Guidance on registration.
Date: 2017-04-19
Institutions: European Chemicals Agency
Subjects: administrative formalities, chemical industry, chemical product, dangerous substance, industrial chemistry, user guide

G U I D A N C E  

Guidance on registration 

November 2016 
Version 3.0 

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Guidance on registration 
Version 3.0 - November 2016 

2 

LEGAL NOTICE 

This document aims to assist users in complying with their obligations under the REACH 
Regulation. However, users are reminded that the text of the REACH Regulation is the only 
authentic legal reference and that the information in this document does not constitute legal 
advice. Usage of the information remains under the sole responsibility of the user. The 
European Chemicals Agency does not accept any liability with regard to the use that may be 
made of the information contained in this document. 

Version 

Changes 

Version 0 

First edition 

Date 

June 2007 

Version 1 

First revision 

February 2008 

Version 1.1  Warning added on Only Representative issue 

April 2008 

Version 1.2 

“Only  Representative”  and  the  “Assigning  a  registration 
number” chapters amended 

May 2008 

Version 1.3  Clarification on “Only Representative” added 

September 2008 

Version 1.4  Clarification on “Only Representative” added 

November 2008 

Version 1.5  Clarification on information that needs to be submitted for 
updating dossiers of previously notified substances (NONS) 

November 2009 

Version 1.6  Corrigendum covering the following: 

January 2011 

-  Amendment  of  Annex  IV  and  Annex  V  of  REACH  by 
Commission  Regulation  (EC)  No  987/2008  of  8  October 
2008. 

-  Amendment  of  Annex  XI  of  REACH  by  Commission 
Regulation (EC) No 134/2009.  

- Amendment of REACH by the CLP Regulation ((Regulation 
(EC) No 1272/2008 of 16 December 2008). 

-  Amendment  of  Annex  II  of  REACH  by  Commission 
Regulation No 453/2010 of 20 May 2010. 

- Ratification of REACH under the EEA Agreement. 

the 
-  Clarification  on 
classification and labelling notification processes. 

registration,  updating  and 

-  Reference  to  the  Data  Submission  Manuals,  REACH-IT 
Industry  User  Manuals  and  Practical  Guides  published  by 
ECHA. 

- Editorial corrections. 

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Guidance on registration 
Version 3.0 - November 2016 

3 

Version 

Changes 

Date 

Version 2.0  Revision of the document covering the following: 

May 2012 

- Restructuring of the content of the guidance: 

-  Part  I  focuses  on  the  explanation  of  the  regulatory 
requirements. 

- Part II provides practical information for registrants. 

-  Further  clarifications  and  examples  of  the  registration 
requirements added. 

The changes are listed in Appendix 3 of the guidance.  

Version 3.0  Revision of the document addressing the content  
and structure. Main changes include the following: 

November 2016 

  Removal of Part II and Appendix 3; 

  Clarification of the registration scope in section 2.2.1; 

  Update of the text on substances regarded as 

registered (section 2.2.4.1 and 2.2.4.2); 

  Clarification of the text and addition of new examples 

on calculation of tonnage in section 2.2.3; 

  Change in the sequence of chapters 3 and 4; 

  Update of information on data sharing procedures 

(chapter 3); 

  Update of the information on the inquiry process 

(section 3.4); 

  Update of the text on standard information 

requirements in section 4.1.1; 

  Update of the text about joint submission of data in 

section 4.3; 

  Clarification of opt-out possibilities (section 4.3.2); 

  Explanation of ‘one substance – one registration’ 
principle and of the SIP concept (section 5.2.1); 

  Inclusion of special considerations for 1-10 tonnes 

dossiers in section 5.2.4; 

  Update of the information about CHESAR in section 

5.3.2; 

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Guidance on registration 
Version 3.0 - November 2016 

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Version 

Changes 

Date 

  Addition of a new section 6.1.3; 

  Revision of Appendix 1 and 2 in relation to outdated, 

incorrect or missing information; 

  Inclusion of references to updated technical manuals 
with practical instructions on how to prepare, submit 
and update registration dossiers. 

Guidance on registration 

Reference: ECHA-16-G-06-EN 
Cat. Number: ED-01-16-445-EN-N 
ISBN: 978-92-9495-072-7 
DOI: 10.2823/969 
Publ. date:  November 2016 
Language:  EN 

© European Chemicals Agency, 2016 

If you have questions or comments in relation to this document please send them (indicating 
the document reference, issue date, chapter and/or page of the document to which your 
comment refers) using the Guidance feedback form. The feedback form can be accessed via 
the ECHA Guidance website or directly via the following link: 
https://comments.echa.europa.eu/comments_cms/FeedbackGuidance.aspx 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Annankatu 18, Helsinki, Finland 

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Guidance on registration 
Version 3.0 - November 2016 

Preface 

5 

This document describes when to register a substance under REACH. It is part of a series of 
guidance documents that are aimed to help all stakeholders with their preparation for fulfilling 
their obligations under the REACH Regulation. These documents cover detailed guidance for a 
range of essential REACH processes as well as for some specific scientific and/or technical 
methods that industry and authorities need to make use of under REACH. 

The guidance documents were drafted and discussed within the REACH Implementation 
Projects (RIPs) led by the European Commission services, involving all stakeholders: Member 
States, industry and non-governmental organisations. The European Chemicals Agency (ECHA) 
updates these guidance documents following the Consultation procedure on guidance. These 
guidance documents can be obtained via the ECHA website1.  

This document relates to the REACH Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council of 18 December 20062. 

1 http://echa.europa.eu/guidance-documents/guidance-on-reach 

2 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing 
a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) 
No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, 
corrected version in OJ L136, 29.5.2007, p.3). Most recent REACH version ( i.e. aggregated text with 
successive amendments and corrigenda) is accessible at: http://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:02006R1907-20150601  

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Table of Contents 

1 General Introduction ............................................................................................. 10 

1.1 Aim of this guidance ............................................................................................................. 10 

1.2 Aim of registration................................................................................................................ 12 

1.3 Substances, mixtures and articles .......................................................................................... 12 

2 Registration obligations ........................................................................................ 14 

2.1 Who has to register?............................................................................................................. 14 

2.1.1 Roles under REACH ............................................................................................................ 14 

2.1.2 Actors with registration obligations ...................................................................................... 16 
2.1.2.1 Legal personality ............................................................................................................................... 16 
2.1.2.2 Customs boundaries for manufacturing and import ................................................................................ 17 
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? ....................................................................... 18 
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 ........................................................... 23 

2.2 What to register? ................................................................................................................. 24 

2.2.1 Overview of the registration scope ....................................................................................... 24 

2.2.2 Substances exempted from the REACH Regulation ................................................................. 25 
2.2.2.1 Radioactive substances ...................................................................................................................... 25 
2.2.2.2 Substances under customs supervision ................................................................................................ 25 
2.2.2.3 Substances used in the interest of defence and covered by national exemptions ....................................... 26 
2.2.2.4 Waste .............................................................................................................................................. 26 
2.2.2.5 Non-isolated intermediates ................................................................................................................. 27 
2.2.2.6 Transported substances...................................................................................................................... 27 

2.2.3 Substances exempted from registration ............................................................................... 28 
2.2.3.1 Food or feedingstuffs ......................................................................................................................... 28 
2.2.3.2 Medicinal products ............................................................................................................................. 29 
2.2.3.3 Substances included in Annex IV of the REACH Regulation ...................................................................... 30 
2.2.3.4 Substances covered by Annex V of the REACH Regulation ...................................................................... 30 
2.2.3.5 Recovered substance already registered ............................................................................................... 32 
2.2.3.6 Re-imported substance ...................................................................................................................... 33 
2.2.3.7 Polymers .......................................................................................................................................... 35 
2.2.3.8 Substances used for the purpose of research and development ............................................................... 36 

2.2.4 Substances regarded as registered ...................................................................................... 37 
2.2.4.1 Substances for use in biocidal products ................................................................................................ 38 
2.2.4.2 Substances for use in plant protection products ..................................................................................... 39 
2.2.4.3 Notified substances according to Directive 67/548/EEC .......................................................................... 40 

2.2.5 Obligations related to registration of intermediates ................................................................ 41 

2.2.6 Calculation of the volume to be registered ............................................................................ 42 
2.2.6.1 Calculation of the volume in case of exemptions .................................................................................... 42 
2.2.6.2 Calculation of the volume for intermediates .......................................................................................... 43 
2.2.6.3 Calculation of the total volume ............................................................................................................ 44 

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2.2.6.4 Calculation of the amount of substance in a mixture or in articles ............................................................ 44 
2.2.6.5 Calculation of the volume for phase-in and non-phase-in substances ....................................................... 45 

2.3 When to register? ................................................................................................................. 46 

2.3.1 Phase-in substances vs. non-phase-in substances ................................................................. 46 
2.3.1.1 Phase-in substances .......................................................................................................................... 46 
2.3.1.2 Non-phase-in substance ..................................................................................................................... 47 

2.3.2 Deadlines for registration ................................................................................................... 48 

3 Data-sharing procedures ....................................................................................... 53 

3.1 Basic principles of data-sharing procedures ............................................................................. 53 

3.2 Pre-registration of phase-in substances ................................................................................... 55 

3.3 SIEF formation ..................................................................................................................... 56 

3.4  Inquiry for substances that are non-phase-in or have not been pre-registered ............................ 56 

3.4.1 The inquiry dossier ............................................................................................................ 57 

3.4.2 The inquiry process ........................................................................................................... 57 

4 The registration process ........................................................................................ 60 

4.1 Information requirements...................................................................................................... 60 

4.1.1 Fulfilling the information requirements ................................................................................. 61 

4.1.2 Use of information from other assessments .......................................................................... 65 

4.2 Registration dossier .............................................................................................................. 65 

4.2.1 Structure of the registration dossier ..................................................................................... 65 

4.2.2 Format and submission of the registration dossier ................................................................. 66 

4.3 Joint submission of data ........................................................................................................ 67 

4.3.1 Mechanisms of joint submission .......................................................................................... 68 

4.3.2 Opt-out possibilities ........................................................................................................... 70 

4.4 Access to information and confidential data ............................................................................. 71 

5 Preparation of the registration dossier .................................................................. 74 

5.1 Introduction ........................................................................................................................ 75 

5.2 Generation of the technical dossier ......................................................................................... 77 

5.2.1 General information on the registrant and on the registered substance .................................... 77 

5.2.2 Classification and labelling .................................................................................................. 78 

5.2.3 Manufacture, use and exposure ........................................................................................... 79 
5.2.3.1 Information on manufacture and uses of the substance (section 3 of Annex VI) ........................................ 79 
5.2.3.2 Information on exposure for substances > 10 t ..................................................................................... 80 
5.2.3.3 Information on exposure for substances < 10 tonnes (section 6 of Annex VI) ........................................... 80 

5.2.4 Information requirements on intrinsic properties (Annexes VII to X) ........................................ 81 

5.2.5 Guidance on safe use ......................................................................................................... 82 

5.2.6 Review by an assessor ....................................................................................................... 82 

5.2.7 Confidential information ..................................................................................................... 82 

5.3 Chemical Safety Report ......................................................................................................... 83 

5.3.1 Steps of the chemical safety assessment .............................................................................. 84 
5.3.1.1 Hazard assessment ............................................................................................................................ 84 

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5.3.1.1.1 Human health hazard assessment ..................................................................................................... 84 
5.3.1.1.2 Physicochemical hazard assessment .................................................................................................. 85 
5.3.1.1.3 Environmental hazard assessment .................................................................................................... 85 
5.3.1.1.4 PBT/ vPvB assessment .................................................................................................................... 86 
5.3.1.2 Exposure assessment including risk characterisation .............................................................................. 86 

5.3.2 Chesar tool ....................................................................................................................... 87 
5.3.2.1 Assessment workflow supported by Chesar ........................................................................................... 88 

6 OTHER DUTIES OF REGISTRANTS .......................................................................... 91 

6.1 Registrants duty of communication ......................................................................................... 91 

6.1.1 Provide a safety data sheet (SDS) to customers .................................................................... 91 

6.1.2 Provide other information to customers ................................................................................ 92 

6.1.3 Include identified uses in the dossier ................................................................................... 93 

6.2 Classification and labelling notification .................................................................................... 93 

7 When and how to update a registration ................................................................. 95 

7.1 Duty to keep information up to date ....................................................................................... 95 

7.2 Required update on the registrant's own initiative .................................................................... 96 

7.3 Update as a consequence of an ECHA or a Commission decision ................................................. 100 

7.4 Update of registration dossier for substances regarded as being registered under REACH .............. 101 

8 Appeal procedures ................................................................................................. 103 

9 Fees ....................................................................................................................... 104 

9.1 Applicable fees and calculation of fees .................................................................................... 104 

9.2 Fee for updating of a registration dossier ................................................................................ 105 

10 Duties of ECHA..................................................................................................... 106 

10.1 Initial verification ............................................................................................................... 106 

10.1.1 Virus Scan ...................................................................................................................... 106 

10.1.2 File format validation ....................................................................................................... 107 

10.1.3 Internal structure validation .............................................................................................. 107 

10.1.4 Business rule validation .................................................................................................... 107 

10.2 Assigning submission number .............................................................................................. 107 

10.3 Completeness check and invoicing procedures ....................................................................... 107 

10.3.1 Technical completeness check ........................................................................................... 107 

10.3.2 Financial completeness check ............................................................................................ 108 

10.3.3 Completeness check procedures ........................................................................................ 108 

10.4 Rejection of the registration dossier ...................................................................................... 109 

10.5 Assigning a registration number ........................................................................................... 109 

10.6 Informing the relevant Member State Competent Authority ..................................................... 110 

10.7 ECHA procedure in case of a registration update .................................................................... 110 

Appendix 1. Glossary/List of acronyms .................................................................... 111 

Appendix 2. Roles and duties of the main actors of REACH ....................................... 114 

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Guidance on registration 
Version 3.0 - November 2016 

Table of Figures 

9 

Figure 1: Steps within the registration process and link to the structure of this document ..... 11 

Figure 2: Role and registration obligations of different actors in case of import ...................... 19 

Figure 3: Roles and registration obligations of different actors when an only representative is 
appointed ................................................................................................................................ 23 

Figure 4: Registration deadlines .............................................................................................. 50 

Figure 5: Structure and format of the registration dossier ....................................................... 76 

Table of Tables 

Table 1: Deadlines for the registration of phase-in substances ................................................ 49 

Table 2: Overview of the standard information requirements as defined in REACH ................. 62 

Table 3: Information requirements for the lead dossier and the member dossiers in joint 
submissions ............................................................................................................................. 69 

Table 4: Relation between the information requirements in Article10 and the corresponding 
sections in a IUCLID file .......................................................................................................... 75 

Table 5: Short summary of the CSR format .............................................................................. 83 

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Guidance on registration 
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1 General Introduction 

1.1 Aim of this guidance 

The aim of this guidance is to assist industry in determining which tasks and obligations have 
to be complied with to fulfil their registration requirements under REACH.  

This document guides potential registrants to answer the following questions: 

  Who has registration obligations? 

  Which substances are within the scope of REACH? 

  Which substances need to be registered? 

  When to pre-register and when to submit an inquiry? 

  What is the registration dossier? 

  When does a registration dossier have to be submitted to ECHA? 

  What is a joint submission? 

  What are registrants' obligations regarding data-sharing? 

  When and how to update the registration dossier? 

  What is the registration fee? 

  What are the duties of ECHA once the registration dossier is submitted? 

The guidance is based on descriptions of obligations supplemented by explanations and 
practical advice, which whenever possible are illustrated by examples. Throughout the text, 
explanations of the REACH processes are offered, providing references to relevant guidance 
documents, manuals and other useful tools. 

Whenever in the text of this guidance an ‘Annex’ or an ‘Article’ is mentioned what is meant is 
an Annex or an Article of the REACH Regulation. Whenever the EU is referred to in the text of 
this guidance, Iceland, Liechtenstein and Norway are also covered. 

The document is addressed to all potential registrants with or without an expert knowledge in 
the fields of chemicals and chemicals assessment. It explains what the registration 
requirements are, who is responsible for them and how and when they must be fulfilled. 

Figure 1 guides the reader through this document helping him to identify his registration 
obligations.  

Practical instructions for submitting a registration are available in the ECHA manual ‘How to 
prepare registration and PPORD dossiers’ accessible at: http://echa.europa.eu/manuals. This 
document is also available via the help system built into IUCLID. 

A tool, called the Navigator is also available in 23 languages to help the users identify their 
obligations under REACH. It can be found at 
http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-
implementation/identify-your-obligations/navigator.  

 
 
 
 
 
 
 
Guidance on registration 
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Figure 1: Steps within the registration process and link to the structure of this document 

MAKE SURE THAT YOU KNOW WHAT YOU MANUFACTURE/IMPORT (substance/mixture/article)IDENTIFY IF YOU ARE WITHIN THE SCOPE OF REACHIDENTIFY IF YOUR SUBSTANCE IS WITHIN THE SCOPE OF REGISTRATION CHECK WHETHER YOUR SUBSTANCE CAN BE CONSIDERED  REGISTERED  - have you  notified it according to Directive 67/548/EEC? - does it meet the criteria mentioned in Article 15?   (Substances in plant protection and biocidal products)DETERMINE IF YOUR SUBSTANCE IS USED  AS AN ISOLATED INTERMEDIATEDETERMINE IF YOUR SUBSTANCE IS A PHASE-IN SUBSTANCEsection 1.3 PHASE-IN SUBSTANCE NON PHASE-IN SUBSTANCEPERFORM INQUIRY AND SHARE DATA BEFORE REGISTRATIONPRE-REGISTER YOUR SUBSTANCE(since 1 December 2008, only late pre-registration if conditions apply)TAKE PART IN SUBSTANCE INFORMATION EXCHANGE FORUM (SIEF) AND SHARE DATAIF YOUR SUBSTANCE IS:     - M/I ≥1000t or     - CMR cat 1 or 2 and ≥ 1t or     - R50/53 and ≥100t The registration period expired on 30 November 2010IF YOUR SUBSTANCE IS:      - M/I ≥1tIF YOUR SUBSTANCE IS:      - M/I ≥100t The registration period expired on  1 June 2013If you pre-registered, you will have to  register your substance before 1 June 2018DETERMINE IF YOU MANUFACTURE OR IMPORT THE  SUBSTANCE IN QUANTITIES OF 1 TONNE OR MOREsection 2.2.2section 2.2.3section 2.2.4section 3.2section 2.3.1.1section 3.4section 2.3.1section 2.2.5section 2.3.1.2section 2.3.2yesnoIDENTIFY IF YOU HAVE ANY ROLE WITHIN REACH:Are you manufacturer, importer, only representative, downstream user? section 2.1section 2.2.6section 3.3section 2.2.6CALCULATE THE VOLUME OF YOUR SUBSTANCE TO BE REGISTERED 
 
 
 
 
 
 
 
 
 
Guidance on registration 
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1.2 Aim of registration 

REACH is based on the principle that it is for manufacturers, importers and downstream users 
to ensure that they manufacture, place on the market or use such substances that do not 
adversely affect human health or the environment. The responsibility for the management of 
the risks of substances lies therefore with the natural or legal persons that manufacture, 
import, place on the market or use these substances in the context of their professional 
activities. 

The registration provisions require manufacturers and importers to collect or generate data on 
the substances they manufacture or import, to use these data to assess the risks related to 
these substances and to develop and recommend appropriate risk management measures to 
control these risks. To ensure that they actually meet these obligations, as well as for 
transparency reasons, manufacturers and importers are required to prepare a registration 
dossier in IUCLID format (by using IUCLID software application) and submit it to ECHA via 
REACH-IT (see section 5 of this guidance).  

When a substance is intended to be or is being manufactured or imported by more than one 
manufacturer or importer, certain data must be shared (see section 3) and submitted jointly 
(see section 4.3) with the purpose of increasing the efficiency of the registration system, 
saving costs and reducing testing on vertebrate animals. While still being a part of the joint 
submission, a registrant may opt-out from some information requirements and submit the 
information separately to ECHA in certain specified cases (see section 4.3.2). 

Unless the REACH Regulation indicates otherwise, registration obligations apply to 
substances manufactured or imported in quantities of one tonne or more per year per 
manufacturer or importer (see section 2.2). Normally, the registration must be successfully 
completed and a registration number assigned to the registrant before a substance can be 
manufactured, imported or placed on the market. 

However, for most substances that are already being manufactured or imported (so called 
‘phase-in substances’) a special transition regime applies provided the substances have been 
pre-registered. 

The last phase-in deadline ends on 31 May 2018. For substances that need to be registered 
by this date, the late pre-registrations can be submitted until 31 May 2017. This allows to 
continue the manufacture or import without registration until the corresponding deadline (31 
May 2018) is met (for more information see sections 2.3 and 3.2 of this guidance). 

If a manufacturer or importer does not register by this deadline, the substance may not be 
manufactured in the EU or placed on the EU market until after it has been registered. 

Registered substances can in principle circulate freely on the internal market. 

1.3 Substances, mixtures and articles 

REACH lays down obligations which apply to the manufacture, import, placing on the market 
and use of substances on their own, in mixtures or in articles. Before continuing to explain 
which substances require registration it is important to have a clear understanding of these 
terms and how mixtures and articles are dealt with. 

 
 
 
 
 
 
 
 
 
 
 
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Substance means a chemical element and its compounds. The term substance includes both 
substances obtained by a manufacturing process (for example formaldehyde or methanol) and 
substances in their natural state. The term substance also includes its additives and impurities 
where these are part of its manufacturing process, but excludes any solvent which can be 
separated without affecting the stability of the substance or changing its composition. Detailed 
guidance on substances and substance identity can be found in the Guidance on identification 
and naming of substances under REACH and CLP at: http://echa.europa.eu/guidance-
documents/guidance-on-reach.  

Mixture means a mixture or solution composed of two or more substances. Typical examples of 
mixtures under REACH include paints, varnishes and inks. REACH obligations apply individually 
to  each  of  the  substances  contained  in  the  mixture  depending  on  whether  the  individual 
substances are within the scope of REACH. 

When contained in a mixture, each individual substance needs to be registered if the threshold 
of one tonne per year is reached (for additional information on how to calculate the tonnage 
for registration for substances in mixtures please refer to sections 2.2.6.3 and 2.2.6.4). The 
registration obligation applies to the manufacturer or importer of each individual substance, or 
in case that the mixture is imported as such, to the importer of the mixture. The formulator, 
i.e. the natural or legal entity that mixes the individual substances to produce the mixture, 
does not have registration obligations under REACH unless he is at the same time a 
manufacturer or importer of the individual substances contained in the mixture or an importer 
of the mixture itself.  

The REACH Regulation refers to alloys as "special mixtures". Therefore an alloy is to be treated 
in the same way as other mixtures under REACH. This means that although the alloy is not 
subject to registration, the alloying elements (e.g. metals) have to be registered. The 
obligation to register the alloying elements applies irrespectively of the production process 
involved in the manufacturing of the alloy. Constituents which are not intentionally added to 
the alloy should be considered as impurities (i.e. they are part of one of the substances in the 
mixture) and therefore need not be registered separately. 

An article is an object which during production is given a special shape, surface or design 
which determines its function to a greater degree than does its chemical composition (e.g. 
manufactured goods such as textiles, electronic chips, furniture, books, toys, kitchen 
equipment). An individual substance in an article is subject to the registration obligations in 
case it is present in the article in quantities over one tonne per year and the substance is 
intended to be released under normal or reasonably foreseeable conditions of use. The 
registration obligation applies to the producer of the article or, in case the article is imported, 
to the importer, insofar as the substance has not been registered for that use. Detailed 
guidance on articles and how they are dealt with under REACH can be found in the Guidance 
on requirements for substances in articles available at: http://echa.europa.eu/guidance-
documents/guidance-on-reach  

The registration obligations apply therefore to the individual substances 
themselves, independently of whether they are on their own, in a mixture or in an 
article. In other words, only substances have to be registered under REACH, 
mixtures or articles do not.  

 
 
 
 
 
 
 
 
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2 Registration obligations 

2.1 Who has to register? 

Aim:  

The aim of this chapter is to explain which actors have registration obligations 
and responsibilities under REACH. 

Structure:    The structure of this chapter is as follows: 

2.1.1 Roles under REACH 

The obligation to register a substance applies only to certain actors established in the EU. 
Before explaining the obligations of registrants, it is important to have a clear understanding 
on the different roles a company may have under the REACH Regulation. 

One legal entity (see section 2.1.2.1) may have various roles depending on its activities, even 
for the same substance (e.g. manufacturer and importer). Therefore, it is very important 
that companies correctly identify their role or roles in the supply chain for each 
substance they handle, because this will be a decisive factor in determining their 
registration obligations. 

The following roles may be adopted in the context of REACH: 

Manufacturer: means any natural or legal person established within the EU who 
manufactures a substance within the EU (Article 3(9)). 

Manufacturing: means production or extraction of substances in the natural state (Article 
3(8)).  

WHO HAS TO REGISTER?ROLES UNDER REACHSection 2.1.1ACTORS WITH REGISTRATION OBLIGATIONSSection 2.1.2Legal personalitySection 2.1.2.1Customs boundariesSection 2.1.2.2Responsibility in case of manufacturingSection 2.1.2.3Responsibility in case of importSection 2.1.2.4Only RepresentativeSection 2.1.2.5Role of industry associationsSection 2.1.2.6 
 
 
 
 
 
 
 
 
 
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Importer: means any natural or legal person established within the EU who is responsible 
for import (Article 3(11)).  

Import: means the physical introduction into the customs territory of the EU (Article 3(10)). 

Placing on the market: means supplying or making available, whether in return for payment 
or free of charge, to a third party. Import shall be deemed to be placing on the market 
(Article 3 (12)).  

Only Representative: means a natural or legal person established in the EU and appointed 
by a manufacturer, formulator3  or producer of an article established outside the EU to fulfil 
the obligations of importers (Article 8). 

Downstream user: means any natural or legal person established within the EU, other 
than the manufacturer or the importer, who uses a substance, either on its own or in a 
mixture, in the course of his industrial or professional activities (Article 3(13)). 

Use: means any processing, formulation, consumption, storage, keeping, treatment, filling 
into containers, transfer from one container to another, mixing, production of an article or 
any other utilisation (Article 3(24)). 

Producer of an article: means any natural or legal person who makes or assembles an 
article within the EU (Article 3(4)). 

Distributor: means any natural or legal person established within the EU, including a 
retailer, who only stores and places on the market a substance, on its own or in a mixture, 
for third parties (Article 3(14)). 

Supplier of a substance or a mixture: means any manufacturer, importer, downstream 
user or distributor placing on the market a substance, on its own or in a mixture, or a 
mixture. 

An important point to bear in mind is that the terms used in REACH to describe the various 
roles have very specific definitions and meanings which do not always correspond with how 
they might be interpreted in other fora. 

Example: 

A company purchasing registered substances from within the EU and then formulating 
these into mixtures (e.g. paints) would be regarded as a downstream user under REACH. In 
layman's terms this company might be considered to be a manufacturer of paints. However, 
within the context of REACH the company would not be a manufacturer of a substance and 
so would have no registration obligations for these substances. 

3 A formulator is a producer of mixtures in the context of the REACH Regulation 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
 
 
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2.1.2 Actors with registration obligations 

The only actors with registration obligations are: 

  EU manufacturers and importers of substances on their own or in mixtures in 

quantities of one tonne or more per year. 

  EU producers and importers of articles in case that the article contains a substance 
in quantities over 1 tonne per year and the substance is intended to be released under 
normal or reasonably foreseeable conditions of use. 

 

‘Only representatives’ established in the EU and appointed by a manufacturer, 
formulator or article producer established outside the EU to fulfil the registration 
obligations of importers (see section 2.1.2.5). 

Examples of when registration is needed 

  A manufacturer of a substance who uses the manufactured substance himself has a duty 

to register each substance manufactured in quantities of 1 tonne or more per year, unless 
exemptions apply, and will have to include information on his own use(s) and any 
identified uses of his customers in his registration. 

  An importer of a mixture has to register those substances which are present in the 

imported mixture in quantities of 1 tonne or more per year, unless exemptions apply. He 
will have to include information in his registration on the identified use(s) of the 
substance(s) in the mixture. There is no obligation for importers of mixtures to register the 
mixtures as such; indeed mixtures cannot be registered. 

Examples of when registration is not needed 

  Any user of substances not manufactured or imported by himself, is a downstream user 

and has no obligation to register these substances.  

  An importer of a substance, a mixture or an article, who is importing from a non-EU 

company who has appointed an ‘only representative’ will be considered as a downstream 
user and therefore does not need to register. The non-EU company needs to inform the 
importer of the appointment. In addition, the only representative should have an up-to-
date information on the importer’s identity and quantity of imported substance. 

  A manufacturer or importer of a substance which is exempted from registration under 

REACH has no obligation to register that substance. 

2.1.2.1 Legal personality 

Only a natural or legal person established in the EU can be a registrant. REACH-IT and IUCLID 
as well as the current guidance use the term ‘legal entity’ to refer to such a natural or legal 
person having rights and obligations under REACH.  

Although what constitutes a natural and a legal person is defined by the national laws of each 
EU Member State, the following principles may be of interest: 

  A ‘natural person’ is a concept applied in many legal systems to refer to human beings 

who are capable and have the right to engage into contracts or commercial 
transactions. These are usually people who have reached the age of legal maturity and 
are in full possession of their rights (meaning that these rights have not been taken 
away from them, for example due to a criminal conviction). 

 
 
 
 
 
 
 
 
 
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  A ‘legal person’ is a similar concept, applied in many legal systems to refer to 
companies who have been endowed with legal personality by the legal system 
applicable to them (the law of the Member State where they are established) and 
therefore are capable of carrying rights and obligations, independently of the people or 
other companies behind them (in the case of a ‘société anonyme’ or ‘limited company’, 
their shareholders). In other words, the company usually has its own existence and its 
assets do not coincide with those of its owners. One legal person can work on different 
sites. It can also open so-called ‘branch offices’ which do not have separate legal 
personality from the main or head office. In such a case, it is the head office that has 
the legal personality and that has to respect the provisions of REACH if it is established 
in the EU. On the other hand, a legal person can also open ‘daughter companies’ or 
‘subsidiaries’ in the EU in which it holds shares or another type of ownership. Such EU 
daughters have a different legal personality and therefore qualify as a ‘legal person 
established in the Community’ for the purposes of REACH. They are to be considered as 
different manufacturers and importers who each may be obliged to register for the 
respective quantities they manufacture or import. Often operators do not use the terms 
‘branch’ and ‘office’ in this technical-legal sense and therefore it should be ascertained 
in detail whether the entity being referred to has legal personality or not. 

In principle each legal entity must submit its own registration for each individual substance. In 
the case of a company group which is composed of several legal entities (e.g. a parent 
company and its subsidiaries), each of those legal entities must submit its own registration. On 
the other hand, if one legal entity has two or more production plants which are not separate 
legal entities, then only one registration covering the different sites needs to be submitted by 
the legal entity. 

Example: 

International companies sometimes have several daughter companies in the EU acting as 
importers, often spread over several Member States. Each of those daughter companies, if 
they have legal personality, are legal persons within the meaning of REACH. Depending on 
the distribution of work within the group, each of them can be an ‘importer’ responsible for 
import. It is for the group or the individual companies to assign the tasks and the 
responsibilities to companies in the group. 

2.1.2.2 Customs boundaries for manufacturing and import 

REACH applies to the European Economic Area (EEA), i.e. the 28 EU Member States and 
Iceland, Liechtenstein and Norway. This means that imports from Iceland, Liechtenstein and 
Norway are not considered imports for the purposes of REACH.  

Therefore, an importer of a substance from Iceland, Liechtenstein or Norway is not required to 
register the substance under REACH and is simply regarded as a distributor or downstream 
user. However if the manufacturer of the substance is established in Iceland, Liechtenstein or 
Norway, he will be subject to the same registration obligations as all EU manufacturers.  

Importers of a substance from Switzerland (a non-EU country not belonging to the EEA) will 
have the same obligations under REACH as any other importers. 

Examples: 

A formulator purchasing his substances in Germany or Iceland will be considered as a 
downstream user. 

A formulator purchasing his substances in Switzerland or Japan and introducing them into 
the EU customs territory will be considered as an importer. 

 
 
 
 
 
 
 
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2.1.2.3 Who is responsible for the registration in case of manufacturing? 

In case of manufacturing (see definition in section 2.1.1), the registration should be made by 
the legal entity who undertakes the process of manufacturing. It is important to bear always in 
mind that only manufacturers established in the EU are required to submit a registration for 
the substance they manufacture. The registration obligation also applies in the case that the 
substance is not marketed in the EU but exported outside the EU after manufacturing. 

Who is the registrant in case of toll manufacturing?  

A toll manufacturer (or subcontractor) is normally understood to be a company that 
manufactures a substance in its own technical facilities following the instructions of a third 
party in exchange for an economic compensation.  

The substance is generally put on the market by the third party. Often this arrangement is 
used for an intermediate step in the production process for which sophisticated equipment is 
needed (distillation, centrifugation, etc.). 

In this regard, the legal entity that manufactures the substance according to Article 3(8) on 
behalf of the third party is to be considered a manufacturer for the purposes of REACH and is 
required to register the substance he manufactures. If the legal entity practically undertaking 
the manufacturing process is different from the legal entity owning the production facility, one 
of these entities must register the substance.  

For more details on the obligations of toll manufacturers under REACH please consult ECHA 
fact sheet: ‘Toll manufacturer under the REACH Regulation’ available at: 
http://echa.europa.eu/web/guest/publications/fact-sheets.  

2.1.2.4 Who is responsible for the registration in case of import? 

In case of import (see definition in section 2.1.1), the registration should be made by the legal 
entity established in the EU who is responsible for the import. The responsibility for import 
depends on many factors such as who orders, who pays, who is dealing with the customs 
formalities or the ‘INCOTERMS’4 chosen, but this might not be conclusive on its own.  

For example, in the case of a ‘sales agency’ established in the EU and acting as an 
intermediary, i.e. transmitting an order from a buyer to a non-EU supplier (and being paid for 
that service) but taking no responsibility whatsoever on the goods or the payment for the 
goods and not having their ownership at any stage, then, the sales agency is not to be 
considered as the importer for the purposes of REACH. The sales agency is not responsible for 
the physical introduction of the goods.  

In many instances it will be the ultimate receiver of the goods (the consignee) who is the legal 
entity that is responsible for the import. However this is not always the case. If for example 
company A (established in an EU country) orders goods from company B (established in 
another EU country) who acts as a distributor, company A probably does not know from where 
the goods originate. Company B may choose to order the goods from either an EU 
manufacturer or from a non-EU manufacturer. In case company B chooses to order from a 
non-EU manufacturer (company C) the goods may be delivered directly from company C to 
company A in order to save on transportation costs. Because of this company A will be stated 
as the consignee on the documents used by the customs authorities and customs handling will 
take place in company A's country. Payment for the goods is, however, settled between 
companies A and B. Also note that in the present example company B is not a ‘sales agency’ as 
described above as the ‘sales agency’ does not choose the manufacturer from which to order 
the goods. Because the decision whether to order goods from an EU or non-EU manufacturer 

4 International Commercial Terms - a set of international rules for the interpretation of trade terms. 

 
 
 
 
 
                                           
 
 
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lies with company B, this company (and not company A) should be considered the legal entity 
responsible for the physical introduction of the goods into the customs territory of the EU, 
while company A is a downstream user. The registration obligation consequently would lie with 
company B. Company A on the other hand will have to be able to prove through 
documentation to the enforcement authorities that it is a downstream user, for example by 
showing that the order was placed to company B. 

Figure 2: Role and registration obligations of different actors in case of import 

It is important to note that the ‘non-EU manufacturer’ or supplier who is exporting a substance 
or mixture into the EU has no responsibilities under REACH. The shipping company that is 
transporting the substance or mixture normally has no obligations under REACH either. 
Exceptions may occur under specific contractual arrangements if the shipping company is 
established in the EU and if it is responsible for the introduction of the substance into the EU. 

In addition, it should be noted that when interpreting the term ‘importer’ according to the 
REACH Regulation, it is not possible to fall back upon the Regulation (EU) No 952/2013 laying 
down the Union Customs Code (UCC). 

In case an ‘only representative’ has been appointed the only representative is responsible for 
the registration (see next section). 

Company BCompany ARole and Registration obligationsCompany A- orders 8  tonnes from Company B- receives 8 tonnes from Company C- pays Company B-  is a downstream userCompany B- orders 8 tonnes from Company C- pays Company C- is considered the importer - needs to registerCompany C- receives an order of 8 tonnes from Company B - delivers 8 tonnes to Company A- is a non EU-Manufacturer- has no responsibilities under REACHOUTSIDE EUEUCompany COrders 8 tonnesOrders 8 tonnesDelivers 8 tonnes 
 
 
 
 
 
 
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2.1.2.5 Only representative of a ‘non-EU manufacturer’ 

Substances imported into the EU on their own, in mixtures or, under certain conditions, in 
articles need to be registered by their EU importers. This implies that each individual importer 
needs to register the substance(s) he imports. However, under REACH, a natural or legal 
person established outside the EU, who manufactures a substance, formulates a 
mixture or produces an article can appoint an only representative to carry out the 
required registration of the substance that is imported (as such, in a mixture or in an article) 
into the EU (Article 8(1)). This will relieve the EU importers within the same supply chain from 
their registration obligations, as they will be regarded as downstream users. 

Who can appoint an only representative? 

According to Article 8(1) a ‘non-EU manufacturer’ being a natural or legal person who is 
manufacturing a substance, formulating a mixture or producing an article that is imported into 
the EU, can appoint an only representative to fulfil the registration obligations of the importers. 
‘Non-EU distributors’5 are not mentioned in Article 8(1) and can therefore not appoint an only 
representative. An only representative must be able to document who he is representing and is 
advised to attach a document from the ‘non-EU manufacturer’ appointing him as only 
representative in his registration dossier. Although it is not mandatory to include this 
information in the registration dossier, it needs to be presented to the enforcement authorities 
upon request. 

Who can be an only representative? 

An only representative is a legal entity established in the EU which has sufficient background in 
the practical handling of substances and the information related to them to be able to fulfil the 
obligations of importers.  

It should be noted that an only representative is not the same as a third party representative 
(Article 4). A third party representative can be appointed by a manufacturer, importer or 
where relevant downstream user to allow this potential registrant or data holder to remain 
anonymous vis-à-vis other stakeholders in the data-sharing process. It is neither necessary 
nor advisable for an only representative to appoint a third party representative because an 
only representative is not obliged to disclose to the other participants in the data-sharing 
process the identity of the ‘non-EU manufacturer’ he is representing (for more guidance on this 
see the Guidance on data sharing at http://echa.europa.eu/web/guest/guidance-
documents/guidance-on-reach).  

What should a ‘non-EU manufacturer’ do when appointing an only representative?  

When appointing an only representative, it is recommended that the ‘non-EU manufacturer’ 
provides his only representative with up to date information on the list of EU importers which 
should be covered by the registration of the only representative and the quantities imported 
into the EU. This information may also be supplied by other means (e.g. it may be notified 
directly to the only representative by the EU importers) depending on the arrangements made 
between the ‘non-EU manufacturer’ and the only representative. 

The ‘non-EU manufacturer’ needs to inform all the EU importers in the same supply chain that 
he has appointed an only representative to conduct the registration thus relieving the 
importers from their registration obligations. A ‘non-EU manufacturer’ can only appoint one 
only representative per substance. The only representative’s registration should clearly specify 
which quantity of the imported substance it covers – be it the entire import into the EU from a 

5 Please note that a ‘non-EU distributor’ is not a distributor for the purposes of REACH as he is not a natural 
or legal person established in the EU (as defined in Article 3(14)). An EU-based distributor cannot, of 
course, in any case appoint an only representative. 

 
 
 
 
 
                                           
 
 
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given ‘non-EU manufacturer’, or only specified quantities within that total. In cases where an 
importer is also importing quantities of the same substance from other non-EU sources, then 
both the only representative and the importer must be able to clearly document to 
enforcement authorities which imports are covered by the registration of the only 
representative; and which are covered by the importer; otherwise, the importer remains 
responsible for all his imports. In other words, an importer has to submit a registration for the 
quantity of a substance he imports, but does not have to cover the volume of the substance 
that is covered by the registration of the only representative. 

What are the consequences for the EU importers? 

When an importer receives information from a ‘non-EU manufacturer’ in his supply chain that 
an only representative has been appointed to cover the registration obligations, this importer 
will be regarded as a downstream user of the only representative for the tonnage covered by 
the registration of the only representative. This change of status from importer to downstream 
user only pertains to the same supply chain, i.e. to the tonnage imported from the ‘non-EU 
manufacturer’ having appointed the only representative. If this importer also imports the 
substance from other non-EU suppliers, he still has to register the tonnage imported from this 
or these non-EU suppliers unless the latter has/have appointed an only representative(s) to 
cover the respective imports.  

Although the importer will receive confirmation from his ‘non-EU manufacturer’ on the 
appointment of the only representative, he should preferably also obtain confirmation in 
writing from the only representative that his imported tonnage and use is indeed covered by 
the registration submitted by the only representative. This would not only provide the importer 
with the contact point to whom he, acting as a downstream user, can make his use known, but 
would also give the importer a clear documentation that the imports are indeed covered by the 
registration of the only representative, as otherwise he remains responsible for the imports. 

The importer may decide, as can any downstream user, to perform his own chemical safety 
assessment (for further information see the Guidance on downstream users at 
http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach). This requires 
considerable effort so it is advisable for the importer to consider carefully to what extent it 
may be necessary. 

Obligations of the only representative regarding the registration of substances 

An only representative is fully responsible and liable for fulfilling all obligations of importers for 
the substances he is responsible for. These do not only pertain to registration but also to all 
other obligations of importers under REACH. 

The following paragraphs describe the role of the only representatives in regard to their 
registration obligations. The reader is reminded that other only representative obligations, 
such as pre-registration, data-sharing, etc. are described in the corresponding sections of this 
guidance under the obligations of importers. Where the only representative obligations differ 
from those of the importers, they are specifically mentioned. 

The only representative registers the imported quantities depending on the contractual 
arrangements between the ‘non-EU manufacturer’ and the only representative. 

REACH does not distinguish between direct and indirect imports into the EU and therefore such 
terms are not used in this guidance. It is essential that there is a clear identification of: 

  who in the supply chain of a substance outside the EU is the manufacturer, formulator 

or producer of an article; 

  who has appointed the only representative; 

 
 
 
 
 
 
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  which imports the only representative has responsibility for. 

As long as the above conditions are met, it does not matter what the steps or supply 
chain are outside the EU between the manufacturer, formulator or producer of an 
article and the importer into the EU. 

It should, however, be pointed out that the appointment of an only representative by the ‘non-
EU manufacturer’ creates the need for importers to keep exact documentation on which 
imported quantities of the substance are covered by the only representative registration and 
which imported quantities are not  In case of import of mixtures the importers will also need to 
know what quantity of the substance in a mixture is covered by an only representative 
registration, as he would otherwise be subject to a registration requirement himself. This 
documentation will need to be presented to the enforcement authorities upon request. 

The registration dossier of the only representative should comprise all uses of the importers 
(now downstream users) covered by the registration. The only representative must keep an 
up-to-date list of EU customers (importers) within the same supply chain of the ‘non-EU 
manufacturer’ and the tonnage covered for each of these customers, as well as information on 
the supply of the latest update of the safety data sheet.  

Although the only representative is legally responsible for the registration, it can be anticipated 
that in many cases, it will be the ‘non-EU manufacturer’ that will provide him with all 
necessary data for his registration dossier. If a ‘non-EU manufacturer’ decides to change his 
only representative, the successor will have to update the information related to the legal 
entity provided to ECHA. It is recommended that the new only representative submit evidence 
of his appointment and of the agreement of the earlier only representative to this change. A 
change of only representative constitutes a change of legal personality and the same 
obligations as described in section 7.2 of this guidance apply. In order to prevent disputes, it is 
recommended to include clauses on the eventuality of a later change of the only representative 
in the contracts between the ‘non-EU manufacturer’ and the only representative. 

The only representative can represent one or several ‘non-EU manufacturers’. If he acts on 
behalf of several ‘non-EU manufacturers’, he must submit a separate registration for each of 
these manufacturers. The tonnage of the substance to be registered in each registration is the 
total of the tonnages of the substance covered by the contractual agreements with the only 
representative and the specific non-EU manufacturer represented by him. The information 
requirement for the registration dossier must be determined according to this tonnage. By 
making separate submissions, the confidential business information (CBI) of the ‘non-EU 
manufacturer’ can be preserved and equal treatment with EU manufacturers can be ensured 
(EU manufacturers must submit separate registration dossiers for each legal entity). It is noted 
that only representatives are required to submit separate registrations not only for each ‘non-
EU manufacturer’ they represent but also for quantities of the same substance which they 
manufacture themselves or import from other ‘non-EU manufacturers’.  

The only representative needs to declare the size of the non-EU company that he represents 
and not the size of the company that is an only representative. 

In case several companies established outside the EU are part of the same group, and those 
companies export the same substances into the EU, each company constitutes a ‘non-EU 
manufacturer’ under REACH and may appoint an only representative. Even if the same only 
representative is appointed by several of the companies or by all of them, the only 
representative will have to submit separate registrations for each of the companies he is 
representing. From a technical perspective, this means that the only representative needs to 
create as many OR accounts in REACH-IT as non-EU manufacturers he represents (not only 
one OR account in REACH-IT for several non-EU manufacturers). 

 
 
 
 
 
 
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Figure 3: Roles and registration obligations of different actors when an only 
representative is appointed 

Import of mixtures when an only representative is appointed  

An importer of mixtures is obliged to register the individual substances in the mixtures he 
imports and needs to know therefore the chemical identity and the concentration of the 
substances in the mixtures. If the ‘non-EU manufacturer’ of the mixture or of the individual 
substances in the mixture appoints an only representative, it will be the only representative 
who will carry out the registration of the individual substances instead of the importers. The 
‘non-EU manufacturer’ will inform the importers that an only representative has been 
appointed. If the ‘non-EU manufacturer’ appoints separate only representatives for the 
different substances in the mixture or only appoints only representatives for some of the 
substances in the mixture, this information needs to be communicated clearly to the importers, 
so that they are aware of which obligations they are relieved of and which obligations they still 
have to fulfil pertaining the registration of the substances. In any case, the importers of the 
mixtures and the corresponding only representative(s) must be able to document which 
quantities of the substances imported in the mixture(s) are covered by the registration dossier 
of the only representative(s) and which quantities are covered by the registration dossier of 
the importers themselves. 

2.1.2.6 Role of industry associations and other types of service providers 

The actual registration of a substance can only be done by the manufacturer, importer or 
producer of an article or only representative and cannot be done by any third party including 
industry associations, unless they act as the only representative for one or more non-EU 
companies.  

 
 
 
 
 
 
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However, industry associations can provide very valuable assistance to registrants for the 
preparation of registration dossiers, and can help in co-ordinating the process. In addition they 
may have valuable data on the substance, as well as information on chemical categorisation 
and read-across that can be used in the data-sharing process. They could also be appointed to 
represent a registrant in discussions with other registrants regarding preparation of the joint 
submission of hazard data and act as third party representative. They can include non-EU 
enterprises as members, who, even though having no direct registration obligations, can 
provide information and assistance through these associations. 

2.2 What to register? 

Aim:  

This chapter provides an outline of which substances are subject to registration 
requirements and a detailed explanation of the circumstances under which the 
various exemptions from registration are applicable. Because the tonnage of 
manufacture or import of each substance is critical in determining whether and 
how to register, this chapter also outlines methods for calculating the volume to 
be registered. 

Structure:   The structure of this chapter is as follows: 

2.2.1 Overview of the registration scope 

Registration is required for all substances manufactured or imported in quantities of one tonne 
or more per year per manufacturer or importer unless they are exempted from the scope of 
registration. The registration requirement applies to all substances irrespective of whether they 
are hazardous or not. This includes substances on their own, in mixtures or substances in 
articles when they are intended to be released under normal or reasonably foreseeable 
conditions of use. 

For all registrations, a registration dossier has to be prepared and submitted electronically to 
ECHA. The information that the registrant has to provide in the registration dossier will depend 
on the volume (tonnes manufactured or imported per year) of the substance to be registered. 

The definition of a substance under REACH (see section 1.3) is very broad and includes not 
only chemicals whether hazardous or not, but every type of substance manufactured in or 

WHAT TO REGISTER?OVERVIEW OF THE REGISTRATION SCOPESection 2.2.1CALCULATION OF THE VOLUME TO BE REGISTEREDSection 2.2.6SUBSTANCES EXEMPTEDFROM REACHSection 2.2.2SUBSTANCES EXEMPTED FROM REGISTRATIONSection 2.2.3SUBSTANCES REGARDEDAS REGISTEREDSection 2.2.4REGISTRATION OF INTERMEDIATESSection 2.2.5 
 
 
 
 
 
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imported into the EU. It includes substances which are already closely regulated by other 
legislation such as radioactive substances, medicines, food or feedingstuffs, biocides or 
pesticides. These substances are completely or partially exempted from REACH or from the 
registration requirements (see following sections below). Other substances within the scope of 
specific pieces of legislation, e.g. food-packaging and cosmetics, although subject to 
registration, have reduced risk assessment requirements under REACH (see section 4.2.1). 

When the manufacturer or importer intends to register more than one composition or form of a 
substance (e.g. nanomaterial (NM)6) in the same registration dossier, they would need to 
ensure that the relevant Annex VII-XI information takes into account all compositions or forms 
registered, and that this is transparently reported in the corresponding registration dossiers 
submitted to ECHA.  

For further information and specific advice on preparation of the registration dossiers for 
nanomaterials, please consult Appendix 4: Recommendations for nanomaterials applicable to 
the Guidance on Registration available at: http://echa.europa.eu/guidance-
documents/guidance-on-reach. 

This guidance document focuses on the registration requirements for substances on their own 
and in mixtures. For substances in articles the reader is advised to consult the Guidance on 
requirements for substances in articles (http://echa.europa.eu/guidance-documents/guidance-
on-reach) where the specific conditions and obligations that the REACH Regulation imposes on 
producers or importers of articles are explained in detail. 

2.2.2 Substances exempted from the REACH Regulation 

2.2.2.1 Radioactive substances 

Radioactive substances are substances that contain one or more radionuclides of which the 
activity or concentration cannot be disregarded as far as radiation protection is concerned. In 
other words, they are substances which give off such a degree of radiation that there is a need 
to protect people and the environment against that radiation. Radioactive substances are 
covered by specific legislation7 and therefore exempted from REACH. 

Legal reference: Article 2 (1) (a) 

2.2.2.2 Substances under customs supervision 

If substances (on their own, in a mixture or in an article) are in temporary storage, in a free 
zone or a free warehouse with a view to re-exportation, or in transit, and remain under 
customs supervision without undergoing any treatment or processing, they are not subject to 
the REACH Regulation. 

Importers of substances who wish to rely on the exemption from REACH are therefore advised 
to ensure that these substances meet all the following conditions: 

6  Commission  Recommendation  on  definition  of  nanomaterial  (2011/696/EU)  available  at:  http://eur-
lex.europa.eu/legal-content/EN/TXT/?qid=1464877817743&uri=CELEX:32011H0696 

7 Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of 
the health of workers and the general public against the dangers arising from ionising radiation (OJ L 159, 
29.9.1996, p.1) 

 
 
 
 
 
 
 
 
 
                                           
 
 
 
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 

 

 

the  substances  are  put  in  a  free  zone  or  free  warehouse  as  defined  under  customs 
legislation  or  placed  under  another  relevant  customs  procedure  (transit  procedure, 
temporary storage), 

the substances are kept under supervision of the customs authorities, and 

the substances do not undergo any form of treatment or processing during their stay in 
the EU. A free zone or a free warehouse on the EU territory is part of the EU.  

In case of doubt, it is recommended to contact the customs authorities, who can provide more 
detailed clarification on the possible customs regimes established by Regulation (EU) No 
952/2013 laying down the Union Customs Code (UCC) which may be applied to substances 
merely passing through the EU. 

Legal reference: Article 2 (1) (b) 

2.2.2.3 Substances used in the interest of defence and covered by national 
exemptions 

The REACH Regulation allows individual Member States to exempt in specific cases certain 
substances (on their own, in a mixture or in an article) from the application of REACH, in the 
interests of defence. 

It should be noted that this exemption will only apply once a Member State has taken a formal 
measure, in accordance with its national legal system, to exempt in specific cases certain 
substances from REACH. The exemption will, naturally, only apply within the territory of the 
Member State having fixed the exemption. 

It can be expected that Member States who decide on such an exemption will inform the 
suppliers concerned; however, if in doubt, manufacturers, importers and producers of mixtures 
or articles which are used by Member State military forces or authorities in a defence context, 
are advised to contact those forces or authorities to check if an exemption has been granted 
which may cover their substance, mixture or article.  

To further harmonise national practices towards REACH defence exemptions, a voluntary Code 
of Conduct (CoC) on REACH Defence Exemptions was adopted by European Defence Agency 
participating Member States.  

More information on national exemptions in the interest of defence in individual Member States 
is available on the European Defence Agency website (http://www.eda.europa.eu/reach). 

Legal reference: Article 2 (3) 

2.2.2.4 Waste 

Waste is defined in the Waste Framework Directive 2008/98/EC8 as any substance or object 
which the holder discards or intends or is required to discard. This may be waste from 
households (e.g. newspapers or clothes, food, cans or bottles) or from professional businesses 
or from industry (e.g. tyres, slag, window frames that are discarded).  

The requirements of the REACH Regulation for substances, mixtures and articles do not apply 
to waste; and waste operations are not downstream uses under REACH. This however does not 

8 Directive 2008/98/EC repeals and replaces Directive 2006/12/EC which is mentioned in Article 2(2) of the 
REACH Regulation. 

 
 
 
 
 
 
                                           
 
 
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mean that substances in their waste stage are totally exempted from REACH. When a chemical 
safety assessment is required (see section 4.2.1 of this guidance) it must cover the whole life 
cycle of the substance in the exposure assessment, including the waste stage. Additional 
information on this can be found in the Guidance on waste and recovered substances 
(http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach). 

It is important to remark that once waste is recovered and in this recovery process another 
substance, mixture or article is produced, the REACH requirements will apply to the recovered 
material in the same way as to any other substance, mixture or article manufactured, 
produced or imported in the EU. In specific cases, where a substance recovered in the EU is 
the same as a substance which has already been registered, an exemption from the 
registration obligation may apply. More guidance on recovery is available in section 2.2.3.5 of 
this guidance. 

Legal reference: Article 2 (2) 

2.2.2.5 Non-isolated intermediates 

Intermediates are a class of substances for which specific provisions have been laid down 
under REACH for reasons of workability and because of their special nature. An intermediate is 
defined as a “substance that is manufactured for and consumed in or used for chemical 
processing to be transformed into another substance” (Article 3 (15)). 

REACH distinguishes between non-isolated intermediates and isolated intermediates. Non-
isolated intermediates are not covered by REACH. REACH applies however to isolated 
intermediates, although they may benefit from reduced registration requirements under 
specific conditions. Isolated intermediates are discussed further in section 2.2.5 of this 
document. 

A non-isolated intermediate is defined as an intermediate that during synthesis is not 
intentionally removed (except for sampling) from the equipment in which the synthesis takes 
place. Such equipment includes the reaction vessel, its ancillary equipment, and any 
equipment through which the substance(s) pass(es) during a continuous flow or batch process 
as well as the pipe work for transfer from one vessel to another for the purpose of the next 
reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after 
the manufacture (Article 3 (15) (a)). Intermediates falling within the above definition are 
therefore exempted from REACH. 

Note however that quantities of the same substance may be used in other operations or under 
other conditions, which implies that those quantities cannot be regarded as non-isolated 
intermediates. Only the quantities of the substance used under the conditions qualifying it as a 
non-isolated intermediate are exempted from REACH. For the remaining quantities, the 
relevant requirements under REACH must be fulfilled. 

Additional information on intermediates can be found in the Guidance on intermediates 
(http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach). 

Legal references: Article 2 (1) (c), Article 3 (15) (a)  

2.2.2.6 Transported substances 

The REACH Regulation exempts from its provisions the carriage of dangerous substances and 
dangerous substances in dangerous mixtures by rail, road, inland waterway, sea or air. Please 
note that for all activities (manufacture, import, use) related to the concerned substances 
other than its transport, the REACH requirements apply (unless covered by another 
exemption). 

 
 
 
 
 
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EU transport legislation (for example, Directive 2008/68/EC on the inland transport of 
dangerous goods, with subsequent amendments) already regulates the safety conditions of 
transport of dangerous substances by various means of transport and thus such transport is 
exempted from the provisions of the REACH Regulation.  

Legal reference: Article 2 (1) (d)  

2.2.3 Substances exempted from registration 

Substances that present minimum risk because of their intrinsic properties (like water, 
nitrogen, etc.) and substances for which registration is deemed inappropriate or unnecessary 
(such as substances occurring in nature like minerals, ores and ores concentrates if they are 
not chemically modified) are exempted from registration. 

Polymers are exempted from the requirement to register while the monomer substances or 
any other substances they consist of must be registered provided certain conditions are 
fulfilled.  

REACH also exempts from registration certain substances that are adequately regulated under 
other legislations, like substances used in food or feedingstuffs or in medicinal products, where 
the relevant criteria are met. 

Additional exemptions from registration apply to substances that are already registered and 
are either exported and re-imported into the EU or recovered through a recovery process in 
the EU. 

Note that substances exempted from the obligation to register may still be subject to 
authorisation or restriction provisions under REACH. The specific conditions under which the 
exemptions from registration under REACH apply are described in detail below. 

2.2.3.1 Food or feedingstuffs 

When a substance is used in food for humans or feedingstuffs for animals in accordance with 
the Food Safety Regulation (EC) No 178/2002, the substance does not have to be registered. 
This includes the use of the substance: 

 

 

 

 

as  a  food  additive  in  foodstuffs  within  the  scope  of  Council  Directive  89/107/ECC,  as 
amended by Directive 94/34/EC; 

as  a  flavouring  in  foodstuffs  within  the  scope  of  Council  Directive  88/388/ECC  and 
Commission Decision 1999/217/EC; 

as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003; 

in animal nutrition within the scope of Regulation (EC) 767/2009. 

The Food Safety Regulation already requires that food for humans cannot be placed on the 
market unless it is safe, i.e. not injurious to human health and fit for human consumption. 
Similarly, according to the Food Safety Regulation, feed is not to be placed on the market or 
fed to food-producing animals unless it is safe, i.e. not having an adverse effect on human or 
animal health and not making the food derived from food-producing animals unsafe for 
humans. Moreover, for food additives, food flavourings and their source materials, 
feedingstuffs additives and animal nutrition, specific pieces of EU legislation already create a 
system for authorisation of substances for those particular uses. Therefore, registration under 
REACH would be considered as double regulation. 

Accordingly, it is in the interest of manufacturers and importers of substances which may be 
put to food or feedingstuffs related uses to be aware if their own legal entity or their clients 
actually use the substance in food or feedingstuffs in accordance with the Food Safety 

 
 
 
 
 
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Regulation, since in that case they will not have to register this use at least for the quantities 
of the substance which are used in this way.  

Substances manufactured in the EU and exported to a third country that satisfy the 
requirements of the Food Safety Regulation are also exempted from registration under REACH 
to the extent that the substances are used in food or feedingstuffs. Imports of substances for 
that use from a third country are also covered by the same exception and do not have to be 
registered under REACH.  

Note that quantities of the same substance used for other uses than food and feedingstuffs are 
not exempted from registration. Only the quantities of the substance used in food and 
feedingstuffs are exempted from the registration obligation under REACH. 

Example: 

A manufacturer manufactures 100 tonnes of sulphuric acid in year X. 50 tonnes are used in 
foodstuffs in accordance with the Food Safety Regulation, 50 tonnes are used for the 
formulation of a non-food mixture. The 50 tonnes used for the formulation of the non-food 
mixture will be subject to the registration provisions of the REACH Regulation while the 50 
tonnes used in foodstuffs are exempted. 

Legal reference: Article 2 (5) (b) 

2.2.3.2 Medicinal products 

When a substance is used in a medicinal product within the scope of: 

 

either Regulation (EC) No 726/2004 on Community procedures for the authorisation and 
supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European Medicines Agency; 

  or  Directive  2001/82/EC  on  the  Community  code  relating  to  veterinary  medicinal 

products; 

  or Directive 2001/83/EC on the Community code for medicinal products for human use; 

the  substance  does  not  have  to  be  registered  under  the  REACH  Regulation  for  that  use.  The 
same exemption applies whether the substance is manufactured in the EU and used in the EU 
or exported to a third country. Imports of substances for that use from a third country are also 
covered by the same exemption and do not have to be registered under REACH. 

Accordingly, it is important for manufacturers and importers of substances which may be put 
to pharmaceutical related uses to be aware if their own legal entity or their clients actually use 
the substance in medicinal products covered by the pharmaceuticals legislation referred to 
above, since in that case they will not have to register under REACH to the extent that the 
substance is used in such medicinal products.  

The exemption does not distinguish between active or non-active ingredients as it applies to 
any substance ‘used in medicinal products’. Excipients used in medicinal products are therefore 
also exempted from registration. 

Note that quantities of the same substance used for other uses than pharmaceuticals are not 
exempted. Only the quantities of the substance used in medicinal products are exempted from 
the registration obligation. 

 
 
 
 
 
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Example: 

A manufacturer manufactures 100 tonnes of salicylic acid in year X. 50 tonnes are used in 
medicinal products within the scope of Directive 2001/83/EC on the Community code 
relating to medicinal products for human use, 50 tonnes are used for the formulation of a 
non-medicinal mixture. The 50 tonnes used for the formulation of the non-medicinal 
mixture will be subject to the registration provisions, while the 50 tonnes used in medicinal 
products are exempted from registration. 

Legal reference: Article 2 (5) (a) 

2.2.3.3 Substances included in Annex IV of the REACH Regulation 

Annex IV lists a number of substances for which it is understood that sufficient information is 
available to consider them as causing minimum risk to human health and the environment. 
These substances are typically of natural origin and the list of exempted substances includes, 
for example, water and nitrogen. Substances included in Annex IV are exempted from the 
registration provisions. 

The list is largely based on the exemptions from Regulation (EC) No 793/93 on risk evaluation 
of existing substances, although more substances were added. The registration exemption 
applies to the substance as such, not to a particular use. 

Legal reference: Article 2 (7) (a) 

2.2.3.4 Substances covered by Annex V of the REACH Regulation 

Annex V lists thirteen broad categories of substances for which registration is deemed 
inappropriate or unnecessary. The registration exemption applies to the substances as such, 
provided however that they meet the conditions for the exemption which are given in the 
particular category of Annex V.  

The full Annex V list is shown below. The reader is advised to consult the Guidance for Annex V 
(http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach) if in need of more 
detailed information on any category of substances. The guidance provides explanations and 
background information for applying the different exemptions and clarifies when an exemption 
can be applied and when not.  

