# Autorisatie — Bronsamenvatting ## Bron - Bestand: /root/Documents/HSEQ_kennis/Interne_Procedures/reach/apply_for_authorisation_en.pdf - Type: PDF - Grootte: 1452 KB ## Kerninhoud How to apply for authorisation February 2021 How to apply for authorisation 2 Disclaimer This document aims to assist users in complying with their obligations under the REACH and CLP Regulation. However, users are reminded that the text of the REACH and CLP Regulation is the only authentic legal reference and that the informati on in this document does not constitute legal advice. Usage of the information remains under the sole responsibility of th e user. The European Chemicals Agency does not accept any liability with regard to the use that may be made of the information contain ed in this document . Version Changes 1.1 Editorial changes made and Figure 1.2 updated 1.2 Technical adaptations in response to the conclusions of the General Court’s judgments in case T -837/16, concerning ‘suitable alternatives available’ and the ne ed to prepare substitution plans. Title: How to apply for authorisation Reference: ECHA -21-G-01-EN Cat. Number: ED-05-21-001-EN-N ISBN: 978-92-9481-810-2 DOI: 10.2823/2445 Publ.date: February 2021 Language: EN © European Chemicals Agency, 2021 Cover page © European Chemicals Agency If you have questions or comments in relation to this document please send them (quote the reference and issue date) using the information request form. The information request form can be accessed via th e Contact ECHA page at: http://echa.europa. eu/contact European Chemicals Agency P.O. Box 400, FI -00121 Helsinki, Finland 3 How to apply for authorisation Table of Contents About th is guide ................................ ................................ ................................ . 4 Key messages ................................ ................................ ................................ .... 5 1. Introduction ................................ ................................ ................................ ... 7 1.1 Overview of the aut horisation process ................................ ................................ ....... 7 1.2 Relevant existing guidance documents and support ................................ .................... 13 2. Developing an application strategy ................................ .............................. 14 2.1 Establish the starting point ................................ ................................ ...................... 14 2.2 Consider how to apply ................................ ................................ ............................ 15 2.3 Consider t he scope of your application and the number of uses ................................ ...20 2.4 Consider whether you need external expert advice or support ................................ .....21 2.5 Use of confide ntial business information ................................ ................................ ...21 2.6 Detail and depth of analysis in "fit -for-purpose" applications ................................ .......22 3. Key elements of a n application for authorisation ................................ ......... 23 3.1 Use applied for ................................ ................................ ................................ ......23 3.2 Chem ical safety report ................................ ................................ ............................ 27 3.3 Analysis of alternatives ................................ ................................ ........................... 43 3.4 Socio -economic analysis ................................ ................................ ......................... 52 3.5 Consider summarising key elements for the reader ................................ .................... 62 4. Applications for uses with specific characteristics ................................ ....... 63 4.1 Applications for uses with minimal expected health impacts ................................ ........ 63 5. Data gathering ............... ## Relevante data voor Phoenix Metals [Wordt ingevuld na kruisanalyse] ## Key artikelen / paragrafen ## Kruisverwijzingen [Wordt ingevuld na kruisanalyse]