Compilation of safety data sheets.
Date: 2016-10-19
Institutions: European Chemicals Agency
Subjects: chemical industry, chemical product, disclosure of information, environmental risk prevention, technical regulations, user guide

G U I D A N C E   I N   A   N U T S H E L L  

Compilation of safety data sheets 

The document aims to explain in simple terms the main principles and 
obligations relating to the compilation and provision of safety data sheets 
in accordance with the REACH Regulation 

Version 2.0 
December 2015 

 
 
 
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Guidance in a Nutshell - Compilation of safety data sheets 

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

Catalogue number: ED-04-15-643-EN-N 
Reference:  ECHA-15-G-08-EN 
ISBN: 978-92-9247-585-7 
Publ.date:  December 2015 
Language:  EN 
DOI: 10.2823/56480
The European Chemicals Agency (ECHA) is producing a series of “simplified” versions of the 
REACH guidance documents in order to make the corresponding REACH guidance documents 
published by the Agency more accessible for industry. As short summaries, these documents 
cannot contain all details included in the full guidance documents. Thus, in case of doubt, it is 
recommended to consult the full guidance documents for further information. 

© European Chemicals Agency, 2015 

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 which your 
comment refers to) using the Guidance feedback form. The Guidance feedback form can be 
accessed via the “Support“ section of the ECHA website at: 
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 in a Nutshell - Compilation of safety data sheets 

Version 2.0  December 2015 

3 

Version 

Changes 

Version 1.0 

First edition. 

Date 

December 2013 

Version 2.0 

Update following the update of the parent guidance to version 
3.0. 

December 2015 

The update is limited to the following: 

(1) Addition in chapter 1 of reference to Commission Regulation 
(EU) 2015/830. 

(2) Update in chapter 2.1 and 5 of information about transitional 
period according to Commission Regulation (EU) 2015/830. 

(3) Deletion in chapter 2.3 of reference to the overview of 
changes brought by REACH which was deleted from parent 
guidance. 

(4) Deletion in chapter 3.1 of reference to Dangerous Preparation 
Directive in relation to mixtures. 

(5) Update in chapter 6 of sources for further guidance. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Guidance in a Nutshell - Compilation of safety data sheets 

Table of Contents 

1. INTRODUCTION .............................................................................................................. 5 

2. ESSENTIALS TO UNDERSTAND ........................................................................................ 6 

2.1 The safety data sheet (SDS) ............................................................................................ 6 
2.2 Who is required to compile an SDS?.................................................................................. 6 
2.3 SDSs and REACH ............................................................................................................ 7 

3. FOR WHICH PRODUCTS IS AN SDS REQUIRED? .............................................................. 7 

3.1 SDS to be provided mandatorily without request ................................................................ 7 
3.2 SDS to be provided upon request ..................................................................................... 7 
3.3 Information to be provided to the general public ................................................................ 8 
3.4 Products for which an SDS is not required ......................................................................... 8 

4.  WHEN AND HOW THE SDS HAS TO BE PROVIDED ......................................................... 8 

5.  WHICH INFORMATION HAS TO BE INCLUDED IN AN SDS ............................................. 8 

5.1 Including exposure scenario information ............................................................................ 9 

6.  WHERE TO FIND FURTHER GUIDANCE AND OTHER RELEVANT  INFORMATION ............. 9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1. Introduction 

This Guidance in a Nutshell provides a concise and simple introduction to the obligations 
related to compilation and provision of a safety data sheet (SDS) as foreseen by Article 31 and 
Annex II to Regulation (EC) No 1907/2006 (the REACH Regulation), in particular as amended 
by Commission Regulation (EU) 2015/830. It describes in brief the main principles related to 
compilation of SDSs and the requirements which suppliers of substances and mixtures have to 
fulfil to comply with the obligation of providing an SDS to their customers. 

