Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
Table of Contents
Part I: Registration under REACH ............................................................................. 10
1 General Introduction ............................................................................................. 11
1.1 Aim of this guidance ........................................................................................................... 11
1.2 Aim of Registration............................................................................................................. 12
1.3 Substances, mixtures and articles......................................................................................... 13
2 Registration obligations ........................................................................................ 15
2.1 Who has to register? .......................................................................................................... 15
2.1.1 Roles under REACH.......................................................................................................... 15
2.1.2 Actors with registration obligations .................................................................................... 16
2.1.2.1 Legal personality ...............................................................................................................................17
2.1.2.2 Customs boundaries for manufacturing and import ................................................................................18
2.1.2.3 Who is responsible for the registration in case of manufacturing? ............................................................18
2.1.2.4 Who is responsible for the registration in case of import? .......................................................................19
2.1.2.5 Only representative of a ‘non-EU manufacturer’ ....................................................................................20
2.1.2.6 Role of industry associations and other types of service providers ...........................................................24
2.2 What to register? ............................................................................................................... 26
2.2.1 Overview of the registration scope ..................................................................................... 26
2.2.2 Substances exempted from the REACH Regulation ............................................................... 27
2.2.2.1 Radioactive substances ......................................................................................................................27
2.2.2.2 Substances under customs supervision ................................................................................................27
2.2.2.3 Substances used in the interest of defence and covered by national exemptions .......................................27
2.2.2.4 Waste ..............................................................................................................................................28
2.2.2.5 Non-isolated intermediates .................................................................................................................28
2.2.2.6 Transported substances .....................................................................................................................29
2.2.3 Substances exempted from registration .............................................................................. 29
2.2.3.1 Food or feedingstuffs .........................................................................................................................30
2.2.3.2 Medicinal products.............................................................................................................................30
2.2.3.3 Substances included in Annex IV of the REACH Regulation......................................................................31
2.2.3.4 Substances covered by Annex V of the REACH Regulation ......................................................................31
2.2.3.5 Recovered substance already registered...............................................................................................33
2.2.3.6 Re-imported substance ......................................................................................................................35
2.2.3.7 Polymers ..........................................................................................................................................37
2.2.3.8 Substances used for the purpose of research and development ...............................................................38
2.2.4 Substances regarded as registered .................................................................................... 39
2.2.4.1 Substances for use in biocidal products ................................................................................................39
2.2.4.2 Substances for use in plant protection products.....................................................................................40
2.2.4.3 Notified substances according to Directive 67/548/EEC ..........................................................................41
2.2.5 Obligations related to registration of intermediates............................................................... 42
2.2.6 Calculation of the volume to be registered .......................................................................... 43
2.2.6.1 Calculation of the volume in case of exemptions....................................................................................43
2.2.6.2 Calculation of the volume for intermediates ..........................................................................................44
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