Evaluation under REACH means the scientific assessment of registration dossiers and the scientific assessment of substances and is defined in Title VI (Art. 40-54) of the Regulation. Accordingly, the title is divided into two chapters:
- Dossier evaluation with the evaluation of testing proposals and the compliance check of registration dossiers
- Substance evaluation of substances listed in the Community Rolling Action Plan (CoRAP)
On-site isolated intermediates that are used under strictly controlled conditions are exempt from evaluation. Dossier and substance evaluation differ in their aim and target as well as the data that is reviewed and the possible outcome (see table below). In all procedures, registrants can be obliged to provide additional data but also have the possibility to participate in the different steps. For dossier evaluation, only data required in Annexes VII to X REACH can be requested from the registrant. In contrast, any information identified as required, can be requested in the substance evaluation process. Dossier evaluation is conducted by ECHA while substance evaluation is mainly done by the Member States.
|Dossier evaluation||Substance evaluation|
|Evaluation of testing proposals||Compliance check|
|Aim||Produce reliable and adequate data in compliance with REACH and avoid unnecessary animal testing||Assure compliance of registration dossiers with the REACH requirements||Clarify a concern that a substance constitutes a risk to human health or the environment|
|Target||All testing proposals submitted as part of a registration dossier||At least 5% of the registration dossiers for each tonnage band||Registered substances selected and listed in the CoRAP|
|Possible outcome||ECHA Decision: Registrant to do:|| ECHA Decision:|| ECHA Decision:|
Evaluation of testing proposals
ECHA examines all testing proposals according to Annex IX and X REACH that are submitted as part of a registration dossier or a downstream user report. Tests required in Annex IX and X must only be conducted after a prior confirmation by ECHA to avoid unnecessary animal testing. ECHA publishes all proposals for vertebrate tests to allow third parties to submit scientifically valid information and studies that address the relevant substance and hazard end-point that will be taken into account by ECHA in preparing its decision.
ECHA has four options:
- Accept the testing proposal
- Accept the testing proposal with modifications of the testing conditions
- Accept or reject the proposal but require one or more additional tests
- Reject the testing proposal
The compliance check evaluates whether the information submitted in a registration dossier is in compliance with the REACH requirements. The compliance check is conducted for at least 5% of the dossiers per tonnage band. The aim is to ensure an adequate quality of the registration dossiers. Thereby, the whole dossier can be checked or the evaluation can be targeted on certain parts (for more details, see ECHA’s Q&A on targeted compliance checks).
Steps and possibilities for interaction in dossier evaluation
|Evaluation of the testing proposal (deadlines see Article 43 REACH), or Compliance check of the registration dossier (within 12 months after start)||ECHA|
|Adoption of the ECHA Decision||ECHA, MS, optionally also MSC and COM|
|Evaluation of submitted information||ECHA|
1 The QOBL is a communication by ECHA identifying shortcomings in a dossier that may be relevant for the safe use of the substance. It is an independent outcome of a compliance check although it is often sent at the same time as the ECHA draft decision.
2 Instead, a registrant can decide to cease the manufacture or import, and inform the Agency accordingly (for details see Art. 50 REACH). Besides this, the addressee of an ECHA Decision has also the right to appeal before the ECHA Board of Appeal.
Substances evaluation does not aim at one registration dossier but considers all information available for a substance (e. g. from several registration dossiers and other sources). Substance evaluation is conducted for substances that may constitute a risk to human health or the environment and that have been included in a Community rolling action plan (CoRAP). The objective is to clarify these concerns and, if a risk is identified, to initiate measures to reduce this risk. Substance evaluation is mainly done by competent authorities of the Member States but coordinated by ECHA.
The CoRAP (Community Rolling Action Plan) lists all substances selected by ECHA and the Member States for substance evaluation in the three upcoming years. It is updated once a year. Substances are selected based on information on hazards, exposure, tonnage (aggregated for all registrants), concerns identified in dossier evaluation, and concerns identified by Member States. An inclusion of a substance in the CoRAP does not immediately cause additional obligations. See also ECHA’s Q&A on CoRAP and substance evaluation.
Substance evaluation can result in a request to the registrant(s) of the substance for further information. Following substance evaluation, further action may be taken, if needed, under the authorisation or restriction procedures in REACH, or classification and labelling procedures in CLP. The information may be passed on to other authorities responsible for relevant legislation (e.g. occupational health), or no further action may be taken.
Steps and possibilities for interaction in substance evaluation
|Selection of substances (CoRAP)||ECHA, MS|
Evaluation of the substance (within 12 months after start)
|Adoption of the ECHA decision (on request for further data from the registrant, if any)||ECHA, MS, optionally also MSC and COM|
|Evaluation of submitted information and finalisation of substance evaluation||eMSCA|
1 Instead, a registrant can decide to cease the manufacture or import, and inform the Agency accordingly (for details see Art. 50 REACH). Besides this, the addressee of an ECHA Decision has also the right to appeal before the ECHA Board of Appeal.
- Practical guide 12: How to communicate with ECHA in dossier evaluation
- Substance evaluation under REACH: Tips for registrants and downstream users and webinar.
- ECHA – Websection on Evaluation with ECHA annual Evaluation progress report with valuable tips, and ECHA Procedures on dossier and substance evaluation.