Safety Data Sheets (SDS) are one of the main tools for communicating the hazards of chemical substances and mixtures throughout the supply chain. Their purpose is to provide industrial and professional users with the information they need to handle, store, transport and dispose of chemical products safely, and to take appropriate measures to protect human health and the environment.

In the European Union, SDS are governed by a harmonised legislative framework that sets out when they must be provided, what information they must contain and how they must be kept up to date. This framework is based mainly on REACH, together with CLP classification and labelling requirements, and Annex II to REACH as amended by Regulation (EU) 2020/878.

Although the regulations are common to all Member States, companies marketing chemical products in several EU countries must ensure that SDS are supplied in the official language(s) required by the Member State concerned and meet any applicable additional national requirements, such as national emergency contact information or occupational health and safety provisions.

Keeping SDS up to date is an ongoing challenge for manufacturers, importers, formulators and distributors. Changes to substance classifications, legislative amendments and new scientific data make regular document reviews necessary to ensure regulatory compliance.

This guide covers:

• The regulations governing Safety Data Sheets in the European Union.
• When an SDS is required.
• The requirements SDS must meet under REACH, taking CLP classification and labelling requirements into account.
• The main differences between European SDS and those used in other jurisdictions.
• The most significant regulatory changes.
• Good practices for keeping SDS up to date and compliant.

Contents

• Summary
• Which regulations govern Safety Data Sheets in the European Union?
• Competent authorities
• How are REACH and CLP related?
• When is a Safety Data Sheet required in the European Union?
• Specific requirements for Safety Data Sheets in the European Union
• Comparison of Safety Data Sheet requirements in the European Union
• Recent regulatory changes
• Common mistakes when preparing an SDS under European regulations
• Checklist: Does your SDS meet European Union requirements?
Which regulations govern Safety Data Sheets in the European Union?

Safety Data Sheets are governed primarily by Regulation (EC) No 1907/2006 (REACH), Regulation (EC) No 1272/2008 (CLP) and Regulation (EU) 2020/878, which updates Annex II to REACH and sets current requirements for SDS content and format.

When is it mandatory to provide an SDS?

An SDS must be supplied where required under Article 31 of the REACH Regulation, primarily for substances and mixtures classified as hazardous, as well as in other specific cases provided for by European law.

In what language must an SDS be written?

The SDS must be provided in the official language of the Member State where the substance or mixture is marketed, unless that country’s competent authority provides otherwise.

Companies distributing products in several EU countries generally need different language versions of the same SDS.

What format must an SDS follow?

All SDS prepared in accordance with European legislation must follow a harmonised 16-section structure defined in Annex II to REACH and updated by Regulation (EU) 2020/878.

This structure ensures a consistent presentation of hazard information, preventive measures, safe handling and regulatory requirements.

What is the difference between REACH and CLP?

Although the two regulations are closely related, they have different objectives.

REACH governs the registration, evaluation, authorisation and restriction of chemical substances, and sets out obligations relating to SDS.

CLP governs the classification, labelling and packaging of hazardous substances and mixtures.

Classification under CLP forms the basis for much of the information included in an SDS.

When must an SDS be updated?

An SDS must be updated when:

• new information becomes available about the product’s hazards;
• its classification changes;
• its composition changes;
• new restrictions or authorisations are adopted;
• a legislative amendment affecting SDS content enters into force.

Keeping documentation up to date is a supplier obligation.

What changes did Regulation (EU) 2020/878 introduce?

Regulation (EU) 2020/878 updated Annex II to REACH to align SDS with the latest revisions to the Globally Harmonized System (GHS).

Among other changes, it introduced new requirements relating to:

• nanoforms;
• endocrine disruptors;
• updates to certain SDS sections;
• improved consistency of regulatory information.

Since 1 January 2023, all SDS supplied in the European Union must comply with these requirements.

Can I use a European SDS outside the European Union?

Not always.

Although many countries use the GHS as the basis for their Safety Data Sheets, each jurisdiction may have specific requirements for language, regulatory information, emergency telephone numbers or certain administrative details.

Before marketing a product outside the European Union, it is advisable to review the regulations applicable in the destination country.

What if I market the same product in several Member States?

The regulations are common throughout the European Union, but SDS must be supplied in the official language of the country where the product is marketed.

Some Member States may also require additional national information, so each version should be reviewed before distribution.

• How to keep SDS compliant in the European Union
• Frequently asked questions about SDS in the European Union
• Conclusion
• How can ExESS help?

Summary

Key takeaway

Safety Data Sheets in the European Union must meet the requirements of the REACH Regulation, the CLP Regulation and Regulation (EU) 2020/878. Although the rules are harmonised across all Member States, companies must provide SDS in the official language of each market and check any applicable national requirements.

Which regulations govern Safety Data Sheets in the European Union?

Safety Data Sheets are governed by a set of European rules that harmonise chemical hazard communication across all Member States. These provisions establish both when an SDS is required and the content, format and criteria for keeping it up to date.

The three main regulations are:

• Regulation (EC) No 1907/2006 (REACH).
• Regulation (EC) No 1272/2008 (CLP).
• Regulation (EU) 2020/878, which amends Annex II to REACH.

Together, these rules ensure that professional users receive consistent, up-to-date information on chemical hazards and safe use throughout the European Union.

REACH Regulation

Regulation (EC) No 1907/2006 (REACH) is the main European law on chemicals.

REACH governs the registration, evaluation, authorisation and restriction of chemical substances marketed in the European Union.

With regard to Safety Data Sheets, the Regulation sets out, among other things:

• when SDS must be provided;
• who is responsible for supplying them;
• what information they must contain;
• when they must be updated;
• how they must be communicated throughout the supply chain.

In addition, Annex II to REACH defines the structure and mandatory content of SDS.

CLP Regulation

Regulation (EC) No 1272/2008 (CLP) establishes the criteria for the classification, labelling and packaging of hazardous substances and mixtures in the European Union.

CLP implements the United Nations Globally Harmonized System (GHS) in the European Union and determines how physical, health and environmental hazards must be classified.

Information generated under CLP forms the basis of many SDS sections, particularly those dealing with hazard identification, precautionary information and product classification.

Regulation (EU) 2020/878

Since 1 January 2023, all Safety Data Sheets supplied in the European Union must comply with Regulation (EU) 2020/878, which amended Annex II to REACH.

This update introduced significant changes to SDS content, including:

• new information requirements for substances and mixtures;
• references to nanoforms, where applicable;
• information relating to endocrine disruptors;
• alignment with the latest revisions to the Globally Harmonized System (GHS);
• improved consistency in certain SDS sections.

Any company preparing or updating an SDS for the European market must ensure that it meets these requirements.

Competent authorities

The European chemicals legislation is implemented by both European Union bodies and the national authorities of each Member State.

European Chemicals Agency (ECHA)

The European Chemicals Agency (ECHA) coordinates the implementation of REACH, CLP and other regulations relating to chemicals.

Its responsibilities include:

• preparing technical guidance;
• maintaining European regulatory databases;
• managing substance evaluation and authorisation processes;
• publishing information on harmonised classification;
• supporting national authorities in applying the regulations.

In addition to ECHA, each Member State has competent authorities responsible for market surveillance and enforcement of national legislation implementing REACH and CLP.

How are REACH and CLP related?

The difference between the REACH Regulation and the CLP Regulation is a frequent source of questions for companies.

Although both form part of the European regulatory framework for chemicals, they serve different but complementary purposes.

REACH governs the registration, evaluation, authorisation and restriction of chemical substances, and sets out obligations relating to Safety Data Sheets.

CLP determines how hazardous substances and mixtures must be classified, labelled and packaged.

In practice, the two regulations work together.

