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Dossier Evaluation (compliance check)

REACH requires EU companies manufacturing and importing chemicals to assess their chemicals and propose risk management measures. This assessment needs to be documented in a registration dossier which companies need to prepare and submit to ECHA.

ECHA can examine any registration dossier to verify if the information submitted by registrants is compliant with the REACH legal requirements (i.e. available in the dossier or proposed in a testing proposal). The dossier evaluation process, and in particular the check of compliance, contributes to the generation of relevant data on chemicals and contributes to demonstrate that industry takes responsibility to ensure the safety of the substances they manufacture and import.

In 2019, ECHA and the European Commission published a REACH Evaluation Joint Action Plan to address the lack of compliance of the information in the registration dossiers. (https://echa.europa.eu/-/echa-to-scrutinise-all-reach-registrations-by-2027)

In a nutshell:

  • For all registrations in the tonnage bands over 100 tonnes/year, ECHA will have screened by 2023 all registration dossiers submitted by the 2018 deadline and performed a compliance check for all substances where data gaps prevent from concluding whether the Substance is of concern or whether it is of low priority for further regulatory action.
  • ECHA will perform a similar action for the substances in the tonnage bands 1-100 tonnes/year by 2027

ECHA estimates that 20% of all registration dossiers in each tonnage band will be checked for compliance. Overall this corresponds to 30% of all registered substances.

ECHA has developed an approach in order to decide how all registered substances need to be addressed and accelerate the work:

  • All dossiers are screened using IT-based algorithms in order to group all registered substances according to their structural similarity and other available information such as category information provided by the registrants in their dossiers.
  • Each individual group of substances is then subject to further manual assessment to identify whether the substances are:

                      a. Of priority for regulatory risk management: These are substances with an identified concern.

  • There is sufficient information to initiate either:

              ·      hazard identification (Harmonised Classification and Labelling or identification as Substances of Very High Concern for PBT and/or ED properties); or

              ·      a restriction or authorisation process under REACH or further regulatory risk management measures under other EU legislation.

 

                      b. Currently of low priority for further regulatory action:  These are substances which are already subject to sufficient regulatory requirements including existing risk management measures that are deemed sufficient, or for which available data is sufficient to conclude that they are of low concern at present. For those of low concern, the priority will be reconsidered when/if new information related to hazard or use is submitted.

 

                      c. Of priority for data generation: For the substances which the assessment could not already fit into one of the two pools above, a substance could still be of concern due to its hazardous properties, potential for exposure or data gaps preventing from concluding on the need for regulatory risk management action or low priority. These substances are prime candidates for compliance check and/or substance evaluation. The information generated and/or submitted by the registrants further to the evaluation decision will be assessed to allocate the substances in any other of the two pools above

 

By 2027, the aim is to have checked all registration dossiers, allocated all registered substances in the pools above and requested information where needed.

 

A series of actions were outlined

Action 1: By mid-2019, the Commission will propose an amendment of Article 41(5) of REACH to raise the 5% minimum target in Article 41(5) to 20% of dossiers selected for compliance checking. (done)

Action 2: By end of 2020, ECHA will have concluded for all substances registered above 100 tonnes/y if they are i) of priority for regulatory risk management, ii) currently of low priority for further regulatory action, or iii) need more data for a judgement to be made. Substances under iii) are candidates for further compliance check and/or substance evaluation. This is the so-called mapping of the chemicals universe. Outcomes are available here https://echa.europa.eu/-/mapping-the-chemical-universe-list-of-substances-by-regulatory-action-published 

 Action 3: By end of 2021, ECHA will have developed an approach that will allow drawing similar conclusions for substances registered in lower tonnage bands.

Action 4: By 2023 for all registrations in the tonnage bands over 100 tonnes/year and by 2027 also for the tonnage bands 1-100 tonnes/year, ECHA will have concluded for each of the registered substances submitted by the 2018 deadline if it is a priority for regulatory risk management, of low priority for further regulatory action, or have requested information under compliance check where needed.

Action 5: By end of 2019, the Commission will assess the need, and if necessary make a proposal, to amend the Annexes VI to X of REACH to provide greater clarity to the information requirements set out therein. (done)

Action 6: By end of 2019, on the basis of the experience gained by ECHA, the Commission will assess the need, and if necessary make a proposal, to amend Annex XI to ensure that adaptations to standard information requirements are properly justified.

Action 7: By end of 2019, the Commission will assess the need of a possible implementing regulation that would efficiently put into effect the REACH evaluation decision making process (ongoing discussion).

Action 8: By end of 2019, ECHA will simplify the compliance check decisions and improve the statement of reasons, to be clearer and more focused.

Action 9: By end of 2019, ECHA will organise workshops with Member States, also on bilateral basis, with the aim of resolving underlying differences of view. The result will be presented to ECHA’s Member State Committee for endorsement. In addition, ECHA will continue, as far as possible, identify and plan discussions on more generic issues that may arise in upcoming compliance checks.

Action 10: By end of 2019, ECHA will make a refined proposal to CARACAL how to better integrate substance evaluation and compliance check

Action 11: By end of 2019, ECHA will ensure that any company submitting relevant new information during a restriction, an identification of substance of very high concern, an authorisation or a harmonised classification process and that has not preceded such submission with the corresponding update of the registration dossier, will be informed of its updating obligations according to Article 22 of REACH. Moreover, in such cases ECHA will inform the responsible MS(s), so enforcement action is pursued as appropriate.

Action 12: By end of 2019, ECHA will prepare a compilation of enforcement measures in place in each Member State to address the breach of dossier evaluation decisions and an assessment to what extent enforcement authorities in different Member States address non-compliance with ECHA’s decisions through prohibition of marketing of the substance.

Action 13: By end of 2020, the Commission will assess the effectiveness of the enforcement measures above, including the information submitted by Member States in their Article 127 report by 1st June 2020.

Action 14: By mid-2020, ECHA's Forum will have established the template to test annual reporting to the ECHA’s Secretariat including a summary of all enforcement actions taken by each Member State in the area of dossier compliance. The first such report should be made available by mid-2021. ECHA’s Secretariat will propose to ECHA’s Forum that such annual reporting is permanent and becomes integrated in the Article 127 report

Action 15: By end of 2019, ECHA will have established working arrangements with major industry associations, which will be transparent and inclusive, aiming at industry committing to develop action plans for proactive and continual improvement of their registration dossiers. For our metals/inorganics sector, please see MISA (add link ECHA website + RMG)

 

More information on the dossier evaluation process can be found here: https://echa.europa.eu/documents/10162/13607/procedure_dossier_evaluation_en.pdf/362418b9-4ca1-445f-8bf6-c7c176463e27 

Note: one can follow the progress of the evaluation through the entire process here: https://echa.europa.eu/information-on-chemicals/dossier-evaluation-status 

The table provides a status of the dossiers that ECHA has started to evaluate and follow the progress through the evaluation process. It displays the type, scope and status of the assessment undertaken. The decision date and the non-confidential version of the decision are published shortly after the decision has been adopted.

 

Last page update: 7 January 2020