What changes on 23/11/2007
The text in force from 17/06/2004 compared with the text from 23/11/2007.
214 inserted
0 amended
0 deleted
0 moved
Read the act as of 23/11/2007 · other versions: 06/06/2024 · 10/10/2024 · 22/04/2025 · 23/06/2025 · 01/09/2025 · 23/10/2025 · 11/05/2026 · 22/06/2026
Title I › Chapter 1
- inserted Article 1 - Aim and scope
- inserted Article 2 - Application
Title I › Chapter 2
- inserted Article 3 - Definitions
- inserted Article 4 - General provision
Title II › Chapter 1
- inserted Article 5 - No data, no market
- inserted Article 6 - General obligation to register substances on their own or in preparations
- inserted Article 7 - Registration and notification of substances in articles
- inserted Article 8 - Only representative of a non-Community manufacturer
- inserted Article 9 - Exemption from the general obligation to register for product and process orientated research and development (PPORD)
- inserted Article 10 - Information to be submitted for general registration purposes
- inserted Article 11 - Joint submission of data by multiple registrants
- inserted Article 12 - Information to be submitted depending on tonnage
- inserted Article 13 - General requirements for generation of information on intrinsic properties of substances
- inserted Article 14 - Chemical safety report and duty to apply and recommend risk reduction measures
Title II › Chapter 2
- inserted Article 15 - Substances in plant protection and biocidal products
- inserted Article 16 - Duties of the Commission, the Agency and registrants of substances regarded as being registered
Title II › Chapter 3
- inserted Article 17 - Registration of on-site isolated intermediates
- inserted Article 18 - Registration of transported isolated intermediates
- inserted Article 19 - Joint submission of data on isolated intermediates by multiple registrants
Title II › Chapter 4
- inserted Article 20 - Duties of the Agency
- inserted Article 21 - Manufacturing and import of substances
- inserted Article 22 - Further duties of registrants
Title II › Chapter 5
- inserted Article 23 - Specific provisions for phase-in substances
- inserted Article 24 - Notified substances
Title III › Chapter 1
Title III › Chapter 2
- inserted Article 26 - Duty to inquire prior to registration
- inserted Article 27 - Sharing of existing data in the case of registered substances
Title III › Chapter 3
- inserted Article 28 - Duty to pre-register for phase-in substances
- inserted Article 29 - Substance Information Exchange Forums
- inserted Article 30 - Sharing of data involving tests
Title IV
- inserted Article 31 - Requirements for safety data sheets
- inserted 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
- inserted Article 33 - Duty to communicate information on substances in articles
- inserted Article 34 - Duty to communicate information on substances and preparations up the supply chain
- inserted Article 35 - Access to information for workers
- inserted Article 36 - Obligation to keep information
Title V
- inserted Article 37 - Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures
- inserted Article 38 - Obligation for downstream users to report information
- inserted Article 39 - Application of downstream user obligations
Title VI › Chapter 1
- inserted Article 40 - Examination of testing proposals
- inserted Article 41 - Compliance check of registrations
- inserted Article 42 - Check of information submitted and follow-up to dossier evaluation
- inserted Article 43 - Procedure and time periods for examination of testing proposals
Title VI › Chapter 2
- inserted Article 44 - Criteria for substance evaluation
- inserted Article 45 - Competent authority
- inserted Article 46 - Requests for further information and check of information submitted
- inserted Article 47 - Coherence with other activities
- inserted Article 48 - Follow-up to substance evaluation
Title VI › Chapter 3
Title VI › Chapter 4
- inserted Article 50 - Registrants' and downstream users' rights
- inserted Article 51 - Adoption of decisions under dossier evaluation
- inserted Article 52 - Adoption of decisions under substance evaluation
- inserted Article 53 - Cost sharing for tests without an agreement between registrants and/or downstream users
- inserted Article 54 - Publication of information on evaluation
Title VII › Chapter 1
- inserted Article 55 - Aim of authorisation and considerations for substitution
- inserted Article 56 - General provisions
- inserted Article 57 - Substances to be included in Annex XIV
- inserted Article 58 - Inclusion of substances in Annex XIV
- inserted Article 59 - Identification of substances referred to in Article 57
Title VII › Chapter 2
- inserted Article 60 - Granting of authorisations
- inserted Article 61 - Review of authorisations
- inserted Article 62 - Applications for authorisations
- inserted Article 63 - Subsequent applications for authorisation
- inserted Article 64 - Procedure for authorisation decisions
Title VII › Chapter 3
- inserted Article 65 - Obligation of holders of authorisations
- inserted Article 66 - Downstream users
Title VIII › Chapter 1
- inserted Article 67 - General provisions
Title VIII › Chapter 2
- inserted Article 68 - Introducing new and amending current restrictions
- inserted Article 69 - Preparation of a proposal
- inserted Article 70 - Agency opinion: Committee for Risk Assessment
- inserted Article 71 - Agency opinion: Committee for Socio-economic Analysis
- inserted Article 72 - Submission of an opinion to the Commission
- inserted Article 73 - Commission decision
Title IX
- inserted Article 74 - Fees and charges
Title X
- inserted Article 75 - Establishment and review
- inserted Article 76 - Composition
- inserted Article 77 - Tasks
- inserted Article 78 - Powers of the Management Board
- inserted Article 79 - Composition of the Management Board
- inserted Article 80 - Chairmanship of the Management Board
- inserted Article 81 - Meetings of the Management Board
