by Dr. Martina Schneider
Evaluation under the REACH regulation refers to the process that ECHA and the member states use to review information submitted via the registration dossier. Three different evaluation processes are defined:
- Compliance checks of dossiers
- Examination of testing proposals submitted in dossiers
- Substance evaluation by Member States
Compliance check of dossiers are based on REACH Article 41. According to the regulation, ECHA may examine a registration dossier to verify legal compliance. The compliance check includes the verification of the substance identification, the fulfillment of the standard information requirements and the Chemical Safety Report (CSR). The dossier selection can be either random or based on a concern regarding the safe use.
The anticipated percentage of dossiers to be checked in this way was until now given in REACH article 41 (5) as 5% of each tonnage band. In 2019, ECHA announced that they were planning to increase this number up to 20%. This decision was based on the outcome of several assessments (for example here and here) showing that a high number of registration dossiers were considered non-compliant.
On April 7, 2020, the Commission Regulation (EU) 2020/507 finally amended Article 41 of REACH by increasing the required amount of dossiers to be subject to compliance checks from 5% to 20% with the following time frame:
- until 31 December 2023 up to 20% of the dossiers in tonnage bands of 100 tonnes or more per year;
- until 31 December 2027 up to 20% of the dossiers in tonnage bands of less than 100 tonnes per year
In addition ECHA announced on April 8 that it will delay the launch of completeness checks of Chemical Safety Reports until October 2020, but will retain the launch of completeness checks on dossiers starting 1 May 2020 (20 days after publication in the Official Journal).
Registrants should keep their dossier up to date and if relevant new information is available an update might be needed, e.g., new hazard information is available or the annual tonnage range is changing.
Typical reasons for non-compliance can be erroneous justification for data waiving or a simple lack of data. Possible outcomes of a compliance check can be that ECHA will request new information. If so, the decision will be sent to the registrant.
More information how to handle additional information requests can also be found in the Registrant’s Guide – How to act in substance evaluation, that was just updated in April 2020.
Cefic REACH Action Plan Progress Report
Based on numerous complaints on dossier quality and to support companies complying with data requirements under REACH, the European Chemical Council (Cefic) launched the Cefic REACH Action Plan in 2019 to support a continuous improvement effort for review and update of data for previously submitted REACH registration dossiers. On March 31, 2020, Cefic published their first Progress report on the project. In 2019, 1758 registration dossiers were re-evaluated by the 165 companies that joined the initiative. Cefic has termed these results as promising in its efforts for improved quality. In 2020, Cefic will focus on encouraging more companies (other non-participating Cefic members and non-Cefic members) to join the initiative and will continue to work with ECHA and other associations to improve registration dossier quality.
- Keep your dossier a living document, as recommended by ECHA. If you have new information, update your dossier promptly according to the regulation.
- In case there are some concerns about dossier compliance (e.g. existing data gabs), consider a review of your dossier.
Commission Regulation (EU) 2020/507: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.110.01.0001.01.ENG&toc=OJ:L:2020:110:TOC
Regulation (EC) No 1907/2006 (REACH): https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32006R1907
Cefic REACH Action Plan 1st Progress Report for Improvement of REACH Registration Dossiers 2019: https://cefic.org/app/uploads/2020/03/CEFIC-REACH-ACTION-PLAN-DOSSIER-UPDATE-AND-IMPROVEMENT-PROGRESS-REPORT-2019.pdf?utm_campaign=Europe_cefic_News-Subscriber_Campaign_Reach_9_April_Newsletter__1-2019040_post-organic_REACH-action-plan-dossier-update&utm_source=emailr&utm_medium=post-organic&utm_content=REACH-action-plan-dossier-update&utm_term=
REACH, Evaluation, European Union, Compliance check
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