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How to apply for authorisation October 2017 How to apply for authorisation 2 Disclaimer This document aims to assist users in complying with their...
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10/10/17
Steps Steps Steps
The following main steps are involved in the application for authorisation and the subsequent decision-making process on granting an authorisation for the placing on the market...
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06/10/17
Actors - Links Actors - Links Actors
Related Questions and Answers on Authorisation Risk Assessment Committee (RAC) Socio-economic Analysis Committee (SEAC) Committees Secretariat Unit Risk Management...
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05/10/17
Checklist for preparing an application for authorisation or a review report 1 (20) 12 May 2017 Version 1.1 Annankatu 18, P.O. Box 400, FI-00121...
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13/09/17
Authorisation process - links Authorisation process - links Applications for authorisation process
Related How to apply for authorisation in the Support section Authorisation Q&As
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13/09/17
How to develop the description of uses in the context of Authorisation How to develop the description of uses in the context of Authorisation How to develop the description of uses in the context of Authorisation (616.1k)
How to develop use descriptions in applications for authorisation 1 How to develop use descriptions in applications for authorisation June 2017 2 How to...
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27/06/17
RAC / SEAC meeting - Participation of applicants, third parties and stakeholder observers in the application for authorisation process RAC / SEAC meeting - Participation of applicants, third parties and stakeholder observers in the application for authorisation process RAC / SEAC meeting - Participation of applicants, third parties and stakeholder observers in the application for authorisation process (226.4k)
Helsinki, 14 December 2012 RAC/23/2012/06 (Rev. 2) SEAC/17/2012/06 (Rev. 2) 23RD MEETING OF THE COMMITTEE FOR RISK...
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13/06/17
anALYSIS OF ALTERNATIVES Explanatory note to a review report Introduction It is very likely that changes have occurred to the use, the available technology or the...
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13/06/17
Application for Authorisation - Template Substitution Plan Application for Authorisation - Template Substitution Plan Application for Authorisation - Template Substitution Plan (238.2k)
Substitution plan SUbstitution plan Use number: Legal name of the applicant(s) Use number: Legal name of the applicant(s)/authorisation holder(s) 7 ...
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12/06/17
Application for Authorisation - Template for substitution plan Application for Authorisation - Template for substitution plan Application for Authorisation - Template for substitution plan (487.9k)
Format for SUBSTITUTION PLAN Please note: Instructions in blue are applicable to the Review Report Version 3.2 ...
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12/06/17
Application for Authorisation - Template for analysis of alternatives non-confidential report Application for Authorisation - Template for analysis of alternatives non-confidential report Application for Authorisation - Template for analysis of alternatives non-confidential report (196.1k)
anALYSIS OF ALTERNATIVES Use number: Legal name of the applicant(s) Format for ANALYSIS OF ALTERNATIVES Legal name of applicant(s): [Legal names of...
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12/06/17
Previous events on appliction for authorisation Previous events on appliction for authorisation Previous events on appliction for authorisation
29-30 April 2014 ECHA workshop on sharing experience on applications for authorisation 28-29 April 2014 ECHA seminar on Applications for Authorisation 27-28 March 2014 ECHA...
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24/05/17
Working procedure for RAC and SEAC for developing opinions on the application for authorisation Working procedure for RAC and SEAC for developing opinions on the application for authorisation Working procedure for RAC and SEAC for developing opinions on the application for authorisation (197.5k)
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Page 1 of 10 ...
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04/05/17
Helsinki, 23 February 2017 RAC/40/2017/07 40TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 6-10 MARCH & 14-15 MARCH...
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04/05/17
Task Force on the Workability of Applications for Authorisation March 6 2017 This report outlines the activities undertaken by the Task Force on the...
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24/04/17
Helsinki, 12 April 2017 SEAC/32/2016/05.2 Rev.1† 32ND MEETING OF THE COMMITTEE FOR SOCIO-ECONOMIC ANALYSIS 6-15 SEPTEMBER 2016 HELSINKI, FINLAND ...
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18/04/17
ECHA/2011/01 – SR-11 Final report November 2013 i ...
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22/02/17
European Chemicals Agency (EChA), Helsinki To support the DNEL setting for 1-bromopropane on its toxicity for reproduction, related to the use in Application for...
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08/02/17
1 (16) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Helsinki, 09 September...
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08/02/17
1 European Chemicals Agency (EChA), Helsinki To support the DNEL setting for diisopentylphthalate on its toxicity for reproduction related to the use in ...
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08/02/17
1 (10) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Helsinki , 09 September...
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08/02/17
Member state Institution Document The Netherlands Rijksinstituut voor Volksgezondheid en Milieu Chemische stoffen goed geregeld [NL] The United Kingdom UK Chemicals...