This Guidance in a Nutshell is mainly aimed at managers and decision-makers of companies 
supplying chemical substances in the European Economic Area 1 (EEA), particularly those 
belonging to the Small and Medium-sized Enterprises (SME) category. This Guidance will help 
the reader to understand what is required from those who are in charge of compiling SDSs for 
substances and mixtures and the important link between information in the SDS and 
obligations under the legislation on the protection of workers. Eventually the reader can decide 
whether he needs to read the full Guidance on the compilation of safety data sheets. Please 
note that the information contained in this Guidance in a Nutshell will not suffice for those who 
are required to compile a safety data sheet – they are strongly advised to read the full 
guidance. 

This document will also be useful to recipients of an SDS to understand what they should 
expect and how to deal with the information received.  

Companies located outside the EEA whose products are exported to the EEA may use this 
Guidance in a Nutshell to help them to understand the requirements for SDSs and the 
obligations that their agents and customers in the EEA have to fulfil.

1 The European Economic Area is composed of Iceland, Liechtenstein, Norway and the 28 European Union Member 
States. 

 
                                           
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2. Essentials to understand 

2.1 The safety data sheet (SDS) 

SDSs are a well-established and effective mechanism for transmitting appropriate safety 
information along the supply chain on substances and mixtures which meet specific 
classification criteria. The requirements for SDSs were already in place before the REACH 
Regulation entered into force but the Regulation further developed these requirements. 

The original requirements introduced by REACH have been further adapted to take into 
account the rules of the Global Harmonised System (GHS) 2 for safety data sheets and the 
implementation of the CLP Regulation3. 

The SDS should provide comprehensive information about a substance or mixture that is used 
in a professional or industrial environment. It is a source of information on both environmental 
and health hazards and on safety precautions. 

The content and format of an SDS within the EEA is defined in Annex II to the REACH 
Regulation. Basically, the SDS follows a 16-Section format which is internationally agreed and 
to be provided in the official language of the Member State(s) where the substance or mixture 
is placed on the market. 

It needs to be noted that Annex II to REACH has been amended and a special transition period 
for the implementation of the specific requirements is in place. In particular, under certain 
conditions SDSs provided to any recipient before 1 June 2015 may continue to be used until 31 
May 2017 without bringing them into line with the version in the Annex to Regulation (EU) 
2015/830. The full Guidance on the compilation of safety data sheets provides more 
information on this. 

2.2 Who is required to compile an SDS? 

The SDS is normally first compiled by the manufacturer or importer or Only Representative (or 
by someone on their behalf), but the requirements of REACH in relation to the provision of 
SDSs apply at each stage of the supply chain. A supplier of a substance or mixture, which 
fulfills specific conditions, must provide an SDS for it, regardless of his position in the supply 
chain. When compiling their own SDSs, each of the actors along the supply chain should check 
the adequacy of the SDS received from his supplier and use all the relevant information to 
compile his own SDS. 

Each actor remains responsible for the accuracy of the information in the SDS they provide. 

It should be kept in mind that the compilation of a good SDS requires extensive knowledge in 
different fields, as the SDS itself covers a wide range of aspects concerning the substance or 
mixture properties, occupational health and safety, transport safety and environmental 
protection. REACH indicates that the SDS should be compiled by a “competent” person, but no 
specific definition of “competent” in this context is given in the Regulation. The responsible 
person may need to seek input from different internal or external sources, whilst still ensuring 
consistency of the SDS. 

2 The revised version is available at: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html  
3 Regulation (EU) No 1272/2008. 

 
 
                                           
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2.3 SDSs and REACH 

The REACH Regulation retained, to a large extent, the traditional structure and format of the 
previous legislation. However, it introduced some important changes with the aim to improve 
the quality and completeness of the information to be forwarded downstream. 

One of the main new elements to be considered arises from the requirement under REACH to 
register substances manufactured or imported at a volume above 1 tonne per year. For 
registered substances, information in the SDS for the substance must be consistent with that 
provided in the registration dossier. In addition, where registrants and downstream users are 
required to prepare a Chemical Safety Report (CSR) which results in the generation of an 
exposure scenario, they must attach the relevant exposure scenario(s) as an annex(es) to the 
SDS. 

Downstream users have to consider relevant exposure scenario information received from 
suppliers when compiling their SDSs. Suppliers of mixtures may have several options for 
communicating relevant safe use information on the mixture. These are outlined in chapter 5.1 
of this Gudiance in a Nutshell and in more detail in the parent Guidance on the compilation of 
safety data sheets. 

