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 evaluationSubstance evaluation
      Evaluation of testing proposalsCompliance check
      AimProduce reliable and adequate data in compliance with REACH and avoid unnecessary animal testingAssure compliance of registration dossiers with the REACH requirementsClarify a concern that a substance constitutes a risk to human health or the environment
      TargetAll testing proposals submitted as part of a registration dossierAt least 5% of the registration dossiers for each tonnage bandRegistered substances selected and listed in the CoRAP
      Check
      • Registration dossier and testing proposals of the registrant
      • Outcome of public consultation for vertebrate tests versus the data requirements and waiving options in Annex IX and X REACH
      • Registration dossier of the registrant and data requirements of Articles 10-13, Annexes III and VI-X REACH
      • Adaptations of the standard information requirements
      • Chemical safety assessments/reports
      • Risk management measures
      • Justifications for separate submission
      • All available information on the substance (if reasonable also on related substances), in particular those relevant for the identified concern
      Possible outcomeECHA Decision: Registrant to do:
      • The proposed test
      • The proposed test with modifications
      • One or more additional tests
      • No test
      		 ECHA Decision:
      • Registrant to submit any missing information required according to the REACH Annexes
      • Quality Observation Letter: Registrant to increase quality of the dossier
      • No further action (dossier is already in compliance)
      		 ECHA Decision:
      • Registrant(s) to submit any needed information
      • Further actions by authorities within REACH&CLP (authorisation, restriction, classification and labelling)
      • Further actions by authorities outside REACH&CLP
      • Voluntary actions by registrant(s)
      • No further action (no risk identified)

      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

      Compliance check

      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

      StepActorCompany action
      Evaluation of the testing proposal (deadlines see Article 43 REACH), or Compliance check of the registration dossier (within 12 months after start)ECHA
      • No specific actions; follow your REACH IT account closely
      • Update dossier before the target date stated in a quality observation letter (QOBL) received from ECHA (only for compliance check)1
      Adoption of the ECHA DecisionECHA, MS, optionally also MSC and COM
      • Comment on ECHA’s draft decision within 30 days (testing proposal: 90 days if more than one registrant); also use the ECHA offer to have an informal exchange on the draft decision, update dossier if needed
      • Comment on proposals for amendment by Member States (MS), if any
      • Participate in meeting discussion of proposals for amendment in the Member States Committee (MSC), if any
      • Agree on who generates the requested information with other registrants of the substance, if any, (incl. cost and data sharing)
      • Prepare and submit the requested data to ECHA within the deadline fixed in the final decision and update dossier2
      Evaluation of submitted informationECHA
      • No specific action; if further data is needed, ECHA will restart the process; if request is not fulfilled, ECHA informs MS of non-compliance (enforcement)

       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

      StepActorCompany action
      Selection of substances (CoRAP)ECHA, MS
      • Follow the annual update of the CoRAP

      Evaluation of the substance (within 12 months after start) 

      		eMSCA
      • Contact the evaluating Member States’ Competent Authority (eMSCA) for that substance early in the process to clarify the initial concern and to see if additional data can be provided (if so, update dossier)
      • Communicate with other registrants of the substance
      Adoption of the ECHA decision (on request for further data from the registrant, if any)ECHA, MS, optionally also MSC and COM
      • Comment on ECHA’s draft decision within 30 days (ideally one joint comment for all registrants of the substance), update dossier if needed
      • Comment on proposals for amendment by MS, if any
      • Participate in meeting discussion of proposals for amendment in the MSC, if any
      • Agree with other registrants of the substance, if any, on who generates the requested information (incl. cost and data sharing)
      • Prepare and submit the requested data to ECHA within the deadline fixed in the final decision, and update dossier1
      Evaluation of submitted information and finalisation of substance evaluationeMSCA
      • Follow the finalisation of the substance evaluation and the identification of possible follow-up actions

       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.

      Useful links