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Chemical manufacturers operating in the European Union (EU) must understand and comply with the Material Safety Data Sheet (MSDS) requirements. An MSDS, also known as a Safety Data Sheet (SDS), is a document that provides detailed information on the hazards associated with a chemical substance or mixture, as well as guidance on its safe handling, storage, and disposal.
EU MSDS Requirements and Format
Under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, any hazardous chemicals or mixtures produced in the EU or imported must be accompanied by a compliant SDS. According to Article 31 of REACH, suppliers of chemicals – whether they are manufacturers, importers, downstream users, distributors, or only representatives – must furnish customers with an SDS that adheres to the REACH regulation if the chemical or mixture they supply is deemed hazardous. The SDS provided must be in the official language of the market country where it is being placed, including online sales, and must include the sixteen (16) specified sections outlined in Article 31(6) of the REACH Regulation. Moreover, if new information regarding hazards or risk management measures becomes available, the SDS must be promptly updated.
The EU MSDS requirements are outlined in the Classification, Labeling, and Packaging (CLP) Regulation (EC) No. 1272/2008, which aligns with the United Nations’ (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
For mixtures that are not classified as hazardous but contain certain hazardous substances, an SDS should be provided if requested by downstream users or distributors. When SDS is not required, the supplier must still provide sufficient information for safe use, for example, information on any restrictions for use.
The MSDS format consists of the following sixteen (16) sections:
Key Points for Chemical Manufacturers to Comply with the EU MSDS Requirements
- Ensure accurate classification and labeling of the chemical substance or mixture according to the CLP Regulation.
- Provide detailed information on the chemical’s composition, including the identity and concentration of hazardous ingredients.
- Describe the potential health and environmental hazards associated with the chemical, including acute and chronic effects.
- Include first aid measures and firefighting procedures in case of exposure or emergency.
- Provide guidance on safe handling, storage, and disposal of the chemical to minimize risks to workers and the environment.
- Specify appropriate Personal Protective Equipment (PPE) for handling the chemical.
- Include relevant physical and chemical properties of the chemical, such as boiling point, flash point, and solubility.
- Ensure that the MSDS is reviewed and updated whenever new information becomes available or the chemical’s classification changes.
- Provide the MSDS free of charge to any person requesting it within the EU.
- Ensure that the MSDS is available in the official language(s) of the EU member state(s) where the chemical is marketed.
By adhering to these requirements and providing comprehensive MSDS, chemical manufacturers in the EU can contribute to the safe handling and use of chemicals, protect workers and the environment, and comply with relevant regulations.
Recent Changes to the Current SDS Requirements
A new EC Regulation 2020/878 has been published, which amends REACH Annex II (SDS compilation requirements), and requires significant updates to the current SDS related to:
- Including technical contents like Specific Concentration Limits (SCL), multiplying factors (M-factors), and Acute Toxicity Estimates (ATE).
- Specific hazard communication requirements for new hazards, specifically nanomaterials and endocrine disruptors.
- Detailed description of physicochemical properties.
- Incorporation of workplace exposure limits.
- Structural/formatting changes like unique formula identifier inclusion for mixtures.
SDS were supposed to be compliant with the amended REACH Annex II requirements from January 01, 2023 (adaptation period: January 01, 2021 to December 31, 2022). Freyr can support your product compliance with the above SDS requirements.
Freyr operates globally across major markets, offering a consultative approach to identifying relevant Regulatory requirements and gathering necessary product information for intelligent chemical management solutions. Our thorough product evaluation involves chemists, toxicologists, transportation specialists, and Regulatory experts, ensuring SDS authoring and ongoing compliance. Additionally, Freyr provides efficient multilingual translation of SDS into over forty (40) languages. Ensure global compliance and efficiency with Freyr’s expert chemical management solutions!
