Safety Data Sheets, commonly referred to as SDSs, are essential regulatory documents for communicating information on chemical hazards, safe handling, exposure controls and emergency measures. An accurate and up to date SDS supports regulatory compliance, occupational safety and effective chemical risk management throughout the supply chain.
The regulatory requirements governing Safety Data Sheets vary across jurisdictions. A common GHS structure does not make a single SDS automatically compliant in every market.
In the United States, chemical hazard communication in the workplace is regulated by the Occupational Safety and Health Administration (OSHA) under the Hazard Communication Standard, HCS, 29 CFR 1910.1200.
In May 2024, OSHA published a Final Rule updating the Hazard Communication Standard to improve alignment primarily with Revision 7 of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The updated rule entered into force on 19 July 2024.
Entry into force must be distinguished from the deadlines for compliance. Following the OSHA extension issued in January 2026, the applicable deadlines under 29 CFR 1910.1200(j) are:
- 19 May 2026 for chemical manufacturers, importers and distributors evaluating substances.
- 20 November 2026 for employers to make the necessary workplace labelling, hazard communication programme and additional training updates for substances.
- 19 November 2027 for chemical manufacturers, importers and distributors evaluating mixtures.
- 19 May 2028 for the corresponding employer updates for mixtures.
The transitional provisions apply according to the relevant substance or mixture deadline and the role of the organisation.
In the European Union, the main regulatory frameworks governing Safety Data Sheets and chemical hazard communication are Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008.
Article 31 and Annex II of the REACH Regulation establish the requirements for Safety Data Sheets, while the CLP Regulation establishes the criteria for the classification, labelling and packaging of substances and mixtures. The requirements of Annex II to REACH were further amended by Commission Regulation (EU) 2020/878, which sets out the revised Annex II requirements for SDS format and content.
Classification must also reflect applicable CLP amendments. Commission Delegated Regulation (EU) 2023/707 introduced hazard classes for endocrine disruption affecting human health or the environment, PBT/vPvB and PMT/vPvM properties. The new criteria apply to substances from 1 May 2025 and mixtures from 1 May 2026, with transitional exemptions until 1 November 2026 and 1 May 2028 respectively for substances and mixtures already placed on the market before those application dates. These changes must be considered when reviewing classification and SDS content.
In sectors where chemicals are routinely manufactured, handled or used, including the pharmaceutical, healthcare, manufacturing, laboratory and research sectors, the quality and accessibility of safety information can directly influence occupational safety and regulatory compliance.
What Is a Safety Data Sheet?
A Safety Data Sheet is a standardised document that provides detailed information on the properties of a chemical substance or mixture, its potential hazards and the precautions required for safe handling, storage, exposure control and emergency response.
Under REACH Article 31, SDS provision is required for substances or mixtures meeting the applicable hazardous classification criteria, and for substances meeting the PBT/vPvB criteria or included on the Candidate List for the reasons specified in Article 31(1). An SDS must also be supplied on request for certain mixtures not classified as hazardous when the conditions of Article 31(3) are met.
Specific exemptions and supply conditions must be checked. For example, Article 2(6) exempts medicinal and cosmetic mixtures in their finished state, intended for the final user, from Title IV of REACH. This does not automatically exempt APIs, intermediates or raw materials supplied for manufacturing. Workplace protection duties must be assessed separately. EU exemptions should not be assumed to apply under the US HCS.
Depending on the applicable regulatory framework and the role of the company within the supply chain, manufacturers, importers, distributors and other suppliers may have specific obligations concerning the preparation, provision and updating of SDS documentation.
Employers must also ensure that workers handling hazardous chemicals have effective access to the relevant safety information.
From a chemical risk management perspective, an SDS is a critical tool for identifying hazards, understanding potential exposure routes and implementing appropriate risk management measures.
It also provides essential information for responding to emergency situations, including accidental releases, fires, and unintended occupational exposures.
Why Are Safety Data Sheets Important for Regulatory Compliance?
Safety Data Sheets support organisations in several areas of chemical safety and regulatory compliance.
First, an SDS provides a structured description of the hazards associated with a chemical substance or mixture. These may include physical, human health, and environmental hazards.
Within the European Union, the classification of substances and mixtures is governed by Regulation (EC) No 1272/2008, commonly referred to as the CLP Regulation.
This information allows organisations to identify potential hazards and implement appropriate risk management measures.
Second, SDS documentation supports hazard communication throughout the supply chain. The standardised format of 16 sections established under the GHS framework allows workers, safety professionals, toxicologists, and regulatory specialists to locate relevant information efficiently.
Third, SDSs are an essential component of workplace chemical safety programmes. They support employee training, the development of safe operating procedures, the selection of appropriate personal protective equipment, and emergency preparedness.
However, regulatory compliance requires more than simply possessing an SDS.
The information contained in the document should be scientifically accurate, consistent with the available toxicological and physicochemical data, aligned with the applicable regulatory framework and specific to the substance or mixture being assessed.
What Information Is Included in a Safety Data Sheet?
Under Annex II to REACH, as amended by Commission Regulation (EU) 2020/878, a Safety Data Sheet follows a standardised 16-section structure.
These sections cover:
- Identification of the substance or mixture and of the company
- Hazard identification
- Composition and information on ingredients
- First aid measures
- Firefighting measures
- Accidental release measures
- Handling and storage
- Exposure controls and personal protection
- Physical and chemical properties
- Stability and reactivity
- Toxicological information
- Ecological information
- Disposal considerations
- Transport information
- Regulatory information
- Other information
The list above summarises the EU section topics; a compliant SDS must use the prescribed headings and subsections. Under the US HCS, all 16 section headings are required, but OSHA does not enforce the information requirements in Sections 12 to 15 because those areas fall outside its jurisdiction.
Nevertheless, the preparation of a scientifically robust SDS requires more than completing a standardised template.
The available physicochemical, toxicological and ecotoxicological data must be critically evaluated to determine the appropriate hazard classification, identify relevant exposure concerns and ensure consistency among the different sections of the document.
Who Is Responsible for Preparing and Updating Safety Data Sheets?
Responsibilities for preparing, providing and updating Safety Data Sheets depend on the applicable jurisdiction and the role of the organisation within the chemical supply chain.
Under the REACH Regulation, suppliers of substances and mixtures are responsible for providing Safety Data Sheets when the conditions established under Article 31 are met.
Under REACH, the SDS must be provided free of charge, on paper or electronically, no later than the date on which the substance or mixture is first supplied. It must be supplied in an official language of the Member State where the substance or mixture is placed on the market, unless that Member State provides otherwise.
Annex II requires preparation by a competent person. Suppliers must ensure that this person has received appropriate training, including refresher training. Toxicological expertise may form part of the necessary competence, but REACH does not prescribe an ERT qualification for every SDS author.
Under REACH Article 31(9), suppliers must update the SDS without delay when new information that may affect risk management measures or new information on hazards becomes available, when an authorisation has been granted or refused, or when a restriction has been imposed. The dated revision must be provided free of charge to all former recipients supplied within the preceding 12 months. Relevant changes must be identified in the revised document.
Under OSHA HCS, 29 CFR 1910.1200(g)(5), newly identified significant information about chemical hazards or protective measures must be added to the SDS within three months. If the chemical is not currently produced or imported, the information must be added before it is introduced into the workplace again.
For this reason, SDS management should be considered an ongoing regulatory process rather than a single administrative task.
How Should Safety Data Sheets Be Made Available in the Workplace?
Workers must be able to access relevant Safety Data Sheets when hazardous chemicals are present in the workplace.
Organisations may maintain SDS documentation in printed format, through electronic document management systems or using dedicated digital platforms.
Under OSHA HCS, required SDSs must be readily accessible during each work shift. Electronic access is permitted provided it creates no barrier to immediate employee access. Under REACH Article 35, workers and their representatives must be granted access to the relevant information supplied under Articles 31 and 32.
Organisations should consider appropriate contingency measures to ensure that technical failures, network interruptions or equipment malfunctions do not prevent workers from obtaining necessary information.
Equally important is ensuring that personnel understand how to locate, interpret and use SDS documentation.
Access alone is not sufficient. Workers should be adequately trained to identify relevant information and apply the recommended safety measures in their daily activities.
What Training Is Required for Employees Handling Hazardous Chemicals?
Training is a fundamental component of chemical safety management.
Under the OSHA Hazard Communication Standard, employers must provide effective information and training at initial assignment and whenever a new chemical hazard for which employees have not previously been trained is introduced into their work area.
Within the European regulatory framework, Directive 98/24/EC and its national implementing legislation address worker protection from chemical agents, including information and training. An SDS supplies information for the workplace risk assessment; it does not replace that assessment.
Effective training should address both the interpretation of Safety Data Sheets and the practical implementation of risk management measures.
Employees should understand the hazards associated with the chemicals they handle, potential exposure routes, required personal protective equipment, safe operating procedures and actions to be taken in emergency situations.
Organisations may integrate SDS related training into broader occupational safety and chemical risk management programmes.
How Can Organisations Maintain Compliance with SDS Requirements?
Maintaining compliance with Safety Data Sheet requirements requires a systematic approach.
Organisations should first identify the chemical substances and mixtures present at their facilities and establish an accurate chemical inventory.
Each relevant product should then be associated with an appropriate and up to date Safety Data Sheet.
Missing, incomplete or outdated documentation should be identified and addressed.
When revised SDS versions are received, organisations should evaluate whether the changes affect hazard classification, workplace exposure controls, personal protective equipment requirements or emergency procedures.
A centralised system for managing SDS documentation and monitoring regulatory updates can help organisations reduce compliance risks and improve the consistency of their chemical safety processes.
For companies manufacturing or placing chemical products on the market, particular attention should also be given to the scientific quality of the information included in the SDS.
Hazard classification and toxicological information should be based on a critical evaluation of the available data rather than the mechanical compilation of information from databases or supplier documentation.
Why Is Toxicological Expertise Important in SDS Preparation?
The preparation and review of Safety Data Sheets may require expert toxicological and regulatory judgement, particularly when the available data are incomplete, conflicting or difficult to interpret.
A toxicological assessment may be necessary to evaluate the relevance and reliability of available studies, interpret in vitro, in vivo and in silico data, assess read across information and determine whether the available evidence supports a specific hazard classification.
Expert judgement is also important for ensuring consistency between hazard classification, toxicological information, exposure controls and the overall risk management recommendations provided in the SDS.
This is particularly relevant for complex substances, mixtures, novel materials and products for which the available toxicological database may be limited.
How Can ToxHub Support SDS Preparation and Chemical Safety Compliance?
ToxHub provides scientific and regulatory support for the preparation, review and updating of Safety Data Sheets and for the assessment of chemical hazards.
Our regulatory toxicology expertise allows us to support companies in the critical evaluation of toxicological data, hazard classification, chemical risk assessment and the development of scientifically robust regulatory documentation.
Depending on the characteristics of the substance or mixture and the applicable regulatory framework, our activities may include the evaluation of available toxicological data, identification of data gaps, weight of evidence assessment, in silico analysis, read across evaluation and support for hazard classification according to the applicable regulatory requirements.
By combining regulatory knowledge with toxicological expertise, ToxHub helps organisations develop scientifically sound approaches that comply with applicable regulatory requirements to chemical safety.
Frequently Asked Questions About Safety Data Sheets
Who is responsible for preparing a Safety Data Sheet?
Under REACH, the supplier is responsible for providing a compliant SDS when Article 31 applies. The document must be prepared by a competent person with appropriate training and refresher training. Using an external specialist does not remove the supplier’s responsibility.
When should a Safety Data Sheet be updated?
The applicable jurisdiction determines the obligation. Under REACH, updates are required without delay in the circumstances specified in Article 31(9), with distribution to recipients supplied in the preceding 12 months. Under OSHA HCS, significant new hazard or protective information must be incorporated within three months, subject to the provision for chemicals not currently produced or imported.
Does every chemical product require a Safety Data Sheet?
No. The obligation depends on product status, hazards, composition, supply conditions and applicable exemptions. Some mixtures not classified as hazardous require an SDS on request. Where an SDS is not required, other duties to communicate safety information may still apply.
Can a Safety Data Sheet be prepared without analytical data?
New analytical testing is not automatically required solely to prepare an SDS. Adequate information on product identity and composition is needed, together with reliable available information on relevant properties and hazards. Depending on the endpoint and applicable rules, classification may use ingredient data, calculation methods, bridging principles or other justified evidence. Additional analyses or tests may be needed where existing information is insufficient or a specific regulatory requirement applies.
What information is needed to prepare a Safety Data Sheet?
Information on product composition, physicochemical properties, toxicological and ecotoxicological data, intended uses and applicable regulatory requirements is generally needed. The specific data requirements depend on the substance or mixture being assessed.
Why is toxicological expertise important when preparing an SDS?
Toxicological expertise helps ensure that available data are critically evaluated, data gaps are identified and hazard classifications are scientifically justified, particularly when information is limited, conflicting or requires a weight of evidence assessment.
Written by Chiara Gazerro