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 end-user 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 vital health, safety, and environmental data, as well as guidance on protective measures and risk management procedures. According to Article 31 of the REACH Regulation (EC No 1907/2006), SDSs play a central role in ensuring regulatory compliance in areas such as occupational safety, environmental protection, and chemical risk management. A competent person must update them whenever new information becomes available.

Who compiles the SDS?

SDSs are typically compiled by manufacturers, importers, or only representatives, but the obligation can extend along the supply chain. Each actor is responsible for ensuring the content of the SDS is accurate and appropriate for the intended use. Drafting an SDS requires professional knowledge in fields such as toxicology, environmental science, occupational safety, and transport. REACH states that a “competent person” must prepare the SDS, although the regulation does not specify what qualifications this person needs.

Final exposure scenarios and eSDS

If a substance is subject to registration, manufacturers or importers must prepare exposure scenarios (ES) as part of the chemical safety assessment (CSA). These ES describe the operational conditions and risk management measures necessary for safe use. The final ES must be attached to the SDS, in which case it 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 subject to authorisation, established in accordance with Article 59(1).

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

We must provide a safety data sheet to the buyer on request – in case of non-hazardous mixtures, if:

  • For non-gaseous mixtures, it contains a hazardous substance ≥ 1% by weight.
  • For gaseous mixtures, it contains a hazardous substance ≥ 0.2% by volume.
  • It contains a substance ≥ 0.1% by weight that is:
    • carcinogenic (category 2),
    • toxic to reproduction (category 1A, 1B or 2),
    • skin sensitiser (category 1),
    • respiratory sensitiser (category 1),
    • classified as PBT or vPvB,
    • listed under Article 59(1) (candidate list), or
    • subject to Community workplace exposure limits.

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

Supplying information required by Article 32 – in those cases when supplying an SDS is not compulsory

Even when there is no obligation to provide an SDS, the supplier still holds the responsibility to provide key information in certain cases:

  • If the substance falls under authorisation, the supplier needs to share the details of the granted authorisation, or if it was denied, explain the restriction.
  • If the recipient requires risk management guidance, the supplier must deliver any available data that helps identify and apply appropriate measures.
  • If a registration number exists, the supplier must include it when sharing the relevant substance information.

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

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

In addition, some specific product categories do not require a safety data sheet, as long as alternative information ensures proper risk management.

  • Substances or mixtures intended for consumer use if the label and other product information are sufficient to allow safe use regarding health, safety, and environmental protection.
  • Finished products for end-users such as:
    • Human or veterinary medicinal products
    • Cosmetic products
    • Medical devices that are invasive or in direct contact with the human body
    • Food and feedingstuffs, including:
    • Food additives
    • Flavourings in food
    • Additives in feed

In certain cases, for example at the request of the supplier, a competent person can prepare an SDS for these products as well, but it is important to remember that it is not mandatory to prepare an SDS for them.

Communication of SDS updates and versioning

Under REACH Annex II, any updated SDS must clearly indicate the revision date on the first page, marked as “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. When legislative changes (such as an update to Annex II) require an SDS update under Article 31(9), the supplier must send the revised SDS to all recipients who received the substance or mixture in the past 12 months.

In addition, suppliers may choose to distribute updated SDSs retrospectively in case of other significant revisions, even if not legally required.

In order to support traceability and effective document management, it is useful to create a structured versioning system. For example:

  • 1.0 – original version
  • 1.1, 1.2 – minor updates (not requiring re-distribution)
  • 2.0 – major update triggering mandatory re-distribution

Although REACH does not explicitly require such a system, it enhances transparency and facilitates compliance.

 

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