Preparing Safety Data Sheets (SDS) – Part 2

Responsibilities and the SDS Compilation Process

MSDS-Europe – Safety data sheet knowledge base – Preparing Safety Data Sheets (SDS) – Part 2: Responsibilities and the SDS Compilation Process

In the previous instalment (Preparing SDS – Part 1), we reviewed what a safety data sheet (SDS) is and its legal foundations (REACH and CLP).

Now we discuss who is responsible for preparing the safety data sheet and how it should be compiled, what responsibilities are involved, and what to pay attention to during the process. We also cover when an SDS is required for a product, how SDS compilation proceeds step by step, and what to know about updating, language requirements, and distribution.

(Detailed guidance on this topic is provided in the official ECHA document titled “Guidance on the compilation of safety data sheets” (2021), available on the ECHA website.)

Who is responsible for preparing the SDS?

The legislation clearly defines that the company placing the substance or mixture on the market is ultimately responsible for the content of the SDS—this is typically the manufacturer or importer. They are obliged to ensure that the SDS complies with the REACH requirements and that it is provided to downstream users.

Every manufacturer or importer placing a hazardous substance or mixture on the EU/EEA market must provide an SDS in the appropriate language to their customers.

Distributors (resellers) also have responsibilities to ensure that the relevant SDS is passed along to professional users in the supply chain.

For example, a paint distributor must ensure that a Hungarian-language safety data sheet is made available to the purchaser when the product is supplied in Hungary.

When is a safety data sheet mandatory?

In general, a safety data sheet is required for any substance or mixture classified as hazardous. This means that if a product falls into any hazard class under the CLP Regulation (e.g., flammable, corrosive, toxic, irritant, etc.), the supplier must provide the SDS to the recipient without prior request.

Additionally, there are cases where a mixture is not classified as hazardous, but due to certain components an SDS must still be provided (at least upon request).

Some examples of such cases include:

• Non-hazardous mixture containing a hazardous ingredient above a specified concentration: in such cases, a professional user may request a safety data sheet and it must be provided. For example, if a mixture contains a hazardous substance above the relevant thresholds, then under REACH Article 31(3) the recipient can request the SDS and it must be made available.
• Mixture containing a substance with an occupational exposure limit value: if the mixture contains a substance for which occupational exposure limit values apply, an SDS must be provided on request, even if the mixture itself is not classified as hazardous.
• Mixture requiring specific label elements: in some cases, mixtures that are not classified as hazardous may still require certain label elements (e.g., supplemental information) under the applicable rules; in such situations, an SDS may be required to support professional use and supply-chain communication.

Important: not every product requires an SDS.

If a mixture contains no hazardous ingredients and is intended for consumer (household) use, a safety data sheet generally does not need to be provided—provided that sufficient information is available to ensure safe use.

However, some industrial or professional customers may still request a data sheet. As a good practice, the supplier may provide a technical information sheet or a voluntary SDS to support safe use.

Language requirements

An SDS must be provided in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State provides otherwise. In Hungary, for example, a Hungarian-language safety data sheet is required. If a company supplies a product to multiple EU/EEA countries, the SDS must be prepared or translated into each target country’s official language(s).

How to compile a safety data sheet

Competent person and expertise

According to the rules, a safety data sheet must be compiled by a “competent person”. This refers to a professional with appropriate expertise and chemical safety knowledge. The official guidance also emphasises that competent persons should receive continuous training, since chemical safety regulations are frequently updated.

If such expertise is not available in-house, it may be advisable to engage an external consultant. Many companies specialise in SDS compilation and review and can help prepare safety data sheets that comply with legislation.

Steps to prepare an SDS

Preparing an SDS is a multi-step process that involves gathering, assessing, and organising many types of information. Below is a general outline that helps ensure the SDS is complete and internally consistent:

1. Information gathering:

Collect all relevant data for the substance or mixture. This includes the exact identification of the product (e.g., substance name and identifiers such as CAS number and EC number; for mixtures, the trade name/designation and, where applicable, the unique formula identifier—UFI), the list of components and their concentrations, physical and chemical properties (e.g., boiling point, density, pH, flash point), as well as toxicological and ecotoxicological data. Sources can include existing SDSs of the components, ECHA databases, literature data, and in-house test results. This information forms the foundation of the SDS.

2. Determine the hazard classification:

Based on the collected data, determine the hazard classification according to the CLP Regulation. This involves identifying the relevant hazard classes and hazard categories (e.g., Flammable liquid category 2, Skin corrosion category 1A, Acute toxicity category 3) and selecting the appropriate hazard statements (H statements), precautionary statements (P statements), and the signal word (“Danger” or “Warning”), where applicable.

Ensure that any specific concentration limits and M-factors are taken into account, and that all relevant hazards of the mixture have been assessed.

3. Complete the SDS sections:

Once classification is complete, the 16 sections of the SDS can be completed in the required sequence and numbering. Each section has mandatory content elements—for example, Section 1 covers identification and supplier details, Section 2 covers hazards identification (classification and label elements), Section 3 provides composition/information on ingredients, and so on.

Consistency is crucial: information in different sections must not contradict each other. For example, if Section 2 identifies a mixture as flammable, the flash point in Section 9 should support that classification.

4. Review and approval:

After completing the SDS, it should be reviewed thoroughly. As part of a quality check, verify that all required information is included and that there are no missing sections or errors (e.g., typos, incorrect units). It can be useful to have an internal expert review the SDS or to cross-check it against documentation for similar products. Make sure the latest regulatory references are reflected where relevant.

5. Distribution to users:

The completed safety data sheet must be provided to the recipients. This can be done electronically (e.g., by email as a PDF) or on paper, but in all cases it must be made available free of charge (as required by REACH).

In practice, many companies provide the SDS with the first order/shipment or make it available for download on their website.

It is also essential to keep the SDS up to date: if new relevant information becomes available or the classification changes, the safety data sheet must be updated without delay.

6. Ongoing updates and version control:

If new information on hazards or risk management measures becomes available, or if the classification changes, the SDS must be revised promptly.

Under REACH Article 31(9), the updated version must be sent to all recipients who were supplied with the substance or mixture in the preceding 12 months.

For traceability, it is good practice to retain previous SDS versions and supporting documentation for at least 10 years and to use a clear versioning approach (version number and revision date). For example: Version 1 – 2021-06-01; Version 2 – 2023-03-15 (revised in accordance with Commission Regulation (EU) 2020/878).

When a change occurs (new information, regulatory change, product composition modification, etc.), issue a new version and indicate in Section 16 what has changed. This helps recipients identify updates and stay current.

In summary

Preparing an SDS is a complex task that requires expertise and careful attention. The goal is to inform and protect users and to ensure regulatory compliance. It is not just “paperwork”, but an important tool for occupational safety and environmental protection.

In the following parts, we turn to the detailed content elements of the safety data sheet and review what information needs to be provided in each section.

Further parts:

• Part 1: Introduction and Regulatory Background
• Part 3: The first 8 sections of the SDS in detail
• Part 4: The remaining SDS sections (9–16)
• Part 5: Special cases and best practices

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