Europe - Chemical regulations

What are the key European regulations governing SDS requirements?

The main regulations governing SDS requirements in the EU include:

• REACH Regulation (Regulation (EC) No 1907/2006), Articles 31 and 32: These articles define the obligations for providing an SDS, including when and how it should be updated. Article 31 specifies when an SDS is required, while Article 32 outlines the obligations for communicating information when an SDS is not mandatory.

• REACH Annex II: Annex II provides detailed requirements on the structure and content of an SDS, ensuring consistency and comprehensiveness.

• Commission Regulation (EU) 2020/878: This regulation amends Annex II of REACH and updates the provisions on endocrine disruptors, nanoforms, and specific concentration limits.

For detailed information on European Safety Data Sheets (SDS), please visit the ECHA’s official guidance: Guidance on the compilation of safety data sheets.

What are the 16 sections that must be included in an European SDS according to Annex II of REACH?

Part B of Commission Regulation (EU) 2020/878 outlines the mandatory structure of a Safety Data Sheet (SDS), which must include the following 16 headings:

1. Identification of the substance/mixture and of the company/undertaking
2. Hazards identification
3. Composition/information on ingredients
4. First-aid measures
5. Firefighting measures
6. Accidental release measures
7. Handling and storage
8. Exposure controls/personal protection
9. Physical and chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information
15. Regulatory information
16. Other information.

These sections ensure that the SDS provides comprehensive and standardized safety information across the EU, facilitating proper handling, storage, and disposal of chemical substances and mixtures. The inclusion of these specific sections is mandatory, ensuring consistency and clarity in safety communication.

What are the language requirements for the SDS?

Section 0.2.4 of Commission Regulation (EU) 2020/878 specifies that the Safety Data Sheet (SDS) must be provided in the official language(s) of the country where the chemical product is placed on the market. This ensures that all users can understand the safety information provided.

The table below outlines the required languages for Safety Data Sheets (SDS) in various European countries, based on the latest requirements:

How does the SDS ensure compliance with these regulations?

The SDS must be meticulously prepared to include all relevant legal requirements, ensuring that all hazards, precautions, and legal obligations are clearly communicated. This includes:

• Accurate classification and labeling: In line with CLP Regulation (Regulation (EC) No 1272/2008) and sector-specific laws.
• Inclusion of country-specific information: As required in different sections of the SDS, ensuring compliance with national regulations.
• Timely updates: To reflect changes in legislation, chemical composition, or new hazards, as mandated by REACH Article 31.

What are the mandatory training requirements in Safety Data Sheet (SDS) in Europe?

Regulation (EU) 2020/878 introduces specific training requirements for individuals involved in the preparation and distribution of Safety Data Sheets. Section 0.2.3 of this regulation emphasizes that:

• Training is mandatory for all personnel involved in the compilation of SDSs, particularly those responsible for providing information on hazardous substances and mixtures. This ensures that they are competent and up-to-date with the latest legal and technical developments.
• The training must cover several key areas, including:
  • The latest updates to EU chemical legislation, especially REACH and CLP.
  • Understanding of hazard classification, labeling, and packaging requirements.
  • Proper communication of hazards through SDSs.
  • Updates on relevant sector-specific and national regulations affecting the SDS content.
• Regular updates and refresher courses are required to maintain a high level of competence. This is crucial to ensure that SDSs reflect current knowledge and regulatory changes, thereby protecting workers, consumers, and the environment.

These training requirements underscore the importance of professional development in ensuring that SDSs are accurate, comprehensive, and compliant with EU regulations.