15.1. Safety, Health and Environmental Regulations/Legislation
Subsection 15.1 of a Safety Data Sheet provides information on the safety, health, and environmental regulations and legislation specific to the substance or mixture. This information is crucial for ensuring compliance with applicable regulatory requirements across different jurisdictions and for implementing appropriate risk management measures.
Purpose and Importance
This subsection serves several critical functions:
Regulatory Compliance
Identifies the specific regulations that apply to the substance or mixture, helping users ensure they meet all legal requirements for handling, storage, use, and disposal.
Risk Management
Provides information about regulatory restrictions, prohibitions, and authorization requirements that inform risk management decisions and practices.
Supply Chain Communication
Ensures that all parties in the supply chain are aware of the regulatory status of the substance or mixture, facilitating proper handling throughout its lifecycle.
Due Diligence
Demonstrates that the manufacturer or supplier has conducted the necessary regulatory assessments and is providing transparent information about compliance status.
Regulatory Complexity
Chemical regulations vary significantly between countries and regions, and they are constantly evolving. What is permitted in one jurisdiction may be restricted or prohibited in another. It is essential to ensure that the regulatory information provided in Section 15.1 is specific to the jurisdictions where the substance or mixture will be supplied and used.
Key Regulatory Frameworks
REACH Regulation (EC) No 1907/2006
The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation governs the manufacture, import, and use of chemicals in the EU.
- Registration status and numbers
- Authorization status (Annex XIV)
- Restriction status (Annex XVII)
- SVHC (Substances of Very High Concern) status
CLP Regulation (EC) No 1272/2008
The Classification, Labelling and Packaging (CLP) regulation ensures that hazards are clearly communicated to workers and consumers.
- Harmonized classification status
- Specific concentration limits
- M-factors for environmental hazards
- Special labeling requirements
Seveso III Directive 2012/18/EU
Aims to prevent major accidents involving dangerous substances and limit their consequences for human health and the environment.
- Named substance status
- Qualifying quantities
- Tier classification
Other EU Regulations
- Biocidal Products Regulation (BPR)
- Plant Protection Products Regulation (PPPR)
- RoHS Directive (Restriction of Hazardous Substances)
- POPs Regulation (Persistent Organic Pollutants)
- Industrial Emissions Directive (IED)
- Water Framework Directive
TSCA (Toxic Substances Control Act)
Regulates the introduction of new or existing chemicals in the United States.
- Inventory status
- Section 5 SNUR (Significant New Use Rule) status
- Section 6 restrictions
- Section 12(b) export notification requirements
OSHA (Occupational Safety and Health Administration)
Sets and enforces protective workplace safety and health standards.
- Hazard Communication Standard requirements
- Process Safety Management (PSM) applicability
- Permissible Exposure Limits (PELs)
EPA Regulations
- CERCLA (Superfund) reportable quantities
- SARA Title III (Emergency Planning and Community Right-to-Know Act)
- Clean Air Act (CAA) requirements
- Clean Water Act (CWA) requirements
State Regulations
- California Proposition 65
- Massachusetts Right to Know
- New Jersey Worker and Community Right to Know
- Pennsylvania Right to Know
- State-specific VOC regulations
China
- IECSC (Inventory of Existing Chemical Substances)
- Order No. 7 (New Chemical Substance Notification)
- China REACH (Measures for Environmental Management of New Chemical Substances)
- Catalog of Hazardous Chemicals
- China RoHS
Japan
- CSCL (Chemical Substances Control Law)
- ISHL (Industrial Safety and Health Law)
- PRTR (Pollutant Release and Transfer Register)
- Fire Service Act
Korea
- K-REACH (Act on Registration and Evaluation of Chemicals)
- KECI (Korea Existing Chemicals Inventory)
- CCA (Chemical Control Act)
- OSHA (Occupational Safety and Health Act)
Other Asia-Pacific
- Australia AICS (Australian Inventory of Chemical Substances)
- New Zealand NZIoC (New Zealand Inventory of Chemicals)
- Philippines PICCS (Philippine Inventory of Chemicals and Chemical Substances)
- Taiwan TCSI (Taiwan Chemical Substance Inventory)
- Vietnam National Chemical Inventory
Rotterdam Convention
Promotes shared responsibility in the international trade of certain hazardous chemicals and pesticides.
- Annex III listing status
- Prior Informed Consent (PIC) requirements
Stockholm Convention
Global treaty to protect human health and the environment from persistent organic pollutants (POPs).
- Annex A (Elimination) status
- Annex B (Restriction) status
- Annex C (Unintentional Production) status
Montreal Protocol
International treaty designed to protect the ozone layer by phasing out the production of substances responsible for ozone depletion.
