Languages

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

3.3.: Step 3: Identification of the PNEC

3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC). An assessment factor expresses the difference between effects values derived for a limited number of species from laboratory tests and the PNEC for the environmental sphere ( 32 ).

3.3.2. If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified.