15.2. Chemical Safety Assessment
Subsection 15.2 of a Safety Data Sheet indicates whether a Chemical Safety Assessment (CSA) has been carried out for the substance or mixture. This information helps users understand the extent to which the safety of the substance has been evaluated and whether exposure scenarios are available to guide safe use throughout the lifecycle of the substance.
What is a Chemical Safety Assessment?
A Chemical Safety Assessment (CSA) is a systematic evaluation of the hazards, exposures, and risks associated with a substance throughout its lifecycle. It is a key component of the REACH regulation in the European Union but is also relevant in other regulatory frameworks globally.
Purpose
The CSA aims to:
- Identify and characterize the hazards of a substance
- Evaluate exposure scenarios for different uses
- Assess risks to human health and the environment
- Determine appropriate risk management measures
- Define conditions for safe use
When Required
Under REACH, a CSA is required for:
- Substances manufactured or imported in quantities of 10 tonnes or more per year per registrant
- Substances of very high concern (SVHCs) regardless of volume
- Substances subject to authorization or restriction
- Certain mixtures based on their hazard classification
Chemical Safety Assessment Process
Hazard Assessment
Evaluation of physicochemical, toxicological, and ecotoxicological properties
Exposure Assessment
Identification of exposure scenarios for all identified uses
Risk Characterization
Comparison of exposure levels with hazard thresholds
Risk Management
Definition of measures to ensure safe use
Hazard Assessment
- Physicochemical hazards: Flammability, explosivity, oxidizing potential
- Human health hazards: Acute toxicity, irritation, sensitization, repeated dose toxicity, mutagenicity, carcinogenicity, reproductive toxicity
- Environmental hazards: Aquatic toxicity, persistence, bioaccumulation, endocrine disruption
- PBT/vPvB assessment: Evaluation of persistent, bioaccumulative, and toxic properties
Exposure Assessment
- Exposure scenarios: Description of conditions of use and risk management measures
- Worker exposure: Inhalation, dermal, and oral routes
- Consumer exposure: Product use patterns and exposure routes
- Environmental exposure: Releases to air, water, soil, and waste
- Exposure estimation: Modeling or measurement-based approaches
Risk Characterization
- Risk characterization ratios (RCRs): Comparison of exposure to derived no-effect levels (DNELs) or predicted no-effect concentrations (PNECs)
- Safe use demonstration: RCR < 1 indicates controlled risk
- Qualitative assessment: For hazards without thresholds (e.g., carcinogens)
- Combined exposure assessment: Evaluation of aggregate exposures
Risk Management Measures
- Operational conditions: Duration, frequency, amount used
- Technical measures: Process containment, ventilation, filtration
- Organizational measures: Training, supervision, work procedures
- Personal protective equipment: Gloves, respirators, eye protection
- Environmental measures: Waste treatment, emission controls
Relationship to Other SDS Sections
The information in Section 15.2 should be consistent with other parts of the SDS, particularly:
- Section 7: Handling and storage conditions should align with exposure scenarios
- Section 8: Exposure controls should reflect the risk management measures identified in the CSA
- Section 9: Physicochemical properties used in the hazard assessment
- Sections 11 & 12: Toxicological and ecological information that forms the basis of the hazard assessment
- Section 13: Disposal considerations that reflect safe handling of waste
Chemical Safety Report (CSR)
The Chemical Safety Assessment is documented in a Chemical Safety Report (CSR), which includes:
Part A: Summary
- Declaration that risks are controlled
- Summary of risk management measures
- Statement on communication of information
Part B: Technical Assessment
- Hazard assessment for human health
- Hazard assessment for physicochemical properties
- Environmental hazard assessment
- PBT and vPvB assessment
- Exposure assessment
- Risk characterization
The CSR is submitted to regulatory authorities (e.g., ECHA for REACH registrations) but is not typically distributed with the SDS. However, relevant information from the CSR, particularly exposure scenarios, may be attached to the SDS as an annex.
Exposure Scenarios
Exposure scenarios are a key output of the Chemical Safety Assessment. They describe the conditions under which a substance can be safely used throughout its lifecycle.
Content of Exposure Scenarios
- Short title and description of uses covered
- Operational conditions (duration, frequency, amount)
- Risk management measures for workers
- Risk management measures for consumers
- Environmental risk management measures
- Waste management measures
Communication in the Supply Chain
- Extended Safety Data Sheet (eSDS) includes relevant exposure scenarios as an annex
- Downstream users must check if their use is covered
- If use is not covered, options include:
- Adapting conditions to match the exposure scenario
- Requesting the supplier to include the use
- Finding another supplier who covers the use
- Conducting their own CSA
Example of Section 15.2 Content
Example 1: CSA Completed
15.2 Chemical Safety Assessment
A Chemical Safety Assessment has been carried out for this substance. Relevant exposure scenarios are attached to this Safety Data Sheet as an Annex.
Example 2: CSA Not Required
15.2 Chemical Safety Assessment
A Chemical Safety Assessment has not been carried out for this substance/mixture as it is not required under the REACH Regulation for substances manufactured or imported at less than 10 tonnes per year.
Example 3: Mixture
15.2 Chemical Safety Assessment
Chemical Safety Assessments have been carried out for the following components of this mixture:
- Substance A (EC No. XXX-XXX-X): CSA completed
- Substance B (EC No. YYY-YYY-Y): CSA completed
Relevant exposure scenarios are available upon request.
Status Indicators for Chemical Safety Assessment
| Status | Description | Implications |
|---|---|---|
| Completed | A full CSA has been conducted and documented in a CSR | Exposure scenarios should be available; comprehensive risk management measures have been identified |
| Not Required | CSA not required due to low volume, exemption, or regulatory status | No exposure scenarios available; risk management based on general hazard information |
| In Progress | CSA is being conducted but not yet completed | Preliminary risk management measures may be available; full assessment pending |
| Not Applicable | Substance or mixture not subject to CSA requirements (e.g., not hazardous) | No specific risk management measures required beyond standard practices |
Case Study: Chemical Safety Assessment for a Solvent
A manufacturer of an industrial solvent conducted a Chemical Safety Assessment as part of their REACH registration:
- Substance: Industrial solvent with multiple uses in coatings, cleaners, and processing aids
- Hazard profile: Flammable liquid, skin irritant, specific target organ toxicity (single exposure), aquatic toxicity
- CSA process:
- Hazard assessment identified DNELs for workers and general population, and PNECs for environmental compartments
- Exposure assessment covered 12 different use scenarios across industrial, professional, and consumer settings
- Risk characterization identified several uses with potential risks (RCR > 1)
- Risk management measures were refined to ensure safe use for all scenarios
- Outcome:
- CSR documented all assessments and risk management measures
- Extended SDS included 8 exposure scenarios for downstream users
- Section 15.2 clearly indicated that a CSA had been completed
- Downstream users implemented the specified risk management measures
- Benefits: The comprehensive CSA process identified previously unrecognized risks in certain applications and led to improved safety measures throughout the supply chain.
Common Issues with Section 15.2
When preparing or reviewing Section 15.2 of an SDS, be aware of these common issues:
- Generic statements that don't clearly indicate whether a CSA has been carried out
- Failure to attach relevant exposure scenarios when a CSA has been completed
- Inconsistency between risk management measures in the exposure scenarios and those in Sections 7 and 8
- Outdated information that doesn't reflect the current status of the CSA
- Lack of clarity on which components of a mixture have undergone a CSA
- Failure to update Section 15.2 when regulatory requirements change
Best Practices for Section 15.2
- Clearly state whether a Chemical Safety Assessment has been carried out
- If a CSA has not been carried out, explain why (e.g., not required under applicable regulations)
- For mixtures, indicate which components have undergone a CSA
- Ensure consistency between the CSA status and the risk management measures in other sections
- Attach relevant exposure scenarios as an annex when a CSA has been completed
- Update Section 15.2 whenever the CSA status changes or is revised
- Provide contact information for requesting additional information about the CSA
Important: The Chemical Safety Assessment is a living document that requires periodic review and updates as new information becomes available or regulations change. Section 15.2 of the SDS should always reflect the current status of the CSA to ensure that users have accurate information about the safety evaluation of the substance or mixture.