Preparing Safety Data Sheets (SDS) – Part 1

Introduction and Regulatory Background

MSDS-Europe – Safety data sheet knowledge base – Preparing Safety Data Sheets (SDS) – Part 1: Introduction and Regulatory Background

In our 5-part series, we guide readers step by step through the process of preparing safety data sheets (SDSs). We explain what an SDS is, why it is important, and which regulatory requirements apply (e.g., the REACH and CLP Regulations).

We also address practical questions related to SDS preparation: for hazardous substances and mixtures, when an SDS is mandatory, who is responsible for preparing it, what information it must contain, and when and how it must be updated.

(This guide is based on an official document issued on 7 April 2021, available here: Guidance on the compilation of safety data sheets – ECHA, 2021.)

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What is a Safety Data Sheet (SDS)?

A safety data sheet is a document that provides detailed information about the properties, hazards, and safe use of a substance or mixture.

The purpose of the SDS is to provide downstream users (industrial or professional users, workers) and competent authorities with the information necessary for safe handling of the product. Every substance or mixture classified as hazardous must be accompanied by a safety data sheet under the relevant EU legislation (and in certain other cases specified by those rules as well).

The SDS’s standardised 16-section structure ensures that key information related to the product is presented in a clear, organised manner.

These 16 sections cover, among other things:

product identification
hazard classification
composition/information on ingredients
first-aid measures
fire-fighting and environmental protection measures
handling and storage
effects on human health and the environment
waste management

A well-prepared safety data sheet helps prevent accidents and adverse health effects and supports regulatory compliance.

To complete these sections correctly, SDS compilers need access to key information sources and databases that provide reliable physical, toxicological, and regulatory data.

Legal background: REACH and CLP Regulations

The requirements for SDSs are primarily defined by the EU chemicals legislation, the REACH Regulation (Regulation (EC) No 1907/2006).

Article 31 of REACH specifies when a safety data sheet must be provided, and the detailed content and format requirements are set out in Annex II to REACH. Annex II is updated periodically. Most recently, Commission Regulation (EU) 2020/878 amended Annex II (for example, by introducing requirements to include information on endocrine-disrupting properties, where relevant). The official guidance on which this series is based also reflects these requirements and provides practical advice on implementation.

Closely related to this topic is the CLP Regulation (Regulation (EC) No 1272/2008), which governs the classification, labelling, and packaging of substances and mixtures.

Section 2 of the safety data sheet must include the classification and labelling elements required under the CLP Regulation. Therefore, preparing an SDS requires familiarity with the CLP hazard classes and hazard categories, hazard pictograms, hazard statements (H statements), and precautionary statements (P statements).

Together, the REACH and CLP Regulations ensure that information on hazardous substances and mixtures is communicated in a uniform format to everyone who works with the product.

Further parts: