Етапи
Dossier preparation and submission
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 p.a. or above, a chemical safety report.
When fulfilling the information requirements, the registrant should first collect all relevant available information on the substance. This includes information on substance identity, physico-chemical 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 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.
Registrants submit Testing Proposals to ECHA to undertake 'higher-tier' tests required by REACH at tonnages of 100 or more per annum as listed in Annexes IX and X if they identify a data gap and cannot otherwise fulfil the REACH information requirements.
When fulfilling the information requirements, the registrant should first collect all relevant available information on the substance. This includes information on substance identity, physico-chemical 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 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.
Registrants submit Testing Proposals to ECHA to undertake 'higher-tier' tests required by REACH at tonnages of 100 or more per annum as listed in Annexes IX and X if they identify a data gap and cannot otherwise fulfil the REACH information requirements.
Registration
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.
Dossier selection and evaluation
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. The REACH Regulation 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 erceipt of a dossier witha testing proposal. For phase-in substances there are three examination deadlines (01/12/2012, 01/06/2016 and 01/06/2022) depending on the registration deadlines.
ECHA evaluates all testing proposals within set deadlines
For non-phase-in substances the examination takes place within 180 days of erceipt of a dossier witha testing proposal. For phase-in substances there are three examination deadlines (01/12/2012, 01/06/2016 and 01/06/2022) depending on the registration deadlines.
Substance evaluation
For substance evaluation, the substance is placed on a list of substances to be evaluated. ECHA will submit the first proposal for that list to the Member States by 1 December 2011. The final list (called the Community Rolling Action Plan or CoRAP) will be 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.
Results of Evaluations
Results of Evaluations
- Compliance check
- No action towards the registrant
One possible outcome is that no administrative action is regarded 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, only that no incompliances have been identified, and a new 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. Quality observation letters are used by ECHA to invite the registrant to update the dossier in such cases. Another reason for using quality observation letters may be to clarify issues. For example, the description of the strictly controlled conditions for intermediates is equivocal. A quality observation letter is 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. The Member States may take action if the registrant does not clarify the issue. For the first example, the Member State 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. - Draft and final decisions
If ECHA concludes that additional testing or other information is required, it prepares a draft decision which is sent to the registrant for comments. Based on the comments, the draft decision may be modified accordingly. The draft decision is 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 EU Member States and will only then become final legally binding decisions.
- No action towards the registrant
- Testing proposal
Examination of a testing proposal always results in a draft decision. Following the same procedure as above, the final decision is either adopted by ECHA or the case is referred to the Commission for a decision.- 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 that third parties can submit scientifically valid information and studies addressing the substance and hazard endpoint in question that 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 final testing proposal decision. By doing that, ECHA wishes to improve the transparency of the process and encourage submission of relevant information.
- Testing proposals - submission of information by third parties
Related links
Draft decision requesting further information
A request for further data is always done by drafting a decision.
In a case of compliance check, the draft decision describes the status of the administrative procedure, specifies the currently missing information that is 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 a final decision).
In a case of a testing proposal examination, the options for the draft decision are:
In a case of compliance check, the draft decision describes the status of the administrative procedure, specifies the currently missing information that is 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 a final decision).
In a case of a testing proposal examination, 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 three first options above, in a case where several proposals are submitted for the same substance and the same tests are proposed, an agreement as to who carries out the tests has to be reached.
Comments on draft decision/dossier update
Once ECHA has issued the draft decision to the registrant, the registrant has 30 days to provide comments and update the dossier. The deadline and the way for providing the comments are specified in the notification letter to the draft decision. The registrant may also during this time update the dossier with information relevant for the data gaps addressed in the draft decision (e.g. an improved justification for using adaptations to standard information requirements).
Evaluation of comments/new information
If, after reviewing the registrant's comments and/or updated 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 examination of the comments and/or updated dossier the issues raised in the draft decision are still not satisfactorily resolved, ECHA will proceed with the process of issuing the decision. ECHA will fist consider the need for amending the first draft of the decision based on the registrant's input, then send the final draft decision (possibly amended) and the registrant's comments to the Member States Competent Authorities (MSCA) for their review.
No administrative action is taken if the dossier is considered compliant with the information requirements provided in the REACH Regulation. The case is closed without further notification to the registrant. This, however, does not necessarily mean that there are no shortcomings in the dossier. A compliance check might also be re-opened as the examination may have been a targeted one.
If after examination of the comments and/or updated dossier the issues raised in the draft decision are still not satisfactorily resolved, ECHA will proceed with the process of issuing the decision. ECHA will fist consider the need for amending the first draft of the decision based on the registrant's input, then send the final draft decision (possibly amended) and the registrant's comments to the Member States Competent Authorities (MSCA) for their review.
No administrative action is taken if the dossier is considered compliant with the information requirements provided in the REACH Regulation. The case is closed without further notification to the registrant. This, however, does not necessarily mean that there are no shortcomings in the dossier. A compliance check might also be re-opened as the examination may have been a targeted one.
Final decision requesting further information
The final decision is legally binding and is signed by the Director of Regulatory Affairs of ECHA. The final decision contains the same general elements as the draft decision. It describes the status of the administrative procedure, specifies the currently missing information that is 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. An appeal may be brought against the final decision.
Proposals for amendments of draft decision from Member States
After receiving ECHA's draft decision and the comments of the registrant, the MSCA has 30 days to comment on or propose amendments to the draft decision. If ECHA receives proposals for amendments it will refer the draft decision to the Member State Committee.
Comments on amended draft decision
ECHA will also send the MSCA's proposals for amendments and the second version of the draft decision to the registrant for a second commenting round. Again the registrant has 30 days to provide such comments.
No proposals for amendments of draft decision from Member States
In cases where ECHA receives no proposals for amendments from the Member States, it finalises the decision without further need for involvement of the Member State Committee.
Member State Committee (MSC) meeting
The Member State Committee will assess whether the draft decision should be revised and seeks agreement on the draft decision and will take the comments of the registrant into account. A case-owner, i.e., a concerned registrant or a representative of a group of concerned registrants in the case of joint submissions, may be admitted to the meeting as an observer when their specific case is addressed by the Committee. The case-owners shall conform to the ECHA Code of Conduct for Case Owner Observers at MSC meetings.
MSC does not reach unanimous agreement - European Commission decides
In cases where there is disagreement amongst the Member State Committee members with regard to the draft decision, the matter is referred to the European Commission for its decision-making under the comitology procedure.
MSC reaches unanimous agreement
The Member State Committee must seek agreement on the draft decision within 60 days. If the Member State Committee reaches unanimous agreement, ECHA makes the decision accordingly.