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Recently, our company REACH24h was notified by ECHA regarding the substances which REACH24H is the lead registrant on behalf of our Non-EU clients. The communication letter detailed that for registrants of the same substance, joint submission obligation has been breached since ECHA received submission of separate registrations for the same substance. All registrants that violate the rule are required to jointly submit the required information of the substance within a limited period. If not, ECHA will revoke their registration number and reject the registration.
“One substance one registration” (OSOR) is one of the key rules ECHA authority implements for REACH Regulation. At the initial stage when REACH Regulation came into effect, the REACH-IT system for REACH dossier submission did offer individual submission. Considering the fees for data sharing and time consumed to complete the registration, companies always chose to submit an individual dossier, especially for substances for intermediate use under SCC and Non-phase in substances. However, the new REACH-IT system which was updated in the spring of 2016 no longer offered individual submission. Companies have to join existing joint submissions or to form a new joint registration consortium with other registrants. The previous individual submissions should be added into the existing joint submission.
In accordance with Articles 11(1) and 19(1) of the REACH Regulation, when a substance is intended to be manufactured or imported in the European Union by one or more manufacturers and/or importers, some of the information referred to in Articles 10 and 12 of the REACH Regulation must be submitted first by a lead registrant, acting with the agreement of the other assenting registrants. This requirement is re-affirmed by Article 3(1) of the Implementing Regulation (EU) 2016/9 on joint submission of data and data-sharing. Whilst remaining part of the joint submission for the same substance, registrants can ‘opt-out’ from the relevant parts of the joint submission.
Expert’s advice from REACH24H:
Over the past year, ECHA adopted measures to block individual dossier submission, including manual checking of the dossier and close scrutiny of mandatory joint submission obligations. Companies which submitted the individual dossiers should pay close attention on this issue and contact with the lead registrant to join the existing joint submission consortium. Failure to comply with these requirements can lead ECHA to revoke registration number. In cases where the data sharing fee is not reasonable or other circumstances prohibit consortium formation, companies are supposed to keep all the communication records and submit an official dispute to ECHA without delay. According to our experience, normally ECHA will give 6 months to companies to complete their dossier update from individual submission to joint submission. The analysis of LOA cost calculation, data sharing negotiation and submitting dispute to ECHA are all time consuming.
About the Author
Ms. Stella Lu graduated from Zhejiang University with a master’s degree in chemical engineering. She plays a key role in REACH24H and primarily engages in work related to EU REACH. She has extensive project management experience in EU REACH compliance and has successfully handled cases for many of the world’s largest chemical companies.
