New SDS Requirements Take Effect in January 2021 Via Changes to REACH Annex II

In 2020, Annex II to REACH was amended via EU Commission Regulation 2020/878. Covering requirements for safety data sheet (SDS) composition, the changes to Annex II yield corresponding new requirements in effect as of January 1, 2021. This blog post reviews these changes and their corresponding effects on SDSs.

Safety Data Sheets and Associated Changes

SDSs are a critically important tool for businesses, providing essential chemical hazard information for workers who use or handle chemical substances. In accordance with the Globally Harmonized System of Classification and Labelling of Chemicals, SDSs are required to follow a standardized 16-section format (including associated subsections for each):

  • Section 1: Identification of the Substance/Mixture and of the Company/Undertaking
  • Section 2: Hazard(s) Identification
  • Section 3: Composition/Information on Ingredients
  • Section 4: First-Aid Measures
  • Section 5: Fire-Fighting Measures
  • Section 6: Accidental Release Measures
  • Section 7: Handling and Storage
  • Section 8: Exposure Controls/Personal Protection
  • Section 9: Physical and Chemical Properties
  • Section 10: Stability and Reactivity
  • Section 11: Toxicological Information
  • Section 12: Ecological Information
  • Section 13: Disposal Considerations
  • Section 14: Transport Information
  • Section 15: Regulatory Information
  • Section 16: Other Information

Revised SDS Requirements

The new SDS requirements include updates relative to several sections and subsections:

  • Section 1: Identification of the Substance/Mixture and of the Company/Undertaking
    • Updated subsection 1.1 Product Identifier, requiring inclusion of Unique Formula Identifier (UFI) Information in certain cases and consideration of nanoforms.
  • Section 2: Hazard(s) Identification
    • Includes an update of subsection 2.3 Other hazards, outlining the need to note whether a chemical possesses endocrine disrupting properties at concentrations > 0.1% by weight.
  • Section 3: Composition/Information on Ingredients
    • Updated subsection 3.1 Substances, including the need to provide additional information on acute toxicity estimates, multiplying factors, and specific concentration limits.
    • Updated subsection 3.2 Mixtures, incorporating the need for revisions to hazard categories and mixture concentration limits.
  • Section 9: Physical and Chemical Properties
    • Updated subsection 9.1 Information on Basic Physical & Chemical Properties, incorporating the need for more detailed information.
    • Updated subsection 9.2, including further subdivisions into 9.2.1 Information with Regard to Physical Hazard Classes and 9.2.2 Other Safety Characteristics.
  • Section 11: Toxicological Information
    • Includes the addition of a new subsection, 11.2 Information on other hazards, incorporating information including adverse health effects associated with endocrine disrupting properties.
  • Section 12: Ecological Information
    • Includes the addition of a new subsection, 12.6 Endocrine disrupting properties, focusing on negative impacts to the environment.
  • Section 14: Transport Information
    • Updated subsection 14.7 Maritime transport in bulk according to IMO instruments, elaborating on information requirements for bulk cargo transport.
  • Section 15: Regulatory Information
    • Includes an update to subsection 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture, requiring the addition of more detailed information on restrictions and authorizations.

More information on the changes to REACH Annex II can be found by reviewing the corresponding EU Commission Regulation 2020/878.

Additional SDS Information and More

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