Introduction

Dibutyltin dilaurate (DBTDL), as an efficient catalyst and stabilizer, has been widely used in many industrial fields. However, its potential health and environmental risks have also attracted the attention of global regulators. This article will discuss the compliance requirements and standards of DBTDL worldwide to help companies and practitioners understand and comply with relevant regulations and ensure the legality and safety of its production and use.

1. International regulations and standards

1. United Nations Model Regulations for the Transport of Dangerous Goods (UN Model Regulations)

   • Classification: DBTDL is classified as a hazardous chemical and is classified based on its physical and chemical properties and toxicity.
   • Labeling and packaging: Hazard signs and safety information must be marked on the packaging to ensure safety during transportation.
   • Transportation conditions: Specific conditions must be observed during transportation, such as ventilation, isolation, etc., to prevent leaks and accidents.

2. Globally Harmonized System of Classification and Labeling of Chemicals (GHS)

   • Classification: DBTDL is classified into specific categories based on its physical and chemical properties and toxicity, such as skin corrosion/irritation, severe eye damage/eye irritation, etc.
   • Labels and Safety Data Sheets (SDS): Labels and safety data sheets that comply with GHS requirements must be provided, including hazard identification, preventive measures, emergency response and other information.
   • Training: Enterprises and practitioners need to receive GHS training to ensure correct understanding and use of relevant information.

2. European regulations and standards

1. EU Regulation, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)

   • Registration: Manufacturers and importers are required to register DBTDL with the European Chemicals Agency (ECHA) and provide detailed chemical properties, toxicological and ecotoxicological data.
   • Assessment: ECHA will assess registered chemicals to determine their potential risks and management measures.
   • Permission: For high-risk chemicals, permission is required before use.
   • Restrictions: DBTDL may be restricted for certain specific uses, such as use in food contact materials.

2. EU Classification, Labeling and Packaging Regulation (CLP)

   • Classification: DBTDL needs to be classified according to CLP regulations to determine its hazard category and hazard label.
   • Labeling: The packaging must be marked with hazard labels and safety information that comply with CLP requirements.
   • Packaging: Packaging materials and containers must comply with the requirements of CLP regulations to ensure safe transportation and storage.

3. EU Biocides Regulation (BPR)

   • Registration: If DBTDL is used as a biocide, it needs to be registered with ECHA and provide corresponding safety and efficacy data.
   • Assessment: ECHA will assess registered biocides to determine their potential risks and management measures.
   • Authorization: Only authorized biocides can be sold and used on the EU market.

3. U.S. regulations and standards

1. US Occupational Safety and Health Administration (OSHA)

   • Occupational Exposure Limits: OSHA has established occupational exposure limits (Permissible Exposure Limits, PEL) for DBTDL, which stipulates the concentrations allowed in the workplace.
   • Personal protective equipment: OSHA requires companies to provide standard-compliant personal protective equipment in the workplace, such as respirators, protective clothing, etc.
   • Training: Enterprises need to conduct safety training for employees to ensure that they understand the hazards and protective measures of DBTDL.

2. U.S. Environmental Protection Agency (EPA)

   • Toxic Substances Control Act (TSCA): DBTDL requires registration with the EPA and detailed chemical properties, toxicology and ecotoxicology data.
   • Risk Assessment: EPA will conduct a risk assessment of registered chemicals to determine their potential risks and management measures.
   • Use Restrictions: DBTDL may be restricted for certain uses, such as use in drinking water treatment.

3. U.S. Food and Drug Administration (FDA)

   • Food contact materials: If DBTDL is used in food contact materials, it must comply with relevant FDA regulations to ensure that it does not pose a threat to food safety.
   • Labels: Labels for food contact materials must comply with FDA requirements and provide necessary safety information.

4. Asian regulations and standards

1. China

   • Regulations on the Safety Management of Hazardous Chemicals: DBTDL needs to be registered in China and provide detailed chemical properties, toxicology and ecotoxicology data.
   • Occupational Health Standards: China has formulated DBTDL occupational health standardsExposure limits, which specify the concentrations allowed in the workplace.
   • Labels and Safety Data Sheets: Packaging must be marked with hazard labels and safety information that comply with Chinese standards.
   • Environmental Protection Law: The production and use of DBTDL must comply with China’s environmental protection regulations to reduce the impact on the environment.

2. Japan

   • Chemical Substances Review and Manufacturing Regulation Law (CSCL): DBTDL requires registration in Japan and detailed chemical properties, toxicology and ecotoxicology data.
   • Occupational Safety and Health Law: Japan has established occupational exposure limits for DBTDL, stipulating the concentration allowed in the workplace.
   • Labels and Safety Data Sheets: Packaging must be marked with hazard labels and safety information that comply with Japanese standards.

3. South Korea

   • Chemical Substances Management Act (K-REACH): DBTDL requires registration in South Korea and providing detailed chemical properties, toxicology and ecotoxicology data.
   • Occupational Safety and Health Law: South Korea has established occupational exposure limits for DBTDL, stipulating the concentration allowed in the workplace.
   • Labels and Safety Data Sheets: Packaging must be marked with hazard labels and safety information that comply with Korean standards.

5. Summary of compliance requirements and standards

1. Registration and Declaration

   • International: Classification, labeling and packaging in accordance with the requirements of the United Nations Model Regulations for the Transport of Dangerous Goods and GHS.
   • Europe: Register with ECHA and comply with REACH, CLP and BPR regulations.
   • United States: Registered with EPA and OSHA, complies with TSCA and PEL standards.
   • Asia: Registered in China, Japan and South Korea to comply with their respective chemical management and occupational safety and health regulations.

2. Occupational Safety and Health

   • Occupational exposure limits: Countries have established occupational exposure limits for DBTDL, and companies need to ensure that the concentration in the workplace does not exceed the limit.
   • Personal protective equipment: Provide personal protective equipment that meets standards, such as respirators, protective clothing, etc.
   • Training: Provide safety training to employees to ensure they understand the hazards and protective measures of DBTDL.

3. Environmental Impact

   • Environmental protection: Reduce the emission of DBTDL and prevent it from causing pollution to the environment.
   • Bioaccumulation: Monitor the accumulation of DBTDL in the environment to prevent biomagnification effects.

4. Labels and Safety Data Sheets

   • Labeling: The packaging must be marked with hazard signs and safety information that comply with national standards.
   • Safety Data Sheet: Provides detailed chemical properties, toxicological and ecotoxicological data, and emergency measures.

6. Suggestions and prospects

1. Strengthen regulatory awareness: Enterprises should strengthen their learning and understanding of global regulations and standards to ensure that their production and use comply with relevant requirements.
2. Compliance Management: Establish a sound compliance management system to ensure that every link complies with regulatory requirements.
3. Technology R&D: Increase investment in R&D, develop more efficient and environmentally friendly alternatives, and reduce dependence on DBTDL.
4. International Cooperation: Strengthen cooperation with international organizations and enterprises, share technology and experience, and improve the level of global chemicals management.

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