Call us: +44 870 8 200 310
Or write: experts@regartis.com
registration
| Page | Keyword count |
| TITLE I: GENERAL ISSUES | |
| CHAPTER 1: Aim, scope and application | |
| Article 2: Application | 1 |
| CHAPTER 2: Definitions and general provision | |
| Article 3: Definitions | 1 |
| TITLE II: REGISTRATION OF SUBSTANCES | |
| CHAPTER 1: General obligation to register and information requirements | 1 |
| Article 6: General obligation to register substances on their own or in mixtures | 3 |
| Article 7: Registration and notification of substances in articles | 4 |
| Article 10: Information to be submitted for general registration purposes | 3 |
| Article 11: Joint submission of data by multiple registrants | 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 | 1 |
| CHAPTER 2: Substances regarded as being registered | |
| Article 15: Substances in plant protection and biocidal products | 2 |
| CHAPTER 3: Obligation to register and information requirements for certain types of isolated intermediates | |
| Article 17: Registration of on-site isolated intermediates | 5 |
| Article 18: Registration of transported isolated intermediates | 6 |
| Article 19: Joint submission of data on isolated intermediates by multiple registrants | 1 |
| CHAPTER 4: Common provisions for all registrations | |
| Article 20: Duties of the Agency | 15 |
| Article 21: Manufacturing and import of substances | 5 |
| Article 22: Further duties of registrants | 5 |
| CHAPTER 5: Transitional provisions applicable to phase-in substances and notified substances | |
| Article 23: Specific provisions for phase-in substances | 1 |
| Article 24: Notified substances | 1 |
| TITLE III: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING | |
| CHAPTER 1: Objectives and general rules | |
| Article 25: Objectives and general rules | 2 |
| CHAPTER 2: Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered | 1 |
| Article 26: Duty to inquire prior to registration | 2 |
| Article 27: Sharing of existing data in the case of registered substances | 2 |
| CHAPTER 3: Rules for phase-in-substances | |
| Article 28: Duty to pre-register for phase-in substances | 3 |
| Article 29: Substance Information Exchange Forums | 2 |
| Article 30: Sharing of data involving tests | 8 |
| TITLE IV: INFORMATION IN THE SUPPLY CHAIN | |
| Article 31: Requirements for safety data sheets | 1 |
| 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 | 1 |
| TITLE V: DOWNSTREAM USERS | |
| Article 37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures | 2 |
| TITLE VI: EVALUATION | |
| CHAPTER 1: Dossier evaluation | |
| Article 40: Examination of testing proposals | 1 |
| Article 41: Compliance check of registrations | 3 |
| Article 43: Procedure and time periods for examination of testing proposals | 2 |
| CHAPTER 4: Common provisions | |
| Article 50: Registrants' and downstream users' rights | 3 |
| TITLE VII: AUTHORISATION | |
| CHAPTER 2: Granting of authorisations | |
| Article 62: Applications for authorisations | 1 |
| TITLE VIII: RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES | |
| CHAPTER 2: Restrictions process | |
| Article 69: Preparation of a proposal | 1 |
| TITLE IX: FEES AND CHARGES | |
| Article 74: Fees and charges | 2 |
| TITLE X: AGENCY | |
| Article 76: Composition | 1 |
| Article 77: Tasks | 1 |
| Article 83: Duties and powers of the Executive Director | 1 |
| Article 111: Formats and software for submission of information to the Agency | 1 |
| TITLE XIII: COMPETENT AUTHORITIES | |
| Article 124: Other responsibilities | 1 |
| TITLE XV: TRANSITIONAL AND FINAL PROVISIONS | |
| Article 138: Review | 4 |
| ANNEX I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS | |
| 0.: INTRODUCTION | 1 |
| ANNEX II: REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS | |
| 1.: SECTION 1: Identification of the substance/mixture and of the company/undertaking | |
| 1.1.: Product identifier | 2 |
| 1.3.: Details of the supplier of the safety data sheet | 1 |
| 8.: SECTION 8: Exposure controls/personal protection | |
| 8.2.: Exposure controls | 1 |
| 9.: SECTION 9: Physical and chemical properties | 1 |
| 9.1.: Information on basic physical and chemical properties | 1 |
| 11.: SECTION 11: Toxicological information | 1 |
| 11.1.: Information on toxicological effects | 2 |
| 12.: SECTION 12: Ecological information | 1 |
| 12.1.: Toxicity | 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 | 3 |
| STEP 2: CONSIDER INFORMATION NEEDS | 1 |
| 1.: GENERAL REGISTRANT INFORMATION | 3 |
| 3.: INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S) | 2 |
| 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 | |
| 1.5.: Grouping of substances and read-across approach | 1 |
| ANNEX XIII: CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES | |
| 2.: SCREENING AND ASSESSMENT OF P, vP, B, vB and T PROPERTIES | |
| 2.2.: Authorisation | 1 |
| ANNEX XV: DOSSIERS | |
| I.: INTRODUCTION AND GENERAL PROVISIONS | 1 |