1 Overview of the EU REACH Regulation
1.1 EU Chemicals Policy
1.1.1 Main Problems of the Existing EU Chemicals Policy
1.1.2 Political Objectives of the New Chemicals Regulation
1.1.3 Main Elements of the New Chemicals Regulation
1.2 Relevance of Chemical Risk Assessment Knowledge
1.2.1 Intrinsic properties
1.2.2 Development and validation of chemical detection and assessment methods
1.2.3 Exposure and use
1.2.4 Costs and benefits
1.3 The new EU chemicals regulation - REACH System
1.3.1 Registration
1.3.2 Evaluation
1.3.3 Licensing of Chemicals of Very High Concern
1.3.4 Rapid Risk Management of Other Substances
1.4 Roles, Rights and Responsibilities of Businesses
1.4.1 Access to Data
1.4.2 Hazardous/ Safety Assessment
1.4.3 Information to be provided by the enterprise to the competent authority
1.4.4 Transmission of information on chemical safety
1.4.5 Property rights to test data
1.5 Other issues related to REACH
1.5.1 REACH implementation schedule
1.5.2 Classification and Labeling
1.5.3 System Management of REACH
1.6 Costs and Benefits of REACH Policy
1.6.1 Models and Scope of REACH
1.6.2 Costs of REACH
2 Key Elements of the REACH Regulation in Detail
2.1 Registration
2.1.1 Scope of Substances Exempt from Registration
2.1.2 Scope of Registration Required
2.1.3 Information Requirements for Registered Chemicals
2.1.4 Technical Documents Required for Registration
2.2 Chemical Safety Assessment and Chemical Safety Reporting
2.2.1 Chemical Safety Assessment
2.2 .2 Chemical Safety Reporting
2.3 Assessment
2.3.1 File Assessment
2.3.2 Substance Assessment
2.3.3 Process of Adoption of Assessment Resolutions
2.3.4 Cost Sharing of Tests
2.4 Licensing
2.4.1 Scope of Substances to be Licensed
2.4.2 Procedure for Inclusion of Substances in the License List
2.4.3 Application for License
2.4.4 Granting of License
2.5 Restrictions on the Manufacture, Marketing, and Use of Certain Hazardous Substances and Preparations
2.5.1 General Provisions
2.5.2 Introduction of New Restrictions and Modification of Existing Restrictions
2.6 Other Elements of REACH
2.6.1 Data ***sharing and Avoidance of Unnecessary Testing
2.6.2 Information for the Supply Chain
2.6.3 Obligations of Downstream Users
2.6.4 The European Chemicals Agency (ECHA)
2.7 Introduction to REACH Guidance Documents
2.7.1 RIPl REACH Procedure Description
2.7.2 RIP2 REACH-IT Tools
2.7.3 RIP3 Guidelines for Enterprises
2.7.4 RIP4 Guidelines for Regulatory Authorities
2.7.5 RIP5, RIP6, and RIP7 Guidelines
3 Tools for chemical assessment under REACH in the EU
3.1 Overview
3.2 New tools under REACH
3.2.1 Safe Manufacturing and Use: Chemical Safety Assessment (CSA)
3.2.2 Exposure Statements
3.2.3 Chemical Safety Reports (CSR): information provided to the Competent Authorities
3.2.4 Extended Safety Data Sheet (SDS): information provided to downstream users
3.3 New Methodologies Advocated by REACH
3.3.1 Risk Assessment: New Ideas and General Developments
3.3.2 Alternative Methodologies: Life Cycle Assessments
3.3.3 Alternatives to Animal testing
3.3.4 Harmonization of REACH with international regulations
3.4 Conclusions
References
4 Non-testing methods advocated by REACH
4.1 General information
4.1.1 Background
4.1.2 Non-testing methods for obtaining experimental data
4.1.2 Non-testing methods for obtaining experimental data
4.1.2 Non-testing methods for obtaining experimental data
4.1.2 Non-testing methods for obtaining experimental data
4.1.3 Important Concepts Related to Several Non-Test Methods
4.1.4 Validation of Non-Test Methods
4.1.5 Inter-substance versus Cluster/Analogical Methods
4.2 Current State of the Art in the Application of Non-Test Methods
4.2.1 SARs/QSARs
4.2.2 Chemical Classification Methods
4.2.3 Analogical/Comparative Derivation
4.2.4 Application of Non-Test Methods in the Regulation
