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  1. Introductory Text

  2. TITLE I GENERAL ISSUES

    1. CHAPTER 1 Aim, scope and application

      1. Article 1. Aim and scope

      2. Article 2. Application

    2. CHAPTER 2 Definitions and general provision

      1. Article 3. Definitions

      2. Article 4. General provision

  3. TITLE II REGISTRATION OF SUBSTANCES

    1. CHAPTER 1 General obligation to register and information requirements

      1. Article 5. No data, no market

      2. Article 6. General obligation to register substances on their own or in preparations

      3. Article 7. Registration and notification of substances in articles

      4. Article 8. Only representative of a non-Community manufacturer

      5. Article 9. Exemption from the general obligation to register for product and process orientated research and development (PPORD)

      6. Article 10. Information to be submitted for general registration purposes

      7. Article 11. Joint submission of data by multiple registrants

      8. Article 12. Information to be submitted depending on tonnage

      9. Article 13. General requirements for generation of information on intrinsic properties of substances

      10. Article 14. Chemical safety report and duty to apply and recommend risk reduction measures

    2. CHAPTER 2 Substances regarded as being registered

      1. Article 15. Substances in plant protection and biocidal products

      2. Article 16. Duties of the Commission, the Agency and registrants of substances regarded as being registered

    3. CHAPTER 3 Obligation to register and information requirements for certain types of isolated intermediates

      1. Article 17. Registration of on-site isolated intermediates

      2. Article 18. Registration of transported isolated intermediates

      3. Article 19. Joint submission of data on isolated intermediates by multiple registrants

    4. CHAPTER 4 Common provisions for all registrations

      1. Article 20. Duties of the Agency

      2. Article 21. Manufacturing and import of substances

      3. Article 22. Further duties of registrants

    5. CHAPTER 5 Transitional provisions applicable to phase-in substances and notified substances

      1. Article 23. Specific provisions for phase-in substances

      2. Article 24. Notified substances

  4. TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

    1. CHAPTER 1 Objectives and general rules

      1. 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

    3. CHAPTER 3 Rules for phase-in-substances

      1. Article 28. Duty to pre-register for phase-in substances

      2. Article 29. Substance Information Exchange Forums

      3. Article 30. Sharing of data involving tests

  5. TITLE IV INFORMATION IN THE SUPPLY CHAIN

    1. Article 31. Requirements for safety data sheets

    2. 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

    3. Article 33. Duty to communicate information on substances in articles

    4. Article 34. Duty to communicate information on substances and preparations up the supply chain

    5. Article 35. Access to information for workers

    6. Article 36. Obligation to keep information

  6. TITLE V DOWNSTREAM USERS

    1. Article 37. Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures

    2. Article 38. Obligation for downstream users to report information

    3. Article 39. Application of downstream user obligations

  7. TITLE VI EVALUATION

    1. CHAPTER 1 Dossier evaluation

      1. Article 40. Examination of testing proposals

      2. Article 41. Compliance check of registrations

      3. Article 42. Check of information submitted and follow-up to dossier evaluation

      4. Article 43. Procedure and time periods for examination of testing proposals

    2. CHAPTER 2 Substance evaluation

      1. Article 44. Criteria for substance evaluation

      2. Article 45. Competent authority

      3. Article 46. Requests for further information and check of information submitted

      4. Article 47. Coherence with other activities

      5. Article 48. Follow-up to substance evaluation

    3. CHAPTER 3 Evaluation of intermediates

      1. Article 49. Further information on on-site isolated intermediates

    4. CHAPTER 4 Common provisions

      1. Article 50. Registrants' and downstream users' rights

      2. Article 51. Adoption of decisions under dossier evaluation

      3. Article 52. Adoption of decisions under substance evaluation

      4. Article 53. Cost sharing for tests without an agreement between registrants and/or downstream users

      5. Article 54. Publication of information on evaluation

  8. TITLE VII AUTHORISATION

    1. CHAPTER 1 Authorisation requirement

      1. Article 55. Aim of authorisation and considerations for substitution

      2. Article 56. General provisions

      3. Article 57. Substances to be included in Annex XIV

      4. Article 58. Inclusion of substances in Annex XIV

      5. Article 59. Identification of substances referred to in Article 57

