Since the Regulation concerning Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH Regulation”) came into effect in 2007, manufacturers and importers of substances, mixtures and (if applicable) products containing substances have numerous new obligations, including the obligation to register substances.
Under the REACH Regulation, manufacturers and importers of known substances (so called “Phase-in-Substances”) had the option to delay full registration of their substances, so long as they pre-registered by 1 December 2008. The final registration deadlines for pre-registered substances were staggered based on the quantity of production or import.
Two of these deadlines for registration of the larger tonnages have already passed in 2010 and 2013. The last remaining deadline for registering substances manufactured or imported in a quantity of one to 100 tonnes per year is 31 May 2018. Due to this volume range, this registration deadline will especially affect small and medium-sized enterprises, which now face the challenge of creating a registration dossier to provide information about their substances.
Coordination in the Substance Information Exchange Forum
As manufacturers and importers of the same substances must file joint submissions, it will be necessary for them to coordinate their submissions in the Substance Information Exchange Forum (“SIEF”), which were designed to facilitate registration coordination.
The first step in doing this will be for the manufacturers and importers to clarify that their substances are the same. Although 2018 seems far off, affected manufacturers and importers must start the preliminary work now as it will require data and studies, the results of which must be documented in the dossier. Furthermore, the coordination in the SIEF and especially the coordination regarding cost sharing can take a considerable amount of time.
The members of a particular SIEF are apparent by the account established with REACH-IT during pre-registration. If no other registrants exist in a SIEF, the sole registrant must create the dossier and, if required, conduct the required studies alone.
Filing the Dossier and Data Sharing
The lead registrant, appointed by the other SIEF-members, will be responsible for filing the joint dossier. Alongside the joint dossier, SIEF members must also file individual dossiers. Registrants may only rely on substance-related data and studies of the joint dossier if a prior agreement on the data usage has been reached with the data owner. Due to the ban on repeating vertebrate animal tests, registrants are obliged to rely on existing data if such testing was used. If an agreement on the sharing of data cannot be reached, the ECHA can force data sharing or replace the approval of the data owner.
Guideline provide assistance
As well as the ECHA, the German Federal Institute for Occupational Safety and Health also provides Guidelines and Information for assistance with registration.
For more information on the REACH Regulation, please contact: Dr. Anne Rausch.