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21/12/16
Report Reference: UCUC10376.02 June 2015 SR 20 Support for the assessment of remaining risks related to the use of MOCA, MDA and EDC, and DNEL...
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10/11/16
ECHA 2015/248: Assess the risk estimate for the intrinsic property “Toxic to reproduction” of the Cr(VI) compounds listed in Annex XIV except...
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07/11/16
Helsinki, 04 December 2015 RAC/35/2015/09 35TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 24-27 NOVEMBER _ 1-4 DECEMBER...
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07/11/16
The Economics Interface Limited Registered in England and Wales, company number 09213724 Registered office: 6 Ash Grove, Chester CH4 7QN United Kingdom Valuing the social...
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10/10/16
NOTE 1 (5) 16 September 2016 Review report of an authorisation 1. Purpose According to Article 61(1) of the REACH Regulation,...
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03/10/16
SEAC/24/2014/04 (Agreed at SEAC-24) Evaluation of restriction reports and applications for authorisation for PBT and vPvB substances in SEAC SEAC/24/2014/04 (Agreed at SEAC-24) Evaluation of restriction reports and applications for authorisation for PBT and vPvB substances in SEAC SEAC/24/2014/04 (Agreed at SEAC-24) Evaluation of restriction reports and applications for authorisation for PBT and vPvB substances in SEAC (80.8k)
1(12) Helsinki, 9 June 2016 SEAC/31/2016/05 Rev.1 (Agreed at SEAC 31) Evaluation of restriction reports and applications for authorisation for PBT and...
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02/09/16
IR/CSA Chapter R.14: Occupational exposure estimation IR/CSA Chapter R.14: Occupational exposure estimation IR/CSA Chapter R.14: Occupational exposure estimation (1,210.7k)
G U I D A N C E Guidance on Information Requirements and Chemical Safety Assessment Chapter R.14: Occupational exposure assessment Version 3.0 August 2016 ...
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23/08/16
Application for Authorisation Analysis of alternatives Non-confidential report Application for Authorisation Analysis of alternatives Non-confidential report Application for Authorisation Analysis of alternatives Non-confidential report (2,507.7k)
ANALYSIS OF ALTERNATIVES (Public Version) Legal name of applicant(s): DOMO Caproleuna GmbH Submitted by: DOMO Caproleuna GmbH Substance: ...
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22/08/16
Guidance paper on opinion trees for non-treshold substances Guidance paper on opinion trees for non-treshold substances Guidance paper on opinion trees for non-treshold substances (369.9k)
1 January 2016 Version 1.1 RAC/35/2015/08 SEAC/29/2015/06 Guidance Paper on Opinion Trees for Non-Treshold Substances1 in Applications for...
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01/06/16
Report of the AfA task force Report of the AfA task force Report of the AfA task force (435.6k)
Task Force on the Workability of Applications for Authorisation March 8 2016 The Task Force on the Workability of Applications for Authorisation has concluded the...
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18/04/16
Checklist for evaluating chemical safety assessment in applications for authorisation Checklist for evaluating chemical safety assessment in applications for authorisation Checklist for evaluating chemical safety assessment in applications for authorisation (154.2k)
RAC checklist 1 (8) 6 April 2016 Version 1.1 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 |...
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12/04/16
AFA Public Consultations: 0042-01 AFA Public Consultations: 0042-01 AFA Public Consultations: 0042-01 (1,131.6k)
SOCIO-ECONOMIC ANALYSIS (non-confidential version) Legal name of applicant: LANXESS Elastomers B.V. Submitted by: LANXESS Elastomers B.V. Substance: ...
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05/02/16
AFA Public Consultations: 0042-01 AFA Public Consultations: 0042-01 AFA Public Consultations: 0042-01 (2,018.7k)
CHEMICAL SAFETY REPORT (Section 9 and 10 non-confidential version) Legal name of applicant: LANXESS Elastomers B.V. Submitted by: LANXESS Elastomers B.V. ...
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05/02/16
AFA Public Consultations: 0060-01 AFA Public Consultations: 0060-01 AFA Public Consultations: 0060-01 (1,059.9k)
CHEMICAL SAFETY REPORT 1 CHEMICAL SAFETY REPORT 7 December 2015 PUBLIC VERSION Authorisation application: Industrial use as a...
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04/02/16
Checklist for evaluating socio-economic analysis in applications for authorisation Checklist for evaluating socio-economic analysis in applications for authorisation Checklist for evaluating socio-economic analysis in applications for authorisation (113.4k)
AfA – SEA checklist 1 (4) 15 January 2016 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 |...
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15/01/16
GENERIC EXEMPTIONS FROM THE AUTHORISATION REQUIREMENT GENERIC EXEMPTIONS FROM THE AUTHORISATION REQUIREMENT GENERIC EXEMPTIONS FROM THE AUTHORISATION REQUIREMENT (150.2k)
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16/11/15
TEMPLATE for third party submission of information on alternatives for Applications for Authorisation CONFIDENTIAL TEMPLATE for third party submission of information on alternatives for Applications for Authorisation CONFIDENTIAL TEMPLATE for third party submission of information on alternatives for Applications for Authorisation CONFIDENTIAL (90.0k)
Submission of Information On ALTERNATIVES (CONFIDENTIAL) Submission of Information on ALTERNATIVES (CONFIDENTIAL) Format for third party submission of information on...
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11/11/15
Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0 Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0 Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0 (24,310.8k)
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10/11/15
Applications for authorisation Socio-economic analysis Chromium trioxide, EC 215-607-8, CAS 1333-82-0 Applications for authorisation Socio-economic analysis Chromium trioxide, EC 215-607-8, CAS 1333-82-0 Applications for authorisation Socio-economic analysis Chromium trioxide, EC 215-607-8, CAS 1333-82-0 (19,379.1k)
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10/11/15
Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0 Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0 Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0 (49,771.7k)
...
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10/11/15
TEMPLATE for third party submission of information on alternatives for Applications for Authorisation NON-CONFIDENTIAL TEMPLATE for third party submission of information on alternatives for Applications for Authorisation NON-CONFIDENTIAL TEMPLATE for third party submission of information on alternatives for Applications for Authorisation NON-CONFIDENTIAL (84.0k)
Submission of Information On ALTERNATIVES (NON-CONFIDENTIAL) Submission of Information on ALTERNATIVES (NON-CONFIDENTIAL) Submission of information on FORMAT for third...
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09/11/15
Submission of information on alternatives by interested third parties for the public consultations on alternatives for Applications for Authorisation Instructions & Templates Submission of information on alternatives by interested third parties for the public consultations on alternatives for Applications for Authorisation Instructions & Templates Submission of information on alternatives by interested third parties for the public consultations on alternatives for Applications for Authorisation Instructions & Templates (847.9k)
Submission of information on alternatives by interested third parties for the public consultations on alternatives for Applications for Authorisation ...
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09/11/15
How to prepare a downstream user chemical safety report Practical guide 17 How to prepare a downstream user chemical safety report Practical guide 17 How to prepare a downstream user chemical safety report Practical guide 17 (657.1k)
How to prepare a downstream user chemical safety report Practical guide 17 ABC Legal Notice This document contains guidance on REACH explaining the REACH obligations and...
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21/09/15
Feedback ECHA welcomes your suggestions regarding the needs and expectations from the pre-submission information sessions. Send your feedback For suggestions about the content...
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15/09/15
24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 HELSINKI, FINLAND Concerns: Authorisation, establishing reference DNELs for DEHP Agenda Point: 7 a) i. DNEL setting (DEHP) Action requested: For agreement 24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 HELSINKI, FINLAND Concerns: Authorisation, establishing reference DNELs for DEHP Agenda Point: 7 a) i. DNEL setting (DEHP) Action requested: For agreement 24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 HELSINKI, FINLAND Concerns: Authorisation, establishing reference DNELs for DEHP Agenda Point: 7 a) i. DNEL setting (DEHP) Action requested: For agreement (88.1k)
Helsinki, 12 April 2013 RAC/24/2013/09_rev 2 Agreed in written procedure 24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 ...
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09/09/15
24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 HELSINKI, FINLAND Concerns: Authorisation – Establishing reference DNELs for DBP Agenda Point: 7 a) ii. DNEL setting (DBP) Action requested: For discussionagreement 24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 HELSINKI, FINLAND Concerns: Authorisation – Establishing reference DNELs for DBP Agenda Point: 7 a) ii. DNEL setting (DBP) Action requested: For discussionagreement 24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013 HELSINKI, FINLAND Concerns: Authorisation – Establishing reference DNELs for DBP Agenda Point: 7 a) ii. DNEL setting (DBP) Action requested: For discussionagreement (90.7k)
Helsinki, 12 April 2013 RAC/24/2013/08 rev. 2 Agreed in written procedure 24TH MEETING OF THE COMMITTEE FOR RISK ASSESSMENT 5 - 8 MARCH 2013...
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09/09/15
RAC/26/2013/07 Rev.1 APPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELS FOR BBP RAC/26/2013/07 Rev.1 APPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELS FOR BBP RAC/26/2013/07 Rev.1 APPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELS FOR BBP (244.3k)
1 Helsinki, 12 September 2013 RAC/26/2013/07 Rev.1 (Agreed at RAC-26) APPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELS FOR BBP ...
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09/09/15
Reference DNELs RAC 33 diglyme Reference DNELs RAC 33 diglyme Reference DNELs RAC 33 diglyme (1,273.1k)
1 (17) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Helsinki, 05 June 2015 ...
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09/09/15

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