3. For which products is an SDS required? 

3.1 SDS to be provided mandatorily without request 

REACH establishes specific criteria for when an SDS must be provided for a substance or a 
mixture. An SDS must be provided for a substance or mixture that meets the criteria for 
classification as hazardous on the basis of the criteria established by the CLP Regulation ((EC) 
No 1272/2008). 

Furthermore, the obligation to provide an SDS also applies to substances which are considered 
to be Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative  
(vPvB) according to Annex XIII to REACH or are included in the Candidate List of substances 
for possible inclusion in the Authorisation List4. It should be noted that the Candidate list is 
regularly updated with the addition of new substances. 

3.2 SDS to be provided upon request 

When the substance or mixture does not meet the criteria5 for classification as hazardous, the 
supplier is not obliged to provide an SDS for this substance or mixture. Nevertheless, if a 
mixture contains classified substances, substances that are PBT or vPvB or a substance 
included in the Candidate List above a certain threshold specified in the REACH Regulation or 
substances which have Community workplace exposure limits6, the customer is entitled to 
request an SDS and the supplier has the obligation to provide it. 

Only a downstream user (industrial or professional user)7 or a distributor8 has the right to 
request an SDS for a mixture meeting the above mentioned criteria. 

4 For more information on the Candidate List and the authorisation process please refer to the dedicated ECHA web page 
at echa.europa.eu/web/guest/regulations/reach/authorisation/the-candidate-list.  
5 Note that from 1 June 2015 this refers to criteria for classification as hazardous according to the CLP regulation also for 
mixtures. 
6 A relevant source of information is the web page on OELs on the OSHA website available at 
osha.europa.eu/en/topics/ds/exposure_limits. 
7 Defined accroding to REACH (Article3(13)). 
8 Defined according to REACH (Article 3(14)). 

 
 
 
                                           
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3.3 Information to be provided to the general public 

When hazardous substances or dangerous mixtures are also offered or sold to the general 
public, an SDS does not need to be supplied. To rely on this exemption however, the supplier 
must provide “sufficient information to enable the user to take all necessary measures as 
regards the protection of human health, safety and the environment”. REACH does not specify 
how this safety information should be provided, hence the supplier can choose the most 
suitable means according to the case and the recipient (e.g. by labelling or with product 
inserts).   

3.4 Products for which an SDS is not required 

For some mixtures REACH provides a general exemption from the need to supply information 
covered by Title IV “Information in the supply chain”, including the provision of SDSs. The 
mixtures which benefit from such an exemption are such that are in the finished state, 
intended for the final user, and that belong to specific categories for which other pieces of 
legislation exist and an ovelap with REACH requirements should be avoided (e.g. medicinal 
products, cosmetic products and food and feedingstuffs). 

Certain substances are not in the scope of the REACH Regulation (radioactive substances, 
substances under customs supervision, non-isolated intermediates, products during carriage 
by rail, road, inland waterway, sea or air, etc.) and therefore again the SDS-related obligations 
do not apply. 

4. When and how the SDS has to be provided 

The SDS must be provided free of charge, no later than when the substance or the mixture is 
first supplied. It can be provided on paper or electronically. In every case, it is a duty of the 
supplier to actually deliver the SDS to the recipient. This means, for instance, that to only 
make it available on a web page is not sufficient. 

There is no need to supply further copy(ies) of an SDS with subsequent deliveries to the same 
recipient unless the SDS is revised. An SDS must however be updated without delay when 
specific new information is available. The REACH Regulation specifies which new information 
triggers the obligation for an update: information affecting risk management measures, 
information on hazards, when authorisation has been granted or refused or when a restriction 
has been imposed. Updates for other reasons can be made voluntarily at any time by the 
supplier. The update must also be provided to all former recipients to whom the substance or 
mixture has been supplied within the preceding 12 months.  

5. Which information has to be included in an SDS 

Annex II to REACH specifies the 16 Sections and their subsections which must form the 
structure of the SDS as well as the content of each. 

