When the REACH regulation took effect some eleven years ago, in June of 2007, it seemed like plenty of time was available to meet the final phase-in registration deadline of May 31, 2018, for substances placed on the European Economic Area (EEA) market in quantities of 1-100 tonnes per year, but as the deadline approached, many organizations found themselves scrambling to demonstrate substance identity, issue purchase orders to obtain Letters of Access (LoA), etc. With May 31 now behind us, new approaches to REACH compliance are expected.
Many companies’ REACH compliance efforts over the past ten years have been focused purely on generating the data necessary to complete registration. Meanwhile, the European Chemicals Agency (ECHA) has been primarily focused on verifying the technical completeness of the dossiers—not the quality of the data submitted. Whether you’re an organization placing chemicals on the EEA market, or working as a regulator for ECHA—the focus is about to change.
With all obligated phase-in substances now registered, companies can begin to turn their attention to new substance registrations (i.e. non-phase-in substances), and no longer need to perform administrative tasks related to pre-registration. On the other hand, companies will no longer benefit from the pre-registration scheme afforded to phase-in substances, which prior to May 31, 2018, allowed companies to begin registration without first submitting an inquiry dossier—a process that sometimes takes between 6-12 months! With the phase-in deadline over, organizations must now submit an inquiry dossier to ECHA for any new substance it wishes to register. Finally, for those organizations who were party to a joint registration, there will likely be additional effort focused on consortia management issues, such as managing data-sharing disputes, seeking reimbursement upon final re-calculation of LoA costs, etc.
Since ECHA have received the final phase-in registration dossiers now, of which only 5% are reviewed for their quality, ECHA will begin to focus their attention on the quality of the dossiers they’ve received. As a result, it is expected that the number of ECHA-requested dossier updates by industry will begin to rise. In addition, once their focus moves away from quality review of final phase-in registration data, ECHA will eventually begin to focus more attention on review of REACH Annex XV dossiers submitted for proposing chemicals as Substances of Very High Concern (SVHC), as well as general administrative management of SVHCs already in the process of Risk Management Options Analysis, such as Authorization, Harmonized Classification & Labeling, etc.—industry should expect greater progress in these areas in the years to come.
Whatever your REACH regulatory needs are, Global Safety Management and our team of compliance experts are here to help. Questions? Contact us today!