Evaluating applications

Documents on how applications are treated and evaluated including the reference DNELs or dose-response relationshipsWhile the documents relate to the Committees' evaluation of applications, companies preparing applications are likely to find the documents useful as well.

Document Description  
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
Guidance paper on opinion trees for non-threshold substances The purpose of the opinion trees is to help RAC and SEAC in concluding on authorisation opinions and making recommendations in a consistent and efficient manner Download
Reporting format for the RAC and SEAC opinions Format used by ECHA's Committees to write their opinions is provided. Download
Note
Format
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.

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Note

Working procedure

Economic feasibility How SEAC evaluates economic feasibility Download
Review period How RAC and SEAC recommend the duration of the review period  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

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DEHP
DBP
B
BP
Diglyme
Cr(VI)
Cr(VI) -  consultant's report
1-Bromopropane
1-Bromopropane - consultant’s report
DIPP
DIPP – consultant’s report

Reference dose‑response relationship ECHA project on carcinogenicity dose-response analysis

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Cr (VI)
-containing
substances


Cr (VI) containing substances- consultant's report

Inorganic As-containing substances

Inorganic As-containing substances - consultant's report

Trichloroethylene

Trichloroethylene - consultant's report

Technical MDA

MOCA

EDC

Consultant's report on MOCA, techn. MDA, EDC and Diglyme

AfA A-listing criteria Outlines the approach of fast-tracking opinions through an A-list Download


 


 

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