A transitional period has been established to allow a smooth change to information based on 
the CLP Regulation. Particular provisions concern, for example, the information on classification 
and labelling and the identification of the constituents of substances or components of a 
mixture to be indicated on the SDS. 

From 1 June 2015, only information on classification according to CLP should be given for both 
substances and mixtures in the SDS (as well as on labels). There are transitional provisions for 

 
 
 
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SDSs (and for labelling) for substances and mixtures already on the market before 1 June 
2015. However the information in the SDS has always to correspond to that on the label. 

The full Guidance on the compilation of safety data sheets provides more guidance on the 
application of this transitional period. 

When compiling the SDS, it needs to be noted that where specific data are not used, or where 
data are not available, this must be clearly stated in the corresponding Section or subsection of 
the SDS, as the SDS must not contain blank subsections. The reason for a lack of information 
must be a valid one. Since the SDS must enable users to take the necessary measures to 
protect human health, safety at the workplace, and protection of the environment, information 
which is required to appear in an SDS cannot be claimed as confidential for the purposes of 
communication of information in the supply chain. 

5.1 Including exposure scenario information 

One of the main concepts introduced by REACH and affecting SDSs is that of  the exposure 
scenario. Any actor required to prepare a CSR including exposure scenarios has to attach the 
relevant exposure scenario(s) to the SDS. An exposure scenario describes how a substance 
can be manufactured or used in a safe way (i.e. ensuring protection of human health and 
environment) and should refer to the uses identified in the SDS itself. In practice, the exposure 
scenario(s) extend(s) the information given in the main body of the SDS. Thus the exposure 
scenario and the SDS need to be considered together and be consistent. It is very important 
that the supplier presents the information in a way that is readily understandable by the 
immediate downstream user who has to identify, apply and recommend the relevant measures 
further downstream.  

Downstream users and other actors who need to supply an SDS for a substance or mixture, 
but are not required to prepare a CSR, have to consider and include relevant safe use 
information sourced from exposure scenario(s) received from their supplier(s) when compiling 
their SDS(s). They can either attach the relevant exposure scenarios to the SDS, integrate 
relevant exposure information in the body of the SDS (i.e. Sections 1 – 16 of the SDS) or 
append safe use information for the mixture derived from the exposure scenarios of the 
component substances. The most suitable option should be selected based on considerations 
made on a case by case basis. It should be considered that not all the possible options are 
equally suitable for the specific recipients who should, furthermore, receive only the 
information relevant to them. More detailed information on this is provided in chapter 2.23 and 
Appendix 2 of the parent guidance and also in the ECHA Guidance for downstream users. 

By contrast with the case for an SDS, the format of the exposure scenario is not fixed by the 
legal text. One available supporting tool to generate a suitable format is the Chemical Safety 
Assessment and Reporting tool, Chesar 9, which generates exposure scenarios ready to be 
annexed to the SDS. 

6. 

Where to find further guidance and other relevant 
information 

This Guidance in a Nutshell should provide you with a summary and short explanation of the 
main principles concerning the compilation of safety data sheets under Article 31 and Annex II 
to the REACH Regulation. However, those actually compiling SDSs are strongly recommended 
to consult the full Guidance on the compilation of safety data sheets to meet communication 
requirements. This is available at  

9  Available at chesar.echa.europa.eu. 

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

The full Guidance on the compilation of the safaty data sheets provides more detailed 
information on the content of each Section of the SDS and on special cases, as well as some 
examples entries in subsections. Additional insight and relevant information may also be 
gained by consulting in particular the following documents and web pages: 

-  The ECHA Safety data sheet eGuide: http://view.pagetiger.com/ECHAeGuide1-1/Issue1  

-  The ECHA database on registered substances: echa.europa.eu/web/guest/information-

on-chemicals/registered-substances; 

-  The ECHA classification and labelling inventory: echa.europa.eu/web/guest/information-

on-chemicals/cl-inventory-database; 

-  The ECHA Guidance for downstream users: echa.europa.eu/web/guest/guidance-

documents/guidance-on-reach; 

 
 
 
 
 
 
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EUROPEAN CHEMICALS AGENCY 
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ECHA.EUROPA.EU