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Page | Keyword count |
TITLE I: GENERAL ISSUES | |
CHAPTER 2: Definitions and general provision | |
Article 3: Definitions | 1 |
TITLE II: REGISTRATION OF SUBSTANCES | |
CHAPTER 1: General obligation to register and information requirements | |
Article 7: Registration and notification of substances in articles | 1 |
Article 10: Information to be submitted for general registration purposes | 3 |
Article 13: General requirements for generation of information on intrinsic properties of substances | 1 |
Article 14: Chemical safety report and duty to apply and recommend risk reduction measures | 3 |
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 | 2 |
TITLE IV: INFORMATION IN THE SUPPLY CHAIN | |
Article 31: Requirements for safety data sheets | 6 |
TITLE VI: EVALUATION | |
CHAPTER 1: Dossier evaluation | |
Article 40: Examination of testing proposals | 1 |
CHAPTER 2: Substance evaluation | |
Article 44: Criteria for substance evaluation | 1 |
CHAPTER 4: Common provisions | |
Article 50: Registrants' and downstream users' rights | 1 |
TITLE VII: AUTHORISATION | |
CHAPTER 2: Granting of authorisations | |
Article 60: Granting of authorisations | 1 |
ANNEX I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS | |
0.: INTRODUCTION | 2 |
0.6.: Steps of a chemical safety assessment | 4 |
1.: HUMAN HEALTH HAZARD ASSESSMENT | |
1.0.: Introduction | 2 |
1.4.: Step 4: Identification of DNEL(s) | 6 |
4.: PBT AND VPVB ASSESSMENT | |
4.0.: Introduction | 1 |
5.: EXPOSURE ASSESSMENT | 1 |
5.0.: Introduction | 1 |
5.1.: Step 1: Development of exposure scenarios | 5 |
5.2.: Step 2: Exposure Estimation | 16 |
6.: RISK CHARACTERISATION | 4 |
7.: CHEMICAL SAFETY REPORT FORMAT | 4 |
ANNEX II: REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS | |
1.: SECTION 1: Identification of the substance/mixture and of the company/undertaking | |
1.2.: Relevant identified uses of the substance or mixture and uses advised against | 1 |
3.: SECTION 3: Composition/information on ingredients | |
3.2.: Mixtures | 3 |
4.: SECTION 4: First aid measures | |
4.1.: Description of first aid measures | 2 |
4.2.: Most important symptoms and effects, both acute and delayed | 1 |
7.: SECTION 7: Handling and storage | 1 |
7.3.: Specific end use(s) | 1 |
8.: SECTION 8: Exposure controls/personal protection | 2 |
8.1.: Control parameters | 1 |
8.2.: Exposure controls | 1 |
8.2.2.: Individual protection measures, such as personal protective equipment | 2 |
8.2.3.: Environmental exposure controls | 3 |
11.: SECTION 11: Toxicological information | |
11.1.: Information on toxicological effects | 8 |
12.: SECTION 12: Ecological information | |
12.6.: Other adverse effects | 1 |
13.: SECTION 13: Disposal considerations | 1 |
ANNEX V | 1 |
ANNEX VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 | |
guidance note on fulfilling the requirements of annexes vi to xi: GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI | 1 |
STEP 1: GATHER AND SHARE EXISTING INFORMATION | 1 |
STEP 2: CONSIDER INFORMATION NEEDS | 1 |
6.: INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFATCURER OR IMPORTER | 4 |
ANNEX VII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE | 1 |
ANNEX VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE | |
8.: TOXICOLOGICAL INFORMATION | 9 |
ANNEX IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE | |
8.: TOXICOLOGICAL INFORMATION | 8 |
ANNEX X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE | |
8.: TOXICOLOGICAL INFORMATION | 6 |
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 | |
1.1.: Use of existing data | |
1.1.2.: Data on human health and environmental properties from experiments not carried out according to GLP or the test methods referred to in Article 13(3) | 2 |
1.1.3.: Historical human data | 2 |
1.5.: Grouping of substances and read-across approach | 2 |
3.: SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING | 1 |
ANNEX XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS | |
introduction: INTRODUCTION | 4 |
ANNEX XV: DOSSIERS | |
2.: Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59 | 1 |
ANNEX XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES | 7 |