Extended SDS and exposure scenarios under REACH

What an extended SDS is and why it exists

The 16-section SDS gives generic safe-handling advice. For many registered substances REACH asks for more: a chemical safety assessment that shows, use by use, that risks to people and the environment are controlled. The result of that assessment is the chemical safety report (CSR). Its practical output for the supply chain is the set of exposure scenarios that the registrant attaches to the SDS as an annex. The SDS together with the annex is called an extended SDS (eSDS); the regulation itself says that the relevant exposure scenarios "shall be placed in an annex to the safety data sheet" (Annex II, 0.1). This article covers that annex. For the base duty to supply an SDS, see REACH Article 31 and SDS obligations.

When an eSDS is required

The trigger sits with the registrant, not with the recipient of the SDS. The conditions build on each other:

Two limits are worth knowing. A chemical safety assessment is not required for a substance present in a mixture below the concentration set by Article 14(2): the CLP cut-off value, or 0.1 % w/w for a substance meeting the PBT/vPvB criteria. And for end uses in food contact materials and cosmetic products, human health risks need not be considered (Art. 14(5)). A substance below 10 tonnes per year, or one that does not meet the hazard criteria, does not come with exposure scenarios; its SDS is not extended.

What an exposure scenario contains

Annex I, 0.7 defines an exposure scenario as the set of conditions that describe how a substance is manufactured or used during its life-cycle and how the registrant controls, or recommends downstream users to control, exposures of humans and the environment. These conditions contain a description of both the risk management measures and the operational conditions. In practice a scenario is written for a use or a group of uses and typically contains:

• Title and description of the process or use covered, so the recipient can match it to its own activity.
• Operational conditions: for example duration and frequency of exposure, amount used, process temperature, physical form and concentration of the substance in the product.
• Risk management measures: for example local exhaust ventilation, closed systems and protective equipment, and for the environment measures such as waste water treatment or emission controls.
• Exposure estimates and risk characterisation: expected exposure compared with the derived no-effect level (DNEL) for human health and the predicted no-effect concentration (PNEC) for the environment. SDS subsection 8.1.4 gives the relevant DNELs and PNECs for the scenarios in the annex.

The level of detail varies from case to case. A scenario may cover a wide range of processes or uses and is then sometimes called an exposure category (Annex I, 0.8). Annex II adds that where a scenario containing the information is attached, the SDS may refer to it instead of repeating what subsections 7.1, 7.2 and 8.2 require.

How the annex ties into the SDS body

Annex II, as replaced by Regulation (EU) 2020/878, requires the body of the SDS to be consistent with the CSR and the attached scenarios:

• Subsection 1.2 states the identified uses and the uses advised against. Where a CSR is required it must be consistent with the identified uses in the CSR and with the scenarios in the annex.
• Sections 7 (handling and storage) and 8 (exposure controls) must be consistent with the identified uses and the scenarios showing control of risk.
• Subsection 8.1.4 gives the relevant DNELs and PNECs for the scenarios in the annex.

For how the 16 sections fit together, see the 16 SDS sections explained.

Downstream users: what to do when you receive an eSDS

If you use the substance, the scenario is the supplier's statement of the conditions under which your use is considered controlled. Articles 37 to 39 set out what follows:

1. Compare your use with the scenario. Article 37(5) requires downstream users to identify, apply and, where suitable, recommend the measures found in the SDS, in their own CSR or in information received under Article 32.
2. If your use is not covered, you may notify your supplier in writing so that the use can become an "identified use" (Art. 37(2)). If the supplier cannot include the use for health or environmental reasons, it must give the reasons in writing to ECHA and to you (Art. 37(3)).
3. Prepare your own chemical safety report for any use outside the conditions of a scenario, or one your supplier advises against (Art. 37(4)). Exemptions include: no SDS is required; the supplier is not required to prepare a CSR; total use is below one tonne per year; you implement a scenario that meets at least the conditions in the SDS; the substance is below the Article 14(2) concentration in the mixture; or the use is product and process oriented research and development with risks adequately controlled.
4. Report to ECHA. If you must prepare a CSR under Article 37(4), or rely on the one-tonne or R&D exemption, Article 38 requires a report to ECHA with your identity, the substance, your supplier, a brief description of the use and its conditions, and any proposal for additional vertebrate animal testing. Changes must be updated without delay.
5. Watch the deadlines. Article 39 gives 12 months from receiving a registration number in an SDS for Article 37, and six months for Article 38.

The one-tonne exemption is not a free pass: you must still consider the uses, apply appropriate risk management measures and include them in your SDS where necessary (Art. 37(6)). A downstream user who prepares a CSR must keep it available and up to date (Art. 37(7)).

Formulators: passing the information on in a mixture SDS

A formulator is a downstream user that becomes a supplier. Under Article 31(7), when it compiles its own SDS it must include the relevant exposure scenarios and other relevant information from the SDS it received. For a mixture this means:

• The identified uses in subsection 1.2 of the mixture SDS should correspond to uses covered by the scenarios of the ingredients.
• Handling advice in Sections 7 and 8 should reflect the operational conditions and risk management measures of the ingredient scenarios.
• If an actor in the supply chain has carried out a chemical safety assessment for the mixture itself, Annex II (7.3) accepts that the SDS and the scenarios are consistent with the CSR for the mixture rather than with the CSR of each ingredient.
• Where scenarios of different ingredients conflict, for example closed handling for one and open handling for another, a cautious approach is to apply the stricter measure and document the reasoning. This is a practical suggestion, not a REACH rule.

Practical checklist

1. Check each raw-material SDS for an annex or for exposure scenarios after Section 16.
2. Map your processes to the use descriptions in the scenarios and record the result with the date.
3. Note the date you received each registration number, because the Article 38 and 39 deadlines run from it.
4. Update subsection 1.2 and Sections 7 and 8 of your own SDS to reflect the conditions you rely on.
5. Tell the supplier in writing about uses that are not covered, and keep the answer.

Chemoris builds the main body of the SDS from component data and CLP rules; exposure scenario annexes come from the registrants of your raw materials. You can open a free account. For differences between EU, UK and US requirements, see SDS requirements in the EU, UK and US.

Frequently asked questions

Is an extended SDS a different document from the SDS?

No. It is the normal 16-section SDS plus an annex of exposure scenarios. The annex is part of the SDS and is passed on with it (Art. 31(7)).

Does every substance at 10 tonnes per year come with exposure scenarios?

No. The exposure assessment is required only if the substance meets the hazard criteria listed in Annex I, 0.6.3, or is PBT/vPvB (Art. 14(4)).

My use is not in the scenario. Must I do my own assessment?

Either ask your supplier to include the use as an identified use, or prepare your own chemical safety report, unless one of the Article 37(4) exemptions applies. If you prepare one, Article 38 requires you to report to ECHA.

Does a mixture SDS need its own annex?

It must carry the relevant exposure scenarios and information from the SDS you received (Art. 31(7)). The content must be consistent with the scenarios; how it is laid out is a drafting choice.

This article summarises legal texts for orientation only; it is not legal advice. Check the current consolidated text of REACH and the ECHA guidance before relying on it.

Sources

• REACH, Regulation (EC) No 1907/2006, Articles 14, 31, 37, 38 and 39 and Annexes I and II (consolidated text) — CELEX:02006R1907.
• Commission Regulation (EU) 2020/878 replacing Annex II to REACH — CELEX:32020R0878.
• REACH Articles 14, 37, 38, 39 and Annexes I and II as published by legislation.gov.uk — article/37, annex/II.
• ECHA, Guidance on REACH (chemical safety assessment, downstream users, safety data sheets) — echa.europa.eu.