Guidance for downstream users.
Date: 2015-04-23
Institutions: European Chemicals Agency
Subjects: chemical industry, chemical product, dangerous substance, dissemination of information, environmental risk prevention, user guide

G U I D A N C E  

Guidance for downstream users 

Version 2.1 
October 2014 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
2 

LEGAL NOTICE 

Guidance for downstream users 
Version 2.1  October 2014 

The 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 contents of this 
document. 

Guidance for downstream users 

Reference: ECHA-13-G-09.1-EN 
ISBN: 978-92-9244-013-8 
Publ.date:  October 2014 
Language:  EN 

© European Chemicals Agency, 2014 

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 

 
 
 
 
 
 
 
 
 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

3 

Date 

January 2008 

December 2013 

DOCUMENT HISTORY 

Version 

Changes 

Version 1.0 

First edition 

Version 2.0 

Full revision of the guidance addressing structure and content. 
The whole guidance has been revised by correcting or deleting 
mistakes and inconsistencies and to reflect the best practices 
and experience developed so far with regard to the obligations 
for downstream users (DUs). 

The main drivers for the update are issues related to checking 
compliance with exposure scenario (including scaling) and 
communication of information on mixtures. 

The structure has been generally reviewed to render the 
document clearer and more readable. Information already 
covered by newer manuals or falling under the scope of other 
guidance documents has been removed. The format consisting 
in flowcharts with explanatory notes has been replaced by more 
user friendly and clear explanations of the main DU obligations. 

The update includes the following: 

- Revision of chapters 0 and 1 in order to eliminate outdated 
information and reflect the new structure of the updated 
guidance. The introductory chapter starts now with an overview 
of the REACH Regulation focusing on aspects relevant for DUs 
and on communication in the supply chain. The way how the 
reader should navigate through the guidance is explained via 
table and flowchart. A new sub-chapter on the explanation of 
the key terms has been included using part of the information 
originally in chapter 5. 

- Revision of chapter 2 by eliminating out of date information, 
moving sub-chapter of REACH overview to chapter 1 and 
restructuring the information in order to highlight first the 
identification of the DU role and DU activities and then other 
possible roles. 

- Elimination of original chapter 3; information considered still 
relevant was moved to chapter 1 and 2. 

-  Creation of a new chapter 3 where it is explained, right after 
the initial identification of the role, how DU should collect 
information on its own use(s) and its customers’ use(s). 
Furthermore the chapter addresses communication upstream 
with the aim to have the use(s) identified. The approach 
identified as preferred is a sector description of uses as it 
reflects the current best practice. 

- Elimination of original chapter 4. 

 
 
 
 
 
 
 
 
 
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Guidance for downstream users 
Version 2.1  October 2014 

- Creation of new chapter 4 to address the actions to be taken 
by the DU when receiving an ES. It is explained how to check 
compliance with the conditions of use and which are the 
possible outcomes of this assessment. The concept of scaling is 
introduced while for technical details and practical examples is 
provided reference to the Practical Guide. The chapter gives an 
overview of the possible actions to be undertaken in case the 
use is not covered by the ES. 

- Elimination of original chapter 5. Information on key terms 
moved to chapter 1 and relevant information on compliance 
check moved to chapter 4. 

- Elimination of chapter 6; relevant information moved to new 
chapter 4. 

- Creation of a new chapter 5 where the option of preparing a 
downstream user chemical safety report (CSR, introduced in 
chapter 4) is described in details. The chapter covers legal 
requirements, difference with standard chemicals safety 
assessment (CSA), practical steps to carry out a downstream 
user CSA and reporting obligations. 

- Creation of new chapter 6 to cover the obligation for the DU to 
communicate new information on hazards and risk management 
measures upstream and on new classification to ECHA. 

- Elimination of chapter 7; relevant information on DU CSR 
updated and moved to new chapter 5. Technical details reduced 
to what is directly of interest of the DU and reference is 
provided to the relevant chapters of the Guidance on IR&CSA to 
avoid duplication.  

- Elimination of chapters 8, 9, 10 and 11. Relevant information 
has been updated and used in the new chapters 3, 4 and 6 
according to the new structure and workflow of the guidance. 

- Creation of new chapter 7 covering the communication 
obligations in the supply chain related to mixtures. The chapter 
illustrates first the legal references related to mixtures. It then 
elaborates and provides guidance and general principles for the 
formulator who needs to collect and select the relevant 
information on substances or mixtures he receives from the 
suppliers and chose the most appropriate mean to communicate 
information on his mixture downstream which is relevant for his 
customers. 

- Merging of chapters 12 and 13 in a new chapter 8 addressing 
requirements related to authorisation and restriction relevant for 
DUs. Existing information has been updated and reduced by 
providing reference to other more appropriate sources. 

 
 
 
 
 
 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

5 

- Addition of a new subchapter 8.3 to highlight the compliance 
with obligations related to substance in articles for DUs. 

- Elimination of chapter 14. Relevant information has been 
moved to the new chapter 7. 

- Transfer of original chapter 15 to an appendix as distributors 
are not DU. The content has been revised by eliminating out of 
date information and highlighting what is currently relevant for 
distributors. 

- Elimination of Appendixes 1, 2, 4, 5 as the information on ES, 
how to develop it and examples is currently covered by other 
more appropriate and up to date documents. 

- Elimination of Appendix 3. The formats are to be provided in 
electronic version and made available on the website in order to 
facilitate the update and the usability. 

- Creation of new appendix 2 where scaling principles and 
methodology are described in more detail. Part of the 
information is taken from existing Part G of Guidance on 
IR&CSA. 

- Creation of a new Appendix 3 where core principles for the 
selection of information to communicate on mixture are 
elaborated. The Appendix is meant to complement chapter 7. 

- Update of original Appendix 6 (moved to Appendix 4) on 
relevant EU legislation. 

Version 2.1 

Corrigendum covering the following: 

October 2014 

- Addition in chapter 7.1 of: the minimum individual 
concentration in mixtures of Substances of Very High Concern 
included in the Candidate List that triggers an obligation to 
provide a safety data sheet; 

- Further minor editorial corrections (to the English language 
version only). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PREFACE 

Guidance for downstream users 
Version 2.1  October 2014 

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

The guidance documents have been originally drafted and discussed within the REACH 
Implementation Projects (RIPs) led by the European Commission services, involving 
stakeholders from 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 
website of ECHA
finalised or updated. 

. Further guidance documents will be published on this website when they are 

1

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

. 

2

1

 echa.europa.eu/web/guest/guidance-documents/guidance-on-reach.  

2 Corrigendum to 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); amended by Council Regulation (EC) No 1354/2007 of 
15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) by reason of the accession of Bulgaria and 
Romania (OJ L 304, 22.11.2007, p. 1). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                           
Guidance for downstream users 
Version 2.1 October 2014 

Table of content 

7 

Table of content ............................................................................................................ 7 

Table of tables ............................................................................................................. 10 

Table of figures ............................................................................................................ 11 

0  Objectives of this guidance ...................................................................................... 13 

1 

Introduction ........................................................................................................... 14 

1.1  Overview of the REACH processes ..................................................................... 14 

1.1.1  Registration ....................................................................................... 14 

1.1.2 

Evaluation .......................................................................................... 15 

1.1.3 

Authorisation ...................................................................................... 16 

1.1.4  Restriction ......................................................................................... 16 

1.2  Communication in the supply chain under REACH ............................................... 17 

1.2.1 

The role of registrant in supply chain communication .............................. 17 

1.2.2 

The role of the downstream users in supply chain communication ............. 18 

1.3  Explanation of key terms ................................................................................. 21 

1.3.1 

Placing on the market .......................................................................... 21 

1.3.2   Use, own use and identified use ............................................................ 21 

1.3.3   Exposure scenario ............................................................................... 22 

1.3.4  Conditions of use ................................................................................ 22 

1.4  Overview of the main downstream user obligations under  REACH and how they 

are dealt with in the guidance .......................................................................... 23 

1.4.1  Navigate through the guidance ............................................................. 24 

2  Understanding your roles under REACH ..................................................................... 27 

2.1 

Identification of downstream user roles ............................................................. 27 

2.1.1  Who is a downstream user under REACH? .............................................. 27 

2.1.2  Other roles under REACH ..................................................................... 30 

3  Collecting and communicating information on your  uses of chemical substances ............ 33 

3.1 

Introduction ................................................................................................... 33 

3.2  Life cycle of a substance .................................................................................. 34 

3.3  Communicating information on uses via sector organisations ............................... 35 

3.3.1  Main elements when communicating information on uses via sector  

organisations...................................................................................... 36 

3.4  Communicating information on uses directly to the supplier ................................. 37 

3.4.1  Main elements when communicating information on uses directly to the  

supplier ............................................................................................. 37 

3.5  Supplier response on receiving information on customer uses .............................. 39 

4  Downstream users and Exposure Scenarios ............................................................... 41 

 
 
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Guidance for downstream users 
Version 2.1  October 2014 

4.1  Legal requirements related to downstream users’ compliance  with the information 

received by the supplier .................................................................................. 41 

4.2  Checking if the use and conditions of use are covered by the   exposure scenario ... 42 

4.2.1  Checking the use ................................................................................ 42 

4.2.2  Checking processes/activities of the exposure scenario ............................ 43 

4.2.3   Checking the conditions of use (OC and RMM) ........................................ 43 

4.2.4 

Scaling .............................................................................................. 45 

4.2.4.1  When scaling is applicable .................................................................... 45 

4.2.5   Uses advised against ........................................................................... 46 

4.3  What to do if the use and conditions of use are covered by  the exposure scenario. 46 

4.4  What to do if uses and conditions of use are not covered by  the exposure 

scenario. ....................................................................................................... 47 

4.4.1 

Introduction ....................................................................................... 47 

4.4.2  Do exemptions to preparing a downstream user chemical safety report  

apply? ............................................................................................... 48 

4.4.3  Make your use known to your supplier with the aim of having it identified .. 51 

4.4.4 

Implement the conditions of use of the exposure scenario ....................... 51 

4.4.5   Substituting the substance or substance in mixture ................................. 52 

4.4.6  Downstream user chemical safety report (DU CSR) ................................. 52 

4.5   Your use is confidential .................................................................................... 52 

4.6  Timescales for fulfilling obligations .................................................................... 52 

5  Use not covered: preparing a downstream user  chemical safety report (DU CSR) .......... 54 

5.1  Legal requirements related to a downstream user chemical  safety report (DU 

CSR) ............................................................................................................. 54 

5.1.1  Obligation to report information ............................................................ 55 

5.2  What is a chemical safety assessment and report ............................................... 56 

5.3  What is a downstream user chemical safety report (DU CSR) ............................... 57 

5.4  Key steps for the downstream user chemical safety  assessment .......................... 58 

5.4.1  Review the supplier’s hazard information (and adapt if necessary) ............ 60 

5.4.2  Develop exposure scenarios (for uses not covered) ................................. 61 

5.4.3 

Exposure Estimation ............................................................................ 61 

5.4.4  Characterise the Risk .......................................................................... 63 

5.4.5  Documenting the downstream user chemical safety assessment in the  

report ................................................................................................ 63 

5.5  Reporting to ECHA .......................................................................................... 64 

5.6  Annex relevant Exposure Scenario(s) to updated SDS ......................................... 64 

6  Communicating new information on hazards and risk  management measures upstream . 66 

6.1 

Introduction ................................................................................................... 66 

6.2  Communicating new information on hazardous properties up  in the supply chain ... 66 

 
Guidance for downstream users 
Version 2.1 October 2014 

9 

6.3  Communicating on the appropriateness of the risk  management measures 

upstream ....................................................................................................... 68 

6.4  Reporting new classification of a substance to ECHA ........................................... 69 

7  Communication in the supply chain related to  mixtures .............................................. 71 

7.1  Legal obligations related to mixtures under REACH ............................................. 71 

7.2  Communicating information on conditions of use regarding  mixtures in safety 

data sheets .................................................................................................... 81 

7.2.1  Collating information on substances and mixtures from suppliers .............. 81 

7.2.2 

Identifying information to communicate to downstream users .................. 82 

7.2.3  Options for including information to communicate to downstream users .... 84 

7.2.4  General guidelines when communicating information downstream ............ 88 

8  Requirements related to authorisation, restrictions  and substances in articles ............... 90 

8.1  Authorisation requirements and downstream users ............................................. 90 

8.1.1  Uses exempted from authorisation ........................................................ 91 

8.1.2 

Fulfilling authorisation requirements ...................................................... 93 

8.1.3  Contributing to public consultations ....................................................... 96 

8.2  Downstream users and restriction requirements ................................................. 99 

8.2.1  Restrictions in a nutshell ...................................................................... 99 

8.2.2  General exemption from restrictions .................................................... 100 

8.2.3 

Ensuring compliance with restrictions .................................................. 100 

8.2.4  Contributing to public consultations ..................................................... 101 

8.3  Compliance with requirements related to substances in  articles ......................... 102 

8.3.1 

Exemptions from the requirements ..................................................... 102 

8.3.2 

Staying prepared .............................................................................. 103 

8.3.3 

Forwarding information with articles .................................................... 103 

Appendix 1 

Compliance with REACH for distributors ............................................... 104 

A1.1  Overview of REACH and distributors ................................................................ 104 

A1.2  Obligations for distributors under REACH ......................................................... 104 

Appendix 2 

Scaling ............................................................................................ 110 

A2.1  Boundaries of scaling .................................................................................... 110 

A2.2  Defining scaling options ................................................................................. 111 

A2.3  Methodologies to be used for scaling ............................................................... 113 

Appendix 3 

Core principle for selecting information to  communicate with mixtures ... 115 

Appendix 4 

EU Legislation with requirements relevant to REACH ............................. 119 

Appendix 5 

Structured overview of communication needs along the supply chain ...... 126 

 
 
 
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Table of tables 

Guidance for downstream users 
Version 2.1  October 2014 

Table 1 Summary of the communication obligations for registered substances under REACH .. 17 

Table 2 Examples of uses .............................................................................................. 22 

Table 3 Examples of operational conditions ...................................................................... 23 

Table 4 Main obligations/actions of downstream users and the relevant timelines ................. 24 

Table 5 Identification of your role – downstream user ....................................................... 28 

Table 6 Identification of your role – other actors treated like downstream users ................... 29 

Table 7 Identification of your role – manufacturers/importers of substances as such, in 

mixtures or articles ................................................................................................. 31 

Table 8 Identification of roles – roles other than downstream user or manufacturer/importer . 31 

Table 9 Checking risk management measures .................................................................. 44 

Table 10 Options if exposure scenario does not cover the use ............................................ 47 

Table 11 Checking if the exemptions from the duty of Article 37(4) to prepare a downstream 

user chemical safety report (DU CSR) apply ............................................................... 49 

Table 12 Summary of total use and “Use not covered” tonnages with associated reporting 

requirements ......................................................................................................... 55 

Table 13 Forwarding information on classified substances and mixtures .............................. 67 

Table 14 Legal references in Title IV REACH relating to formulation of mixtures together 

with clarification ..................................................................................................... 74 

Table 15 Generic exemptions from the authorisation requirement ....................................... 91 

Table 16 Information flow in the supply chain ................................................................ 107 

Table 17 Core principles for selecting relevant information from exposure scenarios to 

communicate for mixtures ..................................................................................... 116 

 
 
Guidance for downstream users 
Version 2.1 October 2014 

Table of figures 

11 

Figure 1 Simplified representation of communication flows under REACH (dotted-dashed 

lines represent industry-industry communication flow; dashed lines represent industry-
authority communication) ........................................................................................ 20 

Figure 2 General overview of the actions triggered by information received by the 

downstream users under REACH ............................................................................... 26 

Figure 3 Schematic presentation of potential uses of a substance at different life cycle 

stages. The downstream user uses are marked with “(DU)”. ........................................ 35 

Figure 4 Work process for downstream user chemical safety assessment ............................. 58 

Figure 5 Workflow summarising when a safety data sheet or other information on a mixture 
must be forwarded to downstream users and distributors. Note that a supplier is not 
obliged to provide a safety data sheet to consumers. .................................................. 73 

Figure 6 Suggested simplified decision tree for formulators to identify how to communicate 

information on the safe use of mixtures downstream .................................................. 87 

Figure 7 Workflow on fulfilling authorisation requirement ................................................... 98 

Figure 8 Workflow checking compliance with restrictions ................................................. 101 

Figure 9 The distributor and the supply chain ................................................................. 105 

 
 
 
12 

List of acronyms 

Guidance for downstream users 
Version 2.1  October 2014 

AC 

BREF 

CL 

CMR 

CSA 

CSR 

DMEL 

DNEL 

DU 

Article category 

Best available techniques reference documents 

Candidate List 

Carcinogenic, mutagenic or toxic for reproduction 

Chemical safety assessment 

Chemical safety report 

Derived minimal effect level 

Derived No-Effect Level 

Downstream user 

DU CSR  

Downstream User Chemical Safety Report 

ECHA  

European Chemicals Agency 

EEA 

ERC 

ES 

European Economic Area 

Environment release category 

Exposure Scenario 

(ext)SDS 

Extended safety data sheet 

GES 

Generic Exposure Scenario 

Guidance on 
IR&CSA 

(ECHA) Guidance on Information Requirements and Chemical Safety 
Assessment  

OC 

OEL 

PC 

PNEC 

PPORD 

PROC 

RMM 

SCED 

SDS 

SpERC 

SU 

SVHC 

Operational Condition 

Occupational Exposure Limit 

Chemical product category 

Predicted No Effect Concentration 

Product and Processes Orientated Research and Development 

Process category 

Risk Management Measure 

Specific consumer exposure determinant 

Safety data sheet 

Specific environmental release category 

Sector of use category 

Substance of Very High Concern 

 
 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

13 

0 

Objectives of this guidance 

This guidance is intended for downstream users of chemical substances. A company can have 
many different roles under REACH, as a role is tied to the company’s activities related to a 
given substance. A downstream user is a specific role under REACH. It refers to using a 
substance, either on its own or in a mixture, in the course of his industrial or professional 
activities. Manufacturer and importers are examples of other roles under REACH. 

Many different types of companies can have a downstream user role, including formulators of 
mixtures, industrial users of chemicals and mixtures, producers of articles, craftsmen, 
workshops and service providers (e.g. professional cleaners) or refillers.  

This guidance also provides useful information for other actors in the supply chain, who are not 
downstream users or manufacturers and importers, but still have obligations under REACH. 
This includes distributors, retailers and storage providers. 

This guidance helps the reader to clarify the role(s) under REACH. It covers the obligations 
that a downstream user may face under REACH, as well as the different circumstances that a 
downstream user may encounter. Information is also provided on the downstream users web 
4
 provides an additional form of help to identify 
page of the ECHA website
roles and obligations under REACH with regard to the substances you are using. A range of 
other publications, including the Practical Guide on “How downstream users can handle 
exposure scenarios”

, may also be of assistance. 

. The Navigator tool

3

5

Please note, in this guidance footnotes are in general used to provide complementary 
information such as references to related documents and to the legislation or explanation of 
additional duties. 

3

4

5

 Available at echa.europa.eu/regulations/reach/downstream-users. 

 Available at echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations. 

 Available on the ECHA website at echa.europa.eu/practical-guides. 

 
 
 
 
 
 
 
                                           
14 

1 

Introduction 

Guidance for downstream users 
Version 2.1  October 2014 

1.1 

Overview of the REACH processes 

6

REACH
, the European regulation on registration, evaluation, authorisation and restriction of 
chemicals, entered into force on 1 June 2007. The Regulation aims to ensure a high level of 
protection of human health and the environment, including the promotion of alternative 
methods for assessment of hazards of substances, as well as the free circulation of substances 
on the internal market while enhancing competitiveness and innovation. It applies in all 
Member States of the European Union and in the EEA countries Iceland, Norway and 
Liechtenstein. 

1.1.1 

Registration 

One of the main requirements of REACH is the registration of chemical substances. This 
means that each manufacturer or importer of a substance, if he manufactures/imports the 
substance at 1 tonne or more per year, must provide a defined set of information, in the form 
of a registration dossier, to the European Chemicals Agency (ECHA). This information includes 
the hazards of the substance and the expected exposure from using the substance

. 

7

If the substance is manufactured or imported in quantity of 10 tonne or more per year a 
chemical safety assessment (CSA) is required. Firstly, the hazards resulting from intrinsic 
properties of the substance are assessed (hazard assessment). If the substance fulfils certain 
, an assessment of the nature and extent of the exposure it is also required 
hazard criteria
(exposure assessment and risk characterisation). The aim is to demonstrate that the risks 
stemming from exposure can be controlled with a set of operational conditions (OC) and risk 
management measures (RMM) designed for that use.  

8

The CSA and its results are documented in a chemical safety report (CSR) which forms a part 
of the registration dossier. This should be updated whenever new relevant information is 
available. 

How does registration affect you as downstream user? The registration process yields 
information on the substance hazard and risk. Information on recommended risk management 
measures for specified uses is detailed in the chemical safety report. This is provided, where 
applicable, in the form of exposure scenarios that are annexed to the safety data sheet (SDS). 
For mixtures, the relevant information from exposure scenarios may be included in the SDS in 
different ways according to the case

. 

9

Some substances are registered as intermediates. If your use of a substance is as 
intermediate

 under Strictly Controlled Conditions

11  you have to make sure that your 

10

6

 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). 

7

 Some substances and uses are outside the scope of REACH. Details are provided in echa.europa.eu/guidance-
documents/guidance-on-reach.  

8

 Substance fulfilling the criteria for the hazard classes or categories set out in Annex I to the CLP Regulation and listed in 
Article 14(4) of REACH. 

9

 Please see chapter 7 of this guidance for more information. Furthermore, the Guidance for the compilation of safety 
data sheets (echa.europa.eu/guidance-documents/guidance-on-reach) provides also relevant information. 

10

 Intermediates are defined in REACH under Art 3(15). 

 
                                           
Guidance for downstream users 
Version 2.1 October 2014 

15 

use is performed in compliance to REACH requirements for intermediates. You may also be 
required to send a written confirmation to your supplier about your use as intermediate. 
Additional details on intermediates are available in the ECHA Guidance on Intermediates

. 

12

REACH applies to most of the hazardous substances in use today. Registration of substances 
that have been already on the market is taking place on a phased basis between 2010 and 
2018 depending on the tonnage and hazardous properties of the substance13. New substances 
need to be registered before they can be placed on the market. 

1.1.2 

Evaluation 

Under REACH, the compliance of individual registration dossiers of single substances may be 
evaluated by the authorities. Two types of evaluation are undertaken, dossier evaluation and 
substance evaluation. 

ECHA is required to assess at least 5% of the registration dossiers in each tonnage band to 
confirm whether the information in the dossiers complies with the information requirements 
set in REACH. If ECHA concludes that a dossier is non compliant, it will request the registrant 
to update his dossier. ECHA also scrutinises the testing proposals
registration dossiers and either grants the permission to conduct the test, refuses it, or 
proposes changes to the testing protocol.  

 submitted as part of the 

14

Substance evaluation takes into account all registration dossiers for a given substance and is a 
task carried out by the Member State Competent Authorities. It is undertaken if there are 
reasons to consider that a substance may pose a risk to human health or the environment. 
During the process the Competent Authorities may approach registrants to gather more 
information on the substance, on its uses or on the exposure related to it.  

How does evaluation affect downstream users? Both dossier and substance evaluation 
concern the registrants, and downstream users are not directly affected by these processes.  

Both processes may result in a change in the registrant’s assessment and consequently uses 
supported and/or the conditions of use recommended. As a result, you may receive an 
updated safety data sheet.  

Furthermore, an outcome of substance evaluation is that substances that have serious effects 
on human health or the environment are identified as Substances of Very High Concern 
(SVHCs) and placed in the Candidate List
supply substances (as such or in mixtures) that are included in the Candidate List, as 
described in chapter 8 of this Guidance. Also companies supplying articles containing 
substances in the Candidate List may have obligations to forward information on safe use and 

. Downstream users have legal obligations if they 

15

11

12

 Strictly controlled conditions and related obligations are defined in  Art. 17 and Art. 18 of REACH. 

 Available at: echa.europa.eu/guidance-documents/guidance-on-reach . 

13

 Deadline 30 November 2010: Substances manufactured/imported at 1000 tonnes/year or more,  substances that are 
very toxic to aquatic environments and manufactured/imported at 100 tonnes/year or more and all CMR substances at 1 
tonne/year or more; deadline 31 May 2013: Substances manufactured/imported at 100 tonnes/year or more; deadline 31 
May 2018: all other pre-registered phase-in  substances. For more information on registration, see Guidance on 
Registration at echa.europa.eu/guidance-documents/guidance-on-reach. 

14

 One of the aims of the REACH Regulation is to reduce unnecessary animal testing. Therefore,  companies are not 

allowed to undertake a test on vertebrate animals that is required under REACH Annexes IX and X without the 
permission of ECHA. To this end, registrants who consider that a test on vertebrate animals would be necessary to 
conclude on the safe use of their substance, submit a testing proposal to ECHA as part of their registration dossier.  

15

 More information on SVHC and the candidate list are available at the ECHA website under 

echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-
identification/candidate-list-of-substances-of-very-high-concern-for-authorisation. 

 
 
                                                                                                                                            
16 

Guidance for downstream users 
Version 2.1  October 2014 

to notify ECHA. Additional information on obligations resulting from inclusion of substances in 
the CL can be found in the dedicated ECHA web page

. 

16

1.1.3 

Authorisation 

SVHCs included in the Candidate List and subsequently placed in Annex XIV of REACH will 
require authorisation before they can be used. The aim of authorisation is to properly control 
the risks stemming from these substances and progressively replace them with suitable less 
hazardous alternatives or technologies where these are economically and technically viable and 
ensuring the efficient functioning of the single market. After a substance has been included in 
Annex XIV, it cannot be placed on the market or used after a given date (sunset date), unless 
an authorisation is granted for their specific use, or the use is exempted from authorisation. 

How does authorisation affect downstream users? A downstream user may use a 
substance subject to authorisation provided that the use is in accordance with the conditions of 
an authorisation granted to an actor up in the supply chain. The downstream user can also 
decide to apply for an authorisation for his own use and, if relevant, for his customers’ uses. 
This decision should be made as soon as the substance is included in Annex XIV as the 
processing of the authorisation application takes time.  

If a substance is subject to authorisation, this information should be communicated by the 
supplier and the authorisation number should also be included on the label and in Section 2 of 
the safety data sheet

. 

17

Authorisation requirements relating to downstream users are detailed in chapter 8 of this 
guidance.  

1.1.4 

Restriction 

Finally, Community-wide restrictions may be placed on certain substances to protect human 
health and the environment from unacceptable risks posed by chemicals. Restrictions may limit 
or ban the manufacture, placing on the market or use of a substance, and hence may also 
affect the use of a substance by a downstream user. 

How does restriction affect downstream users? If a restriction applies to a substance that 
is used by a downstream user, either on its own or in a mixture or in an article, he may only 
continue to use it if his use is not one of the restricted uses. The restriction process is not new 
under REACH, and previous restrictions under Directive 76/769/EC have been carried over into 
Annex XVII of REACH. 

Chapter 8 of this guidance describes how restriction affects downstream users.  

16

17

 echa.europa.eu/candidate-list-obligations.  

 Please refer to the Guidance on the compilation of the safety data sheets available at echa.europa.eu/guidance-

documents/guidance-on-reach.   

 
                                           
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17 

1.2 

Communication in the supply chain under REACH 

REACH reversed the burden of proof concerning the safety of chemical substances: it is now up 
to manufacturers, importers and downstream users to ensure that they manufacture and use 
chemical substances in a way that does not adversely affect human health or the environment. 
Communication in the supply chain between registrants and downstream users is important to 
achieve this goal.  

Downstream users can expect different communication from their suppliers depending on 
whether the substance or mixture is hazardous; whether the substance is registered; and on 
the quantity manufactured/imported by the registrant in their supply chain. 

Just as before the implementation of REACH, downstream users receive information on 
hazardous substances and mixtures in safety data sheets. Now, with REACH, safety data 
sheets may have exposure scenario(s) as annexes when a hazardous substance has been 
registered in quantities of over 10 tonnes per year. The exposure scenario gives more specific 
information on how to use the substance safely, and how the workers, customers, consumers 
and the environment can be protected from risks. 

An overview of the communication obligations for registered substances under REACH is 
presented in Table 1. The communication of information related to mixtures is discussed in 
chapter 7. The information gathered in the registration process may trigger a need to update 
the safety data sheets. 

Suppliers may also provide a safety data sheet on a voluntary basis even for substances for 
which is not required. 

Table 1 Summary of the communication obligations for registered substances under REACH  

Type of communication 

Substance is not hazardous  Substance is hazardous 

Safety Data Sheet  

•  SDS is not required.  
•  SDS may be provided 

voluntarily  

•  SDS is required (for 

substances hazardous 
according to Article 31(1)) 

Exposure scenario 

• 

• 

Information according to 
Article 32 shall be provided 

ES is not required 

• 

ES is required if 
manufacturer/importer 
registered above 10 
tonnes/year (for substances 
hazardous according to 
Article 14(1)) 

1.2.1 

The role of registrant in supply chain communication 

The registrants compile the information on hazardous properties and uses for individual 
substances as part of the registration process. They have the duty to conduct a chemical 
safety assessment for the substances that they manufacture or import in quantities of 10 
tonnes or more per year. Exposure scenarios are based on the chemical safety assessments 
that are conducted by the registrants for the substances. Registrants themselves may have 
limited knowledge on the use of the substance further down in the supply chain. Consequently, 
the information they receive on uses from downstream users is crucial to ensure that the 
information they communicate through exposure scenarios is applicable. 

There are mechanisms foreseen under REACH to bring together the knowledge on the 
substance properties from registrants and knowledge on the substance uses from downstream 
users. Downstream users can even request to become a member of the Substance Exchange 

 
 
 
 
 
 
 
18 

Guidance for downstream users 
Version 2.1  October 2014 

Information Forum (SIEF) for a specific substance with the intention to share relevant data 
which they may own 18.  

In order to carry out the chemical safety assessment for the substances they intend to 
register, the registrants first need to understand how the substance is used throughout its life 
cycle. This analysis is complicated by the fact that in real life most substances occur in 
mixtures and/or articles, while REACH requires to follow the life cycle of a substance. 

The life cycle of a substance starts upon its manufacture and ends when the substance is 
either transformed into another substance, is released as an emission to air or waste water or 
becomes waste. Relatively few substances follow a simple life cycle where the substance is 
manufactured, used as such, and is emitted/becomes waste. More typically, a substance is 
manufactured and then mixed with other substances in the process of formulation. These 
mixtures are then used as a basis for formulating other mixtures, or used as such. There may 
be several further formulation steps in the substance’s life cycle, and some mixtures may end 
up in articles. Finally, if not emitted, substances become waste that also needs to be handled 
safely. 

REACH foresees that the registrants gather the information on how the substance is used from 
the downstream users. This includes listing the uses of the substance through its life cycle, 
uses of articles containing the substance and the waste stage as well as information on the 
actual conditions of use, i.e. what are the operational conditions for each use and what kind of 
risk management measures have been put in place for each use. The registrants use this 
information as a starting basis for their chemical safety assessment. In a potentially iterative 
process, the registrants need to come to a conclusion on operational conditions and risk 
management measures under which the substance can be used safely. 

As there are many possibilities for a substance to be used, the compilation of information on 
uses needs to be done in a systematic way using harmonised approaches (see chapter 3). 
Sector organisations, where they exist, play a crucial role in the process, as a structured 
dialogue between downstream users and registrants is necessary. In short, it is advised that 
the sector organisations gather information from their members and convert it into generic 
assessment elements that cover majority of uses in their sector, and pass this information on 
to the registrants. Also the uses communicated directly by the downstream user to his supplier 
should be communicated with agreed, harmonised means. This way the information presented 
to the registrants contains all the necessary elements required for the chemical safety 
assessment, and at the same time represents reliably the existing practises in the supply 
chain. 

After the registrants have concluded their chemical safety assessment and produced a 
chemical safety report, they submit it to ECHA as part of their registration dossier. The CSR 
may be scrutinised by ECHA, and the registrants may need to update it after a compliance 
check. The registrants use the CSR as a basis for generating exposure scenarios, that are 
annexed to the safety data sheets, for communication down the supply chain. The ECHA 
Guidance on Information requirements and chemical safety assessment, (IR&CSA) Part A
provides a comprehensive description of the key elements of a chemical safety assessment. 

19

1.2.2 

The role of the downstream users in supply chain communication 

Downstream users communicate information on the substance, its uses and the conditions of 
safe use up and down the supply chain to ensure that every use has been assessed as safe. 

18

 Companies that intend to register the same phase-in substance will join a Substance Information Exchange Forum 
(SIEF) to share data on the intrinsic properties of the substance, avoid the duplication of studies (in particular, they have 
the obligation to share all test data on vertebrate animals) and eventually come to the preparation of one joint submission 
for each substance. More information on the data sharing processes and possible involvement of downstream users, 
please consult the Guidance on data sharing available at echa.europa.eu/guidance-documents/guidance-on-reach. 

19

 echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment. 

 
 
                                           
Guidance for downstream users 
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19 

When downstream users receive safety data sheets, they should identify, apply and 
recommend appropriate measures to adequately control the risk. When downstream users 
receive exposure scenarios, or information derived from them, they need to check if their use 
and foreseeable uses of their products and conditions of use are covered in it. If so, this means 
the uses have been included in the registrant’s chemical safety assessment and assessed to be 
safe. If not, the downstream user has to take action. This process of checking the information 
in an extended safety data sheet applies both to formulators and end-users and is described in 
chapter 4. 

When formulators receive safety data sheets and exposure scenarios, they have to pass 
relevant information along the supply chain to their customers. They need to decide how to 
best convert the information they receive on substances into information concerning safe use 
of mixtures. The approaches and options are described in chapter 7. 

