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 compiling safety data sheets (SDS). We explain what an SDS is, why it is important, and what regulatory requirements apply to it (e.g. REACH and CLP regulations).

We also address practical questions of SDS compilation: for hazardous mixtures and substances, when it is mandatory, who is responsible for preparing the SDS, what information it must contain, and how and in which cases it must be updated.

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

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 hazardous substance or mixture.

The purpose of the SDS is to make available to downstream users (industrial or professional users, workers) and authorities the data necessary for safe handling of the product. Every chemical substance or mixture classified as hazardous must have a safety data sheet under the relevant EU regulations (and in certain other cases specified by those regulations as well).

The SDS’s standardized structure of 16 sections ensures that important information related to the product is presented in a clear, organized manner.

These 16 sections cover, among other things

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

Thus, a well-prepared safety data sheet helps prevent accidents and health damage, and also supports regulatory compliance.

Legal background: REACH and CLP Regulations

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

Article 31 of REACH specifies in which cases a safety data sheet must be provided, and the detailed content requirements are set out in Annex II of REACH. Annex II is updated periodically; most recently, Commission Regulation (EU) 2020/878 updated the requirements for SDS content (for example, introducing the inclusion of information on endocrine-disrupting properties). The official guidance on which this series of articles is based also incorporates these current requirements and provides practical advice on how to implement them.

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

Section 2 of the safety data sheet must provide the classification and labelling elements according to the CLP regulation. Therefore, compiling an SDS requires familiarity with the CLP hazard categories, hazard pictograms, H statements, and P statements.

Together, the REACH and CLP regulations ensure that information related to hazardous substances is conveyed in a uniform format to everyone who works with the product.

Further parts: