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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
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08/06/15
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08/06/15
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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
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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
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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
Application for Authorisation
Analysis of alternatives
Non-confidential report Application for Authorisation Analysis of alternatives Non-confidential report afa_tce-0018-01-aa_en.pdf (857 KBk)
Application for Authorisation Analysis of alternatives Non-confidential report
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11/11/14
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18/09/14
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10/09/14
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10/09/14
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10/09/14
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10/09/14
../file-system/small/txt ../file-system/small/txt MS information AfA see also
See also ECHA's legal Notice
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27/08/14
Application for authorisation Analysis of alternatives
Legal name of applicant(s): Vlisco Netherlands BV
Submitted by: Vlisco Netherlands BV
Prepared by: 1. Vlisco Netherlands, BV
2. Apeiron-Team NV
Substance: Trichloroethylene
Use title: Use of trichloroethylene as Application for authorisation Analysis of alternatives Legal name of applicant(s): Vlisco Netherlands BV Submitted by: Vlisco Netherlands BV Prepared by: 1. Vlisco Netherlands, BV 2. Apeiron-Team NV Substance: Trichloroethylene Use title: Use of trichloroethylene as afa_tce-0014-02-aa_en.pdf (8.2 MBk)
Application for authorisation Analysis of alternatives Legal name of applicant(s): Vlisco Netherlands BV Submitted by: Vlisco Netherlands BV Prepared by: 1. Vlisco Netherlands, BV 2. Apeiron-Team...
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12/08/14
Application for authorisation Socio-economic analysis
Legal name of applicant(s): Vlisco Netherlands BV
Submitted by: Vlisco Netherlands BV
Prepared by: 1. Vlisco Netherlands, BV
2. Economics for the Environment Consultancy Ltd (eftec)
3. Apeiron-Team NV
Substance: Trichloroethylene
Use title: Use 1: Use of trichloroethylene as a solvent for the removal
and recovery of resin from dyed cloth
Use 2: Use of trichloroethylene as a solvent in a process to
recover and purify resin from process water Application for authorisation Socio-economic analysis Legal name of applicant(s): Vlisco Netherlands BV Submitted by: Vlisco Netherlands BV Prepared by: 1. Vlisco Netherlands, BV 2. Economics for the Environment Consultancy Ltd (eftec) 3. Apeiron-Team NV Substance: Trichloroethylene Use title: Use 1: Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth Use 2: Use of trichloroethylene as a solvent in a process to recover and purify resin from process water afa_tce-0014-01-sea_en.pdf (14.6 MBk)
Application for authorisation Socio-economic analysis Legal name of applicant(s): Vlisco Netherlands BV Submitted by: Vlisco Netherlands BV Prepared by: 1. Vlisco Netherlands, BV 2. Economics for...
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12/08/14
Application for authorisation Analysis of alternatives
Legal name of applicant(s): Vlisco Netherlands BV
Submitted by: Vlisco Netherlands BV
Prepared by: 1. Vlisco Netherlands BV
2. Apeiron-Team NV
Substance: Trichloroethylene
Use title: Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth Application for authorisation Analysis of alternatives Legal name of applicant(s): Vlisco Netherlands BV Submitted by: Vlisco Netherlands BV Prepared by: 1. Vlisco Netherlands BV 2. Apeiron-Team NV Substance: Trichloroethylene Use title: Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth afa_tce-0014-01-aa_en.pdf (9.5 MBk)
Application for authorisation Analysis of alternatives Legal name of applicant(s): Vlisco Netherlands BV Submitted by: Vlisco Netherlands BV Prepared by: 1. Vlisco Netherlands BV 2. Apeiron-Team NV...
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12/08/14
Express your interest Fill in the webform
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01/08/14
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16/07/14
Trichloroethylene - Carcinogenicity dose-response analysis
Final report Trichloroethylene - Carcinogenicity dose-response analysis Final report tce_carcinogenity_dose-response_analysis_final_report_en.pdf (2 MBk)
Trichloroethylene - Carcinogenicity dose-response analysis Final report
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30/06/14
Are you looking for partners to prepare for an application for authorisation? Do you want to learn from your suppliers or your clients? Do you lack specific skills or the knowledge to prepare an...
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24/06/14
Disclaimer and Terms of conditions The users of this service accept that the information is provided by ECHA as is. ECHA does not guarantee the authenticity and correctness of the provided...
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16/06/14
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11/06/14
An elaboration of key aspects of the authorisation process in the context of aviation industry An elaboration of key aspects of the authorisation process in the context of aviation industry aviation_authorisation_final_en.pdf (1.3 MBk)
An elaboration of key aspects of the authorisation process in the context of aviation industry
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10/06/14
Application for Authorisation: Establishing a reference dose-response relationship for carcinogenicity of Trichloroethylene Application for Authorisation: Establishing a reference dose-response relationship for carcinogenicity of Trichloroethylene carcinogenicity_dose_response_tce_en.pdf (271 KBk)
Application for Authorisation: Establishing a reference dose-response relationship for carcinogenicity of Trichloroethylene
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17/04/14
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11/04/14
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11/04/14
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11/04/14
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11/04/14
Related links Authorisation list Applications for authorisation Regulations Applying for authorisation Support Applications for authorisation Addressing Chemicals of Concern
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02/04/14
../file-system/small/txt ../file-system/small/txt Chemicals of Concern - AfA sidelink
Addressing Chemicals of Concern Applications for Authorisation
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02/04/14
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02/04/14
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02/04/14
Setting DNELs and dose-response curves prior to the application for authorisation phase

During the capacity building sessions on applications for authorisation (AfA) held in RAC in 2012 and in the seminars/workshops held with industry, it has been suggested that agreeing on a mode of action as well as establishing DNELs1 prior to the application phase would be worth considering for reasons of efficiency of the process..... Setting DNELs and dose-response curves prior to the application for authorisation phase During the capacity building sessions on applications for authorisation (AfA) held in RAC in 2012 and in the seminars/workshops held with industry, it has been suggested that agreeing on a mode of action as well as establishing DNELs1 prior to the application phase would be worth considering for reasons of efficiency of the process..... setting_dnels_and_dose-response_curves_en.pdf (106 KBk)
Setting DNELs and dose-response curves prior to the application for authorisation phase During the capacity building sessions on applications for authorisation (AfA) held in RAC in 2012 and in the...
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02/04/14
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01/04/14
Final report for Hexavalent chromium
Services to support the assessment of remaining cancer risks related to
the use of chromium- and arsenic-containing substances in Applications
for Authorisation. Final report for Hexavalent chromium Services to support the assessment of remaining cancer risks related to the use of chromium- and arsenic-containing substances in Applications for Authorisation. carcinogenicity_dose_response_cr_vi_report_en.pdf (658 KBk)
Final report for Hexavalent chromium Services to support the assessment of remaining cancer risks related to the use of chromium- and arsenic-containing substances in Applications for Authorisation.
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19/03/14
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07/03/14
Questions and Answers Questions and Answers on REACH Questions and Answers on Authorisation Questions and Answers on Applications for Authorisation Questions and Answers on Downstream Users
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24/02/14