REACH requires EU companies to submit registration dossiers providing information on the intrinsic properties of substances manufactured or imported in quantities of one tonne or more per year. The higher the tonnage, the more information needs to be submitted. The submission includes a technical dossier including, for substances manufactured or imported in quantities of 10 tonnes per year or more, a chemical safety report.
When fulfilling the information requirements, registrants should first collect all relevant available information on the substance. This includes information on substance identity, physicochemical properties, toxicity, ecotoxicity, environmental fate, exposure and instructions for appropriate risk management. Data sharing with other registrants for the same substance is one of the major tools in REACH that can be used to avoid unnecessary testing. REACH lists standard information requirements and possibilities to adapt the standard information requirements. Such adaptations can also avoid unnecessary testing. The registrant must always provide detailed scientific justification for using adaptation options for the standard information requirements.
If registrants identify a data gap and cannot fulfil the REACH information requirements, they should submit testing proposals to ECHA for undertaking 'higher-tier' tests required by REACH at tonnages of 100 or more per year.
ECHA checks each submitted dossier during the technical completeness check (TCC) to confirm that the necessary information has been provided and the appropriate fee has been paid before it issues a registration number.
ECHA initiates compliance checks for at least 5% of all dossiers received within each tonnage band. ECHA can decide which dossiers to check and whether only part of any dossier will be investigated. REACH provides dossier selection criteria but additional criteria are used including random selection. A compliance check can start at any time in respect of any dossier.
ECHA evaluates all testing proposals within set deadlines.
For non phase-in substances the examination takes place within 180 days of receipt of a dossier with a testing proposal.
For phase-in substances there are three examination deadlines (1 December 2012, 1 June 2016 and 1 June 2022) depending on the registration deadlines.
For substance evaluation, the substance is placed on a list of substances to be evaluated which is called the community rolling action plan (CoRAP) and is adopted on the basis of the opinion of the Member State Committee. The designated Member State performs the substance evaluation and, if necessary, prepares a draft decision within one year of the publication of the CoRAP.
No action towards the registrant
No administrative action is necessary on the basis of the compliance check performed. The registrant is not notified in such a case. This outcome does not mean that the dossier is considered as fully compliant with the information requirements provided in the REACH Regulation in all respects, but only that no incompliances have been identified. An additional compliance check can still be opened at any time.
Quality observation letter
ECHA may identify shortcomings which are not necessarily related to a lack of information. For example, the risk management measures proposed by the registrant may be inadequate if the proposed classification and labelling does not reflect the reported study results. In such cases, quality observation letters are used by ECHA to invite the registrant to update the dossier.
Quality observation letters may also be used to clarify issues. For example, if the description of the strictly controlled conditions for intermediates is ambiguous, a quality observation letter can be used to clarify the conditions in an updated dossier. ECHA informs the Member States on the quality observation letters and on the response of the registrants. Member States may take action if registrants do not clarify the issue.
For the first example, Member States might prepare a proposal for harmonised classification and labelling for the substance. A quality observation letter can be combined with a draft decision on the same dossier. .
ECHA evaluation decisions
If ECHA concludes that additional testing or other information is required; it prepares a draft decision to be sent to the registrant for comments. Based on the comments, the draft decision may be modified accordingly. The draft decision is then sent to the Member States which can propose amendments to it. If any amendments are proposed, the issue is referred to the Member State Committee.
All draft decisions made by the Agency must be unanimously supported by the Member States and will only then become legally binding decisions.
Examination of a testing proposal always results in a draft decision. Following the same procedure as above, the decision is either adopted by ECHA or referred to the Commission.
Testing proposals - submission of information by third parties
If a testing proposal involves tests on vertebrate animals, REACH requires ECHA to publish the name of the substance, the hazard endpoint for which vertebrate testing is proposed, and the date by which any third party information is required.
The purpose of publishing this information is so that third parties can submit scientifically valid information and studies addressing the substance and hazard endpoint in question, which could be taken into account by ECHA in preparing its decision on the testing proposal.
Submission of relevant information
After a testing proposal has been published, third parties have 45 days to submit scientifically valid information and studies that address the relevant substance and hazard endpoint as covered in the testing proposal. To facilitate the evaluation of the information, ECHA recommends submitting it in English (i.e. the working language of ECHA) and providing a non-confidential version of the information, which ECHA may make available to the public. Confidential details to support the non-confidential information may be submitted as well, but third parties must give justification explaining why the information is confidential.
Evaluation of submitted information
Any scientifically valid information and studies received from third parties will be taken into account by ECHA in preparing its draft decision. Based on relevant information provided by third parties, the testing proposal can be rejected. However, the information provided has to meet the REACH requirements as specified in the Annexes.
ECHA publishes conclusions of the information provided by third parties after the adoption of the testing proposal decision to improve the transparency of the process and encourage the submission of relevant information.
A request for further data is always done by drafting a decision.