Downstream users also have a role in ensuring that the risk management measures identified 
in a safety data sheet are appropriate, by informing suppliers when this is not the case.  

Eventually the safety information reaches the end-users of the substance, that can be either 
. They are operators who do not have the duty to forward the 
industrial or professional ones
exposure scenario information, but only have the duty to check that their use and conditions of 
use are covered by it. 

20

A schematic representation of communication flow under REACH with one formulator level only 
is presented in Figure 1. 

20

 The terms “industrial user” and “professional user” are explained in Table 5. 

 
 
                                           
20 

Guidance for downstream users 
Version 2.1  October 2014 

ECHA

Report DU 
CSR or 
exemptions

 Dossier Evaluation 

CSR

Registrant

Extended SDS

e
s
U

n
o
i
t
a
m
r
o
f
n

i

Formulator 
(Downstream user)

Sector 
organisation

e
s
U

n
o
i
t
a
m
r
o
f
n

i

(Extended) 
SDS

End-user 
(Downstream user)

Use 
information

Figure 1 Simplified representation of communication flows under REACH21 (dotted-dashed 
lines represent industry-industry communication flow; dashed lines represent industry-
authority communication) 

The simplified summary presented above illustrates that communication in the supply chain 
between the registrant and downstream user is crucial for the overall success: the better the 
uses and existing conditions of use are described to the registrants in the first place, the 
smoother the subsequent communication down in the supply chain operates. 

It is important that the downstream users carefully check the information contained in the 
safety data sheet received before starting the communication with the supplier.  

21

 Different downstream user roles are explained in Tables 5 and 6. 

 
 
 
 
 
 
 
 
                                           
Guidance for downstream users 
Version 2.1 October 2014 

1.3 

Explanation of key terms  

21 

This chapter provides a summary of key terms which are significant for downstream users. 

1.3.1 

Placing on the market 

Article 3(12) 

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. 

Placing a substance or mixture on the market under REACH means supplying or making it 
available to third parties, whether in return for payment or free of charge within the territory 
of the EEA (EU Member States and those EEA i.e. Iceland, Norway and Liechtenstein)
addition, import, defined as the physical introduction of a substance or mixture into the 
customs territory of the EU and those EEA countries, is deemed to be placing on the market

. In 

23

22

. 

1.3.2  

Use, own use and identified use 

Article 3(24) 

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; 

Under REACH a “use” is almost any activity carried out with a substance as such or in a 
mixture. While the term use can be interpreted very broadly, there are more specific terms 
under REACH which are very important for downstream users as well as for registrants: the 
term “registrant’s own use” and the term “identified use”. 

Article 3(25)  

Registrant’s own use: means an industrial or professional use by the registrant; 

Article 3(26) 

Identified use: means a use of a substance on its own or in a mixture, or a use of a mixture, 
that is intended by an actor in the supply chain, including his own use, or that is made known 
to him in writing by an immediate downstream user; 

A use may become an “identified use” if an actor (manufacturer/importer, distributor or 
downstream user) in the supply chain: 

-  uses (or intends to use) a substance -as such or in a mixture- or mixture himself, or 

- 

is informed by one of his immediate downstream users in writing of an existing (or 
intended) use. 

Some examples of use are given in the table below. 

22

 Purchasing substances or mixture from Switzerland, which is not an EEA member,  or e.g. from Japan is considered as 

import. 

23

 The definition of “placing on the market” is provided also in CLP  FAQ nr 160  while more information on the 

definition of “import” is provided in REACH FAQs “Import of substances into the EU”. FAQs and Q&As are available at 
www.echa.europa.eu/support/faqs. 

 
 
 
 
                                           
22 

Table 2 Examples of uses 

Formulation of a paint 

Electroplating of metal 

Blowing of plastic films 

Guidance for downstream users 
Version 2.1  October 2014 

Substances and mixtures are used in a mixing process. The use 
consists of several activities, such as the handling of raw 
materials and loading of vessels, the mixing process and the 
filling of paint into containers. In addition, vessels may have to 
be cleaned. 

Electrolytes (substances or mixtures) are used to cover metals. 
The use consists of several activities, such as the preparation of 
the electroplating baths (filling and adjustment), the immersion 
of parts into the baths and the drying of parts. Cleaning and 
maintenance activities are also part of the use. 

Raw materials of polymer compounds are mixed, filled into the 
extruder, heated and blown, the material is cooled and 
packaged. 

1.3.3  

Exposure scenario 

The exposure scenario (ES) for an identified use (or a group of uses) describes the conditions 
under which a substance can be used whilst controlling risks. The identified use is indicated in 
the title of the exposure scenario as well as under Section 1 (sub-section 1.2) of the safety 
data sheet. 

The exposure scenario is an instrument for communicating operational conditions and risk 
management measures that are suitable to ensure control of risks to the users throughout the 
supply chain. An exposure scenario may be comprised of a number of contributing scenarios 
which describe various scenarios (covering the environment, workers and consumers as 
applicable) within a given exposure scenario.  

1.3.4 

Conditions of use 

The term “conditions of use” covers the parameters which have an influence in the assessment 
of the exposure to a substance during the use (so-called determinants of exposure). It 
includes: 

• 

• 

the operational conditions (OC) of use; and 

the risk management measures (RMM). 

The operational conditions describe the conditions under which workers or consumers use a 
substance. This includes for example process conditions (e.g. temperature, contained or open 
process), frequency and duration of the use, amounts used. Operational conditions include also 
the physical form of the substance in the process or product (solid/liquid/gaseous, degree of 
dustiness of the solid state), as well as the characteristics of the surroundings within which the 
substance is used (e.g. size of the room and ventilation rate) and into which the substance is 
emitted (e.g. river flow rate and capacity of sewage system).  

The term “risk management measure” means a measure that is introduced during 
manufacture or use of a substance (either as such or in a mixture) and that limits or prevents 
the exposure of humans or the environment. Risk management measures applied in industrial 
uses include, for example, containment of process, exhaust ventilation, waste gas incinerators, 
on-site waste (water) treatment or municipal sewage treatment. The use of personal 
protective equipment, such as gloves or masks, is also a risk management measure. 

Table 3 below provides practical examples of operational conditions and risk management 
measures. 

 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

Table 3 Examples of operational conditions 

23 

Example 1 

Example 2 

Identified use 

Industrial use of a hard surface cleaner 

Industrial use of a hard surface cleaner 

Washing and cleaning product    

Washing and cleaning product 

•  Dilution of a concentrated solution 

•  Dilution of a concentrated solution 

•  Spray onto surfaces to be cleaned. 

•  Spray onto surfaces to be cleaned. 

•  Wiping off surface with a cloth. 

•  Wiping off surface with a cloth 

Type of 
activity/use 

Operational 
condition 

Concentration 

> 25% 

Duration  

1 hrs/day  

> 25% 

8 hrs/day  

Frequency  

5 workdays/week 

5 workdays/week 

Risk 
Management 
Measures 

Ventilation 
conditions 

The application takes place indoors 

The application takes place outdoors 

Normal air exchange of 0.5/hr 

Containment   Open process 

Open process 

1.4 

Overview of the main downstream user obligations under 
REACH and how they are dealt with in the guidance 

The main obligations and actions of downstream users are presented in Table 4. Depending on 
the circumstances and sometimes also on your own choices, you as a downstream user can 
have one or several of the following obligations: 

• 

• 

• 

Identify the appropriate measures described in the safety data sheets you receive and 
apply them.  
If you receive an exposure scenario, or information sourced from one, check whether 
your current use is covered and whether you comply with the conditions described in it. 
If your use is not covered by an exposure scenario, communicate with your supplier 
with the aim of having your use covered by an exposure scenario, or take another 
action (see chapter 4.4 and chapter 5). 

•  Contact your suppliers if you have new information on the hazard of the substance or 
mixture, or if you believe that the risk management measures communicated to you 
are not appropriate (see chapter 6). 
If you place substances or mixtures on the market (e.g. you are a formulator), or are a 
producer of articles, provide appropriate information to your customers to enable safe 
use (see chapters 7 and 8). 

• 

•  Comply with the obligations related to the authorisation or restriction of the substance 
that you use. Relevant information and conditions to be complied with are indicated by 
your supplier, usually in the safety data sheet (see chapter 8). 

In addition, to facilitate communication in the supply chain you (preferably via your sector 
organisation), you should communicate your typical uses and conditions of use to the 
registrants of the substance prior to registration so that they can base their chemical safety 

 
 
 
 
 
 
 
 
 
 
 
24 

Guidance for downstream users 
Version 2.1  October 2014 

assessment and the resulting exposure scenarios on realistic information from downstream in 
the supply chain. 

The obligations relating to identifying and applying risk reduction measures, to downstream 
user chemicals safety assessments and reporting obligations are described in Title V of REACH. 
The obligations under REACH related to information in the supply chain, including compilation 
of safety data sheets, are described in Title IV of REACH. The provisions of Title IV and V do 
not apply to certain substances and mixtures which pose minimum risk, for which the safe use 
is regulated by other pieces of legislation or that fall outside the scope of application of REACH 
(see Article 2). 

1.4.1 

Navigate through the guidance 

The guidance is structured so that your main obligations and requirements as downstream 
users are dealt with in different chapters. The main obligations and actions required from you 
as downstream users, as well as the relevant timelines are summarised in the table 4 and the 
subsequent flowchart below (Figure 2). Reference to further information in this guidance is 
included. 

The REACH regulation addresses manufacture and use of chemical substances, as such or 
incorporated in mixtures, or incorporated into articles. Throughout the present guidance the 
term “substances” refers to this broader understanding when applicable. 

Table 4 Main obligations/actions of downstream users and the relevant timelines 

Obligations/Actions 

Timeline 

Go to 
chapter(s) 

Obligations 
related to 
communication 
in the supply 
chain 

Identify roles under REACH. 

Make uses known to the registrants 
(voluntary action). 

Identify and apply appropriate measures to 
control the risks communicated in SDS or 
other information supplied. 

Check if own use covered in supplier’s 
exposure scenario, and take further action in 
case your use is not covered. 

Communicate to the supplier information 
that might call into question the 
appropriateness of the risk management 
measures in any exposure scenario received. 

1 June 2007 
onwards. 

By 31 May 2017 
for the phase-in 
substances to be 
registered by 31 
May 2018. 

Within 12 months 
of receiving a SDS 
for a registered 
substance. 

6 months to 
report 
unsupported use 
to ECHA, 12 
months to 
implement 
measures after 
receiving SDS for 
a registered 
substance. 

Without delay. 

Inform suppliers of any new information on 
hazards, including classification and 

Without delay. 

2 

3 

4 

4 & 5 

6 

6 

 
 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

labelling.  

Additional 
obligations for 
formulators 
and re-fillers 
only 

Provide information to your customers, 
including retailers / consumers, to enable 
safe use of substances or mixtures. This 
should be in accordance with Title IV of the 
Regulation. 

Without delay, for 
information 
specified in Article 
31(9). 

Obligations 
related to the 
substances 
subject to 
authorisation 

Obligations 
related to the 
substances 
subject to 
restrictions 

Additional 
obligations for 
article 
producers only 

Additional 
obligations for 
re-importer 

Your supplier or you need to apply for an 
authorisation for your use if you want to 
continue to use the substance listed in 
Annex XIV after the sunset date. 

For substances subject to authorisation, 
comply with the conditions of the 
authorisation covering your use, and (if the 
supplier has applied for the authorisation) 
notify your use of the authorised substance 
to ECHA.  

Check compliance with any restrictions on 
the substance. 

Provide information to enable safe use of 
articles you produce or supply containing 
substances of very high concern in 
concentrations above 0.1 % w/w and, if 
requested, to consumers (Article 33 of 
REACH). 

Document that substance(s) are identical to 
those registered in the EEA by someone in 
your supply chain. Have documentation 
according to Article 31 (safety data sheet 
and exposure scenario where applicable) or 
Article 32 of REACH. 

Notify use of 
authorised 
substance to 
ECHA within 3 
months of the first 
supply of the 
substance. 

As specified in 
Annex XVII of 
REACH. 

For industrial/ 
professional users 
when supplying 
the article; For 
consumers upon 
request and within 
45 days. 

Upon re-import of 
the substance. 

25 

7  

8 

8 

8 

2.1.1  

(Table 5) 

 
 
 
 
 
 
26 

Guidance for downstream users 
Version 2.1  October 2014 

- Identification of your role as DU (section 2)
- Collection and communication upstream of 
information on your use(s) (section 3)

Receipt of a substance or 
mixture

Are you a 
distributor?

Yes

You don’t have DU’s 
obligation. Consult 
Appendix 1

No / Not only

SDS received?

no

Other information 
received?

no

New information 
on hazard/RMMs?

yes

no

ES(s) attached

yes

Implement advice, 
comply with 
authorisation/
restriction
(section 8)

yes

Forward upstream 
(section 6)

- Identify, apply and 
recommend 
appropriate measure 
to control risks
- comply with 
authorisation/
restriction
(section 8)

yes

Check compliance
(section 4) 
+ auth/rest obligations 
(section 8)

Use(s) covered?

no

Take actions:
-  Identify use to 
supplier (section 3)
- DU CSA (section 5)
- other (section 4)

yes

Are you a  
formulator/re-
filler?

no

Are you an 
article 
producer?

no

END

yes

yes

Identify and 
communicate relevant 
information 
(section 7)

Consult section 8 and 
Guidance for 
requirements for 
substances in article

no

Figure 2 General overview of the actions triggered by information received by the downstream 
users under REACH 

 
 
 
Guidance for downstream users 
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27 

2 

Understanding your roles under REACH 

This chapter provides guidance to assist downstream users to identify their roles under REACH. 

2.1 

Identification of downstream user roles 

Your obligations under REACH will depend on the exact activity you carry out in relation to 
each specific substance that you use, either on its own, in a mixture or in an article
is important to check that you are not a manufacturer or an importer, as you may then have 
an obligation to register the substances or other obligations related to articles. Secondly, you 
should check if your activities correspond to the roles of a distributor or a consumer, as these 
roles are explicitly excluded from the definition of a downstream user.  Read chapter 2.1.2 
beneath to answer these questions. 

24

. Firstly, it 

If you come to the conclusion that your activity with regard to a substance is downstream use 
in the meaning of REACH, you need to ascertain which of the downstream user obligations 
apply to you. 

Keep in mind that the requirements under REACH apply to you in relation to the individual 
substances that you use. Therefore, you may have more than one role and you should follow 
Tables 4, 5, 6 and 7 for each of your substances in order to identify all of your roles. 

Furthermore it is to be noted that REACH applies to you also in case you carry out your 
activities individually, i.e. regardless the number of workers or personnel involved. 

2.1.1 

Who is a downstream user under REACH? 

Article 3(13) 

Downstream user: means any natural or legal person established within the Community, 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. A distributor or a consumer is 
not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded 
as a downstream user; 

There are a number of downstream user roles reflecting the type of activity you carry out and 
your position in the supply chain. The roles of the following actors with downstream user 
obligations are explained in tables 5 and 6. 

Table 5: Downstream user 

•  Formulator of mixtures 
• 
Industrial end-user of substances as such or in mixtures 
•  Professional end-user of substances as such or in mixtures 
•  Article producer 
•  Re-filler. 

Table 6: Other actors treated like downstream user  

Importer of substances where supplier has nominated an only representative 

• 
•  Re-importer of substances. 

24

 In this guidance the term substance means substance as such or in a mixture, unless otherwise indicated. 

 
 
 
 
                                           
28 

Guidance for downstream users 
Version 2.1  October 2014 

 Table 5 Identification of your role – downstream user 

Question 

Your role as a downstream 
user  

Supporting information, examples 

Do you mix 
substances 
purchased from EEA 
suppliers and mix 
them to make 
mixtures that you 
place on the market? 

Do you re-fill 
substances or 
mixtures from one 
container to another? 

You are a Formulator: Actor 
producing mixtures. 

Your customers/recipients may 
also be formulators if they use 
your mixtures to make other 
mixtures (e.g. if you supply a 
solution of an additive or a 
pigment paste). 

Your customers/recipients may 
be commercial actors (and thus 
either formulators, industrial end-
users or professional end-users 
under REACH) or consumers. 
They may use your mixtures to 
produce articles or apply them in 
other end-uses. This means that, 
once your customers have 
applied your mixture, it no longer 
exists in its supplied form, but is 
either used up in an end-use or 
incorporated in an article. 
Examples include decorative 
paints, cleaning products or 
polymer masterbatches. 

You are a Re-filler: Actor who 
transfers substances or mixtures 
from one container to another. 

If you only formulate mixtures, and no 
chemical reaction occurs during mixing, 
you do not manufacture any new 
substance. Dissolving a substance in 
water is not manufacturing a substance 
but a use.  In contrast, an activity 
consisting in reacting e.g. acid with base, 
which results in a new substance, would 
be considered as manufacturing 

25

process

 (see table 7 for further details). 

You may be contracted to make a 
mixture by a third party, who owns the 
formulation and places it on the market.  
When making a mixture, you are 
considered a downstream user.  An 
example is a formulator of a detergent 

sold under a retailer’s own brand

. 

26

The transfer of substances or mixtures 
into new/different containers (re-
packaging) is considered a use under 
REACH. Therefore, re-fillers are also 
downstream users, even if they do not 
apply the substances or mixtures in any 
other activity.  

Do you operate at an 
industrial site and 
use substances 
which do not remain 
in the product? 

You are an industrial end-
user: End- user using substances 
which do not remain in the 
product (e.g. applied as 
processing aids) in the context of 
an industrial process. 

If the substance(s) as such or in a 
mixture is not included in the product 
you produce, but is used to facilitate the 
processing or “washed off” after the 
production is finished, you use them 
solely as processing aids.  

25

 For further details on ionic mixtures, see Guidance for Annex V (attachment 1) at echa.europa.eu/guidance-

documents/guidance-on-reach. 

26

An actor may contract a third party (“sub-contractor”) to carry out a specific activity on his behalf. In cases where sub-

contractors manufacture substances, they will have the obligation to register, if the substance is subject to registration 
(see Table 7). This is consistent with the concept of toll manufacturing under Directive 67/548/EEC (see Manual of 
Decisions of Directive 67/548/EEC, 7.4, p.113 available at 
publications.jrc.ec.europa.eu/repository/handle/111111111/5384).  Sub-contractors performing the role of downstream 
users under REACH must comply with the downstream user obligations (see Tables 4 and 5).  The principal actor might 
wish, for reasons of confidentiality, to undertake some of the tasks on behalf of the sub-contractor, e.g. preparing the 
safety data sheet/exposure scenario for the formulation. This does not change the responsibilities of the sub-contractor 
under REACH. The nature of the obligations is determined by the activity agreed upon by both parties in the contract. It 
is advisable that the allocation of the activities between the contractor and sub-contractor should be specified in the 
contract. 

 
 
 
 
 
                                           
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29 

You do not forward any 
substance or mixture to another 
actor. 

You are an article producer: 
user incorporating a substance 
into articles. 

For obligations of an article 
producer see the Guidance on 
requirements for substances 

in articles

. 

27

You are a Professional end-
user: End-user using substances 
or mixtures in the context of 
professional activity, which is not 
considered an industrial process. 

Do you operate at an 
industrial site and  
incorporate 
substances into 
articles in the 
context of 
professional activity? 

Do you use 
substances and 
mixtures in the 
context of 
professional activities 
other than industrial 
use? 

Examples of industrial users are users of 
surface cleaners prior to electroplating or 
users of intermediates in chemical 
synthesis.  

Incorporation of a substance as such or 
in a mixture into an article means: 

a) inclusion into the article matrix, e.g. 
dying of textile fibres; or  

b) application onto the article’s surface, 
e.g. lacquering of steel.  

Users who apply substances in a 
professional capacity which is not 
regarded as an industrial use. This 
includes craftsmen, and service providers 
that may or may not have a fixed 
workplace / workshop. 

Examples of such users are flooring 
contractors, mobile cleaning companies, 
professional painters, construction 
companies, farmers, and users of 
lubricants for equipment such as 
chainsaws. 

Table 6 Identification of your role – other actors treated like downstream users  

Question 

Do you import 
substances or 
mixtures from a 
non-EU supplier, 
who has nominated 
an only 
representative? 

Your role as an actor with 
downstream user obligations 

You are an importer from a 
non-EU supplier which has 
an only representative who 
has registered the 
substance: If your supplier has 
appointed an only 
representative, you will not be 
considered an importer but a 
downstream user. 

Supporting information, examples 

If the non-EEA supplier has an only 

28

, this only 

representative
representative takes over the 
responsibilities linked to the import of 
that substance into the EEA. Therefore 
you are regarded as a downstream 
user, even though you purchase directly 
from the non-EEA supplier and not from 
the only representative. It is 
recommended that you ask your non-
EEA supplier whether he has such an 
only representative (if it’s not the case, 
please consult table 7) and request 
written confirmation from the only 
representative that your imported 
substances are in compliance with 
REACH. 

Do you know that a 
substance that you 

You are a re-importer of 
substances: Actor who imports 

You will need to have documentation 
showing that the substance is identical 

27

 Available at echa.europa.eu/guidance-documents/guidance-on-reach. 

28

 An only representative is a natural or legal person who is appointed by a manufacturer of a substance outside the EU 
(who may manufacture substances, mixtures or articles) to fulfil the obligations as importer under REACH.  Example: If 
you purchase from a manufacturer in Japan which has appointed an only representative then you shall be regarded as a 
downstream user. See Guidance on Registration for more information on only representatives 
(echa.europa.eu/guidance-documents/guidance-on-reach).  

 
 
 
 
 
 
                                           
30 

import from non-
EU suppliers has 
been originally 
manufactured and 
registered in the 
EU up in your 
supply chain? 

substances, as such or in 
mixtures, which have originally 
been produced in the EU. 

In terms of REACH, you are 
considered a downstream user 
if you can prove that the 
substance was registered in the 
EU by someone in your supply 
chain. 

Guidance for downstream users 
Version 2.1  October 2014 

to that registered in the EU by someone 
upstream in your supply chain. You can 
show this by tracing and documenting 
the supply chain and identifying the 
original registrant of the substance. This 
may apply internally, e.g. for trans-
national companies which have split 
their production over different 
countries, but also for actors not 
belonging to the same company.   

Furthermore, in order to avoid having to 
register the re-imported substance, you 
need to have available, e.g. from the 
registrant, a safety data sheet for 
hazardous substances/mixtures, or 
similar information. 

E.g. a substance in a mixture that you 
bring into the EEA was first 
manufactured in EEA, then exported 
(for example to be formulated into that 
mixture). See Guidance on Registration 
for more information. 

2.1.2 

Other roles under REACH 

It is important to clarify – for each substance that you use in your activities – whether your 
role with regard to them is that of a downstream user or/and something else. In the next two 
tables the following roles under REACH are explained: 

Table 7: Manufacturers/importers 

•  Manufacturer of substances 
• 
• 

Importer of substances as such or in mixtures 
Importer of substances in articles. 

Table 8: Roles other than downstream user or manufacturer/importer 

•  Distributor 
•  Retailer 
•  Re-brander. 

Check the tables beneath to find out if you carry out any of these roles with the substances 
you receive/purchase. If so, then you have additional duties under the REACH Regulation. 

 
 
 
 
 
 
 
 
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31 

Table 7 Identification of your role – manufacturers/importers of substances as such, in 

mixtures or articles

29

Question 

Your Role is… 

Supporting information, examples 

Do you produce 
substances or 
extract substances 
in the natural state? 
This includes 
substances created 
while making 
mixtures. 

Manufacturer of a substance, 
either on its own or in one or 
more mixtures.   

See the Guidance on 
registration (in particular 
chapter 2.1 for the 
definition of manufacturer) 

Do you import 
substances or 
mixtures from 
outside the EEA? 

Importer of substances as 
such or in mixtures 

See the Guidance on 
registration. 

Do you import 
articles? 

Importer of substances in 
articles 

See the Guidance on 
requirements for 
substances in articles. 

The formation of “substances” during 
the normal use of a substance or 
mixture is, in principle, exempted from 
the registration requirement under 
Annex V. 
For instance, if you use a reactive 
textile dye, there is a chemical reaction 
in your process, but this needs not to be 
registered, as it is a “reaction upon 
use”, which is exempted. In contrast, if 
you produce calcium sulphate, as a by-
product of neutralisation, and place it 
on the market, this is a marketed by-
product and you need to register it 
(manufacturer/importer role).  

Substances as such or substances 
contained in mixtures are imported if 
you are responsible for bringing them 
into the customs area of the EEA. If you 
import a polymer, you will need to 
check whether you have to register 
monomers and/ or other substances in 
the polymer. 

REACH defines an article as “an object 
which during production is given a 
special shape, surface or design which 
determines its function to a greater 
degree than its chemical composition 
does”.  

If the substance is present in quantities 
over 1 tonne per year in the articles you 
import and is intended to be released, 
you will need to register the substance.  

If the substance is not intended to be 
released, but it is a substance of very 
high concern, you may have an 
obligation to notify ECHA. 

Table 8 Identification of roles – roles other than downstream user or manufacturer/importer 

Question 

Role 

Supporting information, examples 

Are you established 
in the EEA and only 
store or place  
substances, on their 
own or in a mixture, 
on the market, by 

Distributor: Actor who only 
stores and places on the 
market substances, on their 
own or in a mixture  

You are not a downstream 

To be a distributor as defined by 
REACH, you can only store and make 
substances and mixtures available to 
third parties (e.g. resell).  

29

 The Guidance documents mentioned in the table are available at echa.europa.eu/web/guest/guidance-

documents/guidance-on-reach. 

 
 
 
 
 
 
 
                                           
32 

supplying or making 
it available, whether 
in return for 
payment or free of 
charge, to a third 
party? 

user, but you do have 
obligations under REACH 

Go to Appendix 1 of this 
guidance. 

Do you affix your 
brand on a product 
that somebody else 
has manufactured? 

Re-brander: Actor who affixes 
his own brand to a product 
that somebody else has 
manufactured. 

Do you sell 
substances, 
mixtures or articles 
to consumers? 

You are not a downstream 
user. You are considered a 
distributor and you do have 
obligations under REACH. 

Go to Appendix 1 of this 
guidance. 

Retailer: Actor who stores and 
places on the market 
substances, mixtures or 
articles to final consumers 
and/or professional users in 
retail stores. 

You are not a downstream 
user, but you do have 
obligations under REACH. 

Go to Appendix 1 of this 
guidance. 

Guidance for downstream users 
Version 2.1  October 2014 

If you undertake any activity with the 
substance defined as "use" under 
REACH, and do not merely store or 
place it on the market, you will be 
considered a downstream user and 
Table 4 will apply. 

If, besides affixing your brand, you use 
the product, as understood under 
REACH, e.g. by transferring the 
substance from one container to the 
other, you are a downstream user and 
have to comply with the downstream 
user obligations. 

Retailers are a sub-group of 
distributors.   

If you undertake an activity with the 
substance defined as a "use" under 
REACH (note, for example, that refilling 
or mixing paints in-store is considered a 
use under REACH), you will be 
considered a downstream user and 
Table 4 will apply. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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33 

3 

Collecting and communicating information on your 
uses of chemical substances 

Under REACH, effective communication on the safe use of a substance relies on describing the 
uses in an unambiguous way, in REACH terms. The registrants prepare the chemical safety 
assessment for the whole life cycle of that substance based on information received from 
downstream. When the information registrants receive initially is clear and accurate, they can 
then communicate clear and accurate information for the safe use of the substance 
downstream. 

This chapter explains the life cycle approach to chemical safety assessment under REACH 
(chapter 3.2). It describes how downstream user’s uses can be communicated to the suppliers: 
collective communication via sector organisation (chapter 3.3), considered most practical 
according to the experience gathered so far, and direct communication with the supplier 
(chapter 3.4).  Eventually the chapter explains also what suppliers should do when they 
receive information about downstream user’s use (chapter 3.5). 

3.1 

Introduction 

Article 37(2) 

Any downstream user shall have the right to make a use, as a minimum the brief general 
description of use, known in writing (on paper or electronically), to the manufacturer, importer 
or downstream user who supplies him with a substance on its own or in a mixture with the aim 
of making this an identified use. In making a use known, he shall provide sufficient information 
to allow the manufacturer, importer or downstream user who has supplied the substance, to 
prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the 
manufacturer, importer or downstream user’s chemical safety assessment. 

REACH gives downstream users the right to make a use known upstream to their supplier
This may be done prior to registration, to ensure the use is covered. It may also be done after 
registration, because the use or conditions of use are not covered by the exposure scenario the 
downstream user has received.  

. 

30

It is not an obligation, and you do not have to communicate your use upstream. For example, 
you may for confidentiality reasons not want to make your use known to others. In that case, 
you need to carry out the chemical safety assessment yourself, if it is required for that 
substance (see chapter 5).  

When the downstream user intends to make the use known to the supplier, he should be 
aware that the supplier has to comply within specified timelines, as indicated in Article 37(3). 
For registered substances the supplier 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 supplier has to comply, provided the request was made  
a minimum of 12 months before this deadline (i.e. before 1 June 2017). See chapter 3.5 for 
more details. 

Identifying uses to the supplier is a crucial step for the whole process, particularly for 
hazardous substances where a chemical safety report is required for their registration. As a 
downstream user you need to comply with the conditions of safe use identified in the chemical 
safety report (see chapter 4). Therefore it is in your interest that i) your uses are known to the 

30

 This right does not apply to recipients of articles. 

 
 
 
 
                                           
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Guidance for downstream users 
Version 2.1  October 2014 

registrant prior to registration and ii) the registrant’s chemical safety assessment is based on 
the actual conditions of use down in the supply chain. 

Registrants are encouraged to actively communicate, for example on their websites, which 
substances they intend to register and which uses they intend to cover in their registrations. 
Another good source for you to check whether your use will be covered is the Section 1 of the 
current safety data sheet – if the use is mentioned there, it will probably also be covered in the 
forthcoming registration and subsequent exposure scenario. Also any other technical 
information received from the supplier or a sector organisation website can give assurance that 
the use will be covered. If you still remain in doubt whether your use of the substance will be 
covered, you could contact your supplier directly. 

3.2 

Life cycle of a substance 

Under REACH, the registrants’ chemical safety assessments must cover all life cycle stages of 
the supported uses of the substances they intend to register. The registrants need to consider 
whether the six life cycle stages below are relevant for their substance and hence for their 
chemical safety assessment of it. For this, they need information from their downstream 
users

. 

31

1.  Manufacture: A substance is manufactured from raw materials and/or intermediates. 
Activities with the substance during the manufacture, such as chemical processing or 
substance transfers are considered manufacturing. This life cycle stage has no 
relevance for the downstream users. 

2.  Formulation: A substance is transferred and mixed with other substances in order to be 

placed on the market in a mixture. This is the activity of formulators. 

3.  Use at industrial sites: This life cycle stage covers all uses of a substance carried out at 
industrial sites. The substance may be used in many ways including: as a raw material 
in a process; as a processing aid; for cleaning or sterilising; for incorporation into an 
article. In summary, use at industrial sites covers activities of industrial end-users, 
including producers of articles. 

4.  Uses by professional workers: As the name implies, this life-cycle stage covers all 

activities of a substance carried out by professional workers. These activities do not 
take place at industrial sites, and hence the nature of exposure stemming from them is 
different: they can take place anywhere, the potential group of users is large, and the 
amount used by a single user is typically low compared to industrial use. This life-cycle 
stage covers the activities of professional end-users, including craftsmen, cleaners, 
employees in public administration and self-employed. 

5.  Consumer uses: This life cycle stage covers all uses of the substance carried out by 

consumers. Consumers are not considered downstream users under REACH. 

6.  Article service life: If a substance ends up in an article, the so called service life of that 
article is to be considered under this life cycle stage. In layman terminology this means 
using the article (either by industrial users, professional users or consumers), but it 
must be noted that using an article does not mean “use” as defined under 3(24) of 
REACH. 

31

 For the roles referred to in the steps below, refer to chapter 2.1. 

 
                                           
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35 

It is important to note that information on the waste generated at each stage and possible 
emissions from waste treatments may be relevant and hence to be forwarded, if available, to 
the supplier to support the registration process.  

Figure 3 below depicts in a simplified way potential uses at each stage of the life cycle of the 
substance. 

Manufacture of 
a substance

Formulator 
produces a 
mixture (DU)

Use of 
substance/
mixture by 
industrial end-
user (DU)

Use of substance/
mixture by 
professional end-
user (DU)

Use of 
substance/
mixture by 
consumer

Service life of 
article 
containing 
substance

Figure 3 Schematic presentation of potential uses of a substance at different life cycle stages. 
The downstream user uses are marked with “(DU)”.  

3.3 

Communicating information on uses via sector organisations 

Collective communication via sector organisations has been found to be an efficient way of 
handling the flow of communication on uses, where such sectors exist.  

The typical approach is for sector organisations to collect information from their members on 
the tasks and activities and to generate “use mappings”. Use mappings collate the uses and 
conditions of use of substances within their sector. They should, to the extent possible, cover 
the whole life cycle of the substances, on their own, in mixtures or in articles. 

The uses are documented in one or more standard description(s) of use for the sector. These 
descriptions are published on the sector organisation websites, and they typically consist of: 

•  A brief general description of the use, composed of: 

o  a short verbal/technical description of the use; and 

o  an agreed set of use descriptors for that use; and 

•  A typical set of operational conditions and risk management measures for that use, 

preferably expressed in the format of harmonised exposure assessment elements for 
worker (industrial or professional), environmental and consumer exposure. These 
include, for example: 

o  a generic exposure scenario for worker exposure; 

o  a specific environmental release category for that use; and 

 
 
 
36 

Guidance for downstream users 
Version 2.1  October 2014 

o  a specific consumer exposure determinant for that use (if relevant). 

Such sector-specific descriptions represent the common understanding within the supply chain 
on the typical uses and conditions of use for a substance. They also help to communicate 
information to suppliers without having to disclose confidential business information or to 
document detailed information on your use. 

You should contact your organisation to know whether such standardised descriptions of use 
exist for your sector. If they do, you should confirm that these standard descriptions cover 
your use and conditions of use. For the typical uses within a given sector this is expected to be 
the case. You should also check whether you understand the safety advice documented in 
these harmonised elements, as you need to comply with the extended safety data sheets that 
result from the sector level use mappings. If you remain in doubt, you should contact your 
sector organisation. 

It may also be that such standardised descriptions of use do not yet exist in your sector, and 
you may be contacted by the sector organisation. If so, you should be able to reply to your 
organisation’s enquiries by describing your use in the harmonised terminology. Templates have 
been developed for gathering use information. You should understand what standardised 
elements have been built, and what information you should provide to your sector organisation 
in order to compile the information at sector level. 

For substances that are yet to be registered, the collection and compilation on information on 
the uses should preferably take place via sector organisations whenever possible. It is 
desirable for you to provide information requested by your sector organisation to develop 
standardised descriptions of use, although it is not an obligation. 

3.3.1 

Main elements when communicating information on uses via sector 
organisations 

The main elements you should be familiar with in order to obtain a clear and standardised 
definition of your use(s) are the following. 

A short verbal/technical description of the use 
It is desirable that the verbal description of typical uses within a sector are harmonised at the 
sector level. For your uses, explain the processes and activities that you carry out with the 
substance (formulators) or mixtures (formulators and end-users), so that harmonisation over 
the whole membership can be done at the sector level. 

Use descriptors 
The verbal description of use is supported by a system of standard use descriptors that 
characterise the different aspects of a given use. These include the main user sector (industrial 
users, professional users or consumers), sectors where end use of substance may happen 
(SUs), application techniques or process types defined from the occupational perspective 
(PROCs), broad conditions of use defined from the environmental perspective (ERCs), chemical 
product type in which the substance is supplied to end use (PCs) and article types where 
substance ends up (ACs). For further information on the use descriptor system, please see 
ECHA Guidance on IR&CSA, Chapter R.12

. 

32

Many use descriptors have been incorporated as input elements into the commonly used 
exposure assessment tools, and a link between the use descriptor and the assumptions on the 
related exposure has been built in the tools. Be aware that the choice of the use descriptor 
may heavily impact the outcome of the exposure assessment. 

Generic exposure scenarios (GES) 
Generic exposure scenarios document the typical conditions of use for a typical product or 

32

 For use descriptor system, please see ECHA Guidance on IR&CSA chapter R.12 available at echa.europa.eu/guidance-

documents/guidance-on-information-requirements-and-chemical-safety-assessment.  

 
 
                                           
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37 

process within a sector. The conditions of use are expressed in a form that can be fed into the 
commonly applied exposure assessment tools. The applicability of a GES may refer to ranges 
of substance properties (e.g. vapor-pressure-bands or DNEL-bands). GESs have been mainly 
developed to cover conditions of use that are relevant for worker exposure
have also included environmental exposure in the GESs. 

. Some sectors 

33

Specific environmental release categories (SpERCs)  
Specific environmental release categories document the typical use conditions for products and 
processes in a sector from the environmental perspective. This includes the emission factors 
resulting from the use conditions. The conditions of use are expressed in a form that can be 
fed into the commonly applied exposure assessment tools. SpERCs are published on the 
respective web pages of the sector associations.  

Specific consumer exposure determinants (SCEDs)  
Specific consumer exposure determinants document the typical conditions of use related to 
substances in consumer products. The conditions of use are expressed in a form that can be 
fed into the commonly applied exposure assessment tools. This includes information on 
concentration, application form of product and sets of information related to consumer habits 
and practises (e.g. frequency of use, room sizes). 

GES, SpERCs and SCEDs are being developed by many sector organisations.       

3.4 

Communicating information on uses directly to the supplier 

Communication via sector organisations may not be feasible, for example where the uses are 
infrequent or exceptional, or where there is not a suitable sector organisation. In such cases, 
you need to describe your use and conditions of use directly to your supplier to have them 
included in the chemical safety assessment. 

If you are a formulator or article producer, you can also collect information on the foreseeable 
uses of your products further down in the supply chain from your customers, with a view to 
provide information on the whole life cycle of the substance to your supplier. In this case, you 
should involve your key customers in the collection of information on the uses further 
downstream. 

When communicating with your supplier on uses, and when collecting information from your 
customers and even further downstream, you are advised to use the publicly available 
 or supplier questionnaires developed for the purpose of collecting information on 
templates
uses. They give orientation on which information is needed on the use and conditions of use 
for preparing a chemical safety assessment.  

34

3.4.1 

Main elements when communicating information on uses directly to the 
supplier 

In requesting that your use becomes an identified use, you must provide sufficient information 
on your own operational conditions and risk management measures to enable the supplier to 
start developing an exposure scenario covering your use. This should include, for example, the 
following: 

• 

• 

short description of process/activity 

short description of article type in which you incorporate the substance 

33

 Please note that the term “generic exposure scenario” can be also used to refer to a documentation of a set of 

conditions of safe use. In this case the conditions of use compiled into the generic exposure scenario have been assessed 
safe.  

34

 See the downstream user section of the ECHA website (echa.europa.eu/regulations/reach/downstream-users). 

 
 
 
                                           
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38 

•  applicable use descriptors

35

•  applicable SpERC    

•  physical state of substance (solid or not) 

•  duration and frequency of exposure 

•  process temperature if elevated 

•  outdoor or indoor activity 

• 

• 

for indoor activity, if local exhaust ventilation is available 

respiratory protection and type in place 

•  eye protection and type (goggles) in place 

•  hand protection and type (gloves) in place 

• 

• 

concentration of the substance in a mixture 

release rate from your processes to water, air and soil (if it takes place) 

•  environmental risk management measures in place and their efficiency 

• 

information on measured exposure data available. 

For more hazardous substances and for uses where high exposure is expected, the standard 
set of information may not be adequate for the registrant to finalise the chemical safety 
assessment. You should make him aware, for example, if your uses create aerosol or dust, 
potentially result in direct skin or mouth contact or include application to a large surface 
indoors. Also events in the article service life that may lead to exposure from articles are 
relevant to inform the registrant about. 

The type of information that is needed to enable your supplier to develop an exposure scenario 
is similar to what is collected by sector organisations when they prepare sector-specific 
description of uses. Please refer to chapter 3.3.1 for explanations of these elements. When 
collecting information on your own use, you should structure your information collection, 
depending on which level of detail is needed. 

You are advised to collect information that is readily available within your organisation, for 
example, process descriptions, risk assessments at workplaces, environmental permits or 
measurements of emissions, or exposures related to your products. Appendix 4 to this 
guidance lists EU legislation from which information relevant to REACH may be available. 

If this information is not sufficient for carrying out a CSA (either by you or your supplier), you 
may be able to fill the gaps by talking to technical experts, sales people and others within your 
organisation. 

If gaps remain, you may need to consult external sources. Standard process descriptions may 
be available from industry associations or from regulators. BREF notes

 describing specific 

36

35

 See Guidance on IR&CSA, chapter R.12 at echa.europa.eu/guidance-documents/guidance-on-information-

requirements-and-chemical-safety-assessment. 

 
 
                                           
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processes or emission scenario documents may be available
Guidance prepared under the Biocidal Products Directive
in biocides and in similar application types or processes. 

38

39 

37

. The Technical Notes for 

 may be helpful for substances used 

3.5 

Supplier response on receiving information on customer uses  

As described in previous chapters, a downstream user may contact his supplier to make a 
downstream use known. 

The supplier who deals with the query may be a distributor, a downstream user or a 
manufacturer/importer who has registered the substance. If the supplier is a distributor, he 
should forward the information to his own supplier without delay. If you, as a downstream 
user, are the supplier (such as a formulator who supplies substances as such or in mixtures 
further downstream), you can choose whether to forward the information to your own supplier 
or deal with it directly yourself. 

The supplier dealing with the query can respond in a number of ways, including: 

•  The supplier can assess the use and update or prepare a chemical safety 

assessment as applicable. If appropriate, the supplier then provides the resulting 
exposure scenario to the customer. 

•  The supplier can conclude that he is unable to include the use as an identified use 
because it is not safe for human health or the environment. In this case, this 
becomes a use he advises against. The supplier must provide the user and ECHA 
with the reason(s) for that decision in writing without delay.  

If the supplier concludes that the use is unsafe, and the downstream user disagrees, they 
should discuss this further. It is possible that the supplier’s assessment is based on incomplete 
or incorrect information, for example not taking into account the specific operational conditions 
or risk management measures that are in place at the site. If this is the case, the downstream 
user should provide additional information on the conditions of use that will enable the supplier 
to revise his assessment. 

If the supplier still concludes that the use is unsafe and he communicates the reasons, the 
supply of the substance can continue if the downstream user carries out a downstream user 
chemical safety assessment and demonstrates that the use is safe (see chapter 5). 

The supplier may need to update the information provided to customers, such as the safety 
data sheet or Article 32 information. 

The supplier has to respect the following timeframes for preparing or updating the chemical 
safety report: 

•  For substances which have not yet been registered: the use must be included in the 

chemical safety report and the resulting extended safety data sheet before the deadline 

36

 Best Available Techniques (BAT) reference documents are designed to demonstrate best available techniques for each 
sector covered by the International Plant Protection Convention (IPPC) (available at: eippcb.jrc.ec.europa.eu/reference/) 
. Please note that BREF notes do not necessarily contain treatment efficiencies for specific substances. 

37

 Emission scenario documents are available for various sectors at EU level (Technical Guidance document for the 
assessment of risks according to the new substances directive and the Biocidal Products Directive), and through the 
OECD. They describe specific processes and provide default emission factors for the environment.  

38

 ihcp.jrc.ec.europa.eu/our_activities/public-health/risk_assessment_of_Biocides/guidance-documents. Please note 
that on 1 September 2013 the Biocides Products Regulation entered into operation and ECHA took over the regulatory 
management of biocides. ECHA makes related Guidance documents available on its website.  

 
 
                                                                                                                                            
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Guidance for downstream users 
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for registration, provided that the downstream user has made his request at least 12 
months before that deadline. 

•  For registered substances: the use must be included in the chemical safety report and 
the resulting extended safety data sheet before he next supplies the substance or 
mixture to the downstream user, provided that the request was made at least one 
month before the supply (or within one month after the request, whichever is the 
later). 

It may arise that, for valid reasons, no actor in the supply chain assesses the use. If so, the 
user further downstream should be informed without delay and he needs to take alternative 
action to fulfil his obligations.  

One possible action is to source another supplier who supports his use/conditions of use. If no 
other supplier supports his conditions of use, the downstream user should consider 
implementing the measures in the exposure scenario he receives. Alternatively, if the 
downstream user considers the use is safe under his conditions, he can demonstrate this by 
preparing a downstream user chemical safety report (see chapter 4.4). Another option to fulfil 
his obligations is to substitute the substance or process with a safer alternative. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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41 

4 

Downstream users and Exposure Scenarios 

This chapter describes the obligations for a downstream user upon receipt of information from 
the supplier. In particular it provides guidance on how a downstream user can determine 
whether his use and/or conditions of use are supported by this information. It also describes 
what to do based on the outcome of that evaluation. 

4.1 

Legal requirements related to downstream users’ compliance 
with the information received by the supplier 

Article 37(5) 

5. Any downstream user shall identify, apply and where suitable, recommend, appropriate 

measures to adequately control risks identified in any of the following: 

(a) the safety data sheet(s) supplied to him; 

(b) his own chemical safety assessment; 

(c) any information on risk management measures supplied to him in accordance with Article 
32. 

As a downstream user, you are required to identify and apply the appropriate measures that 
allow you to control risks. These measures are normally communicated to you by the supplier 
via the safety data sheet. 

If you are supplying to customers, you may have to communicate appropriate measures to 
them. Chapter 7 provides detailed guidance for formulators supplying mixtures. 

The downstream user should receive a safety data sheet for hazardous substances and 
mixtures. The safety data sheet may include one or more exposure scenarios attached to it. 
Exposure scenarios describe the conditions under which a substance as such or in mixtures can 
be used safely. They are explained in chapter 1 of this guidance and detailed information about 
exposure scenarios is provided in Part D of the Guidance on IR&CSA

. 

39

Article 37(4) relates to the obligation to prepare a chemical safety report for any use outside 
the conditions described in an exposure scenario, unless specified situations apply. These 
cases are described in chapter 4.4.2.  

Article 37(4) 

A downstream user of a substance on its own or in a mixture shall prepare a chemical safety 
chemical report in accordance with Annex XII for any use outside the conditions described in 
an exposure scenario or if appropriate a use and exposure category communicated to him in a 
safety data sheet or for any use his supplier advises against. 

… 

Consequently, the first step when you receive a safety data sheet and attached exposure 
scenario(s), is to check whether your use and/or your conditions of use are covered by that 
scenario. If you supply the substance further downstream (e.g. you are a formulator of 
mixtures), you should also assess if the foreseeable uses of your products containing the 
substance are covered by the exposure scenarios that you have received from your suppliers. 

39

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When you check if your use and conditions of use are covered, the outcome of such a check 
may result in the following situations. 

1.  Use, operational conditions and risk management measures correspond to those 
specified in the exposure scenario (see chapter 4.3 of this guidance for more 
detail).  

2.  Use, operational conditions and risk management measures do not exactly 

correspond to the exposure scenario, but adjustments may be applied to balance 
the differences and maintain as a minimum an equivalent level of exposure (see 
chapter 4.2.4 of this guidance).  

3.  Use and/or conditions of use are not covered by the exposure scenario. In this 
case you have multiple options and you will need to decide what action to take. 
Chapter 4.4 of this guidance provides more information. You do not need to take 

40

further actions
the other letters contained in Article 37(4) of REACH. 

 if you are exempted from preparing your own CSR under any of 

An explanation on how to check use and use conditions is provided in the following chapter 4.2 
and in the Practical Guidance 13 “How Downstream users can handle exposure scenarios”

41.

The obligations of Article 37 are triggered by receiving a safety data sheet with a registration 
number (Art 39.1 of REACH). 

4.2  Checking if the use and conditions of use are covered by the 

exposure scenario  

In order to compare your use(s) and your conditions of use with the information in the 
exposure scenario, you may need to collect information on your own use(s), and the 
foreseeable uses of your products by your customers. Information may be gathered from 
various sources, including documentation prepared for other legislation (e.g. the Chemical 
Agents Directive
Directive
experience of your site personnel, such as technical experts and sales persons. The level of 
detail of the information required will depend on the level of detail of the information in the 
exposure scenario. The meaning of key terms used in this chapter is explained in chapter 1.3 
of this guidance. 

), workplace measurements and/or emission monitoring data as well as the 

, compliance with environmental permits under the Industrial Emission 

42

43

4.2.1 

Checking the use  

As first step, you have to check if your use and foreseeable uses of your products are included 
within the “identified uses” covered by the exposure scenarios attached to the safety data 
sheet. Identified uses are named in the safety data sheet, normally under section 1.2 and in 

40

 In this sentence is intended that no further actions are needed under REACH, but there may be actions required under 

other applicable EU legislation on protection of human health and the environment (see appendix 4 for details). 

41

42

echa.europa.eu/practical-guides.  

 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related 

to chemical agents at work (Chemical Agents Directive), CAD directive. The directive is available at eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:01998L0024-20070628:EN:NOT. 

43

 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions 

(integrated pollution prevention and control). 

 
 
 
 
 
 
                                           
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43 

the title section of the attached exposure scenarios. The naming should be consistent with the 
title of the exposure scenario even though the title section of the exposure scenario may 
contain additional information (e.g. list of use descriptors) which is not necessarily included in 
section 1.2 of the safety data sheet
different conditions of use that relate to the same identified use. Also, one exposure scenario 
can be used for various identified uses with similar conditions of use. A standard system for 
describing uses is provided in Chapter R.12 of the Guidance on IR&CSA and in Chesar Manual 
2

. There may be different exposure scenarios with 

. 

  44

45

4.2.2 

Checking processes/activities of the exposure scenario  

The second step is to check if your processes/activities are covered. The activities/processes 
are described in section 1 of the exposure scenario in a short text and/or list of use descriptors 
(i.e. PROCs and ERCs
where exposure to the relevant substance or substances in mixture is expected. Assess 
whether you carry out activities with the substance or substances in mixture that are not listed 
and may cause higher or different exposures than those listed. 

). The activities relating to the identified use will only include those 

46

4.2.3  

Checking the conditions of use (OC and RMM) 

4.2.3.1 

Comparison of operational conditions (OCs) 

Compare the information given in the exposure scenario with your own operational conditions. 
If you have carried out a risk assessment under the Chemical Agents Directive, you may use 
that information for compliance checking. Information from applications for environmental 
permits may also be a valuable information source. In case of differences between the 
description of conditions of use in the exposure scenario and your own practice it does not 
always mean that the use is not covered. In chapter 4.2.4 of this guidance you may find 
information on how to check if your conditions of use are covered by the exposure scenario.   

The exposure scenario may also specify factors describing basic parameters about the 
surrounding environment or the workplace (for example air volume available) to which 
substances are emitted. This information is important in estimating exposures as it specifies, 
for example, the dilution of a substance in the natural, workplace or consumer environment. 

4.2.3.2 

Comparison of risk management measures (RMMs) 

Compare the information given on risk management measures, including their effectiveness, 
with those you apply.  

Effectiveness is the key information related to risk management measures. It is the degree of 
exposure or emission reduction achieved by application of the risk management measure (for 
example local exhaust ventilation reduces the substance concentration in workplace air by 
50%, gloves reduce dermal exposure by 80%). In some cases you may need to make 
qualitative assumptions when the numeric values are not comparable, for example when the 
exposure scenario specifies that a waste gas incinerator should destroy 95 % of the organic 

44

 It is recommended to avoid including potentially long list of use descriptors in section 1.2 of the safety data sheet. 
Alternative and more viable ways are mentioned in the Guidance on the compilation of safety data sheet (chapter 4.1) 
available at echa.europa.eu/guidance-documents/guidance-on-reach. 

45

 ECHA Guidance on IR&CSA is available at echa.europa.eu/guidance-documents/guidance-on-information-

requirements-and-chemical-safety-assessment; Chesar manuals are available at 
chesar.echa.europa.eu/web/chesar/support/manuals-tutorials. 

46

 Use descriptors such as PROCs and ERCs are defined in the ECHA Guidance on IR&CSA, chapter R12 – Use 
descriptor systems available at echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment. 

 
 
                                           
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Guidance for downstream users 
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compounds in the waste gas and you only have information on the concentration of organic 
carbon in the emitted waste gas. To find out how effective your risk management measures 
are, you should discuss with technical staff, and/or consult maintenance instructions or 
measurement protocols of technical devices. Furthermore, producers of these devices could 
provide information on functioning and effectiveness. 

Table 9 Checking risk management measures  

Information in exposure scenario 

Outcome of your check  

•  Half mask (protection factor 10 assumed) 

•  Appropriate half masks are worn 

•  Gloves (nitrile) should be worn 

•  Appropriate gloves are used 

•  No environment related measures needed 
under given operational conditions of use 

•  No environmental measures are 

implemented 

Residual paints and empty cans must be 
disposed of as hazardous waste 

Wastes are disposed of as hazardous waste  

You can be sure that your risk management measures are covered if their effectiveness is 
equal to, or higher than, what is specified in the exposure scenario. This would be the case if, 
for example, you use half masks with a protection factor of 25 and the exposure scenario 
requires, as a minimum, a protection factor of 10.  

Note that a given risk management measure may have a different effectiveness for different 
(groups of) substances. Gloves may, for example, be more or less suitable for the conditions of 
use or waste gas incinerators may fully destroy organic compounds but have no effect on 
metals. If you are unsure, contact the supplier of the relevant risk management equipment. It 
is also important to mention that the hierarchy of risk management measure defined in worker 
legislation
Available Techniques reference documents (BREFs) adopted under both the IPPC Directive and 

or best available technologies defined in the environmental legislation (Best 

47 

the Industrial Emission Directive
effectiveness of a risk management measure.  

48

), must be taken into account when assessing the 

If you adopt a risk management measure that is considered higher in hierarchy by other 
applicable legislations and more effective compared to the risk management measure in the ES 
you may conclude that your conditions of use are covered. For example the exposure scenario 
indicates use of PPE with 90% effectiveness and you have an enclosed system where residual 
releases are <3% (equal 97% effectiveness). In this case, your risk management measure can 
be considered higher in hierarchy and also more effective and therefore your conditions of use 
are covered. 

4.2.3.3 

Discrepancy between OC and RMM’s from different suppliers 

If you purchase a substance from more than one supplier, you may receive exposure scenarios 
and contributing scenarios which are not comparable. They could differ in scope (number and 
types of uses covered), in conditions of use or there may be differences in the substance 
properties. 

You should check if your conditions of use are covered by the most stringent of the exposure 
scenarios received. If so, your use is also covered by the other exposure scenarios.  

47

48

 Council directive 98/24/EC.  Note that Appendix 4 provides an (not exhaustive) overview of relevant EU legislation. 

 BREF documents can be downloaded at eippcb.jrc.ec.europa.eu/reference. 

 
 
 
                                           
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45 

If your conditions of use are covered by another exposure scenario received, but do not lead to 
the lowest exposure communicated to you in all exposure scenarios, a competent person 
should undertake the following: 

a.  verify that the substance, its properties and the use are actually the same;  
b.  confirm that the selected measures ensure safe use, even though they are less 

stringent than measures recommended by other suppliers; 

c.  document the justification for your decision. 

When exposure scenarios from different suppliers diverge, you should contact your suppliers 
and inform them of the differences with a view to aligning their exposure scenarios. 
Alternatively one of the actions described in chapter 4.4 could be undertaken. 

4.2.4 

Scaling 

If your conditions of use differ slightly from the exposure scenario of your supplier, you may be 
able to demonstrate that, under your conditions of use, the exposure levels (for humans and 
the environment) are equivalent or lower than under the conditions described by the supplier. 
If so, you can conclude that you implement, as a minimum, the conditions described in the 
exposure scenario communicated to you in the safety data sheet. 

The way in which you determine if your conditions are equivalent or lower is termed “scaling”. 
When scaling is applied, modification of one factor can be compensated by modification of 
another factor. Scaling is intended to provide you with a simple way of checking if your 
conditions are “equivalent” to the conditions defined in the exposure scenario. 

If applicable, your supplier should provide information in the exposure scenario to help you to 
determine if your use is covered by scaling the determinants of exposure. 

4.2.4.1   When scaling is applicable 

Scaling is a mathematical approach whereby the conditions of use described in an exposure 
scenario may be modified in order to determine if the actual conditions of use on a 
downstream user site are still covered by the exposure scenario. Safe use of the substance 
must still be assured. The application of scaling may allow you to implement conditions of use 
that differ from those described in the supplier’s exposure scenario without the need for 
further action described in chapter 4.4. 

Scaling can only be applied if the registrant has used an exposure estimation tool in his CSR in 
order to calculate the exposure to humans and to the environment for specific uses of the 
substance. Scaling cannot be applied if the registrant has based his assessment on measured 
exposure data. This is because an assessment based on measured exposure data relates to the 
actual conditions of use during measurement.  

Scaling options applicable to the exposure scenario covering one (or more) uses of a substance 
have to be communicated by your supplier in the extended safety data sheet for the substance 
which is supplied to you. If no scaling rules are provided, then scaling is not applicable to the 
use of the substance. 

Scaling options should be provided in the Section 4 of the exposure scenario “Guidance for 
downstream user” if your supplier has prepared an exposure scenario which is in line with 
ECHA Guidance on IR&CSA Part D and Chesar

. 

49

49

 The updated Part G of the Guidance on IR&CSA is available at echa.europa.eu/guidance-documents/guidance-on-
information-requirements-and-chemical-safety-assessment; Chesar Manual 6, Annex 1  provide instruction as well as 
instructions for using the revised ES format developed in the context of Chesar development and can be found at 
chesar.echa.europa.eu/support/manuals-tutorials.  

 
 
 
                                           
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Guidance for downstream users 
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If scaling is appropriate, then the information provided by the supplier must include: 

• 

• 

• 

the mathematical method which has to be applied (this could be a formula, or a web 
interface to a scaling tool or to the same exposure estimation tool used by the supplier for 
his assessment); 

the (determinants of exposure) parameters which can be scaled; 

the boundaries of scaling (to what extent changes in some parameters can be 
compensated by variation in other parameters). 

Additional information on methodology of scaling is available in Appendix 2 of this guidance. 
Examples on scaling will be developed and included in the Practical Guide “How downstream 
users can handle exposure scenarios” available on the ECHA website

. 

50

4.2.5  

Uses advised against 

If Section 1.2 of the safety data sheet specifies that your use is advised against, communicate 
with your supplier, as described in chapter 3.5. 

After having confirmed the use is advised against, consider the following options: 

• 

• 

stop this use of the substance as such or in a mixture; 

switch to a supplier who has covered your use with the necessary risk management 
measures; 

•  undertake a downstream user chemical safety report to verify that the use is safe. 

4.3 

What to do if the use and conditions of use are covered by 
the exposure scenario. 

If the conclusion of your check is that your use is covered by the exposure scenario received, 
no further action under REACH is needed.  

You should nevertheless document your check and any action you may have taken to 
guarantee the compliance with the conditions of use in the exposure scenario including the 
outcome from scaling calculations (if applicable). This can be relevant for example to facilitate 
checking the use of other mixtures that you use in the same application. You may also 
consider integrating compliance checking in your health, safety and environmental 
management system. You should also include all the necessary safety information in any 
safety data sheet prepared by you and supplied to your customers. 

If you are applying the ES you have received from your supplier (i.e. you implement the 
conditions of use from the ES you have received from your supplier), you can also use 
measured exposure data to demonstrate that you are working within the boundaries of the ES. 
The results from worker and environmental monitoring can help to verify that exposure levels 
at your site are within the range of the safe use. This information can also be used as 
supporting evidence for inspectors. If your measured data indicates that application of the 
exposure scenario may lead to unsafe conditions of use (e.g. RCR> 1 for humans and/or for 
the environment), you should immediately inform your supplier and take actions to control the 
risks. 

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47 

4.4 

What to do if uses and conditions of use are not covered by 
the exposure scenario.  

This subchapter aims to assist downstream user in deciding what to do if his use is not covered 
by the conditions of use set out in the exposure scenario. 

4.4.1 

Introduction 

You may have established that the use and/or conditions of use of your substance, as such or 
in a mixture, are not covered by the exposure scenario received from your supplier. If so, a 
number of options are available under REACH, as described in Article 37(4). The following list 
summarizes the key options that are available to you: 

1.  make your use known to your supplier with the aim of making it an “identified use” and 
included in the supplier’s chemical safety assessment: in this case, you need to contact 
your supplier and provide information on your use/conditions of use (not covered by the 
ES) to allow the supplier to refine his assessment and send you an updated ES covering 
your use/use conditions (see chapter 3.3 and 3.4 of this guidance). The supplier has to 
assess the use within one month or before the next supply, whichever is later.); or 

2.  implement the conditions of use described in the exposure scenario you have received; 

or 

3.  substitute the substance with a different substance for which an exposure scenario is 

not required or where an exposure scenario(s) is available which covers your conditions 
of use. Alternatively, substitute the process with a  process not requiring the substance; 
or 

4.  find another supplier who provides the substance with safety data sheet and exposure 

scenario that covers your use; or 

5.  prepare a downstream user chemical safety report (DU CSR) (check first if any 

exemptions apply, see chapter 4.4.2). 

The advantages and disadvantages associated with these options are outlined in Table 10. 

Table 10 Options if exposure scenario does not cover the use  

Option 

This option could be best if 

Advantages 

Disadvantages 

Exemptions 
apply  (see 
chapter 
4.4.2) 

Make your 
use known 
to your 
supplier 
(see 4.4.3) 

Case-by-case 

- this does not raise confidentiality 
concerns for you; 

- you don’t understand whether 
your use is covered because the 
exposure scenario you received is 
too general or broad. 

No changes in 
process or 
substances / 
mixtures needed. 

- A more specific 
assessment by your 
supplier based on 
your conditions of 
use may show that 
there is no risk. 

- Allow the supplier 
to better understand 
how a customer’s 
use is to be covered 

Your supplier may 
not be able to 
respond 
favourably. 

Implement 
conditions 
of use  (see 

- your use is not covered by the 
(similar) conditions of use in 
several exposure scenarios; 

- Certainty that the 
use is assessed and 
does not pose any 

- Upgrading 
existing or 
introducing new 

 
 
 
 
 
 
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48 

4.4.4) 

- you have problems in complying 
with other legislation and consider 
modifying your risk management in 
these areas too. 

risks. 

- Synergies for 
compliance with 
other legal 
obligations. 

- Potential benefit in 
the long run. 

risk management 
measures can be 
costly. 

-  New/different 
OC/RMM can 
conflict with other 
relevant legislation 
with defined use 
conditions. 

- Changes in the 
process may be 
needed. 

- Unnecessary 
additional costs 
due to RMMs 
which may be too 
conservative. 

- Substitution may 
require time and 
resources. 

 -Changes in the 
process may be 
needed. 

- Substitution may 
be not possible. 

- Suitable 
substitute may not 
be registered or 
fully assessed yet. 

Change of source 

- Resource and 
some expertise are 
required.  

- Changes in the 
process may be 
needed if adequate 
control of risks 
cannot be 
demonstrated with 
existing conditions 
of use. 

Substitute 
your 
substance 
or mixture 
(see 4.4.5) 

- you have very few substances or 
mixtures which are not covered by 
the exposure scenario; 

- Several risks can 
be eliminated or 
reduced. 

- you want to substitute the 
substances / mixtures also for 
other reasons. 

- Product quality 
may improve. 

Find 
supplier 
with 
exposure 
scenario 
covering 
your use  

Downstream 
user 
chemical 
safety 
report 
(4.4.6) 

No changes to 
current practice, 
except sourcing of 
raw materials. 

- you do not want to disclose 
information on your use- you have 
enough information and expertise 
to do the assessment; 

-OCs and RMMs are relatively 
unique and not representative of 
the sector in general. 

- Safe use is 
demonstrated and 
documented. 

- You can continue 
using the substance. 

4.4.2 

Do exemptions to preparing a downstream user chemical safety report 
apply?  

If your use is not covered by the exposure scenario, article 37(4) states that you have to 
prepare a chemical safety report, unless one of the six exemptions mentioned in the same 

 
 
 
 
 
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49 

provision apply. Therefore, you should first check if any of the exemptions of Article 37(4)(a) 
to 37(4)(f) of REACH apply to you

 before commencing a chemical safety report.  

51

Table 11 lists the exemptions of Article 37(4) of REACH. 

Table 11 Checking if the exemptions from the duty of Article 37(4) to prepare a downstream 
user chemical safety report (DU CSR) apply 

Exemption 
from Article 
37(4) of 
REACH 

37(4)(a) No 
safety data 
sheet required 
for substance 
or mixture  

37(4)(b) No 
chemical 
safety report 
is required to 
be completed 
by the  
supplier  

37(4)(c) Use is 
less than 1 
tonne per year 

37(4)(d) As a 
minimum the 
conditions of 

Explanation - your own use  

Explanation - customer’s 

52

use

If your supplier is not obliged to provide you 
with a safety data sheet for a substance, you 
do not have the obligation to prepare a DU 
CSR for your use of that substance.  

It is possible that you may receive a safety 
data sheet and exposure scenarios on a 
voluntary basis. This may be, for example, 
the case when a substance is not classified. If 
the SDS is voluntary, the requirement to 
make a downstream user chemical safety 
assessment does not apply.  

A downstream user chemical safety 
assessment (and consequent DU CSR) is only 
required for those substances in a mixture for 
which the manufacturer or importer 
(registrant) had to complete one, or which 
have not been diluted in the mixture you use 
to below the concentration thresholds in 
Article 14 (2) of REACH. You should find 
relevant information in Section 15 (sub-
section 15.2) of the safety data sheet on 
whether a CSA has been carried out by the 
registrant. Further detail is given in chapter 7 
of this guidance. 

If you supply your customers 
with a mixture, but your 
mixtures do not require a SDS 
(e.g. substances are used in 
concentration below threshold 
limits), information according to 
Article 32 of REACH needs to be 
forwarded (see also chapter 7). 

If you make a chemical safety 
assessment for the use of a 
substance in your mixture, you 
only have to consider doing it if 
your suppliers had to make a 
chemicals safety report.  

See discussion below this table. Note that if you claim this exemption, you need to 
report to ECHA, see chapter 5.5. 

See chapter 4.2 of this guidance for details on coverage of as a minimum the 
conditions of use. 

51

 Even if you are exempted from performing a DU CSR, you still have to perform risk assessment and apply measures to 

guarantee safe use of the substance /mixture in accordance to applicable EU EHS legislations (e.g. Chemical Agents 
Directive).   

52

 If you supply substances and/or mixtures down to the supply chain (e.g. you are a formulator), you have to provide 
information about your products to your customers (e.g. via the safety data sheet).  In order to prepare such information,  
you have to assess if the ESs of the substances (as such or in mixtures) that you have received from your suppliers, cover 
also the foreseeable uses of your products by your customers.  If one or more uses by your customers are not covered,  
you have the option to prepare a DU CSR to cover these uses or you may consider other options (see chapter 4.4.1 of this 
guidance). Please check chapter 5 of this guidance for more information on DU CSR and chapter 7 of this guidance for 
information to be communicated on mixtures. For additional information on communication in the supply chain, please 
consult the Practical Guide “How downstream users can handle exposure scenarios”. 

