What is a safety data sheet?
The REACH Regulation requires manufacturers, importers, and distributors to provide a safety data sheet (SDS) when a substance or mixture meets the criteria for classification as hazardous under Regulation (EC) No 1272/2008 ( CLP ), when it is persistent, bioaccumulative, and toxic, or when it is listed as a candidate substance for other reasons. For certain unclassified mixtures containing hazardous substances above certain thresholds, the SDS must be provided upon request. It is provided free of charge, in paper or electronic format, in the official language of the Member State where the product is marketed, and must be updated when new hazard information becomes available or when an authorization or restriction is granted or refused.
The sixteen-section structure is mandatory and uniform throughout the European Union, allowing for product comparisons and the systematic extraction of information needed for prevention. Sections 2 (hazard identification), 3 (composition), 7 (handling and storage), 8 (exposure controls and personal protection, including limit values and recommended equipment), 9 (physical and chemical properties), 10 (stability and reactivity), 11 (toxicological information), and 15 (regulatory information) are the most useful for chemical risk assessment. When the registrar has prepared a chemical safety report, the exposure scenarios are attached as an annex to the extended data sheet.
The data sheet does not replace the risk assessment: it describes the product and the conditions of use provided by the supplier, but it is the employer who must assess the actual exposure in their workplace, in accordance with Royal Decree 374/2001, and adopt the corresponding measures.
The sixteen sections
- 1 and 2. Identification and hazards. Product identifier, relevant uses, supplier details and emergency telephone number; classification according to CLP, label elements (pictograms, signal word, hazard statements and precautionary statements) and other hazards.
- 3. Composition. Substances or components of the mixture with their identifiers and classification, and concentration ranges.
- 4, 5 and 6. Emergencies. First aid by route of exposure, fire fighting measures (extinguishing means, resulting hazards) and measures in case of accidental spillage.
- 7 and 8. Handling, storage and exposure control. Handling precautions, storage conditions and incompatibilities; occupational and biological exposure limit values, appropriate engineering controls and personal protection (eye, skin, respiratory) with their specifications.
- 9 and 10. Properties and reactivity. Physical state, flash point, explosive limits, vapor pressure, density, solubility; stability, hazardous reactions, conditions and materials to avoid and decomposition products.
- 11 and 12. Toxicology and ecology. Effects by route of exposure, acute toxicity, corrosion and irritation, sensitization, mutagenicity, carcinogenicity, reproductive toxicity and specific organ effects; environmental toxicity and persistence.
- 13 and 14. Disposal and transport. Waste treatment methods and classification for the transport of dangerous goods.
- 15 and 16. Regulations and other information. Specific applicable regulations, chemical safety assessment performed, revision date, changes from the previous version and full text of the hazard statements cited.
Use of the data sheet in preventive management
- Inventory of chemical products. Record of all substances and mixtures present with their current data sheet, classification, quantities and places of use.
- Chemical risk assessment. Identification of hazards, exposure routes, limit values and recommended measures as a starting point for the assessment of Royal Decree 374/2001.
- Selection of equipment and controls. Extraction, ventilation, glove materials, respiratory filter type and eye protection from section 8.
- Emergencies. Content of sections 4 to 6 in emergency plans and at points of use.
- Information and training. Providing relevant information to employees in understandable language, with access to the full information sheet.
- Substitution. Comparison of hazards between alternative products to apply the substitution principle.
Organizational application: how to manage safety data sheets
- Require the safety data sheet in the official language from each supplier before the first purchase and before each update, and reject products without a data sheet when required.
- Maintain a centralized inventory of products with current record, revision date, classification, quantities and locations.
- Systematically extract information from sections 2, 3, 7, 8, 9, 10 and 11 for chemical risk assessment and selection of measures.
- Make the forms available to workers and worker safety representatives, with quick access at the points of use.
- Prepare understandable job summaries or fact sheets with specific handling, protection and emergency measures.
- Verify the consistency between the data sheet, the label and the actual use, and consult the supplier in case of discrepancies or uncovered exposure scenarios.
- Review the records periodically and register any classification changes that require updating the evaluation.
Preventive management software allows you to maintain the inventory of products with their data sheets, versions and dates, link them with the chemical risk assessment and with the positions and guarantee their access from any center.
Limits and common mistakes
- Consider that having the data sheets is equivalent to having assessed the chemical risk.
- Using cards in another language, outdated cards, or cards for a different product than the one actually being used.
- Do not transfer the information from section 8 to the selection of protective equipment and technical controls.
- Ignore the storage incompatibilities in sections 7 and 10.
- File the data sheets so they are not accessible at the points of use or understandable to the person handling the product.
- Forget that certain unclassified mixtures may require a data sheet at the user’s request.
The content and format requirements of the data sheet are updated by regulation; the current version of Annex II of the REACH Regulation should be consulted.
Practical example
Situation: A surface treatment workshop with 22 workers receives a new degreaser to replace the previous one.
- Reception. Request for the data sheet in Spanish before purchase; verification of the classification (skin and eye irritant, category 3 flammable) and comparison with the previous product.
- Assessment. Update of the chemical risk assessment of the degreasing station with the limit values and recommendations of section 8.
- Measures. Localized extraction in the tank, nitrile gloves of the indicated thickness, enclosed safety goggles and storage in a flammable-liquid storage cabinet.
- Communication. Job description with the measures, training of the people affected and complete information sheet accessible in the workshop and in the management system.
Regulatory framework in the European Union and in Spain
- Regulation (EC) 1907/2006 (REACH), Article 31 and Annex II . Requirements for safety data sheets.
- Commission Regulation (EU) 2020/878 of 18 June 2020. Amendment to Annex II to REACH on the content of safety data sheets.
- Regulation (EC) 1272/2008 (CLP) . Classification, labelling and packaging of substances and mixtures.
- Royal Decree 374/2001, of April 6. Protection against risks related to chemical agents during work; the data sheet as a source of information for the assessment.
- Law 31/1995, articles 18 and 41. Information to workers and obligations of manufacturers, importers and suppliers.
Directive 98/24/EC on chemical agents stipulates that employers must obtain from suppliers the information necessary to assess risks. In Colombia, the Globally Harmonized System is applied in accordance with Decree 1496 of 2018.
