22 Jul
Table of Contents
- Understanding the 21st ATP: What You Need to Know
- Key Changes and Substance Classifications
- Timeline and Implementation Requirements
- Industry-Specific Impacts
- Compliance Strategies for Businesses
- Documentation and SDS Updates
- Supply Chain Communication
- Enforcement and Penalties
- Preparing for Future ATPs
- Conclusion and Next Steps
Understanding the 21st ATP: What You Need to Know
The Commission Delegated Regulation (EU) 2024/197, officially known as the 21st Adaptation to Technical Progress (ATP) to the CLP Regulation, represents a significant milestone in European chemical safety regulation. Published on January 5, 2024, and taking effect on September 1, 2025, this regulation introduces harmonized classification and labeling requirements for numerous chemical substances across various industrial sectors.
What is an ATP?
An Adaptation to Technical Progress (ATP) is a regulatory mechanism that updates the harmonized list of chemical classifications and labeling requirements under the EU’s Classification, Labeling and Packaging (CLP) Regulation (EC) No 1272/2008. These updates ensure that chemical hazard information remains current with the latest scientific evidence and risk assessment data.The 21st ATP is particularly comprehensive, incorporating opinions from the European Chemicals Agency’s Risk Assessment Committee (RAC) adopted between March 2021 and November 2021, covering a diverse range of substances from industrial chemicals to pesticides and specialty compounds.
Legal Foundation and Authority
This regulation operates under Article 37(5) of Regulation (EC) No 1272/2008, giving the European Commission the authority to update harmonized classifications based on scientific evidence. The classifications become legally binding across all EU Member States, ensuring consistent hazard communication and risk management practices throughout the European market.
Key Changes and Substance Classifications
Major Substance Categories Affected
The 21st ATP introduces or updates harmonized classifications for over 40 chemical substances, spanning multiple industrial sectors:
1. Agricultural Chemicals and Pesticides
- Clothianidin (ISO): Classified as Reproductive Toxicity Category 2 (H361f), Acute Toxicity Category 4 (H302), and STOT SE 1 (H370 – nervous system)
- Cymoxanil (ISO): New classification includes Reproductive Toxicity Category 2 (H361fd) and Skin Sensitization Category 1
- Benalaxyl (ISO): Updated with Acute Toxicity Category 4 and enhanced aquatic toxicity classifications
2. Industrial Chemicals and Solvents
- Benzyl Alcohol: Receives new harmonized classification affecting its use in cosmetics and pharmaceutical applications
- Resorcinol: Updated classification impacts its use in rubber and adhesive industries
- Various Acrylates and Methacrylates: Enhanced skin sensitization and reproductive toxicity classifications
3. Flame Retardants and Specialty Chemicals
- Tetrabromobisphenol-A: Strengthened environmental and health hazard classifications
- Lithium Compounds: New harmonized approach for lithium carbonate, chloride, and hydroxide
4. Reaction Masses and Complex Substances
Multiple reaction masses involving epoxy compounds, phosphonium salts, and other complex chemical mixtures receive specific harmonized classifications.
Classification Categories Introduced
The regulation establishes classifications across multiple hazard classes:
- Reproductive Toxicity (Categories 1A, 1B, 2)
- Carcinogenicity (Categories 1A, 1B, 2)
- Mutagenicity (Categories 1A, 1B, 2)
- Acute Toxicity (Categories 1-4 for oral, dermal, and inhalation routes)
- Skin and Respiratory Sensitization (Categories 1, 1A, 1B)
- Specific Target Organ Toxicity (Single and repeated exposure)
- Environmental Hazards (Aquatic acute and chronic toxicity)
Timeline and Implementation Requirements
Critical Dates
- January 5, 2024: Official publication in the Official Journal
- January 25, 2024: Entry into force (20 days after publication)
- September 1, 2025: Mandatory application date
- Ongoing: Voluntary early implementation permitted
Transition Provisions
The regulation provides flexibility during the transition period:Early Implementation Option: Companies may choose to implement the new classifications immediately after entry into force, providing competitive advantages in terms of regulatory compliance and market positioning.Mandatory Compliance: All substances and mixtures placed on the market after September 1, 2025, must comply with the new harmonized classifications without exception.No Grandfathering: Unlike some regulatory updates, there are no provisions for continued use of old classifications beyond the application date.
