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Contents
PREAMBLE: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals
TITLE-I: GENERAL ISSUES
CHAPTER-1: Aim, scope and application
ARTICLE-1: Aim and scope
ARTICLE-2: Application
CHAPTER-2: Definitions and general provision
ARTICLE-3: Definitions
ARTICLE-4: General provision
TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-1: General obligation to register and information requirements
ARTICLE-5: No data, no market
ARTICLE-6: General obligation to register substances on their own or in preparations
ARTICLE-7: Registration and notification of substances in articles
ARTICLE-8: Only representative of a non-Community manufacturer
ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD)
ARTICLE-10: Information to be submitted for general registration purposes
ARTICLE-11: Joint submission of data by multiple registrants
ARTICLE-12: Information to be submitted depending on tonnage
ARTICLE-13: General requirements for generation of information on intrinsic properties of substances
ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures
CHAPTER-2: Substances regarded as being registered
ARTICLE-15: Substances in plant protection and biocidal products
ARTICLE-16: Duties of the Commission, the Agency and registrants of substances regarded as being registered
CHAPTER-3: Obligation to register and information requirements for certain types of isolated intermediates
ARTICLE-17: Registration of on-site isolated intermediates
ARTICLE-18: Registration of transported isolated intermediates
ARTICLE-19: Joint submission of data on isolated intermediates by multiple registrants
CHAPTER-4: Common provisions for all registrations
ARTICLE-20: Duties of the Agency
ARTICLE-21: Manufacturing and import of substances
ARTICLE-22: Further duties of registrants
CHAPTER-5: Transitional provisions applicable to phase-in substances and notified substances
ARTICLE-23: Specific provisions for phase-in substances
ARTICLE-24: Notified substances
TITLE-III: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER-1: Objectives and general rules
ARTICLE-25: Objectives and general rules
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
ARTICLE-27: Sharing of existing data in the case of registered substances
CHAPTER-3: Rules for phase-in-substances
ARTICLE-28: Duty to pre-register for phase-in substances
ARTICLE-29: Substance Information Exchange Forums
ARTICLE-30: Sharing of data involving tests
TITLE-IV: INFORMATION IN THE SUPPLY CHAIN
ARTICLE-31: Requirements for safety data sheets
ARTICLE-32: Duty
to communicate information down the supply chain for substances on
their own or in preparations for which a safety data sheet is not
required
ARTICLE-33: Duty to communicate information on substances in articles
ARTICLE-34: Duty to communicate information on substances and preparations up the supply chain
ARTICLE-35: Access to information for workers
ARTICLE-36: Obligation to keep information
TITLE-V: DOWNSTREAM USERS
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures
ARTICLE-38: Obligation for downstream users to report information
ARTICLE-39: Application of downstream user obligations
TITLE-VI: EVALUATION
CHAPTER-1: Dossier evaluation
ARTICLE-40: Examination of testing proposals
ARTICLE-41: Compliance check of registrations
ARTICLE-42: Check of information submitted and follow-up to dossier evaluation
ARTICLE-43: Procedure and time periods for examination of testing proposals
CHAPTER-2: Substance evaluation
ARTICLE-44: Criteria for substance evaluation
ARTICLE-45: Competent authority
ARTICLE-46: Requests for further information and check of information submitted
ARTICLE-47: Coherence with other activities
ARTICLE-48: Follow-up to substance evaluation
CHAPTER-3: Evaluation of intermediates
ARTICLE-49: Further information on on-site isolated intermediates
CHAPTER-4: Common provisions
ARTICLE-50: Registrants' and downstream users' rights
ARTICLE-51: Adoption of decisions under dossier evaluation
ARTICLE-52: Adoption of decisions under substance evaluation
ARTICLE-53: Cost sharing for tests without an agreement between registrants and/or downstream users
ARTICLE-54: Publication of information on evaluation
TITLE-VII: AUTHORISATION
CHAPTER-1: Authorisation requirement
ARTICLE-55: Aim of authorisation and considerations for substitution
ARTICLE-56: General provisions
ARTICLE-57: Substances to be included in Annex XIV
ARTICLE-58: Inclusion of substances in Annex XIV
ARTICLE-59: Identification of substances referred to in Article 57
CHAPTER-2: Granting of authorisations
ARTICLE-60: Granting of authorisations
ARTICLE-61: Review of authorisations
ARTICLE-62: Applications for authorisations
ARTICLE-63: Subsequent applications for authorisation
ARTICLE-64: Procedure for authorisation decisions