ANNEX V 

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH 
ARTICLE 2(7)(b) 

1.  Substances which result from a chemical reaction that occurs incidental to exposure of 

another substance or article to environmental factors such as air, moisture, microbial 
organisms or sunlight. 

2.  Substances which result from a chemical reaction that occurs incidental to storage of 

another substance, mixture or article. 

3.  Substances which result from a chemical reaction occurring upon end use of other 

substances, mixtures or articles and which are not themselves manufactured, imported or 
placed on the market. 

4.  Substances which are not themselves manufactured, imported or placed on the market 

and which result from a chemical reaction that occurs when: 

 
 
 
 
 
 
 
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(a) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, 
plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation 
inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating 
agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, 
flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions 
as intended; or 

(b) a substance solely intended to provide a specific physicochemical characteristic 

functions as intended. 

5.  By-products, unless they are imported or placed on the market themselves. 

6.  Hydrates of a substance or hydrated ions, formed by association of a substance with 

water, provided that the substance has been registered by the manufacturer or importer 
using this exemption. 

7. The following substances which occur in nature, if they are not chemically modified: 

 Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal. 

8. Substances which occur in nature other than those listed under paragraph 7, if they are 
not chemically modified unless they meet the criteria for classification as dangerous 
according to Regulation (EC) No 1272/2008 or unless they are persistent, 
bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with 
the criteria set out in Annex XIII or unless they were identified in accordance with Article 
59(1) at least two years previously as substances giving rise to an equivalent level of 
concern as set out in Article 57(f). 

9. The following substances obtained from natural sources, if they are not chemically 
modified, unless they meet the criteria for classification as dangerous according to 
Directive 67/548/EEC with the exception of those only classified as flammable [R10], as a 
skin irritant [R38] or as an eye irritant [R36] or unless they are persistent, 
bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with 
the criteria set out in Annex XIII or unless they were identified in accordance with Article 
59(1) at least two years previously as substances giving rise to an equivalent level of 
concern as set out in Article 57(f): 

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; 
fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; 
glycerol. 

10. The following substances if they are not chemically modified: 

Liquefied petroleum gas, natural gas condensate, process gases and components thereof, 
coke, cement clinker, magnesia. 

11. The following substances unless they meet the criteria for classification as dangerous 
according to Directive 67/548/EEC and provided that they do not contain constituents 
meeting the criteria as dangerous in accordance with Directive 67/548/EEC present in 
concentrations above the lowest of the applicable concentration limits set out in Directive 
1999/45/EC or concentration limits set out in Annex I to Directive 67/548/EEC, unless 
conclusive scientific experimental data show that these constituents are not available 
throughout the lifecycle of the substance and those data have been ascertained to be 
adequate and reliable: 

Glass, ceramic frits. 

12. Compost and biogas. 

13. Hydrogen and oxygen. 

Legal reference: Article 2 (7) (b) 

 
 
 
 
 
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2.2.3.5 Recovered substance already registered 

The REACH Regulation exempts from registration substances which are recovered in the EU, 
provided a number of conditions are met. Recycling is a form of recovery and therefore 
covered by this exemption. 

‘Recovery’ is currently defined in EU law as any of the recovery operations provided in Annex II 
of the Waste Framework Directive 2008/98/EC. This non-exhaustive list covers the following 
operations:  

R1 

Use principally as a fuel or other means to generate energy 

R2 

Solvent reclamation/regeneration 

R3 

Recycling/reclamation of organic substances which are not used as solvents (including 
composting and other biological transformation processes) 

R4 

Recycling/reclamation of metals and metal compounds 

R5 

Recycling/reclamation of other inorganic materials 

R6 

Regeneration of acids or bases 

R7 

Recovery of components used for pollution abatement 

R8 

Recovery of components from catalysts 

R9 

Oil re-refining or other reuses of oil 

R10 

Land treatment resulting in benefit to agriculture or ecological improvement 

R11  Use of waste obtained from any of the operations numbered R1 to R10 

R12 

Exchange of waste for submission to any of the operations numbered R1 to R11 

R13  Storage of waste pending any of the operations numbered R1 to R12 (excluding 
temporary storage, pending collection, on the site where it is produced). 

Criteria for defining when waste is no longer considered to be waste (so-called end of waste 
criteria) after recycling are currently under development in relation to the Waste Framework 
Directive. Such a decision must be taken within the legislative framework of the Waste 
Framework Directive. A recovered substance will only fall within the scope of the REACH 
Regulation when a decision has been taken, in accordance with the provisions of the Waste 
Framework Directive, that the waste it is originated from meets the end of waste criteria and 
as such is no longer waste.  

The REACH Regulation sets the following conditions which have to be respected in order to 
benefit from the exemption from registration: 

(1) The same substance must have been registered. This means that if, for some reason, the 
same substance has not been registered at manufacturing or import stage, the recovered 
substance has to be registered. 

The legal entity performing the recovery should check whether a registration exemption 
applies to the recovered substance. If this is the case, then that exemption can of course 
be invoked. 

(2) The substance must be the same (the sameness of the substance must be assessed 

 
 
 
 
 
 
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according to the criteria defined in Guidance for identification and naming of substances 
under REACH and CLP available at: http://echa.europa.eu/web/guest/guidance-
documents/guidance-on-reach). For example, if the substance itself was modified in the 
recovery and the modified substance has not been registered, then the recovered 
substance has to be registered. 

(3) The legal entity that did the recovery must have available: 

 

 

 

the information that is contained in a safety data sheet (see section 6.1.1); or 

if the substance is supplied to the general public, sufficient information to enable users 
to take the necessary protection measures; or  

if a safety data sheet is not required, the information on any authorisation or restriction 
on  the  substance  and  other  relevant  information  necessary  to  identify  and  apply  risk 
management measures, as applicable (see section 6.1.2). 

The form in which this information has to be available to the company carrying out the 
recovery is not specified in REACH. It is however important to remark that recovery operators, 
relying or not on this exemption from registration, have also to comply with their duties 
regarding the provision of information on the substance down the supply chain, as specified in 
sections 6.1.1 and 6.1.2. 

More detailed information can be found in the Guidance on waste and recovered substances. 
The guidance explains in detail the conditions under which recovered substances may be 
exempted from registration and provides advice on how to fulfil the different criteria. The 
guidance also presents the recovery process of specific materials such as paper, glass, and 
metals in relation with the requirements of the REACH Regulation. The reader is strongly 
advised to become familiarised with the guidance if he intends to register or claim an 
exemption from registration for a recovered substance. 

It is worth noting that this exemption does not require that the substance has been registered 
by an actor of the supply chain leading to the waste generation. It is sufficient that a 
registration has been submitted for the substance by any registrant. 

ECHA recommends a recycler, who starts recycling a phase-in substance, to late pre-register 
that substance where possible in order to benefit from the transitional provisions for 
registration (see section 2.3.2). He can still be exempted from the registration requirements if 
another pre-registrant registers the substance. 

Legal reference: Article 2 (7) (d)  

2.2.3.6 Re-imported substance 

In cases where a substance is first manufactured in the EU, then exported – for example, to be 
formulated into a mixture – and then brought back into the EU again – for example, to be 
marketed or for further processing – this could lead to a double registration obligation if it 
happens within the same supply chain: first at the stage of original manufacture, by the 
original manufacturer, and a second time at the stage of import back into the EU, by a re-
importer down in the same supply chain (who may or may not be the original manufacturer). 
Therefore, substances which have been registered, exported and then re-imported are 
exempted from registration under certain conditions. 

The following conditions must be fulfilled to benefit from this exemption: 

(1) The substance must have been registered before it was exported from the EU. This means 
that if, for some reason, the substance was not registered at the manufacturing stage, the 
substance has to be registered upon re-import. 

(2) The substance already registered and exported must be the same, as the substance being 

 
 
 
 
 
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re-imported, on its own or in a mixture (the sameness of the substance must be assessed 
according to the criteria defined in the Guidance for identification and naming of substances 
under REACH and CLP available at: http://echa.europa.eu/web/guest/guidance-
documents/guidance-on-reach). For example, if the exported substance itself was modified 
outside the EU and therefore it is not the same substance as that which is now being re-
imported, the re-imported substance has to be registered.  

Again, the reason is clear; if the substance is not the same, it has not yet been registered 
(the registration information will be different), and therefore there will not be duplication of 
registrations. 

(3) The substance must not only be the same but it must actually proceed from the same 

supply chain in which the substance was registered. 

(4) The re-importer must have been provided with information on the exported substance, and 

that information must comply with the requirements established under REACH for the 
provision of information down the supply chain. The required information is described in 
detail in section 6.1.1 and 6.1.2 of this guidance. 

Legal reference: Article 2 (7) (c)  

Example (1) 

Manufacturer AManufacturer BSUBSTANCE XSUBSTANCE YFormulator CNon-EU Formulator DMIXTURE XYMIXTUREVXYZMIXTUREVZImporter EMIXTUREVXYZEU outside EU Registration obligations:Manufacturer A registers substance XManufacturer B registers substance YImporter E registers only substances VZ as in this example substances X and Y are in the same supply chain EU border 
 
 
 
 
 
 
 
 
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35 

2.2.3.7 Polymers 

A polymer means a substance consisting of molecules characterised by the sequence of one or 
more types of monomer units. Such molecules must be distributed over a range of molecular 
weights wherein differences in the molecular weight are primarily attributable to differences in 
the number of monomer units. A polymer comprises the following: 

a)  a simple weight majority of molecules containing at least three monomer units which 

are covalently bound to at least one other monomer unit or other reactant; 

b)  less than a simple weight majority of molecules of the same molecular weight. 

In the context of this definition a monomer unit means the reacted form of a monomer 
substance in a polymer (Article 3(5)). 

Owing to the especially extensive number of different polymer substances on the market, and 
since polymer molecules are generally regarded as representing a low concern in relation to 
their high molecular weight, this group of substances is exempted from registration. 
Manufacturers and importers of polymers must however register the monomer substance(s) or 
other substance(s) used for the manufacture of the polymers if all the following conditions are 
met: 

a)  the monomer substance(s) or other substance(s) have not been already registered by 

their supplier or another actor up their supply chain; 

b)  the polymer consists of 2% weight by weight or more of such monomer substance(s) or 
other substance(s) in the form of monomer units and chemically bound substance(s); 

c)  the total quantity of such monomer substance(s) or other substance(s) makes up one 

tonne or more per year (for further information on how to calculate the total quantity in 
this context the reader should consult the Guidance for monomers and polymers 
available at: http://echa.europa.eu/web/guest/guidance-documents/guidance-on-
reach). 

EU borderEU outside EU Registration obligations:Manufacturer A registers 60t of substance Xand 60 t of substance YImporter C imports Mixture consisted of 120t of substance X and 120t of substance Y but registers only 60t of substance Xand 60 t of substance Y  Manufacturer AMIXTURE XYSubstance X = 60tSubstance Y = 60tSUBSTANCE X60tSUBSTANCE Y60tNon-EU Formulator BSUBSTANCE X60 tSUBSTANCE Y60tImporter CMIXTURE XYSubstance X = 120tSubstance Y = 120tMIXTURE XYSubstance X = 120tSubstance Y = 120tMIXTURE XYSubstance X = 60tSubstance Y = 60t 
 
 
 
 
 
 
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Therefore, the manufacturer or importer of a polymer will not need to register the monomer 
substance, or any other substance chemically bound to the polymer, if these have already 
been registered by the supplier or another actor up their supply chain. For most polymer 
manufacturers the situation will generally be that their monomers and other substances will be 
registered by the suppliers of these substances. However, for an importer of a polymer 
consisting of monomer(s) or other substance(s) fulfilling both the conditions (b) and (c) stated 
above, the monomer(s) or other substance(s) must be registered unless: 

 

 

 

 

an only representative has been appointed by the non-EU manufacturer to fulfil the 
obligations of the importer. In this specific case, it is the duty of the only representative 
to proceed with the registration of the monomer(s); 

the monomer substances or any other substances used for the manufacture of the 
polymer have already been registered up the supply chain, e.g. if they have been 
manufactured within the EU and exported to a non-EU manufacturer; 

the monomer substances or any other substances used for the manufacture of the 
polymer are exempted from registration under Annex IV or V; 

imported polymer is natural (i.e. it is the result of a polymerisation process that has 
taken place in nature, independently of the extraction process with which it has been 
extracted). In this case the monomer substance(s) or any other substance(s) in the 
form of monomeric units and chemically bound substance(s) in natural polymer can, for 
practical reasons, be treated as "non-isolated intermediates" and do not have to be 
registered. 

More detailed information can be found in the Guidance for monomers and polymers. The 
guidance describes the provisions for monomers and polymers under REACH and provides 
clarification on how to deal with specific cases such as naturally occurring polymers and 
recycled polymers. The reader is advised to consult the document if in need of further 
information on these topics. 

Legal references: Article 2 (9), Article 6 (3) 

2.2.3.8 Substances used for the purpose of research and development  

One of the main objectives of REACH is to enhance innovation. To achieve this objective, 
REACH allows substances manufactured or imported at above 1 tonne per year to be exempted 
from registration under certain conditions, i.e. when they are used in product and process 
orientated research and development (PPORD).  

Scientific research and development 

Scientific research and development means any scientific experimentation, analysis or 
chemical research carried out under controlled conditions in a volume below 1 tonne per year 
(Article 3 (23)). A substance being used solely for scientific research and development does 
not need to be registered since the registration obligation applies to volumes of one tonne or 
more per year. 

Product and process orientated research and development (PPORD) 

Product and process orientated research and development is defined as any scientific 
development related to product development or the further development of a substance, on its 
own, in mixtures or in articles in the course of which pilot plant or production trials are used to 
develop the production process and/or to test the fields of application of the substance (Article 
3 (22)). 

Substances manufactured or imported on their own or in mixtures, as well as substances 

 
 
 
 
 
 
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incorporated in articles or imported in articles9 for the purpose of PPORD in quantities of one 
tonne or more per year can be exempted from the registration obligation for a period of five 
years. To benefit from the exemption a company needs to submit a PPORD notification to 
ECHA according to Article 9(2). The notifier must pay a fee to ECHA when submitting the 
notification dossier in addition to providing certain information about the substances and the 
PPORD use. Substances used for PPORD in quantities below one tonne per year do not need to 
be notified since they fall below the registration threshold of one tonne per year. 

The exemption applies only to the quantity of substance manufactured or imported only for the 
purpose of PPORD by a manufacturer, importer or producer of articles, himself or in 
cooperation with listed customers referred to in Article 9(4). The notifier must identify these 
customers in his notification dossier including their names and addresses.  

Upon request, ECHA may extend the exemption period for up to a further five years (or ten 
years in the case of medicinal products for human or veterinary use or substances that are not 
placed on the market). The notifier needs to present the research and development 
programme to demonstrate that such an extension is justified.  

ECHA will undertake a completeness check of the PPORD notification. The completeness check 
will verify whether all required information elements have been submitted and the payment of 
the fee has been received.  

As detailed in Article 9(4), ECHA may decide to impose conditions to ensure that the substance 
will be handled only by staff of listed customers in reasonably controlled conditions and will not 
be made available to the general public and that remaining quantities will be re-collected for 
disposal after the exemption period. For this purpose, ECHA may also ask a manufacturer or 
importer of a substance, who has submitted a PPORD notification, to provide additional 
information necessary to set conditions in accordance with Article 9(4). A manufacturer or 
importer has to comply with any conditions imposed by ECHA according to Article 9(4). For any 
detailed or specific issues on research and development see the Guidance on Scientific 
Research and Development (SR&D) and Product and Process Orientated Research and 
Development (PPORD) available at http://echa.europa.eu/guidance-documents/guidance-on-
reach. 

Legal references: Article 3 (22), Article 3(23), Article 9 

2.2.4 Substances regarded as registered 

Certain substances or uses of substances are regarded as being registered, and so no 
registration will be required for these substances for these uses. This applies to: 

 

 

substances in biocidal products as described below; and 

substances in plant protection products as described below. 

Similarly, a notification under Directive 67/548/EEC10 (the so-called Notification of New 
Substances - NONS) that has been made before the entry into force of REACH is regarded as a 
registration.  

9 Article 7(1) specifies the conditions under which the registration is required for substances contained in 
articles. 
10 Directive 67/548/EEC was repealed by the CLP Regulation on 1 June 2015.  

 
 
 
 
 
 
 
                                           
 
 
 
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2.2.4.1 Substances for use in biocidal products 

According to Article 3(1)(c) of Regulation (EU) No 528/2012 (BPR) ‘active substance’ 
means a substance or micro-organism11 that has an action on or against harmful 
organisms.  

A biocidal product may be composed of only one active substance, with or without co-
formulants, or it may be a mixture containing several active substances. 

Active substances manufactured or imported for use in biocidal products are regarded as 
registered for the uses in biocidal products in the following situations: 

(1) The active substance has been approved in accordance with Regulation (EU) No 

528/2012 (BPR), or 

(2) The active substance is under assessment in the review programme of existing active 
substances established under Article 16(2) of Directive 98/8/EC and continued under 
Article 89 of BPR. 

Please consult the list of approved active substances available on ECHA website at: 
http://echa.europa.eu/information-on-chemicals/biocidal-active-substances  

To check which active substances are in the review programme, please consult Annex II, part I 
to Commission Delegated Regulation (EU) No 1062/2014. For more information about the 
review programme, please consult the following page on the ECHA website: 
http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-
substances/existing-active-substance  

An exemption from REACH registration also applies in the following cases: 

–  The active substance is manufactured/imported for use in a biocidal product which has 

a simplified authorisation (Article 27 of BPR); 

–  The active substance is manufactured/imported for use in a biocidal product which has 

a provisional authorisation (Article 55 of BPR); 

–  The active substance is manufactured/imported for use exclusively in a biocidal product 
which is the subject of experiments or tests for the purposes of scientific or product and 
process-orientated research and development (Article 56 of BPR). 

Note that only active substances can be regarded as registered and that other 
substances used for producing the biocidal product are subject to registration. 

It is important to remark that if the substance is used in non-biocidal products it will have to 
be registered even if it fulfils the definition of an active substance according to Article 3(1)(c) 
of BPR and falls in the situation (1) or (2) mentioned above.  

If a manufacturer or importer manufactures or imports the substance for biocidal and non-
biocidal uses, it will have to submit a registration for the quantities of the substance used in 

11 The reader is reminded that microorganisms are not included within the scope of the definition of a 
substance under REACH and are therefore outside the scope of the REACH Regulation. 

 
 
 
 
 
 
 
 
 
                                           
 
 
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39 

Once a decision is adopted that an active substance is not approved, the manufacture and 
import of the substance is subject to the same registration requirements as any other 
substance under the scope of REACH.  

Example: 

A manufacturer manufactured 100 tonnes of quaternary ammonium compounds in year X. 
50 tonnes are used as active substances in biocides (e.g. wood preservatives) and the active 
substance is included in one of the acts mentioned under (2) above, the other 50 tonnes are 
used as surfactants in cleaning products. This latter use is in non-biocidal products and has 
to be registered; the former use is in biocidal products and is regarded as registered. 

Legal references: Articles 15 (2) and 16 of REACH, Article 57 of BPR 

2.2.4.2 Substances for use in plant protection products 

An active substance12 in the context of plant protection products is a substance, including 
micro-organisms13 having general or specific action against harmful organisms or on 
plants, parts of plants or plant products. 

Co-formulants in the context of plant protection products are substances or mixtures 
which are used in a plant protection product or adjuvant but are neither active substances 
nor safeners or synergists. 

Safeners are substances or mixtures that are added to a plant protection product to 
eliminate or reduce phytotoxic effects of the plant protection product on certain plants.  

Synergists are substances or mixtures that can give enhanced activity to the active 
substance(s) in a plant protection product. A plant protection product may be composed of 
active substances, safeners or synergists with or without co-formulants. 

Active substances manufactured or imported for use in plant protection products in accordance 
with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the 
market, are regarded as registered under REACH (for that use) if the active substance:  

(1) is approved and included in the Commission Implementing Regulation (EU) No 

12 Regulation (EC) No 1107/2009 repealed Directive 91/414/EEC with effect from 14 June 2011 while it 
provides for transitional measures to ensure the smooth transition to the new legislative regime. The 
references in the REACH Regulation to Directive 91/414/EEC and the legislation adopted thereunder 
should therefore be construed as references to Regulation (EC) 1107/2009 and its implementing 
legislation. For that reason, the Guidance refers to the definitions and the applicable legal requirements 
provided for in the Regulation (EC) 1107/2009.  Please refer to Article 2(3) (a), (b), (c) and (d) of 
Regulation (EC) No 1107/2009 where the definitions of safeners, synergists, co-formulants and adjuvants 
are given. 

13 Note that microorganisms are not included within the scope of the definition of a substance under 
REACH and are therefore outside the scope of the REACH Regulation. 

 
 
 
 
 
 
 
 
                                           
 
 
 
 
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540/2011 (list of approved active substances), or   

(2) where the application for approval of the active substance is deemed admissible in 

accordance with Article 9 of Regulation (EC) No 1107/2009.  

Note that quantities of the same active substance used for other uses than in plant protection 
products are not regarded as being registered even if they are approved.  

Under Regulation (EC) 1107/2009, synergists and safeners are subject to similar approval 
requirements as active substances. Thus, sufficient information on their use in plant protection 
products is obtained allowing them to be adequately controlled within the framework of the 
plant protection products legislation. Therefore, they should also be regarded as registered 
under Article 15 (1), as long as they meet the requirements set out therein.  

Given that co-formulants in plant protection products cannot satisfy the requirements of Article 
15 (1), they cannot benefit from that provision and thus are subject to registration.   

Adjuvants are not substances used in plant protection products but they may be placed on the 
market to be mixed by the user with a plant protection product. Therefore, they cannot satisfy 
the requirements of Article 15 (1) and are subject to registration. 

Example: 

A manufacturer manufactured 100 tonnes of copper sulphate in year X. 50 tonnes are used 
as active substances in pesticides and the active substance is approved, the other 50 
tonnes are used for other purposes. This latter use is in non-plant protection products and 
has to be registered; the former use is in plant protection products and is regarded as 
registered. 

The Commission maintains an electronic list of the approved (and non-approved) active 
substances which is available at the following link: 
http://ec.europa.eu/food/plant/pesticides/eu-pesticides-
database/public/?event=activesubstance.selection&language=EN  

Legal references:  Article 15 (1), Article 16 

2.2.4.3 Notified substances according to Directive 67/548/EEC 

Directive 67/548/EEC introduced a notification requirement for so-called new substances, 
which were substances not appearing on the European Inventory of Existing Commercial 
Chemical Substances (EINECS). The EINECS list contains, in principle, all substances on the 
Community market on 18 September 1981.  

Notifications made in accordance with Directive 67/548/EEC contain much of the technical 
dossier information which the REACH Regulation aims to have assembled by registrants 
through the registration requirement. This is the reason why such notifications are 
regarded as registrations. Notified substances according to Directive 67/548/EEC are 
generally referred to as NONS (Notification of New Substances) in the context of REACH.  

ECHA has assigned registration numbers to all notifications and distributes them electronically 
upon request of the notification’s owner through REACH-IT. Please note that the registration is 
assigned for the tonnage band referred to in the notification of the substance. As soon as the 
actual volume differs from this initial tonnage band the registrant will have to update his 
registration dossier as described in section 7.4 of this guidance.  

Legal entities are advised to check whether they submitted a notification for their substance to 
a Member State competent authority in accordance with the national legislation implementing 

 
 
 
 
 
 
 
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Directive 67/548/EEC. If this is the case, they have an official notification number on file which 
was allocated by the Member State competent authority. The substance will in that case also 
appear on the European List of Notified Chemical Substances (ELINCS). 

Notification under Directive 67/548/EEC was only required if a substance was placed on the EU 
market or imported into the EU. If a substance was merely manufactured in the EU, but not 
placed on the market, a notification would not have been made. These substances will have to 
be registered under REACH.  

Manufacturers or importers of polymers which were notified according to Directive 67/548/EEC 
are advised to read the Guidance for monomers and polymers 
(http://echa.europa.eu/guidance-documents/guidance-on-reach) where the specific steps to 
claim a registration number for a notified polymer are explained in detail. 

It is important to remark that a notification under Directive 67/548/EEC is 
nominal so that only the notifier benefits from being considered registered; any 
other parties manufacturing or importing the substance but who have not notified 
it, must register, unless there is another exemption that applies to them. 

Legal reference: Article 24 

2.2.5 Obligations related to registration of intermediates 

REACH establishes specific obligations for intermediates as previously explained in section 
2.2.5. While non-isolated intermediates are not covered by REACH, isolated intermediates 
have reduced requirements depending on the conditions of manufacture and use.  

The following types of isolated intermediates are defined under REACH: 

  On-site isolated intermediate  
  Transported isolated intermediates 

An on-site isolated intermediate is an intermediate not meeting the criteria of a non-
isolated intermediate and where the manufacture of the intermediate and the synthesis of 
(an)other substance(s) from that intermediate take place on the same site, operated by one or 
more legal entities (Article 3(15)(b)). 

A transported isolated intermediate is an intermediate not meeting the criteria of a non-
isolated intermediate and transported between or supplied to other sites (Article 3(15)(c)).  

A manufacturer or importer of an isolated intermediate in quantities of one tonne or more per 
year is required to register his substance under REACH. However he may benefit from reduced 
registration requirements provided the manufacture and use of the substance takes place 
under strictly controlled conditions. In case the registrant cannot demonstrate that the strictly 
controlled conditions are met, he will have to comply with the standard registration 
requirements defined by REACH. Note that the requirements for registration vary depending on 
whether the isolated intermediate is an on-site or a transported intermediate. It is important to 
remark that isolated intermediates can benefit from an exemption for registration under 
REACH as far as the conditions for the exemption apply. 

For the sake of simplification, isolated intermediates will be referred to simply as intermediates 
in the context of this document. The reader is advised to consult the Guidance on 
intermediates available at http://echa.europa.eu/guidance-documents/guidance-on-reach if in 

 
 
 
 
 
 
 
 
 
 
 
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need of more detailed information. The guidance is designed to support potential registrants of 
intermediates in assessing whether the conditions of manufacture and use fulfil the 
requirements to be considered as strictly controlled conditions. A detailed description of the 
registration requirements is also included. 

Legal reference: Article 3 (15), Article 17, Article 18 

2.2.6 Calculation of the volume to be registered 

The following sections describe how to calculate the volume (tonnes per year) to be used in 
order to decide whether a registration must be submitted for a substance, what are the 
information requirements that have to be fulfilled and in the case of pre-registered phase-in 
substances, to identify when the registration of the substance is due. 

According to REACH, once a substance is manufactured or imported in quantities of one tonne 
per year (or present in an article in quantities over one tonne per year under specific 
conditions) it has to be registered, unless an exemption applies. The registration requirement 
is therefore triggered by the volume of the substance manufactured or imported (or present in 
an article, if applicable). 

The volume of the substance will also determine the information to be submitted in the 
registration dossier. REACH defines four tonnage bands (1 to <10 tonnes, 10 to <100 tonnes, 
100 to <1000 tonnes, 1000 tonnes or more per year) and the standard information 
requirements for each of them. If the volume of the substance reaches the lower limit of a 
tonnage band, the standard information requirements for that tonnage band apply. The 
standard information to be submitted depending on the tonnage band is discussed in detail in 
section 4.1. 

The volume of the substance also plays a role in determining when the registration dossier for 
a substance is due (see section 3.2 of this guidance where the pre-registration process of 
phase-in substances is outlined). Although in principle substances should not be manufactured 
in the EU or placed on the market unless they have been previously registered, REACH defines 
a transition regime for the registration of certain substances that are already on the market 
provided that they have been pre-registered (the so called phase-in substances). These 
transitional arrangements introduce different deadlines for the registration of phase-in 
substances based on the hazards of a substance and on the yearly tonnage manufactured or 
imported (see section 2.3.2). 

2.2.6.1 Calculation of the volume in case of exemptions 

In principle a potential registrant needs to calculate the total volume (tonnes per year) of the 
substance he manufactures or imports and based on that decide whether a registration must 
be submitted and within which tonnage band. However if certain exemptions to 
registration apply (such as in food or medicinal products or for PPORD purposes as in the 
examples below) the potential registrant does not need to include those quantities in his 
calculation to determine the volume he has to register.  

 
 
 
 
 
 
 
 
 
 
 
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For details on the different exemptions, please, refer to the previous sections. 

Example 1: Use in medicinal products 

If a company manufactures a substance to be used in a medicinal product, it does not need 
to register the substance for that use. However, this company or its customers may at the 
same time make other uses of the same substance. To determine its registration obligation 
under REACH, it must determine the quantities for the other uses. E.g., company A 
manufactures 120 tonnes of magnesium hydroxide in year X. 70 tonnes are used in 
medicinal products and 50 tonnes are used for the formulation of a mixture. The 50 tonnes 
used for the formulation of the mixture will be subject to the provisions of the REACH 
Regulation, while the 70 tonnes used in medicinal products are exempted from registration 
under the REACH Regulation.  

Example 2: Use for PPORD purposes 

If  a  company  manufactures  11  tonnes  per  year  of  a  substance,  of  which  2  tonnes  are  for 
PPORD,  the  registration  obligation  is  defined  by  the  9  tonnes  per  year  which  are  not  for 
PPORD. The company will also have to submit a PPORD notification dossier for the 2 tonnes 
used for PPORD purposes. 

2.2.6.2 Calculation of the volume for intermediates 

In addition to the exemptions from registration, the potential registrant should consider 
whether the substance he intends to register is used as an intermediate and is manufactured 
and used under strictly controlled conditions (see previous section 2.2.5). If this is the case, he 
can benefit from the limited information requirements defined for intermediates and need not 
comply with the full set of information required for a standard registration. If the manufacture 
or use of the intermediate does not take place under strictly controlled conditions, the potential 
registrant will have to submit a standard registration dossier and comply with the information 
requirements established for the tonnage band in which he intends to register the 
intermediate. 

Where a dossier contains both the use of a substance as an intermediate under strictly 
controlled conditions and as an intermediate where strictly controlled conditions are not met, 
and/or as a non-intermediate, the information requirements will depend on the volume of the 
non-intermediate and of the intermediate use that is not taking place under strictly controlled 
conditions. 

Example:  Volume to consider for the registration dossier in the case of 

intermediates 

A company manufactures 2300 tonnes per year of substance A, of which 1700 tonnes are 
used as intermediate in strictly controlled conditions and the other 600 tonnes are used for 
other purposes not exempted from registration. This company will submit only one 
registration dossier for substance A, covering the 1700 tonnes used as intermediates and 
the 600 tonnes for the other purposes. However, the information requirements of the 
registration dossier will be determined by the 600 tonnes, since for the intermediate use 
under strictly controlled conditions only a limited set of information is required. This means 
that the information requirements defined under REACH for the 100-1000 tonnage band will 
be used as a basis for this dossier. The fact that the substance is also used as an 
intermediate under strictly controlled conditions should be indicated in the dossier and the 
volume of 1700 tonnes used as intermediates will also need to be documented in the 
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2.2.6.3 Calculation of the total volume 

In any case, it will be necessary to calculate the total volume (tonnes per year) of the 
substance that is intended to be manufactured and imported by the given registrant and that 
is not exempted from registration. As stated before, this total volume will determine the 
information to be submitted in the registration dossier and in the case of a pre-registered 
phase-in substance it also defines the registration deadline (see section 2.3.2 and 3.2 on 
phase-in substances). Note, however, that for combined registrations of substances used as 
intermediates under strictly controlled conditions and for other uses, as in the example above, 
the volume to be used as an intermediate will not be taken into account for the definition of 
the information requirements. The total volume, covering the use as intermediate and the 
other uses, determine in any case the deadline for the registration of the substance. 

In the case that the same registrant manufactures and/or imports the same substance at 
different sites which belong to the same legal entity, then the volume of the substance to be 
registered is the total volume of the substance manufactured and/or imported at the different 
sites, because the sites are not separate legal entities. 

If a substance is imported in several mixtures, the volume of the substance in each mixture 
(calculated as defined in section 2.2.6.4) will have to be aggregated. 

Moreover, if a substance is imported in several articles from which it is intended to be 
released, the potential registrant needs to sum up all quantities of the substance present in 
those articles. For this purpose, he needs to count only those articles from which the substance 
is intended to be released. Whenever a substance is intended to be released from an article, 
the total volume present in that article needs to be counted and not only the volume intended 
to be released. Note that if the substance has already been registered for that use by any 
registrant in the EU, the importer of the articles is relieved from the registration obligation. 

Example: If a company X imports per year three articles A, B, and C with 60 tonnes of the 
substance present in each but: 

- 
- 

- 

in article A, the substance is not intended to be released 
in article B, the substance is intended to be released and 40 out of 60 tonnes are 
released under normal conditions 
in article C, the substance is intended to be released and 10 out of 60 tonnes are 
released under normal conditions 

the company X will need to register the total volume of the substance in article B and C: 
120 tonnes, i.e. in the 100-1000 tonnes band, provided that the substance has not been 
registered before for that use by any registrant. 

If the potential registrant manufactures or imports a substance and at the same time produces 
an article from which the substance is intended to be released, he is required to register the 
volume of the substance he manufactures or imports. He need not submit a separate 
registration for the volume of the substance in the article. Nevertheless, the registration of the 
substance manufactured or imported needs to contain a description of the incorporation of the 
substance into the article as an identified use and this use needs to be assessed in the 
chemical safety assessment (see section 5.3 of this guidance). Additional information on the 
requirements for the registration of substances in articles is available in the Guidance on 
requirements for substances in articles at http://echa.europa.eu/guidance-
documents/guidance-on-reach. 

2.2.6.4 Calculation of the amount of substance in a mixture or in articles 

Specific situations may occur for substances present in mixtures or in articles:  

 
 
 
 
 
 
 
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45 

In order to be able to calculate the amount of a substance in a mixture, the total volume of the 
mixture is multiplied by the fraction of the constituent substance. This value can, for example, 
be obtained from the safety data sheet of the mixture. When only a range of concentrations of 
a substance in a mixture is available, then the maximum volume of the substance is calculated 
using the highest possible content of that substance in the mixture. Without more precise 
information on the composition, this may be the only way to ensure that the registration 
requirements are being respected. 

Amount of a substance in an article 

In the case of articles which contain a substance that is intended to be released under normal 
or reasonably foreseeable conditions of use, then: 

 

 

If the weight by weight content of that substance is known, then this value is multiplied 
by the total mass of the produced and/or imported article; or 

If the weight of substance per unit article is known then this value is multiplied by the 
total number of imported articles.  

More detailed guidance can be found in the Guidance on requirements for substances in 
articles. 

2.2.6.5 Calculation of the volume for phase-in and non-phase-in substances 

For a registration, the registrant must report in tonnes the volume he manufactures or imports 
per year. REACH defines different methods to determine the tonnes per year (Article 3 (30)) 
depending on whether a substance is a phase-in substance or a non-phase-in substance. For 
the definition of phase-in substances and non-phase-in substances please refer to sections 
2.3.1.1 and 2.3.1.2 respectively. 

Calculation of tonnes per year for the registration of non-phase-in substances 

The tonnes per year of a non-phase-in substance to be reported in a registration dossier is the 
estimated quantity in tonnes that is expected to be manufactured and/or imported in the 
calendar year (1 January - 31 December) of registration. If manufacturing starts only later in a 
particular calendar year, the registration dossiers can cover the expected tonnes for a full 
calendar year rather than the remaining months of the first calendar year, in order to avoid the 
need for a very quick update of the registration dossier for the second year. 

Calculation of the tonnes per year for the registration of phase in-substances  

In the case of a phase-in substance that has been imported or manufactured for at least three 
consecutive years, the tonnes per year must be calculated for registration purposes on the 
basis of the average tonnes manufactured or imported in the three preceding calendar years. 
If the substance has not been manufactured or imported for three consecutive years then the 
tonnes manufactured or imported in a calendar year should be used. This provision has been 
put in place to avoid situations where a sudden increase in demand would lead to the 
impossibility to comply with the registration obligations. Note that in the case of pre-registered 
phase-in substances manufactured or imported for three consecutive years the tonnes per year 
(calculated as a three-year average) determine the deadline for registration (please refer to 
section 2.3 and 3.2 of this guidance which describes the pre-registration process of phase-in 
substances). Detailed examples on how to determine the tonnes per year and the registration 
deadline for phase-in substances are provided in section 2.3.2.  

Legal Reference: Article 3 (30), Article 22(1)(c) 

 
 
 
 
 
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2.3 When to register?  

Aim:  

The aim of this chapter is to inform potential registrants when they should 
submit their registrations to ECHA. It explains in detail what are phase-in and 
not phase-in substances and what the deadlines for registration are.  

Structure:   The structure of this chapter is as follows: 

2.3.1 Phase-in substances vs. non-phase-in substances 

2.3.1.1 Phase-in substances 

The REACH Regulation creates a special transition regime for substances which, under certain 
conditions, were already being manufactured or placed on the market before the entry into 
force of the REACH Regulation on 1st June 2007 and were not notified according to Directive 
67/548/EEC. For these substances, the registration can be submitted within deadlines foreseen 
by the REACH Regulation and described in section 2.3.2.  

Such substances are called phase-in substances because they are being subjected to the 
registration system in different phases over time, rather than immediately in one go. 

A precondition to benefit from the transitional regime for registration is that the 
phase-in substance has been pre-registered between the 1st June 2008 and the 1st 
December 2008. Phase-in substances which are manufactured or imported for the 
first time after 1st December 2008 can benefit from a later pre-registration under 
special conditions.  

WHEN TO REGISTER?PHASE-IN SUBSTANCES VS. NON PHASE-IN SUBSTANCESSection 2.3.1DEADLINES FOR REGISTRATION Section 2.3.2Phase-in substances Section 2.3.1.1Non phase-in substances Section 2.3.1.2See section 3.2 on pre-registration See section 3.4 on inquiry. 
 
 
 
 
 
 
 
 
 
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Further information on pre-registration of phase-in substances is included in section 3.2. 

Phase-in substances are substances which fall under at least one of the following criteria: 

  The substance is listed in the European Inventory of Existing Commercial Chemical 
Substances (EINECS) (Article 3 (20)(a)). The EINECS list contains, in principle, all 
substances on the Community market on 18 September 1981. These are the so-called 
‘existing substances’. The full and exhaustive list is part of the EC Inventory accessible 
on the ECHA website: http://echa.europa.eu/information-on-chemicals/ec-inventory. 
Note that the list has been ‘frozen’ and no more substances can be added to it or 
removed from it. 

  The substance was manufactured at least once in any of the current Member States of 
the EU, without being placed on the EU market by the manufacturer or importer after 
31 May 1992 (15 years before entering into force of REACH), provided that the 
manufacturer or importer has documentary evidence of this. Such documentary 
evidence can be, for example, order sheets, stock lists, or any other documents which 
can be undoubtedly traced back to a date after 31 May 1992. If the substance would 
have been placed on the market by the manufacturer or importer, it would normally 
have been notified under Directive 67/548/EEC and in that case it will be considered as 
registered. 

  The substance was placed on the market in any of the current Member States of the EU 

before 1 June 2007 by the manufacturer or importer, and is a so-called ‘no-longer 
polymer’ (NLP). A NLP is a substance which was considered as having been notified in 
accordance with the first indent of Article 8 (1) of Directive 67/548/EEC in the version 
resulting from the amendment effected by Directive 79/831/EEC (and hence did not 
have to be notified under that Directive), but which does not meet the REACH definition 
of a polymer. Also in this case, the manufacturer or importer must have documentary 
evidence that he placed the substance on the market and that it was a NLP and that the 
substance was placed on the market by any manufacturer or importer between 18 
September 1981 and 31 October 1993 inclusive. Such documentary evidence can be, 
for example, order sheets, stock lists, labels, safety data sheets, or any other 
documents which can be undoubtedly traced back to a date between 18 September 
1981 and 31 October 1993 inclusive. A non-exhaustive list of NLPs is accessible at 
http://echa.europa.eu/information-on-chemicals/ec-inventory. Note that it only serves 
information purposes. 

Please note that the transitional regime for phase-in substances also applies to on-site and 
transported isolated intermediates as well as to substances in articles which need to be 
registered.  

Legal references: Article 3 (20)  

2.3.1.2 Non-phase-in substance 

All substances that do not fulfil any of the criteria for phase-in substances as presented in the 
previous section are considered to be non-phase-in substances. Non-phase-in substances 
do not benefit from the transitional regime provided for phase-in substances and need to be 
registered before they can be manufactured, imported or placed on the market in the EU, 
unless they have already been notified under Directive 67/548/EEC (see section 2.2.4.3).  

It is important to stress that registration of non-phase-in substances will first require the 
submission of an inquiry dossier to determine whether a registration or another inquiry has 
already been submitted for the same substance so that data-sharing mechanisms can apply. 
For more information on inquiry and data-sharing processes see section 3.4. 

 
 
 
 
 
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2.3.2 Deadlines for registration 

Substances falling under the scope of the REACH Regulation and not exempted from the 
registration obligation must be registered before they can be manufactured, imported or 
placed on the market. Phase-in substances and non-phase-in substances have different 
timelines for registration.  

Non-phase-in substances and phase-in substances which have not been pre-registered, must 
be registered before manufacture or import. 

For phase-in substances, which are manufactured or imported in a quantity of one tonne or 
more per year and which have been pre-registered between 1 June 2008 and 1 December 
2008 (inclusive), the registration provisions are applied in a stepwise way to facilitate the 
transition to REACH. 

The transitional arrangements introduce different deadlines for registration, without the need 
to interrupt the manufacture or import of these substances. 

The deadlines set for the registration of phase-in substances have been based on the tonnage 
manufactured or imported per manufacturer or importer or producer of articles. This follows 
from the assumption that chemicals manufactured in high volumes will in many cases be more 
likely to present a greater risk to humans and the environment. A greater priority has also 
been given to substances of higher concern, such as carcinogenic, mutagenic and reprotoxic 
substances (CMR) and substances which are very toxic to aquatic organisms and may cause 
long-terms effects in the aquatic environment (classified as R50/53).  

The 'phase-in' deadlines after entry into force of the Regulation are presented in Table 1 on 
the next page (applicable only if the substance has been pre-registered). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1: Deadlines for the registration of phase-in substances 

Deadline to submit registration 
dossier to ECHA 
30 November 2010 
at 23:59:59 (GMT) (at the 
latest) 

30 November 2010 
at 23:59:59 (GMT) (at the 
latest) 

30 November 2010 
at 23:59:59 (GMT) (at the 
latest) 

Criteria for substances 

Phase-in substances manufactured in the EU or imported in 
quantities of 1000 tonnes or more per year per 
manufacturer or per importer, at least once after 1 June 
2007; 

Phase-in substances classified14 as carcinogenic, mutagenic 
or toxic to reproduction, category 1 or 2, in accordance 
with Directive 67/548/EEC and manufactured in the 
Community or imported in quantities reaching 1 tonne or 
more per year per manufacturer or per importer, at least 
once after 1 June 2007; 

Phase-in substances classified as very toxic to aquatic 
organisms which may cause long-term adverse effects in 
the aquatic environment (R50/53) in accordance with 
Directive 67/548/EEC and manufactured in the Community 
or imported in quantities reaching 100 tonne or more per 
year per manufacturer or per importer at least once after 1 
June 2007; 

31 May 2013 
at 23:59:59 (GMT) (at the 
latest) 

Phase-in substances manufactured or imported in 
quantities of 100 tonnes or more per year per 
manufacturer in the Community or per importer at least 
once after 1 June 2007; 

31 May 2018 
at 23:59:59 (GMT) (at the 
latest) 

Phase-in substances manufactured in the Community or 
imported in quantities of 1 tonne or more per year per 
manufacturer or per importer at least once after 1 June 
2007. 

Figure 4 on the next page presents the registration deadlines graphically. 

14 ‘Classified in accordance with Directive 67/548/EEC’ refers to substances listed in Annex VI of the CLP 
Regulation with a harmonised classification and labelling and substances self-classified by the registrant. 

 
 
 
 
 
 
                                           
 
 
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Figure 4: Registration deadlines 

Therefore, if you are a manufacturer or importer of a phase-in substance, your registration 
deadline will depend on the criteria above.  

As explained in section 2.2.6.5, the ‘tonnes per year’ for phase-in substances that have been 
imported or manufactured for at least three consecutive years is calculated on the basis of the 
average volume for the three preceding calendar years. If the substance has not been 
manufactured or imported for three consecutive years then the calendar year tonnage should 
be used as for non-phase-in substances. 

Note that the highest tonnage per year (calculated as the average of the three 
preceding years or per calendar year, as applicable) manufactured or imported after 
1 June 2007 will determine the deadline for registration. However, the information 
requirements will be based on the three-year average tonnage calculated in the year 
of the registration (please refer to the examples on the next pages). 

The following examples show how to calculate the registration deadline for pre-registered 
phase-in substances based on the yearly tonnage (i.e. based on the average over the three 
preceding years). 

Pre-registrationREACH entry into force≥1000 tonnesCMRs (≥1 tonne)very toxic to aquatic organisms (R50/53)  (≥100 tonnes)100-1000 tonnes1-100 tonnesNon phase-in substances1 June 20081 Dec 20081 June 200730 Nov 201031 May 201331 May 2018 
 
 
 
 
 
 
 
 
 
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Example 1: 

51 

Company X needed to determine its registration deadline. For this purpose, Company X 
needed each year to calculate its yearly tonnage as the average over the three preceding 
years (e.g. in 2007 it was the average over 2004-2006). The deadline for registration is 
based on the highest tonnage calculated starting in 2007.  

Based on the abovementioned manufacture projections, Company X determined that it 
needed to register a phase-in substance by 31st May 2013 (as its manufacture volume was 
expected to be in the 100-1000 tonnes range). The tonnage for 2013 (calculated as the 
average over 2010-2012) had to be reported in the registration dossier and provided the 
basis for the information requirements. If the calculated tonnage had reached 1000 tonnes, 
the registration would have been due by 1st December 2010. If this had happened in 2011 
or 2012, the registration would have been due without delay.  

Once the substance has been registered, Company X needs to determine the volume every 
calendar year. If for example in 2017 alone the volume reaches 1000 tonnes, Company X 
will need to submit an update and comply with the additional information requirements in 
accordance with Annex X to REACH. 

Example 2: 

If the volume manufactured by Company Y was 120 tonnes (calculated as three-year 
average) in 2009 and decreased to less than 100 tonnes after that, Company Y still had to 
register by 31 May 2013, as the substance has been manufactured at least once at 100 
tonnes or more after 1st June 2007. The tonnage to be reported in the registration dossier 
was the 2013 tonnage calculated as the average over 2010-2012. This tonnage determined 
the registration information requirements. 

Example 3: 

The volume manufactured by Company Z was 60 tonnes in 2010, 90 tonnes in 2011, 140 
tonnes in 2012 and 200 tonnes in 2013. The three-year average in 2013 was 97 tonnes per 
year, but the three-year average in 2014 was 144 tonnes per year. In this case company Z 
had to register the substance as soon as possible, as the registration deadline for the 
substances at 100 tonnes or more per year had passed on 1 June 2013. The registration 
requirements were based on the 2014 tonnage calculated as the average over 2011-2013, 
i.e. 144 tonnes. 

Example 4: 

Company W manufactures 9 tonnes in 2015, 14 tonnes in 2016 and 20 tonnes in 2017. 

The three-year average tonnage in 2018 is 14.3 tonnes per year. 

In this case, the registration deadline of 31 May 2018 applies (substances below 100 
tonnes and not classified as CMR). The registration requirements should be based on the 
2018 tonnage calculated as the average over 2015-2017, i.e. 14.3 tonnes. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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Example 5: 

Company U imports 9 tonnes of a substance in 2015, 0 tonnes in 2016 and 10 tonnes in 
2017 and continues the import in 2018 estimating that the total quantity for the full year 
will stay below 10 tonnes.  

The company already exceeded the 1 tonne tonnage threshold once after 1 June 2007 and 
remained under the threshold of 100 tonnes. Therefore, registration of this substance is 
due by 31 May 2018 at the latest.  

Since the substance has not been imported during the three consecutive years, to 
determine the information requirements for the registration, the estimated tonnage during 
the calendar year of registration should be used. Therefore, the information requirements 
for the registration will be based on the estimated quantity in the year of registration, i.e. 
2018 tonnage (below 10 tonnes). 

Example 6a: 

Company V imports 15 tonnes in 2015, 20 tonnes in 2016, 15 tonnes in 2017 and 0.5 
tonnes in 2018 up to the month of April. The company then ceases all imports of the 
substance (and does not manufacture it) from May 2018. 

As company V has lost the status of importer (and is not a manufacturer either) it has no 
registration obligations on 31 May 2018 or thereafter, unless it re-starts imports. 

Example 6b: 

Company W imports 15 tonnes in 2015, 20 tonnes in 2016, 15 tonnes in 2017 and 0.15 
tonnes in 2018 up to the month of May and intends to import a further 0.35 tonnes before 
the end of 2018 (total 2018 tonnage 0.5 tonnes). In this case a registration is due on 31 
May 2018; in the registration the estimated annual volume for 2018 should be stated as 
0.5 tonnes, but the data requirements will be based on the average volume for the 
preceding 3 years (16.7 tonnes). 

Legal references: Article 23  

 
 
 
 
 
 
 
 
 
 
 
 
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53 

Aim:  

This chapter provides an overview on the data-sharing provisions set out in 
REACH to facilitate the sharing of data between registrants. It describes the 
main principles of data-sharing as well as the pre-registration and inquiry 
process. If in need of further information, the reader is advised to refer to the 
Guidance on data sharing at http://echa.europa.eu/guidance-
documents/guidance-on-reach where the data-sharing procedures are described 
in detail. 

Structure:   The structure of this chapter is as follows: 

3.1 Basic principles of data-sharing procedures 

The purpose of data-sharing is to increase the efficiency of the registration system as well as 
to reduce costs and to reduce testing on vertebrate animals. Duplicate animal testing has to be 
avoided and tests on vertebrate animals must only be undertaken as a last resort (Article 25).  

To facilitate data-sharing, the REACH Regulation requires that, prior to registration, all 
substances must either be pre-registered or an inquiry must be submitted according 
to Article 26. In general, pre-registration is relevant for phase-in substances and inquiry for 
non-phase-in substances, as well as for phase-in substances that have not been pre-registered 
(see section 2.3.1 for the definition of phase-in and non-phase-in substances). 

The communication mechanism for phase-in substances is the Substance Information 
Exchange Forum (SIEF) established following pre-registration. For non-phase-in substances 
and for phase-in substances that have not been pre-registered the mechanism is the inquiry 

DATA SHARING PROCEDURESBASIC PRINCIPLES OF DATA SHARING Section 3.1PRE-REGISTRATIONSection 3.2SIEF FORMATIONSection 3.3INQUIRYSection 3.4 
 
 
 
 
 
 
 
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process.  

With respect to data-sharing, the following principles apply: 

  Data must be shared for the same substance in the case of information 

involving tests on vertebrate animals. Before testing is carried out on vertebrate 
animals, a potential registrant must request available data either in the SIEF or 
through the inquiry process from the previous registrant.  

 

Information not involving tests on vertebrate animals must be shared if 
requested by a potential registrant of the same substance. The potential 
registrant may request the study he needs within the SIEF or from the previous 
registrant, as applicable.  

The existing registrants and potential registrants must make every effort to reach an 
agreement on sharing the data and ensure that the costs of sharing the information are 
determined in a fair, transparent and non-discriminatory way.  

The obligation to make every effort applies to any information requested, whether this 
concerns data involving testing on vertebrates, other data not involving testing on vertebrate 
animals, or conditions of access to joint submission. Article 25 stipulates that animal testing 
must be conducted only as a last resort. 

The data-sharing mechanisms aim to ensure that sharing of studies which are already 
available and of their related costs is agreed amongst potential registrants in a fair, 
transparent and non-discriminatory way. Importantly, in the case of lacking data, the aim of 
the sharing mechanism is for potential registrants of the same substance to agree who will 
undertake the necessary data collection to ensure that the test (if agreed that it is needed and 
cannot be covered by alternatives to testing) is carried out only once. The Implementing 
Regulation (EU) 2016/09 on joint submission and data-sharing15 (which entered into force on 
26 January 2016) established rules to ensure an efficient implementation of the already existing 
data-sharing and joint submission obligations.  

In accordance with the REACH Regulation, ECHA has set up procedures to assist in the 
resolution of data-sharing disputes. When potential registrants submit a data-sharing dispute, 
they must provide documentary evidence showing the efforts made by the negotiating parties 
to reach an agreement. To ensure equal treatment and the right to be heard, ECHA will also 
request the other party to provide documentary evidence. ECHA will assess the parties' efforts 
to reach an agreement on the sharing of the data and its costs. This assessment is solely 
based on the negotiations, meaning all documented communication between the parties.  

After the assessment, ECHA issues a decision either allowing the potential registrant to refer to 
the requested data or requesting both parties to continue their negotiations. All data-sharing 
dispute decisions are appealable at the Board of Appeal within three months. Note that data-
sharing dispute procedures must be initiated as a last resort, i.e. only after all the possible 
efforts and arguments have been exhausted. 

More details on the ECHA dispute mechanism can be found on the webpage “Data sharing 
disputes in practice”: http://echa.europa.eu/regulations/reach/registration/data-sharing/data-
sharing-disputes/data-sharing-disputes-in-practice.  

15 Commission Regulation (EU) 2016/9 on joint submission and data-sharing in accordance with Regulation 
(EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH), OJ L 3, 6.1.2016, p.41.  

 
 
 
 
 
                                           
 
 
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To view ECHA decisions on data-sharing disputes under REACH, please consult the following 
webpage: http://echa.europa.eu/regulations/reach/registration/data-sharing/data-sharing-
disputes/echa-decisions-on-data-sharing-disputes-under-reach.  

For practical advice on data-sharing negotiations, please consult the ECHA webpage: 
http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-
sharing-negotiations.   

Third party representative for data-sharing proceedings 

Any manufacturer, importer, or where relevant, downstream user, may, whilst retaining full 
responsibility for complying with his obligations under REACH appoint a third party 
representative for all data-sharing proceedings involving discussions with other manufacturers, 
importers, only representatives and where relevant downstream users. In these cases, the 
identity of a manufacturer or importer or downstream user who has appointed a third party 
representative must not be disclosed by ECHA to other manufacturers, importers, or, where 
relevant, downstream users. It is important to note that it is up to the manufacturer or 
importer of the substance to submit the registration, as a third party cannot register a 
substance for the company he represents in the data-sharing discussions. 

3.2 Pre-registration of phase-in substances 

Each potential registrant of a phase-in substance in quantities of one tonne or more per year 
must take part in the pre-registration process in order to benefit from the later registration 
deadlines outlined in section 2.3.2. The pre-registration mechanism allows potential registrants 
to get in contact for the purpose of data-sharing through the formation of a SIEF (see section 
3.3). 

Manufacturers or importers not submitting a pre-registration dossier will have to register their 
substance before being allowed to restart manufacture, or import. According to Article 26 they 
will have to submit an inquiry dossier to ECHA (see section 3.4 of this guidance) and then 
restart manufacture or import of their substance once a registration is completed.  

Although the main pre-registration period ended on 1 December 2008, potential registrants 
who for the first time manufacture or import a phase-in substance in a quantity of one tonne 
per year or more after 1 December 2008 can still benefit from the transitional regime and the 
phase-in deadlines for registration. In order to achieve this, the potential registrant would have 
to submit to ECHA a pre-registration dossier within six months of first manufacturing or 
importing the substance and no later than 12 months before the relevant registration deadline, 
for his tonnage band (see section 2.3.2 of this guidance). This means that the late pre-
registrations can be submitted until 31 May 2017 for substances that need to be 
registered by 31 May 2018. For substances which cannot be pre-registered anymore, 
potential registrants need to submit an inquiry to ECHA before registering. 

Producers or importers of articles containing a phase-in substance that would require 
registration and not having submitted a pre-registration dossier before 1 December 2008 will 
similarly have to register their substance before being allowed to restart the production or 
import of the articles containing the substance. They can also benefit from the late pre-
registration of the substance in case that they produce or import the articles containing the 
substance in a quantity over one tonne per year for the first time after 1 December 2008. To 
benefit from this, the producer or importer will have to submit a pre-registration dossier within 
six months of first using the substance for the production of the articles or first importing the 
article containing the substance and no later than 12 months before the registration deadline 
for their tonnage band. 

Note that in the case of a non-EU manufacturer appointing an only representative, it will be 

 
 
 
 
 
 
 
 
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the only representative who will have to pre-register the substance in order to benefit from the 
extended registration deadlines. An only representative appointed after 1 December 2008 can 
pre-register the substance until 12 months before the relevant registration deadline, provided 
that the substance originating from the non-EU manufacturer was not placed on the market 
previously in a quantity at or above one tonne per year after 1 June 2008 (when the 
registration obligations entered into force). If a non-EU manufacturer decides to change his 
only representative and the previous only representative had pre-registered the substance 
originating from the non-EU manufacturer, then the successor should communicate the change 
of only representative to ECHA in order to continue to benefit from the phase-in deadlines for 
registration of that substance. 

Legal reference: Article 28 

3.3 SIEF formation  

All potential registrants and data holders for the same pre-registered phase-in substance are 
participants in a ‘Substance Information Exchange Forum’ (SIEF). Registrants who registered 
the same phase-in substance earlier, or whose substance is considered as registered (see 
section 2.2.4) are also participants of the SIEF. The aims of the SIEF are to: 

 

 

facilitate data-sharing for the purposes of registration, thereby avoiding the duplication 
of studies, and 

agree on the classification and labelling of the substance concerned where there is a 
difference in the classification and labelling of the substance between the potential 
registrants. 

Participants are free to organise themselves as they see fit to carry out their duties and 
obligations under REACH. The organisation used for the SIEF co-operation may also be used to 
jointly submit the relevant Annex VII-XI information.  

Note that the responsibility for defining the ‘sameness’ or scope of the registered  substances 
lies with the SIEF participants. The Guidance on data sharing 
(http://echa.europa.eu/guidance-documents/guidance-on-reach) provides extensive 
information on the rights and duties of SIEF participants. The reader is advised to consult this 
guidance if in need of further information on the subject. 

For practical information regarding the organisation of the SIEF and related data gathering and 
data-sharing processes, please consult the following ECHA website: 
http://echa.europa.eu/support/registration/working-together.  

Legal reference: Article 29 

3.4  Inquiry for substances that are non-phase-in or have not been 
pre-registered  

Inquiry is the process by which a potential registrant must inquire from ECHA whether a valid 
registration has already been submitted for the same substance. This is to ensure that data 
are shared by the relevant parties. The duty to submit an inquiry applies to non-phase-in 
substances and to phase-in substances that have not been pre-registered. 

Therefore, for non-phase-in substances and for phase-in substances that have not 
been pre-registered an inquiry must always be submitted before proceeding with the 
registration of the substance. If the potential registrant wishes to access the market he 
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3.4.1 The inquiry dossier 

57 

When submitting an inquiry, potential registrants are required to submit a dossier with the 
following information:  

Identity of the inquirer 

This will include contact details and the location of the inquirer's production site. 

Substance identity 

The information must be sufficient to enable the substance to be identified. The information 
required for substance identity is identical to that required in the technical dossier for standard 
registration (section 2 of Annex VI) and is outlined in the Guidance on identification and 
naming of substances under REACH and CLP available at http://echa.europa.eu/guidance-
documents/guidance-on-reach. Please refer also to section 5.2.1 of this guidance.  

It is important to remark that for substances used as intermediates, the information to be 
provided in the inquiry dossier for the identification of the substance will have to comply with 
the same requirements as for non intermediates and will not benefit from reduced 
requirements even if manufactured and used under strictly controlled conditions (see section 
2.2.5). 

Providing thorough and accurate information on substance identity is essential to enable ECHA 
to provide the contact details of existing and potential registrants to the inquirer and so to 
facilitate all parties in their data-sharing obligations. Potential registrants are strongly 
recommended to consult the Guidance on identification and naming of substances under 
REACH and CLP to ensure that the information on substance identity they provide in the 
inquiry dossier follows the current guidelines.  

List of information requirements and of new studies which may be required 

The information requirements for a specific substance will depend on the intended tonnage 
band to be manufactured or imported. The potential registrant needs to identify the list of 
information requirements for their particular substance in order to facilitate the subsequent 
data-sharing stage (see section 4.1.1 on fulfilling the information requirements). The potential 
registrant must identify in the inquiry dossier the list of information requirements for which he 
would require to fulfil his registration obligations. 

Practical instructions for the preparation of an inquiry are available in the ECHA manual ‘How 
to prepare an inquiry dossier’ accessible at: http://echa.europa.eu/manuals. This document is 
also available via the help system built into IUCLID. 

3.4.2 The inquiry process  

Upon receipt of the inquiry dossier ECHA will perform a substance identity check to identify 
existing registrants and/or other successful inquirers of the same substance. This assessment 
can lead to the following, possible outcomes: 

1.  The same substance has not been registered and no party has submitted a 

successful inquiry to date 

In this situation, the potential registrant receives a communication from ECHA which 
includes the inquiry number and the link to the relevant Co-Registrants page in 
REACH-IT. On the Co-Registrants page, this potential registrant will see himself listed 
under the "Potential registrants" tab and the list under the “Registrants” tab will be left 

 
 
 
 
 
  
 
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empty. 

The potential registrant will also be able to access the pre-SIEF and see if there are 
companies which pre-registered the same substance. In this case, the potential 
registrant will need to contact the SIEF and determine how to fulfil the obligations to 
share data and submit a joint registration.  

2.  The same substance has been previously registered  

In this situation, ECHA will provide the potential registrant with a link to the Co-
Registrants page in REACH-IT which will contain the contact details of the existing 
registrants and other successful inquirers of the same substance. Once the lead 
registrant has registered the joint dossier for that substance, his contact details will 
also be visible.  

In parallel, ECHA will inform the existing and potential registrants of the submitted 
inquiry (name and contact details of potential registrant and his registration 
requirements). 

Based on the information submitted in the inquiry, ECHA will also provide the potential 
registrant with the list of relevant study summaries or robust study summaries 
already submitted and available. 

  For studies submitted at least 12 years previously16, ECHA will provide 

with the inquiry communication in the “Annotation” in REACH-IT, a copy of the 
relevant study summaries which can only be used for the purpose of 
registration by the potential registrant. ECHA will also identify the registrant(s) 
who have submitted the data. 

  For studies submitted less than 12 years previously17, as part of a 

notification under the previous legislation (Directive 67/548/EEC), or as part of 
a registration under REACH, ECHA will identify the registrant(s) who have 
submitted the data. 

The data-sharing process can be initiated, and the potential registrant will need to form part of 
a joint submission with the previous registrants. The rules to ensure an efficient 
implementation of the data-sharing and joint submission obligations are established by the 
Implementing Regulation (EU) 2016/09 on joint submission and data-sharing. For further 
information, please refer to the Guidance on data sharing at http://echa.europa.eu/guidance-
documents/guidance-on-reach.  

Please note also that the potential registrant: 

–  must, in the case of information involving tests on vertebrate animals, and 

–  may in the case of information not involving tests on vertebrate animals,  

16  Any study summaries or  robust study summaries submitted in the framework of a registration under 
REACH at least 12 years previously can be used for the purposes of registration by another manufacturer 
or importer. In the case of an update of the registration because a higher tonnage band is reached and 
information on additional studies for this higher tonnage band is submitted, a period of 12 years starts for 
the  new  information  when  it  is  submitted  (Article  25(3)).  In  addition,  for  data  that  has  already  been 
submitted  within  a  notification  dossier  under  Directive  67/548/EEC,  these  data  will  be  available  for  the 
purpose of registration, starting 12 years after their submission date. 

17 Data submitted at least 12 years previously may be requested as part of the inquiry process to ECHA. 

 
 
 
 
 
 
 
                                           
 
 
 
 
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request the (robust) study summaries required for registration, directly from the 
previous registrants.  

Registrants are encouraged to request and to share all available data, irrespective of whether 
these were derived using animal studies or not. 

It is recommended that the potential registrant contacts first the lead registrants displayed on 
the Co-Registrants page. This communication will enable the potential registrant to request 
sharing of existing data from the previous registrant(s), while engaging in negotiations to 
join/create the joint registration dossier. 

Legal references: Article 26 and 27 

 
 
 
 
 
 
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4 The registration process 

Aim: 

The aim of this chapter is to present the information that the registrant has to 
submit as part of his registration. It also describes what a joint submission of 
registration data is. 

Structure:   The structure of this chapter is as follows: 

Practical instructions for the preparation of a registration dossier are available in the ECHA 
manual ‘How to prepare registration and PPORD dossiers’ accessible at: 
http://echa.europa.eu/manuals. This document is also available via the help system built into 
IUCLID. 

4.1 Information requirements 

Manufacturers and importers will need to obtain information on the substances they 
manufacture or import and use this information to assess the risks arising from the 
manufacture and uses of the substances and to ensure that the risks that the substances may 
present are controlled.  

The information gathered and the assessment performed has to be documented in the 
registration dossier and submitted to ECHA for the registration of the substance.  

THE REGISTRATION PROCESSINFORMATION REQUIREMENTS Section 4.1REGISTRATION DOSSIERSection 4.2JOINT SUBMISSION OF DATASection 4.3ACCESS TO INFORMATION & CONFIDENTIAL DATASection 4.4 
 
 
 
 
 
 
 
 
 
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4.1.1 Fulfilling the information requirements  

Manufacturers and importers have to collect all available existing information on the 
properties of the substance for registration purposes, regardless of the tonnage manufactured 
or imported. This information has in turn to be compared with the standard information 
requirements set up by the REACH Regulation.  

The information to be gathered includes: 

 

test data (in vivo and in vitro); 

  non  test  data  from  alternative  methods  such  as  (Q)SARs  ((Quantitative)  Structure 

Activity Relationships), grouping of substances and read across; 

 

information on manufacture, uses, risk management measures and resulting exposures. 

Table 2 below presents an overview of the standard information requirements defined in 
REACH (Annex VII to X). For each tonnage band, REACH defines the minimum information that 
the registrant has to provide on the intrinsic properties of the substance. For the lowest 
tonnage level, the standard information requirements are defined in Annex VII, and when a 
new tonnage level is reached, the requirements of the corresponding Annex have to be added. 
These standard requirements may, however, be adapted (waived or increased) when 
appropriately justified according to the criteria set out in Annexes VII to XI. Therefore, for 
each substance the precise information requirements may differ depending on the 
available information on intrinsic properties as well as on tonnage, use and 
exposure. 

Where available data are not adequate to meet the requirements of REACH, additional testing 
may need to be generated. It should be noted that any study required to fulfil the information 
requirements defined in Annex IX and X (see Table 2) should not be conducted by the 
registrant at the stage of registration. Instead the registrant will have to develop a testing 
proposal and include it in his registration dossier.  

Before proposing a new test involving vertebrate animals the registrant needs to consider all 
the relevant and available data sources as well as available testing methods other than in vivo 
tests to avoid unnecessary animal testing. For example, the registrant may use a variety of 
alternative methods such as in vitro or in chemico tests, (Q)SARs ((Quantitative) Structure 
Activity Relationships) grouping or read-across, provided that the use of such methods is 
justified. All sources of information can also be used in a weight of evidence approach. If the 
outcome of this analysis justifies a proposal for animal testing, registrants need to make their 
justifications for animal testing clear in the registration dossier, including a documented 
analysis of alternative methods they have considered. 

Article 25 states that animal testing should only be performed as a last resort. Therefore, 
where possible the registrant is obliged to share or generate data with other 
registrants of the same substance, instead of generating data by himself, if this would 
involve animal experiments (see section 3.1 on data-sharing). 

Where tests on substances are required to generate information on intrinsic properties of 
substances, they must be conducted in accordance with the test methods laid down in 
Commission Regulation (EC) No 440/2008 and its amendments or in accordance with other 
international test methods recognised by the Commission or ECHA. Ecotoxicological and 
toxicological tests and analyses must be carried out in compliance with the principles of good 
laboratory practice (GLP) or other international standards recognised as being equivalent18 by 

18 Note that no other international standards have so far been recognised as being equivalent. 

 
 
 
 
 
                                           
 
 
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ECHA or the Commission and with the provisions of Directive 2010/63 EU on the protection of 
animals used for scientific purposes.  

For further information about the process for information gathering and data generation please 
refer to Guidance on information requirements and chemical safety assessment 
(http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment). The following chapters may be particularly useful for the reader: 

 

Part B: Hazard Assessment 

  Chapter R.2: Framework for generation of information on intrinsic properties 

  Chapter R.3: Information gathering 

  Chapter R.4: Evaluation of available information 

  Chapter R.5: Adaptation of information requirements 

  Chapter R.6: QSARs and grouping of chemicals 

  Chapter R.7: Endpoint specific guidance 

Practical information on alternative methods for the generation of information on intrinsic 
properties of substances can also be found in the following documents: 

 

Practical  Guide:  ‘How  to  use  alternatives  to  animal  testing  to  fulfil  your  information 
requirements’ 

 

Practical Guide 5: ‘How to use and report (Q)SARs’ 

The above-mentioned practical guides are available at http://echa.europa.eu/practical-guides.    

Table 2: Overview of the standard information requirements as defined in REACH 

7 

7.1 

7.2 

7.3 

7.4 

7.5 

7.6 

7.7 

7.8 

7.9 

7.10 

7.11 

7.12 

7.13 

7.14 

8 

ANNEX VII (1 tonne or more) 

INFORMATION  ON  THE  PHYSICOCHEMICAL  PROPERTIES  OF  THE 
SUBSTANCE 

State of the substance (at 20 oC and 101,3 kPa) 

Melting/freezing point 

Boiling point 

Relative density 

Vapour pressure 

Surface tension 

Water solubility 

Partition coefficient n-octanol/water 

Flash point 

Flammability 

Explosive properties 

Self-ignition temperature 

Oxidising properties 

Granulometry 

TOXICOLOGICAL INFORMATION 

 
 
 
 
 
 
63 

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8.1 

8.1.1 

8.1.2 

8.2 

8.2.1 

8.3 

8.3.1 

Skin irritation or skin corrosion 

Skin irritation (in vitro) 

Skin corrosion (in vitro) 

Serious eye damage or eye irritation 

Serious eye damage or eye irritation (in vitro) 

Skin sensitisation  

Skin sensitisation (in vitro/in chemico)  

The test(s) do not need to be conducted if an in vivo study under point 8.3.2 of 
Annex VII is available, or the available in vitro/in chemico test methods are not 
applicable  for  the  substance  or  are  not  adequate  for  classification  and  risk 
assessment under point 8.3. 

8.3.2 

Skin sensitisation (in vivo) 

An  in  vivo  study  must  be  conducted  only  if  in  vitro/in  chemico  test  methods 
described under point 8.3.1 of Annex VII are not applicable, or the results obtained 
from  those  studies  are  not  adequate  for  classification  and  risk  assessment 
according to point 8.3.  

8.4.1  Mutagenicity (in vitro gene mutation in bacteria) 

8.5.1  Acute toxicity (by oral route) 

9 

9.1.1 

9.1.2 

ECOTOXICOLOGICAL INFORMATION 

Short term aquatic toxicity on invertebrates ( preferred species Daphnia) 

Growth inhibition aquatic plants (algae preferred) 

9.2.1.1 

Ready biodegradability 

ANNEX VIII (10 tonnes or more) 

8 

8.1 

TOXICOLOGICAL INFORMATION 

Skin corrosion or skin irritation  

(An in vivo study must be considered only if the in vitro studies under points 
8.1.1 and 8.1.2 of Annex VII are not applicable, or the results of these studies 
are not adequate for classification and risk assessment) 

8.2                Serious eye damage or eye irritation  

(An in vivo study for eye corrosion/irritation must be considered only if the in vitro 
study(ies) under point 8.2.1 of Annex VII are not applicable, or the results obtained from 
these study(ies) are not adequate for classification and risk assessment). 

8.4.2 

8.4.3 

8.5.2 

8.5.3 

8.6.1 

8.7.1 

8.8.1 

9 

Cytogenicity in mammalian cells (in vitro) 

Gene mutation in mammalian cells (in vitro) 

Acute toxicity (by inhalation) 

Acute toxicity (by dermal route) 

Short-term repeated dose toxicity test (28 days) 

Screening for reproductive/developmental toxicity 

Toxicokinetics 

ECOTOXICOLOGICAL INFORMATION 

 
 
 
 
 
 
 
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9.1.3 

9.1.4 

Short-term aquatic toxicity to fish 

Activated sludge respiration inhibition test 

9.2.2.1 

Hydrolysis as a function of pH 

9.3.1 

Adsorption/desorption screening 

7 

7.15 

7.16 

7.17 

8 

8.6.1 

8.6.2 

8.7.2 

8.7.3 

9 

9.1.5 

9.1.6 

ANNEX IX (100 tonnes or more) 

INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE 
SUBSTANCE 

Stability in organic solvents and identity of relevant degradation products 

Dissociation constant 

Viscosity 

TOXICOLOGICAL INFORMATION 

Short-term repeated dose toxicity test (28 days) 

Sub-chronic toxicity (90 days) 

Pre-natal developmental toxicity  

Extended One-Generation Reproductive Toxicity Study 

ECOTOXICOLOGICAL INFORMATION 

Long-term aquatic toxicity on invertebrates (preferred species Daphnia) 

Long-term aquatic toxicity on fish 

9.2.1.2 

Simulation testing on ultimate degradation in surface water 

9.2.1.3 

Soil simulation testing 

9.2.1.4 

Sediment simulation testing 

9.2.3 

9.3.2 

9.3.3 

9.4.1 

9.4.2 

9.4.3 

8 

8.6.3 

8.7.2 

8.7.3 

8.9.1 

9 

9.2 

9.3.4 

9.4.4 

9.4.6 

Identification of degradation products 

Bioaccumulation in aquatic species (preferably fish) 

Further information on adsorption/desorption 

Short-term terrestrial toxicity to invertebrates 

Effects on soil micro-organisms 

Short-term terrestrial toxicity to plants 

ANNEX X (1000 tonnes or more) 

TOXICOLOGICAL INFORMATION 

Long-term repeated dose toxicity (≥ 12 months) 

Developmental toxicity 

Extended One-Generation Reproductive Toxicity Study 

Carcinogenicity 

ECOTOXICOLOGICAL INFORMATION 

Further biotic degradation testing 

Further information on the environmental fate and behaviour of the substance 
and/or degradation products 

Long-term terrestrial toxicity to invertebrates 

Long-term terrestrial toxicity to plants 

 
 
 
 
 
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9.5.1 

9.6.1 

Long-term toxicity to sediment organisms 

Long-term or reproductive toxicity to birds 

65 

4.1.2 Use of information from other assessments  

As stated under REACH, ‘Available information from assessments carried out under other 
international and national programmes shall be included. Where available and appropriate, an 
assessment carried out under Community legislation (e.g. risk assessments completed under 
Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected 
in, the chemical safety report. Deviations from such assessments shall be justified’ (Annex I 
Section 0.5). Registrants may rely on existing assessments in meeting the information 
requirements given in the Annexes VIII - X as long as they are in legitimate possession or 
have permission to refer to the full study reports that have been summarised in the 
registration dossier. Therefore, registrants need to take into account and to use these already 
available assessments to prepare their registration dossier. This includes in particular 
assessments carried out under other EU programmes such as the Existing Substances Risk 
Assessment Programme, assessments of active substances under the Biocidal Products 
Regulation or the Plant Protection Products Regulation when such substances are covered by 
REACH.  

Another important source of information is the OECD HPV (Organisation for Economic Co-
operation and Development High Production Volume) Chemicals Programme where a lot of 
similarities exist with REACH. Those similarities should be taken into account when preparing a 
registration dossier where a dossier for the OECD HPV Chemicals Programme is available. To 
reduce duplicative testing and save the government and industry resources the OECD has 
developed the Mutual Acceptance of Data (MAD) system, which allows participating countries 
(including non-members) to share the results of various non-clinical tests done on chemicals 
using OECD methods and principles. Further information on MAD system is available at 
http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm.  

4.2 Registration dossier 

4.2.1 Structure of the registration dossier  

The registration dossier is the set of information submitted electronically by a registrant for a 
particular substance. It consists of two main components: 

 

 

a technical dossier, always required for all substances subject to the registration 
obligations; 

a chemical safety report, required if the registrant manufactures or imports a 
substance in quantities of 10 tonnes or more per year. 

The technical dossier contains a set of information about: 

(i) 

the identity of the manufacturer/importer;  

(ii)  the identity of the substance; 

(iii)  information on the manufacture and use of the substance; 

(iv)  the classification and labelling of the substance; 

(v)  guidance on its safe use; 

(vi)  study summaries of the information on the intrinsic properties of the substance; 

 
 
 
 
 
 
 
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(vii) robust study summaries of the information on the intrinsic properties of the substance, 

if required; 

(viii) an indication as to whether the information on manufacture and use, the classification 

and labelling, the (robust) study summaries and/or, if relevant, the chemical safety 
report has been reviewed by an assessor; 

(ix)  proposals for further testing, if relevant; 

(x)  for substances registered in quantities between 1 and 10 tonnes, information on 

exposure; 

(xi)  a request as to which information should be considered confidential, including a 

justification. 

The chemical safety report (CSR) is the documentation of the registrant's chemical safety 
assessment (CSA) (see section 5.3). The requirement to prepare a CSA and document it in the 
CSR is triggered by the yearly tonnage manufactured or imported by the registrant (the 
threshold being 10 tonnes per year). The following exemptions apply: 

 

 

a CSR need not be performed for a substance present in a mixture if the concentration 
of the substance in the mixture is less than the lowest of the values defined in Article 
14(2); 

for uses in food contact materials and cosmetics, the CSR need not address human 
health aspects because these are addressed under other legislation. 

The obligations that apply to registrants regarding the information to be submitted in the 
registration dossier are explained in more detail in section 5. 

Legal references: Article 10, Article 14, Annex I, Annexes VI to X 

4.2.2 Format and submission of the registration dossier 

The format of the registration dossier must be IUCLID (International Uniform Chemical 
Information Database). Other IT tools can be used to prepare the dossier as long as they 
produce the exact same format.   

IUCLID is a software application to capture, store, maintain and exchange data on the 
properties and uses of chemical substances. Although the design and build of IUCLID was 
triggered by the entering into force of REACH, the software tool can be used for a large 
number of purposes. The data storage formats have been developed in co-operation with the 
OECD and have been accepted by many national and international regulatory authorities. 
IUCLID data can therefore be used in different chemical assessment programmes, such as the 
OECD HPV Chemicals Programme, US HPV Challenge Programme, the Japan Challenge 
Programme as well as in the EU Biocides Directive. The IUCLID software is downloadable from 
the IUCLID website at https://iuclid6.echa.europa.eu/ free of charge by all parties, if used for 
non-commercial purposes. 

Each manufacturer or importer or only representative is individually obliged to submit a 
registration dossier for each of his substances to ECHA in order to register them. The 
registration dossier must be submitted electronically through the REACH-IT portal accessible 
at: https://reach-it.echa.europa.eu. Practical instructions for the preparation of a registration 
dossier are available in ECHA manual ‘How to prepare registration and PPORD dossiers’ 
accessible at: http://echa.europa.eu/manuals. This document is also available via the help 
system built-in IUCLID. 

Legal reference: Article 111 

 
 
 
 
 
 
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4.3 Joint submission of data  

The ‘one substance, one registration’ principle 

67 

If the same substance is manufactured or imported or intended to be manufactured or 
imported by more than one company, all the registrants must submit part of data within one, 
joint submission. In other words: multiple registrants of the same substance are obliged to be 
part of the same, joint submission for that substance. 

Registrants are required to jointly submit the following information: 

–  classification and labelling of their substance; 

–  (robust) study summaries and proposals for testing, if any; 

– 

indication as to which of the submitted information on classification and labelling study 
summaries and robust study summaries has been reviewed by an assessor chosen by 
the registrant and having appropriate experience (see section 5.2.6 of this guidance). 

Under specific conditions (listed in Article 11(3) and 19(2)) which need to be justified in the 
dossier, separate submission of the above mentioned data is allowed by members of a joint 
submission (see section 4.3.2 of this guidance document where opt-out possibilities are 
described). However, the registration must be part of the same joint submission even in this 
case. Separate registrations are not allowed. 

Registrants may decide to submit jointly or separately: 

–  guidance on safe use of the substance; 

–  chemical safety report (CSR) when required; 

–  an indication which of the information submitted for the CSR has been reviewed by an 

assessor. 

The intention of a joint submission is that registrants will minimise costs by co-operating within 
the SIEF on the preparation of the dossier, participate in the data and cost sharing process to 
finally submit to ECHA jointly one set of information for the substance. The joint submission 
also ensures reducing the need for testing, in particular on vertebrate animals. In addition, 
registrants submitting data jointly can benefit from a reduced registration fee. For more 
information on how to gather and share existing information see also section 3 of this 
guidance. 

It is important to stress that in case an only representative has been appointed by a non-EU 
manufacturer to carry out the registration of the substance, he must be part of a joint 
submission with the other manufacturers, importers and only representatives for the same 
substance. Only representative must join the joint submission for each non-EU manufacturer 
he represents separately. 

The joint submission of data applies both for the registration of phase-in substances and that 
of non-phase-in substances. It also applies if a given substance is a phase-in substance to 
some of the registrants and a non-phase-in substance to others. The requirement to make a 
joint submission also applies regardless of whether the substance has been pre-registered by 
all, some or none of the registrants.  

Due to the reduced information requirements applicable to intermediates (used under strictly 
controlled conditions), registrants of intermediates may choose for practical reasons to either 

 
 
 
 
 
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form a joint submission together with the ‘normal’ registrants or to form one parallel joint  
submission for intermediate use only. However, in case of the separate joint submission for 
intermediate use only it is recommended to bring all existing, available information together 
(especially the information necessary for the classification of the substance). For more 
information about the registration of intermediates, please consult section 6.2 of the Guidance 
on data sharing. 

Note that the joint submission of data does not eliminate the obligation for each registrant 
(manufacturer, importer or only representative) to also submit an individual dossier as part of 
the joint submission.  

Registrants must submit individually: 

– 

their identity; 

– 

the identity of the substance; 

– 

information on the manufacture and uses; 

–  exposure information for substances in quantities of 1 to 10 tonnes; 

–  an indication which of the information on manufacture and use has been reviewed by 

an assessor. 

For details on which information must be submitted jointly as part of the lead dossier, and 
which must be submitted individually in each member dossier, please refer to Table 3 on the 
next page. 

The Implementing Regulation (EU) 2016/09 on joint submission and data-sharing establishes 
the rules to ensure an efficient implementation of the data-sharing and joint submission 
obligations. For more information, please refer to the Guidance on data sharing at 
http://echa.europa.eu/guidance-documents/guidance-on-reach. 

Legal reference: Article 11 

4.3.1 Mechanisms of joint submission 

The information that needs to be submitted jointly is submitted by one lead registrant on 
behalf of the other registrants (the so-called ‘member registrants’). Other information needs to 
be submitted by all registrants individually.  

The lead registrant of a joint submission could, for example, be the largest producer as he in 
any case will have to register the entire data set by the earlier deadline. However, this is not 
obligatory: the joint submission registrants have the possibility to appoint a lead registrant 
with a lower tonnage (for instance, if they have to prepare joint submissions for more 
substances and decide to share the workload of managing the joint submissions). If they 
arrange their joint submission in this way, a lead registrant in a lower tonnage band has to 
provide a complete dossier (i.e. with studies for the highest tonnage band to be registered for 
that substance).  

It is important to stress that the lead registrant will always pay the fee corresponding only to 
his own tonnage band, as well as any other member of the joint submission. In practice this 
implies that there will be two different types of registration dossiers, namely:  

 
 
 
 
 
 
 
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1.  the ‘lead dossier’ (containing the information of the lead registrant and the data set 
required in REACH for the highest tonnage band to be registered for that substance) 
and  

2.  the ‘member dossier’ (with the individual information to be submitted by each 

member of the joint submission).  

The information requirements for each type of registration dossier are shown in Table 3. 

Table 3: Information requirements for the lead dossier and the member dossiers in 
joint submissions 

Information requirements 

(a) Technical dossier 

(i)  identity of the manufacturer 

or importer 

(ii) identity of the substance 

(iii) manufacture and uses of the 
substance and if relevant use 
and exposure categories 

Lead dossier 

Member dossier 

Joint    
information 

Individual 
information 

Individual 
information 

X 

X 

X 

X 

X 

X 

(iv) classification and labelling * 

X 

(v) guidance on safe use 

upon agreement 

upon agreement 

upon agreement 

(vi) study summaries of 

information derived from the 
application of Annexes VII to 
XI * 

(vii)robust study summaries of 

the information derived from 
the application of Annexes 
VII to XI if required under 
Annex I *  

(viii) indication regarding the 
review by an assessor of 
information submitted under 
(iii), (iv), (vi), (vii) and (b) 

(ix) proposals for testing * 

(x) exposure information for 

substances in quantities of 1 
to 10 tonnes 

(xi) request as to which 

information in Article 119(2) 
should not be made available 
on the Internet 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

(b) Chemical safety report 

upon agreement 

upon agreement 

upon agreement 

* Subject to opt-out (see section 4.3.2 ) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Once the lead registrant has been appointed by the other registrants (Article 11) he needs to 
create a joint submission in REACH-IT and will submit the lead dossier for the joint submission 
first. Only once the lead dossier for the joint submission is accepted for processing, (i.e. it has 
passed the business rules check step, see section 10.1), the members can submit their 
dossiers. The joint submission page in REACH-IT will indicate to members when the lead 
dossier has passed the business rules check and that they may now begin submitting their 
respective member dossiers. 

When a potential registrant prepares to register a non-phase-in substance and the inquiry 
process (see section 3.4) results in finding that one or several registrations have previously 
been submitted for the same substance, the potential registrant will not only need to share 
data with the previous registrants, but he will also need to be part of the joint submission.  

Where the same substance has previously been registered by only one other company, the 
potential registrant will need to make contact with this previous registrant. They must agree 
on who will be the lead registrant. In most cases, it would be most sensible if the previous 
registrant takes over the role of the lead registrant, as he has already submitted a full dataset. 
However, the previous registrant and the potential registrant are also free to agree that the 
potential registrant will be the lead registrant and make the joint submission. In that case, the 
potential registrant must create and submit a joint submission with the full dataset required for 
the highest tonnage range of the two registrants, and the previous registrant will subsequently 
need to join this submission.  

The joint submission obligation also applies to previous notifiers under Directive 67/548/EEC. 
Given that the joint submission obligation did not exist prior to REACH and in order to ease the 
previous notifications into the registration system, they are regarded as registrations under 
REACH that are outside a joint submission. Therefore, such notifications are not linked to any 
existing joint submission. According to Articles 11 or 19 of REACH, a joint submission that 
includes the previous notifier(s) must be established when another entity intends to register 
the same substance.  

In case the lead registrant ceases manufacture the other registrants will have to consider the 
need to appoint a new lead registrant. For further information about designation or transferring 
the lead registrant role please consult Guidance on data sharing at 
http://echa.europa.eu/guidance-documents/guidance-on-reach. The registration fees, set by 
Commission Regulation (EC) No 340/2008 of 16 April 2008, as amended19 take into account 
whether the submission is joint or separate. 

Legal references: Article 11, Article 19 

4.3.2 Opt-out possibilities  

A manufacturer or importer may submit part of the data of the registration dossier separately 
(opt-out) in cases where at least one of the following reasons (listed in Article 11(3) or for 
substances in intermediates respectively in Article 19(2)) applies: 

(a) it would be disproportionately costly for him to submit this information jointly; or  

(b) submitting the information jointly would lead to disclosure of information which he 

considers to be commercially sensitive and is likely to cause him substantial commercial 
detriment; or 

19 The latest consolidated version of the Fee Regulation is accessible at 
http://echa.europa.eu/web/guest/regulations/reach/legislation.    

 
 
 
 
 
 
                                           
 
 
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(c) he disagrees with the lead registrant on the selection of the information submitted in 

the lead registration. 

In this case the registrant has to submit in his IUCLID registration dossier an explanation as to 
why the costs would be disproportionate, why disclosure of information would be likely to lead 
to substantial commercial detriment or the nature of the disagreement, as the case may be. 
For technical instructions please refer to ECHA manual ‘How to prepare registration and PPORD 
dossiers’ accessible at: http://echa.europa.eu/manuals. 

Opting out can be partial and refer for example only to a specific study. The registrant may 
also decide to opt out for all the information specified in Article 10(a)(iv), (vi), (vii) and (ix) of 
REACH.  

Please note that the joint submission is required even if the registrant decides to 
opt-out for part or all of the data. In such case the registrant still remains part of 
the same joint submission and will be able to submit his dossier only after the 
lead dossier has been accepted for processing. Hence, a registrant can opt-out 
from certain information requirements but not from the joint submission as such.  

Registrants who decide to opt out for some or all the information, are still 
required to contribute to their share of costs related to the joint submission and, 
if relevant, other related administrative costs.  

More information on the opting out possibilities and mechanisms can be found in the Guidance 
on data sharing available at: http://echa.europa.eu/guidance-documents/guidance-on-reach. 

Legal references: Article 11 (3), Article 19 (2) 

4.4 Access to information and confidential data 

Although the REACH Regulation requires information to be provided to ECHA and potentially 
exchanged with the other manufacturers and importers, some provisions (Articles 118 and 
119) to protect commercially sensitive information are foreseen. 

The general provisions on access to information are as follow:  

 

Information that is listed in Article 119 (1) and submitted in the registration dossier will 
be made publicly available on the ECHA website. 

  A registrant may identify certain information listed in Article 119 (2) as confidential in 
his registration dossier for reasons of commercial interests (Article 10(a)(xi)). If the 
justification is accepted as valid by ECHA, such information will not be made publicly 
available. The information listed in Article 119 (2) will be published on the ECHA 
website if no valid confidentiality claim is submitted by the registrant and is accepted as 
valid by ECHA. 

  Access to such pieces of information and other pieces of information may be granted by 

ECHA on request on a case-by-case basis whenever this is foreseen in Regulation (EC) 
No 1049/2001. This Regulation also defines cases in which public access to documents, 
whatever its medium, has to be denied, for instance for reasons related to commercial 
interests. Where it is not clear whether a document may or may not be disclosed, the 
regulation requires ECHA to consult the owner of the document with a view to assessing 
whether it should or should not be disclosed.  

 
 
 
 
 
  
 
 
 
 
 
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According to Article 119(2) the following pieces of information can be claimed confidential for 
reasons relating to commercial interests of the registrant or any other party, if justified: 

 

 

 

 

 

 

 

If essential to classification and labelling, the degree of purity of the substance and the 
identity of impurities and/or additives which are known to be dangerous; 

the total tonnage band (i.e. 1-10 tonnes, 10-100 tonnes, 100-1000 tonnes or over 
1000 tonnes) within which a particular substance has been registered; 

the study summaries or robust study summaries of the information on physicochemical 
data concerning the substance, on pathways and environmental fate as well as on 
toxicological and ecotoxicological studies, but not where these data were generated by 
means of vertebrate animal studies; 

certain information contained in the safety data sheet as defined in Article 119(2); 

the trade name(s) of the substance;  

the name in the IUPAC Nomenclature for non-phase-in substances which fulfil the 
criteria for any of the hazard classes set out in Article 58 (1) of Reg (EC) No 1272/2008 
for a period of six years; 

the name in the IUPAC Nomenclature for substances which fulfil the criteria for any of 
the hazard classes set out in Article 58 (1) of the CLP Regulation that are only used as 
one or more of the following: 

(i) as an intermediate; 

(ii) in scientific research and development; 

(iii) in product and process orientated research and development. 

Disclosure of the following information must normally be deemed to undermine the protection 
of the commercial interests of the concerned person, and therefore according to Article 118 
this information must not be published on the ECHA website or disclosed otherwise, with an 
exception when urgent action is essential to protect human health, safety or the environment: 

  details of the full composition of a mixture; 

  without prejudice to Article 7(6) and Article 64(2), the precise use, function or 

application of a substance or mixture, including information about its precise use as an 
intermediate; 

 

 

the precise tonnage of the substance or mixture manufactured or placed on the market; 

the links between a manufacturer or importer and his distributors or downstream users. 

In contrast, the following information submitted in the registration dossier and held by ECHA 
on substances whether on their own, in mixtures or in articles, must be made publicly 
available, free of charge on the ECHA website: 

 

the name in the IUPAC Nomenclature, for substances which fulfil the criteria for any of 
the hazard classes set out in Article 58 (1) of the CLP Regulation20, without prejudice to 
paragraph 2(f) and (g); 

20  

–  hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 

2, 2.14 categories 1 and 2, 2.15 types A to F; 

 
 
 
 
 
 
                                           
 
 
Guidance on registration 
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 

 

if applicable, the name of the substance as given in EINECS; 

the classification and labelling of the substance; 

  physicochemical data concerning the substance and on pathways and environmental 

fate; 

 

 

 

 

the result of each toxicological and ecotoxicological study; 

any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) 
established in accordance with Annex I; 

the guidance on safe use provided in accordance with section 4 and 5 of Annex VI; 

the analytical methods if requested in accordance with Annexes IX or X which make it 
possible to detect a dangerous substance when discharged into the environment as well 
as to determine the direct exposure of humans. 

Legal references: Article 118, Article 119 

–  hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 

3.8 effects other than narcotic effects, 3.9 and 3.10; 

–  hazard class 4.1; 

–  hazard class 5.1; 

 
 
 
 
 
 
 
                                           
 
 
 
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5 Preparation of the registration dossier 

Aim: 

The aim of this chapter is to describe how to prepare a registration dossier. It 
offers an overview on the information the registrant has to submit as part of his 
registration dossier and explains how this information has to be reported. It does 
not, however, provide specific practical instructions on how to successfully submit 
a registration dossier to ECHA. For this latter information, the reader is advised to 
consult the ECHA manual ‘How to prepare registration and PPORD dossiers’ 
accessible at: http://echa.europa.eu/manuals. This document is also available via 
the help system built into IUCLID. 