- Ozone-depleting substance status
- Phase-out schedule applicability
Other Conventions
- Basel Convention (Transboundary Movements of Hazardous Wastes)
- Minamata Convention (Mercury)
- Chemical Weapons Convention
- International Maritime Dangerous Goods (IMDG) Code
National Regulations
In addition to major regulatory frameworks, many countries have specific national regulations that must be addressed in Section 15.1:
| Country | Key Regulations | Information Required |
|---|---|---|
| Germany | AwSV (Ordinance on Facilities Handling Substances Hazardous to Water) | Water hazard class (WGK 1, 2, or 3) |
| Switzerland | ChemO (Chemicals Ordinance) | Swiss poison class, VOCV status |
| Canada | DSL/NDSL, CEPA, WHMIS | Domestic Substances List status, WHMIS classification |
| United Kingdom | UK REACH, UK CLP | UK registration status, UK authorization status |
| Brazil | ANVISA, IBAMA | Chemical control regulations compliance |
| India | Manufacture, Storage and Import of Hazardous Chemical Rules | Schedule listing status |
| Russia | GOST, Technical Regulations | Russian inventory status |
Example of Section 15.1 Content for Acetone
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU Regulatory Information:
- REACH Registration Status: Registered (01-2119471330-49-XXXX)
- REACH Annex XIV (Authorization List): Not listed
- REACH Annex XVII (Restricted Substances): Not restricted
- CLP Regulation: Harmonized classification in Annex VI
- Seveso III Directive: P5c FLAMMABLE LIQUIDS
- EU VOC Directive 2010/75/EU: This product is a VOC according to Directive 2010/75/EU
US Regulatory Information:
- TSCA Inventory Status: Listed
- SARA 302 Extremely Hazardous Substances: Not listed
- SARA 311/312 Hazard Categories: Fire Hazard, Immediate (Acute) Health Hazard
- SARA 313 Toxic Release Inventory: Not listed
- California Proposition 65: Not listed
- OSHA Hazard Communication Standard: Hazardous
International Inventories:
- Australia AICS: Listed
- Canada DSL: Listed
- China IECSC: Listed
- Japan ENCS: Listed (2-542)
- Korea KECI: Listed (KE-29367)
- New Zealand NZIoC: Listed
- Philippines PICCS: Listed
- Taiwan TCSI: Listed
National Regulations:
- Germany Water Hazard Class (WGK): 1 (slightly hazardous to water)
- Switzerland: VOCV 100%
International Conventions:
- Montreal Protocol: Not listed
- Stockholm Convention: Not listed
- Rotterdam Convention: Not listed
Case Study: Regulatory Challenges for a Global Chemical Company
A multinational chemical company faced significant challenges when introducing a new solvent mixture to global markets:
- Challenge: The mixture contained a substance that was:
- Subject to authorization under EU REACH
- Listed on California Proposition 65
- Restricted for certain uses in China
- Subject to specific labeling requirements in Japan
- Impact: The company needed to create region-specific SDSs with accurate regulatory information for each market, and implement different risk management measures depending on the jurisdiction.
- Solution: The company:
- Developed a comprehensive regulatory tracking system
- Created market-specific SDS templates with appropriate Section 15.1 content
- Implemented an automated update system to ensure regulatory changes were promptly reflected in all SDSs
- Provided detailed guidance to customers on compliance requirements in different regions
- Outcome: Successfully maintained market access while ensuring regulatory compliance across all jurisdictions, demonstrating the critical importance of accurate and comprehensive information in Section 15.1.
Common Compliance Challenges
When preparing Section 15.1 of an SDS, be aware of these common challenges:
- Regulatory Complexity: Navigating the complex and sometimes overlapping regulatory requirements across different jurisdictions
- Keeping Current: Maintaining up-to-date information as regulations frequently change
- Substance Identity: Ensuring consistent substance identification across different regulatory frameworks
- Mixture Classification: Determining the regulatory status of mixtures based on component substances
- Confidential Business Information: Balancing regulatory disclosure requirements with the need to protect proprietary information
- Supply Chain Communication: Obtaining accurate regulatory information from suppliers and communicating it effectively to customers
Best Practices for Section 15.1
- Provide specific, accurate information rather than generic statements
- Include relevant registration numbers, where applicable (e.g., REACH registration number)
- Clearly indicate the regulatory status under major frameworks (REACH, TSCA, etc.)
- Specify any use restrictions, authorization requirements, or other regulatory controls
- Tailor the information to the specific jurisdiction where the SDS will be used
- Ensure consistency between regulatory information and hazard classification
- Regularly review and update regulatory information as regulations evolve
- Consult with regulatory experts when dealing with complex substances or mixtures
Important: The information provided in Section 15.1 must be specific to the substance or mixture and relevant to the jurisdiction where it is being supplied. Generic statements about regulations without specific information about the regulatory status of the substance or mixture do not meet regulatory requirements and may lead to compliance issues.