Due to increasing industry concern, the European Commission has reconsidered the deadlines for the submission of Lead Registrants’ Registration Dossiers to the European Chemicals Agency.
In light of the forthcoming registration deadline for substances in the highest tonnage band to be submitted to the European Chemicals Agency (ECHA) on 1 December 2010, the European Commission has recently provided a new interpretation of the Registration Dossier’s submission deadline for the Lead Registrants as well as other registrants.
Earlier Submission by the Lead Registrant
In prior communications from ECHA, Lead Registrants have been advised to submit their Registration Dossiers to ECHA in June 2010. This early submission requirement was to allow enough time for ECHA to undertake a completeness check of the Dossier as required by the Registration, Evaluation, Authorization and Restriction of Chemicals regulations (REACH). This check was expected to take between 13 to 15 weeks. Once the Registration Dossier was confirmed as being complete, companies which intend to participate in the joint submission could then use the Lead Registrant’s registration number to register before 1 December 2010. This would have the practical affect of accelerating the deadline by six months.
New Interpretation by ECHA and the European Commission
Due to increasing industry concern that it may be impossible to prepare the Registration Dossiers properly by June 2010, ECHA’s ‘early registration’ advice has been reconsidered. According to the Commission and ECHA, the Lead Registrants and other registrants can now register right up to the end of the registration deadline, 30 November 2010. Co-registrants will no longer have to wait for the positive outcome of the Lead Registrant’s completeness check of the Dossier and receipt of the registration number. Consequently, companies which intend to participate in the joint submission can submit their Dossiers independently (provided that they meet the deadline of 30 November 2010). Following the submission, ECHA will check the Dossiers for completeness within the following three weeks after the submission date, or within three months for substances that are considered dangerous or are in the highest tonnage band.
Late Registration Dossier Submission Causes Concerns
Despite the increased flexibility offered by this new interpretation, companies should be aware that problems could arise if the Lead Registrant’s Registration Dossier is found to be incomplete after the registration deadline.
After submission of the Registration Dossier, REACH Article 20 requires ECHA to check whether the registration is complete and gives ECHA authority to set a reasonable deadline for providing additional information if necessary (ECHA will issue such requests before the expiry of a three month completeness check). If the Lead Registrant’s submission is missing information relating to the data which is part of the joint submission and cannot meet the deadline set by ECHA to submit additional information, all co-registrants would have to suspend the manufacture or import of the substance until the additional information is submitted.
Lead Registrants should exercise caution in submitting their Dossiers as required to ensure information is submitted properly. Accordingly, it remains highly advisable for the Lead Registrant to register as far in advance of 30 December 2010 as possible, leaving enough room to update the Registration Dossier if needed and without risking that ECHA will impose an unworkable deadline. Indeed, the European Commission has recommended that Lead Registrants should submit their dossier preferably before 30 September 2010.
Further Clarification by ECHA and the European Commission
Further clarity on the subject of the Registration Dossier’s submission deadline by the Lead Registrant may be added during the “Lead Registrant Workshop”, which is to be held by ECHA and the European Commission on 11 September 2009 in Brussels or at the 3rd Meeting of Competent Authorities for REACH, which is to be held by the European Commission in October 2009. McDermott’s REACH team will closely follow the events and report on whether further changes to the European Commission’s interpretation have been made.