July 6, 2020 by Sylwia Kosmala-Grzechnik
The second report on Integrated Regulatory Strategy, entitled ‘Grouping speeds up regulatory action’, released recently by ECHA, provides an update on the current status of registration dossiers evaluations and the steps undertaken in order to accelerate this process. As stated in the report, ECHA’s main goal is to increase the level of compliance of registration dossiers as well as to identify new substances of concern and to address these as soon as possible. ECHA have also changed their approach from evaluation of individual substances to assessing groups of structurally similar substances with intention to have a full understanding of substances registered under REACH by 2027.
These aims will be achieved by screening of all registered substances, the so-called “chemical universe”, and assigning each substance to one of three ‘pools’:
- Substances of high priority for regulatory risk management: Consisting of substances with identified concerns and where relevant regulatory actions have been already undertaken (such as substances identified as substances of very high concern (SVHC)), or substances which have been identified for action but where the process has not been initiated.
- Substances of high priority for data generation and assessment: The substances in this group are currently under evaluation and require further data generation, are currently under assessment by the PBT/ED Expert Groups, or are petroleum and coal stream (PetCo) substances, or have been identified for further data generation but action has not yet been initiated by authorities.
- Substances of low priority for further regulatory action: Substances which are already regulated and do not require further regulatory risk management as they are already included on the Candidate List or under the POPs or PIC Regulation, or substances concluded to be low priority following assessment.
The first REACH registration deadline passed 10 years ago, and approximately 20,000 substances have now been registered under REACH (including substances registered as intermediates under Articles 17 and 18). During that time, the expectations for REACH registration dossiers have changed quite significantly, and therefore many dossiers may not be complaint with the current completeness checks, even if they were compliant at the time when they were originally submitted. According to the report published by the German authorities earlier this year, almost half of all REACH dossiers submitted in the 100 -1,000 tonnes per annum (tpa) tonnage band are likely to be non-compliant. Indeed, the ECHA report indicates that 56% of 220 dossiers of high volume substances reviewed in 2019 required more data to clarify the need for further risk management, and only 22% of dossiers did not require any action.
The report highlights that the compliance of dossiers, and their systematic review and updating, is the registrant’s responsibility and ECHA is therefore encouraging industry to actively update their existing registrations. Considering that ECHA’s plan is to complete mapping of substances registered at or above 100 tpa tonnage band by the end of 2020 and all remaining substances by 2027, a number of regulatory decisions can be expected for many substances over the next few years. Therefore, we advise companies to regularly review and update their registration dossiers to make sure that the data included in the dossier are up-to-date and the dossier remains compliant.
If you require assistance with your dossier updates or need support in preparing response to a decision letter from ECHA, please contact us.