Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

1. Introductory Text

2. CHAPTER I GENERAL PROVISIONS

   1. Article 1. Subject matter and purpose

   2. Article 2. Scope

   3. Article 3. Definitions

3. CHAPTER II ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS

   1. SECTION 1 Active substances

      1. Subsection 1 Requirements and conditions for approval

         1. Article 4. Approval criteria for active substances

         2. Article 5. First approval

         3. Article 6. Conditions and restrictions

      2. Subsection 2 Approval procedure

         1. Article 7. Application

         2. Article 8. Dossiers

         3. Article 9. Admissibility of the application

         4. Article 10. Access to the summary dossier

         5. Article 11. Draft assessment report

         6. Article 12. Conclusion by the Authority

         7. Article 13. Approval Regulation

      3. Subsection 3 Renewal and review

         1. Article 14. Renewal of approval

         2. Article 15. Application for renewal

         3. Article 16. Access to the information for renewal

         4. Article 17. Extension of approval period for the duration of the procedure

         5. Article 18. Work programme

         6. Article 19. Implementing measures

         7. Article 20. Renewal Regulation

         8. Article 21. Review of approval

      4. Subsection 4 Derogations

         1. Article 22. Low-risk active substances

         2. Article 23. Approval criteria for basic substances

         3. Article 24. Candidates for substitution

   2. SECTION 2 Safeners and synergists

      1. Article 25. Approval of safeners and synergists

      2. Article 26. Safeners and synergists already on the market

   3. SECTION 3 Unacceptable co-formulants

      1. Article 27. Co-formulants

4. CHAPTER III PLANT PROTECTION PRODUCTS

   1. SECTION 1 Authorisation

      1. Subsection 1 Requirements and contents

         1. Article 28. Authorisation for placing on the market and use

         2. Article 29. Requirements for the authorisation for placing on the market

         3. Article 30. Provisional authorisations

         4. Article 31. Contents of authorisations

         5. Article 32. Duration

      2. Subsection 2 Procedure

         1. Article 33. Application for authorisation or amendment of an authorisation

         2. Article 34. Exemption from the submission of studies

         3. Article 35. Member State examining the application

         4. Article 36. Examination for authorisation

         5. Article 37. Period for examination

         6. Article 38. Assessment of equivalence under point (b) of Article 29(1)

         7. Article 39. Reporting and exchange of information on applications for authorisation

      3. Subsection 3 Mutual recognition of authorisations

         1. Article 40. Mutual recognition

         2. Article 41. Authorisation

         3. Article 42. Procedure

      4. Subsection 4 Renewal, withdrawal and amendment

         1. Article 43. Renewal of authorisation

         2. Article 44. Withdrawal or amendment of an authorisation

         3. Article 45. Withdrawal or amendment of an authorisation at the request of the authorisation holder

         4. Article 46. Grace period

      5. Subsection 5 Special cases

         1. Article 47. Placing on the market of low-risk plant protection products

         2. Article 48. Placing on the market and use of plant protection products containing a genetically modified organism

         3. Article 49. Placing on the market of treated seeds

         4. Article 50. Comparative assessment of plant protection products containing candidates for substitution

         5. Article 51. Extension of authorisations for minor uses

         6. Article 52. Parallel trade

      6. Subsection 6 Derogations

         1. Article 53. Emergency situations in plant protection

         2. Article 54. Research and development

   2. SECTION 2 Use and information

      1. Article 55. Use of plant protection products

      2. Article 56. Information on potentially harmful or unacceptable effects

      3. Article 57. Obligation to keep information available

5. CHAPTER IV ADJUVANTS

   1. Article 58. Placing on the market and use of adjuvants

6. CHAPTER V DATA PROTECTION AND DATA SHARING

   1. Article 59. Data protection

   2. Article 60. List of test and study reports

   3. Article 61. General rules on avoidance of duplicative testing

   4. Article 62. Sharing of tests and studies involving vertebrate animals

7. CHAPTER VI PUBLIC ACCESS TO INFORMATION

   1. Article 63. Confidentiality

8. CHAPTER VII PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS

   1. Article 64. Packaging and presentation

   2. Article 65. Labelling