    2. CHAPTER 2 Granting of authorisations

      1. Article 60. Granting of authorisations

      2. Article 61. Review of authorisations

      3. Article 62. Applications for authorisations

      4. Article 63. Subsequent applications for authorisation

      5. Article 64. Procedure for authorisation decisions

    3. CHAPTER 3 Authorisations in the supply chain

      1. Article 65. Obligation of holders of authorisations

      2. Article 66. Downstream users

  9. TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

    1. CHAPTER 1 General issues

      1. Article 67. General provisions

    2. CHAPTER 2 Restrictions process

      1. Article 68. Introducing new and amending current restrictions

      2. Article 69. Preparation of a proposal

      3. Article 70. Agency opinion: Committee for Risk Assessment

      4. Article 71. Agency opinion: Committee for Socio-economic Analysis

      5. Article 72. Submission of an opinion to the Commission

      6. Article 73. Commission decision

  10. TITLE IX FEES AND CHARGES

    1. Article 74. Fees and charges

  11. TITLE X AGENCY

    1. Article 75. Establishment and review

    2. Article 76. Composition

    3. Article 77. Tasks

    4. Article 78. Powers of the Management Board

    5. Article 79. Composition of the Management Board

    6. Article 80. Chairmanship of the Management Board

    7. Article 81. Meetings of the Management Board

    8. Article 82. Voting of the Management Board

    9. Article 83. Duties and powers of the Executive Director

    10. Article 84. Appointment of the Executive Director

    11. Article 85. Establishment of the Committees

    12. Article 86. Establishment of the Forum

    13. Article 87. Rapporteurs of Committees and use of experts

    14. Article 88. Qualification and interests

    15. Article 89. Establishment of the Board of Appeal

    16. Article 90. Members of the Board of Appeal

    17. Article 91. Decisions subject to appeal

    18. Article 92. Persons entitled to appeal, time-limits, fees and form

    19. Article 93. Examination and decisions on appeal

    20. Article 94. Actions before the Court of First Instance and the Court of Justice

    21. Article 95. Conflicts of opinion with other bodies

    22. Article 96. The budget of the Agency

    23. Article 97. Implementation of the budget of the Agency

    24. Article 98. Combating fraud

    25. Article 99. Financial rules

    26. Article 100. Legal personality of the Agency

    27. Article 101. Liability of the Agency

    28. Article 102. Privileges and immunities of the Agency

    29. Article 103. Staff rules and regulations

    30. Article 104. Languages

    31. Article 105. Duty of confidentiality

    32. Article 106. Participation of third countries

    33. Article 107. Participation of international organisations

    34. Article 108. Contacts with stakeholder organisations

    35. Article 109. Rules on transparency

    36. Article 110. Relations with relevant Community bodies

    37. Article 111. Formats and software for submission of information to the Agency

  12. TITLE XI CLASSIFICATION AND LABELLING INVENTORY

    1. Article 112. Scope

    2. Article 113. Obligation to notify the Agency

    3. Article 114. Classification and labelling inventory

    4. Article 115. Harmonisation of classification and labelling

    5. Article 116. Transitional arrangements

  13. TITLE XII INFORMATION

    1. Article 117. Reporting

    2. Article 118. Access to information

    3. Article 119. Electronic public access

    4. Article 120. Cooperation with third countries and international organisations

  14. TITLE XIII COMPETENT AUTHORITIES

    1. Article 121. Appointment

    2. Article 122. Cooperation between competent authorities

    3. Article 123. Communication to the public of information on risks of substances

    4. Article 124. Other responsibilities

  15. TITLE XIV ENFORCEMENT

    1. Article 125. Tasks of the Member States

    2. Article 126. Penalties for non-compliance

    3. Article 127. Report

  16. TITLE XV TRANSITIONAL AND FINAL PROVISIONS

    1. Article 128. Free movement

    2. Article 129. Safeguard clause

    3. Article 130. Statement of reasons for decisions

    4. Article 131. Amendments to the Annexes

    5. Article 132. Implementing legislation

    6. Article 133. Committee procedure

    7. Article 134. Preparation of establishment of the Agency

    8. Article 135. Transitional measures regarding notified substances

    9. Article 136. Transitional measures regarding existing substances

    10. Article 137. Transitional measures regarding restrictions

    11. Article 138. Review

    12. Article 139. Repeals

    13. Article 140. Amendment of Directive 1999/45/EC

    14. Article 141. Entry into force and application

  17. Signature

    1. ANNEX I

      GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS

      1. 0. INTRODUCTION

        1. 0.1. The purpose of this Annex is to set out how...

        2. 0.2. The chemical safety assessment shall be prepared by one or...

        3. 0.3. The chemical safety assessment of a manufacturer shall address the...

        4. 0.4. Substances whose physicochemical, toxicological and ecotoxicological properties are likely to...

        5. 0.5. The chemical safety assessment shall be based on the information...

        6. 0.6. A chemical safety assessment performed by a manufacturer or an...

        7. 0.7. The main element of the exposure part of the chemical...

        8. 0.8. The level of detail required in describing an exposure scenario...

        9. 0.9. Where information is not necessary in accordance with Annex XI,...

        10. 0.10. In relation to particular effects, such as ozone depletion, photochemical...

        11. 0.11. When assessing the risk of the use of one or...

        12. 0.12. Where the methodology described in this Annex is not appropriate,...

        13. 0.13. Part A of the chemical safety report shall include a...

      2. 1. HUMAN HEALTH HAZARD ASSESSMENT

        1. 1.0. Introduction

          1. 1.0.1. The objective of the human health hazard assessment shall be:...

          2. 1.0.2. The human health hazard assessment shall consider the toxicokinetic profile...

          3. 1.0.3. The hazard assessment shall comprise the following four steps:

          4. 1.0.4. The first three steps shall be undertaken for every effect...

          5. 1.0.5. For any effect for which no relevant information is available,...

          6. 1.0.6. Step 4 of the human health hazard assessment shall be...

        2. 1.1. Step 1: Evaluation of non-human information

          1. 1.1.1. The evaluation of non-human information shall comprise:

          2. 1.1.2. When it is not possible to establish the quantitative dose...

          3. 1.1.3. All non-human information used to assess a particular effect on...

          4. 1.1.4. If one study is available then a robust study summary...

        3. 1.2. Step 2: Evaluation of human information

        4. 1.3. Step 3: Classification and Labelling

          1. 1.3.1. The appropriate classification and labelling developed in accordance with the...

          2. 1.3.2. If the information is inadequate to decide whether a substance...

        5. 1.4. Step 4: Identification of DNEL(s)

          1. 1.4.1. Based on the outcomes of steps 1 and 2, (a)...

          2. 1.4.2. If it is not possible to identify a DNEL, then...

      3. 2. PHYSICOCHEMICAL HAZARD ASSESSMENT

        1. 2.1. The objective of the hazard assessment for physicochemical properties shall...

        2. 2.2. As a minimum, the potential effects to human health shall...

        3. 2.3. The assessment of each effect shall be presented under the...

        4. 2.4. For every physicochemical property, the assessment shall entail an evaluation...

        5. 2.5. The appropriate classification and labelling developed in accordance with the...

      4. 3. ENVIRONMENTAL HAZARD ASSESSMENT

        1. 3.0. Introduction

          1. 3.0.1. The objective of the environmental hazard assessment shall be to...

          2. 3.0.2. The environmental hazard assessment shall consider the potential effects on...

          3. 3.0.3. For any environmental sphere, for which no effect information is...

          4. 3.0.4. The hazard assessment shall comprise the following three steps, which...

        2. 3.1. Step 1: Evaluation of information

          1. 3.1.1. The evaluation of all available information shall comprise:

          2. 3.1.2. When it is not possible to establish the quantitative dose...

          3. 3.1.3. All information used to assess the effects on a specific...

          4. 3.1.4. All information used to assess the environmental fate of the...

          5. 3.1.5. If one study is available then a robust study summary...

        3. 3.2. Step 2: Classification and Labelling

          1. 3.2.1. The appropriate classification and labelling developed in accordance with the...

          2. 3.2.2. If the information are inadequate to decide whether a substance...

        4. 3.3. Step 3: Identification of the PNEC

          1. 3.3.1. Based on the available information, the PNEC for each environmental...

          2. 3.3.2. If it is not possible to derive the PNEC, then...

      5. 4. PBT AND VPVB ASSESSMENT

        1. 4.0. Introduction

          1. 4.0.1. The objective of the PBT and vPvB assessment shall be...

          2. 4.0.2. The PBT and vPvB assessment shall comprise the following two...

        2. 4.1. Step 1: Comparison with the Criteria

        3. 4.2. Step 2: Emission Characterisation

      6. 5. EXPOSURE ASSESSMENT

        1. 5.0. Introduction

        2. 5.1. Step 1: Development of exposure scenarios

          1. 5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall...

          2. 5.1.2. Where a manufacturer, importer or downstream user applies for an...

        3. 5.2. Step 2: Exposure Estimation

          1. 5.2.1. The exposure shall be estimated for each exposure scenario developed...

          2. 5.2.2. The emission estimation shall consider the emissions during all relevant...

          3. 5.2.3. A characterisation of possible degradation, transformation, or reaction processes and...

          4. 5.2.4. An estimation of the exposure levels shall be performed for...

          5. 5.2.5. Where adequately measured representative exposure data are available, special consideration...

      7. 6. RISK CHARACTERISATION

        1. 6.1. The risk characterisation shall be carried out for each exposure...

        2. 6.2. The risk characterisation shall consider the human populations (exposed as...

        3. 6.3. The risk characterisation consists of:

        4. 6.4. For any exposure scenario, the risk to humans and the...

        5. 6.5. For those human effects and those environmental spheres for which...

      8. 7. CHEMICAL SAFETY REPORT FORMAT

        1. CHEMICAL SAFETY REPORT FORMAT

          1. PART A 1. SUMMARY OF RISK MANAGEMENT MEASURES

            1. 1. SUMMARY OF RISK MANAGEMENT MEASURES

            2. 2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED

            3. 3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED

          2. PART B 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES...

            1. 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES

            2. 2. MANUFACTURE AND USES

              1. 2.1. Manufacture

              2. 2.2. Identified uses

              3. 2.3. Uses advised against

            3. 3. CLASSIFICATION AND LABELLING

            4. 4. ENVIRONMENTAL FATE PROPERTIES

              1. 4.1. Degradation

              2. 4.2. Environmental distribution

              3. 4.3. Bioaccumulation

              4. 4.4. Secondary poisoning

            5. 5. HUMAN HEALTH HAZARD ASSESSMENT

              1. 5.1. Toxicokinetics (absorption, metabolism, distribution and elimination)

              2. 5.2. Acute toxicity

              3. 5.3. Irritation

                1. 5.3.1. Skin

                2. 5.3.2. Eye

                3. 5.3.3. Respiratory tract

              4. 5.4. Corrosivity

              5. 5.5. Sensitisation

                1. 5.5.1. Skin

                2. 5.5.2. Respiratory system

              6. 5.6. Repeated dose toxicity

              7. 5.7. Mutagenicity

              8. 5.8. Carcinogenicity

              9. 5.9. Toxicity for reproduction

                1. 5.9.1. Effects on fertility

                2. 5.9.2. Developmental toxicity

              10. 5.10. Other effects

              11. 5.11. Derivation of DNEL(s)

            6. 6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES

              1. 6.1. Explosivity

              2. 6.2. Flammability

              3. 6.3. Oxidising potential

            7. 7. ENVIRONMENTAL HAZARD ASSESSMENT

              1. 7.1. Aquatic compartment (including sediment)

              2. 7.2. Terrestrial compartment

              3. 7.3. Atmospheric compartment

              4. 7.4. Microbiological activity in sewage treatment systems

            8. 8. PBT AND VPVB ASSESSMENT

            9. 9. EXPOSURE ASSESSMENT

              1. 9.1. (Title of exposure scenario 1)

                1. 9.1.1. Exposure scenario

                2. 9.1.2. Exposure estimation

              2. 9.2. (Title of exposure scenario 2)

                1. 9.2.1. Exposure scenario

                2. 9.2.2. Exposure estimation

            10. 10. RISK CHARACTERISATION

              1. 10.1. (Title of exposure scenario 1)

                1. 10.1.1. Human health

                  1. 10.1.1.1. Workers

                  2. 10.1.1.2. Consumers

                  3. 10.1.1.3. Indirect exposure to humans via the environment

                2. 10.1.2. Environment

                  1. 10.1.2.1. Aquatic compartment (including sediment)

                  2. 10.1.2.2. Terrestrial compartment

                  3. 10.1.2.3. Atmospheric compartment

                  4. 10.1.2.4. Microbiological activity in sewage treatment systems

              2. 10.2. (Title of exposure scenario 2)

                1. 10.2.1. Human health

                  1. 10.2.1.1. Workers

                  2. 10.2.1.2. Consumers

                  3. 10.2.1.3. Indirect exposure to humans via the environment

                2. 10.2.2. Environment

                  1. 10.2.2.1. Aquatic compartment (including sediment)

                  2. 10.2.2.2. Terrestrial compartment

                  3. 10.2.2.3. Atmospheric compartment

                  4. 10.2.2.4. Microbiological activity in sewage treatment systems

              3. 10.x. Overall exposure (combined for all relevant emission/release sources)

                1. 10.x.1. Human health (combined for all exposure routes)

                2. 10.x.2. Environment (combined for all emission sources)

    2. ANNEX II

      GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

      1. This Annex sets out the requirements for a Safety Data...

      2. The purpose of this Annex is to ensure consistency and...

      3. The information provided by Safety Data Sheets shall also meet...

      4. The information in the Safety Data Sheet shall be written...

      5. For preparations not classified as dangerous, but for which a...

      6. Additional information may be necessary in some cases in view...

      7. Give the date of issue of the Safety Data Sheet...

      8. Note

      9. 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

        1. 1.1. Identification of the substance or preparation

        2. 1.2. Use of the substance/preparation

        3. 1.3. Company/undertaking identification

        4. 1.4. Emergency telephone

      10. 2. HAZARDS IDENTIFICATION

      11. 3. COMPOSITION/INFORMATION ON INGREDIENTS

        1. 3.1. It is not necessary to give the full composition (nature...

        2. 3.2. For a preparation classified as dangerous according to Directive 1999/45/EC,...

        3. 3.3. For a preparation not classified as dangerous according to Directive...

        4. 3.4. The classification (derived either from Articles 4 and 6 of...

        5. 3.5. The name and the Registration number, assigned under Article 20(1)...

        6. 3.6. If, in accordance with the provisions of Article 15 of...

      12. 4. FIRST AID MEASURES

      13. 5. FIRE-FIGHTING MEASURES

      14. 6. ACCIDENTAL RELEASE MEASURES

        1. Note

      15. 7. HANDLING AND STORAGE

        1. Note

        2. 7.1. Handling

        3. 7.2. Storage

        4. 7.3. Specific use(s)

      16. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

        1. 8.1. Exposure limit values

        2. 8.2. Exposure controls

          1. 8.2.1. Occupational exposure controls

          2. 8.2.2. Environmental exposure controls

      17. 9. PHYSICAL AND CHEMICAL PROPERTIES

        1. 9.1. General information

          1. Appearance:

          2. Odour:

        2. 9.2. Important health, safety and environmental information

        3. 9.3. Other information

          1. Note 1

          2. Note 2

      18. 10. STABILITY AND REACTIVITY

        1. 10.1. Conditions to avoid

        2. 10.2. Materials to avoid

        3. 10.3. Hazardous decomposition products

          1. Note

      19. 11. TOXICOLOGICAL INFORMATION

      20. 12. ECOLOGICAL INFORMATION

        1. 12.1. Ecotoxicity

        2. 12.2. Mobility

        3. 12.3. Persistence and degradability

        4. 12.4. Bioaccumulative potential

        5. 12.5. Results of PBT assessment

        6. 12.6. Other adverse effects

          1. Remarks

      21. 13. DISPOSAL CONSIDERATIONS

        1. Note

      22. 14. TRANSPORT INFORMATION

      23. 15. REGULATORY INFORMATION

      24. 16. OTHER INFORMATION

    3. ANNEX III

      CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

      1. Criteria for substances registered between 1 and 10 tonnes, with...

      2. substances for which it is predicted (ie by the application...

    4. ANNEX IV

      EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)

      1. Annex IV Table 1

    5. ANNEX V

      EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)

      1. 1. Substances which result from a chemical reaction that occurs incidental...

      2. 2. Substances which result from a chemical reaction that occurs incidental...

      3. 3. Substances which result from a chemical reaction occurring upon end...

      4. 4. Substances which are not themselves manufactured, imported or placed on...

      5. 5. By-products, unless they are imported or placed on the market...

      6. 6. Hydrates of a substance or hydrated ions, formed by association...

      7. 7. The following substances which occur in nature, if they are...

      8. 8. Substances occurring in nature other than those listed under paragraph...

      9. 9. Basic elemental substances for which hazards and risks are already...

    6. ANNEX VI

      INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

      1. GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO...

      2. STEP 1 — GATHER AND SHARE EXISTING INFORMATION

      3. STEP 2 — CONSIDER INFORMATION NEEDS

      4. STEP 3 — IDENTIFY INFORMATION GAPS

      5. STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY

        1. NOTES

      6. INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v)

        1. 1. GENERAL REGISTRANT INFORMATION

          1. 1.1. Registrant

          2. 1.1.1. Name, address, telephone number, fax number and e-mail address

          3. 1.1.2. Contact person

          4. 1.1.3. Location of the registrant's production and own use site(s), as...

          5. 1.2. Joint submission of data

          6. 1.3 Third party appointed under Article 4

          7. 1.3.1. Name, address, telephone number, fax number and e-mail address

          8. 1.3.2. Contact person

        2. 2. IDENTIFICATION OF THE SUBSTANCE

          1. 2.1. Name or other identifier of each substance

          2. 2.1.1. Name(s) in the IUPAC nomenclature or other international chemical name(s)...

          3. 2.1.2. Other names (usual name, trade name, abbreviation)

          4. 2.1.3. EINECS or ELINCs number (if available and appropriate)

          5. 2.1.4. CAS name and CAS number (if available)

          6. 2.1.5. Other identity code (if available)

          7. 2.2. Information related to molecular and structural formula of each substance...

          8. 2.2.1. Molecular and structural formula (including SMILES notation, if available)

          9. 2.2.2. Information on optical activity and typical ratio of (stereo) isomers...

          10. 2.2.3. Molecular weight or molecular weight range

          11. 2.3. Composition of each substance

          12. 2.3.1. Degree of purity ( %)

          13. 2.3.2. Nature of impurities, including isomers and by-products

          14. 2.3.3. Percentage of (significant) main impurities

          15. 2.3.4. Nature and order of magnitude (… ppm, … %) of...

          16. 2.3.5. Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)...

          17. 2.3.6. High-pressure liquid chromatogram, gas chromatogram

          18. 2.3.7. Description of the analytical methods or the appropriate bibliographical references...

        3. 3. INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)

          1. 3.1. Overall manufacture, quantities used for production of an article that...

          2. 3.2. In the case of a manufacturer or producer of articles:...

          3. 3.3. An indication of the tonnage used for his own use(s)...

          4. 3.4. Form (substance, preparation or article) and/or physical state under which...

          5. 3.5. Brief general description of the identified use(s)

          6. 3.6. Information on waste quantities and composition of waste resulting from...

          7. 3.7. Uses advised against (see Safety Data Sheet heading 16)

        4. 4. CLASSIFICATION AND LABELLING

          1. 4.1. The hazard classification of the substance(s), resulting from the application...

          2. 4.2. The resulting hazard label for the substance(s), resulting from the...

          3. 4.3. Specific concentration limits, where applicable, resulting from the application of...

        5. 5. GUIDANCE ON SAFE USE CONCERNING:

          1. 5.1. First-aid measures (Safety Data Sheet heading 4)

          2. 5.2. Fire-fighting measures (Safety Data Sheet heading 5)

          3. 5.3. Accidental release measures (Safety Data Sheet heading 6)

          4. 5.4. Handling and storage (Safety Data Sheet heading 7)

          5. 5.5. Transport information (Safety Data Sheet heading 14)

          6. 5.6. Exposure controls/personal protection (Safety Data Sheet heading 8)

          7. 5.7. Stability and reactivity (Safety Data Sheet heading 10)

          8. 5.8. Disposal considerations

          9. 5.8.1. Disposal considerations (Safety Data Sheet heading 13)

          10. 5.8.2. Information on recycling and methods of disposal for industry

          11. 5.8.3. Information on recycling and methods of disposal for the public....

        6. 6. INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1...

          1. 6.1. Main use category:

          2. 6.1.1. industrial use; and/or professional use; and/or consumer use.

          3. 6.1.2. Specification for industrial and professional use:

          4. 6.2. Significant route(s) of exposure:

          5. 6.2.1. Human exposure:

          6. 6.2.2. Environmental exposure:

          7. 6.3. Pattern of exposure:

    7. ANNEX VII

      STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE

      1. Column 1 of this Annex establishes the standard information required...

      2. non-phase-in substances manufactured or imported in quantities of 1 to...

      3. Any other relevant physicochemical, toxicological and ecotoxicological information that is...

      4. Column 2 of this Annex lists specific rules according to...

      5. In addition to these specific rules, a registrant may adapt...

      6. Before new tests are carried out to determine the properties...

      7. When, for certain endpoints, information is not provided for other...

      8. 7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

        1. Annex VII Table 1

      9. 8. TOXICOLOGICAL INFORMATION

        1. Annex VII Table 2

      10. 9. ECOTOXICOLOGICAL INFORMATION

        1. Annex VII Table 3

      11. Any other relevant physicochemical, toxicological and ecotoxicological information that is...

    8. ANNEX VIII

      STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

      1. Column 1 of this Annex establishes the standard information required...

      2. In addition to these specific rules, a registrant may adapt...

      3. Before new tests are carried out to determine the properties...

      4. When, for certain endpoints, information is not provided for other...

      5. 8. TOXICOLOGICAL INFORMATION

        1. Annex VIII Table 1

      6. 9. ECOTOXICOLOGICAL INFORMATION

        1. Annex VIII Table 2

    9. ANNEX IX

      STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

      1. At the level of this Annex, the registrant must submit...

      2. Column 1 of this Annex establishes the standard information required...

      3. In addition to these specific rules, a registrant may propose...

      4. Before new tests are carried out to determine the properties...

      5. When, for certain endpoints, it is proposed not to provide...

      6. 7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

        1. Annex IX Table 1

      7. 8. TOXICOLOGICAL INFORMATION

        1. Annex IX Table 2

      8. 9. ECOTOXICOLOGICAL INFORMATION

        1. Annex IX Table 3

      9. 10. METHODS OF DETECTION AND ANALYSIS

    10. ANNEX X

      STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE

      1. At the level of this Annex, the registrant must submit...

      2. Column 1 of this Annex establishes the standard information required...

      3. In addition to these specific rules, a registrant may propose...

      4. Before new tests are carried out to determine the properties...

      5. When, for certain endpoints, it is proposed not to provide...

      6. 8. TOXICOLOGICAL INFORMATION

        1. Annex X Table 1

      7. 9. ECOTOXICOLOGICAL INFORMATION

        1. Annex X Table 2

      8. 10. METHODS OF DETECTION AND ANALYSIS

    11. ANNEX XI

      GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X

      1. Annexes VII to X set out the information requirements for...

      2. one tonne or more in accordance with Article 12(1)(a), 10...

      3. In addition to the specific rules set out in column...

      4. 1. TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY

        1. 1.1. Use of existing data

          1. 1.1.1. Data on physical-chemical properties from experiments not carried out according...

          2. 1.1.2. Data on human health and environmental properties from experiments not...

          3. 1.1.3. Historical human data

        2. 1.2. Weight of evidence

        3. 1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)

        4. 1.4. In vitro methods

        5. 1.5. Grouping of substances and read-across approach

      5. 2. TESTING IS TECHNICALLY NOT POSSIBLE

      6. 3. SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING

        1. 3.1. Testing in accordance with Sections 8.6 and 8.7 of Annex...

        2. 3.2. In all cases, adequate justification and documentation shall be provided....

        3. 3.3. The Commission shall adopt the measures designed to amend non-essential...

