By Abisola Elegba ReachReady
At the time of writing, logged on the ECHA’s website1 was a record of 99,268 registrations for 22, 877 substances from 15,418 companies. With the final REACH registration deadline for phase in substances 31 May 2018 now passed, ECHA seeks to check the compliance of all relevant dossiers and address its decisions to all registrants with non-compliant dossiers.
The European Commission is legally required to review some elements of REACH and publish a general report on its implementation every five years, the Commission and the European Chemicals Agency (ECHA) published a joint action plan2 on REACH evaluation to tackle issues around quality of dossiers. This plan was in response to the conclusions of the second REACH Review.
Conclusions of the second REACH review showed that extensive use of alternatives to animal testing led to hazard information not being generated to the extent predicted. Additionally, it showed that adaptations to standard information requirements used by registrants are often considered to be insufficiently justified. According to the Commission, data gaps and or other data quality issues in dossiers hamper the identification of priority substances for any further regulatory action that may be needed.
In terms of dossier compliance checks, the minimum target was recently raised from 5% to 20% for each tonnage band, meaning that around 30% of all registered chemicals will be checked by 2027. An interim goal for ECHA is to conclude for all high tonnage substances by the end of 2020 whether; they are a priority for risk management, need more data for a judgement to be made or are of low priority for further action. For those substances where data gaps prevent from concluding a potential risk, ECHA aims to perform a compliance check by 2023. Similar conclusions will be drawn on lower tonnage substances, with a view of having full clarity on all registered substances that are part of the “chemical universe” by 2027.
Separately, to tackle the quality of information in the registration dossiers, the Commission has also drafted an implementing regulation to clarify the requirement of updating registration dossiers and is considering an amendment of the REACH Annexes to clarify the information requirements.
For this reason, in relation to Article 22 of REACH, the Commission put forward for consultation, a proposal for the Implementing Regulation on the duties placed on registrants to update their registration dossiers under REACH. The intention of this regulation is to further specify by which timelines the updates should be made. Implementing regulations are usually issued when further measures are necessary to ensure uniform implementation of a given legislation by the Member States. The feedback period for this consultation was 18th December 2019 to 15th January 2020 which has now passed.
Following the public consultation on this Implementation Regulation, the REACH Committee (In which every EU country is represented) will be required later this year to adopt an opinion on the regulation by a qualified majority vote. The Commission then decides on adoption of the regulation. If adopted, entry into force is within 60 days from its publication in the Official Journal.
Article 22 of REACH stipulates several “further duties of registrants”. These duties can be divided into duties that registrants are expected to do spontaneously under their own initiative and those required by ECHA during the evaluation process.
The Commission’s draft Implementation regulation states that “a deadline of three months should be specified for updates of a more administrative nature and deadlines of six or twelve months for more complex updates, such as those requiring the generation of data or changes to the safety assessment”. Detailed in the Regulation also are specific deadlines for: (i) changes in a registrant’s status or in their identity (ii)changes in the composition of the substance (iii) changes in tonnage band (iv) new identified uses and new uses advised against (v)new knowledge of the risks to human health and/or the environment (vi) changes in the classification and labelling of the registered substance (vii) updates or amendments of the chemical safety report (viii) testing proposals prior to conducting a test listed in Annex IX or Annex X (ix) changes in the access granted to information in the registration (x) updates of joint submissions.
With an increased focus on evaluation and an expected increase in the number of evaluation decisions in future, ECHA has also invited enforcement authorities to prioritise the enforcement of evaluation decisions going forward.
At this stage it is important that companies take stock of the situation on quality of dossiers and the recommendations provided by ECHA on how to improve registration dossiers. The responsibility to maintain registration dossiers remains a key aspect of REACH compliance that requires attention and an appropriate level of resources within companies.
With ECHA and Member States under great pressure to accelerate evaluation and the upcoming implementing regulation on dossier updates coming down the line, it is vital that businesses keep their registration dossiers up to date.
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(Accessed 11th March 2020)
2 REACH Evaluation Joint Action Plan https://echa.europa.eu/documents/10162/21877836/final_echa_com_reach_evaluation_action_plan_en/0003c9fc-652e-5f0b-90f9-dff9d5371d17 (Accessed 11th March 2020)