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Regulations

Preamble
TITLE I / GENERAL ISSUES
- CHAPTER 1 / Aim, scope and...
  - Article 1 / Aim and scope
  - Article 2 / Application
- CHAPTER 2 / Definitions and...
  - Article 3 / Definitions
  - Article 4 / General provision
TITLE II / REGISTRATION OF SUBSTANCES
- CHAPTER 1 / General...
- CHAPTER 2 / Substances...
  - Article 15 / Substances in...
  - Article 16 / Duties of the...
- CHAPTER 3 / Obligation to...
- CHAPTER 4 / Common...
- CHAPTER 5 / Transitional...
  - Article 23 / Specific...
  - Article 24 / Notified substances
TITLE III / DATA SHARING AND...
- CHAPTER 1 / Objectives and...
  - Article 25 / Objectives and...
- CHAPTER 2 / Rules for...
  - Article 26 / Duty to inquire...
  - Article 27 / Sharing of...
- CHAPTER 3 / Rules for...
TITLE IV / INFORMATION IN...
- Article 31 / Requirements...
- Article 32 / Duty to...
- Article 33 / Duty to...
- Article 34 / Duty to...
- Article 35 / Access to...
- Article 36 / Obligation to...
TITLE V / DOWNSTREAM USERS
- Article 37 / Downstream user...
- Article 38 / Obligation for...
- Article 39 / Application of...
TITLE VI / EVALUATION
- CHAPTER 1 / Dossier evaluation
- CHAPTER 2 / Substance evaluation
- CHAPTER 3 / Evaluation of...
  - Article 49 / Further...
- CHAPTER 4 / Common provisions
TITLE VII / AUTHORISATION
- CHAPTER 1 / Authorisation requirement
- CHAPTER 2 / Granting of...
- CHAPTER 3 / Authorisations...
  - Article 65 / Obligation of...
  - Article 66 / Downstream users
TITLE VIII / RESTRICTIONS ON...
- CHAPTER 1 / General issues
  - Article 67 / General provisions
- CHAPTER 2 / Restrictions process
TITLE IX / FEES AND CHARGES
- Article 74 / Fees and charges
TITLE X / AGENCY
- Article 75 / Establishment and review
- Article 76 / Composition
- Article 77 / Tasks
- Article 78 / Powers of the...
- Article 79 / Composition of...
- Article 80 / Chairmanship of...
- Article 81 / Meetings of the...
- Article 82 / Voting of the...
- Article 83 / Duties and...
- Article 84 / Appointment of...
- Article 85 / Establishment...
- Article 86 / Establishment...
- Article 87 / Rapporteurs of...
- Article 88 / Qualification...
- Article 89 / Establishment...
- Article 90 / Members of the...
- Article 91 / Decisions...
- Article 92 / Persons...
- Article 93 / Examination and...
- Article 94 / Actions before...
- Article 95 / Conflicts of...
- Article 96 / The budget of the Agency
- Article 97 / Implementation...
- Article 98 / Combating fraud
- Article 99 / Financial rules
- Article 100 / Legal...
- Article 101 / Liability of the Agency
- Article 102 / Privileges and...
- Article 103 / Staff rules...
- Article 104 / Languages
- Article 105 / Duty of confidentiality
- Article 106 / Participation...
- Article 107 / Participation...
- Article 108 / Contacts with...
- Article 109 / Rules on transparency
- Article 110 / Relations with...
- Article 111 / Formats and...
TITLE XII / INFORMATION
- Article 117 / Reporting
- Article 118 / Access to information
- Article 119 / Electronic...
- Article 120 / Cooperation...
TITLE XIII / COMPETENT AUTHORITIES
- Article 121 / Appointment
- Article 122 / Cooperation...
- Article 123 / Communication...
- Article 124 / Other responsibilities
TITLE XIV / ENFORCEMENT
- Article 125 / Tasks of the...
- Article 126 / Penalties for...
- Article 127 / Report
TITLE XV / TRANSITIONAL AND...
- Article 128 / Free movement
- Article 129 / Safeguard clause
- Article 130 / Statement of...
- Article 131 / Amendments to...
- Article 132 / Implementing...
- Article 133 / Committee procedure
- Article 134 / Preparation of...
- Article 135 / Transitional...
- Article 136 / Transitional...
- Article 137 / Transitional...
- Article 138 / Review
- Article 139 / Repeals
- Article 140 / Amendment of...
- Article 141 / Entry into...
LIST OF ANNEXES
ANNEX I / GENERAL PROVISIONS...
- 0. / INTRODUCTION
  - 0.6. / Steps of a chemical...
- 1. / HUMAN HEALTH HAZARD ASSESSMENT
- 2. / PHYSICOCHEMICAL HAZARD...
- 3. / ENVIRONMENTAL HAZARD ASSESSMENT
- 4. / PBT AND VPVB ASSESSMENT
- 5. / EXPOSURE ASSESSMENT
- 6. / RISK CHARACTERISATION
- 7. / CHEMICAL SAFETY REPORT FORMAT
ANNEX II / REQUIREMENTS FOR...
- 0.1. / Introduction
- 0.2. / General requirements...
- 0.3. / Safety data sheet format
- 0.4. / Safety data sheet content
- 0.5. / Other information requirements
- 0.6. / Units
- 0.7. / Special cases
- 1. / SECTION 1:...
  - 1.1. / Product identifier
  - 1.2. / Relevant identified...
  - 1.3. / Details of the...
  - 1.4. / Emergency telephone number
- 2. / SECTION 2: Hazards...
  - 2.1. / Classification of the...
  - 2.2. / Label elements
  - 2.3. / Other hazards
- 3. / SECTION 3:...
  - 3.1. / Substances
  - 3.2. / Mixtures
- 4. / SECTION 4: First aid measures
  - 4.1. / Description of first...
  - 4.2. / Most important...
  - 4.3. / Indication of any...
- 5. / SECTION 5: Firefighting measures
  - 5.1. / Extinguishing media
  - 5.2. / Special hazards...
  - 5.3. / Advice for firefighters
- 6. / SECTION 6: Accidental...
  - 6.1. / Personal precautions,...
    - 6.1.1. / For non-emergency personnel
    - 6.1.2. / For emergency responders
  - 6.2. / Environmental precautions
  - 6.3. / Methods and material...
  - 6.4. / Reference to other sections
- 7. / SECTION 7: Handling and storage
  - 7.1. / Precautions for safe handling
  - 7.2. / Conditions for safe...
  - 7.3. / Specific end use(s)
- 8. / SECTION 8: Exposure...
  - 8.1. / Control parameters
  - 8.2. / Exposure controls
- 9. / SECTION 9: Physical and...
  - 9.1. / Information on basic...
  - 9.2. / Other information
- 10. / SECTION 10: Stability...
  - 10.1. / Reactivity
  - 10.2. / Chemical stability
  - 10.3. / Possibility of...
  - 10.4. / Conditions to avoid
  - 10.5. / Incompatible materials
  - 10.6. / Hazardous...
- 11. / SECTION 11:...
  - 11.1. / Information on...
- 12. / SECTION 12: Ecological...
  - 12.1. / Toxicity
  - 12.2. / Persistence and degradability
  - 12.3. / Bioaccumulative potential
  - 12.4. / Mobility in soil
  - 12.5. / Results of PBT and...
  - 12.6. / Other adverse effects
- 13. / SECTION 13: Disposal...
  - 13.1. / Waste treatment methods
- 14. / SECTION 14: Transport...
  - 14.1. / UN number
  - 14.2. / UN proper shipping name
  - 14.3. / Transport hazard class(es)
  - 14.4. / Packing group
  - 14.5. / Environmental hazards
  - 14.6. / Special precautions for user
  - 14.7. / Transport in bulk...
- 15. / SECTION 15: Regulatory...
  - 15.1. / Safety, health and...
  - 15.2. / Chemical safety assessment
- 16. / SECTION 16: Other information
ANNEX III / CRITERIA FOR...
ANNEX IV
ANNEX V
ANNEX VI / INFORMATION...
- GUIDANCE NOTE ON FULFILLING...
- STEP 1 / GATHER AND SHARE...
- STEP 2 / CONSIDER INFORMATION NEEDS
- STEP 3 / IDENTIFY INFORMATION GAPS
- STEP 4 / GENERATE NEW...
- NOTES
- 1. / GENERAL REGISTRANT INFORMATION
- 2. / IDENTIFICATION OF THE SUBSTANCE
- 3. / INFORMATION ON...
- 4. / CLASSIFICATION AND LABELLING
- 5. / GUIDANCE ON SAFE USE CONCERNING:
- 6. / INFORMATION ON EXPOSURE...
ANNEX VII / STANDARD...
- 7. / INFORMATION ON THE...
- 8. / TOXICOLOGICAL INFORMATION
- 9. / ECOTOXICOLOGICAL INFORMATION
ANNEX VIII / STANDARD...
- 8. / TOXICOLOGICAL INFORMATION
- 9. / ECOTOXICOLOGICAL INFORMATION
ANNEX IX / STANDARD...
- 7. / INFORMATION ON THE...
- 8. / TOXICOLOGICAL INFORMATION
- 9. / ECOTOXICOLOGICAL INFORMATION
- 10. / METHODS OF DETECTION...
ANNEX X / STANDARD...
- 8. / TOXICOLOGICAL INFORMATION
- 9. / ECOTOXICOLOGICAL INFORMATION
- 10. / METHODS OF DETECTION...
ANNEX XI / GENERAL RULES FOR...
- 1. / TESTING DOES NOT APPEAR...
- 2. / TESTING IS TECHNICALLY...
- 3. / SUBSTANCE-TAILORED...
ANNEX XII / GENERAL...
- INTRODUCTION
ANNEX XIII / CRITERIA FOR...
- 1. / CRITERIA FOR THE...
  - 1.1. / PBT Substances
  - 1.2. / vPvB Substances
    - 1.2.1. / Persistence
    - 1.2.2. / Bioaccumulation
- 2. / SCREENING AND...
  - 2.1. / Registration
  - 2.2. / Authorisation
- 3. / INFORMATION RELEVANT...
  - 3.1. / Screening Information
  - 3.2. / Assessment Information
ANNEX XIV / LIST OF...
ANNEX XV / DOSSIERS
- I. / INTRODUCTION AND...
- II. / CONTENT OF DOSSIERS
- 2. / Dossier for the...
- 3. / Dossiers for...
ANNEX XVI / SOCIO-ECONOMIC ANALYSIS
ANNEX XVII / RESTRICTIONS ON...
Appendices 1 to 6
- FOREWORD
- explanations of column...
Appendix 1 / Entry 28 —...
Appendix 2 / Entry 28 —...
Appendix 3 / Entry 29 —...
Appendix 4 / Entry 29 —...
Appendix 5 / Entry 30 —...
Appendix 6 / Entry 30 —...
Appendix 7 / Special...
Appendix 8 / Entry 43 —...
Appendix 9 / Entry 43 —...
Appendix 10 / Entry 43 —...
Appendix 11

Article 39: Application of downstream user obligations

1. Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

2. Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet.