- ECHA
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- Authorisation
- How to apply for authorisation
- Start preparing your application
- Evaluating applications
Evaluating applications
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How to apply for authorisation
- Are you affected by authorisation?
- Develop an application strategy
- Start preparing your application
- Notify ECHA and request a teleconference based information session
- Finalise your application
- Submit your application
- Engage during the opinion development
- Fulfil your obligations
- Submit a review report if you still need to use the substance
- Ask ECHA about authorisation applications
Evaluating applications
Documents on how applications are treated and evaluated including the reference DNELs or dose-response relationships. While the documents relate to the Committees' evaluation of applications, companies preparing applications are likely to find the documents useful as well.
| Document | Description | |
|---|---|---|
| SEAC’s approach to assessing changes in producer surplus | The aim of this document is to provide detailed guidance to applicants to make case-by-case assessments or evaluations of, and motivate for, estimating producer surplus losses (when such losses are expected to occur). | Download |
| Approach for evaluating review reports | This note describes RAC's and SEAC's approaches for evaluating review reports. It outlines issues common to RAC and SEAC, as well as specific considerations related to either committee. | Download |
| SEA-related considerations in applications for authorisation for endocrine disrupting substances for the environment, specifically OPnEO and NPnEO | This paper describes one possible approach for SEA in applications for authorisation for endocrine disrupting substances for the environment. | Download |
| Risk-related considerations in applications for authorisation for endocrine disrupting substances for the environment, specifically OPnEO and NPnEO | This question and answer paper is intended to provide general advice to companies intending to apply for Authorisation for uses of OPnEO and NPnEO with regard to environmental risk assessment | Download |
| Reference willingness-to-pay values for monetising chemicals health impacts | Reference willingness-to-pay values that SEAC uses as a starting point for valuing chemicals health impacts | Download |
| Note on the social cost of unemployment | How SEAC evaluates unemployment effects | Download SEAC note Consultant's report |
| Review Report of an authorisation | Approach to Review Reports outlining to what in the review process and report are identical to an application for authorisation and what they are different. | Download |
| Checklist for evaluating chemical safety assessment in applications for authorisation | This checklist is designed to support RAC rapporteurs in the appraisal of applications for authorisation | Download |
| Checklist for evaluating socio-economic analysis in applications for authorisation | This checklist is designed to support SEAC rapporteurs in the appraisal of applications for authorisation | Download |
| How to evaluate PBT and vPvB substances in SEAC? | Describes a consistent approach for evaluation of restriction reports and applications for authorisation for PBT and vPvB substances in SEAC. | Download |
| Participation of applicants, third parties and stakeholder observers in the application for authorisation process | This note defines ECHA's approach to the participation of applicants, third parties and stakeholder observers in the application for authorisation process | Download |
| Submission of information on alternatives | Instructions of how interested third parties can submit information for the public consultation on alternatives for applications for authorisation. | Download |
| Non-confidential template | Download | |
| Confidential template | Download | |
| How RAC and SEAC intend to evaluate the applications | Outline of the key principles in the development of RAC and SEAC opinions is provided. It focuses on issues where a common approach is needed in both RAC and SEAC. | Download |
| Reporting format for the RAC and SEAC opinions | Format used by ECHA's Committees to write their opinions is provided. | Download |
| Public sections of RAC and SEAC opinions | Parts of RAC and SEAC opinions which will be made publicly available are indicated. | Download |
| Publication of information on applications during the opinion-making process | A description of information from applications for authorisations that will be made publicly available is outlined. | Download |
| Working procedure for RAC and SEAC for developing opinions | Describes the main roles and tasks of the (co-)rapporteurs, the members of RAC and SEAC, and the ECHA secretariat as well as the timelines related to the opinion-making process. Note describes the new approach for the Conformity Check. |
Download |
| Economic feasibility | How SEAC evaluates economic feasibility | Download |
| Review period | How SEAC recommend the duration of the review period | Download |
| Review periods for “exceptional cases” | CARACAL document: policy guidance for considering review periods for “exceptional cases” | Download |
| Setting DNELs and dose-response curves prior to the application for authorisation phase | This note establishes how RAC will set reference DNELs and dose-response curves prior to the application for authorisation phase | Download |
| Reference DNELs | Reference DNELs used by RAC when evaluating the exposure |
Download |
| Reference dose‑response relationship | ECHA project on carcinogenicity dose-response analysis |
Download |
| AfA A-listing criteria | Outlines the approach to A-list with scrutiny the opinions | Download |