 
 
 
 
 
 
 
                                           
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If you use a mixture containing a substance below the lowest of the concentration 
thresholds in Article 14(2) of REACH, you do not have to prepare a DU CSR for 
that substance.  Also, if you dilute a substance in your own product below the 
lowest of the concentration thresholds in Article 14(2) of REACH, a DU CSR to 
cover the use of that substance in your product is not required.  Nevertheless, you 
do have to consider all information in compiling your safety data sheet if one is 
required. 

See discussion below this table. Note that if you claim this exemption, you need to 
report to ECHA, see chapter 5.5. 

50 

use are 
covered  

37(4)(e) 
Substance is 
diluted below 
concentrations 
of Article 
14(2) 

37(4)(f) 
Substance is 
used for 
PPORD 

Re: Article 37(4)(c) (table 11) – total use of the substance or mixture is less than 1 
tonne per year

? 

53

The amount considered as “used” includes the amount stored as well (even if storage is 
already covered by the ES of your supplier). Furthermore, the tonnage limit applies to the total 
amount used, regardless of the number of different uses, the supplier and whether or not an 
exposure scenario was received. 

If this exemption applies, you are still required (according to Article 37(6) of REACH) to 
consider the use of the substance and identify and implement measures to ensure control of 
risk to humans and the environment based on information received from your supplier. If you 
supply the substance to others, you must identify and communicate appropriate measures to 
your customers in the safety data sheet, if one is required. You also have to report to ECHA 
(see chapter 5.5). 

Re: Article 37(4)(f) (table 11) - Use in product and process orientated research and 
development 

54

If you are using the substance, as such or in a mixture, in process and product oriented 
), you are not required to make a DU CSR, provided that 
research and development (PPORD
“[…] the risks to human health and the environment are adequately controlled in accordance 
with the requirements of legislation for the protection of workers and the environment”. In this 
case you have to report the information specified in Article 38(2) of REACH to ECHA. This also 
applies to research and development activities which you have notified under Directive 
67/548/EEC, as these notifications are no longer valid after June 1st 2008. Note that reporting 
to ECHA is not required for the use in PPORD if this use is less than 1 tonne per year (Article 
38(5) of REACH). 

Note that substances with which you carry out process and product oriented research and 
development could be subject to authorisation requirements or restrictions.  

If you are included in your supplier’s notification for process and product oriented research and 
development, as a listed customer, you will need to implement the conditions communicated 

53

 It should be noted that in the context of Article 37 of REACH the tonnage should be based on the calendar year and not 

on the 3-year average which was designed for registration purposes. 

54

 REACH defines: “Product and process orientated research and development: means 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;”. Please note that scientific research and development can cover analytical activities. Please 
refer to Q&A on Application for authorisation nr 585 at echa.europa.eu/support/qas-support/qas. More guidance on 
which activities are regarded as PPORD is given in the ECHA Guidance on Scientific Research and Development (SR&D) 
and Product and Process Oriented Research and Development (PPORD)), available at echa.europa.eu/guidance-
documents/guidance-on-reach. 

 
                                           
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51 

by your supplier (including any conditions imposed by ECHA). It is your obligation to 

55

. If you want to use the substance for other purposes than 

implement these conditions
process and product oriented research and development, the substance has to be registered 
for that use (unless exempted). In this case you need to inform your supplier of this to ensure 
that your use of the substance has been registered (in such case you have to receive a safety 
data sheet with a registration number and attached exposure scenario covering your use (if 
applicable) or you need to register the substance for your use).  

If you are using a substance with which you receive an exposure scenario for process and 
product oriented research and development, without being a customer included in the 
notification of your supplier, all the obligations of a downstream user apply. 

4.4.3 

Make your use known to your supplier with the aim of having it identified  

It is possible that your use is completely “missing” from the supplier’s exposure scenario 
(chapter 4.2.1). If this is the case, you have the option to make your use known in writing to 
your supplier, with the aim of making it an identified use. See chapters 3.3 and 3.4 of this 
guidance for more detail. 

It is possible that one of the processes/activities for your identified use is completely "missing" 
from the supplier's exposure scenario (chapter 4.2.2). If this is the case, you have the option 
to make your processes/activities known in writing to your supplier, with the aim of including 
them in the exposure scenario. 

4.4.4 

Implement the conditions of use of the exposure scenario  

If your conditions of use are not covered by the exposure scenario, you could also change the 
way your substance or mixture is used and implement the conditions indicated in the exposure 
scenario. You should ensure that you consider all exposure scenarios that do not cover your 
use conditions, in order to bring yourself into compliance with all of them in one action. This 
option is particularly worth considering when:  

•  exposure scenarios of several substances do not cover your conditions of use and 

similar risk management measures are recommended in them; 

•  you  have  encountered  difficulties  in  complying  with  existing  environmental  or 

workers legislation in the past. 

Implementing the exposure scenario could entail: 

•  adding new risk management measures; and/or  

•  upgrading existing risk management measures; and/or  

• 

• 

changing  the  operational  conditions  according  to  the  information  in  the  exposure 
scenario; 

changing the process (for example, enclosure of machinery) or product design (for 
example, reducing the concentration of the substance or substance in a mixture in 
your product) according to the information in the exposure scenario.  

55

 A safety data sheet must be supplied if the substance or mixture is classified as hazardous according to CLP (or a 

mixture as dangerous according to the DPD until 1 June 2015) or may need to be supplied on request if the mixture in not 
classified as hazardous/dangerous but contains hazardous  substances.  If a safety data sheet is not required, information 
on the conditions to be implemented according to the PPORD notification should be communicated, based on Article 32 
of REACH.  

 
 
 
                                           
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If you decide to change your process, or to install additional risk management measures, you 
must implement these within one year after receipt of a safety data sheet with registration 
number and the exposure scenario (Article 39(1) of REACH). 

4.4.5  

Substituting the substance or substance in mixture 

Substitution of the substance may be achieved by exchange of raw materials and/or by 
optimising process design in such a way that the substances under question become 
superfluous. If you, as downstream user are planning to substitute a substance with another 
substance you have to be sure that the exposure scenario of the substitute, if required, will 
cover your use and conditions of use. You should also look at the physicochemical properties 
and hazard profile of the substitute in order to assure that the new substance will pose lower 
risks than the original one. Other factors to consider when you plan to substitute a substance 
may be: 

• 

• 

• 

changes  would  have  to  be  discussed  with  customers  and  potentially  tried  out  with 
the downstream users; 
changes would have to be clearly communicated in advance to customers who may 
have long requalification times; 
costs 
processes/equipment etc.); 

tests,  qualification/certification, 

change  of 

substitution 

(e.g. 

for 

•  ease and practicability of change;  
• 

if a substance (as such or in the mixture) is listed on the candidate list (see REACH 
Article 59), it may have to be authorised in future;  

•  availability of alternatives; 
•  outcomes of a socio-economic analysis. 

The Guidance on the preparation for an application for authorisation
to assess the availability and feasibility of substitution and could help you in organising 
substitution.   

 contains advice on how 

56

4.4.6 

Downstream user chemical safety report (DU CSR) 

Preparing a DU CSR means that you yourself assess whether the risks from your use of the 
substance as such or in a mixture are adequately controlled. Further information is given in 
chapter 5 of this guidance. 

4.5  

Your use is confidential 

You may want to consider that your use of the substance as such or in a mixture is 
confidential. In this case you have the same three options described above to achieve 
compliance with REACH: you can substitute the substance with one that does not require an 
exposure scenario or one that covers your use, you can adapt your use to the exposure 
scenario provided by your supplier or you can prepare a DU CSR that shows adequate control. 

4.6 

Timescales for fulfilling obligations 

Article 39 (1) states: 

Downstream users shall be required to comply with the requirements of Article 37 at the latest 
12 months after receiving a registration number communicated to them by their suppliers in a 
safety data sheet. 

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53 

If your use is advised against (as described in the safety data sheet Section 1.2) then within 
12 months you have to: 

• 

cease that use, or 

•  prepare a DU CSR that includes that use. 

If you conclude that your use is outside the conditions described in the received exposure 
scenarios (after checking as outlined in chapter 4), then within 12 months you have to: 

• 

• 

• 

implement the conditions described in your supplier’s exposure scenario and 
recommend the conditions to your customers; or 

request your supplier to clarify if your use is already covered and if not, ask him to 
include your use in his assessment; or 

find another supplier that supports your use; or 

•  prepare a DU CSR (unless you qualify for an exemption from undertaking a DU CSR). 

The time period starts on receipt of the safety data sheet with the registration number, 
however it is not possible to check if your use is not covered without the receipt of exposure 
scenarios. It is recommended that if you receive a safety data sheet without any exposure 
scenarios attached that you formally communicate with your supplier to check the reason why. 
Document this action, and if and when you receive the exposure scenario(s). 

Article 39(2) 

Downstream users shall be required to comply with the requirements of Article 38 at the latest 
six months after receiving a registration number communicated to them by their suppliers in a 
safety data sheet.  

Downstream users must report to ECHA in accordance with the requirements of Article 38 of 
REACH (see chapter 5.1.1) within 6 months after having received a safety data sheet 
containing a registration number. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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5 

Guidance for downstream users 
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Use not covered: preparing a downstream user 
chemical safety report (DU CSR) 

When a downstream user checks whether his use is covered in the exposure scenario received 
from the supplier, as described in chapter 4, he may establish that his use (including the 
use(s) further downstream) is not covered. 

One of the options presented in chapter 4.4 is to undertake a downstream user chemical safety 
assessment (DU CSR). This chapter provides guidance on carrying out this assessment and on 
documenting it in the DU CSR. The issues discussed in this chapter include: 

•  what are the requirements related to the DU CSR; 

•  what is scope of the DU CSR; 

•  how to carry out the assessment and prepare the DU CSR; 

•  how to communicate with ECHA and the customers. 

5.1 

Legal requirements related to a downstream user chemical 
safety report (DU CSR) 

Article 37(4) of REACH states that: 

Article 37(4) 

A downstream user of a substance on its own or in a mixture shall prepare a chemical safety 
report in accordance with Annex XII for any use outside the conditions described in an 
exposure scenario or if appropriate a use and exposure category communicated to him in a 
safety data sheet or for any use his supplier advises against. 

You are required to prepare a DU CSR for: 

• 

• 

any use not covered or outside the conditions communicated via an exposure scenario; 

any  use  advised  against  by  your  supplier  (if  you  choose  to  continue  to  use  the 
substance, so that you can document that the use is safe).  

Annex XII of REACH sets out the general provisions for downstream users to assess 
substances and prepare chemical safety reports. 

Before commencing a DU CSR, it is advisable to check all your options, and if any of the 
exemptions in Article 37(4) of REACH apply, as described in chapter 4.4. One of these 
exemptions, Article 37(4)(c) is if “the downstream user uses the substance or mixture in a 
total quantity of less than one tonne per year;”. If this applies, the downstream user must still 
ensure that the risks are adequately controlled, as specified in Article 37(6) of REACH: 

Article 37(6) 

Where a downstream user does not prepare a chemical safety report in accordance with 
paragraph 4(c), he shall consider the use(s) of the substance and identify and apply any 
appropriate risk management measures needed to ensure that the risks to human health and 
the environment are adequately controlled. Where necessary, this information shall be 
included in any safety data sheet prepared by him. 

 
 
 
 
 
 
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5.1.1 

Obligation to report information 

Article 38(1) states: 

55 

Before commencing or continuing with a particular use of a substance that has been registered 
by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall 
report to the Agency the information specified in paragraph 2 of this Article, in the following 
cases 

a)  the downstream user has to prepare a chemical safety report in accordance with Article 

37(4); or 

b)    the downstream user is relying on the exemptions in Article 37(4)(c) or (f) 

You have to report to ECHA if you have to prepare a DU CSR.  

You also have to report to ECHA if you do not need to prepare a chemical safety report 
because you are relying on exemptions from undertaking a DU CSR due to: 

• 

• 

the use of a substance or mixture in a total quantity of less than one tonne per year 
(Article 37(4)(c)); 

the use of the substance for product and process oriented research and development 
(PPORD), provided that the risks to human health and the environment are adequately 
controlled in accordance with the requirements of legislation for the protection of 
workers and the environment. Note that reporting to ECHA is not required if the use for 
PPORD is less than one tonne per year. (Article 37(4)(f)). 

If your total use remains less than one tonne per year across all uses, then all uses not 
covered by the received exposure scenarios have to be reported to ECHA. 

Article 38(5) 

Except where a downstream user is relying on the exemption in Article 37(4)(c), reporting […] 
shall not be required in respect of a substance, on its own or in a  mixture, used by the 
downstream user in quantities of less than one tonne per year for that particular use 

If you have to prepare a downstream user CSR, you do not have to report a particular use 
(that is, a use not covered) to ECHA that is less than one tonne per year. This exemption 
applies only if your total use of the substance (including uses which are covered by a CSA) is 
one tonne or more per year. The table below summarises the links between the tonnages and 
the requirements. 

Table 12 Summary of total use and “Use not covered” tonnages with associated reporting 
requirements 

Total Use  

(tonnes per year) 

Particular  Use  not 
covered  

(tonnes per year) 

DU CSR required? 

Need  to  report  to 
ECHA? 

<1 

>1 

>1 

- 

>1 

<1 

Exempt 

Yes 

Yes 

Yes 

Yes 

No 

 
  
 
 
 
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Guidance for downstream users 
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This is further illustrated with the examples below:  

Example 1:  You use a registered substance of total 5 tonnes per year (total use >1 tonne 

per year). You use 0.8 tonnes of it in a spray application process, and the 
remaining 4.2 tonnes in a dipping process. Your spray application use is not 
covered in the exposure scenarios you receive, but your dipping use is covered.  

•  You have to prepare a DU CSR as per Article 37(4), because your supplier 

and the other actors up the supply chain do not attach an ES to the 
safety data sheet to cover your spray application process and your total 
use of the substance is more than one tonne per year.  

•  You do not have to report to ECHA, because the particular use not 

covered (spraying) is less than one tonne per year while your total use is 
more than one tonne per year. This corresponds to the last row in Table 
12. 

Example 2:  You use a registered substance of total 0.8 tonnes per year and use all of it in a 
spray application process. Your use is not covered in the exposure scenarios you 
receive.  

•  You do not have to prepare a DU CSR because your total use of the 

substance is < 1 tonne per year.  

•  You do have to report to ECHA that your use is not covered. This 

corresponds to the first row in Table 12.  

Details on how to report to ECHA are provided in chapter 5.5 and on the Downstream User 
pages of the ECHA website

. 

57

5.2 

What is a chemical safety assessment and report  

A chemical safety assessment aims to identify the conditions of use under which a 
substance can be used safely throughout its entire life-cycle. It includes hazard and exposure 
assessments, as well as a risk characterisation. The registrant of a substance carries out an 
assessment and documents it in the chemical safety report as part of the registration 
process. The registrant’s chemical safety report is submitted to ECHA. The complete report is 
not made publicly available. 

58

Exposure scenarios are a core element of the chemical safety assessment of certain hazardous 
, and describe operational conditions and risk management measures that provide 
substances
adequate control of the risks. Relevant information from exposure scenarios in the registrant’s 
chemical safety assessment are communicated to downstream users. The exposure scenario 
for communication is annexed to the safety data sheet. They should include practical and 
proportionate information against which a downstream user can check his use(s) without need 
for further assessment.  

57

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57 

5.3 

What is a downstream user chemical safety report (DU CSR) 

When a downstream user has decided to perform a chemical safety assessment, a DU CSR 
documents the results of that assessment. The assessment establishes conditions of use to 
ensure that the risk (to human health and environment) for the use(s) not covered in the 
received exposure scenarios is adequately controlled. 

A DU CSR is a different and generally smaller undertaking than the CSR required for 
registration. The differences include the following: 

•  You do not have to make a hazard assessment. This is the detailed information reported 
in sections 1 to 8 of a registrant’s chemical safety report. A DU CSR is usually based on 
the hazard information provided in the safety data sheet, unless a downstream user 
chooses to carry out his own hazard assessment. 

•  You only assess the uses not covered by your supplier. This is much less than the 

registrant’s chemical safety report which assesses all identified uses of the substance 
(this is the information reported in sections 9 and 10 of a registrant’s chemical safety 
report). 

•  You do not need to use IUCLID, the software used by registrants to submit dossiers to 

ECHA. 

•  The DU CSR is not submitted to ECHA. It may be checked by the national enforcement 

authority and needs to be kept available by the downstream user. 

If the assessment establishes that the risk is not adequately controlled, then changes to your 
conditions of use must be implemented and the assessment must be repeated. If you are a 
supplier, you may need to communicate information from the assessment you carried out in 
the safety data sheets that you provide to your customers. 

 
 
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Guidance for downstream users 
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t
en

ssessm
ical Safety A

em
h
C

DU decides to carry 
out a DU CSA

Report the intention 
to ECHA 
(within 6 months)

Identify uses to be 
assessed

Review hazard 
information (DNELs/
PNECs) and refine if 
necessary

Generate exposure 
scenario

Estimate exposure

No

Characterise risks

Risk 
controlled?

Yes

Document in the DU CSR
(within 12 months)  

Annex exposure scenario to 
SDS and ensure consistency 
in the main body

Figure 4 Work process for downstream user chemical safety assessment 

5.4 

Key steps for the downstream user chemical safety 
assessment  

The approach taken for a downstream user chemical safety assessment under REACH is similar 
to that for risk assessments at workplaces and for the environment, with the differences 
stemming from the specific legislative requirements. The work process is illustrated in Figure 4 
and the main steps are outlined below. It is expected that the person undertaking a DU CSR 

 
 
 
 
 
 
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59 

has some expertise and competence in undertaking risk assessment. Parts D and E of the 
Guidance on IR&CSA

provide additional and detailed guidance. 

59 

i. 

Identify the uses to be assessed 

Start the process with the identification of the uses to be assessed. Begin with 
your use of the substance, and cover any identified uses further down the supply 
chain, if you have decided to cover your customers’ uses. 

ii. 

Review the hazard information provided by your supplier 

Determine if the exposure related hazard information provided in Section 8 of 
the safety data sheet received from your supplier is adequate for the identified 
use(s). Normally all relevant exposure routes should have been considered and 
data provided where attainable. In case of difficulties, such as how to deal with 
missing information, consult chapter 5.4.1 for how to proceed. 

iii.  Generate exposure scenarios for the uses you want to assess 

Develop initial exposure scenarios, containing a technical description of 
processes and/or activities carried out with the substance, and the operational 
conditions and risk management measures for the uses to be assessed. See 
chapter 5.4.2. 

iv. 

Estimate the exposure 

The exposure estimation provides a firm basis on which to demonstrate that 
exposure is adequately controlled. The potential for exposure can be estimated 
using measured exposure data, exposure estimation tools or control banding. 
Section 9 of the safety data sheet provides physical and chemical properties of 
the substance which a DU might find useful for carrying out the exposure 
estimation. Part D and Chapters R14 to R18 of the Guidance on IR&CSA provide 
advice on exposure estimation. 

v. 

Characterise the risk 

Compare estimated exposure levels with quantitative or qualitative hazard 
information, to show that the risks are adequately controlled. For quantitative 
assessment this is referred to as the risk characterisation ratio (RCR). If, based 
on the initial ES, the risks are not adequately controlled, further iterations are 
needed, to refine the conditions of use until the risk is shown to be adequately 
controlled. More information on risk characterisation can be found in the Part E 
of the Guidance on IR&CSA. 

vi. 

 Document in the DU CSR 

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The assessment, including the final exposure scenarios indicating that the risk is 
adequately controlled must be documented in the DU CSR. Information on safe 
use relevant for the next level of DU (and further) in the supply chain must be 
integrated into the extended safety data sheet, if applicable. 

5.4.1 

Review the supplier’s hazard information (and adapt if necessary) 

Safe threshold values must be provided by your supplier (Section 8.1 of the safety data sheet 
(REACH Annex II)) where a CSR is required, and they have been derived. These values will 
also be reported on the ECHA web pages "information on chemicals"
downstream user will use the DNEL/PNEC values provided. 

. Normally, a 

60

Note that a REACH chemical safety assessment is based on DNEL/PNECs rather than 
occupational exposure limit (OEL) values or emission limit values. 

In exceptional cases you may find that:  

(i) 

(ii) 

DNELS/PNECs have not been provided 

you decide that the supplier’s hazard assessment is not appropriate 

(i) DNELs/PNECs not provided 

This may simply be an oversight on the part of your supplier, so you should formally 
communicate with the supplier to check why the relevant DNEL or PNEC is not available. 

It may be the case that the DNELs/PNECs have not been derived. If you have sufficient REACH 
experience and technical competence (for example, if you have done your own registrations), 
you may decide to: 

-  ask your supplier (or his supplier) to forward an inquiry to the SIEF, to ask if there are 

other members in the SIEF interested in, or currently deriving, that value; 

-  derive the value yourself using Chapters R8 and R10 of the Guidance on IR&CSA

61

 and 

the Practical Guide “How to prepare toxicological summaries in IUCLID and how to 

62

derive DNELs” 
ecotoxicological expertise). 

 (note that this requires a high level of toxicological and 

If, after having reviewed the evidence/relevant data, you determine that a DNEL/PNEC cannot 
be derived, you may decide to undertake a qualitative risk assessment. In this case you may 
refer to Part E of the Guidance on IR&CSA and to Practical Guide “How to undertake a 
qualitative human health assessment and document it in a chemical safety report”
practical guide assumes some knowledge of the intrinsic properties of the used substances 
characterised through CLP and the resulting risk assessments of chemicals. 

. This 

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60

61

62

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(ii) Supplier’s hazard assessment is not appropriate  

If, based on your knowledge of the substance, you decide that the hazard information received 
is not appropriate, you may formally communicate with your supplier. You should provide your 
reasoning, and ask him to review the hazard information. 

If you have sufficient REACH experience and technical competence (for example, if you have 
done your own registrations), you may decide to update the hazard assessment yourself, using 
the relevant sections (e.g. Part B, Chapters R.2-R.10 etc.) of the Guidance on IR&CSA.  

5.4.2 

Develop exposure scenarios (for uses not covered) 

Downstream users are normally familiar with the conditions of use for the use(s) not 
supported. The substances are generally used onsite, or for a use that a customer has 
informed you about. Consequently there is a good basis for developing exposure scenarios. 

Generic exposure scenarios have been developed by some industry sectors and some 
companies. These apply to various substances / mixtures and cover a broader range of 
conditions of use. If your sector has developed such generic exposure scenarios that are 
applicable for your use, you can utilise these as a starting point, and adapt them if necessary. 

The risks for workers, the environment and consumers should be considered. When the 
substance is part of an article, the life-cycle of the article should also be taken into 
consideration. Waste stages, if relevant, should also be included.  

If you are a supplier and will be communicating the exposure scenarios to your customers, it is 
advisable that you work with the standardised use descriptor system (see the Guidance on 
IR&CSA, Chapter R.12: Use descriptor system

). 

64

You may also be notified of a use by your customers; in this case you may decide if you want 
to cover it in your chemical safety report or to notify it up the supply chain (to your 
supplier(s)). 

You may be able to demonstrate, based on qualitative considerations, that certain exposure 
routes are negligible and do not have to be quantified to be confident that risk is controlled. 
Some arguments and examples are provided in Chapter R.5 of the Guidance on IR&CSA. 

5.4.3 

Exposure Estimation  

Exposure estimation is important both for quantitative and qualitative risk assessments. There 
are a number of ways in which the exposure can be estimated and the risk characterised, 
including: 

A.  Measured exposure data 

B.  Exposure estimation tools 

C.  Control banding  

A.  Measured exposure data 

Measured exposure data refers to personal exposure or environmental emission measurements 
undertaken for the activity / process category of interest or similar tasks. Many downstream 
users are likely to have measured exposure data available, which were undertaken in 
accordance with their environmental health and safety monitoring program. 

The reliability and representativeness of any data used needs to be assessed as the purpose 
for which it was collected may affect how it can be used in a REACH exposure assessment. Due 

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consideration should be given to the basis and conditions under which the data was collected 
and the standards and protocols implemented for data collection (e.g. EN 689 for assessing 
workplace atmospheres, or “Testing Compliance with OELs for Airborne Substances” (BOHS, 
2011) etc.). This should be documented in the DU CSR. Further information is provided in the 
Guidance on IR&CSA, Chapter R.14: Occupational exposure estimation

. 

65

If measured exposure data is not available, suitable analogous data may be appropriate. This 
is typically data based on similar operations, using the same substance or data based on the 
same operation, but for similar substance properties. When using analogous data, the assessor 
must ascertain that his estimation gives a result on the safe side, to avoid an underestimation 
of the risk. 

B.  Exposure estimation tools 

A number of exposure estimation tools are widely available, such as: 

a.  DU CSR / Scaling tools (typically based on Ecetoc TRA) 

b.  Ecetoc TRA (worker, consumer, environment) 

c.  Stoffenmanager (worker) 

d.  Advanced Reach Tool (ART) (worker) 

e.  EUSES (environment) 

f.  ConsExpo (consumer) 

These tools are publicly available, and are free of charge. Links and summary descriptions of 
the tools, including applicability and limitations, are provided in Chapters R.14, R1.5 and R.16 
of the Guidance on IR& CSA, where additional approaches and tools are also described. The 
tools vary in their level of sophistication and applicability. Some are conservative screening 
models, others incorporate greater specification of parameters, giving a more robust 
estimation for certain scenarios. 

The correct use of these tools and interpretation of the results requires expertise. 

C.  Control banding  

A control banding tool, such as the EMKG-Expo-Tool, can be used for inhalation exposure 
calculations in the working environment. This is an exposure predictive tool which is based on 
the assumption that the workplace exposure is determined by the exposure potential of the 
handled substance and the applied control strategy. Based on information on the substance 
and conditions of use, the tool predicts a lower and an upper value for the exposure range. The 
upper value of the exposure range should normally be used for the risk characterisation, i.e. 
the comparison with the DNEL-value. 

The EMKG-Expo-Tooltool can be downloaded from the Internet
. Its application in chemical 
safety assessment is described further in Part D and in Chapter R.14 of Guidance on IR&CSA 
Stoffenmanager can also be used as a control banding tool and it’s available on the internet.  

66

Chapter R.14 explains that several control strategies (with different RMMs) can be selected and 
the effect of these strategies on the exposure estimate can be calculated. 

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5.4.4 

Characterise the Risk 

63 

To characterise the risk, compare exposure levels to quantitative or qualitative hazard 
information (REACH Annex I, 6). When suitable predicted no-effect concentrations (PNECs) or 
derived no-effect levels (DNELs) are available, derive risk characterisation ratios (RCRs) in 
order to decide if risks are adequately controlled for each environmental compartment and for 
each human population known to be or likely to be exposed (REACH Annex I, 6.4). If all risk 
characterisation ratios are below 1, the risk is considered as adequately controlled and the 
conditions of use can be documented as the “final exposure scenario”. This is termed a 
quantitative risk characterisation. 

Risk Characterisation Ratio RCR =  

Exposure 
_________________ 

DNEL or PNEC 

DNEL: Derived No Effect Level 

PNEC: predicted no-effect concentrations 

67

If there are no DNELs/PNECs to compare with because of non-threshold effects, carry out a 
 is available) or qualitative assessment of the likelihood 
semi-quantitative (in case a DMEL
that these effects are avoided when exposure scenarios are implemented (REACH Annex I, 
6.5). The methodologies used are often based on hazard and control banding, and may be 
applied as long as there is sufficient justification that under the conditions of use the risk is 
controlled. Further information can be found in the Practical Guide “How to undertake a 
qualitative human health assessment and document it in a chemical safety report”

.  

68

Site-based risk assessments carried out due to the requirements of other legislation may also 
provide useful information. 

5.4.5 

Documenting the downstream user chemical safety assessment in the 
report  

When documenting the downstream user chemical safety assessment, include all relevant 
headings of the chemical safety report format given in Annex I of REACH. 

The DU CSR includes: 

Part A.  A declaration that the risk management measures outlined in the relevant exposure 

scenarios are implemented by the downstream user for his own uses and that the 
risk management measures outlined in the exposure scenarios for the identified uses 
are communicated down the supply chain (as applicable). 

Part B. 

Information on the DNELs/DMELs/PNECs used and additional information on your 
own hazard assessment, if performed, the exposure assessment (with any necessary 
argumentation and supporting documents) and risk characterisation for all assessed 
uses. This corresponds to sections 9 and 10 of the format in section 7 of Annex I. 

You are not required to submit the DU CSR to ECHA. You are, however, required to keep the 
chemical safety report up to date and available. It is advisable to check any new safety data 

67

68

 Derived minimum effect level. 

 More information can be found by reading the Practical Guide “How to undertake a qualitative human health 

assessment and document it in a chemical safety report” available at echa.europa.eu/practical-guides.  

 
 
 
 
 
 
 
 
 
                                           
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sheet you receive for the substance to establish whether relevant data which may affect your 
assessment has changed. 

5.5 

Reporting to ECHA 

If you are required to report to ECHA (termed a Downstream User Report), two options are 
available:  

(i) 

(ii) 

a Webform via the downstream user pages of the ECHA website
recommended for most downstream users, in particular those who are not familiar 
with IUCLID 

: this is 

69

via REACH-IT/IUCLID: this is recommended for downstream users who are already 
users of IUCLID and who want to maintain their report records in the REACH-IT 
system. Support is provided by the Data Submission Manual “How to prepare and 
Submit a Downstream user report using IUCLID 5”

. 

70

If you need to report that classification
that using option (ii), via REACH-IT.  

71

 is different to that of your supplier you can only do 

You should go to the web page on downstream user reports
you want to use. 

72

, to select which reporting option 

The information to be provided for unsupported uses includes: 

• 

• 

• 

• 

the identity and contact details of the downstream user; 

the registration number of the substance; 

the identity of the substance; 

the identity of the supplier;  

•  a brief general description of the use(s) and conditions of use; and 

•  a proposal for additional testing on vertebrate animals if this is foreseen. 

The brief general description of use should identify the use(s) not covered, describe the  
factors which influence the exposure levels and outline the main risk management measures. 
It is not a chemical safety report. The downstream user report should be available onsite for 
inspection by national authorities. 

5.6 

Annex relevant Exposure Scenario(s) to updated SDS 

If you have prepared a DU CSR for your customers’ uses you are required to place the relevant 
exposure scenarios (for communication) in an annex to the safety data sheet you supply to 
them (Article 31(7) of REACH). 

69

70

71

72

 echa.europa.eu/regulations/reach/downstream-users. 

 echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals. 

 According to Regulation (EC) No 1272/2008 (CLP Regulation). 

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65 

As part of the communication, information on scaling should also be provided, where scaling is 
applicable. For more details on scaling, including the principles, the communication of scaling 
options, and the boundaries of scaling see Appendix 2. 

More information is provided in the Guidance on the compilation of safety data sheets
Chapter 7 of this guidance provides more detailed guidance for communicating information on 
mixtures. 

. 

73

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6 

Guidance for downstream users 
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Communicating new information on hazards and risk 
management measures upstream 

This chapter provides guidance on how to comply with the obligations placed on downstream 
users by REACH to: 

• 

• 

• 

communicate  new  information  on  the  hazardous  properties  of  substances  and 
mixtures up the supply chain to suppliers; 

communicate  up  the  supply  chain  any  information  that  might  call  into  question  the 
appropriateness of risk management measures identified in a safety data sheet; and 

report  to  ECHA  if  his  classification  of  a  substance  is  different  from  that  of  his 
suppliers. 

6.1 

Introduction 

Sometimes you may not agree with the information provided to you by your supplier via an 
extended safety data sheet. If you consider that the proposed risk management measures are 
not appropriate, or if you, for a justified reason, classify your substance differently to your 
suppliers, you need to take action to inform your supplier or report to ECHA, respectively. 
Moreover, you may have additional information concerning the substance. In this case you 
need to actively communicate this to your supplier(s). 

6.2 

Communicating new information on hazardous properties up 
in the supply chain 

Article 34  

(a): Any actor in the supply chain of a substance or a mixture shall communicate the following 
information to the next actor or distributor up the supply chain: 

(a) new information on hazardous properties, regardless of the uses concerned; 

With any substance or mixture you receive, you may receive information from your supplier, 
either in the form of a safety data sheet or information according to Article 32 of REACH. If you 
receive no specific information, it should mean that the suppliers have concluded that the 
substance or mixture is not hazardous and can be handled without any specific risk 
management measures. 

There is no definition in REACH of what constitutes “new” information, or what source and 
quality of data is acceptable. New information may relate either to substances or to mixtures. 
The main criteria for deciding whether you hold new information are that: 

• 

• 

• 

the information is not communicated to you by your supplier; 

the information is not available in public data bases or literature; 

the  information  is  relevant  for  the  substance  or  mixture  you  receive  from  the 
supplier;  

•  you have good evidence to support the information; 

• 

the  information  could  have  consequences  for  the  management  of  the  risks  of  the 
substance. 

 
 
 
 
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67 

New information could be observations on any adverse effects on human health or the 
environment (e.g. observations on acute human health effects at workplace) or, if you have 
carried out testing of substances and mixtures, results of those tests. 

For non-classified substances and mixtures, you may not receive any information from your 
supplier at all. In this case, the obligation to inform suppliers about “new information” also 
applies. Therefore if you have an indication that a substance or mixture for which you have 
received no information (neither according to Article 32 nor a safety data sheet) is hazardous, 
you should inform your supplier of this. 

Table 13 below lists the Sections of the safety data sheet which you should check against your 
own information on the substance. If your information is different from that in your supplier’s 
safety data sheet, you must communicate this up in the supply chain to him. 

Table 13 Forwarding information on classified substances and mixtures 

Information 
received under a 
given Section of the 
safety data sheet 

2: Hazards 
identification 

8: Exposure limit or 
biological values 

8: Derived no effect 
levels (DNELs) and 
predicted no effect 
concentrations 
(PNECs) 

9: Physicochemical 
properties 

10: Stability & 
reactivity 

11: Toxicology 

12: Ecotoxicology 

(2), (3), 15, (16): R-
phrases or hazard 
statements 

Substance 
/ Mixture 

“New information” and requirements / conditions 
to forward it up the supply chain  

Substances: it is obligatory to forward new information 
on hazards, including new information from testing and 
other sources that change the classification of the 
substance.  

