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Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)

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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 mixtures

      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 mixtures 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 mixtures 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, MIXTURES 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 eco-toxicological properties are likely to...

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

        6. 0.6. Steps of a chemical safety assessment

          1. 0.6.1. A chemical safety assessment performed by a manufacturer or an...

          2. 0.6.2. In the cases referred to in point 0.6.3 the chemical...

          3. 0.6.3. Where as a result of steps 1 to 4 the...

          4. 0.6.4. A summary of all the relevant information used in addressing...

        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. 0.11. bis When nanoforms are covered by the chemical safety assessment, an...

        13. 0.12. Where the methodology described in this Annex is not appropriate,...

        14. 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 objectives 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 developed in accordance with the criteria in...

          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 developed in accordance with the criteria in...

      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 developed in accordance with the criteria in...

          2. 3.2.2. If the information is 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. . . . . . . . . . ....

                2. 5.3.2. . . . . . . . . . ....

                3. 5.3.3. . . . . . . . . . ....

              4. 5.4. Corrosivity

              5. 5.5. Sensitisation

                1. 5.5.1. . . . . . . . . . ....

                2. 5.5.2. . . . . . . . . . ....

              6. 5.6. Repeated dose toxicity

              7. 5.7. Germ cell mutagenicity

              8. 5.8. Carcinogenicity

              9. 5.9. Toxicity for reproduction

                1. 5.9.1. . . . . . . . . . ....

                2. 5.9.2. . . . . . . . . . ....

              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

      REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS

      1. PART A

        1. 0.1. Introduction

          1. 0.1.1. This Annex sets out the requirements that the supplier shall...

          2. 0.1.2. The information on substances provided in the safety data sheet...

          3. 0.1.3. The safety data sheet shall mention in each relevant section...

        2. 0.2. General requirements for compiling a safety data sheet

          1. 0.2.1. The safety data sheet shall enable users to take the...

          2. 0.2.2. The information provided by safety data sheets shall also meet...

          3. 0.2.3. The information in the safety data sheet shall be written...

          4. 0.2.4. The language used in the safety data sheet shall be...

          5. 0.2.5. The date of compilation of the safety data sheet shall...

        3. 0.3. Safety data sheet format

          1. 0.3.1. A safety data sheet is not a fixed length document....

          2. 0.3.2. All pages of a safety data sheet, including any annexes,...

        4. 0.4. Safety data sheet content

        5. 0.5. Other information requirements

        6. 0.6. Units

        7. 0.7. Special cases

          1. 1. SECTION 1: Identification of the substance/mixture and of the company/undertaking...

            1. 1.1. Product identifier

              1. Other means of identification

            2. 1.2. Relevant identified uses of the substance or mixture and uses...

            3. 1.3. Details of the supplier of the safety data sheet

            4. 1.4. Emergency telephone number

          2. 2. SECTION 2: Hazards identification

            1. 2.1. Classification of the substance or mixture

            2. 2.2. Label elements

            3. 2.3. Other hazards

          3. 3. SECTION 3: Composition/information on ingredients

            1. 3.1. Substances

            2. 3.2. Mixtures

              1. 3.2.1. For a mixture meeting the criteria for classification in accordance...

              2. 3.2.2. For a mixture not meeting the criteria for classification in...

              3. 3.2.3. For the substances indicated in subsection 3.2:

              4. 3.2.4. For the substances indicated in subsection 3.2 the name and,...

          4. 4. SECTION 4: First aid measures

            1. 4.1. Description of first aid measures

              1. 4.1.1. First aid instructions shall be provided by relevant routes of...

              2. 4.1.2. Advice shall be provided as to whether:

            2. 4.2. Most important symptoms and effects, both acute and delayed

            3. 4.3. Indication of any immediate medical attention and special treatment needed...

          5. 5. SECTION 5: Firefighting measures

            1. 5.1. Extinguishing media

            2. 5.2. Special hazards arising from the substance or mixture

            3. 5.3. Advice for firefighters

          6. 6. SECTION 6: Accidental release measures

            1. 6.1. Personal precautions, protective equipment and emergency procedures

              1. 6.1.1. For non-emergency personnel

              2. 6.1.2. For emergency responders

            2. 6.2. Environmental precautions

            3. 6.3. Methods and material for containment and cleaning up

              1. 6.3.1. Appropriate advice shall be provided on how to contain a...

