Section 15: Regulatory Information
Section 15 of a Safety Data Sheet (SDS) provides crucial information about the regulatory status of a substance or mixture. This section helps users understand the applicable regulations, restrictions, and compliance requirements across different jurisdictions. Proper regulatory information is essential for legal compliance and safe handling of chemicals.
Purpose of Section 15
Section 15 of an SDS serves multiple important purposes:
Legal Compliance
Identifies the specific regulations that apply to the substance or mixture, helping users ensure they are in compliance with all relevant laws.
Risk Management
Provides information about restrictions, authorizations, and other regulatory controls that may affect how the substance can be used, stored, or disposed of.
Supply Chain Communication
Communicates important regulatory information throughout the supply chain, ensuring all handlers are aware of legal requirements.
International Trade
Helps facilitate international trade by clarifying the regulatory status of substances in different regions and countries.
Structure of Section 15
Section 15 of an SDS is typically divided into two main subsections:
This subsection covers specific regulations and legislation applicable to the substance or mixture, including:
- Chemical inventory status (REACH, TSCA, etc.)
- Classification and labeling requirements
- Restrictions on manufacture, placing on the market, and use
- Authorization requirements
- Specific regulations for protection of human health and environment
This subsection indicates whether a Chemical Safety Assessment (CSA) has been carried out for the substance or mixture, including:
- Status of the chemical safety assessment
- Information about exposure scenarios
- Risk management measures
- Safety thresholds and assessment conclusions
Regional Variations
Regulatory requirements vary significantly between different countries and regions. An SDS must address the specific regulations applicable in the jurisdiction where the product is being supplied. This often means that different versions of an SDS may be needed for different markets.
Key Regulatory Frameworks
European Union
- REACH (Registration, Evaluation, Authorization and Restriction of Chemicals)
- CLP (Classification, Labelling and Packaging) Regulation
- Seveso III Directive (major accident hazards)
- BPR (Biocidal Products Regulation)
- RoHS (Restriction of Hazardous Substances)
- POPs (Persistent Organic Pollutants) Regulation
- Industrial Emissions Directive
United States
- TSCA (Toxic Substances Control Act)
- OSHA Hazard Communication Standard
- CERCLA (Comprehensive Environmental Response, Compensation, and Liability Act)
- SARA Title III (Emergency Planning and Community Right-to-Know Act)
- Clean Air Act
- Clean Water Act
- California Proposition 65
Asia-Pacific
- China IECSC (Inventory of Existing Chemical Substances)
- Japan CSCL (Chemical Substances Control Law)
- Korea KECI (Korea Existing Chemicals Inventory)
- Australia AICS (Australian Inventory of Chemical Substances)
- Philippines PICCS (Philippine Inventory of Chemicals and Chemical Substances)
- Taiwan TCSI (Taiwan Chemical Substance Inventory)
International Conventions
- Rotterdam Convention (Prior Informed Consent)
- Stockholm Convention (Persistent Organic Pollutants)
- Montreal Protocol (Ozone Depleting Substances)
- Basel Convention (Transboundary Movements of Hazardous Wastes)
- Minamata Convention (Mercury)
- GHS (Globally Harmonized System)
Example of Section 15 Content for a Hypothetical Chemical
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU Regulatory Information:
- REACH Registration Status: Registered (01-2119456816-28-XXXX)
- REACH Annex XIV (Authorization List): Not listed
- REACH Annex XVII (Restricted Substances): Not restricted
- Seveso III Directive: Category P5a - FLAMMABLE LIQUIDS
- EU Water Framework Directive: Listed as priority substance
US Regulatory Information:
- TSCA Inventory Status: Listed
- SARA 302 Extremely Hazardous Substances: Not listed
- SARA 311/312 Hazard Categories: Fire Hazard, Acute Health Hazard
- SARA 313 Toxic Release Inventory: Listed
- California Proposition 65: Warning required
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.
Specific Requirements by Substance Type
| Substance Type | Special Regulatory Considerations | Examples |
|---|---|---|
| Persistent, Bioaccumulative and Toxic (PBT) substances | Subject to authorization under REACH; restrictions on use; special risk management measures | Certain brominated flame retardants, some phthalates |
| Carcinogens, Mutagens, Reproductive Toxicants (CMRs) | Strict authorization requirements; workplace restrictions; consumer product limitations | Benzene, formaldehyde, lead compounds |
| Endocrine Disruptors | Increasing regulatory focus; potential for future restrictions; substitution requirements | Bisphenol A, certain phthalates, some pesticides |
| Nanomaterials | Special registration requirements; specific risk assessments; additional safety data | Nano-silver, carbon nanotubes, nano-titanium dioxide |
| Ozone-Depleting Substances | Phase-out schedules; strict use restrictions; reporting requirements | CFCs, HCFCs, halons |
Case Study: Regulatory Compliance Challenges
A global chemical manufacturer faced significant challenges when a substance they produced was added to the REACH Candidate List of Substances of Very High Concern (SVHC):
- Challenge: The substance was used in products exported to over 30 countries, each with different regulatory requirements.
- Impact: Immediate notification requirements to customers, potential authorization requirements, market perception issues.
- Solution: The company:
- Updated all SDSs to reflect the new regulatory status
- Developed region-specific regulatory compliance documentation
- Initiated a substitution program to develop alternatives
- Implemented enhanced supply chain communication
- Outcome: Successfully maintained market access while transitioning to alternative substances, demonstrating the critical importance of accurate and up-to-date regulatory information in Section 15 of the SDS.
Common Compliance Pitfalls
When preparing Section 15 of an SDS, be aware of these common mistakes:
- Providing generic regulatory information not specific to the substance
- Failing to update regulatory status when regulations change
- Omitting important regional regulations for target markets
- Not including registration numbers or other required identifiers
- Overlooking substance-specific restrictions or authorization requirements
- Providing contradictory information across different sections of the SDS
Best Practices for Section 15
- Regularly review and update regulatory information as regulations evolve
- Ensure consistency between regulatory information and hazard classification
- Provide specific registration numbers, where applicable
- Include information on any use restrictions or authorization requirements
- Tailor regulatory information to the specific jurisdiction where the SDS will be used
- Consult with regulatory experts when dealing with complex substances or mixtures
- Maintain documentation of regulatory determinations and decisions
Important: Regulatory information must be kept up-to-date. Chemical regulations are constantly evolving, and it is the responsibility of the SDS author to ensure that Section 15 reflects the current regulatory status of the substance or mixture. Regular reviews and updates are essential for compliance.