Mixtures: if you test the mixture you purchase and this 
information differs from that in the safety data sheet of 
the supplier, it is obligatory to forward this information, 
or if you recognize that the classification of the mixture 
is obviously incorrect or incomplete 

In national or other Community legislation and/or 
workplace risk assessments different limit values are 
imposed on you. You should inform your supplier if 
specific limits applicable in your case change. 

If you carry out tests, e.g. in the scope of a DU CSR to 
refine a PNEC/DNEL value, it is obligatory to forward the 
information upstream. 

If you do not test, but reach different conclusions on 
these values, e.g. because you use different data or 
interpret it differently, you may communicate this 
information upstream.   

New information from testing, practical experience, or 
other sources, should be forwarded to your supplier, if 
relevant to the substance or mixture you obtained from 
him. 

Contact your supplier to clarify whether your supplier 
has classified differently than yourself or has made a 
mistake in the safety data sheet.  

DNELs & 
PNECs in 
mixture 
SDS may 
refer to 
different 
substances. 

Any actor holding new information on hazards should report to his immediate supplier, 
regardless of whether or not his supplier is the registrant of the substance. You may first want 
to communicate only the fact that you have new information on a substance or mixture, and 
the result. You do not have to forward the test report. If your supplier is interested in 

 
 
 
 
 
 
 
 
 
 
 
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Guidance for downstream users 
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obtaining the full study report, you may wish to negotiate the conditions for providing such 
information. Please note that if you yourself receive new hazard information from your own 
customers, you are required to pass the information to the next actor up the supply chain. 

Note that the downstream user has also the option to request to become a member of a SIEF 
as “data holder” with the intention to share relevant information. For more information please 
consult the Guidance on data sharing

. 

74

There are no specific deadlines for communicating information on hazards upstream. You 
should always do so as soon as you become aware that, compared to the information received 
from your supplier, you have “new information”. The requirements relate to the main body of 
the safety data sheet, as well as the exposure scenario. Note also that this type of supply 
chain communication does not involve any reporting to ECHA. 

New information on hazards may influence your supplier’s recommendations on risk 
management measures. If you are a formulator, you should assess whether the new 
information warrants that new safety information is communicated with your mixture to your 
customers (see also chapter 7 of this guidance). 

6.3 

Communicating on the appropriateness of the risk 
management measures upstream 

REACH Article 34: Any actor in the supply chain of a substance or a mixture shall communicate 
the following information to the next actor or distributor up the supply chain: 

(a)[…] 

(b) any other information that might call into question the appropriateness of the risk 
management measures identified in a safety data sheet supplied to him, which shall be 
communicated only for identified uses. 

This provision of REACH aims at ensuring that the risk management measures communicated 
to you in a safety data sheet and/or exposure scenario, and which you are required to 
implement, are adequate to control the risks. It is also your means to react to the supplier’s 
recommendation of measures which are not technically feasible. In short, communicating any 
information calling into question the appropriateness of risk management measures to your 
supplier will contribute to a better quality of safety data sheets. The communication 
requirements relate to the main body of the safety data sheet, as well as the exposure 
scenario. 

Information on risk management measures under Section 8 of the safety data sheet addresses 
measures for all identified uses. They are described in a general manner or just refer to the 
use-specific risk management measures in the attached exposure scenarios. This subchapter 
gives some examples of when you may consider the risk management measures 
recommended under Section 8 of the safety data sheet to be inappropriate. This applies to 
both quantitative and qualitative measures. 

•  The recommended measures are not effective for the type of substances: for 

example, your supplier recommends waste gas incineration during the processing of 
a mixture containing metals. The incineration will remove organic compounds but 
not metals (which will be released as themselves or as various compounds of the 
metals). 

•  The recommended measures are overprotective: for example, full arm gauntlets for 
a substance which is not classified for acute effects. The recommended measures 

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69 

relate to exposure routes that do not occur: an example would be that a gas 
scrubber is recommended for a non-volatile substance. 

If your current practice differs from the recommendations, it may mean not only that the 
recommended measures are inappropriate, but also that the measures are applicable for other 
identified uses but not for yours, or that your current use of the substance or mixture is not 
safe. Another reason may be that your installations are adapted to other and more hazardous 
substances and therefore you have more strict conditions of use than proposed by your 
supplier. This does not necessarily mean that the recommended risk management measures 
are inappropriate. Check why you use the substance as such or in a mixture differently and 
document the findings. Information from technical staff (measures are not feasible) or health, 
safety and environmental management (risk assessments / measurements / new information 
on hazards) may be helpful. 

When communicating on inappropriate risk management measures, REACH does not specify 
what information exactly you should forward, or in what format. You need to provide sufficient 
information to justify why you consider that the recommendations are not appropriate. The 
type of information depends on the reason why you call into question the recommendations. If 
you regard the measures as ineffective or overprotective, you need to indicate why this is the 
case, perhaps with reference to your own operational conditions and the findings of your risk 
assessments. If the recommendations contradict classification and labelling or existing 
legislation (e.g. hierarchy of RMM established by the Chemical Agents Directive), reference to 
this is sufficient. When you are forwarding information concerning risk management measures 
in the exposure scenario, it can include, for example, the documentation of your exposure 
scenario check, measurement results or any other type of information supporting the 
conclusion that the measures are inappropriate. 

Apart from reacting to communicated risk management measures, you may also provide 
information pro-actively to your supplier, in order to make sure that his exposure scenario will 
cover your conditions of use (see chapter 3 of this guidance). 

When your supplier receives information from you, he should review his chemical safety 
assessment and determine whether changes are needed to risk management measures, either 
in the main body of the safety data sheet, in the relevant exposure scenario(s) or both. He 
may then respond either by changing his recommendations according to your information or 
by arguing that your information does not call into question his recommendations. In this case, 
your supplier may not change his recommendations and you may not receive an updated 
safety data sheet. He may also decide not to redo his assessment because he considers it too 
burdensome, or conclude that based on the new information your use is a use advised against. 
For your options in this situation, please see chapter 4 of this guidance. 

6.4 

Reporting new classification of a substance to ECHA 

Article 38(4): A downstream user shall report to the Agency if his classification of a substance 
is different to that of his supplier. 

If you classify a substance, and  your classification is different from that of all of your suppliers 
(as communicated in the safety data sheet under Section 2 for a substance as such, or Section 
3 for the substance as a component of a mixture), you must report your classification to ECHA.  
This information is added to the C&L information for that substance in ECHA’s database.  

Before you report your classification to ECHA, it is recommended that you contact your 
supplier(s) to discuss whether an agreed classification could be found between you. This is 
mandatory if you use new data for classification that was not considered by your supplier (see 
chapter 6.2). If you agree on a classification and this is reflected in the supplier’s updated 
safety data sheet, reporting obligation to ECHA lapses. 

 
 
 
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Guidance for downstream users 
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The requirement to report your own classification only applies to substances that you use, as 
such or in mixtures, in quantities of 1 tonne per year or more (Article 38(5) of REACH). 
Practical instructions on how to report downstream user classification to ECHA can be found in 
the “Q&A on Downstream users reports”

75. 

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71 

7 

Communication in the supply chain related to 
mixtures 

This chapter provides guidance to downstream users who formulate mixtures. It presents the 
main obligations under REACH relating to mixtures and describes how information relating to 
the safe use of mixtures can be communicated in the supply chain. 

Additional guidance relevant for formulators is provided in the “Guidance on the application of 
CLP criteria”, which covers the classification of mixtures, in the ECHA web page dedicated to 
CLP

 and in the Guidance on the compilation of safety data sheets

. 

76

77

A mixture is defined in Article 3(2) of REACH and Article 2(8) of the CLP Regulation as “a 
mixture or solution composed of two or more substances”. A mixture may be in a liquid, a gas 
or a solid phase (such as alloys and plastic pellets). A substance diluted with a solvent (such as 
water) is a mixture.  

The physical state of the mixture may affect the level of exposure to a substance in the 
mixture for an identified use. This should be considered when establishing the conditions of 
use, such that the risk is adequately controlled. 

This chapter is addressed primarily to formulators. It is also relevant to re-fillers and any 
manufacturer, importer or distributor placing a mixture on the market. These roles are 
described in chapter 2.  

7.1 

Legal obligations related to mixtures under REACH 

The legal obligations under REACH that are of most relevance to formulators when they are 
communicating information on mixtures are outlined below. For completeness, some reference 
to relevant requirements under CLP Regulation is included. A decision chart for the main 
obligations is provided in Figure 5. 

The articles in REACH that apply in particular to formulators of mixtures, together with 
comments on the interpretation of these articles, are presented in Table 14. The table covers 
the obligations relating to mixtures contained in Title IV of the Regulation. 

As a supplier of mixtures you may have the following obligations: 

1.  Classify, label and package mixtures. 

i.  Until 1 June 2015 – classification should be in accordance with the Dangerous 
Preparations Directive (DPD 1999/45/EC) and in addition, by choice, in 
accordance with the CLP Regulation before that date. Labelling should be in 
accordance with either DPD or CLP Regulation. If labelled in accordance with CLP, 
the classification according to CLP has to be included; 

ii.  After 1 June 2015 – classification, labelling and packaging must be in accordance 
with the CLP Regulation. However, any mixtures which are placed on the market 
in accordance with DPD before 1 June 2015 are not required to be relabelled and 
repackaged in accordance with CLP until 1 June 2017 (Article 61 of the CLP 
Regulation). 

76

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Guidance for downstream users 
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A supplier should notify ECHA regarding the classification of substances (as such or in a 
mixture) if he is the manufacturer or importer and the classification and labelling has not been 
notified as part of registration (Article 40 of CLP). 

2.  Provide safety data sheets for mixtures compiled in accordance with Annex II of 

REACH, as amended by Regulation 453/2010: 

i. 

for all mixtures classified as hazardous that are supplied to downstream users and 

distributors; 

ii.  on request for non-classified mixtures which contain (Article 31(3) of REACH): 

•  at least one substance posing human health or environmental hazards in 
an individual concentration ≥1% by weight for non-gaseous mixtures and 
0.2% by volume for gaseous mixtures; or 

•  substances that are persistent, bioaccumulative and toxic or very 

persistent and very bioaccumulative in an individual concentration ≥0.1% 
by weight (non-gaseous mixtures only); or 

•  substances of very high concern that are included in the Candidate List of 

substances for authorisation for other reasons in an individual 
concentration ≥ 0.1% by weight (non-gaseous mixtures only); or 

•  substances for which there are Community workplace exposure levels; 

An exemption applies to obligation (i) above. If the mixture is offered or sold to the 
general public and sufficient information for safe use is provided, a safety data 
sheet need not be supplied unless requested by a downstream user or distributor. 
These obligations are detailed in Article 31 of REACH. 

3.  Communicate relevant information down the supply chain when no safety data 

sheet is required: 

i.  provide  any  information  related  to  authorisation  or  restriction,  as  well  as 

information needed to ensure safe use; 

ii.  provide  the  registration  number(s)  for  substances  subject  to  authorisation, 
restriction,  or  for  which  it  is  necessary  to  provide  information  enabling 
implementation of safe use conditions.  

The means of communication will depend on the amount of information required, 
but could include measures such as product inserts, product information sheets and 
labelling. These obligations are detailed in Article 32 of REACH. 

4.  Comply with general obligations relating to downstream users. These are 

contained in Title V of the Regulation and are detailed elsewhere in this guidance. In 
particular, you should: 

i.  communicate information about the uses of substance(s) in the mixtures to your 
supplier  with  the  aim  to  make  these  identified  uses.  This  is  optional.  Refer  to 
chapter 3 for more details. 

ii.  check whether your uses (and the foreseeable uses of your customers) are 
covered in the information you receive from your suppliers. Implement or 
recommend the conditions described in the exposure scenario communicated in 
the safety data sheet (whether in annex or integrated in the main body) or take 
alternative action. Refer to chapter 4 for more details on the available options 
and consequent obligations; 

 
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73 

iii.  communicate up the supply chain, if there is a doubt about the appropriateness of 

the risk management measures identified in the safety data sheet received or if 
any new information on hazards becomes available. Refer to chapter 6 for more 
details; 

No

Yes

Provide SDS 

Provide 
sufficient 
information. 
Provide SDS on 
request to DU/
distributor

Classify mixture 
according to CLP/
DPD

Mixture 
classified?

Yes

Supplied to 
general public?

No

Contains substances 
specified in 
Art.31(3)?

Yes

Provide SDS on 
request 

No

Substance 
authorised/
restricted/other 
info received?

Yes

Provide 
information 
according to 
Article 32 and 
to consumers as 
appropriate

No

END

Figure 5 Workflow summarising when a safety data sheet or other information on a mixture 
must be forwarded to downstream users and distributors. Note that a supplier is not obliged 
to provide a safety data sheet to consumers.  

 
 
 
 
 
 
 
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Guidance for downstream users 
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Table 14 Legal references in Title IV REACH relating to formulation of mixtures together with clarification 

REACH Article 

Regulation 

Clarification 

31(1) 

The supplier of a (…) mixture shall provide the recipient of the (… ) 
mixture  with a safety data sheet compiled in accordance with Annex II:     

(a)   where a (…) mixture meets the criteria for classification as 
dangerous in accordance with Directive 1999/45/EC; (…) 

An SDS is required if the mixture is classified 
as dangerous according to DPD. The 
requirements for the SDS are presented in 
Annex II of REACH. A detailed guidance is 
provided in the Guidance on the compilation 
of SDSs.  

Some of the requirements of Annex II change 
on 1 June 2015, to implement the transition 
to the CLP Regulation. The SDS for any 
mixtures which are on the market before 1 
June 2015 (in accordance with DPD) does not 
have to be updated until 1 June 2017. 
However, if a supplied product is labelled 
according to CLP, the SDS must be in 
compliance with the later version of Annex II 
(June 2015). 

Note that the requirements relating to 
providing an SDS apply to all hazardous 
substances and mixtures, and not only those 
that are registered under REACH. Also, sub 
paragraphs (b) and (c) of Article 31(1) refer 
only to substances. 

Recipients are downstream users and 
distributors (incuding retailers). Aconsumer is 
not a recipient, and there is no obligation to 
providea consumerwith a SDS. 

31(2) 

Any actor in the supply chain who is required, under Articles 14 or 37, to 
carry out a chemical safety assessment for a substance shall ensure that 
the information in the safety data sheet is consistent with the 
information in this assessment.  

The information in the SDS must be 
consistent with the CSA for the substance. If 
a CSA is prepared for a mixture as a whole,  
the SDS can be based on this CSA.  

A CSA for a mixture is not defined in REACH. 
Annex I and Annex XII of REACH refer to 

 
 
 
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78

31(3)

If the safety data sheet is developed for a mixture and the actor in the 
supply chain has prepared a chemical safety assessment for that 
mixture, it is sufficient if the information in the safety data sheet is 
consistent with the chemical safety report for the mixture instead of with 
the chemical safety assessment for each substance in the  mixture 

The supplier shall provide the recipient at his request with a safety data 
sheet compiled in accordance with Annex II, where a mixture does not 
meet the criteria for classification as dangerous in accordance with 
Articles 5, 6 and 7 of Directive 1999/45/EC, but contains: 

(a) in an individual concentration of ≥ 1 % by weight for non-gaseous 
mixtures  and ≥ 0,2 % by volume for gaseous  mixtures  at least one 
substance posing human health or environmental hazards; or  

(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous  
mixtures at least one substance that is persistent, bioaccumulative and 
toxic or very persistent and very bioaccumulative in accordance with the 
criteria set out in Annex XIII or has been included for reasons other than 
those referred to in point (a) in the list established in accordance with 
Article 59(1); or 

(c) a substance for which there are Community workplace exposure 
limits. 

CSA/CSR for single substances for registrants 
and downstream users respectively. 

75 

An SDS must be provided on request even if 
the mixture is not classified as dangerous but 
meets subparagraphs a, b or c.: 

Re(a) These concentration limits  apply 
whether the substance is classified or not. 

Re (b) Regarding PBT/vPvB substances, this 
applies both for substances known to be 
PBT/vPvB and for substances that are treated 
as if they are PBT/vPvB. The list established 
in accordance with Article 59(1) is the 
Candidate List for eventual inclusion in the 
Authorisation List. 

Re(c) This applies regardless of concentration 
in the mixture. 

From CLP regulation, an SDS must be 
provided on request if certain substances are 
present at a concentration ≥0.1% (including 
a Category 2 caricinogen or Cat1 or Cat 2 
reproductive toxin. See Tables  3.6.2 and 
3.7.2. in CLP) 

31(4) 

The safety data sheet need not be supplied where (…) mixtures that are 
dangerous in accordance with Directive 1999/45/EC, offered or sold to 
the general public, are provided with sufficient information to enable 

For mixtures that are classified, Article 31(1) 
requires the supplier to provide an SDS to 
downstream users or distributors (also termed 

78

 Note that this article will be amended from 1 June 2015 with regard to the classification of mixture as hazardous and to the classification of substances in the mixture 

triggering the obligation (Article 59 of the CLP Regulation). 

 
 
 
                                           
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users to take the necessary measures as regards the protection of 
human health, safety and the environment, unless requested by a 
downstream user or distributor. 

31(5) 

The safety data sheet shall be supplied in an official language of the 
Member State(s) where the substance or mixture is placed on the 
market, unless the Member State(s) concerned provide otherwise. 

31(6) 

31(7) 

The safety data sheet shall be dated and shall contain the following 
headings: (…) 

Any actor in the supply chain who is required to prepare a chemical 
safety report according to Articles 14 or 37 shall place the relevant 
exposure scenarios (including use and exposure categories where 
appropriate) in an annex to the safety data sheet (...) 

“recipients”).  

However, if these mixtures are also available 
to the general public, the requirement to 
provide an SDS to recipients is waived if the 
supplier provides sufficient information to 
ensure that the mixture can be used without 
adverse effect to human health or the 
environment, for example by labelling or with 
product inserts. 

The supplier must ensure (i) that the 
information provided to the recipient is 
sufficient, and (ii) that the mixture is offered 
or sold to the general public. 

A recipient is entitled to receive an SDS on 
request. A supplier is not obliged to provide 
an SDS to a consumer. 

Exposure scenarios are part of the SDS and 
the requirement to supply it in an official 
language of the Member State also applies to 
them, unless the relevant Member State 
provides otherwise.  

Formulators may choose to request exposure 
scenarios in other languages, such as 
English, to facilitate collation of information 
from a number of countries. There is no legal 
obligation on the supplier to provide them, 
although he may choose to for business 
reasons. 

The SDS headings are listed in Article 31(6). 

A formulator may be required to prepare a 
CSR if his use or customer use of a registered 
substance is outside conditions of exposure 
scenario (Article 37). If the formulator is also 
a manufacturer or importer, he may be 
required to prepare a CSR, if the 

 
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77 

31(7) ctd. 

Any downstream user shall include relevant exposure scenarios, and use 
other relevant information, from the safety data sheet supplied to him 
when compiling his own safety data sheet for identified uses.  

requirements of Article 14 apply. 

If a formulator prepares a CSR, he has to 
include the relevant exposure scenarios in an 
annex to the SDS.  

A formulator must convey relevant 
information through the supply chain. 
Information can be obtained from exposure 
scenarios and the SDS provided. The 
formulator can: 

(i) incorporate the relevant information in the 
main body of the SDS.  

(ii) append safe use information for the 
mixture to the SDS 

(iii) attach the relevant exposure scenarios to 
the SDS 

Specific legal obligations apply if the 
conditions described in exposure scenarios 
are not implemented or recommended 
(Article 37(4)). Consequently, it is 
recommended that conditions of use 
incorporated in an SDS that were sourced 
from an exposure scenario for a substance in 
the mixture are clearly identified as such. See 
chapter 7.2.3 for more details. 

31(7) ctd. 

31(8) 

Any distributor shall pass on relevant exposure scenarios, and use other 
relevant information, from the safety data sheet supplied to him when 
compiling his own safety data sheet for uses for which he has passed on 
information according to Article 37(2). 

This provision ensures that downstream 
users, who have made a use known, receive 
the information on safe use in an ES, and not 
incorporated into the body of the SDS.  

A safety data sheet shall be provided free of charge on paper or 
electronically no later than the date on which the substance or mixture 
is first supplied. 

Where a SDS need not be supplied (Article 
31(4)), a reasonable time-limit for provision 
of the SDS following a request is normally 
acceptable. 

 
 
 
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31(9) 

Suppliers shall update the safety data sheet without delay on the 
following occasions: 

(a)  As soon as new information which may affect the risk 

management measures, or new information on hazards becomes 
available 

(b)  once an authorisation has been granted or refused;  

(c)  once a restriction has been imposed; 

The new, dated version of the information, identified as ‘Revision: 
(date)’, shall be provided free of charge on paper or electronically to all 
former recipients to whom they have supplied the substance or mixture 
within the preceding 12 months. Any updates following registration shall 
include the registration number.  

31(10) 

(...) 

Where mixtures are classified in accordance with Regulation (EC) No 
1272/2008 during the period from its entry into force until 1 June 2015, 
that classification may be added in the safety data sheet, together with 
the classification in accordance with Directive 1999/45/EC. However, 
until 1 June 2015, where substances or mixtures are both classified and 
labelled in accordance with Regulation (EC) No 1272/2008 that 
classification shall be provided in the safety data sheet, together with 
the classification in accordance with Directives 67/548/EEC and 
1999/45/EC respectively, for the substance, the mixture and its 
constituents.   

32(1) 

 Any supplier of (...) a mixture  who does not have to supply a safety 
data sheet in accordance with Article 31 shall provide the recipient with 
the following information:  

(a) the registration number(s) (...), for any substances for which 
information is communicated under points (b), (c) or (d) of this 
paragraph;  

(b) (...) details of any authorisation granted or denied (...);  

(c) details of any restriction imposed (...); 

Guidance for downstream users 
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A formulator has to update the safety data 
sheet without delay if the safety advice or 
hazard information needs to be changed, or if 
there is new information on authorisation or 
restriction. 

When formulators receive an extended SDS 
for a registered substance, it is likely to 
include new information such as additional 
risk management measures,  DNELs/ PNECs 
or new classification. Formulators should 
review if they need to update their safety 
data sheet due to the information received. 

Until 1 June 2015, transitional provisions 
apply regarding the classification of mixtures. 
Until this date, the SDS for a mixture should 
include classification information according to 
the DPD requirements. It may also include 
classification according to CLP if it is already 
available.  

However, if the substances or mixtures are 
both classified and labelled according to CLP 
Regulation prior to 1 June 2015, classification 
in the SDS must be provided in accordance 
with both CLP and DSD/DPD. 

Whenever no SDS needs to be supplied in 
accordance with Article 31 REACH, the 
supplier of the mixture has to provide the 
recipient with the information listed in Article 
32(1) REACH. Thereby it is ensured that the 
recipient always receives the necessary 
information to take appropriate risk 
management measures.  

 
 
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79 

32(2) 

32(3) 

(d) any other available and relevant information about the substance 
that is necessary to enable appropriate risk management measures to 
be identified and applied (...) 

The information referred to in paragraph 1 shall be communicated free 
of charge on paper or electronically at the latest at the time of the first 
delivery of a substance on its own or in a mixture after 1 June 2007. 

Similarly to a SDS, this information must be 
actively provided by the supplier to the 
recipient.  

Suppliers shall update this information without delay on the following 
occasions:  

(a) as soon as new information which may affect the risk management 
measures, or new information on hazards becomes available;  

The information referred to in paragraph 1 
must be updated without delay under the 
stated circumstances. These are the same as 
Article 31(9) above. 

(b) once an authorisation has been granted or refused;  

(c) once a restriction has been imposed.  

In addition, the updated information shall be provided free of charge on 
paper or electronically to all former recipients to whom they have 
supplied the substance or mixture within the preceding 12 months. Any 
updates following registration shall include the registration number. 

33 

Duty to communicate information on substances in articles 

Note that Article 32 refers to recipients, 
namely downstream users and distributors. 
The requirements do not apply with respect to 
supply to consumers. 

See chapter 8 of this Guidance and, for 
complete details Guidance on requirements 
for substances in articles 

 
 
 
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34 

Any actor in the supply chain of a substance or a mixture shall 
communicate the following information to the next actor or distributor 
up the supply chain:  

(a) new information on hazardous properties, regardless of the uses 
concerned;  

(b) any other information that might call into question the 
appropriateness of the risk management measures identified in a safety 
data sheet supplied to him, which shall be communicated only for 
identified uses. (…). 

35 

Workers and their representatives shall be granted access by their 
employer to the information provided in accordance with Articles 31 and 
32 in relation to substances or mixtures that they use or may be 
exposed to in the course of their work. 

36 

Obligation to keep information 

Guidance for downstream users 
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If the formulator or downstream user 
becomes aware of any new information about 
the hazards related to a substance or a 
mixture, they have to notify their supplier. 

For example, it may come to his attention that 
the risk management measures recommended 
in the ES or SDS are not sufficient (for 
example, due to occurrence of illness linked to 
the exposure to the substance or substance in 
the mixture, even though the 
recommendations presented in the ES were 
followed). 

Similarly, the risk management measures 
recommended in the ES or SDS may be overly 
precautionary (based for example on 
workplace monitoring data, extensive health 
surveillance records). 

Chapter 6 provides more information on 
upstream communication. 

The “information provided” includes any 
information provided as “sufficient 
information” if the mixture is also sold to the 
general public, and the exemption in Article 
31(4) applies.  

However, if additional information, as 
contained in the SDS, is necessary for safe 
use, then the SDS should be made available 
to workers and their representatives 

This  article  provides  details  obligations 
relating to recording and storing information. 

Please consult the Guidance on the compilation of safety data sheets for additional details. 

 
 
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81 

7.2 

Communicating information on conditions of use regarding 
mixtures in safety data sheets 

A formulator is obliged to “include relevant exposure scenarios, and use other relevant 
information, from the safety data sheet supplied to him when compiling his own safety data 
sheet for identified uses” (Article 31(7) of REACH). The objective is to convey information that 
helps to protect human health and the environment in a way the recipient can easily 
understand.  

This subchapter of the guidance addresses how a formulator can fulfil this obligation. It 
describes how a formulator can: 

•  collate the information he receives from his suppliers such that it is readily 

accessible for further processing (Chapter 7.2.1); 

• 

identify the information that is relevant to communicate downstream (Chapter 
7.2.2); 

•  communicate the information effectively (Chapter 7.2.3). 

7.2.1 

Collating information on substances and mixtures from suppliers 

As a formulator, you typically purchase substances and mixtures from a number of suppliers. 
The information you receive from different suppliers may differ in format and in how the use 
and the conditions of use are described. 

You need to collate and align the information received from the different suppliers before you 
can identify and select the information to communicate downstream. You can then directly 
compare the information with respect to the substances, the uses and the conditions of use. 

When collating and aligning extended safety data sheets, difficulties may arise in practice, 
particularly in the early stages of communication of REACH related information in the supply 
chain. These difficulties typically relate to gaps or conflicts in information contained in 
exposure scenarios, and the point in time when information is received and issued. 

Guidelines for how you can deal with these issues are presented below. Some of these points 
are discussed in further detail in chapter 4. 

7.2.1.1 

Guidelines relating to collating information 

The following guidelines are intended to assist the process of collating information you receive 
from your suppliers. All guidelines are not relevant to every situation, as it depends on the 
methods you use to identify and communicate the information. 

Receiving information from your suppliers 

i. 

ii. 

Establish whether the substances in your mixtures have been registered in REACH, and if 
you expect to receive exposure scenarios for these substances. 

If you should receive exposure scenarios for some of the substances (as such or in 
mixtures) in your mixtures, but have not received them, contact your supplier.  

 
 
 
 
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iii. 

iv. 

v. 

vi. 

Guidance for downstream users 
Version 2.1  October 2014 

If, for any reason, you do not receive exposure scenarios for substances and/or mixtures 
you use in your formulations, review the information provided by your suppliers in the 
safety data sheet when identifying the information to communicate for your mixture.  

If you receive exposure scenarios for a relevant use from one supplier but not from another 
supplier  for  the  same  substance,  you  can  use  the  information  received.  However,  you 
should  first  verify  that  the  properties  and  hazards  of  the  substances  received  from  the 
different suppliers are the same. Check also that the suppliers who have not included that 
use did not deliberately omit that use for valid reasons. 

In the unlikely event that a use is advised against by one supplier but not by another, you 
are obliged to communicate with your suppliers under Article 34(b) of REACH. 

Collating information you receive  

Align the received exposure scenarios into consolidated versions, if this is necessary both 
to facilitate information handling and /or to generate standardised exposure scenarios. You 
may need to harmonise the terminology, and match the substances, uses and the 
conditions of use. Scaling may be useful when aligning exposure scenarios. See chapter 4 
and appendix 2 for further information on scaling.  

If you receive exposure scenarios for the same substance from different suppliers, you 
need to match the contents. Check the classification to make sure that the hazard 
description of the substances and/or mixtures is the same. If this is not the case, clarify 
why the differences in classification arise and whether this has an influence on the content 
of the exposure scenarios attached.  

vii. 

If you establish that the substance and its properties are the same, but the risk 
management measures differ significantly from different suppliers, take the steps described 
in chapter 4.2.3.3. 

Updating information you receive 

When you receive updated extended safety data sheets from your suppliers, ensure that you 
review the information that you communicate downstream. Your safety data sheet needs to be 
updated without delay when new information becomes available and is relevant for your 
customers (namely, information which affects risk management, and new information on 
hazard, on authorisation or on restriction). 

7.2.2 

Identifying information to communicate to downstream users 

When the exposure scenario information on the substances is received and collated, the 
formulator then identifies the information to communicate downstream for mixtures.  

The main objective is to communicate the appropriate conditions of use. These are the 
operational conditions (OC’s) and risk management measures (RMMs) that are necessary to 
protect human health and the environment when using the mixture. This should be undertaken 
in a systematic way that is proportionate to the risk. Factors such as the composition of the 
mixture, the hazardous properties of the mixture and of each substance in the mixture, as well 
as the uses should be taken into account. 

Industrial and regulatory bodies are currently developing and/or testing methodologies to 
support formulators undertaking this process. These methodologies are not described here but 
further information on these activities and relevant links will be provided as soon as they are 
established. This is an evolving area, and the appropriate methodology will depend on the 

 
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83 

situation. At the time of publication of this guidance, many of the methodologies being 
developed fall within one of following general approaches: 

A.  Exposure Scenario approach: Build information on conditions of use for the mixture 

from the exposure scenario information received. 

B.  Existing Controls approach: Check existing information on conditions of use for the 

mixture against the exposure scenario information received from suppliers.  

7.2.2.1  

Exposure Scenario approach 

The starting point for the exposure scenario approach is the relevant exposure scenarios for 
the individual substances. From these, the appropriate information on conditions of use for the 
mixture is identified. This is also referred to as the “top down” approach. 

Depending on the number of hazardous substances and the routes of exposure, the safe use 
information may be consolidated in a number of ways. These ways often start by taking the 
most stringent risk management measures or by identifying the lead-components that 
determine the appropriate conditions for each exposure route. 

The current methods for identifying the lead components are generally based on the 
classification and/or on the DNELs/PNECs of the single substances. Substance properties that 
determine the exposure potential, such as vapour pressure, may also be taken into account. 

When identifying conditions of use for the mixture in this way, the risk associated with a 
hazardous raw material for which an exposure scenario has not been received (for any 
reason), should also be taken into account. The safe use information should also be consistent 
with the measures required according to the classification of the mixture. 

7.2.2.2  

Mixture Use approach 

The starting point for the mixture use approach is the information on operational conditions 
and risk management measures which is currently provided for safe use of the mixture as a 
whole. The conditions are usually based on the classification and labelling of the mixture, the 
related precautionary statements, and additional good practice advice based on experience or 
generic assessment

. This is also referred to as the “bottom up” approach. 

79

The existing controls may be found in locations that include: Section 8 of the safety data 
sheet; control sheets from control banding tools such as COSHH
Available Techniques Reference Documents); sector specific publications; or generic exposure 
scenarios developed by sector organisations. (Generic exposure scenarios document the typical 
conditions of use for a typical product or process within a sector. See chapter 3.3 for more 
information.) 

; BREF documents (Best 

80

The existing controls are checked against those contained in the exposure scenarios received 
from the supplier for the component substances. This is to confirm, and document, that the 
conditions of safe use that are communicated by the formulator are supported by exposure 
scenarios the formulator has received from his suppliers. Alternatively, the formulator could 
provide his suppliers with all the uses and conditions of use he recommends, to request that 
they are supported. 

If the existing controls are not supported by the exposure scenarios, the formulator must take 
appropriate action in accordance with the downstream user obligations of Article 37 of REACH 
as described in chapter 4. 

79

 Guidance on classification of mixtures is provided in chapter 1.6 of the Guidance on the Application of the CLP criteria 

available at echa.europa.eu/guidance-documents/guidance-on-clp.  

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7.2.2.3  

Factors which indicate a more detailed evaluation may be needed 

A simple evaluation of the information that is available on the hazard and conditions of use is 
sufficient in the majority of situations. Often the well-established rules for classification and 
labelling of mixtures can help to reduce the complexity of judgement for the formulator.  

However, more complex cases arise when a more detailed evaluation is required. Indicators of 
when this is likely to occur are presented below. A more detailed consideration of the possible 
complexities, and the core principles to apply, are presented in Appendix 3. The methodology 
implemented should include a step to check whether a more detailed evaluation is required. 

Some situations when more detailed evaluation should be considered include: 

a.  There could be an interaction between the substances in the mixture, either to 

enhance or diminish the hazardous property. 

