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../file-system/small/txt ../file-system/small/txt MS information on AfA links
Member state Institution Document The Netherlands Rijksinstituut voor Volksgezondheid en Milieu Chemische stoffen goed geregeld [NL] The United Kingdom UK Chemicals Stakeholder Forum (UKCSF) "Forum...
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21/12/16
Further support National helpdesk ECHA's Helpdesk Information by Member States and industry organisations Contact the Authorisation team at: application-authorisation [at] echa.europa.eu
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19/12/16
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10/11/16
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07/11/16
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07/11/16
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10/10/16
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03/10/16
Essential links Submission windows
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20/09/16
../file-system/small/txt ../file-system/small/txt Applying for authorisation link
How to apply for authorisation Information, guidance documents and further support on how industry can apply for authorisation. More
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20/09/16
Regulations Authorisation
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20/09/16
Further support Q&As National helpdesk ECHA's Helpdesk Information by Member States Contact the Authorisation team at: applications-authorisation [at] echa.europa.eu
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20/09/16
Back to How to apply for authorisation
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20/09/16
Addressing Chemicals of Concern Authorisation Substances of Very High Concern identification Candidate List table Recommendation for inclusion in the Authorisation List Applications for authorisation
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20/09/16
IR/CSA Chapter R.14: Occupational exposure estimation IR/CSA Chapter R.14: Occupational exposure estimation information_requirements_r14_en.pdf (1.2 MBk)
IR/CSA Chapter R.14: Occupational exposure estimation
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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 afa_tce-0020-01-aa_en.pdf (2.4 MBk)
Application for Authorisation Analysis of alternatives Non-confidential report
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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 opinion_trees_non_treshold_subs_en.pdf (370 KBk)
Guidance paper on opinion trees for non-treshold substances
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01/06/16
Report of the AfA task force Report of the AfA task force afa_task-force_report_en.pdf (436 KBk)
Report of the AfA task force
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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_eval_csa_in_afa_en.pdf (154 KBk)
Checklist for evaluating chemical safety assessment in applications for authorisation
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12/04/16
AFA Public Consultations: 0042-01 AFA Public Consultations: 0042-01 afa_sd-0042-01-sea_en.pdf (1.1 MBk)
AFA Public Consultations: 0042-01
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05/02/16
AFA Public Consultations: 0042-01 AFA Public Consultations: 0042-01 afa_sd-0042-01-es_en.pdf (2 MBk)
AFA Public Consultations: 0042-01
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05/02/16
AFA Public Consultations: 0060-01 AFA Public Consultations: 0060-01 afa_edc-0060-01-es_en.pdf (1 MBk)
AFA Public Consultations: 0060-01
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04/02/16
GENERIC EXEMPTIONS FROM THE
AUTHORISATION REQUIREMENT GENERIC EXEMPTIONS FROM THE AUTHORISATION REQUIREMENT generic_exemptions_authorisation_en.pdf (150 KBk)
GENERIC EXEMPTIONS FROM THE AUTHORISATION REQUIREMENT
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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 conf_template_afa_en.doc (90 KBk)
TEMPLATE for third party submission of information on alternatives for Applications for Authorisation CONFIDENTIAL
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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 afa_chromiun_trioxide-0034-02-aa_en.pdf (23.7 MBk)
Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0
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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 afa_chromiun_trioxide-0034-01-sea_en.pdf (18.9 MBk)
Applications for authorisation Socio-economic analysis Chromium trioxide, EC 215-607-8, CAS 1333-82-0
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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 afa_chromiun_trioxide-0034-01-aa_en.pdf (48.6 MBk)
Applications for authorisation Analysis of alternatives Chromium trioxide, EC 215-607-8, CAS 1333-82-0
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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 non_conf_template_afa_en.doc (84 KBk)
TEMPLATE for third party submission of information on alternatives for Applications for Authorisation NON-CONFIDENTIAL
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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 instructions_third_parties_afa_en.pdf (848 KBk)
Submission of information on alternatives by interested third parties for the public consultations on alternatives for Applications for Authorisation Instructions & Templates
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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 pg17_du_csr_final_en.pdf (657 KBk)
How to prepare a downstream user chemical safety report Practical guide 17
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21/09/15
../file-system/small/txt ../file-system/small/txt PSIS - Feedback
Feedback ECHA welcomes your suggestions regarding the needs and expectations from the pre-submission information sessions. Send your feedback For suggestions about the content of this page or of...
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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 rac_24_dnel_dbp_comments_en.pdf (88 KBk)
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...
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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 rac_24_dnel_dehp_comments_en.pdf (91 KBk)
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...
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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_reference_dnels_bbp_en.pdf (244 KBk)
RAC/26/2013/07 Rev.1 APPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELS FOR BBP
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09/09/15
../file-system/small/txt ../file-system/small/txt MS information on AfA top text
Some Member States and industry organisations have published useful information on applications for authorisation on their own websites. Some of this information is linked below. Please note that...
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27/08/15
Format for Succinct summary of representative risk management measures (RMMs) and operational conditions (OCs) Format for Succinct summary of representative risk management measures (RMMs) and operational conditions (OCs) afa_format_succint_summary_rmm_oc_en.docx (41 KBk)
Format for Succinct summary of representative risk management measures (RMMs) and operational conditions (OCs)
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31/07/15
Instructions for Format for Succinct summary of representative risk management measures (RMMs) and operational conditions (OCs) Instructions for Format for Succinct summary of representative risk management measures (RMMs) and operational conditions (OCs) afa_inst_format_succint_summary_rmm_oc_en.pdf (65 KBk)
Instructions for Format for Succinct summary of representative risk management measures (RMMs) and operational conditions (OCs)
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31/07/15
APPLICATION FOR AUTHORISATION: ESTABLISHING A
REFERENCE DOSE RESPONSE RELATIONSHIP FOR
CARCINOGENICITY OF 1,2-DICHLOROETHANE APPLICATION FOR AUTHORISATION: ESTABLISHING A REFERENCE DOSE RESPONSE RELATIONSHIP FOR CARCINOGENICITY OF 1,2-DICHLOROETHANE rac_33_dose_response _1_2dichloroethane_en.pdf (334 KBk)
APPLICATION FOR AUTHORISATION: ESTABLISHING A REFERENCE DOSE RESPONSE RELATIONSHIP FOR CARCINOGENICITY OF 1,2-DICHLOROETHANE
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30/06/15
afa_5.jpg afa_5.jpg afa_5 (17 KBk)
afa_5.jpg
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08/06/15
afa_6.jpg afa_6.jpg afa_6 (18 KBk)
afa_6.jpg
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08/06/15
afa_graph.png afa_graph.png afa_graph (65 KBk)
afa_graph.png
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08/06/15
../file-system/small/txt ../file-system/small/txt PSIS - Prior Information
Prior information General information on Authorisation Guidance documents Data submission manual 22 - How to prepare and submit an application for authorisation using IUCLID 5 Assessment report...
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02/06/15
pen_paper_blue_sm.png pen_paper_blue_sm.png pen_paper_blue_sm (16 KBk)
pen_paper_blue_sm.png
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22/05/15
../file-system/small/txt ../file-system/small/txt PSIS - Timing
Timing Request a pre-submission information session no later than eights months before the planned submission of your application. Send the request for a pre-submission information at least two...
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23/04/15
APPLICATION FOR AUTHORISATION: ESTABLISHING A
REFERENCE DOSE RESPONSE RELATIONSHIP FOR
CARCINOGENICITY OF MOCA APPLICATION FOR AUTHORISATION: ESTABLISHING A REFERENCE DOSE RESPONSE RELATIONSHIP FOR CARCINOGENICITY OF MOCA dose-response-carc-moca_en.pdf (317 KBk)
APPLICATION FOR AUTHORISATION: ESTABLISHING A REFERENCE DOSE RESPONSE RELATIONSHIP FOR CARCINOGENICITY OF MOCA
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22/04/15
Application for authorisation: establishing a reference dose response relationship for carcinogenicity of Moca Application for authorisation: establishing a reference dose response relationship for carcinogenicity of Moca rac_32_notes_moca_en.pdf (1.4 MBk)
Application for authorisation: establishing a reference dose response relationship for carcinogenicity of Moca
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22/04/15
Are you a Small or Medium Sized Enterprise (SME) and planning to apply for authorisation to use a substance of very high concern? Have you still got questions about the process? Why not ask ECHA? ...
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02/02/15
Fotolia_60832770_lores.gif Fotolia_60832770_lores.gif Fotolia_60832770_lores (20 KBk)
Fotolia_60832770_lores.gif
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23/01/15
../file-system/small/txt ../file-system/small/txt Actors
Application for Authorisation process: Actors
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18/12/14
Application for Authorisation
Analysis of alternatives
Non-confidential report Application for Authorisation Analysis of alternatives Non-confidential report afa_tce-0024-05-aa_en.pdf (16.7 MBk)
Application for Authorisation Analysis of alternatives Non-confidential report
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11/11/14
Application for Authorisation
Analysis of alternatives
Non-confidential report Application for Authorisation Analysis of alternatives Non-confidential report afa_tce-0024-02-aa_en.pdf (13.4 MBk)
Application for Authorisation Analysis of alternatives Non-confidential report
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11/11/14