For compliance checks, the draft decision describes the status of the administrative procedure, specifies which information is currently missing and needed to bring the dossier into compliance with the REACH requirements, and provides the statement of reason for requesting this information and the deadline for submitting the information to ECHA (once adopted as an ECHA decision).
For testing proposal examinations, the options for the draft decision are:
- a decision accepting the testing proposal;
- a decision accepting the testing proposal with modifications of the testing conditions;
- a decision accepting or rejecting the testing proposal but requiring one or more additional tests;
- a decision rejecting the testing proposal, or
- a decision covering any of the three first options.
For a decision covering any of the first three options, where several proposals are submitted for the same substance and the same tests are proposed, an agreement as to who carries out the tests must be reached.
Once ECHA has notified the registrant of the draft decision, the registrant has 30 days to provide comments for a compliance check or a testing proposal. The deadline and the method for providing comments will be specified to the registrant. In exceptional periods, such as Christmas holidays, 45 days are given.
While adopting a draft decision on a compliance check, ECHA does not normally take into account dossier updates submitted after the draft decision has been sent to the registrant for comments. In the case of testing proposals, updates will be considered during the adoption process, if submitted 30 calendar days after the end of the period for commenting on the draft decision.
This applies without prejudice to the obligation of registrants to update their registrations without undue delay in accordance with Article 22(1) REACH.
The aforementioned cut-off dates are applied for an efficient administration of the adoption process. ECHA will, however, evaluate all information submitted, and thus also such provided in updates after the above cut-off dates, after the expiry of the deadline set in the decision for provision of additional information.
For testing proposals, if, after reviewing the registrant's comments or timely updates of the registration dossier, ECHA now considers the dossier to be compliant, the decision process is terminated and the examination closed with no further administrative action.
If, after examining the comments and/or applicable updated dossier, the issues raised in the draft decision are still not satisfactorily resolved, ECHA will proceed with issuing the decision. ECHA will take into account the registrant's input and may amend the original draft decision based on that. ECHA will then send the draft decision (possibly amended) and the registrant's comments to the Member State competent authorities (MSCAs) for their review.
For compliance checks, ECHA will take into account the registrant's input and may amend the original draft decision based on that, and then send the draft decision (possibly amended) and the registrant's comments to the Member State competent authorities (MSCAs) for their review.
Where ECHA receives no proposals for amendment from the Member States, it takes the decision without further need for involvement of the Member State Committee.
If there are no proposals for amendment of a draft decision from Member States, go to step "Decision requesting further information".
The REACH evaluation process is only successful when the registrant delivers the requested information (i.e. complies with the ECHA decision) by the given deadline. When an ECHA decision becomes effective, the addressee of this decision must comply with the decision and deliver the information requested within the stated deadline. In the follow-up part of the evaluation process, ECHA looks in the latest submission of the respective registration dossier for the requested information.
When the registrant has successfully updated the dossier meeting all the requests of the ECHA decision, ECHA notifies the Member State competent authorities and the Commission of both the information that was provided as well as of its conclusions made according to Article 42(2). The Member State competent authorities may use this new information for the purposes of other processes (i.e. substance evaluation, authorisation and restriction).
In addition, the new information may serve as a basis for harmonised classification or lead to identification as a candidate for the CoRAP.
There may be the situation where the new information leads to further concerns. In such cases, ECHA may open a new process of dossier evaluation and issue a decision requesting further information (Article 42 (1)).
When registrants fail to provide some or all of the required information by the deadline set in the decision, they are in breach of the REACH Regulation. Non-compliance with ECHA's decision will lead to the consideration of enforcement actions by the national enforcement authorities of the Member States, as introduced by Article 126 of the REACH Regulation.
ECHA does not have the competence to carry out enforcement actions concerning the decision nor does ECHA have the competence to extend the deadline given in the decision. Furthermore, REACH does not provide for the postponement of the deadline of an ECHA decision. If for any reason registrants cannot provide the required information by the deadline given, they can indicate such reasons in the updated dossier. ECHA can then communicate such delays and the reasons thereof to the Member State.
The Member States alone have the authority to undertake enforcement actions, which they have delegated to the respective national enforcement authorities. The communication between ECHA, Member State competent authorities and national enforcement authorities requires good coordination. The coordinator of the Member States enforcement authorities, the Forum, organised a workshop on 9 October 2012 at ECHA's premises and agreed on a procedure along the lines described in the paragraph below.
ECHA informs the REACH competent authority as well as the agreed focal points for enforcement issues of the responsible Member State about the breach (i.e. the non-compliance with an ECHA decision) and asks the national authorities for enforcement of the decision. A copy of the communication is sent to the registrant. The Member State focal points will inform ECHA, when an enforcement action is taken and by when the missing information will potentially arrive. ECHA will examine the dossier as soon as it receives the update of the dossier and proceeds as explained for the normal follow-up process.
Only after ECHA has carried out this step successfully and confirmed the compliance with the information request of the decision, is the process of dossier evaluation completed.