4.3 Improvements in Progress
4.3.1 SARs and QSARs
4.3.2 Chemical Classification Methods
4.3.3 Taxonomic/Comparative Derivation
4.4 Additional Information Needs Required by REACH
4.4.1 SARs and QSARs
4.4.2 Chemical Classification
4.4.3 Analogies/Comparison Derivation
References
5 Requirements for Substance Information under REACH
5.1 Available Data
5.1.1 Information Sources
5.1.2 REACI-I Recommended Data Sources
5.2 Progress in Research on Inherent Properties of Chemicals and Exposure Information
5.2.1 Exposure
5.2.2 Physical and Chemical Data
5.2.3 Testing Methods
5.2.4 Adoption of REACH Based Non Adoption of Test Methods
5.3 Provisions Related to Information on Substances Used in REACH
5.3.1 Guidance on Standards
5.3.2 Use of Existing Human Data
5.3.3 Use of In Vitro Experimental Data
5.3.4 Use of Results from Non-GLP and Non-Regulated Studies
5.3.5 Future REACH-Based Non 5.3.5 Future REACH Information Requirements
5.3.6 Utility Considerations
5.3.7 Further Information Requirements Necessary for REACH
References
6 Typical Examples
6.1 Potentially Releasable Substances in Permanent Markers
6.1.1 Description
6.1.2 Substance Identification
6.1.3 Confirmation of Existing Registrations
6.1.4 Registration Decision Making Process
6.2 Notifiable Substances in Clothing
6.2.1 Description
6.2.2 Substance Identification
6.2.3 Registration Decision Making Process
6.3 Polycyclic Aromatic Hydrocarbons (PAHs) in Automotive Tires Polycyclic Aromatic Hydrocarbons (PAHs)
6.3.1 Description
6.3.2 Substance Identification
6.3.3 Information on Substance Concentration
6.3.4 Decision-making Process for the Existence of a Liability
6.4 Bis (2-Ethylhexyl) Phthalate (DEHP) in Bathroom Mats
6.4.1 Description
6.4.2 Substance Identification
6.4.3 Registration Decision Process
6.5 Two Exposure Cases
6.5.1 Textile Dye Exposure
6.5.2 Paint Exposure
7 Typical Questions and Answers on REACH
7.1 Reasons for the Introduction of REACH in the EU
7.1.1 Main problems with existing European chemicals management legislation
7.1.2 Overall objectives of the new chemicals policy
7.2 The REACH framework
7.2.1 Scope
7.2.2 Registration
7.2.3 Data ****sharing
7.2.4 Information exchange in the supply chain
7.2.4 Supply chain Information Exchange
7.2.5 Downstream Users
7.2.6 Assessment
7.2.7 Licensing
7.2.8 Restrictions
7.2.9 European Chemicals Agency (ECHA)
7.2.10 Classification and Labeling Inventory
7.2.11 Information Access
7.3 Benefits and Costs of REACH
7.3.1 Benefits
7.3.2 Costs
7.4 The Precautionary Principle in relation to REACH
7.4.1 Does the REACH regulation directly set out the precautionary principle?
7.4.2 How do you interpret the phrase "REACH is underpinned by the precautionary principle"?
7.5 Registration
7.5.1 How to Register
7.5.2 Who will be the Registrant
7.5.3 Information Requirements
7.5.4 Chemical Safety Assessments/Chemical Safety Reports
7.5.5 Prioritization of Registrations
7.5.6 Reciprocal Recognition of Test Results
7.5.6 The Mutual Recognition of Test Results
7.5.1 Is the precautionary principle directly stated in REACH?
7.5.7 Integrity Audit
7.5.8 Fees
7.5.9 Substances
7.5.10 Polymers
7.5.11 Intermediates
7.6 Data **** Sharing
7.7 Downstream Users
7.8 Evaluation of the Substance
7.9 Permitting
7.9.1 Permitting procedures
7.9.2 Alternatives program
7.10 Classification & Labeling
7.11 European Chemicals Agency (ECHA) and Member State Competent Authorities
7.12 Enforcement
7.13 Comments on provisions
7.14 Need for Response and Right of Appeal
7.15 Relationship between REACH and other ****similar regulations/international agreements
7.15.1 Waste Management Laws
7.15.2 International Agreements and Projects
7.16 Competition
7.16.1 REACH Confidentiality
7.16.2 Small and Medium-sized Enterprises (SMEs)
7.16.3 Trade Issues
7.16.4 Innovations
7.16.5 Impact Evaluation
- Wrap Up All<<