Conditions under which a safety data sheet must be supplied

Safety data sheet knowledge base – Conditions under which a safety data sheet must be provided

This article explains when and how to provide a safety data sheet (SDS) under the REACH Regulation. It details supplier obligations, conditions for hazardous substances and mixtures, exemptions for consumer products, and the rules for SDS updates and versioning. The guide also highlights how proper risk communication and structured document management support compliance across the supply chain.

 

Safety data sheet and the flow of information

Safety data sheets are essential communication tools within the supply chain. They provide critical information to all actors involved, helping them fulfil their obligations regarding the safe use, handling and disposal of substances and mixtures. SDSs contain health, safety and environmental information, as well as guidance on protective measures and risk management measures. Under Article 31 of Regulation (EC) No 1907/2006 (REACH), SDSs play a central role in ensuring compliance in areas such as occupational safety, environmental protection and chemical risk management. The supplier must update the SDS whenever new relevant information becomes available.

 

Who compiles the SDS?

SDSs are typically compiled by manufacturers, importers, or only representatives (ORs), but obligations apply throughout the supply chain. Each supplier is responsible for ensuring that the SDS content is accurate and appropriate for the identified uses. Drafting an SDS requires professional knowledge in areas such as toxicology, environmental science, occupational safety and transport. REACH requires that the SDS be compiled by a “competent person”, although the regulation does not define specific qualifications.

 

Exposure scenarios and extended SDS (eSDS)

If a substance is subject to registration and a chemical safety assessment (CSA) is required, manufacturers or importers prepare exposure scenarios (ES) as part of the assessment. These ES describe the operational conditions and risk management measures necessary for safe use. Where relevant, the exposure scenario(s) must be attached to the SDS as an annex; in that case, the SDS is referred to as an extended SDS (eSDS).

 

A safety data sheet must be provided to the customer

  • The substance or mixture is classified as hazardous under the CLP Regulation.
  • The substance is identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), according to the criteria in Annex XIII of REACH.
  • The substance is included in the candidate list of substances of very high concern (SVHC) established in accordance with Article 59(1) of REACH.

In these cases, providing the SDS free of charge and in a documented form is a mandatory legal requirement.

 

A safety data sheet must be provided on request (non-hazardous mixtures) if:

  • For non-gaseous mixtures, it contains a hazardous substance at ≥ 1% by weight.
  • For gaseous mixtures, it contains a hazardous substance at ≥ 0.2% by volume.
  • It contains at least one substance present at ≥ 0.1% by weight (for non-gaseous mixtures) that is:
    • carcinogenic (category 2),
    • toxic to reproduction (category 1A, 1B or 2),
    • skin sensitiser (category 1),
    • respiratory sensitiser (category 1),
    • has effects on or via lactation,
    • classified as PBT or vPvB,
    • listed under Article 59(1) (candidate list), or
    • is a substance for which EU occupational exposure limits exist.

In such cases, the SDS must be provided upon the recipient’s explicit request.

 

Supplying information required by Article 32 (when an SDS is not required)

Even when there is no obligation to provide an SDS, the supplier still has obligations to provide information in certain cases. Under Article 32 of REACH, this includes:

  • If the substance is subject to authorisation, details of the authorisation granted or refused.
  • Details of any restrictions applicable under REACH (where relevant).
  • Any other available and relevant information necessary to enable appropriate risk management measures to be identified and applied.
  • The REACH registration number(s), if available, for any substances for which information is communicated under the points above.

By doing so, the supplier helps downstream users stay informed and manage risks effectively, even without a formal SDS.

 

No safety data sheet needs to be compiled and made available for

In addition, certain product categories do not require a safety data sheet, provided that sufficient information is made available to ensure safe use and appropriate risk management.

  • Substances or mixtures intended for consumer use, where sufficient information is provided (e.g., through labelling and other product information) to enable users to take the necessary measures to protect human health, safety and the environment, unless a downstream user or distributor requests an SDS.
  • Finished products for end users such as:
    • human or veterinary medicinal products
    • cosmetic products
    • medical devices that are invasive or used in direct physical contact with the human body
    • food and feedingstuffs, including:
    • food additives
    • flavourings in food
    • additives in feed

In some situations, a supplier may still choose to provide an SDS voluntarily or an SDS may be requested by a downstream user or distributor; however, it is important to note that preparing an SDS is not mandatory for the categories listed above.

 

Communication of SDS updates and versioning

Under REACH Annex II, any updated SDS should clearly indicate the revision date on the first page (e.g., “Revision: (date)”), along with a reference to the previous version it replaces (e.g., version number or superseded date).

Furthermore, the supplier should summarise the nature of the changes in Section 16 of the SDS, or elsewhere if appropriate. Where an SDS update is required under Article 31(9) of REACH, the supplier must send the revised SDS to all recipients who received the substance or mixture in the preceding 12 months, free of charge and without request.

To support traceability and effective document management, it can be helpful to use a structured versioning system, for example:

  • 1.0 – original version
  • 1.1, 1.2 – minor updates (e.g., editorial corrections where no redistribution obligation applies)
  • 2.0 – major update (e.g., update requiring redistribution under Article 31(9))

Although REACH does not prescribe a specific numbering scheme, consistent versioning enhances transparency and facilitates compliance.

 

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Quick questions and answers

Who is responsible for preparing the safety data sheet (SDS)?

Primarily the manufacturer, importer or only representative, but each supplier in the supply chain is responsible for providing an accurate SDS that is appropriate for the identified uses.

When must an exposure scenario be attached to the SDS (eSDS)?

Where relevant as part of the chemical safety assessment for a registered substance, the exposure scenario(s) must be attached to the SDS as an annex (extended SDS).

When must an SDS be provided for a mixture not classified as hazardous, upon request?

When the mixture contains specified substances above the thresholds set out in REACH Article 31(3) (e.g., certain CMR category 2 substances, sensitisers, PBT/vPvB substances, candidate list substances, or substances with EU occupational exposure limits).

What information must be supplied if an SDS is not required under REACH Article 32?

Relevant information necessary for safe use, details of any authorisation granted or refused and any applicable restrictions (where relevant), and—if available—the REACH registration number(s) must still be provided.

 

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