Structure:   The structure of this chapter is as follows: 

PREPARATION OF THE REGISTRATION DOSSIERTECHNICAL DOSSIERSection 5.2General informationSection 5.2.1INTRODUCTIONSection 5.1CHEMICAL SAFETY REPORTSection 5.3Information requirementsSection 5.2.4Classification and labellingSection 5.2.2Guidance on safe useSection 5.2.5Manufacture, use and exposureSection 5.2.3Review by an assesorSection 5.2.6Confidential informationSection 5.2.7Steps of the Chemical Safety AssessmentSection 5.3.1Chesar toolSection 5.3.2 
 
 
 
 
 
 
 
 
 
 
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All relevant and available information has to be documented in both the technical dossier and 
(for substances manufactured or imported in quantities of 10 tonnes or more per year per 
registrant) in the chemical safety report (CSR). The information needs to be reported in 
IUCLID format, and submitted to ECHA via REACH-IT, as shown in Figure 5. Members of the 
joint submission have also the possibility to create their registration dossiers online in REACH-
IT, instead of installing and using IUCLID21. This is however not possible for the lead 
registrant. For further technical details, see ECHA manual ‘How to prepare registration and 
PPORD dossiers’ (http://echa.europa.eu/manuals). 

Article 10 (a), in combination with Annexes VI to X defines the information to be documented 
in the technical dossier. Annex XI establishes the rules for the adaptation of the information 
defined in Annexes VI to X and has to be considered in combination with these annexes. 
Similarly, Article 10 (b), Article 14 and Annex I set out the general requirements for the CSA 
and the CSR applicable for substances subject to registration in quantities of ten tonnes or 
more per year. The relation between the information to be submitted for registration, as 
defined in REACH, and the IUCLID sections where it has to be reported is shown in Table 4 
below. 

Table 4: Relation between the information requirements in Article10 and the 
corresponding sections in a IUCLID file  

Information requirements  

Article 10 

IUCLID  

(a) Technical dossier 

(i) 

identity of the manufacturer or importer 

Article 10 (a) 

Annex VI section 1 

Legal entity & Section 
1 

(ii)  identity of the substance 

Annex VI section 2 

Section 1 

(iii)  manufacture and uses of the substance and if 

Annex VI section 3 

Section 3 

relevant use and exposure categories 

(iv)  classification and labelling 

Annex VI section 4 

Section 2 

(v)  guidance on safe use 

Annex VI section 5 

Section 11 

(vi)  study summaries of information derived from 

Annex VII to XI 

Sections 4, 5, 6 and 7 

the application of Annexes VII to XI 

(vii) robust study summaries of the information 

derived from the application of Annexes VII to 
XI if required under Annex I 

(viii)  indication regarding the review by an assessor 
of information submitted under (iii), (iv), (vi), 
(vii) and (b) 

Annex I, Annex VII 
to XI 

Sections 4, 5, 6 and 7 

Dossier header22 

(ix) proposals for testing 

Sections 4, 5, 6, 7  

(x)  exposure information for substances in 

Annex VI section 6 

Section 3  

quantities of 1 to 10 tonnes 

21 Please note that only those dossiers created online in REACH-IT can be updated via REACH-IT. 

22 The dossier header consists of information which is going to be used for administrative purposes and it 
is completed by the applicant when preparing his dossier from the substance data set.  

 
 
 
 
 
 
 
 
 
                                           
 
 
 
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(xi) request as to which information in Article 

119(2) should not be made available on the 
Internet 

(b) Chemical safety report 

All relevant sub 
sections 

Article 10 (b) 

Article 14, Annex 1 

Attachment in section 
13 

In order to generate his registration dossier, the registrant will have to undertake the following 
tasks: 

  Document the technical dossier with all relevant and available information 

  Carry out the chemical safety assessment (CSA) for substances manufactured or 

imported in quantities of 10 tonnes or more per year per registrant 

  Record the results of the CSA in the CSR. 

These tasks are described in detail in the following sections for an individual registration. Note 
that in case of a joint submission the information to be provided by the lead registrant and the 
members of the joint submission will not be the same as explained previously in section 4.3. 

Figure 5: Structure and format of the registration dossier  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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5.2 Generation of the technical dossier 

All relevant and available information on the substance, from its identification and intrinsic 
properties to the classification and evaluation of its hazards needs to be reported in the 
technical dossier. The information requirements depend on the three-year average tonnage 
calculated in the year of the registration for substances manufactured/imported during the 
three consecutive years. For substances which has not been manufactured/imported during the 
three consecutive years the information requirements depend on the tonnage estimated during 
the calendar year of registration. 

The data will be reported in IUCLID which is the reporting format for the technical dossier. 

In some cases more than one hazard profile would be relevant for a substance (for example if 
various compositions of the registered substance exist with different hazard profiles or if a 
substance transforms during the use and both parent and transformation products play a role 
in a safety assessment). To ensure a transparent organisation of the dataset for such 
substances, so-called “assessment entities” can be defined in IUCLID. For more information 
about this concept please refer to chapter D.2 of the Guidance on information requirements 
and chemical safety assessment, Part D: Framework for exposure assessment available at: 
http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment.  

The technical dossier will also include the administrative data required for the identification of 
the registration and its further processing by ECHA (registrant’s identity, tonnage band, etc.).  

The following sections of this guidance describe in a general way the content and level of detail 
needed in the registration dossier.  

Before the preparation of a registration dossier registrants are advised to consult the ECHA 
manual ‘How to prepare registration and PPORD dossiers’ accessible at: 
http://echa.europa.eu/manuals. This document is also available via the help system built into 
IUCLID. 

5.2.1 General information on the registrant and on the registered substance 

General information for the identification of the registrant and the substance that need to be 
reported in the registration dossier include: 

 

 

 

 

registrant identification (as specified in section 1 of Annex VI), i.e. registrant’s 
name, address, telephone number, fax number and e-mail address, details about the 
contact person and when appropriate information about location of registrant’s 
production and own use sites.  

role of the registrant (manufacturer, importer or only representative). If the 
registrant is an only representative acting on behalf of a non-EU manufacturer he is 
advised to attach a document from the non-EU manufacturer appointing him as only 
representative. 

information required for traceability purposes, such as the number of the pre-
registration or the inquiry preceding the registration. 

identification of the substance (as specified in section 2 of Annex VI). This includes 
the name of the substance, its chemical identifiers (EC number, CAS name and number, 
etc.), the molecular and structural formula and its composition (degree of purity, 
constituents, analytical data, etc.).  

The ‘one substance, one registration’ principle requires multiple registrants of the same 
substance to be part of the same, joint submission for that substance. This means that 

 
 
 
 
 
 
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registrants of the same substance agree to submit a joint registration covering the 
substances manufactured/imported by them individually. Such an agreement on the 
data submitted must be relevant for the scope of the substance as jointly registered by 
the registrants. In this respect, the joint registration is expected to include specification 
of the boundaries of the substance covered by the registration, in terms of its chemical 
composition. The specifications of the boundary of the substance covered by the 
registration are commonly known as the substance identity profile (SIP). The SIP 
concept has been developed by Cefic to aid preparation of SIEFs document sameness 
criteria for the joint submission23. 

It is the responsibility of the registrant to identify the substance. Information on the 
principles of substance identification can be found in the Guidance on identification and 
naming of substances under REACH and CLP (http://echa.europa.eu/guidance-
documents/guidance-on-reach). 

In the case of import of a mixture, it can be difficult to obtain information on the 
composition of the mixture from a non-EU supplier. However, also under existing EU 
legislation (e.g. for classification and labelling of mixtures) importers need to know 
which substances are present in the mixtures being imported to be sure they are 
complying with the law. It will be up to companies to improve the communication 
through their supply chain to ensure their compliance with REACH. In case disclosure of 
the composition of the mixture may have consequences, the non-EU manufacturer has 
the possibility to appoint an only representative, as explained in section 2.1.2.6 of this 
guidance. 

5.2.2 Classification and labelling 

Registration dossiers must include information on the classification and labelling of the 
substance according to the CLP criteria.  

The registrant has to determine the classification and labelling of his substance with respect to 
physico-chemical properties, environment and human health. Within a joint submission, the 
lead dossier can report several classifications in case several compositions of the registered 
substance (having different percentage of constituents, impurities and/or differing in their 
form) have different hazard profiles. In such case classification records in IUCLID have to be 
clearly linked to the relevant compositions. 

If a member registrant disagrees and wants to propose another classification, then he needs to 
‘opt-out’ from this information requirement (see section 4.3.2 of this guidance). Different 
classifications for the same substance may be reported and justified jointly in the lead dossier. 
However, in case of disagreement a member registrant will need to opt-out from this 
information requirement in his own dossier. 

The rationale for the decision for a classification (as well as the rationale for non classification 
when this is the case) should be clearly documented. A reason for non classification can be due 
to  

  a lack of data,  

 

inconclusive data, or  

  data which is conclusive for non classification. 

23 Cefic guidance documents, for example Guidance for Lead Registrants (http://www.cefic.org/Industry-
support/Implementing-reach/Guidances-and-Tools1/) outline the advantages of having a documented SIP 
available for transparency on cost sharing for joint submission. 

 
 
 
 
 
 
                                           
 
 
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The classification and labelling proposed in registration dossiers are reported within the 
Classification and Labelling Inventory (C&L Inventory) established and maintained by ECHA, 
see http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database. The 
C&L Inventory contains the classification of all substances subject to registration as well as of 
all substances within the scope of the CLP Regulation which meet the criteria for classification 
as hazardous and are placed on the market. 

It is recommended that registrants, before classifying their substance, consult Annex VI to the 
CLP Regulation (containing all harmonised classification and labelling of hazardous substances) 
as well as the C&L Inventory to check if their substance is already included. If the substance is 
included in Annex VI to the CLP Regulation (and therefore harmonised at EU level) the 
registrant must follow this harmonised classification. If the substance needs to be classified for 
additional endpoints to those covered by the harmonised classification, the registrant should 
report these next to the harmonised endpoints in his registration dossier. If the substance is 
already listed in the C&L Inventory but not in Annex VI to the CLP Regulation, the registrants 
should make every effort to agree their classification with other registrants, potential 
registrants having pre-registered and other notifiers of the classification and labelling of the 
same substance.    

For further information on harmonised classification and labelling please consult Questions and 
answers on Annex VI to CLP http://echa.europa.eu/support/qas-support/browse/-
/qa/70Qx/view/scope/clp/annex+vi+to+clp. It may be also useful to view ‘Harmonised 
classification and labelling’ section on the ECHA website 
http://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling.  

5.2.3 Manufacture, use and exposure 

5.2.3.1 Information on manufacture and uses of the substance (section 3 of Annex VI) 

Information on the manufacture and uses of the substance is to be provided as part of a 
registration dossier. This information plays an important role in many different REACH 
processes including the generation of CSR when one is needed, dissemination of (non-
confidential) information on where substances are used as well as input to the 
prioritisation/deprioritisation of substances for further regulatory processes.  

Substances that are not used in a wide-dispersive manner (e.g. no uses by consumers of the 
substance as such, in mixtures or in articles, no widespread uses by professional workers and 
no industrial uses with potential for exposure) may be deprioritised from REACH/CLP 
regulatory actions. To reflect the absence of the types of uses above, the use description 
should:  

 

 

 

not include entries in sections 3.5.4 to 3.5.6 of IUCLID (as there are no registered 
professional, consumer or service life uses), 

indicate that uses at industrial sites are limited to a few sites only  
(for example < 5),  

claim that uses at industrial sites take place under closed (rigorously contained) 
conditions leading to insignificant exposure to humans and insignificant release to 
the environment on the various routes. Note: These conditions need to be 
described in the exposure assessment (for substances > 10 t/a) or in the 
exposure information according to Annex VI (6) (substances < 10 ta).   

Please note: Registrants may be aware that one or more uses of their substances are to be 
considered wide dispersive (and thus qualify for being of priority concern for authorities). 

 
 
 
 
 
 
 
 
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However in the context of the overall use pattern of the substance the extent of such uses may 
be minor, which would be a key information for authorities in priority setting. Therefore, 
registrants are advised to provide specific information on the tonnage for such uses. 

Members of a joint submission also have to report their own uses and cannot simply refer to 
the dossier of the lead registrant, even if the chemical safety report (CSR) has been submitted 
jointly. In order to provide the use information, use maps developed under the CSR/ES 
roadmap can be helpful (http://www.echa.europa.eu/en/web/guest/csr-es-roadmap/use-
maps). Use maps include the description of use and its contributing activities as well as the 
references to the corresponding inputs to the exposure assessment of workers, environment or 
consumers.   

For more detailed guidance on use description, including advice on how to source and report 
the information please consult the Guidance on information requirements and chemical safety 
assessment, Chapter R12: Use description available at http://echa.europa.eu/guidance-
documents/guidance-on-information-requirements-and-chemical-safety-assessment.  

5.2.3.2 Information on exposure for substances > 10 t   

If according to Article 14 (4) the registrant is required to perform an exposure assessment as 
defined in section 5 of Annex I, then all identified uses of the registrant should be assessed 
(see section 5.3 of this guidance). This can be reported either in a joint or an individual 
chemical safety report (CSR). The exposure assessment includes a description of the 
conditions of use and an estimation of the exposure resulting from these conditions. The 
outcome of the exposure assessment is compared with the hazard characteristics of the 
substance for demonstrating control of risk (risk characterisation according to section 6 of 
Annex I).  

Registrants wishing to demonstrate that a substance is of low priority for the REACH/CLP 
regulatory processes may describe in their exposure assessment the condition ensuring 
absence/insignificance of exposure to humans and release to the environment on the various 
routes, e.g. how the substance is used under closed (rigorously contained) conditions. Such 
information may also be relevant for justifying that a certain information or test is not needed 
(exposure based waiving). REACH Annexes VIII to X establish in column 2 the specific rules for 
adaptation of standard information requirements and Annex XI establishes general rules for 
adaptation of those requirements (see also section 4.1.1 of this guidance).       

5.2.3.3 Information on exposure for substances < 10 tonnes (section 6 of Annex VI) 

For substances manufactured or imported between 1 and 10 tonnes per year, the registrant 
must provide information on exposure as specified under section 6 of Annex VI.  
Information regarding point 6.1.1 – industrial use and 6.1.2 (b) – use resulting in inclusion into 
or onto matrix will be satisfied when describing the use according to Guidance on information 
requirements and chemical safety assessment, Chapter R12: Use description (corresponding 
section 3.5 of IUCLID – Life cycle description).    

The extent of exposure information expected depends on what the registrant intends to 
demonstrate. Registrants claiming that Article 12(1) (b) does not apply for a substance due to 
absence of dispersive or diffuse uses (claim to be made in section 14 of IUCLID) should 
provide the following information in the technical dossier: 

  absence of consumer uses, wide-spread uses by professional workers and service life. 

Registrants indicate such absence by not including the above-mentioned uses into their 
technical dossier  (sections 3.5.4 to 3.5.6 of IUCLID empty) and advising against such uses 
in their safety data sheet (if a safety data sheet is required) and in section 3.6 of IUCLID;  

 
 
 
 
 
 
 
 
 
 
 
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  description of the condition ensuring absence/insignificance of exposure to humans and 
release to the environment on the various routes, e.g. how the substance is used under 
closed (rigorously contained) conditions. 

The same information will also be relevant if registrants intend to demonstrate that the 
substance is of low priority for the REACH/CLP regulatory processes.  

5.2.4 Information requirements on intrinsic properties (Annexes VII to X) 

All relevant available information on the physicochemical, toxicological and ecotoxicological 
properties of the substance as specified under Annexes VII to X (and its adaptations according 
to Annex XI) have to be provided in the technical dossier.  For substances 
manufactured/imported below 10 tonnes per year, Annex III sets the criteria triggering 
information requirements set out in Annex VII.  

Special considerations for 1-10 tonnes dossiers  

For the lowest tonnage level (1-10 tonnes per year) the standard information requirements are 
defined in Annex VII and divided into two types: 

1.  Information on physicochemical properties required for all substances in this 

tonnage band (Annex VII, section 7); 

2.  Information on toxicological and ecotoxicological properties required for substances 

predicted to be hazardous (Annex VII, sections 8-9).  

According to Article 12(1)(a), the information in section 8-9 of Annex VII is only required when 
existing information suggests that a substance meets the criteria of Annex III. Registrants can 
claim in their technical dossier (section 14 of IUCLID) that Annex III criteria are not fulfilled (and 
thus information according to section 8 and 9  of Annex VII is not required). For this  purpose 
registrants should review and subsequently verify available information, including: 

  data from submitted REACH registrations (i.e. ECHA’s dissemination website: 

http://echa.europa.eu/en/information-on-chemicals) or C&L notifications (i.e. ECHA’s C&L 
Inventory: http://echa.europa.eu/information-on-chemicals/cl-inventory-database) or any 
other relevant databases, for example OECD eChemPortal (http://www.echemportal.org);  

 

regulatory data (e.g. Annex VI of CLP);  

  experimental data, e.g. in QSAR Toolbox (http://www.qsartoolbox.org/), ECHA’s inventory 

of substances likely to meet the Annex III criteria (http://echa.europa.eu/information-on-
chemicals/annex-iii-inventory);   

  alternatives to test data (e.g. QSAR, read-across, in-vitro);  

 

in-house marketing information and information provided by customers or downstream 
sector organisations for characterising the uses of the substance (see also chapter 5.2.3 of 
this guidance). 

Information on how to fill in section 14 – Annex III criteria in IUCLID is given in the ECHA 
manual ‘How to prepare registration and PPORD dossiers’ accessible at: 
http://echa.europa.eu/manuals. This document is also available via the help system built-in 
IUCLID.  

The reader is also advised to consult Practical guide 3: ‘How to report robust study summaries’ 
if in need of more specific information on the level of detail to be reported for each individual 

 
 
 
 
 
 
 
 
 
 
 
 
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endpoint. The document is available at http://echa.europa.eu/practical-guides.  

For more information please visit the Annex III inventory the ECHA website 
(http://echa.europa.eu/information-on-chemicals/annex-iii-inventory). 

5.2.5 Guidance on safe use 

The registrant will have to report the following information (as required under section 5 of 
Annex VI): 

 

 

First aid measures 

Fire-fighting measures 

  Accidental release measures 

  Handling and storage  

  Transport information 

Where a CSR is not required the following additional information is also required: 

  Exposure controls and personal protection measures 

  Stability and reactivity 

  Disposal information  

The information needs to be reported in the registration dossier and must be consistent with 
that in the safety data sheet (SDS), where an SDS is required (see section 6.1.1 of this 
guidance).  

The registrant is advised to follow in-house current practices or Guidance on the compilation of 
safety data sheets (http://echa.europa.eu/guidance-documents/guidance-on-reach) when 
filling this section of the technical dossier. 

5.2.6 Review by an assessor 

The registrant is required to indicate in the technical dossier which of the following information 
has been reviewed by an assessor. Assessor is a person chosen by the registrant with 
appropriate experience in: 

 

Information on the manufacture and use 

  Classification and labelling of the substance 

 

(Robust) Study summaries on the information requirements defined in Annexes VI to X  

  Chemical Safety Report 

Such special experience allows the assessor to make judgements and interpret the measured 
data related to the substance. Assessor may be a person representing a manufacturer or 
importer, a formulator, a sector specific organisation, or a single company. Please note that 
choosing an assessor is a voluntary option. 

5.2.7 Confidential information 

The registrant has the possibility in IUCLID to flag as confidential those sections, endpoint 
study records or any other information that can be claimed as confidential according to REACH 
(Article 119). The list of information that can be claimed confidential is included in section 4.4 
of this guidance. 

In order for ECHA to assess the confidentiality claim the registrant needs to provide a 
justification in the corresponding field. It is strongly recommended to use the justification 

 
 
 
 
 
 
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template (already included in the justification field) to ensure that the justification contains all 
the necessary information. Please note that confidentiality claims are subject to fee payment. 

For technical instruction on how to make a confidentiality claim, please consult ECHA manual 
‘Dissemination and confidentiality requests under REACH Regulation’ accessible at 
http://echa.europa.eu/manuals. 

5.3 Chemical Safety Report 

For substances manufactured or imported at 10 tonnes or more per year, the registrant needs 
to submit as part of his registration dossier a chemical safety report (CSR), as described in 
section 3.2.1. 

The CSR is a standalone document which is to be attached in section 13 of IUCLID to the 
registration dossier and it contains partly information that should already have been reported 
in the technical dossier.  

A summary of the CSR format (as defined in Annex I of REACH) is presented in Table 5 below. 

Table 5: Short summary of the CSR format 

1.  

2. 

3. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Summary of risk management measures 

PART A 

Declaration that risk management measures are implemented 

Declaration that risk management measures are communicated 

Identity of the substance and physical and chemical properties 

PART B 

Manufacture and uses 

Classification and labelling 

Environmental fate properties 

Human health hazard assessment 

Human health hazard assessment of physicochemical properties 

Environmental hazard assessment 

PBT and vPvB assessment 

Exposure assessment 

10. 

Risk characterisation 

The CSR should document the chemical safety assessment (CSA) performed by the registrant. 
The purpose of the CSA is to ensure that the risks arising from the manufacture and use of a 
substance (on its own, in a mixture or in an article) are under control. The CSA of a 
manufacturer must address the manufacture and all identified uses of the substance while an 
importer will have to address only the identified uses. All stages of the life-cycle of the 
substance resulting from the manufacture (if applicable) and the identified uses must be 
considered in the CSA, including, where relevant, the waste stage and the service life of 
articles. A CSA should include the following steps: 

  Hazard assessment: 

 
 
 
 
 
 
 
 
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-  Human health hazard assessment 

-  Physicochemical hazard assessment 

-  Environmental hazard assessment 

-  PBT/vPvB24 assessment 

If the substance fulfils the criteria for any of the hazard classes or categories set out in Article 
14 (4) or is assessed to be a PBT or vPvB the chemical safety assessment will have to include 
the following additional steps: 

  Exposure assessment. 

-  Generation of exposure scenario(s)  

-  Exposure estimation 

  Risk characterisation 

The different steps of the CSA are explained below although the assessment should have been 
done earlier in the process, while preparing the technical dossier. 

The reader should also consult the Guidance on information requirements and chemical safety 
assessment (http://echa.europa.eu/guidance-documents/guidance-on-information-
requirements-and-chemical-safety-assessment) if in need of further help and advice. Please 
refer specifically to Part D (Building the Chemical Safety Report Report). 

Those readers without any previous knowledge on risk assessment might find it useful to refer 
first to the Guidance in a nutshell on chemical safety assessment  
(http://echa.europa.eu/guidance-documents/guidance-on-reach) to get familiarised with the 
concepts of the CSA. 

Note that ECHA has developed an IT tool called Chesar to help registrants perform a CSA and 
generate a CSR. This is explained in further detail in section 5.3.2. 

5.3.1 Steps of the chemical safety assessment 

5.3.1.1 Hazard assessment 

The assessment starts with the assessment of the physicochemical, human health and 
environmental hazards. In addition, the registrant has also to assess whether the substance is 
persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative 
(vPvB).  

As mentioned previously the hazard assessment should be performed on the basis of all 
available and relevant information which should be reported in the technical dossier. The 
registrant should rely particularly on the key studies identified in the technical dossier for the 
relevant endpoints. In addition to these key studies, information available in other studies 
could also be used by the registrant as supporting information or as part of a weight of 
evidence approach as described previously in section 5.2.4 of this guidance. 

5.3.1.1.1 Human health hazard assessment 

24 PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative. 

 
 
 
 
 
 
 
                                           
 
 
 
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The objective of the human health hazard assessment is to determine the classification and 
labelling of the substance and to define the level of exposure above which humans should not 
be exposed. This level of exposure is known as the derived no-effect level(s) (DNEL). The 
DNEL is regarded as an exposure level below which an adverse effect will not occur. It is 
derived from toxicity test results using appropriate assessment factors. While toxicity test 
results are reported in the technical dossier in the different endpoint study records, the DNEL 
values and the assessment factors used in their calculation should be reported in the endpoint 
summary records, as previously explained in section 5.2.4 of this guidance.  

Guidance on how to derive a DNEL is available in Guidance on information requirements and 
chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response 
for human health (http://echa.europa.eu/guidance-documents/guidance-on-information-
requirements-and-chemical-safety-assessment).  

The reader is also advised to consult Practical Guide 14: ‘How to prepare toxicological 
summaries in IUCLID and to derive DNELs’ available at http://echa.europa.eu/practical-guides. 

The classification and labelling of the substance should be performed on the basis of 
information available in the endpoint study records as detailed in section 5.2.2 of this 
guidance.  

In conclusion, the main task of the registrant is to first document the human health 
assessment of the relevant endpoints in the endpoint summaries in IUCLID and then to use 
this information in section 5 of the CSR. 

Please, note that for substances used in food contact materials within the scope of Regulation 
(EC) No 1935/2004 or in cosmetic products within the scope of Regulation (EC) 1223/2009, 
the human health risk assessment does not need to consider these uses, as they are already 
taken into account in the aforementioned regulations. 

5.3.1.1.2 Physicochemical hazard assessment 

The objective of the physicochemical hazard assessment is to determine the classification and 
labelling of the substance and to assess, as a minimum, the potential effects to human health 
for explosivity, flammability and oxidising potential.  

Guidance on how to assess physico-chemical properties is available in sub-chapter R.7.1 
"Physicochemical properties" within "Chapter R.7a: Endpoint specific guidance of the Guidance 
on information requirements and chemical safety assessment 
(http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment). 

The classification and labelling of the substance should be performed on the basis of 
information available in the endpoint study records as detailed in section 5.2.2 of this 
guidance. 

A summary of the different effects and at least the explosivity, flammability and oxidising 
potential must be reported in section 6 of the CSR on the basis of the information available in 
the endpoint study records. 

5.3.1.1.3 Environmental hazard assessment 

The objective of the environmental hazard assessment is to classify and label the substance 
and to determine a predicted no-effect concentration (PNEC) below which adverse 
environmental effects in the environmental compartments are not expected to occur.  

 
 
 
 
 
 
 
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Guidance on how to derive a PNEC is available in Chapter R.10: Characterisation of dose 
[concentration]-response for environment within Guidance on information requirements and 
chemical safety assessment, (http://echa.europa.eu/guidance-documents/guidance-on-
information-requirements-and-chemical-safety-assessment). 

The classification and labelling of the substance should be performed on the basis of 
information available in the endpoint study records as detailed in section 5.2.2 of this 
guidance. 

A summary of the different effects on the environmental targeted compartments (aquatic, 
terrestrial, atmospheric and micro-organisms of the sewage treatments systems) must be 
reported in section 7 of the CSR on the basis of the information available in the technical 
dossier under the relevant IUCLID endpoint study record. The result of the assessment, once 
finalised, should also be reported under the relevant endpoint summaries in IUCLID as well as 
the calculated PNECs values. In addition to information on potential effects on the 
environment, the registrant has also to document the environmental fate (e.g. degradation, 
bioaccumulation) of the substance under section 4 of the CSR.  

5.3.1.1.4 PBT/ vPvB assessment  

The objective of the PBT/vPvB assessment is to determine if the substance fulfils the criteria 
given in Annex XIII and if so, to characterise the potential emissions of the substance.  

Guidance on how to perform a PBT/vPvB assessment is available in Chapter R.11: PBT/vPvB 
assessment of the Guidance on information requirements and chemical safety assessment 
(http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment). 

Relevant information regarding the persistent, bioaccumulative and toxic (PBT) properties of 
the substance should be already available in the CSR under respectively sections 4 for 
Persistence and Bioaccumulation and 5 and 7 for Toxicity. The registrant should then be 
consistent with what is written under these sections when performing the PBT/vPvB 
assessment. In addition further information, like monitoring data might also be useful. The 
conclusion of the PBT, vPvB assessment should be reported in section 8 of the CSR. If at the 
end of the assessment the substance is assessed to be PBT/vPvB, an emission characterisation 
must be performed and reported as well under section 8 of the CSR25. 

5.3.1.2 Exposure assessment including risk characterisation 

When the result of the hazard assessments indicates that the substance fulfils the criteria for 
any of the hazard classes or categories set out in Article 14(4) or is assessed to be a PBT or 
vPvB in accordance with the criteria in Annex XIII the registrant needs to perform an exposure 
assessment. The exposure assessment must address all the hazards identified in the 
previous steps.  

For an overview on how the scope of exposure assessment can be determined, please refer to 
chapter D.2.3 of the Guidance on information requirements and chemical safety assessment, 
available at: http://echa.europa.eu/guidance-documents/guidance-on-information-
requirements-and-chemical-safety-assessment. 

The exposure assessment consists of determining quantitatively or qualitatively the 
dose/concentrations of the substance to which humans and the environmental are or may be 

25 IUCLID has been adapted (from version 5.4 onwards) to include a section to report the outcome of the 
PBT assessment. 

 
 
 
 
 
 
                                           
 
 
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exposed. The assessment must consider all stages of the lifecycle of the substance resulting 
from the manufacture and identified uses.  

The exposure assessment includes two steps: 

1)  Generation of exposure scenario(s) 

2)  Exposure estimation 

An exposure scenario (ES) is a set of conditions that describe how a substance is 
manufactured or used during its life-cycle and how the manufacturer or importer or 
downstream user controls or recommends controlling exposure of humans and the 
environment. It must include the appropriate risk management measures and operational 
conditions that, when properly implemented, ensure that the risks from the uses of the 
substance are controlled.  

These exposure scenarios are the output of the iterative CSA. The exposure assessment has to 
be reported in section 9 of the CSR. 

For more guidance on how to carry out an exposure assessment please consult the Guidance 
on information requirements and chemical safety assessment, Part D and the following 
Chapters: 

–  R.14: Occupational exposure assessment 

–  R.15: Consumers exposure assessment 

–  R.16: Environmental exposure assessment 

–  R.18: Exposure scenario building and environmental release estimation for the waste 

life stage.  

All the guidance documents listed above are available at http://echa.europa.eu/guidance-
documents/guidance-on-information-requirements-and-chemical-safety-assessment.  

The risk characterisation is the final step in the chemical safety assessment where it should 
be determined whether risks arising from manufacture/import and uses of the substance are 
controlled. The registrant must compare the no-effect levels (DNELs) and the predicted no-
effect concentrations (PNECs) with the calculated exposure concentrations to human and the 
environment respectively. Where no DNEL or PNEC is available for an identified toxicological or 
ecotoxicological hazard, a qualitative or semi-quantitative risk characterisation is required.  

The risk characterisation consists also of the assessment of the likelihood and severity of an 
event occurring due to physico-chemical properties of the substance and a qualitative or 
quantitative estimation/description on the uncertainties related to the risk assessment.  

The risk characterisation must be carried out for each exposure scenario for both the human 
health and the environment and the results and discussion reported in section 9 and 10 of the 
CSR. As the purpose is to prove that the risks are controlled it is expected that the results of 
the risk characterisation should not indicate a risk. 

5.3.2 Chesar tool  

Chesar stands for Chemical safety assessment and reporting tool. The tool has been 
developed by ECHA to help registrants perform a CSA, generate a CSR and ESs for 
communication (to be annexed to the safety data sheet) in an efficient way. It provides a 

 
 
 
 
 
 
 
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structured workflow for carrying out a standard safety assessment for the different uses of a 
substance. It supports the re-use of assessment elements across substances. The tool also 
helps to structure the information needed for the exposure assessment and risk 
characterisation which will facilitate the generation of a transparent CSR. By using Chesar 
registrants can more easily maintain their CSR and the consistency with their registration 
dossier as the uses assessed in Chesar can be exported to IUCLID together with an extract of 
their related assessment. The tool can be downloaded free of charge from 
https://chesar.echa.europa.eu/. 

To use Chesar, a registrant needs to have sufficient information available on the properties of 
the substance, the uses of the substance, the related tonnages and the conditions under which 
the uses take place. Based on these inputs the tool calculates exposure estimates that are 
compared to the predicted no-effect levels. Workers’ exposure estimations provided by Chesar 
are calculated using the ‘ECETOC TRA worker’ tool (available on http://www.ecetoc.org/tra). 
Environmental exposure estimates provided by Chesar are based on the EUSES 2.1 fate model 
(the EUSES software is available on https://ec.europa.eu/jrc/en/scientific-tool/european-
union-system-evaluation-substances). Chesar also supports the assessments based on other 
exposure estimation tools or measured data. 

Chesar enables re-use of whole assessments or parts of them already carried out by the 
registrant or prepared by industry associations via its data exchange functionality. In 
particular, use maps developed by downstream users associations can be imported in the form 
of a life cycle tree, with or without exposure assessment inputs (see Box 6 below). Such data 
exchange functionalities support efficient CSA processes and cross-industry harmonisation of 
the description of uses and of the safe conditions of use.  

Please note that Chesar is not a mandatory tool to carry out the CSA and generate the CSR. 
More information on different tools used for exposure estimation can be found in Guidance on 
information requirements and chemical safety assessment, Part D, Chapters R.14, R.15 and 
R.16 (http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment). 

5.3.2.1 Assessment workflow supported by Chesar 

Chesar is divided in six major groups of functionalities listed below and called Boxes. All Boxes 
are connected and contribute to the generation of the CSR and/or the ES for attachment as an 
annex to the safety data sheet (SDS). 

Box 1 – Substance management 

When starting the assessment process for a certain substance with Chesar, the assessor will 
usually assume that the hazard assessment (see section 5.3.1.1 of this guidance) has been 
largely finalised. Thus, all the information related to the substance intrinsic properties should 
be available in the endpoint summaries in IUCLID. This information is imported from IUCLID 
into Chesar with the Box 1 functionalities. Based on this information the required scope of 
exposure assessment and the type of risk characterisations (qualitative or quantitative) is 
determined by the tool. 

Box 2 - Report uses  

Chesar provides a life cycle tree structure in which the assessor can report the relevant 
information with regard to the uses of the substance. This includes information relevant from 
both the human health and the environmental perspective, including a tonnage break-down 
into the different uses. Life cycles can be made available by sectors in the form of use maps 
for direct use by registrants. Also a registrant may re-use an existing life cycle for several 
substances. When the assessment has been finalised, the uses reported in Box 2 can be 

 
 
 
 
 
 
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exported to IUCLID (see section 5.2.3). 

Box 3 – Exposure assessment  

89 

In Box 3, the assessor carries out the exposure assessment and derives the corresponding risk 
characterisation. Depending on the substance properties and the uses, it may be sufficient to 
only apply the plugged in exposure estimation tools to demonstrate control of risk. However, 
the assessor may also face the situation that he needs to switch to another method (e.g. using 
other exposure estimation tools or measured data), or to even combine different methods in 
the exposure assessment. For situations where a qualitative risk characterisation is required 
the assessor needs to include in the contributing scenarios26 appropriate conditions of use and 
make a qualitative statement on control of risk, justifying that those conditions of use 
(operational conditions and measures) lead to a sufficiently low level and/or likelihood of 
exposure. Functionalities exist to carry out qualitative risk characterisation for several uses or 
contributing activities in one go. 

Box 4 – Generation of CSR 

The generation of the full CSR is launched from Box 4, including those chapters of the CSR 
(chapter 1 to 8) that are directly populated with information from IUCLID. 

Box 5 – Generation of exposure scenarios for communication 

Box 5 supports the building of exposure scenarios for communication along the supply chain 
(i.e. to be annexed to the SDS). The exposure scenarios for communication are based on the 
exposure scenarios built in the CSR but normally expressed using standard phrases. Principles 
defined in the CSR/ES roadmap27 are implemented (e.g. the generation of a table of content 
for the annex to the SDS composed of structured short titles for all the ESs). 

Box 6 – Library management 

Box 6 includes all functionalities with regard to the Chesar library of elements used for the 
chemical safety assessment and its reporting. The library enables creation, storage, import and 
export of objects that the assessor may need for his assessment. These are for example 
description of conditions of use or exposure assessment inputs that may be used for several 
CSAs. Exposure assessment inputs are usually defined by sector associations and describe the 
standard practice in the sector. They are called Specific Environmental Release Category 
(SPERCs) for the environment28, Specific Consumer Exposure Determinants (SCEDs) for 

26 A contributing scenario (CS) is a set of OC/RMM reflecting safe conditions of use for the environment and 
for a given use for workers/consumers. An exposure scenario contains as default structure one contributing 
scenario  for  the  environment  and  one  contributing  scenario  for  each  contributing  activity  (for 
workers/consumers). For more information about the concept and use of CSs please refer to the Guidance 
on  information  requirements  and  chemical  safety  assessment,  Chapter  R.12:  Use  description 
(http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-
safety-assessment). 

27 http://echa.europa.eu/regulations/reach/registration/information-requirements/chemical-safety-
report/csr-es-roadmap  

28 See Guidance on information requirements and Chemical Safety Assessment, Chapter R.16: 
Environmental exposure assessment  

 
 
 
 
 
                                           
 
 
 
 
 
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consumers29 and Specific Workers Exposure assessment Description (SWEDs) for workers30.  

Use maps developed by sectors will also be available in the library in a future version of 
Chesar. Finally, standard phrases (in particular ESCom phrase catalogue) can be imported in 
the Chesar library for use in the ES for communication. 

Registrants are advised to consult the Chesar user manuals if in need of more detailed 
information on the use of the tool. They are available at http://chesar.echa.europa.eu/. 

29 See Guidance on information requirements and Chemical Safety Assessment, Chapter R.15: Consumer 
exposure estimation  

30 See Guidance on information requirements and Chemical Safety Assessment, Chapter R.14: Occupational 
exposure estimation  

 
 
 
 
 
                                           
 
 
 
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6 OTHER DUTIES OF REGISTRANTS 

6.1 Registrants duty of communication 

91 

In order to prepare his registration dossier it is important that the registrant communicates 
with his downstream users. In particular he will need information about their uses, the 
operational conditions of use and the risk management measures they have already put in 
place. This includes the uses of the direct customers and the uses of the customers’ customers 
that have been identified further down the supply chain. Tentative Exposure Scenarios (ES) 
could be used for the communication with the downstream users in order to refine the ES.  

6.1.1 Provide a safety data sheet (SDS) to customers 

According to Article 31(1) when supplying a substance or a mixture, the supplier must 
provide an SDS formatted according to Annex II of REACH to all the downstream users and 
distributors he supplies to as of 1st June 2007, whenever a substance or a mixture:  

  meets the criteria for classification as hazardous in accordance with the CLP 

Regulation; or 

 

 

it is persistent, bioaccumulative and toxic (PBT) or very persistent and very 
bioaccumulative (vPvB) in accordance with Annex XIII of the REACH Regulation; or 

it is included in the candidate list of substances31 which may be subjected to 
authorisation.  

In addition, Article 31(3) specifies conditions under which an SDS must be supplied on request 
for a mixture which does not meet the criteria for classification as hazardous in accordance 
with the CLP Regulation but which contains: 

  ≥1% (by weight) for non-gaseous mixtures (or ≥0.2% by volume for a gaseous 
mixture) of a substance posing human health or environmental hazards; or  

 

for non-gaseous mixtures, ≥0.1% (by weight) of a PBT or a vPvB substance in 
accordance with Annex XIII or has been included in the candidate list of substances 
which may be subjected to authorisation; or 

 

a substance for which there are Community workplace limits. 

It is therefore highly recommended that each supplier compiles an SDS for those mixtures, in 
order to have it available.  

When supplying a substance on its own, the SDS has to be prepared for the substance itself. 
When supplying a substance in a mixture, the SDS has to be prepared for the mixture.  

The SDS need not be supplied where substances or mixtures that are hazardous in accordance 
with the CLP Regulation, offered or sold to the general public, are provided with sufficient 
information (e.g. by labelling or with product inserts) to enable users to take the necessary 
measures as regards the protection of human health, safety and the environment, unless this 
is requested by a downstream user or a distributor. For further information on requirements 
for safety data sheets please refer to the Guidance on the compilation of the safety data sheets 

31 Substances may be identified as Substances of Very High Concern (SVHC) pursuant to Article 59 of the 
REACH Regulation based on a proposal prepared by a Member State or a proposal prepared by ECHA on 
request of the Commission. ECHA includes these substances in the so called ‘Candidate List’ of 
substances for possible inclusion in the authorisation list (Annex XIV of the REACH Regulation) following a 
unanimous agreement of ECHA’s Member State Committee, or a Commission decision if a unanimous 
agreement is not reached. The list is available at: http://echa.europa.eu/web/guest/candidate-list-table.  

 
 
 
 
 
                                           
 
 
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(http://echa.europa.eu/guidance-documents/guidance-on-reach). 

Where an exposure assessment has been carried out, the final ESs developed for the identified 
uses as part of the CSA have to be communicated to the registrant’s customers as an annex to 
the SDS, as this provides instructions on risk management measures that should be in place in 
order to ensure control of risks. This also applies, if the registrant having carried out the CSA 
supplies the substance in a mixture.  

The registrant must ensure that the information in the CSR and in the main body of the safety 
data sheet is consistent with the exposure scenarios annex.  

It is the responsibility of the supplier to keep the SDS updated. 

Please, note that from 1 June 2015 both substances and mixtures must be classified, 
labelled and packaged according to CLP only32. This classification must be provided in the 
SDS for substances and mixtures. There is no longer a requirement to provide either DSD33 
classifications of substances themselves or of component substances in mixtures or the DPD34 
classifications for mixtures in the SDS. Only the corresponding information according to CLP 
need be provided.  

Further information is available in the Guidance on the compilation of safety data sheets. 

Legal reference: Article 31, Annex II 

6.1.2 Provide other information to customers  

When supplying a substance or a mixture for which an SDS is not required (see section 
above), the supplier still has to provide to all downstream users and distributors he supplies 
the following information: 

 

 

if the substance is subject to authorisation35 and details of any authorisation granted or 
denied in this supply chain; 
the details of any restriction36 imposed; 

32 In the situation where a mixture was already classified, labelled and packaged according  the DPD rules 
and placed on the market before 1 June 2015, the manufacturer, importer, downstream user or distributor 
may postpone its re-labelling and re-packaging to comply with the CLP rules until 1 June 2017. This means 
that the mixture can be sold further in the supply chain with the DPD label until 1 June 2017 (see Article 
61 (4) of CLP). The mixtures prepared before 1 June 2015 and stored in a formulator’s warehouse after 1 
June  2015  can  also  benefit  from  this  arrangement  provided  they  are  already  labelled  and  packaged 
according to the DPD rules. 

33 Dangerous Substances Directive (67/548/EEC) 

34 Dangerous Preparations Directive (1999/45/EC) 

35 For further information on the authorisation process, please refer to the Guidance on the preparation of 
an application for authorisation (http://echa.europa.eu/guidance-documents/guidance-on-reach ) 

36 For further information on the restriction process please refer to the Guidance for the preparation of an 
Annex XV dossier for restriction (http://echa.europa.eu/guidance-documents/guidance-on-reach). It is 
also recommended to view the ‘Restriction’ section of the ECHA website at: 
http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/restriction   

 
 
 
 
 
 
                                           
 
 
 
 
 
 
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 

 

any available and relevant information about the substance that is necessary to enable 
appropriate risk management; 

the registration number if available for any substances for which information is 
communicated as outlined above. 

This information must be communicated at the latest at the time of the first delivery of the 
substance on its own or in a mixture after 1 June 2007. 

Legal reference: Article 32 

6.1.3 Include identified uses in the dossier  

According to Article 37(2), a downstream user may intend to make his use known to the 
supplier. The supplier may be a distributor, a downstream user but also a registrant, i.e. 
manufacturer/importer who has registered the substance. In such case, the registrant needs to 
prepare a new or update the existing CSR to include relevant ES covering the communicated 
use. In this respect, the registrant has to comply within specified timelines, as indicated in 
Article 37(3).  

For registered substances the registrant has to comply at least 1 month before the next 
supply, or within 1 month of the request, whichever is later.  

For phase-in substance for which the last registration deadline still applies, the registrant 
has to comply, provided the request was made a minimum of 12 months before this deadline 
(i.e. before 1 June 2017).  

For more details about the communication between the registrant and downstream user please 
refer to the Guidance for downstream users available at http://echa.europa.eu/guidance-
documents/guidance-on-reach.  

Legal reference: Article 37  

6.2 Classification and labelling notification 

If the substance is subject to registration, but has not yet been registered, or if the substance 
is within the scope of the CLP Regulation, meets the criteria for classification as hazardous and 
is placed on the market either on its own or contained in a hazardous mixture above specified 
concentration limits, the registrant must notify to ECHA the information related to its 
classification and labelling. This has to be done within one month after placing the substance 
on the market.  

For registered substances the classification and labelling is reported in the registration dossier 
and no separate notification is required.  

The obligation to classify and label a substance according to the CLP Regulation applies from 
1 December 201037. This means that in cases where a registration was submitted earlier than 
1 December 2010, the registration dossier might still contain only the classification and 
labelling information according to DSD. In this case the registrant needs to update his 

37  For  more  information  on  CLP  transitional  provisions  for  classification,  labelling  and  packaging  please 
consult  Guidance  on  labelling  and  packaging  in  accordance  with  Regulation  (EC)  No  1272/2008 
(http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp). 

 
 
 
 
 
 
 
                                           
 
 
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registration dossier without undue delay. Further information on how to update a registration 
dossier is provided in section 7 of this guidance.  

The classification and labelling notification can be prepared using any of the following tools: 

 

IUCLID: a classification and notification dossier can be created in IUCLID, in a similar 
way to a registration dossier. This is the only option if confidentiality of the IUPAC name 
of the substance is to be claimed. 

  Online: the information can be entered manually in REACH-IT. This can be the preferred 

option if the notifier is not currently using IUCLID. 

Submission of the classification and labelling notification must be done electronically via the 
REACH-IT portal on the ECHA website (https://reach-it.echa.europa.eu/). 

ECHA has compiled all the information submitted on classification and labelling and established 
a C&L Inventory as required by the CLP Regulation. The Inventory is publicly accessible 
through the ECHA website (http://echa.europa.eu/web/guest/information-on-chemicals/cl-
inventory-database) and allows free access to most of the information provided, in particular 
to the classification and labelling of the substance.  

Access to part of the information is however restricted to notifiers and registrants who have 
submitted information on the same substance. If the classifications submitted for the same 
substance by different registrants or notifiers differ, the registrants and notifiers are required 
to make every effort to come to an agreed classification, and update their 
registrations/notifications as appropriate. 

Additional information is provided in the Introductory Guidance on the CLP Regulation and the 
Guidance on the application of the CLP criteria (both available at: 
http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp).  

For technical instruction please consult ECHA manual ‘How to prepare a classification and 
labelling notification’ available at http://echa.europa.eu/manuals. It is also advised to view the 
‘Notification to the C&L Inventory’ section on the ECHA website 
(http://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory). 

Legal reference: Article 40 and 41 of the CLP Regulation 

 
 
 
 
 
 
 
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7 When and how to update a registration 

Aim:  

The aim of this chapter is to explain when and how to update a registration. It 
explains all reasons why the registrant should update the registration on his own 
initiative and when the authorities can request the registrant to update the 
registration dossier. It also describes what the updating duties for substances 
regarded as registered are.  

If in need of updating his registration information the reader is advised to consult the ECHA 
manual ‘How to prepare registration and PPORD dossiers’ accessible at: 
http://echa.europa.eu/manuals. This document is also available via the help system built into 
IUCLID. 

Structure: The structure of this chapter is as follows: 

7.1 Duty to keep information up to date 

The information submitted to ECHA will have to be kept up to date. It is the responsibility of 
the registrant to update his registration information when needed. If the information to be 
updated is part of jointly submitted information, it will be the lead registrant who will have to 
update the registration on behalf of the members of the joint submission.  

In order to update his registration information, the registrant will have to update his IUCLID 
dossier and submit it to ECHA through REACH-IT. Where the update relates exclusively to 
administrative data such as the identity of the registrant or the composition of the group of 
registrants in a joint submission, however, the updated information will be directly reported in 
REACH-IT. No update of the IUCLID dossier is required in this case. 

 WHEN AND HOW TO UPDATE A REGISTRATIONUPDATE FOR SUBSTANCES REGARDED AS BEING REGISTEREDSection 7.4DUTY TO KEEP INFORMATION UP-TO-DATESection 7.1UPDATE ON THE REGISTRANT'S OWN INITIATIVESection 7.2UPDATE AS A CONSEQUENCE OF AUTHORITIES’ DECISIONSSection 7.3 
 
 
 
 
 
 
 
 
 
 
 
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There are basically two types of situations where a registrant needs to update the information 
concerning his registration: 

1.  Update on the registrant's own initiative 

Registrants are required to report to ECHA without undue delay any new relevant 
available information (e.g. new tonnage band, new uses) concerning their registration 
(Article 22 (1)). 

2.  Update as a consequence of a decision made by ECHA  or the Commission  

The registrant has to update his registration as a consequence of an ECHA or a 
Commission decision under the evaluation38 procedure but also, when relevant, 
following any decision made in accordance with the authorisation and the restriction 
processes. These updates have to be performed within the deadline specified by 
ECHA/the Commission in the decision (Article 22(2)). 

For substances regarded as registered because a notification according to Directive 
67/548/EEC has been submitted, registrants need to submit updates of their dossier when any 
of the situations mentioned above occurs, including updates following decisions taken 
according to Directive 67/548/EEC and now regarded as ECHA decisions (Article 135). 
However, the update does not have to meet the full information requirements under REACH 
corresponding to the respective tonnage band, unless the quantity manufactured/ imported of 
the notified substance by the registrant reaches the next tonnage threshold.  

There is no requirement to update a registration dossier for substances in plant protection and 
biocidal products (Article 16(2)).  

The next sections explain in further detail the different situations a registrant may encounter 
as a consequence of which an update of his registration dossier may be required. 

Note that an update will in certain cases be subject to the payment of a fee in accordance with 
the Commission Regulation (EC) No 340/2008, as amended (see section 9.2). 

Legal references: Article 22, Article 20 (2), Article 20 (6), Article 16 (2), Article 135  

7.2 Required update on the registrant's own initiative 

A registrant is responsible on his own initiative for updating his registration information without 
undue delay. The following cases are identified (Article 22(1)):  

a)  Any change in his status, such as being a manufacturer, an importer or a producer 

of articles, or in his identity, such as his name or address 

The registrant must inform ECHA of any change in his identity and contact details. These 
changes can be made directly in REACH-IT without submitting an update of the 
registration dossier.  

Further duties may arise in cases where a change in identity involves a change in the 

38 For more information please consult ECHA Evaluation webpages accessible directly via the following 
links: http://echa.europa.eu/web/guest/regulations/reach/evaluation and 
http://echa.europa.eu/web/guest/about-us/the-way-we-work/procedures-and-policies/public-
procedures 

 
 
 
 
 
 
                                           
 
 
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legal personality of the company. This might be the case when a merger, takeover or 
split takes place or in case a company sells its assets related to a registration. It also 
applies to the appointment of a new only representative by a non-EU manufacturer as a 
replacement for a previous one. 

As a general rule, a registration may be transferred from one legal entity to another legal 
entity following a change of legal personality. It is important to note that one registration 
cannot be owned by more than one legal entity. 

In the case of a merger or takeover where the individual legal entities have previously 
registered the same substance, attention has to be paid to the total tonnage of the 
manufactured/imported substance after the merger or takeover. If the total tonnage 
reaches a higher tonnage band, then the registration dossier has to be updated 
accordingly. 

Detailed information on how to report changes in the identity of legal entities can be 
found in Practical guide 8: ‘How to report changes in identity of legal entities’ 
(http://echa.europa.eu/practical-guides). Additionally, any change in the role of the 
registrant regarding the registered substance (e.g. a manufacturer becoming an 
importer) will have to be reported to ECHA through an update of the registration dossier. 

b)  Any change in the composition of the substance  

  If the composition of the substance changes, e.g. due to a change of process, this should 

be reported to ECHA by resubmitting the updated registration dossier. It is important 
that the registrant evaluates whether the change in the composition of its substance has 
some influence on its intrinsic properties. Further guidance on when a change in, for 
example, the degree of purity would trigger an update is available in the Guidance for 
identification and naming of substances under REACH and CLP 
(http://echa.europa.eu/guidance-documents/guidance-on-reach). 

c)  Changes in the annual or total quantities manufactured or imported by the 

registrant or in the quantities of substances present in articles produced or 
imported by the registrant, if these result in a change of tonnage band, 
including cessation of manufacture or import 

After a registration dossier has been submitted, the tonnage should be always calculated 
based on the annual manufacture or import (i.e. the tonnes manufactured and/or 
imported in a calendar year). This rule applies to all substances.  

As soon as the volume of a registered substance reaches a higher tonnage band, the 
information requirements of the registration dossier change, i.e. at 10, at 100 and at 
1000 tonnes per year.  

Before submitting an update of the registration dossier the registrant has to inform ECHA 
of the additional information that he would require to comply with the information 
requirements for the new tonnage level (Article 12(2)). This is achieved by submitting an 
inquiry dossier to ECHA (see section 4.4 of this guidance).  

If a registrant has ceased the manufacture or import of the substance, or the production 
or import of an article, he needs to inform ECHA of this fact with the consequence that 
the registered volume in his registration, if appropriate, must be put to zero (Article 
50(2)). He must keep the relevant information for 10 years after last manufacture or 
import and make it available on request (Article 36(1)). In the case where he restarts the 
manufacture or import of the substance or he restarts the production or import of the 
article he has to notify ECHA accordingly.  

 
 
 
 
 
 
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d)  New  identified  uses  and  new  uses  advised  against  for  which  the  substance  is 

manufactured or imported 

If  a  downstream  user  informs  the  registrant  about  a  new  use  of  the  substance,  not 
identified in the registration dossier, there might be two situations: 

1. 

If the registrant has registered in a tonnage band starting at 10 tonnes per year 
and therefore is required to prepare a chemical safety report (CSR), he must 
assess the chemical safety for this use, and include that use in his CSR if the 
results of the chemical safety assessment (CSA) indicate that risks to human 
health and the environment from that use are controlled. He will then, where 
relevant, provide the downstream user with a revised safety data sheet (SDS), 
including the new use as well as the exposure scenarios (ES) describing the 
operational conditions for which the substance can be used safely. If on the basis 
of the CSA he is unable to include that new identified use for reasons of human 
health or environmental protection, he must inform without delay ECHA and the 
downstream user(s) in writing with the reason for this decision. The registrant 
must not supply the downstream user(s) with the substance without updating the 
SDS by indicating the use(s) advised against. 

2. 

If the registrant has registered in a tonnage band of less than 10 tonnes per year, 
he has no obligation to perform a CSA. However he may decide to include or not 
the new use(s) in the SDS. 

In both situations the registrant needs to update his registration to take into account the 
new identified use or the new use advised against.  

Note that the registrant may decide not to assess a new use (e.g. because he considers 
the assessment of the use as not technically possible or disproportionately costly) in 
which case he must stop supplying the substance for that use without updating the SDS 
by including the use in the uses advised against. The registrant’s assessment of what is 
technically possible or disproportionally costly should also take into account if the 
information provided by the DU is sufficient to prepare an exposure scenario. In that 
respect in some cases a more intense dialog between the registrant and concerned DU 
might become necessary. 

It can also be the case that the registrant has to take into account a new own use or that 
he himself decides to identify a new use that his downstream user(s) are or may be 
interested in. 

e)  New knowledge of the risks of the substance to human health and/or the 
environment of which the registrant may reasonably be expected to have 
become aware which leads to changes in the SDS or the CSR 

If the registrant becomes aware of information that could lead to other or different risks 
for human health or the environment caused by the substance he manufactures or 
imports, such as monitoring data in the environment or epidemiological studies, he needs 
to take those data into account and evaluate the appropriateness of the risk 
management measures put in place or recommended down the supply chain.  

New information triggering a revision of the chemical safety assessment or the safety 
data sheet could also be an international review such as International Programme on 
Chemical Safety (IPCS) review or an OECD dossier, or any kind of publication dealing 
with the release and exposure or hazard of the substance. Even if the initial registration 
has been completed accurately there will be an on-going need to update the CSA/CSR 
and the SDS as new or additional information on the risks of the substance  becomes 
available that has an impact on  the results of the CSA. 

 
 
 
 
 
 
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f) 

Any change in the classification and labelling of the substance 

In cases where a harmonised classification and labelling has been adopted in accordance 
with Article 37 of the CLP Regulation the registration dossier needs to be updated 
accordingly. Moreover, each registrant also has an obligation to update his registration 
dossier in the light of any other new data relevant to the classification. 

g)  Any update or amendment of the CSR or the Guidance on safe use  

In addition to the reasons mentioned in the previous points, there may be a need to 
update the CSA/CSR due to: 

 

 

 

Innovation in the supply chain. 

New products and applications 

New equipment and processes (conditions of use) at the downstream user 

Moreover, an update of the CSA/CSR may be triggered by an increase of the production 
and/or import volumes. 

h)  The registrant identifies the need to perform a test listed in Annex IX or Annex 

X, in which cases a testing proposal must be developed 

In some cases, even if higher level studies are not required by REACH i.e. due to lower 
tonnage band, they still might be considered as necessary in the opinion of the registrant 
in order to control the risks arising from the manufacture and use(s) of the substance. In 
such a case when the registrant identifies the need to perform a higher-level study listed 
in Annexes IX or X, he will have to submit to ECHA an update of the registration dossier 
including the testing proposal for this test, documentation showing that all non-animal 
methods have been considered and justification for proceeding to an animal study. 

i)  Any change in the access granted to information in the registration 

Any change in confidentiality claims made either by the lead or the members of the joint 
submission will require an update of the registration dossier and a new submission to 
ECHA. 

Please note: 

The registrants should consider their registration dossiers as “living documents” and 
regularly update them whenever new information is available or a need to improve the 
quality of data is identified. Special attention should be paid to the following areas of the 
registration dossier: substance identity, use, exposure information and justifications for 
adaptations to information requirements and for using alternative methods.  

Better quality of information on substances helps ECHA and MSCAs to select and prioritise 
the most hazardous substances for regulatory attention. This may also benefit registrants 
since, with better and more transparent information, their substances may be 
deprioritised from regulatory actions. 

ECHA regularly performs IT screening campaigns on dossiers to highlight the aspects of 
registrations that can be improved. The response to such campaigns can be spontaneous 
updates of the registrations addressing the highlighted concerns, as well as better quality 
of data in further submissions. For more details on IT screening campaigns please consult 
the ECHA dedicated webpage: http://echa.europa.eu/support/how-to-improve-your-
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7.3 Update as a consequence of an ECHA or a Commission decision 

The registrant may have to update his registration as a consequence of an ECHA or a 
Commission decision under the evaluation procedure or he may have to take into account 
decisions made under the authorisation or restriction processes. This task has to be performed 
within the deadline specified by ECHA/ the Commission in their decision.  

a)  Evaluation procedures 

There are two types of evaluation procedures, a substance evaluation and a dossier evaluation. 
The latter is further subdivided into an examination of any testing proposal and a compliance 
check of the registration dossier. The different decisions taken under the evaluation process 
that can have an impact on the updating obligations of registrants will be analysed separately 
below. 

In the examination of testing proposals, all proposals for tests specified in Annexes IX and X 
submitted as part of registrations have to be examined by ECHA within certain timelines. The 
examination of a testing proposal by ECHA could trigger the need for the registrant to update 
his registration dossier when a decision requesting one or several tests to be carried out is 
taken by ECHA or the Commission.  

All tests carried out based on a decision of ECHA on a testing proposal have to be submitted in 
the form of a study summary, or a robust study summary (if required by Annex I), in an 
updated registration dossier. Moreover, depending on the outcome of the new test conducted, 
the registrant may have to update the hazard profile of the substance and/or the CSR including 
the ES. 

In the compliance check, ECHA may examine any registration dossier to check whether the 
registrant has met his obligations and the registration dossier complies with the provisions of 
REACH.  

For details on compliance check please consult the ECHA Evaluation webpages accessible 
directly via the following links: http://echa.europa.eu/web/guest/regulations/reach/evaluation 
and http://echa.europa.eu/web/guest/about-us/the-way-we-work/procedures-and-
policies/public-procedures). 

As the outcome of the compliance check ECHA or the Commission can require the registrant to 
submit, within a given time limit, any information needed to bring this registration into 
compliance with the relevant information requirements. In response the registrant should 
update his registration dossier, including the CSR, with any additional information requested. 

Substance evaluation aims to clarify a concern that a given substance constitutes a risk to 
human health or the environment. 

Substance evaluation provides a mechanism for authorities to require industry to obtain and 
submit additional information in case of suspicion of a risk to human health or the 
environment. When the Member State Competent Authority considers that additional 
information is necessary for clarifying the suspicion, it will prepare a draft decision stating the 
reasons for this request. 

When a decision is taken by ECHA or the Commission under the substance evaluation process, 
the registrant has to provide the requested information by way of submitting an update of his 
registration dossier to ECHA by the deadline set. Please note that substance evaluation 
addresses all registrations of a substance (the lead registrant’s dossier and the dossiers of the 
members). This means that that the updates of both the lead and/or member registration 
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101 

If the use of a substance is authorised through a Commission decision, the conditions for the 
authorisation should be reflected in the registration dossier. As a consequence, the registration 
dossier will have to be updated if it does not take into account these conditions already. 

For a substance subjected to restriction, the registration dossier should reflect the relevant 
uses that are exempted from restriction or the relevant conditions for use that are included in 
the restriction. 

7.4 Update of registration dossier for substances regarded as being 
registered under REACH 

a) Substances notified in accordance with Directive 67/548/EEC 

A distinction must be made between updates of notification dossiers made due to a change of 
tonnage, updates to become part of a joint submission and updates of notification dossiers for 
other reasons. 

Tonnage update 

Under the REACH Regulation, substances notified in accordance with Directive 67/548/EEC 
(NONS) are regarded as registered by the manufacturer or importer who submitted the 
notification. Nevertheless, the REACH registration dossier for those substances which are 
regarded as registered should be updated without undue delay when the 
manufactured/imported quantity reaches the next tonnage threshold i.e. 10, 100 or 1000 
tonnes per year. Moreover, an update is required for notified substances notified in the 
tonnage range below one tonne under Directive 67/548/EEC, when reaching the one tonne 
threshold under REACH. The update should not only contain the information required by 
REACH which corresponds to that higher tonnage threshold, but also any information which 
corresponds to lower tonnage thresholds but which was not yet submitted. 

However, in order to avoid unnecessary testing on vertebrate animals, the registrant first has 
to inform ECHA of the additional information that he would require to comply with the 
information requirements for the new tonnage level by submitting an inquiry dossier as soon 
as possible (see section 3.4) (Article 12(2)). After submitting an inquiry dossier, the registrant 
receives a communication from ECHA which includes the link to the relevant Co-Registrants 
page in REACH-IT. In this way ECHA informs the registrant of the names and addresses of the 
previous registrants. For substances registered less than 12 years previously ECHA will inform 
of the relevant summaries or robust study summaries already submitted by the registrants. 
For substances registered at least 12 years previously ECHA will attach to the communication 
any relevant study summaries already submitted by them in order to share existing data and 
to ensure that studies on vertebrate animals are not unnecessarily repeated. When making a 
tonnage update, registrants of notified substances will also have to comply with all other 
REACH requirements and provisions. For example, when submitting their update they will have 
to prepare a CSR and to prepare an ES to attach to their SDS when relevant.  

Update to become part of a joint submission 

Given that the joint submission obligation did not exist prior to REACH, notifications under 
Directive 67/548/EEC are regarded as registrations under REACH that are outside a joint 
submission, and therefore they are not linked to any existing joint submission. However, when 
the same substance needs to be registered by another actor, a joint submission needs to be 
established with the NONS notifier according to Article 11 or 19 of REACH, which apply to 
notified substances too. 

In such cases, the previous notifier might decide to become the lead registrant of the joint 

 
 
 
 
 
 
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submission. This means that he will submit the joint information with the agreement of the 
other registrants. In this situation, similar to the case of tonnage band update, the dossier has 
to be fully in line with REACH requirements in the IUCLID format specified by ECHA. 

Alternatively, the previous notifier might decide to join the joint submission as a member 
registrant. As for any other registrant, the possibility of opting-out for some or all of the 
information applies, provided that vertebrate data are shared. 

Other updates 

All the updates described under sections 7.2 and 7.3 above must also be submitted if and 
when relevant. This includes updates following a decision made according to Directive 
67/548/EEC, which is now regarded as an ECHA decision under REACH (Article 135).  

For such updates, it is strongly encouraged to provide all information according to REACH. 
However, derogation statements may be used stating that for such an update additional 
REACH data is not necessary. 

In these cases the notifier does not normally need to submit a CSR, or to provide an ES and an 
SDS for uses and information covered in the original notification, as the risks have been 
assessed and the necessary measures taken based on the risk assessment of the relevant 
Member State Competent Authority.  

The registrant is only required to submit a CSR in the following cases:  

 

 

 

a CSR must be submitted only for the new identified uses, though submitting a CSR for 
all identified uses is encouraged; 

a CSR must be submitted when new knowledge arises with regard to the risks of the 
substance to human health and/or the environment which would lead to changes in the 
SDS; 

a CSR must be submitted because of the change in the classification and labelling of the 
substance if this leads to changes in the SDS resulting in a stricter classification. 

However, the notifier is strongly encouraged to submit a CSR as defined under REACH in order 
i) to confirm that the ESs developed by the regulatory authority are still appropriate and ii) to 
describe risk management measures (and subsequent advice to downstream users) at the 
earliest opportunity. 

The notifier must, where this is required under REACH, submit robust study summaries for any 
new study such as the studies requested following decisions made according to Directive 
67/548/EEC. For data which was originally submitted as part of the notification and which have 
already been evaluated by the Member State Competent Authority, the robust study 
summaries need not to be prepared, unless required due to the generation of the CSR. 

b) Substances in Biocidal products and in Plant Protection Products 

For uses of substances regarded as registered under the Biocidal Product Regulation or Plant 
Protection Products Regulation (see sections 2.2.4.1 and 2.2.4.2) the updating requirements 
do not apply (Article 16(2)). 

 
 
 
 
 
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103 

Where a registrant or potential registrant disagrees with certain decisions issued by ECHA, he 
can appeal against the decision to ECHA’s Board of Appeal. 

An appeal may be brought against ECHA’s decisions in the following cases: 

1)  PPORD exemptions 

a.  decision of ECHA to impose additional conditions on the exemption to ensure 
that the substance is handled and disposed of in a controlled way and is not 
made available to the public (Article 9(4)); 

b.  decision of ECHA on the extension of the exemption period (Article 9(7)). 

2)  Completeness check - decision of ECHA to reject a registration if the registrant failed 
to complete his registration within the deadline set by ECHA (Article 20(2)) (see 
section 10.4 of this guidance). 

3)  Data-sharing  

a.  decision of ECHA to give permission to a potential registrant of a non-phase-in 
substance to refer to the information submitted by a previous registrant in his 
registration dossier (Article 27(6)); 

b.  decision of ECHA on data-sharing for phase-in substances (Article 30 (3)). 

4)  Evaluation - decision of ECHA requesting the submission of additional information 

under the evaluation procedures (Articles 51 (3), 51(6) and 52(2)). 

An appeal has suspensive effect. All appeals must contain a statement of the grounds on which 
the appeal is based.  

Any natural or legal person may appeal against a decision addressed to that person, or against 
a decision which although addressed to another person is of direct and individual concern to 
the person making the appeal. 

The appeal must be filed in writing to ECHA within three months of the notification of the 
decision to the person concerned, or in the absence of notification, within three months of the 
day on which the decision became known to him. For fees on the appeal, please consult 
Commission Regulation (EC) No 340/2008 of 16 April 2008, as amended on the fees and 
charges payable to the European Chemicals Agency. 

If, after consultation with the Chairman of the Board of Appeal, the Executive Director of ECHA 
considers the appeal to be admissible and well-founded he may rectify the decision within 30 
days of the appeal being filed. Otherwise the Chairman of the Board of Appeal examines if the 
appeal is admissible within 30 days of the appeal being filed. If yes, he remits the appeal to 
the Board of Appeal for examination of the grounds. The Board of Appeal may exercise any 
power which lies within the competence of ECHA or remit the case to the competent body of 
ECHA for further action. 

If the party concerned still disagrees with the result, an action may be brought before the 
General Court or the Court of Justice contesting the decision taken by the Board of Appeal. 

Similarly, where no right of appeal lies before the Board, action against an ECHA decision may 
be brought before the General Court or the Court of Justice. 

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9 Fees 

Title IX of the REACH Regulation describes the general principles regarding the payment of 
fees and charges in relation to REACH. More specifically, the Fee Regulation (Commission 
Regulation (EC) No 340/2008 of 16 April 2008, as amended) stipulates the payment terms for 
ECHA’s invoices. The amount and deadlines for payment depend on the type of submission 
under consideration.  

Legal reference: Article 74 

9.1 Applicable fees and calculation of fees 

A registrant is obliged to pay a fee for his registration as a contribution to covering the costs 
imposed on ECHA and the Member States Competent Authorities. In order for ECHA to be able 
to establish an invoice, the registrant is asked to submit his billing information on-line either 
before the first registration is made or during the first registration process. 

The system to be applied for the computation of the applicable fee must be the following: 

Once the registrant has submitted a registration dossier and it has been accepted for 
processing (see section 10.1), the REACH-IT system automatically computes the applicable fee 
for the dossier submitted.  

When calculating the fee, the following points will be taken into consideration: 

 

 

 

 

the scale of fees fixed for the different tonnage bands; 

an SME (small and medium-sized enterprise) reduction if applicable, for this purpose 
the registrant will be asked to make a declaration of his status in REACH-IT; 

a reduction for joint submission, if applicable; 

the items flagged as confidential (see section 4.4 of this guidance on access to 
information and confidential data). 

Where a registration is submitted by an only representative, the size of the ‘non-EU 
manufacturer’ is decisive for the fee and must be entered into the relevant field in REACH-IT, 
not the size of the only representative. 

As soon as possible after the registration dossier has been accepted for processing, normally in 
the course of the next working day, ECHA will issue an invoice for the registration dossier(s) 
submitted. Upon receipt of the invoice, the registrant needs to carry out the payment as 
indicated in the invoice.  

ECHA checks whether companies that claimed to be SMEs and thus paid reduced fees for their 
registrations are indeed SMEs. Where such a verification results in a finding that the registrant 
was not a SME and hence not entitled to the fee reduction, he will be liable to pay the 
difference between the reduced fee and the full registration fee as well as an administrative 
charge.  

The criteria to be applied for the definition of an SME are established in Commission 
Recommendation 2003/361/EC. The reader is advised to consult the ECHA website 
(http://echa.europa.eu/web/guest/support/small-and-medium-sized-enterprises-smes) if in 
need of more specific information on the SME status. 

 
 
 
 
 
 
 
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9.2 Fee for updating of a registration dossier 

An update must be accompanied by the relevant part of the fee. As with a first time 
registration, the registrant has to submit the updated dossier through REACH-IT and the 
system will automatically compute the applicable fee for the update and send the relevant 
invoice to the registrant. 

Note that in practice an update will only trigger a fee in case there is a change to a higher 
tonnage band or an increase in the number of items flagged as confidential. 

 
 
 
 
 
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10 Duties of ECHA 

Aim:  

The aim of this chapter is to explain, for reasons of transparency, what the 
duties of ECHA are after the submission of the registration dossier. It explains 
what kind of initial verifications are required, how the submission number and 
date are assigned, what the completeness check is, what the registration 
number is and how and when the relevant Member State Competent Authorities 
are informed about registrations 

Structure:   The structure of this chapter is as follows: 

10.1 Initial verification 

All dossiers submitted to ECHA undergo a number of initial technical and administrative checks 
in order to ensure that they can be handled properly and that the required regulatory 
processes can be successfully carried out. The different initial checks are described below in 
the chronological order in which they take place. 

10.1.1 Virus Scan  

The submitted dossier is scanned for known viruses. Only virus-free dossier files will proceed 
to the next step. 

DUTIES OF ECHAINITIAL VERIFICATIONSection 10.1PROCEDURE IN CASE  OF A REGISTRATION UPDATESection 10.7 ASSIGNING SUBMISSION NUMBERSection 10.2COMPLETENESS CHECK AND INVOICINGSection 10.3REJECTION OF THE REGISTRATION DOSSIERSection 10.4ASSIGNING A REGISTRATION NUMBERSection 10.5INFORMING THE MEMBER STATE COMPETENT AUTHORITYSection 10.6 
 
 
 
 
 
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The file format validation checks that the submitted dossier file is of the appropriate format (.i6z 
file format) and is compliant with the XML schema used by IUCLID.  

10.1.3 Internal structure validation  

This verification ensures that the submitted dossier file does not contain attachments for which 
the format is not supported or recognised by REACH-IT. 

10.1.4 Business rule validation 

The business rules are a set of pre-requisites that must be fulfilled before ECHA can establish 
that the dossier can be accepted for processing. They are checked using the REACH-IT 
software.  

A dossier can be accepted for processing only if all of the relevant business rules are satisfied. 
After that, the submission can proceed to the next steps (technical completeness check and 
invoicing). If the dossier submission fails at the business rule level, the dossier cannot be 
accepted for processing and a new submission is required before any regulatory processes 
can be initiated.  

10.2 Assigning submission number 

The REACH-IT system automatically assigns a submission number and submission date to 
any submission which is accepted for processing after successful business rule validation. The 
REACH-IT system without delay communicates this submission number and date to the 
concerned registrant. The submission number is to be used for all correspondence regarding 
the relevant dossier type (e.g. pre-registration, registration or PPORD notification). In the case 
of registration (including registration of on-site isolated intermediates and transported isolated 
intermediates) and PPORD notification the submission number is to be used until the 
registration/notification is deemed to be complete (Article 20 (1)). It will then be replaced by 
the registration/notification number. 

10.3 Completeness check and invoicing procedures 

The completeness check process comprises two distinct sub-processes:  

  Technical completeness check  

 

Financial completeness check 

The technical completeness check is performed for the following dossier types: registration 
(including intermediates), updated registration and PPORD notification. The financial 
completeness check is performed for those dossier types for which a fee is required. 

10.3.1 Technical completeness check  

This process is aimed at checking the technical completeness of the dossier. The main purpose 
of this check is to make sure that all information as required in REACH has been provided.  

After being accepted for processing, each received dossier is screened for technical 
completeness using a specially created algorithm that is specific for each dossier type 
depending on the legal requirements. The system checks if all required fields are filled and all 
testing proposals, derogation statements, waving statements etc. are included. In the case of 
a negative result, ECHA will verify the outcome of the completeness check to make sure that 
the decision is fully correct.  

 
 
 
 
 
 
 
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Registrants are strongly encouraged to verify the technical completeness of their dossiers 
before submission with the help of the  IUCLID application called “Validation Assistant plugin”. 
This tool offers registrants the possibility to check the completeness of the dossier before 
submitting it to ECHA. It is recommended to run the plugin first on the substance dataset and 
then on the final dossier. Using the plugin in both steps is vital to avoid any unnecessary 
failures and potential rejection if the submission is for a requested update.  

The latest version of the plugin can be downloaded from the IUCLID website  

In addition to the algorithms included in the “Validation Assistant”, ECHA will also stop and 
manually verify registration dossiers where manifestly irrelevant data is provided instead of the 
required information. 

It is recommended to consult the ECHA manual ‘How to prepare registration and PPORD 
dossiers’ accessible at: http://echa.europa.eu/manuals. This document is also available via the 
help system built into IUCLID. 

10.3.2 Financial completeness check 

ECHA will monitor the payment of the fee as specified in the invoice. If a registrant fails to pay 
the full amount by the deadline indicated on the invoice, ECHA will set a second reasonable 
deadline. If the registrant fails to meet the second deadline, the registration dossier will be 
rejected. There could be circumstances, such as internal procedures or periods of limited 
service within a company, under which timely payment could be problematic. In that case it is 
recommended to prepare the payment of the fee due before submitting the dossier so that 
ECHA will receive the proof of payment in time before finalising the completeness check after 
submission of the dossier. 

10.3.3 Completeness check procedures 

ECHA will undertake the completeness check of a registration dossier within three weeks of the 
submission date, or within three months of the relevant deadline (see section 2.3.2) as 
regards registrations of pre-registered phase-in substances submitted in the course of the two-
month period immediately preceding that deadline (Article 20(2)). The completeness check 
verifies whether all the required information elements have been submitted and the payment 
of the fee has been received. 

If the registration dossier is incomplete and/or the fee payment is missing, ECHA will inform 
the registrant, before expiry of the given period, as to what further information is required in 
order for the registration to be complete. ECHA will set a reasonable deadline for providing the 
necessary information and /or payment (Article 20(2)).  

If the registration dossier is incomplete, the registrant must complete his registration 
accordingly and submit it once more to ECHA, this time identified as an update, within the 
deadline set. ECHA will confirm the submission date of the further information to the registrant 
and will perform a second completeness check, considering all information submitted in the 
update. Registrants are strongly encouraged to verify the technical completeness of their 
dossiers before submission by using the Validation Assistant plugin. 

A registrant may start or, in the case of a phase-in substance, continue without interruption 
the manufacture or import of a substance or production or import of an article, if there is no 
indication to the contrary from ECHA within three weeks of the submission date or, in the case 
of registrations of phase-in substances submitted within the two-month period before the 
relevant deadline, if there is no indication to the contrary from ECHA within the three months 
of that deadline (Article 21(1)). 

 
 
 
 
 
 
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10.4 Rejection of the registration dossier 

In case the registrant fails to complete his registration within the deadline set, ECHA will reject 
his registration. This decision can be challenged through the appeal procedure. Where a 
registration is rejected, the registration fee will not be reimbursed (Article 20(2)).  

If a manufacturer or importer submits a registration dossier for a pre-registered phase-in 
substance, which is rejected before the expiry of the appropriate registration deadline, it may 
submit a new registration dossier and pay a new fee using the same pre-registration number.  

If a registration dossier for a pre-registered phase-in substance is submitted within the two-
month period before the expiry of the relevant registration deadline, manufacturing or 
importing can continue beyond this deadline if there is no indication to the contrary from ECHA 
within three months of the deadline. 

If the registration of a pre-registered phase-in substance is rejected after the expiry of the 
relevant registration deadline, or if no registration dossier is submitted by the relevant 
registration deadline, the manufacturer or importer will not be allowed to manufacture or 
import this substance in the EU. In order to be allowed to manufacture or import the substance 
again, the manufacturer or importer will need to submit a new registration dossier and pay the 
fee required. Then he may start importing or manufacturing once ECHA has confirmed the 
completeness of the registration, or three weeks after the submission date, if there is no 
indication to the contrary from ECHA.  

Similarly, if the registration dossier for a non-phase-in substance or for a phase-in substance 
which is not pre-registered is rejected, the company will need to submit a new registration 
dossier and pay the required fee in order to be allowed to manufacture or import the 
substance. The import or manufacture can be commenced once ECHA has confirmed that the 
registration is complete, or three weeks after the submission of the dossier, if there is no 
indication to the contrary from ECHA.  

10.5 Assigning a registration number 

Once the registration is complete the REACH-IT system at ECHA automatically assigns a 
registration number to the registrant for the substance concerned and a registration date that 
will be the same as the submission date. ECHA without delay communicates the registration 
number and date to the concerned registrant. From that moment on the registrant must use 
the registration number for the subsequent correspondence regarding registration procedures 
(Articles 20 (3)).  

For a given substance, distinct dossier types may apply. For example, a substance initially 
notified as a PPORD may require the submission of a registration dossier at the end of the 
exemption period if the PPORD leads to a commercial use of the substance. Also, a substance 
for which initially a notification of the classification and labelling was submitted may later lead 
to the submission of a registration dossier. In those cases, the substance will hold an 
identification number of each kind, a PPORD number and a registration number in the first 
above example, and a classification and labelling number and a registration number in the 
second above example. All those numbers are called ‘reference numbers’. The reference 
number is unique for every dossier type, substance and company and is issued only once at 
the end of the initial and successful submission process. 

 
 
 
 
 
 
 
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10.6 Informing the relevant Member State Competent Authority 

Within 30 days of the submission date, ECHA has to notify the competent authority of the 
Member State within which the manufacture takes place or the importer is established that the 
registration has been submitted and that the information is available in the ECHA database 
(Article 20(4)). 

If the manufacturer has production sites in more than one Member State, all relevant Member 
States will be notified. 

ECHA will also notify about any request for further information including deadlines set and 
when any further information submitted by the registrant is available on ECHA database. 

10.7 ECHA procedure in case of a registration update 

New relevant information prepared either on the registrant's own initiative or in response to a 
request by the authorities has to be communicated to ECHA without undue delay. If the 
changes trigger an update of the registration dossier, the updated dossier will undergo upon 
submission a similar process to the initial dossier:  

– 

initial verification,  

–  assignment of a submission number and  

–  completeness check. 

Manufacture or import may continue if there is no indication to the contrary from ECHA within 
three weeks after the updated registration dossier has been accepted for processing (Article 
21(1)). 

ECHA will inform the relevant Member State Competent Authority accordingly (Articles 22(1), 
22(2)). 

 
 
 
 
 
 
 
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Appendix 1. Glossary/List of acronyms 

111 

C&L 

CBI 

Cefic 

Classification and labelling 

Confidential Business Information 

‘Conseil Européen des Fédérations de l'Industrie 
Chimique’ - European Chemical Industry Council 

Chesar 

Chemical Safety Assessment and Reporting tool 

CMR 

CSA 

CSR 

CWG 

DNEL 

DSD 

DPD 

DU 

ECHA 

EEA 

EFTA 

a substance or mixture that is carcinogenic, mutagenic 
or toxic to reproduction 

Chemical safety assessment 

Chemical safety report 

Commission Working Group 

Derived No-Effect Level 

Dangerous Substances Directive (67/548/EEC) 

Dangerous Preparations Directive (1999/45/EC) 

Downstream user 

European Chemicals Agency 

European Economic Area 

European Free Trade Association 

EINECS 

European Inventory of Existing Commercial Chemical 
Substances 

ELINCS 

European List of Notified Chemical Substances 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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ES 

EU 

GHS 

GLP 

IPCS 

IUCLID 

IUPAC 

NGO 

NLP 

OC 

Exposure scenario 

European Union 

Globally Harmonised System for Classification and 
Labelling 

Good Laboratory Practice 

International Programme on Chemical Safety 

International Uniform Chemical Information Database 

International Union of Pure and Applied Chemistry 

Non-Governmental Organisation 

No-Longer Polymer 

Operational conditions 

OECD HPV 

Organisation for Economic Co-operation and 
Development, High Production Volume (chemicals) 

PBT 

PNECs 

PPORD 

QSARs 

REACH 

RIPs  

RMM 

Persistent, Bioaccumulative, Toxic substances 

Predicted No-Effect Concentrations 

Product and Process Orientated Research and 
Development 

Quantitative structure-activity relationships 

Registration, Evaluation, Authorisation and Restriction of 
Chemicals 

REACH Implementation Projects 

Risk Management Measures 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Robust study summary 

113 

a detailed summary of the objectives, methods, results 
and conclusions of a full study report providing sufficient 
information to make an independent assessment of the 
study minimising the need to consult the full study 
report  

SCED 

SDS 

SIEF 

SIP 

SME 

Specific Consumer Exposure Determinants 

safety data sheet 

Substance Information Exchange Forum 

Substance identity profile 

Small and Medium Sized Enterprise 

SPERC 

Specific Environmental Release Category 

Study summary 

SWED 

SVHC 

a summary of the objectives, methods, results and 
conclusions of a full study report providing sufficient 
information to make an assessment of the relevance of 
the study 

Specific Workers Exposure assessment Description 

Substances of Very High Concern 

UVCB substance 

substances of Unknown or Variable Composition, 
Complex reaction products or Biological materials 

vPvB 

vPvB - very Persistent and very Bioaccumulative 
substances 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix 2. Roles and duties of the main actors of REACH 

This appendix provides an overview of the main responsibilities defined by REACH or derived 
from REACH in the context of the registration, evaluation, authorisation and restriction 
processes. Please note that it is not an exhaustive list and should only be used for reference 
purposes. The reader is advised to consult the related guidance document if in need of detailed 
information on a specific process. 

I. Industry 

(1) Manufacturers and importers of substances in quantities of less than 1 tonne per 
year need to: 

 

 

Prepare and supply safety data sheets (SDS) for substances and mixtures (as required 
by Article 31 and Annex II) to downstream users and distributors;  

Prepare and supply information on substances that do not require an SDS (as defined 
by Article 32) to direct customers; 

  Comply with any restrictions on manufacture, placing on the market and use of 

substances and mixtures as set out in Annex XVII; 

  Apply for authorisation for use(s) of substances listed in Annex XIV; 

 

In the case of having relevant data, decide whether to act as data holder in Substance 
Information Exchange Fora (SIEF).  

(2) Manufacturers of substances in quantities of 1 tonne or more per year need to: 

 

 

Pre-register their substances with ECHA if they wish to secure their substances’ phase-
in status;  

In case their substance is a non-phase-in substance, submit an inquiry to ECHA as to 
whether a registration has already been submitted for the same substance;  

  Collect and share existing, and generate and propose to generate new, information on 
properties and use conditions of substances. The vertebrate animal data should be 
shared and should not be duplicated; 

 

 

 

 

Prepare a technical dossier (note that special provisions apply for intermediates); 

Prepare CSA and CSR (for each substance ≥ 10 tonnes per year per manufacturer);  

Prepare CSA and CSR including exposure scenarios and risk characterisation (for each 
substance ≥ 10 tonnes per year per manufacturer, which fulfils the criteria for any of 
the hazard classes or categories set out in Article 14(4) or is assessed to be a PBT or 
vPvB); 

Implement appropriate Risk Management Measures (RMM) for own manufacture and 
use; 

  Submit registration for substances (≥ 1 tonne per year per manufacturer) unless an 

exemption applies; 

  Keep the information submitted in the registration up to date and submit updates to 

ECHA; 

 

Prepare and supply safety data sheets (SDSs) for substances and mixtures (as required 
by Article 31 and Annex II) to downstream users and distributors; 

  Recommend appropriate RMMs in the SDS; 

  Communicate ESs developed in CSA as annex(es) to the SDS (≥ 10 tonnes per year per 

manufacturer); 

 
 
 
 
 
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 

Prepare and supply information on substances that do not require an SDS within the 
scope of Article 32 to downstream users and distributors; 

  Respond to any decision requiring further information as a result of the evaluation 

process;  

  Comply with any restrictions on manufacture, placing on the market and use of 

substances and mixtures as set out in Annex XVII; 

  Apply for authorisation for use(s) of substances listed in Annex XIV. 

(3) Importers of substances and mixtures in quantities of 1 tonne or more per year: 

 

 

Pre-register their substances with ECHA if they wish to secure their substances’ phase-
in status; 

In case their substance is a non-phase-in substance, send an inquiry to ECHA as to 
whether a registration has already been submitted for the same substance;  

  Collect and share existing, and generate and propose to generate new, information on 
properties and use conditions of substances. The vertebrate animal data should be 
shared and should not be duplicated; 

 

 

Prepare a technical dossier (note that special provisions apply for intermediates); 

Prepare CSA and CSR including exposure scenarios and risk characterisation (for each 
substance ≥ 10 tonnes per year per manufacturer, which fulfils the criteria for any of 
the hazard classes or categories set out in Article 14(4) or is assessed to be a PBT or 
vPvB); 

 

Implement appropriate RMMs for own use; 

  Submit registration for substances, on their own or in mixtures (≥ 1 tonne per year per 

importer) unless an exemption applies; 

  Keep the information submitted in the registration up-to-date and submit updates to 

ECHA; 

 

Prepare and supply safety data sheets (SDS) for substances and mixtures (as required 
by Article 31 and Annex II) to downstream users and distributors; 

  Recommend appropriate RMMs in the SDS; 

  Communicate ESs developed in CSA as annex(es) to SDS (≥ 10 tonnes per year per 

importer); 

 

Prepare and supply information on substances that do not require an SDS within the 
scope of Article 32 to downstream users and distributors; 

  Respond to any decision requiring further information as a result of the evaluation 

process; 

  Comply with any restrictions on manufacture, placing on the market and use of 

substances and mixtures as set out in Annex XVII; 

  Apply for authorisation for use(s) of substances listed in Annex XIV.  

(4) Producers of articles: 

 

If the conditions of Article 7(1) are met register substances in articles (tonnage trigger 
> 1 tonne per year per producer). Comply with pre-registration and inquiry obligations 
if relevant; 

  Keep the information submitted in the registration up-to-date; 

 
 
 
 
 
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 

 

If the conditions of Article 7(2) are met notify substances in articles (tonnage trigger > 
1 tonne per year per producer); 

If the article contains a substance included in the candidate list in a concentration 
above 0.1 % w/w (weight by weight), provide the recipient of the article (and 
consumers on request) with sufficient information to allow safe use of the article; 

  When receiving SDS with ESs annexed for hazardous substances and mixtures to be 

incorporated into the articles: 

– 

– 

if the use is covered by the ES, implement RMMs as set out in ES, or 

if the use is not covered by the ES, inform supplier of the use (i.e. make use 
known with the aim to make it an identified use) and await new SDS with 
updated ES(s) or conduct own chemical safety assessment and (if ≥ 1 tonne 
per year) notify ECHA. 

 

Implement those RMMs as set out in SDSs for hazardous substances and mixtures 
which are applicable when incorporated into the articles; 

  Respond to any decision requiring further information as a result of the evaluation 

process (only relevant for registered substances);  

  Comply with any restrictions on manufacture, placing on the market and use of 

substances and mixtures as set out in Annex XVII; 

  Use substances authorised for incorporation into the articles as set out in the 

authorisation or apply for authorisation for use(s) of substances listed in Annex XIV. 

(5) Importers of articles: 

 

If the conditions of Article 7(1) are met register substances in articles (tonnage trigger 
> 1 tonne per year per producer). Comply with pre-registration and inquiry obligations 
if relevant; 

  Keep the information submitted in the registration up to date; 

 

If the conditions of Article 7(2) are met notify substances in articles (tonnage trigger > 
1 tonne per year per importer); 

  Respond to any decision requiring further information as a result of the evaluation 

process (only relevant for registered substances); 

  Comply with any restrictions on manufacture, placing on the market and use of 

substances and mixtures as set out in Annex XVII. 

 (6) Downstream Users (DU): 

  Check if the substance is placed on the list of pre-registered substances published by 
ECHA. If not, and considered relevant, ask ECHA to add the substance to the list; 

 

In the case of having relevant data, decide whether to act as data holder in Substance 
Information Exchange Fora (SIEF);  

 

Implement RMMs as set out in the SDS; 

  When receiving SDSs with ESs annexed: 

– 

– 

if DU use is covered by the ES, implement RMMs as set out in ES annexes to 
SDS; or 

if DU use is not covered by the ES, inform supplier of the use (i.e. make use 
known with the aim to make it an identified use) and await new SDS with 
updated ES(s) or conduct own chemical safety assessment and (if ≥ 1 tonne 
per year) notify ECHA. 

 
 
 
 
 
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 

 

 

Prepare and supply SDS(s) and recommend appropriate RMMs in them and annex ES(s) 
for further downstream use; 

Prepare and supply information on substances that do not require a SDS within the 
scope of Article 32 to further downstream users and distributors; 

Pass on new information directly to their suppliers on the hazard of the substance and 
information that might call into question the RMM identified in the SDS for identified 
uses; 

  Respond to any decision requiring further information as a result of the evaluation of 

testing proposals in downstream user reports;  

  Comply with any restrictions on manufacture, placing on the market and use of 

substances and mixtures as set out in Annex XVII; 

  Use authorised substances as set out in the authorisation (this information should be 

found in the suppliers’ SDS) or apply for authorisation for use(s) of substances listed in 
Annex XIV; 

  Notify use of an authorised substance to ECHA. 

II. Member States: 

 

Provide advice to manufacturers, importers, downstream users and other interested 
parties on their respective responsibilities and obligations under REACH (competent 
authorities' help desks); 

  Conduct substance evaluation of prioritised substances listed in the Community Rolling 

Action Plan. Prepare draft decisions; 

 

Identify substances of very high concern for authorisation; 

  Suggest restrictions; 

  Nominate candidates to membership of ECHA’s Committee for Risk Assessment and 

Committee for Socio-Economic Analysis; 

  Appoint member for ECHA’s Member State Committee (MSC). Amongst other tasks, the 
MSC is responsible for resolving divergences of opinions among Member States on 
decisions following evaluation;  

 

Provide adequate scientific and technical resources to the members of the Committees 
that they have nominated; 

  Appoint member to the Forum and meet to discuss enforcement matters; 

  Enforce REACH. 

III. ECHA: 

 

 

Provide technical and scientific guidance and tools for the operation of REACH in 
particular to assist the development of CSR by industry and especially by SMEs;  

Provide technical and scientific guidance on the operation of REACH for Member State 
competent authorities and provide support to the competent authorities' helpdesks; 

  Receive and check requests for PPORD exemptions; 

 

Pre-registration: 

– 

receive information and grant access to all manufacturers and importers who 
have submitted information on one substance. When foreseen decide about 
conflicting issues, 

 
 
 
 
 
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–  publish a list of pre-registered substance on ECHA website. Update the list on 

the request of downstream users.  

  Operate the rules on data-sharing for non-phase-in substances; 

  Registration: check completeness, require completion of registration and reject 

incomplete registrations; 

  Evaluation:  

–  ensure a harmonised approach,  

–  set priorities and take decisions, 

–  conduct dossier evaluation of registrations including testing proposals and 

other selected registrations, 

–  prevent any unnecessary animal testing by verifying if the testing proposals 

are likely to produce reliable and adequate data, 

–  substance evaluation: Propose draft Community rolling action plans, 

coordinate the substance evaluation process, 

– 

take decisions on testing proposals. 

  Substances in articles: take decisions on notifications; 

  Authorisation/restrictions: manage the process and provide opinions. Suggest priorities; 

  Secretariat for the Forum and Committees; 

  Take decisions on access to submitted data; 

 

Publish certain specified data on a publicly accessible database; 

  Help to share the available data on animal testing, if the registrants cannot agree; 

 

Promote the use of non-animal methods of hazard assessment; 

  Deal with complaints and appeals. 

IV. Commission: 

  Take decisions on further information needs under the evaluation process where there 

is no unanimous agreement by the Member State Committee; 

 

Include substances into the authorisation system; 

  Take decisions on granting or rejecting authorisations; 

  Take decisions on restrictions. 

V. All stakeholders including trade or industry associations, NGOs, and the public: 

The following are possibilities/options for stakeholders: 

  Access to non-confidential information via the ECHA website; 

  Request access to information; 

  Evaluation: submit scientifically valid, relevant information and studies addressed by 

the testing proposal published on the ECHA website. 

  Authorisation: 

–  provide comments on substances which ECHA has proposed to be prioritised 
and on uses which are to be exempted from the authorisation requirement, 

–  provide information on possible alternatives. 

 
 
 
 
 
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  Restrictions: 

119 

–  provide comments on restriction proposals, 

–  provide socio-economic analysis for suggested restrictions, or information to 

contribute to one, 

–  provide comments on draft opinions from ECHA’s Committee for Risk 

Assessment and Committee for Socio-Economic Analysis. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU