substance

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TITLE I: GENERAL ISSUES
CHAPTER 1: Aim, scope and application
Article 2: Application 8
CHAPTER 2: Definitions and general provision
Article 3: Definitions 29
TITLE II: REGISTRATION OF SUBSTANCES
CHAPTER 1: General obligation to register and information requirements
Article 6: General obligation to register substances on their own or in  mixtures 8
Article 7: Registration and notification of substances in articles 16
Article 8: Only representative of a non-Community manufacturer 1
Article 9: Exemption from the general obligation to register for product and process orientated research and development (PPORD) 7
Article 10: Information to be submitted for general registration purposes 4
Article 11: Joint submission of data by multiple registrants 1
Article 12: Information to be submitted depending on tonnage 1
Article 13: General requirements for generation of information on intrinsic properties of substances 3
Article 14: Chemical safety report and duty to apply and recommend risk reduction measures 6
CHAPTER 2: Substances regarded as being registered
Article 15: Substances in plant protection and biocidal products 1
CHAPTER 3: Obligation to register and information requirements for certain types of isolated intermediates
Article 17: Registration of on-site isolated intermediates 1
Article 18: Registration of transported isolated intermediates 3
CHAPTER 4: Common provisions for all registrations
Article 20: Duties of the Agency 2
Article 21: Manufacturing and import of substances 5
Article 22: Further duties of registrants 4
TITLE III: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER 2: Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
Article 26: Duty to inquire prior to registration 5
Article 27: Sharing of existing data in the case of registered substances 1
CHAPTER 3: Rules for phase-in-substances
Article 28: Duty to pre-register for phase-in substances 7
Article 29: Substance Information Exchange Forums 2
TITLE IV: INFORMATION IN THE SUPPLY CHAIN
Article 31: Requirements for safety data sheets 15
Article 32: Duty to communicate information down the supply chain for substances on their own or in  mixtures for which a safety data sheet is not required 5
Article 33: Duty to communicate information on substances in articles 4
Article 34: Duty to communicate information on substances and  mixtures up the supply chain 1
Article 36: Obligation to keep information 2
TITLE V: DOWNSTREAM USERS
Article 37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures 10
Article 38: Obligation for downstream users to report information 4
TITLE VI: EVALUATION
CHAPTER 1: Dossier evaluation
Article 40: Examination of testing proposals 3
Article 41: Compliance check of registrations 2
CHAPTER 2: Substance evaluation
Article 44: Criteria for substance evaluation 3
Article 45: Competent authority 10
Article 46: Requests for further information and check of information submitted 1
Article 47: Coherence with other activities 4
CHAPTER 4: Common provisions
Article 50: Registrants' and downstream users' rights 8
Article 53: Cost sharing for tests without an agreement between registrants and/or downstream users 1
TITLE VII: AUTHORISATION
CHAPTER 1: Authorisation requirement
Article 56: General provisions 12
Article 58: Inclusion of substances in Annex XIV 14
Article 59: Identification of substances referred to in Article 57 9
CHAPTER 2: Granting of authorisations
Article 60: Granting of authorisations 5
Article 61: Review of authorisations 3
Article 62: Applications for authorisations 9
Article 63: Subsequent applications for authorisation 2
Article 64: Procedure for authorisation decisions 2
CHAPTER 3: Authorisations in the supply chain
Article 65: Obligation of holders of authorisations 2
Article 66: Downstream users 2
TITLE VIII: RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES,  MIXTURES AND ARTICLES
CHAPTER 1: General issues
Article 67: General provisions 3
CHAPTER 2: Restrictions process
Article 68: Introducing new and amending current restrictions 2
Article 69: Preparation of a proposal 8
TITLE IX: FEES AND CHARGES
Article 74: Fees and charges 2
TITLE X: AGENCY
Article 77: Tasks 1
TITLE XII: INFORMATION
Article 118: Access to information 2
Article 119: Electronic public access 6
TITLE XV: TRANSITIONAL AND FINAL PROVISIONS
Article 128: Free movement 1
Article 129: Safeguard clause 2
Article 135: Transitional measures regarding notified substances 2
Article 136: Transitional measures regarding existing substances 2
ANNEX I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
0.: INTRODUCTION 12
0.6.: Steps of a chemical safety assessment 6
1.: HUMAN HEALTH HAZARD ASSESSMENT
1.0.: Introduction 3
1.1.: Step 1: Evaluation of non-human information 1
1.3.: Step 3: Classification and Labelling 2
1.4.: Step 4: Identification of DNEL(s) 2
2.: PHYSICOCHEMICAL HAZARD ASSESSMENT 3
3.: ENVIRONMENTAL HAZARD ASSESSMENT
3.0.: Introduction 2
3.1.: Step 1: Evaluation of information 1
3.2.: Step 2: Classification and Labelling 1
4.: PBT AND VPVB ASSESSMENT
4.0.: Introduction 2
4.1.: Step 1: Comparison with the criteria 1
4.2.: Step 2: Emission Characterisation 3
5.: EXPOSURE ASSESSMENT
5.0.: Introduction 2
5.1.: Step 1: Development of exposure scenarios 6
5.2.: Step 2: Exposure Estimation 10
6.: RISK CHARACTERISATION 6
ANNEX II: REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS 1
0.1.: Introduction 1
0.2.: General requirements for compiling a safety data sheet 4
0.3.: Safety data sheet format 1
1.: SECTION 1: Identification of the substance/mixture and of the company/undertaking 5
1.1.: Product identifier 4
1.2.: Relevant identified uses of the substance or mixture and uses advised against 3
1.3.: Details of the supplier of the safety data sheet 1
1.4.: Emergency telephone number 1
2.: SECTION 2: Hazards identification 2
2.1.: Classification of the substance or mixture 4
2.3.: Other hazards 2
3.: SECTION 3: Composition/information on ingredients 1
3.1.: Substances 2
3.2.: Mixtures 8
5.: SECTION 5: Firefighting measures 2
5.1.: Extinguishing media 1
5.2.: Special hazards arising from the substance or mixture 3
6.: SECTION 6: Accidental release measures
6.1.: Personal precautions, protective equipment and emergency procedures
6.1.1.: For non-emergency personnel 1
6.2.: Environmental precautions 1
7.: SECTION 7: Handling and storage 1
7.1.: Precautions for safe handling 3
7.2.: Conditions for safe storage, including any incompatibilities 1
7.3.: Specific end use(s) 1
8.: SECTION 8: Exposure controls/personal protection
8.1.: Control parameters 3
8.2.: Exposure controls 1
8.2.1.: Appropriate engineering controls 2
8.2.2.: Individual protection measures, such as personal protective equipment 4
8.2.3.: Environmental exposure controls 1
9.: SECTION 9: Physical and chemical properties 2
9.1.: Information on basic physical and chemical properties 4
10.: SECTION 10: Stability and reactivity 1
10.1.: Reactivity 5
10.2.: Chemical stability 3
10.3.: Possibility of hazardous reactions 1
10.5.: Incompatible materials 1
11.: SECTION 11: Toxicological information 1
11.1.: Information on toxicological effects 14
12.: SECTION 12: Ecological information 5
12.1.: Toxicity 1
12.2.: Persistence and degradability 3
12.3.: Bioaccumulative potential 2
12.4.: Mobility in soil 2
13.: SECTION 13: Disposal considerations 1
13.1.: Waste treatment methods 1
14.: SECTION 14: Transport information
14.1.: UN number 1
14.5.: Environmental hazards 3
15.: SECTION 15: Regulatory information 3
15.1.: Safety, health and environmental regulations/legislation specific for the substance or mixture 3
15.2.: Chemical safety assessment 1
16.: SECTION 16: Other information 6
ANNEX IV 2
ANNEX V 7
ANNEX VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
STEP 1: GATHER AND SHARE EXISTING INFORMATION 4
STEP 2: CONSIDER INFORMATION NEEDS 1
STEP 3: IDENTIFY INFORMATION GAPS 1
2.: IDENTIFICATION OF THE SUBSTANCE 6
3.: INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S) 5
4.: CLASSIFICATION AND LABELLING 2
ANNEX VII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE 1
7.: INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE 24
8.: TOXICOLOGICAL INFORMATION 15
9.: ECOTOXICOLOGICAL INFORMATION 6
ANNEX VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE
8.: TOXICOLOGICAL INFORMATION 24
9.: ECOTOXICOLOGICAL INFORMATION 12
ANNEX IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE
7.: INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE 3
8.: TOXICOLOGICAL INFORMATION 17
9.: ECOTOXICOLOGICAL INFORMATION 9
ANNEX X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE
8.: TOXICOLOGICAL INFORMATION 19
9.: ECOTOXICOLOGICAL INFORMATION 5
ANNEX XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
1.: TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY
1.2.: Weight of evidence 2
1.3.: Qualitative or Quantitative structure-activity relationship ((Q)SAR) 1
1.5.: Grouping of substances and read-across approach 2
2.: TESTING IS TECHNICALLY NOT POSSIBLE 3
3.: SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING 8
ANNEX XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
introduction: INTRODUCTION 3
ANNEX XIII: CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES 3
1.: CRITERIA FOR THE IDENTIFICATION OF PBT AND vPvB SUBSTANCES
1.1.: PBT Substances 2
1.1.1.: Persistence 1
1.1.2.: Bioaccumulation 1
1.1.3.: Toxicity 3
1.2.: vPvB Substances 2
1.2.1.: Persistence 1
1.2.2.: Bioaccumulation 1
2.: SCREENING AND ASSESSMENT OF P, vP, B, vB and T PROPERTIES
2.1.: Registration 3
3.: INFORMATION RELEVANT FOR THE SCREENING AND ASSESSMENT OF P, vP, B, vB and T PROPERTIES
3.2.: Assessment Information
3.2.2.: Assessment of B or vB properties 2
3.2.3.: Assessment of T properties 1
ANNEX XIV: LIST OF SUBSTANCES SUBJECT TO AUTHORISATION 12
ANNEX XV: DOSSIERS 2
I.: INTRODUCTION AND GENERAL PROVISIONS 2
2.: Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59 4
3.: Dossiers for restrictions proposal 1
ANNEX XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES 56
Appendices 1 to 6
explanations of column headings: Explanations of column headings 15
Appendix 2: Entry 28 — Carcinogens: category 1B (Table 3.1)/category 2 (Table 3.2) 2
Appendix 5: Entry 30 — Toxic to reproduction: category 1A (Table 3.1)/category 1 (Table 3.2) 2