August 09, 2024
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, Authorization 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 provide customers with an SDS that adheres to the REACH regulation if the chemical or mixture they supply is deemed hazardous. The SDS 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 also outlined in the Classification, Labelling, and Packaging (CLP) Regulation (EC) No. 1272/2008, which aligns with the United Nations’ (UN) Globally Harmonized System of Classification and Labelling 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 an SDS is not required, the supplier must still provide sufficient information for safe use, such as information on any restrictions for use.
The MSDS format consists of the following sixteen (16) sections:
Identification of the substance/mixture and of the company/undertaking
- Hazards identification
- Composition/information on ingredients
- First aid measures
- Firefighting measures
- Accidental release measures
- Handling and storage
- Exposure controls/personal protection
- Physical and chemical properties
- Stability and reactivity
- Toxicological information
- Ecological information
- Disposal considerations
- Transport information
- Regulatory information
- Other information
Key Points for Chemical Manufacturers to Comply with the EU MSDS Requirements
Accurate Classification and Labelling: Ensure accurate classification and labelling of the chemical substance or mixture according to the CLP Regulation.
Detailed Composition Information: Provide detailed information on the chemical’s composition, including the identity and concentration of hazardous ingredients.
Health and Environmental Hazards: Describe the potential health and environmental hazards associated with the chemical, including acute and chronic effects.
First Aid and Firefighting Measures: Include first aid measures and firefighting procedures in case of exposure or emergency.
Safe Handling, Storage, and Disposal: Provide guidance on safe handling, storage, and disposal of chemicals to minimize risks to workers and the environment.
Personal Protective Equipment (PPE): Specify appropriate PPE for handling the chemical.
Physical and Chemical Properties: Include relevant physical and chemical properties of the chemical, such as boiling point, flash point, and solubility.
Regular Updates: Ensure that the MSDS is reviewed and updated whenever new information becomes available or the chemical’s classification changes.
Free Availability: Provide the MSDS free of charge to any person requesting it within the EU.
Language Requirements: 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, amending REACH Annex II (SDS compilation requirements), requiring significant updates to the current SDS related to:
Technical Contents: Including Specific Concentration Limits (SCL), multiplying factors (M-factors), and Acute Toxicity Estimates (ATE).
New Hazards: Specific hazard communication requirements for new hazards, specifically nanomaterials and endocrine disruptors.
Physicochemical Properties: Detailed description of physicochemical properties.
Workplace Exposure Limits: Incorporation of workplace exposure limits.
Structural/Formatting Changes: Unique formula identifier inclusion for mixtures.
SDS were required to be compliant with the amended REACH Annex II requirements from January 1, 2023 (adaptation period: January 1, 2021, to December 31, 2022). Maven can support your product compliance with the above SDS requirements.
Maven’s Comprehensive SDS Services
Maven 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, Maven provides efficient multilingual translation of SDS into over forty (40) languages. Ensure global compliance and efficiency with Maven’s expert chemical management solutions!
By leveraging Maven’s expertise, chemical manufacturers can navigate the complexities of EU MSDS requirements, ensuring compliance and contributing to the safety and well-being of workers and the environment.
Conclusion
In chemical manufacturing, adhering to EU Material Safety Data Sheet (MSDS) requirements is essential for safety, compliance, and risk management. Understanding and implementing REACH and CLP regulations ensures that manufacturers provide crucial information on hazards and handling, protecting workers and the environment.
Recent updates under EC Regulation 2020/878 highlight the need for precise hazard communication and detailed physicochemical property descriptions. Staying compliant with these standards is vital for regulatory adherence and safe chemical practices.
Maven can help navigate these requirements with comprehensive SDS authoring and multilingual translation services, ensuring your MSDS meets the latest standards and supports global compliance. Partnering with Maven helps manage regulatory obligations and fosters a safer, more sustainable chemical industry.
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