This may be due to physical interaction between the component substances (for 
example, the mixture may be formulated to have particular technical properties 
that inadvertently affect the availability of the component substances from release 
from the mixture). Alternatively there may be synergistic effects on combined 
exposure from two or more substances (for example, human exposure to 
solvents). 

b.  Mixtures contain substances with significant long-term hazards in concentrations 
that are below the general cut-off point for the classification of the mixture. 

Although the mixture as a whole is not considered hazardous, there may be the 
need to consider risk management measures to minimise exposure. This refers to 
substances that are carcinogens, mutagens, toxic to reproduction (CMRs) or 
sensitisers (dermal or respiratory). 

c.  Mixtures contain substances that are PBT or vPvB in concentrations below 0.1 %. 

Although the concentration is low there may be the need to consider risk 
management measures to minimise the amounts of substance released into the 
environment. 

d.  Hazards are identified for a component substance, which however do not lead to 

a classification as hazardous, and hence the mixture is not classified.  

This may, for example, be the case for a substance with adverse effects on 
sediment and soil organisms. It is likely to have PNECs assigned for soil and 
sediments and potentially corresponding risk management measures in the 
exposure scenarios for the substances.  

e.  Both classification and PNECs/DNELs are available for the component substances but 
lead to conflicting conclusions regarding the lead substances for determining risk 
management measures. 

f.  When the substances in the mixture are likely to influence the performance of the 

environmental risk management measures for the single components 

7.2.3 

Options for including information to communicate to downstream users 

Once the information has been received and collated from suppliers and the relevant 
information has been identified, you are now ready to consider how best to communicate 

 
 
  
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85 

information on the appropriate operational conditions and risk management measures for the 
mixtures to users further downstream. 

The way in which you include this information depends on aspects such as the uses, the level 
of detail, the recipient and business considerations. The information requirements differ for 
different customer groups. For example, customers who are formulators are likely to require a 
lot of detail. Other customers may be end users and use the mixtures directly, such as 
lubricants, adhesives, cleaning agents and coatings. End users may have limited familiarity 
with chemicals and need information that is clear and concise. In practice, the customers for a 
given mixture often fall within a spectrum of needs and abilities. 

If you prepare a chemical safety report for the mixture or its component substances, the 
relevant exposure scenarios shall be annexed to the safety data sheet. Otherwise, the 
formulator can choose the most appropriate means to include the information such as: 

integrate the information into the main body of the SDS; or 
append safe use information for the mixture; or 

(i) 
(ii) 
(iii)  attach relevant exposure scenarios for the substances in the mixture in an annex. 

The formulator can select the most effective method or provide information in different ways to 
different customer groups as appropriate. The process should be as efficient as possible, 
proportionate to the risk, and relevant and understandable to the recipients. 

A simplified decision tree of how to communicate the information is illustrated in Figure 6. 
Aspects to consider are discussed further here. 

7.2.3.1 Integrate information into the main body of the safety data sheet 

One option is to integrate the relevant information from the exposure scenarios received from 
your suppliers into the main body of the safety data sheet. This is the recommended approach 
when communicating to end users, if it is applicable. This is the case when, for example, there 
are a relatively small number of identified uses and/or conditions of use.  

Integrating information has the advantage that it is clear and concise. However, it is usually 
not suitable if diverse advice on the operational conditions and risk management measures for 
various uses is necessary. One of the options described in the following subchapters may be 
more appropriate. 

Integrating information in the main body of the safety data sheet is not an option if you were 
required to prepare a CSR, either in the role of registrant or as a downstream user. In this 
case, the relevant exposure scenarios must be placed in annex to the safety data sheet. 

When you integrate information sourced from an exposure scenario of your supplier into the 
main body of the safety data sheet, the legal obligations associated with Article 37(4) of 
REACH still apply to the recipients of your mixture. These are detailed in chapter 4, and relate 
to implementing the exposure scenario or taking alternative action. Consequently, it is 
recommended that operational conditions and risk management measures sourced from an 
exposure scenario are clearly identified as such. The way in which this is done will need to 
consider technical and business considerations. 

The location of information in the safety date sheet is specified in Annex II of the Regulation. 
Information on exposure controls and personal protection is provided in Section 8. Regulatory 
information, including whether a chemical safety assessment has been carried out for the 
substance (or a substance in the mixture) is provided in Section 15. Other information, which 
could include sources of data in compiling the safety data sheet, information on scaling etc. 
can be provided in Section 16. 

 
 
 
 
 
 
 
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Guidance for downstream users 
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7.2.3.2 Append safe use information for the mixture 

Safe use information for the mixture can be derived from the exposure scenarios of the use of 
the component substances in a mixture received from your suppliers and consolidated into a 
single description of the safe use of the mixture. The information to include is identified using 
an approach described in chapter 7.2.2.   

The safe use information is appended to the safety data sheet, and is identified as being 
sourced from exposure scenarios. It consists of the relevant information from the exposure 
scenarios you received from your suppliers and the risk management measures to ensure safe 
use. Check with your sector organisation if a standardised format for safe use information has 
been proposed. 

Appending safe use information for the mixture can be a suitable approach when useful 
information cannot be readily integrated into the main body of the safety data sheet. This is 
often the case when there are a wide range of uses, with different conditions of use, and when 
the scenarios are more complex. 

Appending safe use information for the mixture is not an option if you were required to 
prepare a CSR, either in the role of registrant or as a downstream user. In this case, the 
relevant exposure scenarios must be placed in annex to the safety data sheet. 

7.2.3.3 Attach relevant exposure scenarios for the substance(s) in an annex 

The relevant exposure scenarios for the substance(s) in the mixture can be placed in an annex 
to the safety data sheet. This is likely to be the most suitable approach when communicating 
to customers who are also formulators, and who are generating safety data sheets for their 
own mixtures. It may also be suitable for end users when the appropriate risk management 
measures for an identified use are clearly specified in one exposure scenario for each identified 
use. 

The attached exposure scenario may be the same as received from your supplier or, where 
you have a number of suppliers for the same substance, may be collated and consolidated 
from the exposure scenarios you receive. 

If you were required to prepare a CSR, either in the role of registrant or as a downstream 
user, the relevant exposure scenarios must be attached (Article 31(7) of REACH). This is the 
only situation where there is no alternative option available to the formulator. 

 
 
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87 

START

Do you prepare 
a CSR?

No

Who are your 
customers?

Other 
formulators

End users

Yes

Are the 
conditions of 
use diverse?

Yes

No

Attach relevant 
ES(s) to the SDS

Append safe use 
information to SDS

Integrate 
information in body 
of SDS

Figure 6 Suggested simplified decision tree for formulators to identify how to communicate 
information on the safe use of mixtures downstream 

 
 
 
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7.2.4 

General guidelines when communicating information downstream 

The previous subchapters have outlined the main considerations relating to communicating 
information on mixtures as a formulator. General guidelines to consider when communicating 
information are summarised here: 

a) Only relevant identified uses are included. For example, uses such as formulation at 
own site and consumer use are not relevant if you are supplying to industrial/professional end 
users only. 

b) Only the exposure scenarios that are relevant for the mixture are included. If you 
are forwarding exposure scenarios received from your supplier, it may not be necessary to 
annex exposure scenarios for every registered substance in the mixture, but only for those 
substances which are necessary to indicate the conditions of safe use. However recipients who 
are also formulators may prefer to receive all exposure scenarios. 

c) The operational conditions and risk management measures are appropriate and 
proportionate. The conditions of use should be suited to the mixture, the uses and the 
sector/user group. They should provide adequate protection, without being overly 
precautionary. 

d) Important information is easy to retrieve and to understand. Include structural 
elements such as a table of contents to aid retrieval of information. Avoid an overload of 
information as the essential information can then be difficult to find. Include information on 
exposure estimation and scaling only if is of relevance to recipients (typically also formulators). 

e) Standardised methods and descriptors are used as far as possible. Clear descriptions 
and terms that are readily understandable by the reader should be used. The standard use 
descriptor system, standard phrases (EuPhraC phrases
formats support the smooth processing of exposure scenario information, automation and 
translation. However, the familiarity of the recipient with this terminology should be 
considered, and sector specific terminology used as appropriate. 

) and harmonised exposure scenario 

81

f) The supplier’s exposure scenarios for substances are grouped into relevant 
identified uses or use and exposure categories, as far as feasible. Grouping can be 
implemented using generic exposure scenarios or a “use and exposure category”. A use and 
exposure category is an exposure scenario covering a wide range of processes or uses. When 
such groupings are applied as appropriate, it can promote clarity and convenience, without 
losing information necessary to adequately control the risks. 

g) The information in the exposure scenario is consistent with the information in the 
main body of the safety data sheet. A summary of the relevant key information from the 
annexed exposure scenario should be included into the core Sections of the safety data sheet, 
with a cross-reference to the details in the exposure scenario. Appendix 2 of the ECHA 
Guidance on the compilation of safety data sheets provides more guidance to the actor who 
needs to include exposure scenario information in the safety data sheet. 

h) Information on operational conditions and risk management measures sourced 
from an exposure scenario of your supplier should be clearly identified as such. This 
applies if it is integrated into the main body of the safety data sheet or appended to it in some 
form. The legal obligations associated with Article 37(4) of REACH apply to the recipients of 
your mixture if the conditions described in exposure scenarios are not implemented. 

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89 

i) All relevant information received is included. You will receive information on 
substances and/or mixtures in your mixture in a variety of forms, either integrated in the 
safety data sheet, appended as safe use information for a mixture, or annexed in an exposure 
scenario. Ensure that information received other than in an exposure scenario is not 
overlooked when identifying information to communicate to your customers.  

j) Safety data sheets and exposure scenarios are provided in the national language 
of the Member State where the substance is placed on the market. This applies unless 
82
provided otherwise by the member state concerned (Article 31(5) of REACH). Use of EuPhraC
, a multilingual 
phrases help to promote harmonisation and good translations. ECHA-term
database for chemical terminology developed by ECHA, also helps to improve the quality of 
translations and enhance clear communication.  

83

k) The safety data sheet is reviewed as soon as new information becomes available. 
A challenge for formulators is that new information arrives at different times. Contact your 
supplier to ensure all exposure scenario are received, as far as possible. When relevant 
information is received, you must update your own safety data sheet. For substances for which 
ESs are not yet available, use existing information from the safety data sheet to identify 
appropriate risk management measures. If an exposure scenario becomes available after 
publication of your safety data sheet, an update is required if the hazard information or safety 
advice needs to be changed (in general when relevant new information becomes available, as 
given in Article 31(9) of REACH). Review all incoming information from suppliers to ensure that 
the necessary information is communicated downstream. 

l) The process is documented. Activities such as communication with suppliers, 
identification of information to be communicated and communication downstream should be 
recorded and maintained in accordance with Article 36 of REACH.

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8 

Guidance for downstream users 
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Requirements related to authorisation, restrictions 
and substances in articles  

8.1 

Authorisation requirements and downstream users 

This chapter describes the actions that downstream users are required to take in relation to 
substances subject to authorisation. The authorisation system (REACH Title VII) provides for 
Substances of Very High Concern to be first identified and put on the Candidate List, then 
gradually included in Annex XIV of the REACH Regulation (the “authorisation list”). Once 
included in Annex XIV, they cannot be placed on the market or used after the so-called “sunset 
date”. An actor may continue his use of a substance in Annex XIV after the sunset date only if 
an application for authorisation has been made before the latest application date, but a 
decision on the application has not yet been taken, or his use is in accordance with the 
conditions of an authorisation granted to him or to an actor up his supply chain for that use. 
Moreover, a manufacturer, importer or downstream user can continue placing on the market 
an Annex XIV substance for a use which his immediate downstream user has been granted an 
authorisation. There is no tonnage trigger for this requirement. 

An application for authorisation can be submitted by a manufacturer, importer or downstream 
user on their own or together. A duly mandated Only Representative (OR) of a non-EEA 
manufacturer can also submit an application for authorisation. 

It is very important to realise that an authorisation is specific to actors within a given supply 
chain, for given uses of a given substance. 

84

 for which the applicant shows that the risks 
Authorisations will be granted for (specific) uses
posed by the substance are adequately controlled. Authorisations may also be granted where 
the applicant can show that the socio-economic benefits of a use outweigh the risks and that 
there are no suitable alternative substances or technologies available. Authorisations will be 
granted by the Commission and are subject to reviews, the time-interval being decided on a 
case-by-case basis. ECHA’s Committees for Risk Assessment (RAC) and Socio-economic 
Analysis (SEAC) provide the Commission with opinions on the application for authorisation. 
Your use can be included in the authorisation granted to an actor up your supply chain. 
Alternatively you can make an application for authorisation for your use or for uses by your 
downstream users, either on your own or together with the manufacturer/importer, ORs or 
other downstream users. How to apply for an authorisation is explained in detail in the 
Guidance on the preparation of an application for authorisation
authorisation procedure are provided on the dedicated section of the ECHA website

. More details on the 
. 

86

85

If a substance is subject to authorisation there is a need for proactive communication between 
the applicant (e.g. the supplier of the substance) and the downstream users before the 
application is submitted to ensure that all concerned uses are covered. Once authorisation is 
granted the downstream user of the authorisation holder should receive information about that 
by his supplier, either in sub-sections 15.2 of the safety data sheet or in accordance with 
Article 32 of REACH, and is required to notify ECHA. The authorisation number has also to be 

84

 Please note, although identified uses described in the registration context are a good basis for the description of uses 
applied for, they may need to be further refined under the authorisation context. Use descriptors are recommended to be 
used in an application of an authorisation. 

85

86

 Available on the ECHA website at echa.europa.eu/guidance-documents/guidance-on-reach. 

 echa.europa.eu/addressing-chemicals-of-concern/authorisation. 

 
 
 
                                           
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mentioned in the label of substances and mixtures placed on the market in accordance with 
Article 65 of REACH, and the recipient must be informed pursuant to Article 32 of REACH. 

8.1.1 

Uses exempted from authorisation 

The REACH Regulation foresees exemptions from the authorisation requirements for uses of 
substances placed on Annex XIV under certain conditions. You should check if your substance 
can benefit from such an exemption before considering any other action. 

A) Generic exemptions from the authorisation requirements: substances on Annex XIV 
may be used for uses which are exempted from authorisation. Thus, if your use is exempted 
from authorisation, you can continue your use without an authorisation after the sunset date. 
Nevertheless, you have to implement the conditions of use and risk management measures 
communicated to you, for example, in an exposure scenario annexed to a safety data sheet. 

Exemptions from authorisation do not have to be communicated by your suppliers. Therefore, 
you should check whether your particular use is exempted. Table 15 lists the exemptions from 
the authorisation requirements according to REACH. Further information on exemptions can be 
found in the section on Q&A on application for authorisation

. 

87

Table 15 Generic exemptions from the authorisation requirement 

Exemption 
(short) 

Description of the exemption:  

Out of scope 

Substances not within the scope of REACH  

Intermediates 

Medicinal 
products for 
human and 
veterinary use 

See also scope of REACH in the navigator and the Guidance on 

registration

88

On-site isolated intermediates and transported isolated 
intermediates. 

Use in medicinal products for human or veterinary use within the 
scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of 
the European Parliament and of the Council of 6 November 2001 
on the Community code relating to veterinary medicinal products 
and Directive 2001/83/EC of the European Parliament and of the 
Council of 6 November 2001 on the Community code relating to 
medicinal products for human use. 

REACH 
Article 

2 

2 (8) (b) 

2 (5) (a) 

Food or 
feedingstuffs 

Use in food or feedingstuffs according to Regulation (EC) No 
178/2002 including use: 

2 (5) (b) 

- as a food additive in foodstuffs within the scope of Council 
Directive 89/107/EEC of 21 December 1988 on the approximation 
of the laws of the Member States concerning food additives 
authorised for use in foodstuffs intended for human consumption; 

- as a flavouring in foodstuffs within the scope of Council Directive 
88/388/EEC as a flavouring in foodstuffs within the scope of 
Council Directive 88/388/EEC of 22 June 1988 on the 
approximation of the laws of the Member States relating to 

87

88

 Available on the ECHA website at echa.europa.eu/support/qas-support. 

 You can start a Navigator session at echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-

your-obligations. Guidance documents are available in the “Support” section of the ECHA website at 
echa.europa.eu/guidance-documents/guidance-on-reach. 

 
 
 
 
 
                                           
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flavourings for use in foodstuffs and to source materials for their 
production and Commission Decision 1999/217/EC of 23 February 
1999 adopting a register of flavouring substances used in or on 
foodstuffs drawn up in application of Regulation (EC) No 2232/96 
of the European Parliament and of the Council; 

- as an additive in feeding stuffs within the scope of Regulation 
(EC) No 1831/2003 of the European Parliament and of the Council 
of 22 September 2003 on additives for use in animal nutrition; 

- in animal nutrition within the scope of Council Directive 
82/471/EEC of 30 June 1982 concerning certain products used in 
animal nutrition. 

Scientific 
research and 

development

89

Use in scientific research and development as defined in Article 

3(23) of REACH

. 

90

Plant protection 
products 

Use in plant protection products within the scope of the Council 
Regulation (EC) No 1107/2009 

Use in biocidal products within the scope of the Biocidal Products 
Regulation (BPR 528/2011) 

Use as motor fuels covered by Directive 98/70/EC of the 
European Parliament and of the Council of 13 October 1998 
relating to the quality of petrol and diesel fuels (Art. 56(4)(c) 
REACH) 

Use as fuel in mobile or fixed combustion plants of mineral oil 
products and use of fuels in closed systems (Art. 56(4)(d) 
REACH) 

Use in cosmetic products within the scope of Council Directive 
76/768/EEC in the case of substances that are subject to 
authorisation only because they meet the criteria in Article 57(a), 
(b) or (c) or because they are identified in accordance with Article 
57(f) only because of hazards to human health 

Use in food contact materials within the scope of Regulation (EC) 
No 1935/2004 in the case of substances that are subject to 
authorisation only because they meet the criteria in Article 
57(a),(b) or (c) or because they are identified in accordance with 
Article 57(f) only because of hazards to human health 

Use of substances when present in mixtures below a 
concentration limit of 0.1% weight by weight (w/w) for 
substances referred to in Article 57(d), (e) and (f) of REACH 

56(3) 

56(4) 

56(5)(a) 

56(5)(b) 

56(6)(a) 

Biocidal 
products 

Motor fuel 

Fuel in 
combustion 
plants 

Cosmetic 
products 

Food contact 
materials 

Concentration-
based 
exemptions: 
PBTs, vPvBs or 
substances of 
similar concern 

Concentration-
based 
exemptions: 
CMRs category 
1A and 1B 

Use of substances when present in mixtures below the lowest 
concentration limits specified in Directive 1999/45/EC or in Part 3 
of Annex VI to Regulation (EC) No 1272/2008 which results in the 
classification of the mixture as dangerous) 

56(6)(b) 

89

 Please note that scientific research and development can cover analytical activities. Please refer to Q&A on Application 

for authorisation nr 585 at echa.europa.eu/support/qas-support. 

90

 Article 3(23) of REACH defines scientific research and development as “any scientific experimentation, analysis or 

chemical research carried out under controlled conditions in a volume less than one tonne per year”.  

 
 
 
 
                                           
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93 

B) Exemptions included in Annex XIV: in addition to the generic exemptions listed in the 
previous paragraph, entries in Annex XIV to REACH may include the following exemptions: 

- product and process orientated research and development below the specified maximum 
quantity (Article 56(3) of REACH); 

- uses or categories of uses under the specified conditions (Article 58(1) and (2) of REACH). 

In Annex XIV you will find information on which uses are exempted and whether the 
exemption is subject to further conditions. Any information or conditions in Annex XIV has to 
be implemented, or you cannot regard the use as exempted.  

It is recommended to document the basis on which your use is exempt from authorisation 
requirements in order to have it ready for inspectors. 

C) For uses of mixtures there is no authorisation requirement below certain concentration 
limits

.  

91

D) Although incorporation of a substance into an article in the EU requires authorisation, use 
of (imported) articles is not subject to authorisation

. 

92

8.1.2 

Fulfilling authorisation requirements 

If you use a substance on Annex XIV you should: 

• 

check the latest application date of the substance

93

; 

•  ensure that your supplier is including your use (and/or uses by your DUs) in the 

authorisation application or consider to apply for authorisation. 

In addition you are obliged to:  

•  ensure an authorisation was granted to you or an actor up your supply chain, for your 

use (if you want to continue to use the substance after the sunset date); 

• 

• 

comply with the conditions of the authorisation decision, and 

report to ECHA if you use a substance under the authorisation granted to an actor up 
your supply chain

. 

94

It is important to check the Authorisation List as it develops to see whether any of the 
substances that you use are on it. This list is typically updated once a year, after a final 
decision by the European Commission. The concerned substances are indicated in ECHA’s draft 

91

92

 These are laid down in Article 56(6) of the REACH Regulation. 

 However, note that for substances in Annex XIV, after their sunset date ECHA has to consider whether the use of 

substance in articles poses a risk that is not controlled and if that is the case, ECHA has to prepare a restriction proposal 
to address this concern. 

93

 Latest application date is indicated in Annex XIV. This is the latest date by which an application for authorization has 
to be submitted to insure that the use can be continued after the sunset date even if the decision has not be made by that 
time.    

94

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and final Annex XIV recommendations to the Commission, which are published about 1 and 1.5 
years before the update, accordingly. 

If you incorporate such substances into mixtures, it may be beneficial for business purposes to 
ensure that your customers’ uses are included in the application for authorisation. If your 
customers’ uses do not comply with the conditions of authorisation, they will need to cease the 
use of your mixture or to ask for an authorisation that covers their use. 

The applications for authorisation are made to ECHA and can be submitted by the 
manufacturer(s), importer(s), downstream user(s) of the substances and/or duly mandated 
ORs. The uses applied for can be the applicant’s own use(s) and/or uses for which the 
applicant intends to place the substance on the market. 

An application for authorisation needs to specify the use for which an authorisation is 
requested, and to document in a chemical safety report how the risks are adequately 
controlled and/or minimised. It also needs to include an analysis of alternatives and, where 
suitable alternatives are available, a substitution plan. Applications for substances for which no 
DNELs/PNECs exist or where exposure exceeds the DNEL shall include a socio-economic 
analysis (SEA). 

Contact your  supplier well in advance of the latest application date to find out whether an 
application will be made by him or another actor up your supply chain. 

In case your supplier intends to apply for authorisation, you should verify with him which 
conditions of use he will specify in the application. 

If your use is not to be covered by an authorisation submitted by a supplier in your supply 
chain and you decide to apply for an authorisation, you could ask your supplier access to his 
chemical safety report to prepare your application dossier. If your supplier makes an 
application covering your use(s), he may ask you for support in describing appropriate 
operational conditions of use and risk management measures. Further information and 
cooperation requests may relate to the assessment of alternatives, development of 
substitution plans or carrying out a socio-economic analysis. Further help is given in the 
Guidance on the preparation of an application for authorisation and in the Guidance on the 
preparation of socio-economic analysis as part of an application for authorisation

. 

95

8.1.2.1  

Assess the need for actions concerning your use and applying for 
authorisation 

You can anticipate the need to take actions concerning authorisation requirements for the use 
of a substance by monitoring the ECHA website at different steps of the process leading to the 
inclusion in the Annex XIV. Once the substance is in Annex XIV, and if no suppliers intend to 
apply for an authorisation for your use, consider in advance whether substituting the 
substance may be a better option than continuing the use. Guidance on assessing alternatives 
and making substitution plans is provided in the Guidance on the preparation of an application 
for authorisation. 

If any actor up the supply chain has not applied for an authorisation covering your use, this 
may be for a number of reasons; for example because your use is not known to your suppliers, 
the application was not profitable for other actors or the risk associated with the use proved 
not to be adequately controlled. If you believe that the risks associated with the substance can 
be adequately controlled in your use, or that the socio-economic benefits of your use outweigh 
the risks, you may decide to apply for an authorisation for your use. 

It is possible to prepare and apply for an authorisation with a group of actors for same use or 
different uses of the substance. For example, you could consider: 

95

 Both available in the “Support” section of the ECHA website at echa.europa.eu/guidance-documents/guidance-on-

reach. 

 
 
 
                                           
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95 

informing your supplier and asking him to apply for the authorisation, or  

• 
•  submitting the application with your supplier, and/or 
•  submitting the application with other downstream users who need authorisation for 

the same use, and/or 

•  submitting the application with your customers (if they are also downstream users) 

who depend on the substance or mixture you sell them. 

It is important to remember that if no application for authorisation covering your use is made 
(either by you or an actor up the supply chain), you must stop using the substance by the 
sunset date and the substance as such, or in a mixture, may not be supplied to your 
customers for further uses after that date. 

8.1.2.2 

Sunset date 

In case the substance you use is subject to authorisation and none of the exemptions applies 
to your use, you can continue using a substance as such, or in a mixture or article, until its so-
called “sunset date” is reached. The sunset date is specified in Annex XIV for each substance. 
After the sunset date, you may only use the substance as such or in a mixture or incorporate it 
into an article if an authorisation has been granted to you or to an actor up your supply chain 
and you comply with the conditions of the authorisation, or if you or your supplier has applied 
for an authorisation before the latest application date but the decision is pending.  

8.1.2.3 

Comparing authorised uses and conditions with your own use 

If an authorisation has been granted to an actor up your supply chain your supplier should 
provide enough information to enable you to use the substance according to the conditions of 
this authorisation. He may provide additional information related to the authorisation, e.g. 
when the granted authorisation will be reviewed. This information can in any case be found on 
the ECHA website

. 

96

Where Article 31 of REACH applies the supplier must communicate the conditions under which 
the substance can be used according to the authorisation in an exposure scenario annexed to 
or in the main body of the safety data sheet. 

Checking if a use is covered by an authorisation is similar to the “normal” checking of coverage 
of an exposure scenario (chapter 4 of this guidance). 

The conditions communicated (e.g. in the exposure scenario) are to be applied strictly. You 
may apply stricter conditions leading to lower exposure (shorter durations, less frequent use, 
more tightly encapsulated processes etc.). 

To comply with the conditions of the authorisation, you may have to upgrade or modify your 
process to implement the conditions described in the exposure scenario. 

8.1.2.4 – Notifying ECHA 

If you are relying on an authorisation granted to your supplier or another actor up the supply 
chain, you must notify ECHA at the latest 3 months after first receiving an authorised 
substance as such or in a mixture (Article 66 of REACH). A notification format will be provided 
via web form and will require as a minimum the following information: 

•  your identification and contact details; 

96

 At echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-

authorisation-list/authorisation-list. 

 
 
 
                                           
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Guidance for downstream users 
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• 

the authorisation number, which you will find on the label and/or in the safety data 
sheet  of  the  substance  or  mixture  or  in  the  information  provided  according  to 
Article 32 of REACH; 

•  brief general description of use. 

Furthermore, if you are in compliance with the conditions of the authorisation, it is advisable 
that you document this for internal follow-up and future use (for example, if you make any 
changes to your process, then you will need to re-check your compliance).  

8.1.2.5 – Communicating relevant information downstream 

If you are a formulator and supply mixtures to your customers, you have to forward the 
authorisation number and any information on the conditions of the authorisation that is 
relevant for your customer. The authorisation number must also be provided on the label 
(Article 65 of REACH) and in Section 2 of the safety data sheet when one is required. 

Since the authorised substance is a SVHC, if you produce articles, you have to supply your 
customers with information on the authorised substance, if it is contained in the article in 
concentrations above 0.1 % (w/w). Further guidance on this is provided in chapter 8.3 and, in 
more detail in the Guidance on requirements for substances in articles

. 

97

8.1.2.6 – Time-limited review period 

Authorisations are subject to a time-limited review in which context the Commission may 
decide to withdraw or amend the authorisation. To be noted that an authorisation may be 
reviewed at any time by the Commission if the circumstances of the authorised use change so 
as to affect the risks or the socio-economic impact, or if new information on alternatives 
becomes available. 

This will normally be reported in the safety data sheet or in the information communicated to 
the downstream user according to Article 32 of REACH. Otherwise, this information can be 
99
. 
found in the Commission decision published in the Official Journal
Holders of authorisations must submit a review report at least 18 months before the expiry of 
the time-limited review period

and on ECHA website

.  

100

98 

8.1.3 

Contributing to public consultations 

During the authorisation process you can provide comments on the substance concerned at 
different steps of the process:  

-  When a proposal for identification of a substance as SVHC has been submitted: ECHA 
particularly welcomes comments related to the substance identity and/or intrinsic 
properties used to justify the identification as SVHC. Comments questioning CLH are 
not to be considered in this context. Other types of comments, particularly those on 
uses, can be made and will be taken into account at the next stage in the process. 

-  When the SVHC is recommended by ECHA for inclusion in Annex XIV: information on 
the complexity of the supply chain is particularly welcome. ECHA also welcomes 

97

 All the guidance documents are available in the “Support” section of the ECHA website at echa.europa.eu/guidance-

documents/guidance-on-reach. 

98

99

 eur-lex.europa.eu/JOIndex.do. 

  echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-

list/authorisation-list. 

100

 More details on the process and the timeline are provided on the dedicated section of the ECHA website at 
echa.europa.eu/en/regulations/reach/authorisation/applications-for-authorisation/authorisation-process/steps.  

 
 
 
                                           
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97 

comments on the review periods, the transitional arrangements and on those uses 
which could possibly be exempted from the authorisation requirement. ECHA takes the 
comments received into account when updating the draft recommendation. 

-  When the application for authorisation is under evaluation by the Committees during 
the opinion making phase: ECHA welcomes comments related to the existence and 
suitability of alternative substances or technologies to the uses applied for 
authorisation. RAC and SEAC then evaluate the relevance of this new information for 
the application and balance it against the Applicant’s assessment and response to these 
comments. 

-  After the decision has been made (e.g. new information on alternatives becomes 

available) on the specific application for authorisation. 

 
 
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Substance on REACH Annex 
XIV

Use generally exempted?

Yes

No

Document 
basis for 
exemption 
(voluntary)

You may 
continue the 
use of the 
substance

Exemption in Annex XIV?

Yes

Use necessary?

No

You may use the 
substance until 
the sunset date

No

You may use the 
substance until 
the sunset date

Yes

Your supplier is including 
your use in his 
application?

Yes

Compare uses applied for & 
condition with own uses 

No

Own use in line with 
uses applied for? 

Yes

No

RMMs and OCs adaptable?

Yes

Notify 
ECHA(after 
authorisation 
granted)

Make 
necessary 
changes

No

Wish to apply for 
authorisation?

Yes

No

Phase out 
use by the 
sunset date

Check if an application can be 
made jointly

Guidance on   
authorisation 
application

Document 
compliance 
(voluntary)

Communicate 
relevant 
information 
downstream

Continue use in 
line with 
conditions and 
time limitations

Figure 7 Workflow on fulfilling authorisation requirement 

 
 
 
 
 
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99 

Further information related to applications for authorisation in general, and more specifically 
related to supply chain and downstream users’ considerations, can be consulted at the ECHA 
website in the Q&A section

. 

101

8.2  Downstream users and restriction requirements  

This chapter covers the requirements of REACH concerning restrictions and what a 
downstream user should do to ensure compliance with restrictions. It provides guidance on 
how a downstream user can provide information during the preparation of the restriction 
proposals and how they can get information on existing restrictions. 

8.2.1 

Restrictions in a nutshell 

Article 67 

General provisions 

1. A substance on its own, in a mixture or in an article, for which Annex XVII contains a 
restriction shall not be manufactured, placed on the market or used unless it complies with the 
conditions of that restriction. … 

Article 68 

Introducing new and amending current restrictions 

1. When there is an unacceptable risk to human health or the environment, arising from the 
manufacture, use or placing on the market of substances, which needs to be addressed on a 
Community-wide basis, Annex XVII shall be amended…by adopting new restrictions, or 
amending current restrictions…for the manufactures, use or placing on the market of 
substances on their own, in mixtures or articles…Any such decision shall take into account the 
socio-economic impact of the restriction, including the availability of alternatives. 

Under REACH, restrictions may limit your use of a substance. If restrictions apply to a 
substance that you use, on its own, in a mixture or an article or when incorporating the 
substance into an article during the production of the article, you may only continue to use it if 
you comply with the restrictions. Restrictions under REACH are very similar to the marketing 
and use restrictions under Directive 76/769/EC, made before the entry into force of REACH. 
Therefore, only brief guidance is provided here. Restrictions introduced under Directive 
76/769/EC were carried over into Annex XVII of REACH. 

Your EEA supplier must include information on whether a substance he supplies is subject to 
restriction in Section 15 of the safety data sheet or in other information supplied to you 
according to Article 32 of REACH. If a restriction is imposed, your supplier must provide you 
with an updated safety data sheet or other information without delay. You can consult the list 
of restrictions in Annex XVII on the ECHA website

. 

102

More information on the restriction procedure is available on the ECHA website
can find out also which substances are considered for restriction, and the type of restriction 
proposed. 

.  There you 

103

101

102

103

 echa.europa.eu/support/qas-support. 

 Available at echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions. 

 At echa.europa.eu/regulations/reach/restriction. 

 
 
 
                                           
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In some cases, the restriction may take the form of an outright ban on the use of the 
substance, in which case you will no longer be able to use it. In other cases, specific uses may 
be prohibited or other conditions applied, to control the risks of the substance. 

It should be noted that even though a substance is on the authorisation list (Annex XIV) due to 
specific intrinsic property, there can be a restriction for this substance due to its other intrinsic 
properties. In addition, there can be a restriction of a substance listed in Annex XIV when the 
substance is present in article(s). If all uses are prohibited by a restriction in Annex XVII, this 
substance need not be included in the authorisation list or will be removed from it. 

8.2.2 

General exemption from restrictions 

Restrictions do not apply to the manufacturing, placing on the market or uses of a substance in 
scientific research and development in a volume less than one tonne per year when carried out 
in controlled conditions. 