              2. 6.3.2. Appropriate advice shall be provided on how to clean-up a...

              3. 6.3.3. Any other information shall be provided relating to spills and...

            4. 6.4. Reference to other sections

          7. 7. SECTION 7: Handling and storage

            1. 7.1. Precautions for safe handling

              1. 7.1.1. Recommendations shall be specified to:

              2. 7.1.2. Advice on general occupational hygiene shall be provided, such as:...

            2. 7.2. Conditions for safe storage, including any incompatibilities

            3. 7.3. Specific end use(s)

          8. 8. SECTION 8: Exposure controls/personal protection

            1. 8.1. Control parameters

              1. 8.1.1. Where available, the following national limit values, including the legal...

              2. 8.1.1.1. the national occupational exposure limit values that correspond to Union...

              3. 8.1.1.2. the national occupational exposure limit values that correspond to Union...

              4. 8.1.1.3. any other national occupational exposure limit values;

              5. 8.1.1.4. the national biological limit values that correspond to Union biological...

              6. 8.1.1.5. any other national biological limit values.

              7. 8.1.2. Information on currently recommended monitoring procedures shall be provided at...

              8. 8.1.3. If air contaminants are formed when using the substance or...

              9. 8.1.4. Where a chemical safety report is required or where a...

              10. 8.1.5. Where a control banding approach is used to decide on...

            2. 8.2. Exposure controls

              1. 8.2.1. Appropriate engineering controls

              2. 8.2.2. Individual protection measures, such as personal protective equipment

                1. 8.2.2.1. The information on use of personal protective equipment shall be...

                2. 8.2.2.2. Taking into account Regulation (EU) 2016/425 of the European Parliament...

              3. 8.2.3. Environmental exposure controls

          9. 9. SECTION 9: Physical and chemical properties

            1. 9.1. Information on basic physical and chemical properties

            2. 9.2. Other information

              1. 9.2.1. Information with regard to physical hazard classes

              2. 9.2.2. Other safety characteristics

          10. 10. SECTION 10: Stability and reactivity

            1. 10.1. Reactivity

              1. 10.1.1. The reactivity hazards of the substance or mixture shall be...

              2. 10.1.2. If data for mixtures are not available, data on substances...

            2. 10.2. Chemical stability

            3. 10.3. Possibility of hazardous reactions

            4. 10.4. Conditions to avoid

            5. 10.5. Incompatible materials

            6. 10.6. Hazardous decomposition products

          11. 11. SECTION 11: Toxicological information

            1. 11.1. Information on hazard classes as defined in Regulation (EC) No...

              1. 11.1.1. Information shall be provided for each hazard class or differentiation....

              2. 11.1.2. The data included in this subsection shall apply to the...

              3. 11.1.3. Where there is a substantial amount of test data on...

              4. 11.1.4. Where the classification criteria for a particular hazard class are...

              5. 11.1.5. Information on likely routes of exposure

              6. 11.1.6. Symptoms related to the physical, chemical and toxicological characteristics

              7. 11.1.7. Delayed and immediate effects as well as chronic effects from...

              8. 11.1.8. Interactive effects

              9. 11.1.9. Absence of specific data

              10. 11.1.10. Mixtures

              11. 11.1.11. Mixture versus substance information

                1. 11.1.11.1. The substances in a mixture may interact with each other...

                2. 11.1.11.2. It is necessary to consider whether the concentration of each...

            2. 11.2 Information on other hazards

              1. 11.2.1. Endocrine disrupting properties

              2. 11.2.2. Other information

          12. 12. SECTION 12: Ecological information

            1. 12.1. Toxicity

            2. 12.2. Persistence and degradability

            3. 12.3. Bioaccumulative potential

            4. 12.4. Mobility in soil

            5. 12.5. Results of PBT and vPvB assessment

            6. 12.6. Endocrine disrupting properties

            7. 12.7. Other adverse effects

          13. 13. SECTION 13: Disposal considerations

            1. 13.1. Waste treatment methods

          14. 14. SECTION 14: Transport information

            1. 14.1. UN number or ID number

            2. 14.2. UN proper shipping name

            3. 14.3. Transport hazard class(es)

            4. 14.4. Packing group

            5. 14.5. Environmental hazards

            6. 14.6. Special precautions for user

            7. 14.7. Maritime transport in bulk according to IMO instruments

          15. 15. SECTION 15: Regulatory information

            1. 15.1. Safety, health and environmental regulations/legislation specific for the substance or...

            2. 15.2. Chemical safety assessment

          16. 16. SECTION 16: Other information

      2. PART B

        1. SECTION 1: Identification of the substance/mixture and of the company/undertaking

          1. 1.1. Product identifier

          2. 1.2. Relevant identified uses of the substance or mixture and uses...

          3. 1.3. Details of the supplier of the safety data sheet

          4. 1.4. Emergency telephone number

        2. SECTION 2: Hazards identification

          1. 2.1. Classification of the substance or mixture

          2. 2.2. Label elements

          3. 2.3. Other hazards

        3. SECTION 3: Composition/information on ingredients

          1. 3.1. Substances

          2. 3.2. Mixtures

        4. SECTION 4: First aid measures

          1. 4.1. Description of first aid measures

          2. 4.2. Most important symptoms and effects, both acute and delayed

          3. 4.3. Indication of any immediate medical attention and special treatment needed...

        5. SECTION 5: Firefighting measures

          1. 5.1. Extinguishing media

          2. 5.2. Special hazards arising from the substance or mixture

          3. 5.3. Advice for firefighters

        6. SECTION 6: Accidental release measures

          1. 6.1. Personal precautions, protective equipment and emergency procedures

          2. 6.2. Environmental precautions

          3. 6.3. Methods and material for containment and cleaning up

          4. 6.4. Reference to other sections

        7. SECTION 7: Handling and storage

          1. 7.1. Precautions for safe handling

          2. 7.2. Conditions for safe storage, including any incompatibilities

          3. 7.3. Specific end use(s)

        8. SECTION 8: Exposure controls/personal protection

          1. 8.1. Control parameters

          2. 8.2. Exposure controls

        9. SECTION 9: Physical and chemical properties

          1. 9.1. Information on basic physical and chemical properties

          2. 9.2. Other information

        10. SECTION 10: Stability and reactivity

          1. 10.1. Reactivity

          2. 10.2. Chemical stability

          3. 10.3. Possibility of hazardous reactions

          4. 10.4. Conditions to avoid

          5. 10.5. Incompatible materials

          6. 10.6. Hazardous decomposition products

        11. SECTION 11: Toxicological information

          1. 11.1. Information on hazard classes as defined in Regulation (EC) No...

          2. 11.2. Information on other hazards

        12. SECTION 12: Ecological information

          1. 12.1. Toxicity

          2. 12.2. Persistence and degradability

          3. 12.3. Bioaccumulative potential

          4. 12.4. Mobility in soil

          5. 12.5. Results of PBT and vPvB assessment

          6. 12.6. Endocrine disrupting properties

          7. 12.7. Other adverse effects

        13. SECTION 13: Disposal considerations

          1. 13.1. Waste treatment methods

        14. SECTION 14: Transport information

          1. 14.1. UN number or ID number

          2. 14.2. UN proper shipping name

          3. 14.3. Transport hazard class(es)

          4. 14.4. Packing group

          5. 14.5. Environmental hazards

          6. 14.6. Special precautions for user

          7. 14.7. Maritime transport in bulk according to IMO instruments

        15. SECTION 15: Regulatory information

          1. 15.1. Safety, health and environmental regulations/legislation specific for the substance or...

          2. 15.2. Chemical safety assessment

        16. SECTION 16: Other information

    3. ANNEX III

      CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

      1. Criteria for substances and, when applicable, for nanoforms thereof, registered...

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

    4. ANNEX IV

    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 which occur in nature other than those listed under...

      9. 9. The following substances obtained from natural sources, if they are...

      10. 10. The following substances if they are not chemically modified:

      11. 11. The following substances unless they meet the criteria for classification...

      12. 12. Compost, biogas and digestate.

      13. 13. Hydrogen and oxygen.

    6. ANNEX VI

      INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

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

      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. Where a registration covers one or...

          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 (e.g. ultra-violet, infra-red, nuclear magnetic resonance or mass...

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

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

          19. 2.4. Characterisation of nanoforms of a substance: For each of the...

          20. 2.4.1. Names or other identifiers of the nanoforms or sets of...

          21. 2.4.2. Number based particle size distribution with indication of the number...

          22. 2.4.3. Description of surface functionalisation or treatment and identification of each...

          23. 2.4.4. Shape, aspect ratio and other morphological characterisation: crystallinity, information on...

          24. 2.4.5. Surface area (specific surface area by volume, specific surface area...

          25. 2.4.6. 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, mixture 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 Section 1 of the safety data...

        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. Without prejudice to the information submitted for other forms, any...

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

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

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

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

      10. 8. TOXICOLOGICAL INFORMATION

      11. 9. ECOTOXICOLOGICAL INFORMATION

      12. 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. Without prejudice to the information submitted for other forms, any...

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

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

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

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

      7. 8. TOXICOLOGICAL INFORMATION

      8. 9. ECOTOXICOLOGICAL INFORMATION

    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. Without prejudice to the information submitted for other forms, any...

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

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

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

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

      8. 8. TOXICOLOGICAL INFORMATION

      9. 9. ECOTOXICOLOGICAL INFORMATION

      10. 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. Without prejudice to the information submitted for other forms, any...

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

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

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

      7. 8. TOXICOLOGICAL INFORMATION

      8. 9. ECOTOXICOLOGICAL INFORMATION

      9. 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. The requirements specific to nanoforms in this Annex are without...

      5. 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

      6. 2. TESTING IS TECHNICALLY NOT POSSIBLE

      7. 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 specific conditions of use must be communicated through the...

    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. For the identification of PBT substances and vPvB substances a...

      3. A weight-of-evidence determination means that all available information bearing on...

      4. The information used for the purposes of assessment of the...

      5. The identification shall also take account of the PBT/vPvB-properties of...

      6. This Annex shall apply to all organic substances, including organo-metals....

      7. 1. CRITERIA FOR THE IDENTIFICATION OF PBT AND vPvB SUBSTANCES

        1. 1.1. PBT Substances

          1. 1.1.1. Persistence

          2. 1.1.2. Bioaccumulation

          3. 1.1.3. Toxicity

        2. 1.2. vPvB Substances

          1. 1.2.1. Persistence

          2. 1.2.2. Bioaccumulation

      8. 2. SCREENING AND ASSESSMENT OF P, vP, B, vB and T...

        1. 2.1. Registration

        2. 2.2. Authorisation

      9. 3. INFORMATION RELEVANT FOR THE SCREENING AND ASSESSMENT OF P, vP,...

        1. 3.1. Screening Information

          1. 3.1.1. Indication of P and vP properties

          2. 3.1.2. Indication of B and vB properties

          3. 3.1.3. Indication of T properties

        2. 3.2. Assessment Information

          1. 3.2.1. Assessment of P or vP properties

          2. 3.2.2. Assessment of B or vB properties

          3. 3.2.3. Assessment of T properties

    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, MIXTURES AND ARTICLES

      1. Appendices 1 to 6

        1. FOREWORD Explanations of column headings

          1. Substances:

          2. Entries for groups of substances:

          3. Index number:

          4. EC numbers:

          5. CAS number:

          6. Notes:

      2. Appendix 1

        Entry 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2)

      3. Appendix 2

        Entry 28 — Carcinogens: category 1B (Table 3.1)/category 2 (Table 3.2)

      4. Appendix 3

        Entry 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2)

      5. Appendix 4

        Entry 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2)

      6. Appendix 5

        Entry 30 — Toxic to reproduction: category 1A (Table 3.1)/category 1 (Table 3.2)

      7. Appendix 6

        Entry 30 — Toxic to reproduction: category 1B (Table 3.1)/category 2 (Table 3.2)

      8. 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...

      9. Appendix 8

        Entry 43 — Azocolourants — List of aromatic amines

        1. List of aromatic amines

      10. Appendix 9

        Entry 43 — Azocolourants — List of azodyes

        1. List of azodyes

      11. Appendix 10

        1. Entry 43 — Azocolourants — List of testing methods List of testing methods

      12. Appendix 11

      13. Appendix 12

        1. Entry 72 — restricted substances and maximum concentration limits by...

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