   3. Article 66. Advertising

9. CHAPTER VIII CONTROLS

   1. Article 67. Record-keeping

   2. Article 68. Monitoring and controls

10. CHAPTER IX EMERGENCIES

    1. Article 69. Emergency measures

    2. Article 70. Emergency measures in cases of extreme urgency

    3. Article 71. Other emergency measures

11. CHAPTER X ADMINISTRATIVE AND FINANCIAL PROVISIONS

    1. Article 72. Penalties

    2. Article 73. Civil and criminal liability

    3. Article 74. Fees and charges

    4. Article 75. Competent authority

    5. Article 76. Expenditure by the Commission

    6. Article 77. Guidance documents

    7. Article 78. Amendments and implementing measures

    8. Article 79. Committee procedure

12. CHAPTER XI TRANSITIONAL AND FINAL PROVISIONS

    1. Article 80. Transitional measures

    2. Article 81. Derogation for safeners and synergists, co-formulants and adjuvants

    3. Article 82. Review clause

    4. Article 83. Repeal

    5. Article 84. Entry into force and application

13. Signature

14. 1. ANNEX I

       Definition of zones for the authorisation of plant protection products as referred to in Article 3(17)

       1. Zone A — North

       2. Zone B — Centre

       3. Zone C — South

    2. ANNEX II

       Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II

       1. 1. Evaluation

          1. 1.1. During the process of evaluation and decision-making provided for in...

          2. 1.2. The evaluation by the Authority and the rapporteur Member State...

          3. 1.3. During the process of evaluation and decision-making provided for in...

       2. 2. General decision-making criteria

          1. 2.1. Article 4 shall only be considered as complied with, where,...

          2. 2.2. Submission of further information

          3. 2.3. Restrictions on approval

       3. 3. Criteria for the approval of an active substance

          1. 3.1. Dossier

          2. 3.2. Efficacy

          3. 3.3. Relevance of metabolites

          4. 3.4. Composition of the active substance, safener or synergist

             1. 3.4.1. The specification shall define the minimum degree of purity, the...

             2. 3.4.2. The specification shall be in compliance with the relevant Food...

          5. 3.5. Methods of analysis

             1. 3.5.1. The methods of analysis of the active substance, safener or...

             2. 3.5.2. The methods of residue analysis for the active substance and...

             3. 3.5.3. The evaluation has been carried out in accordance with the...

          6. 3.6. Impact on human health

             1. 3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established....

             2. 3.6.2. An active substance, safener or synergist shall only be approved...

             3. 3.6.3. An active substance, safener or synergist shall only be approved,...

             4. 3.6.4. An active substance, safener or synergist shall only be approved...

             5. 3.6.5. An active substance, safener or synergist shall only be approved...

          7. 3.7. Fate and behaviour in the environment

             1. 3.7.1. An active substance, safener or synergist shall only be approved...

                1. 3.7.1.1. Persistence

                2. 3.7.1.2. Bioaccumulation

                3. 3.7.1.3. Potential for long-range environmental transport:

             2. 3.7.2. An active substance, safener or synergist shall only be approved...

                1. 3.7.2.1. Persistence

                2. 3.7.2.2. Bioaccumulation

                3. 3.7.2.3. Toxicity

             3. 3.7.3. An active substance, safener or synergist shall only be approved...

                1. 3.7.3.1. Persistence

                2. 3.7.3.2. Bioaccumulation

          8. 3.8. Ecotoxicology

             1. 3.8.1. An active substance, safener or synergist shall only be approved...

             2. 3.8.2. An active substance, safener or synergist shall only be approved...

             3. 3.8.3. An active substance, safener or synergist shall be approved only...

          9. 3.9. Residue definition

          10. 3.10. Fate and behaviour concerning groundwater

       4. 4. Candidate for substitution

       5. 5. Low-risk active substances

    3. ANNEX III

       List of co-formulants which are not accepted for inclusion in plant protection products as referred to in Article 27

    4. ANNEX IV

       Comparative assessment pursuant to Article 50

       1. 1. Conditions for comparative assessment

       2. 2. Significant difference in risk

       3. 3. Significant practical or economic disadvantages

       4. The comparative assessment shall take authorised minor uses into account....

    5. ANNEX V

       Repealed Directives and their successive amendments as referred to in Article 83