ECHA Inspects Registration Dossiers for Completeness

The European Chemicals Agency (ECHA) plans to inspect more than 800 registration dossiers retroactively for their completeness. The plans are based on a decision of the Board of Appeals of the ECHA. Leaders of the ECHA hope that the decision will strengthen the OSOR (One Substance – One Registration) principle.

The decision is based on the complaint of a company that was the lead registrant for charcoal (Case Number A-022-2013), had submitted all the required documents in full, and registered the substance with the ECHA appropriately. The complaint was directed toward a registrant who registered the substance separately, used the data of the initial registrant, and did not share the costs of the initial registration. The ECHA did not punish the violation and assigned another registration number to the second registrant.

The Board of Appeals agreed with the complainant and based its decision on the following: All registrations of the same substance must be part of a joint submission. That approach should reduce testing on vertebrates to a minimum and ensure that the costs of sharing data are split fairly, and transparently. At the same time, the Board requested that the leaders of the ECHA declare separate registrations incomplete whenever they are not part of an existing joint registration.

The leaders of the ECHA now want to inspect all registrations that are suspected of violating the OSOR principle. That work involves more than 800 registrations, about 1.8% of all registrations. If a violation is found, the company involved can face the revocation of the marketability of its substance.

Fotohinweis: Tumisu, pixabay.com

Fotohinweis: Tumisu, pixabay.com

The ECHA plans to include an automatic check for completeness in the new version of REACH-IT, which is planned for 2016. But part of the data inspection will still be performed manually to prevent any manipulation. You can find more information on REACH-IT here.

We offer a broad palate of services related to REACH. For example, we can submit a registration according to Article 10 and Article 18 (REACH), handle the duties of a sole representative according to Article 8, and manage SIEF tasks (project management; trustee services; and communication with customers, and government agencies).

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