    12. ANNEX XII

      GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS

      1. INTRODUCTION

        1. STEP 1: DEVELOPMENT OF EXPOSURE SCENARIO(S)

        2. STEP 2: IF NECESSARY, A REFINEMENT OF THE HAZARD ASSESSMENT...

        3. STEP 3: RISK CHARACTERISATION

    13. ANNEX XIII

      CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

      1. This Annex lays down the criteria for the identification of:...

      2. persistent, bioaccumulative and toxic substances (PBT-substances), and very persistent and...

      3. A substance is identified as a PBT substance if it...

      4. 1. PBT-SUBSTANCES

        1. 1.1. Persistence

        2. 1.2. Bioaccumulation

        3. 1.3. Toxicity

      5. 2. vPvB-SUBSTANCES

        1. 2.1. Persistence

        2. 2.2. Bioaccumulation

    14. ANNEX XIV

      LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

    15. ANNEX XV

      DOSSIERS

      1. I. INTRODUCTION AND GENERAL PROVISIONS

      2. II. CONTENT OF DOSSIERS

        1. 1. Dossier for harmonised classification and labelling for CMRs, respiratory sensitisers...

          1. Proposal

          2. Justification

          3. Justification for other effects at Community Level

        2. 2. Dossier for the identification of a substance as a CMR,...

          1. Proposal

          2. Justification

          3. Information on exposures, alternative substances and risks

        3. 3. Dossiers for restrictions proposal

          1. Proposal

          2. Information on hazard and risk

          3. Information on alternatives

          4. Justification for Restrictions at Community Level

          5. Socio-economic assessment

          6. Information on stakeholder consultation

    16. ANNEX XVI

      SOCIO-ECONOMIC ANALYSIS

      1. This Annex outlines the information that may be addressed by...

      2. The Agency shall prepare guidance for the preparation of SEAs....

      3. However, the level of detail and scope of the SEA,...

      4. An SEA may include the following elements:

      5. impact of a granted or refused authorisation on the applicant(s),...

    17. ANNEX XVII

      RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

      1. Annex XVII Table 1

      2. Appendices 1 to 6

        1. FOREWORD

          1. Explanations of column headings

            1. Substances:

            2. Index number:

            3. EINECS number:

            4. ELINCS number

            5. CAS number:

              1. Notes:

                1. Note A:

                2. Note C:

                3. Note D:

                4. Note E:

                5. Note H:

                6. Note J:

                7. Note K:

                8. Note L:

                9. Note M:

                10. Note N:

                11. Note P:

                12. Note R:

                13. Note S:

      3. Appendix 1

        Point 28 — Carcinogens: category 1

        1. Annex XVII Table 2

      4. Appendix 2

        Point 28 — Carcinogens: category 2

        1. Annex XVII Table 3

      5. Appendix 3

        Point 29 — Mutagens: category 1

      6. Appendix 4

        Point 29 — Mutagens: category 2

        1. Annex XVII Table 4

      7. Appendix 5

        Point 30 — Toxic to reproduction: category 1

        1. Annex XVII Table 5

      8. Appendix 6

        Point 30 — Toxic to reproduction: category 2

        1. Annex XVII Table 6

      9. Appendix 7

        Special provisions on the labelling of articles containing asbestos

        1. 1. All articles containing asbestos or the packaging thereof must bear...

        2. 2. The label mentioned in this Appendix shall be affixed in...

        3. 3. Labelling of packaged articles containing asbestos

          1. 3.1. The following particulars shall appear on clearly legible and indelible...

          2. 3.2. Labelling in accordance with 3.1 shall be effected by means...

          3. 3.3. Articles containing asbestos and which are packaged only in loose...

        4. 4. Labelling of unpackaged articles containing asbestos

        5. 5. Without prejudice to Community provisions on safety and hygiene at...

        6. 6. The labelling of any article intended for domestic use which...

        7. 7. The labelling of articles containing asbestos shall be in the...

      10. Appendix 8

        Point 43 — Azocolourants

        1. List of aromatic amines

          1. Annex XVII Table 7

      11. Appendix 9

        Point 43 — Azocolourants

        1. List of azodyes

          1. Annex XVII Table 8

      12. Appendix 10

        Point 43 — Azocolourants

        1. List of testing methods

          1. Annex XVII Table 9