This general exemption from restrictions may not be communicated to you by your suppliers. 
Therefore, you should check whether your particular use is exempted. 

8.2.3 

Ensuring compliance with restrictions 

8.2.3.1  

Information on restrictions  

Your supplier must specify, under Section 15 of the safety data sheet, whether the substance 
that you use is subject to restriction. If you do not receive a safety data sheet, your supplier is 
obliged to communicate this separately, according to Article 32 of REACH. You find the 
restrictions also on the ECHA website
can be found on the support page of the ECHA website
Answers on restrictions” are available. 

. Further information on interpretation on restrictions 

, where the FAQs and “Questions and 

104

105

8.2.3.2  

Comparison with conditions of restriction 

If the restriction takes the form of a prohibition on use, you have to phase out the use of the 
substance by the date specified in Annex XVII of REACH. If the restriction takes another form, 
compare the conditions of the restrictions, as set out in the safety data sheet or other 
information you receive from your supplier, with your conditions of use, your risk management 
measures and the mixtures or articles you produce. 

8.2.3.3  

Communication downstream 

If you are a formulator, and you include a substance subject to restrictions in a mixture that 
you place on the market, you must communicate information on the restrictions applying to 
that substance to your customers in the safety data sheet or other information that you 
provide to them. Further information on how a formulator of a mixture can comply with his 
communication requirements is given in chapter 7 of this guidance. 

104

105

 At echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions. 

 Available at echa.europa.eu/support/qas-support. 

 
 
                                           
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101 

Information received by 
supplier (SDS or Article 32)

Is the substance 
subject to 
restrictions?

Yes

Check conditions of restriction

No

Own conditions of 
use in line?

Yes

No

Adaptations 
possible?

No

Phase out the 
substance

Yes

Implement the required 
conditions

Communicate information if 
required

END

Figure 8 Workflow checking compliance with restrictions  

8.2.4 

Contributing to public consultations 

It is important to underline that downstream users, as well as any other interested party, will 
have the possibility to provide information and comments on the substance concerned at 
different steps of the restriction process: 

-  when a proposal to restrict a substance has been submitted and the restriction report is 

published by ECHA; 

-  after ECHA publishes the draft opinion of SEAC (all interested parties may comment 

only on the SEAC draft opinion at this stage); 

During the public consultation phases interested parties can submit comments on the proposed 
restrictions and the dossiers underlying them. You may also prepare a socio-economic 
analysis, or information which can contribute to one, examining the advantages and drawbacks 

 
 
 
 
 
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Guidance for downstream users 
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of the proposed restrictions. More information is given in the Guidance on socio-economic 
analysis - Restrictions

. 

106

In general, please refer to the dedicated page on the ECHA website

107.

8.3 

Compliance with requirements related to substances in 
articles 

Companies producing articles
downstream user only and hence particular obligations. 

 should be aware that they may also have roles other than 

108

As a producer of articles, who incorporates substances into articles, you have to register 
substances which are intended to be released from the articles under normal or reasonably 
foreseeable conditions of use if the quantity of the substance in the articles is over 1 tonne per 
year (Article 7(1) of REACH), if the substance has not already been registered for that use
In case the used quantity is equal to or above 10 tonnes per year a CSR also needs to be 
prepared. If the incorporation into and use of the article has not been covered in the 
registration, you can also inform the manufacturer or importer of the substance (you can refer 
to chapter 3 of this guidance). If the registration is then updated to include the incorporation 
into the article and the use of the article, you don’t need to register the substance in the 
article. 

109.

If the article contains above 0.1% w/w of a Substance of Very High Concern (SVHC) on the 
Candidate List and the quantity of the substance is over 1 tonne per year in the article, you 
have to notify ECHA (Article 7(2) of REACH) within 6 months after the SVHC is included in the 
Candidate List. 

If the article contains above 0.1% w/w of a SVHC on the Candidate List you have to inform 
your customers on safe use of the article, including as a minimum the name of the SVHC in the 
article (Article 33(1) of REACH). Consumers can also request information about Candidate List 
substances in articles (Article 33(2) of REACH). 

Furthermore, the content of substances in articles can be restricted under the restrictions 
procedure. Therefore, article producers have to follow the restrictions outlined in Annex XVII of 
the REACH Regulation. 

Detailed guidance on the obligations related to substances in articles is provided in the 
Guidance on requirements for substances in articles available on the ECHA website
chapter a summary of the information which is most relevant for downstream users is 
provided. 

110

. In this 

8.3.1 

Exemptions from the requirements 

Substances that have been registered for that use, i.e. where the registration dossier covers 
the incorporation into the article and the service-life of the article is adequately considered and 
assessed, do not need to be registered again or notified pursuant to Article 7(6) of REACH. 

106

107

108

 Available at echa.europa.eu/guidance-documents/guidance-on-reach. 

 echa.europa.eu/addressing-chemicals-of-concern/restriction. 

 Please note that importers of articles are not considered downstream users under REACH. See table 6 and the 

Guidance on requirements for substances in articles. 

109

110

 The same obligation applies to importers of articles. 

 Available at echa.europa.eu/guidance-documents/guidance-on-reach. 

 
 
 
 
 
                                           
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103 

For the substances that are already registered, producers of articles should already have 
communicated their use to the registrant for the purpose of registrations or checked whether 
their use is covered, based on information provided by the registrant before and after 
registration. Producers of articles will therefore, in most cases, not have to submit a 
notification for a Candidate List substance in articles or register a substance intended to be 
released from an article. Hence, you will normally be covered by the exemption if the 
communication through the supply chain and the assessment of all identified uses have been 
properly carried out.  

Furthermore, if the importer or producer of an article can exclude exposure during normal or 
reasonably foreseeable conditions of use, including disposal, the notification requirement does 
not apply. In these cases, the producers and importers have to provide appropriate 
instructions to the recipient of the article. In addition producers and importers need to keep 
this documentation available in case of enforcement actions to come. 

8.3.2 

Staying prepared 

Regardless of your role in the supply chain, it is recommended to make an inventory of your 
use(s) of substances which are on the Candidate List since there may be other obligations 
following from their use in articles (see following chapter 8.3.3). The Candidate List is updated 
. The website also contains 
regularly and the updates can be followed on the ECHA website
the Registry of Intentions, where member states and ECHA/the Commission can make public 
their intention to identify a substance as a SVHC for inclusion on the Candidate List. 

111

8.3.3 

Forwarding information with articles 

If you supply an article containing a substance on the candidate list in concentrations of 0.1 % 
w/w or more in the article, you are obliged to forward information on safe use to the recipients 
of the article you produce (Article 33 of REACH). The information includes as a minimum the 
name of the SVHC in the article. The recipients may be other enterprises that use the article 
but also retailers, which provide articles to consumers. Similarly, your supplier of an article 
shall provide you with information if the article contains substances on the Candidate List in 
concentrations above 0.1 % w/w. This requirement still applies after the substance is included 
in Annex XIV. 

All actors, article producers, importers or distributors/retailers must provide this information to 
consumers on request, within 45 days and free of charge. 

REACH does not specify a format for providing information with articles. You should choose a 
format that will ensure that the recipient can readily understand the information. 

111

 At echa.europa.eu/regulations/reach/authorisation/the-candidate-list. 

 
 
 
 
 
 
 
 
 
 
 
                                           
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Guidance for downstream users 
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Appendix 1 

Compliance with REACH for distributors 

This appendix sets out the main aspects of the REACH Regulation which are relevant to 
distributors including retailers. They are not downstream users under the REACH Regulation. 
Before reading this appendix, chapter 2 of this guidance should be consulted in order to 
identify whether the role of a distributor or a retailer under REACH applies to you. 

A1.1 

Overview of REACH and distributors 

112 (see Article 3(14) of REACH). A retailer under REACH is an actor who sells 

A distributor under REACH is any natural or legal person established within the EEA, including 
retailer, who only stores and places on the market a substance, on its own or in a mixtures, for 
third parties
substances and mixtures to private consumers and/or professional users in retail stores. 
Retailers are a sub-group of distributors. Storage providers, who only store substances or 
mixtures for third parties, are also a sub-group of distributors. As long as these actors do not 
perform any operations or activities with them which would be defined as “use” under REACH 
(as specified in table 8), their obligations are limited to forwarding information in the supply 
chain as described in this chapter. 

It is important to note that you should check carefully your own role. In fact you may also 
have roles besides distributor/retailer under REACH. The most common additional roles of a 
distributor are: 

• 

Importer of substances, mixtures or articles. In this case you may have obligations 
to register and other obligations related to the import of substances/mixtures or of 
articles. Consult the Guidance on registration and the Guidance on requirements for 
. 
substances in articles for further details

113

•  Re-filler, who transfers substances or mixtures from one container to another, is a 
downstream user, and as such has to comply with the obligations of a downstream 
user under REACH. 

•  Other downstream users roles, if, for example, you blend the substances with other 

chemicals to produce a mixture. 

This chapter aims to help you to identify the obligations related to your specific role as a 
distributor. For identification of obligations in relation to other possible roles you might have 
under REACH you should consult the relevant guidance as indicated above and in chapter 2 of 
this guidance. To obtain general information on the aims and functioning of REACH, you could 
also use the REACH Navigator
website

 or the introductory information on REACH on the ECHA 

. 

115

114

A1.2 

Obligations for distributors under REACH 

As a distributor, your main obligation under REACH is to pass on information on the goods you 
distribute from one actor in the supply chain to another. This includes safety data sheet for 

112

 A person who solely stores and places articles on the market (i.e. neither substances on their own nor in a mixture), 

for third parties is not a distributor according to the definition in the REACH Regulation.  

113

 All the guidance documents and other supporting material are available in the “Support” section of the ECHA website 

at echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.  

114

115

 Available at echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.  

 echa.europa.eu.  

 
 
                                           
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105 

substances and mixtures. Furthermore, there is a requirement for certain information to be 
provided for substances, mixtures or articles when a safety data sheet is not required.  

You are not a downstream user of substances/mixtures according to REACH, but have a key 
position regarding information flow within the supply chain. You may have direct contact with 
the manufacturer/importer and the end-user of a substance/mixture, but the supply chain may 
also consist of several actors, where you as a distributor are placed between two downstream 
users in the chain. Figure 9 illustrates in a simplified way the possible role of distributors in the 
supply chain. In principle, your role is similar to that before REACH. Therefore, your previous 
experiences and methods for delivering information in the supply chain could also be used 
under REACH. 

Manufacturer/
Importer of 
substance/mixture

Distributor

DU: formulator

Distributor

DU: industrial 
user

Distributor / 
retailer

Distributor

DU: formulator

Distributor / 
retailer

Figure 9 The distributor and the supply chain 

Consumer

DU: End-user

Communication up and down the supply chain is a critical point for the success of REACH and 
the distributor represents a fundamental link between suppliers and downstream users in 
many supply chains. You may decide if necessary to proactively initiate communication 
between a manufacture or an importer of substances and your customers, who will often be 
downstream users. The downstream user could be a formulator of mixtures, as well as an end 
user of substances and mixtures, and he may need to communicate with the supplier for 
different reasons. If this is the case, it is your role as a distributor to pass the request for 
further information from your customer to your supplier and to deliver the response of the 
supplier to the same customer (i.e. the downstream user). This can happen, for example, in 
the following situations: 

 
 
 
 
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Guidance for downstream users 
Version 2.1  October 2014 

•  a formulator or end-user of substances or mixtures, i.e. the downstream user, wants, 
as is his right, to make a use known in writing to his supplier with the aim of making 
this an identified use; 

• 

• 

the downstream user provides a description of his use(s) in writing to the supplier in 
order to support the supplier in the preparation of the registration dossier; 

the downstream user may also decide to make his own chemical safety assessment, for 
his use (s) and/or his customers’ use(s) of a substance or a mixture (as described in 
chapter 5). In this case the downstream user may not be able to make his own 
chemical safety assessment on the basis of the information in a safety data sheet or 
exposure scenario delivered to him; he may need additional information from the 
supplier on, for example, the hazardous properties of a substance or the exposure 
assessment. 

According to the situation, the type of information that you as a distributor may have to pass 
on could include the following. 

• 

Information related to the identification of uses, either from manufacturers / importers 
to downstream users via questionnaires or from downstream users to suppliers, for 
example via standard brief general descriptions of use.  

•  Health and safety information on possible hazards and risks of your product up and 
down the supply chain. You have the duty to pass on information about hazards and 
safe handling received from the supplier to your customers. This may include the safety 
data sheet
may have to pass on information on authorisation or restrictions applying to a 
substance. 

 (with or without the exposure scenario) if appropriate. Furthermore you 

116

• 

Information to allow safe use of an article to your customer when it contains more than 
0,1% w/w of a SVHC included in the Candidate List. 

•  Specific requests for information from a downstream user to the supplier, if the 

downstream user wants to make a DU CSR. 

•  New information on hazardous properties or on the appropriateness of the risk 

management measures from the downstream users to the suppliers. 

You may need to document that you have asked for information from your supplier and 
communicated information delivered to you further down the supply chain and vice versa. You 
are therefore recommended to send requests to suppliers and information to customers in 
writing, either on paper or electronically. Procedures for communication and handling of 
documents in relation to the obligations under REACH could be described and included as a 
part of your quality assurance system. 

Furthermore you should note that a distributor has to keep information on a substance on its 
own or in a mixture for at least 10 years after the last supply of the substance or the mixture 
(Article 36 of REACH). 

Examples of information you are obliged to pass up and down the supply chain is given in 
Table 16. 

116 The distributor may provide the safety data sheet and exposure scenario in the national language and adjusted to 
specific national rules. He may also add his own information in Section 1 of the safety data sheet e.g. an emergency 
number. See also Table 16 Information flow in the supply chain. 

 
 
 
 
                                           
107 

Type of information 
to be forwarded  

Remarks 

Guidance for downstream users 
Version 2.1 October 2014 

Table 16 Information flow in the supply chain

117

Subject 

Preparatory activities 

Manufacturer/importer 
before registration of 
a substance 

Downstream user 
preparatory activities 
and requesting that a 
use becomes an 
118 

identified use

Type of 
information 
received  

Questionnaires from 
suppliers of 
substances/mixtures 
concerning the 
identification of 
use(s) including the 
operational 
conditions of use(s). 

Responses to 
questions from 
suppliers and 
additional questions 
for clarification of 
use conditions. 

Responses to 
questionnaires from 
suppliers.  

Information on the 
uses of a substance as 
such, in mixtures and 
in articles, possibly 
accompanied by a 
request to make a use 
identified for inclusion 
in the registration of 
the 
manufacturer/importer. 

Safety data sheet and other information on a substances and mixture  

Safety data sheet and 
related information 

Safety data sheet 
with or without 
exposure 
scenario(s). 

New information on 
hazard properties, 
information calling into 
question the 
appropriateness of risk 
management measures 
and requests for a 
REACH-compliant 
safety data sheet if not 
received by due 

119

date

. 

Safety data sheet for 
a mixtures and DU 
CSR for a 

substance

120 

Delivery of 
information for 
making a safety 
data sheet for a 
mixture, on request 
from downstream 
user. 

Requests for additional 
substance information 
needed for making a 
DU CSR. 

Requests for a safety 
data sheet when 
concentration of 

Preparatory activities 
before registration of a 
substance could include 
identifying uses and 
conditions of use. 
Preparatory activities 
are expected to take 
place in the 11 year 
period during which all 
existing substances in 
amounts of 1 
tonne/year or more, per 
manufacturer/importer, 
have to be registered. 

Safety data sheets have 
to be passed to the 
downstream user. They 
have to be in the 
national language and 
include specific national 
provisions, e.g. on 
workers’ health. 

New information on 
hazards and information 
questioning 
recommended risk 
management measures 
have to be forwarded. 

If a customer makes a 
DU CSR for a substance 
as such or in a mixture, 
he may request 
information on 
substance hazards.  

You may receive 
requests from 

117

118

119

120

 The table illustrates general examples of the types of information which could be exchanged in the supply chain. 

 See chapter 3 this guidance. 

 See chapter 6 of this guidance. 

 See chapter 5 and chapter 7 of this guidance. 

 
 
 
 
 
 
 
                                           
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Guidance for downstream users 
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hazardous substances 
in a mixture is above a 
threshold value for 
providing of safety 

data sheet

. 

121

Information in the 
supply chain when no 
safety data sheet is 
required 

Information: 

Information: 

- On a substance 
subject to 
authorisation or 
restriction. 

- Needed for 
identifying 
appropriate risk 
management 
measures. 

- On a substance 
subject to 
authorisation or 
restriction. 

- Needed for 
identifying appropriate 
risk management 
measures. 

Information to 
consumers 

Information on:  

Information on:  

- the classification, 
as a minimum. 

- the classification, as 
a minimum. 

- Recommendation 
on safe conditions of 
use has also to be 
included. 

- Recommendation on 
safe conditions of use 
has also to be included. 

customers for safety 
data sheets for non-
classified mixtures. If 
hazardous substances 
are contained above the 
threshold values of 
article 31 (3) of REACH 
you shall provide it. 

Even if no safety data 
sheet is required, you 
may receive and 
forward information 
from the supplier 
according to Article 32 
of REACH. 

A non-classified mixture 
may contain, e.g. a 
substance subject to 
authorization below the 
concentration limits 
specified in Article 31(3) 
of REACH. Then the 
supplier must send this 
information, together 
with the registration 
number (and the 
authorisation number) 
and any other 
information necessary to 
use the mixture safely.  

Classified substances or 
mixtures for the general 
public do not require a 
safety data sheet if 
sufficient documentation 
to enable safe use is 
provided.  

Authorisation/restriction

122

Information in the 
supply chain for an 
SVHC 

Questions from 
suppliers on the 
use(s) of a 
“substance of very 
high concern”, on its 
own or in mixtures.  

Answers to questions 
from suppliers on the 
use(s) but also 
questions from the 
downstream user on 
the substance 
concentration in 
mixtures (and articles).  

For substances 
(expected to be) under 
authorisation/restriction, 
communication in both 
directions can be 
expected. This could be 
when substances are 
included in the 
Candidate List 

Information on substances in articles

123 

 (Article 33 of REACH) 

121

 Article 31(3) in: REACH Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 13. 

December 2006. 

122

 See chapter 8 of this guidance for more information on compliance for downstream users with the authorisation and 

restrictions. 

123

 See chapter 8 of this guidance and the Guidance on requirements for substances in articles for more detailed 

information.  

 
 
 
                                           
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Information in the 
supply chain for 
articles 

Information to 
consumers for articles 

For articles with a 
substance on the 
Candidate List 
present in a 
concentration > 0.1 
% (weight/weight): 

- Available 
information on safe 
use of the articles.  
Name of the 
substance as a 
minimum  

For articles with a 
substance on the 
Candidate List 
present in a 
concentration of 0.1 
% or more 
(weight/weight): 

- Available 
information on safe 
use of the articles. 
Name of the 
substance as a 
minimum. 

Downstream user may 
request information on 
the content of 
“substances of very 
high concern” in 
articles.  

109 

You have to pass the 
information from your 
supplier of an article to 
your customers 
(downstream users and 
distributors/retailers). 
Furthermore, you should 
pass any requests 
upstream. 

Requests from a 
consumer about an 
article containing a 
“substance of very high 
concern". 

If you receive a request 
from a consumer, you 
have to provide him 
with the information, 
free of charge, within 45 
days after you have 
received the request. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix 2 

Scaling 

Guidance for downstream users 
Version 2.1  October 2014 

Note: This appendix is mainly addressed to registrants and to downstream 
users who have prepared DU CSR but are not registrants of the substance. 

The exposure scenario can be described flexibly with a variety of combinations of operational 
conditions (OC) and risk management measures (RMM). If the calculated exposure levels are 
based on the recommended operational conditions and risk management measures or even 
stricter, the downstream user does not have to do any additional verification. However, due to 
the fact that the parameters do not all work in the same direction, there can be situations 
where additional checking may be needed based on the change of OCs/RMMs. If the supplier 
has provided scaling options in the safety data sheets, the downstream user can use scaling to 
check if his combination of operational conditions and risk management measures (different 
from the combination proposed in the exposure scenario as received from the supplier) may 
still lead to, at least, the same level of control of risks. Thus, by applying scaling, downstream 
users do not develop new exposure scenarios with the same equations, but they calculate 
whether their situation is within the boundaries of the exposure scenario described by the 
supplier. It is important to mention that scaling options can only be provided by registrants or 
suppliers of chemicals who have prepared a CSR and if the registrant (or supplier preparing a 
CSR) has used an exposure estimation tool in their assessment. Scaling is not possible if the 
supplier has based his exposure assessment on measured exposure data. In this case the 
assessment is not based on a model and no scaling formula can be derived. Only those who 
have undertaken a chemical safety assessment and prepared a CSR may know to what extent 
the conditions of use of downstream users may be covered by the exposure scenario they have 
developed as part of their assessment. In assessing the exposure to a substance for a specific 
use, registrants (or other suppliers preparing a CSR) take into account multiple factors beyond 
the specific conditions of such use (e.g. impact to the environment at a regional scale, 
exposure to consumers from multiple sources, workers exposed to the same substance in 
different activities, workers exposed to multiple substances during their working shift etc.). For 
this reason registrants (or other suppliers preparing a CSR) may sometimes identify and 
recommend operational conditions and risk management measures leading to exposure levels 
which may be seen to be “very conservative” for a specific use, but which may be justified by 
broader considerations that are reported in the CSR but are not known to downstream users. 

Scaling options defined by registrants (or other suppliers preparing a CSR) should be easy to 
implement by downstream users. Scaling is limited to simple calculations with the scope to 
demonstrate that variation in some parameters is compensated by variation in other 
parameters in order to guarantee that the resulting level of exposure (from application of 
downstream users conditions) is the same or lower than the level of exposure resulting from 
strict application of the exposure scenario as received from the suppliers. Downstream users 
should be able to apply scaling and to rely on the simple outcome from the scaling method in 
order to understand if their conditions are covered by the exposure scenario. If a downstream 
user concludes that application of scaling options is not sufficient to demonstrate that his use 
conditions are covered by the exposure scenario and that further assessment is needed, he 
can provide sufficient information to allow the manufacturer, importer or downstream user who 
has supplied the substance to prepare an exposure scenario for his use (Art 37(2)). If the DU 
does not want to make his use known, he must prepare a DU CSR or check for other options 
(see chapter 4.4 of this guidance).   

A2.1 

Boundaries of scaling 

The exposure scenario represents a set of conditions of use that should be implemented by 
downstream users in order to guarantee that a substance is used safely. This means that if 
such conditions are implemented by a downstream user, the levels of exposure to the 
substance during its use will not generate adverse effects for humans (i.e. workers and 
consumers) and the environment. In this case the exposure scenario “covers” the use and no 

 
 
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111 

additional action is needed by the downstream user (see Guidance on IR&CSA Part D for 
further information on exposure scenario building and definition of safe use). 

If, instead, one or more conditions of use at downstream user site exceed the limits set in the 
exposure scenario, levels of exposure to the substance may be higher than levels obtained by 
applying the conditions defined in the exposure scenario. 

If this is the case, the conditions of use from downstream users have to be considered outside 
of the exposure scenario boundaries. 

If scaling options are provided in the safety data sheet, downstream users may use the scaling 
method to check levels of exposure resulting from the application of their conditions of use.     

The following principles have to be taken into account when scaling is applied:  

• 

scaling cannot be used by downstream users to justify conditions of use 
leading to levels of exposure exceeding the levels of exposure resulting from 
application of the conditions in the exposure scenario; 

•  by applying environmental scaling downstream users have to assure that the 
quantity of the substance released to the environment/ time (release rate) do 
not exceed the release rate obtained by applying the ES as received by the 
supplier. 

It has to be noted that in general scaling has a limited range of applicability. Besides 
what already explained, the following additional considerations should also be taken into 
account to understand why it is so. 

1.  Interpretation of the legal requirements. Article 37(4)(d) of REACH 
requires that downstream users may not need to prepare a CSR if they 
implement and recommend as a minimum the conditions communicated to 
them in the exposure scenario as received by their suppliers. 

2.  Reliability of CSR information. The information in the ESs annexed to 

safety data sheets is consistent with the information in the Chemical Safety 
Report which is a key element of the registration dossier. ECHA consider the 
information contained in CSRs as the primary source of information which is 
needed for other REACH processes (e.g. authorisation, substance evaluation, 
restrictions etc...). 

A2.2 

Defining scaling options  

In order to define specific scaling options to be communicated to downstream users, 
registrants (or other suppliers preparing a CSR) have to establish if scaling may be applied to 
the conditions described in the exposure scenario and, if so, define the boundaries which 
cannot be exceeded via scaling in order to guarantee that resulting levels of exposure (after 
scaling is applied) do not increase. 

For each relevant exposure route, the registrant (or other suppliers preparing a CSR) needs to: 

Step 1 

Determine a set of operational conditions and risk management measures (key determinants 
of exposure) or integrative parameters  (e.g. Environmental release factor) for which control of 
risk for the exposure route can be demonstrated. This is the set of operational conditions and 
risk management measures to be communicated in the exposure scenario. 

 
 
 
 
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Step 2 

Guidance for downstream users 
Version 2.1  October 2014 

Assure that Risk Characterisation Ratio (RCRES) and/or exposure/release levels are 
communicated in the section 3 of the exposure scenario (see Guidance on IR&CSA Part D “ 
exposure scenario building”
of the RCRs is described in Part E of the Guidance on IR&CSA. 

) or made available via other appropriate means. The derivation 

124

Step 3 

For each of the relevant key determinants, which are likely to vary in the actual use situations 
consider if the use of scaling is relevant or if broader range of conditions can be considered. If, 
for example, the derived levels of exposure are well below threshold limits (if available) and 
they are expected to be below the limits for any reasonable values of OC/RMM, there is no 
reason for scaling (e.g. a substance is normally used in concentration <25% for <4hrs/shift in 
industrial settings. No specific risk management measure is required to control exposure to 
workers. If expected levels of exposure for use of the same substance at pure state for > 4 hrs 
/ shift are still below threshold limits, you might consider issuing an exposure scenario with 
this set of conditions instead of proposing scaling as an option). In this case, the exposure 
scenario could be described with a broader set of operational conditions and risk management 
measures that ensure control of risks and allows, in the meantime, for more flexibility at the 
downstream user level. 

•  List all determinants specified in the exposure scenario for the considered 

exposure route and target group. On a Tier 1 level, the following determinants 
would typically be used for scaling: 

o  workers: exposure duration, concentration per activity, RMM effectiveness, 

amount used; 

o  consumer: concentration/amount; 

o  environment: amount per year/per emission day, number of emission days, 

release fractions/RMM effectiveness

. 

125

•  List the operational conditions and risk management measures which are likely 

to be different in the actual use situations. 

• 

Identify the scalable parameters. These parameters have to be selected 
among the determinants working as input parameters of the tool used for the 
exposure assessment. Define the method to be used for scaling for the target 
group and exposure route. The method has to be based on the method used 
by the supplier: it can be an available Tier 1 tool, an algorithm, or a higher 
Tier tool. An exposure estimation tool (Tier 1 or higher Tier tool) can be used 
by downstream users for scaling assuming it is publicly available and is 
reliable also for non-expert users. The registrant should also use the exposure 
scenario to communicate the input parameters that are needed for the 
calculations.  

•  Find the range in which the OC/RMM can vary. These ranges are determined 

by the possibility to demonstrate that: 

124

125

 echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment.  

 What is important in the environmental exposure assessment are the overall release fractions. These may be 

composed of two factors: one factor accounting for the release fraction if no abatement is introduced (f1) and one factor 
accounting for the effectiveness of abatement (f2). The overall release factor would then read f1*(1-f2) or if f2 is expressed 
as a percentage: f1*(100-f2). 

 
 
                                           
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113 

o  resulting levels of exposure do not exceed the levels of the exposure 

scenario; 

o  regional environmental concentration will not be affected; 

o  the OCs/RMMs used for scaling are independent of each other; and   

o  the basic assumptions for the derivation of exposure level still hold.  

• 

• 

In the process of finding and selecting the range include uncertainty analysis 
of the conclusions (see Chapter R.19 of the Guidance on IR&CSA
 for details 
on how to make uncertainty analysis).  

126

If the same determinant is relevant for other exposure routes, ensure that you 
are specifying an applicable range, which holds for all exposure routes.  

•  Validate and document in the CSR that the proposed scaling mechanism is 

valid, i.e. control of risks is demonstrated and exposure levels of the exposure 
scenario are not exceeded. 

Step 4 

Communicate the method and the determinants in the exposure scenario. 

The exposure scenario should contain scaling method (e.g. an algorithm, link or reference to 
web based tool or reference to the same tool used for exposure estimation), parameters which 
can be scaled and the ranges for which the scaling can be used. Scaling option should be 
communicated in the section 4 of the exposure scenario.  

Downstream users may use different RMM than those indicated in the section 2 of the 
exposure scenario if alternative measures are explicitly mentioned in the ES as part of the 
scaling options (e.g. in the section 4). 

Furthermore, instructions on how to use the scaling tools and the ranges for the determinants 
should be clearly communicated. 

A2.3 

Methodologies to be used for scaling 

A simple method to calculate whether one condition, i.e. a key determinant of exposure, 
compensates another can be performed in cases where the relationship between the respective 
determinants of exposure and the resulting levels of exposure (and thus the RCR) is linear. 
Then, the factor describing the difference between actual conditions and those specified in the 
exposure scenario can be derived and compared with the compensating factors for other 
determinants. When the linear scaling applies, the downstream user can check compliance by 
multiplying or dividing with the ratios between the actual value of an OC and the prescribed 
value of the OC in the exposure scenario.  

The basic assumption of linear relations between an exposure determinant and the exposure 
level cannot be used for qualitative OC, e.g. the physical state of a mixture (liquid, solid or 
gas). Also, if the relevant parameters are interrelated, e.g. area covered and amount used 
(relevant for example in surface coating), linear calculation cannot be used. 

Linear relations between the determinants and the exposure level are often valid only for small 
changes of the variable. Applying the rule over a larger range of the variables requires that the 
assumption of linearity is indeed valid. So, when using the linear scaling for the exposure 
scenario, the ranges for the determinants, in which the assumption of linearity between the 

126

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determinant and the exposure level still holds, have to be specified in the exposure scenario, 
by the supplier. 

In conclusion, it may be considered to apply the linear scaling to increase flexibility, but it 
should be clear when doing so, that linear or other relationships between variables must be 
justified and that a sufficient margin of variability in resulting exposure is considered in 
practice. When applying the rule over a larger change in values for the variables, it is essential 
to know that the linearity is indeed applicable. This requires that the particular use of linear 
scaling is well documented in the Chemical Safety Report and is based on accepted algorithms 
for exposure assessment (e.g., coming from the same equations that constitute the Tier 1 
tools). Furthermore, it requires that the linear scaling is well-described in the exposure 
scenario, as well as the relevant boundaries that apply. 

In addition to simple linear algorithm the registrant (or other supplier preparing a DU CSR) 
may prepare a tool enabling the downstream user to check his own use. Such a tool can have 
the form of an algorithm, simple look-up tables, an excel sheet, a database, or a web-based 
tool (e.g. provided by industry associations). It can also be the exposure tool, which the 
registrant used for exposure calculations, e.g. ECETOC TRA and EUSES (In addition to the 
specific tool to be used for scaling, the registrant, or other supplier preparing a DU CSR, needs 
also to communicate via the exposure scenario, the input parameters that can be used for the 
calculations and the ranges for which scaling can be used (see chapter A.2.2 of this guidance).  

Industry associations have provided some web-based scaling tools for downstream users (e.g. 
formulators).  These tools enable downstream users to check whether - based on their 
knowledge about the processes in which his products are used - the exposure scenario 
indicated by the substance manufacturers are appropriate to ensure control of risk or 
modifications are needed. Downstream users may use these tools to check whether they work 
within the conditions of use for control of risk as prescribed by their suppliers, or whether they 
have to modify certain parameters in the exposure estimate to demonstrate control of risks 
(more realistic exposure estimates).  

Information about these tools is available on websites of major downstream user sector 
organisations. 

 
 
 
 
 
 
 
 
 
 
 
 
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115 

Appendix 3 

Core principle for selecting information to 

communicate with mixtures 

Chapter 7.2.2 outlines possible approaches when identifying the information to communicate 
downstream. The objective is to select the operational conditions and risk management 
measures that should be applied to protect humans and the environment when the mixture is 
used. 

The methodologies to support formulators undertaking this process are not described in this 
guidance document. However, the concepts that underpin the methodologies are presented in 
Table 17. These principles can help to identity the factors to consider when selecting the 
relevant information from exposure scenarios to communicate downstream with the mixture. 
The approach used can be tailored to suit the needs of different users. 

The principles are presented in three sections: general, human health (toxicological) and eco-
toxicological. They are listed in approximate order of increasing “sophistication”. Simpler 
situations are near the beginning of the relevant section in the table. Rare and complex cases, 
requiring a more detailed evaluation, are at the end of the sections. The examples presented 
are often a simplification of the actual situations encountered, but are intended to illustrate the 
principle. The proposed solution may only be applicable to some scenarios, such as worker or 
industrial. 

The principles are not prescriptive. Each principle does not all apply to every mixture, and 
every situation. Case-specific expert judgement is required for complex cases. A general 
guideline is that in cases where there is no interaction between substances, the effects on 
human health and on the environment from exposure to a mixture can depend on the 
hazardous properties of either the whole mixture (e.g. for skin and eye irritation) or the 
individual component substances (e.g. for CMR substances).  

For environmental effects, it should be kept in mind that the separate substances may have 
different environmental fates and manifest their effects in different environmental 
compartments. The impacts on the environment of aggregated and synergistic effects are not 
normally taken into account by formulators. 

