noted that out of the 600-plus dossiers evaluated so far, around 80% achieved compliance based on the evaluation decision. A further 10% had become compliant after a Sonc had been issued. Some 56 Soncs are pending.

Ms Bercaru said registrants have the opportunity to comment to Echa during the dossier evaluation decision-making. And many do, to discuss issues such as:

  • deadlines;
  • progress on testing; and
  • requesting advice.

However, once a decision is issued, she said, Echa cannot modify it, adding: ”If [the registrant] is not happy, it can submit an appeal.”

She added that a Sonc is a way of transferring authority to the national bodies responsible for enforcement. Echa does not have the competence for enforcement. “A Sonc is a way to put everyone on an equal footing on the same information,” she said.

Meanwhile, Echa is planning to inform registrants on the outcome of the follow-up to dossier evaluation from next year. Some companies have asked to know if their dossiers have successfully completed this follow-up process. Ms Bercaru said that Echa will send out a statement. But, she added, this would not mean another compliance check cannot be started on another issue. »


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