Guidance
Documentation
The European Commission has revised Annex II of REACH, setting new requirements for the preparation of Safety Data Sheets (SDS).
This update brings Annex II into alignment with the 6th and 7th revisions of the Globally Harmonised System (GHS), introducing several changes to SDS content and structure. The latest amendment was published in the Official Journal on 26 June 2020 (Regulation (EU) 2020/878).
Changes by SDS Section
New requirements
Section 1.1 Product identifier
If an SDS concerns one or more nanomaterials (or materials including them), state this using the term ‘nanoform’. For certain hazardous mixtures not packaged or supplied in bulk for industrial use, the Unique Formula Identifier (UFI) must now be provided, as part of the poison centre notification process. Include the UFI under Other Means of Identification in Section 1.1.
Section 2.3 Other hazards
It is mandatory to declare in Section 2.3 if the substance or any mixture constituent has endocrine-disrupting properties as per Regulation (EU) 2017/2100 or 2018/605, at concentrations ≥0.1% w/w. State each such constituent if present at or above threshold, referencing recognised evaluation lists and methods.
Section 3.1 Substances
For pure substances, report specific concentration limits, multiplying factors, and acute toxicity estimates. If a nanoform is registered or covered by an SDS, describe its particle characteristics as required by Annex VI.
Section 3.2 Mixtures
For hazardous mixtures, update the reporting of hazard classes and concentration thresholds requiring listing. Thresholds for inclusion are reduced: aspiration hazard from 10% to 1%, respiratory/skin sensitisers category 1A from 0.1% to 0.01%. Explicitly mention endocrine disruptors at >0.1%. For each relevant substance, specify SCLs, M-factors, and ATEs if determined. For nanoform mixture components, provide required characterisation.
Hazard class and category | Concentration (%) for declaration |
Acute toxicity, category 1, 2, 3 | ≥ 0.1 |
Acute toxicity, category 4 | ≥ 1 |
Skin corrosion/irritation, category 1, 1A, 1B, 1C, 2 | ≥ 1 |
Serious eye damage/eye irritation, cat. 1, 2 | ≥ 1 |
Respiratory sensitiser cat. 1 or 1B | ≥ 0.1 |
Respiratory sensitiser cat. 1A | ≥ 0.01 |
Skin sensitiser cat. 1 or 1B | ≥ 0.1 |
Skin sensitiser cat. 1A | ≥ 0.01 |
Germ cell mutagenicity cat. 1A, 1B | ≥ 0.1 |
Germ cell mutagenicity cat. 2 | ≥ 1 |
Carcinogenicity cat. 1A, 1B, 2 | ≥ 0.1 |
Reproductive toxicity cat. 1A, 1B, 2, lactation | ≥ 0.1 |
STOT single/repeated exposure cat. 1, 2, 3 | ≥ 1 |
Aspiration toxicity | ≥ 1 |
Aquatic tox. (acute 1; chronic 1) | ≥ 0.1 |
Aquatic tox. chronic 2, 3, 4 | ≥ 1 |
Ozone layer hazard | ≥ 0.1 |
Section 9 Physical and chemical properties
The list of required properties is extended: physical state, colour, odour, melting point/freezing point, boiling point, flammability, explosion limits, flash point, auto-ignition, decomposition temperature, pH, kinematic viscosity, solubility, partition coefficient (log Kow, especially for nanoforms), vapour pressure, density/relative density, relative vapour density, particle characteristics.
Section 9.2 is split into ‘Information on physical hazard classes’ (explosives, flammable gases, liquids, solids, etc.) and ‘Other safety characteristics’ (mechanical sensitivity, self-accelerating polymerisation temp, miscibility, conductivity, etc.). Indicate properties relevant for safe use, use updated list structure and clearly state reasons for missing data.
Section 11 Toxicological information
New subsection 11.2 added: must report adverse health effects caused by endocrine-disrupting properties where available for substances identified under section 2.3. Summarise supporting evidence as per applicable EU assessment criteria. Section 11.2.2: Include any other relevant info on adverse health effects, even if not strictly required.
Section 12 Ecological information
New subsection 12.6 requires reporting adverse environmental effects due to endocrine disruptors. Previous subsection on other adverse effects moves to 12.7.
Section 14 Transport information
Subsection 14.7: Title revised to ‘Maritime transport in bulk according to IMO instruments’, replacing the former reference to MARPOL/IBC conventions. Provide expanded details on bulk transport as required.
Who is affected by these amendments?
UK authorities did not adopt the Annex II update when the UK exited the EU on 31 December 2020. As a result, a single SDS cannot fulfil both UK REACH and EU REACH requirements. Manufacturers and importers of chemical substances in the UK must ensure their Safety Data Sheets comply with the regulations in each jurisdiction, enabling continued trade within both the UK and the EU.
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