CHAPTER-3: Authorisations in the supply chain
ARTICLE-65: Obligation of holders of authorisations
ARTICLE-66: Downstream users
TITLE-VIII: RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES
CHAPTER-1: General issues
ARTICLE-67: General provisions
CHAPTER-2: Restrictions process
ARTICLE-68: Introducing new and amending current restrictions
ARTICLE-69: Preparation of a proposal
ARTICLE-70: Agency opinion: Committee for Risk Assessment
ARTICLE-71: Agency opinion: Committee for Socio-economic Analysis
ARTICLE-72: Submission of an opinion to the Commission
ARTICLE-73: Commission decision
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 Management Board
ARTICLE-79: Composition of the Management Board
ARTICLE-80: Chairmanship of the Management Board
ARTICLE-81: Meetings of the Management Board
ARTICLE-82: Voting of the Management Board
ARTICLE-83: Duties and powers of the Executive Director
ARTICLE-84: Appointment of the Executive Director
ARTICLE-85: Establishment of the Committees
ARTICLE-86: Establishment of the Forum
ARTICLE-87: Rapporteurs of Committees and use of experts
ARTICLE-88: Qualification and interests
ARTICLE-89: Establishment of the Board of Appeal
ARTICLE-90: Members of the Board of Appeal
ARTICLE-91: Decisions subject to appeal
ARTICLE-92: Persons entitled to appeal, time-limits, fees and form
ARTICLE-93: Examination and decisions on appeal
ARTICLE-94: Actions before the Court of First Instance and the Court of Justice
ARTICLE-95: Conflicts of opinion with other bodies
ARTICLE-96: The budget of the Agency
ARTICLE-97: Implementation of the budget of the Agency
ARTICLE-98: Combating fraud
ARTICLE-99: Financial rules
ARTICLE-100: Legal personality of the Agency
ARTICLE-101: Liability of the Agency
ARTICLE-102: Privileges and immunities of the Agency
ARTICLE-103: Staff rules and regulations
ARTICLE-104: Languages
ARTICLE-105: Duty of confidentiality
ARTICLE-106: Participation of third countries
ARTICLE-107: Participation of international organisations
ARTICLE-108: Contacts with stakeholder organisations
ARTICLE-109: Rules on transparency
ARTICLE-110: Relations with relevant Community bodies
ARTICLE-111: Formats and software for submission of information to the Agency
TITLE-XI: CLASSIFICATION AND LABELLING INVENTORY
ARTICLE-112: Scope
ARTICLE-113: Obligation to notify the Agency
ARTICLE-114: Classification and labelling inventory
ARTICLE-115: Harmonisation of classification and labelling
ARTICLE-116: Transitional arrangements
TITLE-XII: INFORMATION
ARTICLE-117: Reporting
ARTICLE-118: Access to information
ARTICLE-119: Electronic public access
ARTICLE-120: Cooperation with third countries and international organisations
TITLE-XIII: COMPETENT AUTHORITIES
ARTICLE-121: Appointment
ARTICLE-122: Cooperation between competent authorities
ARTICLE-123: Communication to the public of information on risks of substances
ARTICLE-124: Other responsibilities
TITLE-XIV: ENFORCEMENT
ARTICLE-125: Tasks of the Member States
ARTICLE-126: Penalties for non-compliance
ARTICLE-127: Report
TITLE-XV: TRANSITIONAL AND FINAL PROVISIONS
ARTICLE-128: Free movement
ARTICLE-129: Safeguard clause
ARTICLE-130: Statement of reasons for decisions
ARTICLE-131: Amendments to the Annexes
ARTICLE-132: Implementing legislation
ARTICLE-133: Committee procedure
ARTICLE-134: Preparation of establishment of the Agency
ARTICLE-135: Transitional measures regarding notified substances
ARTICLE-136: Transitional measures regarding existing substances
ARTICLE-137: Transitional measures regarding restrictions
ARTICLE-138: Review
ARTICLE-139: Repeals
ARTICLE-140: Amendment of Directive 1999/45/EC
ARTICLE-141: Entry into force and application
ANNEXES
ANNEX-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
ANNEX-II: GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
ANNEX-III: CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
ANNEX-IV: EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)
ANNEX-V: EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)
ANNEX-VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ANNEX-VII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE [64]
ANNEX-VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66]
ANNEX-IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68]
ANNEX-X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70]
ANNEX-XI: GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
ANNEX-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
ANNEX-XIII: CRITERIA FOR
THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES,
AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
ANNEX-XIV: LIST OF SUBSTANCES SUBJECT TO AUTHORISATION
ANNEX-XV: DOSSIERS
ANNEX-XVI: SOCIO-ECONOMIC ANALYSIS
ANNEX-XVII: RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES
FOOTNOTES
FOOTNOTES: List of Footnotes