The classification under CLP determines much of the information that must be included in an SDS, while REACH sets out when an SDS must be supplied, what it must contain and how it must be kept up to date.

For this reason, any company marketing chemical products in the European Union must treat both regulations as part of a single compliance system.

When is a Safety Data Sheet required in the European Union?

The obligation to supply a Safety Data Sheet (SDS) in the European Union is governed by Article 31 of the REACH Regulation. It sets out the circumstances in which a supplier must provide an SDS to the recipient of a substance or mixture, as well as the conditions for updating and distributing it.

The purpose of this requirement is to ensure that professional users have the information they need to manage the risks associated with using chemical products and take appropriate preventive measures.

As a general rule, an SDS must be supplied free of charge, on paper or electronically, and written in the official language of the Member State where the product is marketed, unless national law provides otherwise.

Which products require an SDS?

Under the REACH Regulation, an SDS must be provided when supplying:

• A mixture classified as hazardous under the CLP Regulation.
• A persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substance, according to the criteria set out in REACH.
• A substance included in the Candidate List of substances of very high concern (SVHCs) for authorisation, even if it is not classified as hazardous.

A supplier must also provide an SDS where other specific provisions of the REACH Regulation require it.

When must an SDS be provided at the recipient’s request?

Certain mixtures are not classified as hazardous but still require an SDS when requested by a professional user.

This may apply, for example, when the mixture contains certain hazardous components above the limits set by REACH or contains substances with occupational exposure limit values.

In these cases, the supplier must assess the applicable obligations and provide the documentation where required.

Who must provide the SDS?

The obligation to provide the SDS lies with the supplier of the substance or mixture.

Depending on the circumstances, this may be:

• manufacturers;
• importers;
• distributors;
• downstream users who place the product on the market again.

The supplier must ensure that the information is accurate, up to date and reflects the scientific and regulatory knowledge available at the time of supply.

Who should receive the SDS?

SDS are intended primarily for professional users of chemical products.

These include:

• manufacturers;
• formulators;
• downstream users;
• distributors;
• industrial companies;
• professionals who handle chemicals as part of their work.

As a general rule, there is no obligation to provide an SDS to the final consumer unless another specific regulation requires it.

When must an SDS be updated?

An SDS must be revised without delay when the supplier receives new information that may affect risk management measures or when regulatory obligations change.

Common reasons for updating an SDS include:

• new information on the hazards of the substance or mixture;
• changes to the classification under the CLP Regulation;
• the granting or refusal of an authorisation;
• new restrictions established under REACH;
• changes to the product’s composition;
• changes introduced by new European legislation.

When an SDS is updated for one of these reasons, the supplier must make the new version available to recipients supplied with the product during the previous 12 months, as provided for by REACH.

Specific requirements for Safety Data Sheets in the European Union

Safety Data Sheets must meet a set of harmonised requirements to ensure that the information is consistent across all Member States and useful to people handling chemical products.

Although the overall structure is common throughout the European Union, certain aspects, such as language or some national references, may vary depending on the country where the product is marketed.

Language

SDS must be written in the official language of the Member State where the substance or mixture is marketed, unless the country’s competent authority provides otherwise.

This means that a company distributing the same product in several European countries will normally need different language versions of the SDS.

For example:

• Spain: Spanish.
• France: French.
• Germany: German.
• Italy: Italian.

Translating the text alone may not be enough. It is also necessary to check that the national information in the SDS is relevant to the destination country.

Format

All SDS prepared under the REACH Regulation must follow a standardised 16-section structure defined in Annex II to REACH and updated by Regulation (EU) 2020/878.

The sections are:

• Identification of the substance/mixture and of the company/undertaking.
• Hazards identification.
• Composition/information on ingredients.
• First-aid measures.
• Firefighting measures.
• Accidental release measures.
• Handling and storage.
• Exposure controls/personal protection.
• Physical and chemical properties.
• Stability and reactivity.
• Toxicological information.
• Ecological information.
• Disposal considerations.
• Transport information.
• Regulatory information.
• Other information.

