All suppliers of substances or mixtures must have -compliant Safety Data Sheets readily available. They not only help to inform workers about all hazards associated with hazardous chemicals but also assist employers in meeting their obligations to assess the health and safety risks and protect the public health and environment. Slightly different rules in the EU govern SDS than OSHA, but they must all comply with GHS.
Registration Evaluation, Authorization, and Restriction Of Chemicals (REACH), requires SDS. REACH requirements are everchanging and have continuously been adapted to include the Globally Harmonized System (GHS) rules. Further modifications have been made to Regulation (EC) No 1272/2008 (Classification, Labelling and Packaging Regulation CLP); SDS provides safety information when a substance is deemed hazardous. All SDS generated After 31 December 2022 Must be formatted per Regulation (EU 2020/878. Remember to adopt the new format as quickly as possible when creating new SDS.
This article will outline the CLP SDS requirements as well as any changes that have been made following Regulation (EU 2020/878).
The latest updates from the Commission on Regulation 2020-878
General Requirement
- Use clear, simple, and concise language.
- The SDS should have a page number or phrases that indicate the next page (ex., Continued on the next page or End Safety Data Sheet)
Section 1, Requirement
- In section 1 of the SDS, indicate the Unique Formulation Identifier for all your mixtures.
- The Product ID should be displayed in Section 1 on SDS if nanoforms are present.
Section 2. Requirement
- Section 2.3 Other Hazards should include the substance (s) that are included in the list of substances with endocrine disruption properties established by Article 59(1) REACH or identified as such according to the criteria in the Commission Delegated Regulation 2017/2100 or Commission Regulation 2018/605.
Other Requirements
- Sections 11 and 12 should contain information about endocrine disruptors.
CLP Authoring Requirements
In the summary, the EU has clearly defined the requirements of SDS in terms of the format and the objectives that are to be included in it. These must be taken into consideration before drafting your SDS. First, you must avoid jargon and obscure acronyms. If they are not consistent with the classification, avoid any language that could indicate the substance isn’t hazardous. For example, The second rule is to number each page. To elaborate, it says that you should specify the total for each page, such as “page 1 out of 10”, and also indicate the existence of the next page. The next page is followed by the word “Continued” and the last line of the document (“End of Safety Data Sheet”)
Each safety data sheet should also include:
- Prepared by a competent individual (someone who has the knowledge to complete a section or an entire SDS, such as a qualified chemical engineer). The supplier must provide accurate information about the product.
- Allow users to take precautions in the workplace. The SDS writer must inform the intended audience clearly of the hazards associated with a substance or mix and provide information on safe handling, storage, and disposal.
- List the information so that employers can determine if hazardous substances are present in the workplace and evaluate the risk to the health and safety of workers when operating.
- Avoid using jargon, which may be difficult to understand by the reader, and avoid vague acronyms or abbreviations. Also, avoid statements that could indicate that the product was not dangerous (if this is inconsistent with its classification).
CLP Guidance for Completing the SDS
You are now ready to create your SDS. The SDS sections are categorized according to their properties. This requires extensive research and laboratory testing. Below are the EU-approved sections of CLP SDS.
SECTION 1: Identification and identification of the substance/mixture, as well as the company/undertaking
SDS SECTION 2: Hazards identification
SDS SECTION 3: Composition/information on ingredients
SECTION 4 – First Aid Measures
SDS SECTION 5. Firefighting measures
SECTION 6 – Accidental Release Measures
SDS SECTION 7. Handling and Storage
SECTION 8: Personal protection and exposure control
SDS SECTION 9. Physical and Chemical Properties
SDS SECTION 10. Stability and Reactivity
SDS Section 11: Toxicological Information
SDS SECTION 12. Ecological information
SDS SECTION 13. Disposal Considerations
Transport Information SECTION 14, SDS
SDS SECTION 15. Regulatory information
SDS SECTION 16. Other information
You might be wondering which section you should tackle first and how to organize them to ensure efficient data collection. The EU has provided a framework that will help you easily compile your SDS. It is important to follow the sequence of the framework (shown below). For example, identifying hazards for Section 2 may only be possible once you’ve determined all the inputs in the other sections.
Each section of the SDS must be thoroughly researched and evaluated. Many formulas are required to determine hazard class, for example, Acute toxicity. The classification must also be based on the exposure route and severity of the hazard. Carcinogenicity classification requires data evaluation to place them into one of three categories accurately. ERA offers eBooks that explain the various methods of determining these properties.
Requirements for EU safety data sheets – Regulation 2020-878 – EU Commission
CLP compliance is dependent on accurate SDS. REGULATION (EU 2020/878 and define the new content. The EU SDS will request variations to the SDS sections relating to product identification and hazard communications from December 2022 onwards.
Section 1 was amended per REGULATION(EU) 2020/878. CLP regulations require that each chemical have a Unique Formula Identification (UFI), which should be clearly stated on the first page. If you do not have a readily available UFI, you can generate one at https://ufi.echa.europa.eu/#/create.
The SDS must indicate the endocrine-disrupting characteristics of the substance in multiple sections, including Section 2: (Category 2.2.3: Other Hazards), 11: (Subcategory.11.2.1: Endocrine Disrupting Properties), and 12: (Category 12.6: Endocrine Disrupting Properties).
Here are some phrases you can use to indicate whether your substance contains or does not contain endocrine chemicals.
Section 2
Containing Endocrine chemicals
The substance(s) below is/are included in the list of substances that have endocrine disruptive properties established under Article 59(1) REACH or are identified as such according to the criteria in the Commission Delegated Regulation (EU 2017/2100) or Commission Regulation 2018/605.
No Endocrine chemicals
- Other Hazards
The substance(s), if any, is not listed as having endocrine-disrupting properties under Article 59(1) REACH or has not been identified to have endocrine-disrupting properties according to the criteria established by Commission Delegated.