- inserted Article 82 - Voting of the Management Board
- inserted Article 83 - Duties and powers of the Executive Director
- inserted Article 84 - Appointment of the Executive Director
- inserted Article 85 - Establishment of the Committees
- inserted Article 86 - Establishment of the Forum
- inserted Article 87 - Rapporteurs of Committees and use of experts
- inserted Article 88 - Qualification and interests
- inserted Article 89 - Establishment of the Board of Appeal
- inserted Article 90 - Members of the Board of Appeal
- inserted Article 91 - Decisions subject to appeal
- inserted Article 92 - Persons entitled to appeal, time-limits, fees and form
- inserted Article 93 - Examination and decisions on appeal
- inserted Article 94 - Actions before the Court of First Instance and the Court of Justice
- inserted Article 95 - Conflicts of opinion with other bodies
- inserted Article 96 - The budget of the Agency
- inserted Article 97 - Implementation of the budget of the Agency
- inserted Article 98 - Combating fraud
- inserted Article 99 - Financial rules
- inserted Article 100 - Legal personality of the Agency
- inserted Article 101 - Liability of the Agency
- inserted Article 102 - Privileges and immunities of the Agency
- inserted Article 103 - Staff rules and regulations
- inserted Article 104 - Languages
- inserted Article 105 - Duty of confidentiality
- inserted Article 106 - Participation of third countries
- inserted Article 107 - Participation of international organisations
- inserted Article 108 - Contacts with stakeholder organisations
- inserted Article 109 - Rules on transparency
- inserted Article 110 - Relations with relevant Community bodies
- inserted Article 111 - Formats and software for submission of information to the Agency
Title XI
- inserted Article 112 - Scope
- inserted Article 113 - Obligation to notify the Agency
- inserted Article 114 - Classification and labelling inventory
- inserted Article 115 - Harmonisation of classification and labelling
- inserted Article 116 - Transitional arrangements
Title XII
- inserted Article 117 - Reporting
- inserted Article 118 - Access to information
- inserted Article 119 - Electronic public access
- inserted Article 120 - Cooperation with third countries and international organisations
Title XIII
- inserted Article 121 - Appointment
- inserted Article 122 - Cooperation between competent authorities
- inserted Article 123 - Communication to the public of information on risks of substances
- inserted Article 124 - Other responsibilities
Title XIV
- inserted Article 125 - Tasks of the Member States
- inserted Article 126 - Penalties for non-compliance
- inserted Article 127 - Report
Title XV
- inserted Article 128 - Free movement
- inserted Article 129 - Safeguard clause
- inserted Article 130 - Statement of reasons for decisions
- inserted Article 131 - Amendments to the Annexes
- inserted Article 132 - Implementing legislation
- inserted Article 133 - Committee procedure
- inserted Article 134 - Preparation of establishment of the Agency
- inserted Article 135 - Transitional measures regarding notified substances
- inserted Article 136 - Transitional measures regarding existing substances
- inserted Article 137 - Transitional measures regarding restrictions
- inserted Article 138 - Review
- inserted Article 139 - Repeals
- inserted Article 140 - Amendment of Directive 1999/45/EC
- inserted Article 141 - Entry into force and application
Outside any heading
- inserted Recital 1
- inserted Recital 2
- inserted Recital 3
- inserted Recital 4
- inserted Recital 5
- inserted Recital 6
- inserted Recital 7
- inserted Recital 8
- inserted Recital 9
- inserted Recital 10
- inserted Recital 11
- inserted Recital 12
- inserted Recital 13
- inserted Recital 14
- inserted Recital 15
- inserted Recital 16
- inserted Recital 17
- inserted Recital 18
- inserted Recital 19
- inserted Recital 20
- inserted Recital 21
- inserted Recital 22
- inserted Recital 23
- inserted Recital 24
- inserted Recital 25
- inserted Recital 26
- inserted Recital 27
- inserted Recital 28
- inserted Recital 29
- inserted Recital 30
- inserted Recital 31
- inserted Recital 32
- inserted Recital 33
- inserted Recital 34
- inserted Recital 35
- inserted Recital 36
- inserted Recital 37
- inserted Recital 38
- inserted Recital 39
- inserted Recital 40
- inserted Recital 41
- inserted Recital 42
- inserted Recital 43
- inserted Recital 44
- inserted Recital 45
- inserted Recital 46
- inserted Recital 47
- inserted Recital 48
- inserted Recital 49
- inserted Recital 50
- inserted Recital 51
- inserted Recital 52
- inserted Recital 53
- inserted Recital 54
- inserted Recital 55
- inserted Preamble
- inserted Annex I - GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
- inserted Annex II - GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
- inserted Annex III - CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
- inserted Annex IV - EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)
- inserted Annex IX - STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE (68)
- inserted Annex V - EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)
- inserted Annex VI - INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
- inserted Annex VII - STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE (64)
- inserted Annex VIII - STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE (66)
- inserted Annex X - STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE (70)
- inserted Annex XI - GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
- inserted Annex XII - GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
- inserted Annex XIII - CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
- inserted Annex XIV - LIST OF SUBSTANCES SUBJECT TO AUTHORISATION
- inserted Annex XV - DOSSIERS
- inserted Annex XVI - SOCIO-ECONOMIC ANALYSIS
- inserted Annex XVII - RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES