Regulation overview
REACH Annex II: The EU Safety Data Sheet Format
Annex II of the EU REACH Regulation sets out the requirements for compiling a safety data sheet. It uses the same 16 section headings as the GHS and OSHA, but with numbered subsections (for example 1.1, 1.2) and extra requirements such as the e-mail address of the competent person, the UFI, the registration number and, for registered substances, exposure scenarios annexed to the sheet.
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Who it applies to
Annex II applies to anyone in the EU supply chain who must supply an SDS under Article 31 of REACH: manufacturers, importers, downstream users and distributors of hazardous substances and mixtures, and of certain other substances. The annex has been amended several times, including by Commission Regulation (EU) 2020/878, which changed requirements in several sections, including 1, 3, 9 and 11. Check that your suppliers use the current version.
The layout
Annex II sets general rules (clear and concise, dated, in an official language of the member state, with changes in a revision indicated) and then specifies each section and its subsections:
| Section | Typical subsections |
|---|---|
| 1 Identification | Product identifier (with UFI if applicable), relevant identified uses and uses advised against, supplier details, emergency telephone number |
| 2 Hazards identification | Classification, label elements, other hazards (including PBT/vPvB and endocrine disrupting properties) |
| 3 Composition | Substances or mixtures with identifiers (CAS, EC, REACH registration number, index number) and classification of components |
| 4 to 6 | First aid; fire-fighting; accidental release, each with subsections |
| 7 to 8 | Handling and storage including specific end uses; exposure controls including DNELs and PNECs |
| 9 to 11 | Physical and chemical properties; stability; toxicology, divided by hazard class |
| 12 to 14 | Ecological information including PBT assessment and endocrine disrupting properties; disposal; transport information covering the relevant modes (road, rail, inland waterway, sea, air) |
| 15 Regulatory | EU and national regulations; whether a chemical safety assessment has been carried out |
| 16 Other | Indication of changes, abbreviations, key references, full text of hazard statements |
The overview of each section is on the sections page, with details in the individual pages such as Section 1 and Section 8.
Extended SDS and exposure scenarios
For substances that require a chemical safety report, the supplier must attach relevant exposure scenarios to the SDS. These scenarios describe operational conditions and risk management measures under which a use is considered safe. Downstream users must check that their use is covered by a scenario, and if not, take action such as adopting the measures, informing their supplier, or preparing their own assessment. Nothing similar exists in OSHA HazCom.
Key differences versus OSHA Appendix D
- Mandatory content in sections 12 to 15. OSHA does not enforce them; Annex II sets requirements for each.
- Numbered subsections. The EU format gives a numbered subsection structure; OSHA's appendix lists contents without numbering.
- Registration and identifier data. REACH registration numbers, EC numbers, index numbers and UFIs.
- Derived no-effect levels (DNEL) and predicted no-effect concentrations (PNEC). Used in Section 8 and based on the chemical safety assessment.
- Language and revision control. The date and an indication of changes in each revision are explicit requirements.
- Exposure scenarios. Annexed to the SDS for registered substances requiring a safety report.
Despite these differences, a sheet in the Annex II format is usually close to what a US employer needs; the main gaps are US-specific entries such as OSHA PELs, DOT shipping descriptions and TSCA status. See OSHA HazCom for the US requirements.
Practical tips
- When receiving an EU sheet, check the date and version, and see whether it includes exposure scenarios as annexes.
- Find the DNEL/PNEC values in Section 8 and understand they differ from occupational exposure limits; see reading exposure limits.
- Check the regulatory information in Section 15 for EU restrictions and authorisation status.
- For classification details see EU CLP and EU REACH.
Frequently asked questions
What is REACH Annex II?
It is the annex of the REACH Regulation that sets the format and content requirements for safety data sheets in the EU, with 16 sections and numbered subsections.
Is the EU SDS format the same as the OSHA format?
Both use the same 16 section titles in the same order, but the EU format has numbered subsections, additional identifiers and stricter content requirements for sections 12 to 15.
What is an extended SDS?
An SDS with exposure scenarios annexed, supplied for substances that have a chemical safety report under REACH.
Does an EU SDS satisfy OSHA?
It is often very close but may lack US-specific information such as OSHA exposure limits, US emergency contacts and US regulatory listings.