When a substance is classified as hazardous with respect to physicochemical properties, the 
relevant information to enable proper control measures to be taken is provided in Section 9 of 
the safety data sheet. 

 
 
 
 
 
 
 
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Table 17 Core principles for selecting relevant information from exposure scenarios to communicate for mixtures 

Ref 
no. 

1 

2 

3 

4 

Principle 

Example (two substances A and B) / Comment 

General considerations 

A simple approach may be adequate. If the RMMs for the individual 
substances are the same or similar, these can be assigned to the mixtures 
for the same OCs, taking into account any effect due to additivity and/or 
concentration. 

If the RMMs for the individual component substances differ, the RMMs for the 
mixture can be derived using the most stringent RMMs recommended for 
each route of exposure for the individual substances of the mixture, for the 
same OC’s. This is a “worst case” approach. It is a simple yet conservative 
method that may be suitable in some situations.  However, the RMMs 
recommended should not be over-precautionary or impractical. 

The selection of RMMs based on information in the ES of the substances 
should be consistent with the classification of the mixture and the 
precautionary statements derived from that classification.  The final RMMs 
selected for the mixture should therefore always be compared with 
information on classification and labelling.  

Substance A requires local exhaust ventilation (LEV) (90% 
effectiveness) for given operational condition (OC) (conc. 15%, 
duration >4 hours). Substance B requires enhanced general 
ventilation (70% effectiveness) for the same OCs. LEV with 90% 
effectiveness is identified for Mixture AB, corresponding to the 
lower exposure level.  

Substance A requires LEV (90% effectiveness). Substance B 
requires gloves (80% effectiveness). Assuming the OCs for both 
substances are aligned to be the same, the RMMs for the mixture 
AB will be a combination  of the RMMs for the substance driving 
the inhalation risk (LEV) and the RMMs for the substance driving 
the dermal risk (gloves), namely LEV with 90% effectiveness and 
gloves with 80% effectiveness. 

For mixture AB, the RMMs selected from the ESs depend on the 
type of activity. For long term exposure, either use in closed 
systems or use of LEV is specified. For short term exposures, use 
of RPE is specified. 

Mixture AB is classified as a respiratory sensitizer with 
precautionary statement P261: (Avoid breathing 
dust/fume/gas/mist/vapours/spray). The selected RMMs are 
compared with the classification and labelling information. It is 
concluded that there is no conflict between recommended 
measures from ES and classification. 

Human health (toxicological) hazards 

When the mixture is classified as hazardous with respect to toxicological 
properties, the classification of the mixture should align with the selection of 
the OCs and RMMs to adequately control the risk from using the mixture in 
most instances. Normally, new animal studies should not be conducted. 

Mixture AB is classified as a skin irritant (based on concentration 
of irritant component). For uses with long term exposure, a closed 
system is proposed, while for short term exposure such as 
transfer, or consumer use protective gloves or avoiding skin 
contact are specified. This is consistent with the classification 

 
 
 
 
 
 
 
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5 

Known interactions and combined effects between substances should be taken 
into consideration.  

If the classification of the mixture for a given endpoint differs to that of the 
classification of the substances, this indicates that the toxicity of (one of) the 
substances may be accentuated or diminished by other substances in the 
mixture. This is an alert to deal with this in assessing the risk and deciding on 
RMMs. 

For mixtures which contain substances that are carcinogens, mutagens, toxic to 
reproduction (CMRs) or sensitisers (dermal or respiratory) even in 
concentrations below the cut-off point for classification, the conditions of use 
for the mixture should take into account the risk to human health from CMR or 
sensitising substances: risks are to be minimised. Hence, the risk assessment 
and recommendations related to safe use of the mixture should be based on 
the component substances themselves,  present below cut-off point for 
classification. 

117 

Examples of interactions and combined effects are: 

(i) 

(ii) 

(iii) 

Where the chemical properties are affected (e.g. pH of 
the mixture). 

Where the biological properties are affected (e.g. one 
component may enhance the dermal absorption of a 
second component).  

where more than one substance acting on the same 
target organ (e.g. organic solvents on the central 
nervous system).  

Substance A is category 1B carcinogen.  Substance B is not 
classified. Mixture AB contains < 0.1% of Substance A, and hence is 
not classified as a carcinogen. Nevertheless, the need to include the 
RMMs recommended for substance A as part of the RMMs for the 
mixture should be reviewed.  

Ecotoxicological hazards 

The environmental risk results from the release of the mixture to one or more 
of the environmental compartments – air, water, soil. Classification with respect 
to ecotoxicological properties refers only to effects on the aquatic (pelagic) 
compartment. RMMs should cover all emission and environmental risks. 

The effects on the environment from exposure to a mixture can depend on the 
hazardous properties of either the whole mixture or the individual component 
substances. For emissions to water and soil, the first step is to identify the 
environmental release patterns relevant for the mixture uses, in particular 
whether the environmental compartments are exposed to the undiluted mixture 
as such or just to some component. 

Even though a mixture is not classified with respect to hazards in the 
aquatic (pelagic) environment, there may still be a risk to other 
compartments such as sediment and soil.   

For example, for the outdoor use of a biocide with substance A and 
B, the soil and/or water is directly exposed to the undiluted mixture. 
Any interaction between A and B is highly relevant. Conversely, for a 
mixture AB that is emitted through a WWTP, the mixture is diluted, 
substance A may, for example, remain in water and substance B go 
to sediment (or soil via sewage sludge application. Consequently the 
environmental compartments are exposed to the single components 
as emitted after waste water treatment. The original mixture no 
longer exists in the environment.   

6 

7 

8 

 
 
 
 
 
 
 
 
 
118 

9 

Substances in a mixture may have different environmental fates and manifest 
their effects in different environmental compartments. 

Known interactions and combined effects between substances should be taken 
into consideration as this may alter the efficiency and feasibility of the RMM 
compared with the substance on its own. These interactions must be carefully 
considered when RMM proposed for different components are suggested for the 
whole mixture. 

Guidance for downstream users 
Version 2.1 October 2014 

For a mixture A+B emitted through a WWTP, Substance A may 
remain in the aqueous compartment and Substance B may be 
trapped in the sediment. 

For example, if the solubility of Substance A is increased by 
Substance B, a solvent, sedimentation during water treatment may 
be prevented.    

When the physico-chemical and/or environmental fate properties of the 
components in the mixture are very different, the effectiveness of the RMM may 
also differ for each component. This may result in different release patterns for 
each component, so that the composition of the mixture emitted differs from 
that of the marketed mixture. 

For example, substance A and B have differing physico-chemical 
properties, and the effectiveness of the RMM is 90% and 10% for 
substance A and B respectively. If the formulated mixture contains 
A+B at 50% each, the mixture released to the environment  is 5% of 
Substance A and 95% of Substance B  

Mixtures with substances with PBT or vPvB properties are treated on a 
substance basis. The OCs and RMMs for the mixture should ensure minimisation 
of releases to the environment (and consequently human health) from 
PBT/vPvB substances. The RMMs suggested for other components (including 
also human health RRM) may affect the releases of the PBT/vPvB components. 

For example, Substance A is highly acutely toxic by inhalation and 
the RMM recommends a high level of extract ventilation but 
Substance B is a volatile PBT substance and ventilation will increase 
its emission to air. 

10 

11 

12 

 
 
 
 
 
 
 
 
 
 
 
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119 

Appendix 4 

EU Legislation with requirements relevant to REACH  

EU DirectiveA 

Workers Health  

Council Directive 98/24/EC of 7 
April 1998 on the protection of 
the health and safety of 
workers from the risks related 
to chemical agents at work 
(Chemical Agents Directive) 

Main Elements with respect to 
chemicals 

 How does it affect DUs 

How does it link with 
REACHB 

Requires employers to identify risks arising 
from chemical agents through risk 
assessment.  Risks should be reduced by 
substitution, prevention, protection and 
control.  

The provisions for risk assessment 
may be challenging to implement, 
especially if you use many different 
chemical agents.  

Where a national occupational exposure 
limit value (OEL) is exceeded, the 
employer must remedy the situation 
through preventative and protective 
measures.  

The production, manufacture or use at 
work of certain chemical agents and 
activities set out in Annex III is prohibited.  

OELs are important risk reduction 
tools in specific work scenarios. 
However agreed values for OELS 
and not available for all 
substances, although indicative 
values for certain substances are 
listed in Directives 91/322/EEC, 
2000/39/EC, 2006/15/EC and 
2009/161/EU 

Prohibitions specified in Annex III 
may be difficult to implement and 
control, especially if you are a 
small company. 

Greater availability of 
information on substance 
properties and potential 
hazards, through the 
Registration process.  

The SDS communicates the 
conditions of use under which 
risks are controlled, including 
necessary risk management 
measures.  

Council Directive 2004/37/EC 
on 29 April 2004 on the 
protection of workers from the 
risks related to exposure to 
carcinogens or mutagens at 
work 

Requires employers to assess risks, replace 
carcinogens and mutagens with less 
hazardous products (where possible) and 
use closed systems for manufacture and 
use. Where a closed system is not 
technically possible, the level of exposure 
is to be reduced to as low a level as 
possible. In addition, employers are to 
design processes and engineering control 
measures so as to avoid or minimise 
releases the workplace. 

The provisions are important risk 
reduction tools in specific work 
scenarios but may be challenging to 
implement at small and medium-
sized enterprises. Resources for 
control are required.  

(Ext)SDS can assist you by 
giving clear recommendations 
on the most appropriate risk 
management measures 
necessary to control exposure 
to carcinogenic or mutagenic 
substances. 

 
 
 
 
 
120 

Council Directive 92/85/EEC of 
19 October 1992 (including 
COM(2000) 466 final/2) on the 
introduction of measures to 
encourage improvements in the 
safety and health at work of 
pregnant workers and workers 
who have recently given birth 
or are breastfeeding  

Council Directive 89/656/EEC of 
30 November 1989 on the 
minimum health and safety 
requirements for the use by 
workers of personal protective 
equipment at the workplace   

Directive 2003/10/EC of the 
European Parliament and of the 
Council of 6 February 2003 on 
the minimum health and safety 
requirements regarding the 
exposure of workers to the risks 
arising from physical agents 
(noise) 

ATEX 137 (Directive 99/92/EC) 
on minimum requirements for 
improving the safety and health 
protection of workers 
potentially at risk from 
explosive atmospheres and 
ATEX 95 (Directive 94/9/EC) 
concerning equipment and 
protective systems intended for 
use in potentially explosive 
atmospheres. 

Guidance for downstream users 
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The employer is required to assess the 
nature, degree and duration of exposure, 
in the undertaking and/or establishment 
concerned, in order to assess any risks to 
the safety or health and any possible effect 
on the pregnancy or breastfeeding and 
decide what measures should be taken.  

The provisions are important risk 
reduction tools in specific work 
scenarios but may be challenging to 
implement at small and medium-
sized enterprises. Resources for 
control are required.  

Information in (ext)SDS may 
assist SMEs to identify the risks 
associated with substances and 
give clear guidance on the RMM 
required to address them 

Employers must provide PPE free of charge 
and give information to workers on the 
risks which the wearing of the PPE protects 
them against.  Employers must ensure that 
the PPE is appropriate for the risks 
involved, by undertaking a risk 
assessment, without itself leading to any 
increased risk.  

Employers shall carry out a risk 
assessment, which should include, as far 
as technically achievable, any effects on 
workers’ health and safety resulting from 
interactions between noise and work-
related toxic substances 

The directive does not give detailed 
information to the employer how to 
select the proper PPE.   

The provisions for risk assessment 
may require some effort to 
implement, especially if you are a 
small company. 

You need to identify whether any 
ototoxic substances are present in 
the workplace. Even if these can be 
identified, calculating the impacts 
of interactions with noise levels 
may be difficult. 

DUs may need to carry out the risk 
assessment and area classification 
(zoning). 

ATEX 95 is for the manufacture of 
equipment, and ATEX 137 is for the use of 
equipment in potentially explosive 
atmosphere. Employers must classify areas 
where explosive atmospheres may occur 
into zones. The classification given to a 
particular zone, and its size and location, 
depends on the likelihood of an explosive 
atmosphere occurring and its persistence if 
it does. Equipment and protective systems 
intended to be used in zoned areas must 
meet the requirements of the directive. 

Information in (ext)SDS may 
assist you to identify the risks 
associated with substances 
and give clear guidance on the 
risk management measures 
required to address them. 

Information in (ext)SDS may 
assist you to identify the 
presence of any ototoxic 
substances  and give clear 
guidance on the risk 
management measures 
required to address them 

Under REACH greater 
information is available on 
substance properties such as 
flammability and explosivity, 
and those “uses” where there 
may be a potential for an 
explosive atmosphere to arise. 

Where you have already taken 
action in response to this 
Directive, this may provide 
good information and material 
for risk management measures 
for REACH 

 
 
 
 
 
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The Seveso III Directive 
2012/18/EU adopted on 4th 
July 2012, and entered into 
force on 13th August 2012. 
Member States have to 
transpose and implement the 
Directive by 1st June 2015. 

This Directive lays down rules for the 
prevention of major accidents which 
involve dangerous substances, and the 
limitation of their consequences for human 
health and the environment. Using a two-
tier approach based on substance 
threshold quantities, site owners must 
comply with requirements on risk 
assessment, emergency planning, land-use 
planning etc.  

If DUs satisfy the criteria for their 
sites to fall under Seveso, then 
they have certain obligations 
related to e.g. risk assessment. 

Product Safety examples

127

2001/95/EC of the European 
Parliament and the Council of 
3 December 2001 on general 
product safety   

Satisfactory assessment of the 
risks posed by chemicals within 
products is required, in the 
absence of reliable information 
from suppliers.  

The directive places an obligation on 
importers and manufacturers of products 
intended for consumer use to ensure that 
their products do not present unacceptable 
risks to human health or property under 
normal and reasonably foreseeable 
conditions of use. Manufacturers must 
provide consumers with relevant 
information to enable them to assess the 
risk inherent in a product and to take 
precautions against those risks.  If the 
manufacturers or the distributors discover 
that a product is dangerous, they must 
notify the competent authorities and, if 
necessary, cooperate with them. For such 
products the Commission manages the 
Rapid Information System RAPEX and can 
adopt “emergency measures” in 
cooperation with Member States. 

121 

The improved quality of 
substance information made 
available under REACH would 
benefit the DUs in terms of 
knowing the nature of the 
hazard, in particular with 
regard to the risk assessment 
component of Seveso. 

Where you have already taken 
action in response to this 
Directive, this may provide 
good information and material 
for risk management measures 
for REACH. 

Information in (ext)SDS may 
assist manufacturers to identify 
the risks associated with 
substances and mixtures that 
they use and to determine 
whether they are appropriate 
for consumer products. 

REACH will introduce 
requirements concerning 
substances within articles for 
the first time. This will enable 
you to identify whether 
imported articles meet the 
requirements of the GPSD. 

127

 There is a number of sector specific legislation so only a few examples are provided in the table. Other legislation that may be relevant includes: Fertilisers (2003/2003/EC), 

Cosmetic Products (1223/2009/EC), Detergents (648/2004/EC), Aerosol Dispenser Directive (75/34/EEC). 

 
 
 
 
 
 
                                           
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Council Directive2009/48/EC on 
30 June 2009on the 
approximation of the laws of 
the Member States concerning 
the safety of toys  

Toys placed on the market should not 
jeopardise the safety and/or health of 
users or of third parties. They must not 
contain hazardous substances or mixtures 
in amounts which may harm the health of 
children using them (except where 
essential to the functioning of the toy, 
when they are subject to a maximum 
concentration). 

The amount of certain chemicals that may 
be contained in materials used for toys is 
specified. 

The Construction Products 
Regulation (305/2011/EU - 
CPR) which repeals the 
Construction Products 
Directive (89/106/EEC – 
CPD) was adopted on 9 March 
2011 

Buildings must be designed and built in 
such a way that it will not be a threat to the 
hygiene or health of residents or 
neighbours. The CPR’s objective is to ensure 
reliable information on construction 
products in relation to their performances. 
This is achieved by providing a “common 
technical language", offering uniform 
assessment methods of the performance of 
construction products. 

Guidance for downstream users 
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Certain substances (Carcinogenic, 
Mutagenic or toxic for 
Reproduction), are no longer 
allowed in accessible parts of toys. 
For certain other substances 
tolerable limit values have been 
introduced and certain heavy 
metals which are particularly toxic, 
may no longer be intentionally 
used in those parts of toys that are 
accessible to children.  

Satisfactory assessment of the 
risks posed by chemicals within 
products is required and reliable 
information from suppliers may be 
missing. 

Lack of data from suppliers may 
make it more difficult to assess the 
concentration of substances within 
inputs. 

Standards may be developed 
where demands on technical 
performance are in conflict with the 
need to reduce risks relating to 
harmful substances.   

Information in (ext)SDS may 
help manufacturers to identify 
the presence of hazardous 
substances in mixtures (and 
articles) that they use.  The risk 
management measures 
specified may assist you to 
identify whether the substances 
can be safely used in the 
manufacture of toys. 

(Ext)SDS may help construction 
companies to identify safe uses 
of mixtures and necessary risk 
management measures 

 
 
 
 
 
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Biocidal Product Regulation 
(BPR, Regulation (EU) 
528/2012) 

This regulation concerns the placing on the 
market and use of biocidal products, which 
are used to protect humans, animals, 
materials or articles against harmful 
organisms, like pests or bacteria, by the 
action of the active substances contained in 
the biocidal product. 

Environmental Protection 

Directive 2008/1/EC 
Integrated Pollution 
Prevention and Control 
codified as of 15 January 
2008, (replaced on 7 January 
2013 by IED Directive 
2010/75/EU, however its 
provisions remain applicable 
until 6 January 2014). 

Directive 20011/65/EU of 08 
June 2011 on the restriction of 
use of certain hazardous 
substances in electrical and 
electronic equipment (recast), 
including updates 
2008/385/EC, 2009/428/EC 
and 2009/443/EC.  

The aim is to prevent or reduce pollution to 
ensure a high level of environmental 
protection, based on an application for a 
permit which can only be issued if certain 
environmental conditions are met. The 
application for a permit must include 
descriptions of raw and auxiliary materials, 
nature and quantities of foreseeable 
emissions, proposed technology or other 
techniques for preventing or reducing 
emissions, and measures planned to 
monitor emissions.  

The Directive restricts the use of specified 
hazardous substances in electrical and 
electronic equipment 

A chemical safety report is not 
required for active substances 
manufactured or imported for use 
in biocidal products only and 
covered by Article 15(2) of REACH 
and co-formulants in quantity 
below 1 tonne per year. However, 
exposure scenarios are required to 
be attached to SDS in accordance 
with Art 31(7) for active 
substances when they do not meet 
the requirements of Art 15(2) e.g. 
non-biocidal uses, biocidal uses 
taking place outside the EEA. 

If no need to reduce emissions of 
the chemical is mentioned in the 
relevant BREFs, expert knowledge 
is needed on where the chemical is 
likely to be emitted in significant 
quantities. In addition, applicants 
have to identify and assess 
emission reduction possibilities.  

If you manufacture electrical and 
electronic equipment, you may not 
be aware of the composition of 
components that they use.  You 
need to be able to document 
compliance with the Directive, 
which requires knowledge of the 
composition of components. 

123 

Components that may be 
included in a biocidal 
formulation, other than the 
active ingredient, may be 
registered in REACH, and 
information available from that 
process for communicating in 
the supply chain. 

(Ext)SDS may provide useful 
information on the nature and 
concentration of substances 
contained within raw and 
auxiliary materials, which will 
help in determining foreseeable 
emissions. 

They may also provide useful 
information on emission control 
measures. 

REACH introduces requirements 
concerning substances within 
articles for the first time.  This 
enables you to identify whether 
imported articles meet the 
requirements of the Directive. 

Any new restriction under this 
Directive shall be coherent with 
authorization and restriction 
provisions under REACH. 

 
 
 
124 

Waste Framework Directive 
2008/98/EC of 19 November 
2008.  

Council Directive 1999/13/EC 
of 11 March 1999 on the 
limitation of emissions of 
volatile organic compounds 
due to the use of organic 
solvents in certain activities 
and installations (replaced on 
7 January 2013 by IED 
Directive 2010/75/EU, 
however its provisions remain 
applicable until 6 January 
2014). 

Guidance for downstream users 
Version 2.1 October 2014 

This Directive sets the basic concepts and 
definitions related to waste management, 
such as definitions of waste, recycling, 
recovery. It introduces the "polluter pays 
principle" and the "extended producer 
responsibility".  

The list of "hazardous waste" developed 
under Directive 91/689/EC remains 
applicable. Member States must record and 
identify sites where disposal of hazardous 
waste takes place, prohibit mixing of 
different categories of hazardous waste and 
to ensure that waste is properly packaged 
and labelled in the course of collection, 
transport and temporary storage.  

Establishes emission limit values for VOCs 
in waste gases and maximum levels for 
fugitive emissions.  Gives industrial 
operators a possibility to be exempted from 
limit values provided that they achieve by 
other means the same reduction as would 
be made by applying them.  This could be 
achieved by substituting products with a 
high solvent content for low solvent or 
solvent free products and changing to 
solvent free production processes. This will 
become part of the permit application 
process under 2010/75/EU.  

Any wastes included on the list are 
considered hazardous and face 
particular requirements relating to 
their disposal.  You may, however, 
not be aware that your wastes 
contain materials placed on the list. 

The requirements of VOC directive 
are more difficult to meet in small 
enterprises, as many applications 
to collect VOC emissions are 
expensive. 

(Ext)SDS may provide useful 
information on the nature and 
concentration of substances 
contained within raw and 
auxiliary materials, which will 
help in identifying hazardous 
wastes. 

They may also provide useful 
information on safe waste 
disposal. 

Where you have already taken 
action in response to this 
Directive, this may provide 
good information and material 
for risk management measures 
for REACH.  In particular, it 
may provide useful information 
on the use of process-
integrated solutions and 
substitution rather than 
implementation of end-of-pipe 
techniques. 

 
 
Guidance for downstream users 
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Directive 2006/11/EC of the 
European Parliament and of 
the Council of 15 February 
2006 on pollution caused by 
certain dangerous substances 
discharged into the aquatic 
environment of the 
Community (Codified version) 

This Directive lays down rules for protection 
against, and prevention of, pollution 
resulting from the discharge of certain 
substances into the aquatic environment. It 
applies to inland surface water, territorial 
waters and internal coastal waters. 

Two lists of dangerous substances have 
been compiled to combat pollution: 

- 

- 

discharge of substances in list I must be 
eliminated; while 

discharge of substances in list II must be 
reduced. 

The discharges of any DUs using 
substances on List II, would be 
subject to prior authorisation by 
the competent authority. 

125 

By providing greater 
information on substances and 
their conditions of use, it would 
aid the DU is avoiding problems 
caused by discharging 
substances into the aquatic 
environment. 

A.   REACH can also help you to comply with national legislation on occupational health, product safety and environmental protection. 

B.  Although REACH can assist with meeting the requirements of the legislation, compliance with an exposure scenario is not equivalent to compliance with 
the other legislation. You must still follow all aspects of the other legislation. 

 
 
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Appendix 5 

Structured overview of communication needs along the supply chain 

The aim of this overview is to provide a checklist of “all” communication needs, both those between downstream users and others in the 
supply chain and between downstream users and the authorities. The checklist will help to ensure that appropriate tools and formats are 
developed for downstream users to assist with all of these communication needs. 

List of communication needs 

(A) Subject 

(B) Sender 

(C) Recipient 

(D) Date 

(E)              
Guidance’s ch. 

(F) Available 
tools and formats 

Preparing for REACH 

1. 

2. 

3. 

4. 

5. 

 (Voluntary) request for information 
on uses to assist with registration 

 (Voluntary) provision of information 
on uses to assist with registration  
(Art. 37(1)) 

Supplier (M/I; 
distributors; 
DU) 

Any DU 

Any DU 

Any time before 
registration 

Supplier (M/I, 
distributor, 
other DU) 

Any time before 
registration 

 (Voluntary) provide relevant 
information on a substance 

Any DU 

SIEF members 

Any time 

 (Mandatory) react to requests of 
information 

SIEF 
members 

DU who 
participates in a 
SIEF 

Without delay 
following a request 

(Art. 29(3)) 

 (Voluntary) request to determine 
whether it is intended to seek 
registration for a substance 

Any DU 

Supplier (M/I, 
distributor, 
other DU) 

Any time before 
registration 

3 

3 

6 

Chapter R.12 (“ Use 
descriptor system”) 
and chapter R.13 
(“RMMS and OCs”) 
of Guidance 
IR&CSA  

Guidance on data 
sharing 

Guidance on data 
sharing 

List of pre-
registered 
substances  

List of registered 
substances 

 
 
 
 
 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

6. 

7. 

 (Voluntary) request to determine 
whether it is intended to include a 
use in a registration/exposure 
scenario 

 (Voluntary) expression of an interest 
in a substance not listed in the pre-
registration list by ECHA 

Any DU 

Supplier (M/I, 
distributor, 
other DU) 

Any time before 
registration 

Any DU 

ECHA 

After publication of 
pre-registration list 

REACH IT 

127 

Guidance on the 
compilation of SDSs 

Guidance on the 
compilation of SDSs 

Actions triggered by information – substances on their own or in mixtures 

8. 

9. 

10. 

11. 

12. 

 (Voluntary) request for a REACH-
compliant SDS if not received by due 
date 

Any DU 

 (Mandatory) provision of a SDS 
compliant with REACH when required  

Supplier (M/I; 
distributors; 
DU) 

(Art.31) 

 (Voluntary) request for Art.32 
information (SDS not required) if not 
received by due date 

Any DU 

 (Mandatory) information on the 
substance when SDS not required 
(Art.32)  

 (Mandatory) information to enable 
safe use and protection of human 
health and environment when supply 
of SDS not needed 

Supplier (M/I, 
distributor, 
other DU) 

Supplier (M/I, 
distributor, 
other DU) 

(Art. 31(4)) 

Supplier (M/I, 
distributor, other 
DU) 

Any DU 

First supply after 
registration 

When the 
substance/mixture is 
first supplied 

Supplier (M/I, 
distributor, other 
DU) 

Any DU 

First supply after 
registration 

First supply after 
registration 

General public 

When the 
substance/mixture is 
first supplied 

13. 

 (On request) information required to 
comply with REACH 

Supplier (M/I, 
distributor, 
other DU) 

Authorities 

Without delay when 
requested 

(Art. 36) 

Actions triggered by information – substances in articles 

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
128 

14. 

15. 

16. 

17. 

 (Voluntary) request for information 
on whether substances subject to 
restriction are contained in an 
article 

 (Voluntary) request for information 
on  whether SVHC are contained in 
an article at concentrations > 0.1% 
w/w 

 (Mandatory) information on safe use 
of articles containing SVHC in 
concentration > 0,1% w/w 
(Art.33(1)) 

 (On request) information on safe 
use of articles containing SVHC in 
concentration > 0,1% w/w 
(Art.33(2)) 

18. 

 (Mandatory) notify SVHC in articles 
under Art. 7(2) 

DU recipients 
of articles 

Supplier 
(producer/impo
rter) of articles 

Any time 

Supplier 
(producer/ 
importer) of 
articles 

Recipients of 
articles 

Consumer 

ECHA 

DU recipients 
of articles 

Supplier 
(producer/ 
importer) of 
articles 

Supplier 
(producer/ 
importer) of 
articles 

Supplier 
(producer/ 
importer) of 
articles 

Once the substance 
is included in the 
Candidate List 

Once the substance 
is included in the 
Candidate List 

Within 45 days of 
request being 
received 

Once the substance 
is included in the 
Candidate List  

Checking compliance with the exposure scenario 

19. 

  (Mandatory) Reporting use of a 
hazardous substance outside the 
supplier’s ES (Art.38(1)) (needs to 
cover the different exemptions and 
may therefore have different 
information needs) 

DU 

ECHA 

Before commencing 
use after the 
substance has been 
registered and within 
6 months after 
receiving the 
registration number 
in a SDS. 

Guidance for downstream users 
Version 2.1 October 2014 

8 

8 

8 

8 

8 

4 

Guidance on 
requirements for 
substances in 
articles 

Guidance on 
requirements for 
substances in 
articles 

Guidance on 
requirements for 
substances in 
articles  

Data Submission 
Manual “ How to 
Prepare and Submit 
a Substance in 
Articles Notification 
using IUCLID” 

Data Submission 
Manual “How to 
Prepare and Submit 
a Downstream User 
Report using 
IUCLID 5” 

Downstream user 
report web page  

 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

129 

20. 

 (Voluntary) Documenting compliance 
with the ES, in particular if 
conditions are not exactly the same. 

Any DU 

Authorities 

Once supplier’s 
SDS/ES is received 

4 

Preparing a downstream user chemical safety report 

21. 

22. 

 (Voluntary) Checking whether a 
generic ES has been prepared (by an 
industry association) 

 (Voluntary) Obtaining additional 
information from supplier in order to 
carry out a DU CSR 

DU 
considering 
preparing DU 
CSA 

DU 
considering 
preparing DU 
CSR 

Industry 
association, 
other 

Supplier (M/I, 
distributor, 
other DU) 

23. 

 (Voluntary) Obtaining information on 
substance properties in order to 
carry out DU CSR 

DU preparing 
DU CSR 

24. 

 (Voluntary) Obtaining information on 
customers’ use of a substance to 
prepare DU CSA 

Any DU, but 
primarily 
formulator 

Own supplier, 
other M/I of a 
substance or 
SIEF 

Downstream 
users 
(customers, 
distributors) 

Before commencing 
use after the 
substance has been 
registered 

Before commencing 
use after the 
substance has been 
registered and within 
12 months after 
receiving the 
registration number 
in a SDS. 

Before using after 
substance has been 
registered and within 
12 months after 
receiving the 
registration number 
in a SDS. 

Before commencing 
use after the 
substance has been 
registered and within 
12 months after 
receiving the 
registration number 
in a SDS. 

SIEF to be checked 
if possible, may be 
IT-based.  

  
 
 
 
 
 
 
 
 
 
 
130 

25. 

 (Mandatory) notify that the DU CSA 
is to be prepared 

DU 

ECHA 

Before commencing 
or continuing a 
particular use and 
within 6 months after 
receiving the 
registration number 
in a SDS. 

Requesting that a use becomes an identified use 

26. 

 Requesting that a use becomes an 
identified use  

Any DU 

Supplier (M/I, 
distributor, 
other DU) 

At least 12 months 
before the deadline 
for registration 

5 

3 

(Art.37(2)) 

27. 

 Informing that a use cannot be 
included as an identified use for 
reasons of protection of human 
health or the environment and 
reason for this 

Collecting information on uses 

28. 

 (Voluntary) Obtaining information on 
own use of a substance 

Supplier (M/I, 
distributor, 
other DU) 

DU requesting 
that a use 
becomes 
identified 

ECHA 

‘without delay’ 

Any DU, but 
primarily 
industrial 
users 

[other 
departments/ 
entities within 
own company] 

Any time before 
registration or before 
preparing DU CSA 

3 

29. 

 (Voluntary) Obtaining information on 
customers’ use of a substance to 
prepare DU CSR 

Any DU, but 
primarily 
formulator 

Downstream 
users 
(customers, 
distributors) 

3, 5 

Before commencing 
use after the 
substance has been 
registered and within 
12 months after 
receiving the 
registration number 
in a SDS. 

Informing suppliers about new information on hazards 

Guidance for downstream users 
Version 2.1 October 2014 

Data Submission 
Manual “How to 
Prepare and Submit 
a Downstream User 
Report using 
IUCLID 5” 

Downstream user 
report web page 

Chapter R.12 of 
Guidance IR&CSA “ 
Use descriptor 
system” 

Guidance IR&CSA 
chapter R.12 “Use 
descriptor system” 

Guidance IR&CSA 
chapter R.12 “Use 
descriptor system” 

 
 
 
 
Guidance for downstream users 
Version 2.1 October 2014 

30. 

 (Mandatory) Communicating any 
new information on  the hazardous 
properties  

Any DU  

Supplier (M/I, 
distributor, other 
DU) 

Any time (not 
specified) 

(Art. 34) 

31. 

 (Mandatory) Informing if a 
classification of a substance is 
different to that of the supplier  

(Art. 38(4)) 

Any DU 

ECHA 

Any time (not 
specified) 

6 

6 

Informing suppliers about information calling into question the  appropriateness of risk management measures 

32. 

 (Mandatory) Passing on information 
that may call into question the 
appropriateness of risk management 
measures  

Any DU 

Supplier (M/I, 
distributor, 
other DU) 

Any time (not 
specified) 

(Art. 34) 

Compliance with requirements related to authorisation 

33. 

 (Mandatory) Notifying use of a 
substance subject to authorisation  

DU 

ECHA 

Within 3 months of 
first supply of the an 
authorised substance 

(Art. 66(1)) 

34. 

35. 

 (Voluntary) Request to determine 
whether a supplier plans to apply 
for authorisation of a use of a 
substance 

 (Voluntary) Contacting potential 
partners about the possibility of 
making a joint application for 
authorisation of use of a substance 

Any DU 

Any DU 

Supplier (M/I, 
distributor, other 
DU) 

Once a substance 
has been included in 
Annex XIV 

Supplier (M/I, 
distributor, other 
DU); customers; 
competitors 

Once a substance 
has been included in 
Annex XIV 

6 

8 

8 

8 

131 

No prescribed 
format 

Downstream user 
report web page 

Data Submission 
Manual “How to 
Prepare and Submit 
a Downstream User 
Report using 
IUCLID 5” 

No standard 
format, exposure 
scenario including 
exposure 
assessment if 
appropriate 

To be implemented 
in the REACH IT  

Guidance on the 
preparation of an 
application for an 
authorisation 

Guidance on the 
preparation of an 
application for an 
authorisation 

  
 
 
EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU 

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