Industry-Specific Impacts
Chemical Manufacturing and Distribution
Primary Obligations:
- Update all product documentation and labeling
- Revise Safety Data Sheets to reflect new classifications
- Implement enhanced risk management measures where required
- Update internal hazard assessment procedures
Cost Implications:
- Documentation revision costs
- Potential reformulation requirements for affected products
- Enhanced safety equipment and procedures
- Staff training and competency development
Downstream Industries
Cosmetics and Personal Care
Several substances commonly used in cosmetics receive updated classifications, particularly regarding skin sensitization and reproductive toxicity. Companies must:
- Review product formulations
- Update consumer safety assessments
- Revise product information files
- Consider alternative ingredients where appropriate
Agriculture and Crop Protection
The pesticide and biocide classifications significantly impact:
- Product registration requirements
- Application restrictions and guidelines
- Worker protection standards
- Environmental risk assessments
Electronics and Technology
Flame retardants and specialty chemicals used in electronics manufacturing face enhanced restrictions:
- Material selection criteria updates
- Supply chain qualification requirements
- Product safety documentation
- End-of-life disposal considerations
Construction and Building Materials
Industrial chemicals used in construction applications require:
- Updated technical data sheets
- Revised application guidelines
- Enhanced worker protection measures
- Modified storage and handling procedures
Compliance Strategies for Businesses
Immediate Actions (January 2025 – March 2025)
1. Substance Inventory and Impact Assessment
- Conduct comprehensive review of all chemical substances in use
- Identify products containing substances listed in the 21st ATP
- Assess the impact of new classifications on current operations
- Prioritize substances based on volume, criticality, and regulatory impact
2. Gap Analysis
- Compare current classifications with new requirements
- Identify documentation requiring updates
- Assess training needs for staff and customers
- Evaluate supply chain communication requirements
3. Project Planning and Resource Allocation
- Establish dedicated compliance project teams
- Allocate budget for documentation updates and system changes
- Set internal milestones leading to the September 2025 deadline
- Engage external consultants where specialized expertise is needed
Medium-term Implementation (April 2025 – August 2025)
4. Documentation Updates
- Revise Safety Data Sheets according to new classifications
- Update product labels and packaging
- Modify technical data sheets and product information
- Review and update risk assessments
5. System and Process Updates
- Update enterprise resource planning (ERP) systems
- Modify inventory management classifications
- Revise quality control procedures
- Update regulatory compliance tracking systems
6. Training and Communication
- Develop training materials for internal staff
- Conduct workshops for sales and technical teams
- Prepare customer communication materials
- Update supplier qualification requirements
Final Preparation (September 2025)
7. Compliance Verification
- Conduct final compliance audits
- Verify all documentation updates are complete
- Test updated systems and processes
- Prepare for regulatory inspections
Documentation and SDS Updates
Safety Data Sheet Requirements
The new classifications necessitate comprehensive SDS updates across multiple sections:
Section 2: Hazards Identification
- Update GHS pictograms according to new classifications
- Revise signal words (Danger/Warning)
- Include new hazard statements (H-phrases)
- Update precautionary statements (P-phrases)
- Add or modify supplemental hazard information
Section 3: Composition/Information on Ingredients
- Update concentration limits for classified substances
- Include specific concentration limits (SCLs) where applicable
- Add M-factors for environmentally hazardous substances
- Update acute toxicity estimates (ATEs)
Section 8: Exposure Controls/Personal Protection
- Revise occupational exposure limits where updated
- Update personal protective equipment recommendations
- Modify engineering control requirements
- Include additional exposure scenarios if needed
Section 11: Toxicological Information
- Update toxicological data to reflect new classifications
- Include route-specific acute toxicity estimates
- Add information on specific target organs
- Update reproductive and developmental toxicity information
Section 12: Ecological Information
- Include updated environmental hazard information
- Add M-factors for aquatic toxicity calculations
- Update bioaccumulation and biodegradation data
- Revise environmental fate information
Labeling Requirements
Product labels must be updated to include:
- Correct GHS pictograms for new classifications
- Updated signal words
- All applicable hazard statements
- Appropriate precautionary statements
- Supplier identification information
- Product identifiers consistent with SDS
Quality Assurance Measures
Implement robust quality control processes:
- Multi-level review procedures for updated documents
- Cross-reference verification between SDSs and labels
- Regular compliance audits and updates
- Version control and change management systems
Supply Chain Communication
Upstream Communication (Suppliers)
Information Gathering
- Request updated substance information from suppliers
- Verify compliance with new classifications
- Obtain updated certificates of analysis
- Confirm regulatory compliance status
Supplier Qualification
- Update supplier qualification criteria
- Include ATP compliance in supplier audits
- Establish ongoing compliance monitoring
- Implement corrective action procedures for non-compliance
Downstream Communication (Customers)
Proactive Notification
- Develop customer notification letters explaining changes
- Provide updated SDSs and technical documentation
- Offer technical support for transition planning
- Establish dedicated customer support channels
Training and Support
- Conduct webinars explaining regulatory changes
- Provide technical training on updated classifications
- Offer consultation services for customer compliance
- Develop FAQ documents addressing common concerns
Documentation and Record Keeping
Maintain comprehensive records of:
- All supplier communications and responses
- Customer notifications and acknowledgments
- Updated documentation distribution
- Training completion records
- Compliance verification activities
Enforcement and Penalties
Regulatory Authority Structure
European Level:
- European Chemicals Agency (ECHA) provides guidance and coordination
- European Commission monitors overall implementation
- Cross-border enforcement coordination through ECHA
National Level:
- Member State competent authorities conduct inspections
- National enforcement agencies impose penalties
- Local authorities may have specific enforcement roles
Potential Penalties and Consequences
Administrative Penalties
- Fines for non-compliance with classification requirements
- Product withdrawal orders for incorrectly classified substances
- Suspension of marketing authorizations
- Mandatory corrective action requirements
Criminal Penalties
- Serious violations may result in criminal charges
- Personal liability for responsible persons
- Corporate criminal liability in some jurisdictions
- Potential imprisonment for willful violations
Civil Consequences
- Product liability claims for inadequate hazard communication
- Insurance coverage issues for non-compliant operations
- Contractual breaches with customers and suppliers
- Reputational damage and market access restrictions
Compliance Monitoring
Authorities employ various monitoring mechanisms:
- Routine inspections of manufacturing facilities
- Market surveillance of chemical products
- Document reviews and audit procedures
- Whistleblower reporting systems
- Cross-border information sharing
Preparing for Future ATPs {#future-preparation}
Anticipated Developments
22nd and 23rd ATPs
The regulatory pipeline includes additional ATPs already in development:
- 22nd ATP focusing on additional pesticide active substances
- 23rd ATP addressing emerging contaminants and industrial chemicals
- Ongoing RAC opinions will feed into future regulations
CLP Regulation Revision
The European Commission is considering comprehensive CLP Regulation updates:
- Enhanced classification criteria for endocrine disruptors
- New hazard classes for environmental persistence
- Improved digital labeling and communication methods
- Strengthened enforcement mechanisms
Building Regulatory Intelligence Capabilities
Monitoring Systems
- Establish ECHA consultation monitoring
- Track RAC opinion development
- Monitor scientific literature for emerging hazards
- Participate in industry working groups
Proactive Compliance Planning
- Develop early warning systems for regulatory changes
- Create flexible documentation systems for easy updates
- Establish relationships with regulatory consultants
- Build internal regulatory expertise
Technology and Innovation
- Invest in digital compliance management systems
- Develop automated classification assessment tools
- Implement predictive compliance analytics
- Create integrated supply chain communication platforms
Conclusion and Next Steps {#conclusion}
The 21st ATP represents a significant evolution in European chemical safety regulation, requiring comprehensive compliance efforts across multiple industries. Success in implementation depends on early preparation, systematic approach, and ongoing commitment to regulatory excellence.
Immediate Action Items
- Conduct Impact Assessment: Complete by March 2025
- Develop Implementation Plan: Finalize by April 2025
- Begin Documentation Updates: Start immediately
- Engage Stakeholders: Initiate supplier and customer communications
- Allocate Resources: Secure necessary budget and personnel
Long-term Success Factors
- Continuous Monitoring: Stay informed about regulatory developments
- System Integration: Build compliance into business processes
- Stakeholder Engagement: Maintain strong supplier and customer relationships
- Innovation Investment: Leverage technology for compliance efficiency
- Expertise Development: Build internal regulatory capabilities
The September 1, 2025 deadline approaches rapidly, but with proper planning and execution, organizations can not only achieve compliance but also gain competitive advantages through superior regulatory management and stakeholder communication.Companies that view the 21st ATP as an opportunity to strengthen their regulatory compliance programs, enhance customer relationships, and improve operational efficiency will be best positioned for success in the evolving European chemical regulatory landscape.For ongoing updates and detailed guidance on specific substances, consult the official EU regulation and engage with qualified regulatory professionals to ensure comprehensive compliance with all requirements.
This blog post provides general information about Commission Delegated Regulation (EU) 2024/197 and should not be considered as legal advice. Companies should consult with qualified regulatory professionals for specific compliance guidance. For additional questions you can always write us on info@bens-consulting.com and get into contact with our chemical compliance experts.