Each section must contain the information required by law and be kept up to date when relevant changes occur.

Classification and labelling

Substances and mixtures must be classified in accordance with the CLP Regulation.

The information generated through this process determines much of the SDS content, particularly:

• hazard classes and categories;
• pictograms;
• signal words;
• hazard statements (H-statements);
• precautionary statements (P-statements).

Incorrect classification can affect both the label and the SDS content, resulting in regulatory non-compliance.

Regulatory information

Section 15 of the SDS must include the regulatory information applicable to the product.

Depending on the substance or mixture, this section may refer to:

• restrictions established under REACH;
• authorisations;
• specific European Union legislation;
• supplementary national regulations, where applicable.

This information should be reviewed regularly to ensure that it reflects the current regulatory position.

Exposure scenarios

Where required by the REACH Regulation, relevant exposure scenarios must be provided as an annex to the SDS.

These documents describe the operational conditions and risk management measures needed to use a substance safely for the identified uses.

Correctly incorporating exposure scenarios is one of the most complex aspects of preparing and maintaining SDS for certain substances.

National information

Although European legislation harmonises SDS content, some Member States may require additional information in specific areas.

Common examples include:

• contact details for poison information centres;
• national references on occupational health and safety;
• language requirements;
• information specific to certain sectors.

Companies marketing chemical products in several Member States should therefore review each national version of the SDS before distribution.

Maintenance and updates

Regulatory compliance does not end when the initial SDS is prepared.

Companies should establish procedures to:

• monitor legislative changes;
• incorporate relevant scientific information;
• review new harmonised classifications;
• update exposure scenarios;
• keep different language versions consistent.

For organisations managing a large number of products, this can become an operational challenge without specialist tools.

Comparison of Safety Data Sheet requirements in the European Union

The European regulatory framework for Safety Data Sheets is one of the most developed internationally and has served as a reference for legislation in many countries.

However, although many jurisdictions use the Globally Harmonized System (GHS) as the basis for hazard communication, SDS obligations may vary according to national legislation.

Differences commonly relate to language, competent authorities, certain administrative requirements or national information that must be included in the document.

An SDS prepared in accordance with European legislation therefore cannot always be used directly in other markets without the necessary adaptations.

Comparison of an EU SDS with SDS in other jurisdictions

Can a European SDS be used outside the European Union?

In many cases, an SDS prepared in accordance with the REACH Regulation can serve as a starting point for other markets.

However, before marketing a product outside the European Union, it is essential to check whether the destination country requires additional information.

Common adaptations include:

• language changes;
• references to national regulations;
• local supplier contact details;
• emergency telephone numbers;
• specific regulatory information;
• additional administrative requirements.

Companies exporting chemical products therefore often manage jurisdiction-specific versions of the same SDS.

Recent regulatory changes

European chemicals legislation continues to evolve to incorporate new scientific knowledge, improve protection of human health and the environment, and adapt regulations to technical progress.

Keeping Safety Data Sheets up to date requires regular monitoring of these changes.

Implementation of Regulation (EU) 2020/878

One of the most significant changes in recent years was the entry into application of Regulation (EU) 2020/878, which amended Annex II to REACH.

Since 1 January 2023, all SDS supplied in the European Union must meet the new requirements set out in this Regulation.

The main changes include:

• information on nanoforms, where applicable;
• references to endocrine-disrupting properties;
• alignment with the latest versions of the Globally Harmonized System (GHS);
• updates to the content of various SDS sections to improve clarity and consistency.

Updates to the CLP Regulation

The European Commission regularly publishes Adaptations to Technical Progress (ATPs) to the CLP Regulation.

These amendments may introduce:

• new harmonised classifications;
• changes to hazard categories;
• the addition of new substances to Annex VI;
• updated classification criteria.

When these changes affect a substance or mixture placed on the market, companies must review both the label and the Safety Data Sheet.

Developments in REACH

In addition to CLP updates, the REACH Regulation continues to evolve through:

• new restrictions;
• the addition of substances to the Candidate List;
• authorisation decisions;
• publication of new technical guidance by the European Chemicals Agency (ECHA).

Companies should establish procedures to review these changes regularly and assess their impact on SDS.

Common mistakes when preparing an SDS under European regulations

Although the European regulatory framework is well established, certain errors that can affect compliance remain common.

1. Failing to update the SDS after a regulatory change

A common mistake is to keep SDS based on earlier versions of Annex II to REACH or to omit new classifications resulting from CLP updates.

Regularly reviewing documentation is essential for maintaining compliance.

2. Using a single SDS for all Member States

Although European rules are harmonised, SDS must be provided in the official language of the Member State where the product is marketed.

Some countries may also require specific national information.

3. Failing to review classification under CLP

Incorrect classification directly affects the content of the SDS and the label.

Companies must check that the classification used reflects current legislation and takes applicable Adaptations to Technical Progress (ATPs) into account.

4. Failing to update regulatory information

Section 15 must accurately reflect the restrictions, authorisations and other legal provisions applicable to the product.

Adding new substances to the Candidate List or introducing new restrictions may require the SDS to be updated.

5. Managing multiple versions manually

Organisations marketing products in different European countries often maintain numerous language versions of the same SDS.

Managing these versions manually increases the risk of inconsistencies, errors and delays in regulatory updates.

Checklist: Does your SDS meet European Union requirements?

Before supplying an SDS on the European market, check the following:

This checklist can be used for an initial review before distributing a chemical product on the European market.

How to keep SDS compliant in the European Union

For many chemical companies, the main challenge is not preparing a single Safety Data Sheet but keeping hundreds or thousands of versions up to date across different products, languages and markets.

Amendments to REACH, updates to the CLP Regulation, new harmonised classifications and ongoing legislative changes make manual SDS management increasingly complex.

Companies marketing products both inside and outside the European Union must also coordinate different versions of the same document to meet each jurisdiction’s requirements.

In this context, specialist solutions such as ExESS can centralise product regulatory information and automatically generate Safety Data Sheets tailored to different countries and languages from a single data source.

Among other capabilities, ExESS helps companies:

• generate SDS in accordance with REACH and Regulation (EU) 2020/878;
• manage multiple languages and national versions;
• maintain traceability of changes;
• automatically update documentation when regulatory requirements change;
• reduce errors caused by manual document management.

For manufacturers, importers and distributors operating in several markets, this approach helps maintain compliance and improves the efficiency of Regulatory Affairs teams.

Frequently asked questions about SDS in the European Union

Conclusion

Safety Data Sheets are essential for communicating hazards and ensuring the safe use of chemical substances and mixtures in the European Union.

Meeting the requirements of REACH, CLP and Regulation (EU) 2020/878 means keeping documentation up to date, regularly reviewing product classifications and adapting SDS to the languages and national requirements of each Member State.

For companies managing a large product portfolio or marketing substances and mixtures in several countries, keeping everything up to date can become a significant operational challenge.

How can ExESS help?

Managing SDS for one or more markets involves much more than preparing a document. Each regulatory update, change to a substance classification or change to a product’s composition may require multiple versions of the same SDS to be reviewed and reissued.

ExESS centralises all product regulatory information in a single data source and automates the generation, updating and distribution of Safety Data Sheets that comply with the requirements applicable in each market.

This enables companies to keep their SDS aligned with changes to regulations such as REACH, CLP and Regulation (EU) 2020/878, while reducing manual work, minimising inconsistencies between versions and streamlining document management.

For organisations marketing products in several countries or managing a large portfolio, this approach helps maintain compliance throughout the product lifecycle and respond more quickly to regulatory changes.

Book your ExESS demo

See how ExESS works