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