xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"

  1. Introductory Text

  2. Article 1.Scope

  3. Article 2.Definitions

  4. Article 3.Authorisation for placing on the market of biocidal products

  5. Article 4.Mutual recognition of authorisations

  6. Article 5.Conditions for issue of an authorisation

  7. Article 6.Review of an authorisation

  8. Article 7.Cancellation or modification of an authorisation

  9. Article 8.Requirements for authorisation

  10. Article 9.Placing on the market of active substances

  11. Article 10.Inclusion of an active substance in Annexes I, IA or IB

  12. Article 11.Procedure for inclusion of an active substance in Annex I, IA or IB

  13. Article 12.Use of data held by competent authorities for other applicants

  14. Article 13.Cooperation in the use of data for second and subsequent applications for authorisation

  15. Article 14.New information

  16. Article 15.Derogation from the requirements

  17. Article 16.Transitional measures

  18. Article 17.Research and development

  19. Article 18.Information exchange

  20. Article 19.Confidentiality

  21. Article 20.Classification, packaging and labelling of biocidal products

  22. Article 21.Safety-data sheets

  23. Article 22.Advertising

  24. Article 23.Poison control

  25. Article 24.Compliance with requirements

  26. Article 25.Charges

  27. Article 26.Competent authorities

  28. Article 27.Commission procedures

  29. Article 28.Committees and procedures

  30. Article 29.Adaptation to technical progress

  31. Article 30.Modification or adaptation of Annexes V and VI

  32. Article 31.Civil and criminal liability

  33. Article 32.Safeguard clause

  34. Article 33.Technical notes for guidance

  35. Article 34.Implementation of the Directive

  36. Article 35.. . . . . . . . . ....

  37. Article 36.. . . . . . . . . ....

    1. ANNEX I

      LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL FOR INCLUSION IN BIOCIDAL PRODUCTS

      1. . . . . . . . . . ....

    2. ANNEX IA

      LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL FOR INCLUSION IN LOW-RISK BIOCIDAL PRODUCTS

      1. . . . . . . . . . ....

    3. ANNEX IB

      LIST OF BASIC SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL

      1. . . . . . . . . . ....

    4. ANNEX IIA

      COMMON CORE DATA SET FOR ACTIVE SUBSTANCES

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. Dossier requirements

        1. I. . . . . . . . . . ....

        2. II. . . . . . . . . . ....

        3. III. . . . . . . . . . ....

        4. IV. . . . . . . . . . ....

        5. V. . . . . . . . . . ....

        6. VI. . . . . . . . . . ....

        7. VII. . . . . . . . . . ....

        8. VIII. . . . . . . . . . ....

        9. IX. . . . . . . . . . ....

        10. X. . . . . . . . . . ....

        11. I. APPLICANT

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

        12. II. IDENTITY

          1. 2.1. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

          3. 2.3. . . . . . . . . . ....

          4. 2.4. . . . . . . . . . ....

          5. 2.5. . . . . . . . . . ....

          6. 2.6. . . . . . . . . . ....

          7. 2.7. . . . . . . . . . ....

          8. 2.8. . . . . . . . . . ....

          9. 2.9. . . . . . . . . . ....

          10. 2.10. . . . . . . . . . ....

        13. III. PHYSICAL AND CHEMICAL PROPERTIES

          1. 3.1. . . . . . . . . . ....

          2. 3.2. . . . . . . . . . ....

          3. 3.3. . . . . . . . . . ....

          4. 3.4. . . . . . . . . . ....

          5. 3.5. . . . . . . . . . ....

          6. 3.6. . . . . . . . . . ....

          7. 3.7. . . . . . . . . . ....

          8. 3.8. . . . . . . . . . ....

          9. 3.9. . . . . . . . . . ....

          10. 3.10. . . . . . . . . . ....

          11. 3.11. . . . . . . . . . ....

          12. 3.12. . . . . . . . . . ....

          13. 3.13. . . . . . . . . . ....

        14. IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION

          1. 4.1. . . . . . . . . . ....

          2. 4.2. . . . . . . . . . ....

        15. V. EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USES

          1. 5.1. . . . . . . . . . ....

          2. 5.2. . . . . . . . . . ....

          3. 5.3. . . . . . . . . . ....

          4. 5.4. . . . . . . . . . ....

          5. 5.5. . . . . . . . . . ....

          6. 5.6. . . . . . . . . . ....

          7. 5.7. . . . . . . . . . ....

          8. 5.8. . . . . . . . . . ....

        16. VI. TOXICOLOGICAL AND METABOLIC STUDIES

          1. 6.1. . . . . . . . . . ....

            1. 6.1.1. . . . . . . . . . ....

            2. 6.1.2. . . . . . . . . . ....

            3. 6.1.3. . . . . . . . . . ....

            4. 6.1.4. . . . . . . . . . ....

            5. 6.1.5. . . . . . . . . . ....

          2. 6.2. . . . . . . . . . ....

          3. 6.3. . . . . . . . . . ....

          4. 6.4. . . . . . . . . . ....

          5. 6.5. . . . . . . . . . ....

          6. 6.6. . . . . . . . . . ....

            1. 6.6.1. . . . . . . . . . ....

            2. 6.6.2. . . . . . . . . . ....

            3. 6.6.3. . . . . . . . . . ....

            4. 6.6.4. . . . . . . . . . ....

            5. 6.6.5. . . . . . . . . . ....

            6. 6.6.6. . . . . . . . . . ....

          7. 6.7. . . . . . . . . . ....

          8. 6.8. . . . . . . . . . ....

            1. 6.8.1. . . . . . . . . . ....

            2. 6.8.2. . . . . . . . . . ....

          9. 6.9. . . . . . . . . . ....

            1. 6.9.1. . . . . . . . . . ....

            2. 6.9.2. . . . . . . . . . ....

            3. 6.9.3. . . . . . . . . . ....

            4. 6.9.4. . . . . . . . . . ....

            5. 6.9.5. . . . . . . . . . ....

            6. 6.9.6. . . . . . . . . . ....

            7. 6.9.7. . . . . . . . . . ....

            8. 6.9.8. . . . . . . . . . ....

          10. 6.10. . . . . . . . . . ....

        17. VII. ECOTOXICOLOGICAL STUDIES

          1. 7.1. . . . . . . . . . ....

          2. 7.2. . . . . . . . . . ....

          3. 7.3. . . . . . . . . . ....

          4. 7.4. . . . . . . . . . ....

          5. 7.5. . . . . . . . . . ....

          6. 7.6. . . . . . . . . . ....

            1. 7.6.1. . . . . . . . . . ....

              1. 7.6.1.1. . . . . . . . . . ....

              2. 7.6.1.2. . . . . . . . . . ....

            2. 7.6.2. . . . . . . . . . ....

              1. 7.6.2.1. . . . . . . . . . ....

              2. 7.6.2.2. . . . . . . . . . ....

          7. 7.7. . . . . . . . . . ....

          8. 7.8. . . . . . . . . . ....

        18. VIII. MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT

          1. 8.1. . . . . . . . . . ....

          2. 8.2. . . . . . . . . . ....

          3. 8.3. . . . . . . . . . ....

          4. 8.4. . . . . . . . . . ....

          5. 8.5. . . . . . . . . . ....

            1. 8.5.1. . . . . . . . . . ....

            2. 8.5.2. . . . . . . . . . ....

            3. 8.5.3. . . . . . . . . . ....

            4. 8.5.4. . . . . . . . . . ....

          6. 8.6. . . . . . . . . . ....

        19. IX. CLASSIFICATION AND LABELLING

        20. X. SUMMARY AND EVALUATION OF SECTIONS II TO IX

    5. ANNEX IIB

      COMMON CORE DATA SET FOR BIOCIDAL PRODUCTS

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. 3. . . . . . . . . . ....

      4. Dossier requirements

        1. I. . . . . . . . . . ....

        2. II. . . . . . . . . . ....

        3. III. . . . . . . . . . ....

        4. IV. . . . . . . . . . ....

        5. V. . . . . . . . . . ....

        6. VI. . . . . . . . . . ....

        7. VII. . . . . . . . . . ....

        8. VIII. . . . . . . . . . ....

        9. IX. . . . . . . . . . ....

        10. X. . . . . . . . . . ....

        11. I. APPLICANT

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

        12. II. IDENTITY

          1. 2.1. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

          3. 2.3. . . . . . . . . . ....

        13. III. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES

          1. 3.1. . . . . . . . . . ....

          2. 3.2. . . . . . . . . . ....

          3. 3.3. . . . . . . . . . ....

          4. 3.4. . . . . . . . . . ....

          5. 3.5. . . . . . . . . . ....

          6. 3.6. . . . . . . . . . ....

          7. 3.7. . . . . . . . . . ....

          8. 3.8. . . . . . . . . . ....

          9. 3.9. . . . . . . . . . ....

        14. IV. METHODS OF IDENTIFICATION AND ANALYSIS

          1. 4.1. . . . . . . . . . ....

          2. 4.2. . . . . . . . . . ....

        15. V. INTENDED USES AND EFFICACY

          1. 5.1. . . . . . . . . . ....

          2. 5.2. . . . . . . . . . ....

          3. 5.3. . . . . . . . . . ....

          4. 5.4. . . . . . . . . . ....

          5. 5.5. . . . . . . . . . ....

          6. 5.6. . . . . . . . . . ....

          7. 5.7. . . . . . . . . . ....

          8. 5.8. . . . . . . . . . ....

          9. 5.9. . . . . . . . . . ....

          10. 5.10. . . . . . . . . . ....

          11. 5.11. . . . . . . . . . ....

        16. VI. TOXICOLOGICAL STUDIES

          1. 6.1. . . . . . . . . . ....

            1. 6.1.1. . . . . . . . . . ....

            2. 6.1.2. . . . . . . . . . ....

            3. 6.1.3. . . . . . . . . . ....

            4. 6.1.4. . . . . . . . . . ....

          2. 6.2. . . . . . . . . . ....

          3. 6.3. . . . . . . . . . ....

          4. 6.4. . . . . . . . . . ....

          5. 6.5. . . . . . . . . . ....

          6. 6.6. . . . . . . . . . ....

        17. VII. ECOTOXICOLOGICAL STUDIES

          1. 7.1. . . . . . . . . . ....

          2. 7.2. . . . . . . . . . ....

          3. 7.3. . . . . . . . . . ....

        18. VIII. MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMALS AND THE...

          1. 8.1. . . . . . . . . . ....

          2. 8.2. . . . . . . . . . ....

          3. 8.3. . . . . . . . . . ....

          4. 8.4. . . . . . . . . . ....

          5. 8.5. . . . . . . . . . ....

          6. 8.6. . . . . . . . . . ....

          7. 8.7. . . . . . . . . . ....

          8. 8.8. . . . . . . . . . ....

        19. IX. CLASSIFICATION, PACKAGING AND LABELLING

        20. X. SUMMARY AND EVALUATION OF SECTIONS II TO IX

    6. ANNEX IIIA

      ADDITIONAL DATA SET FOR ACTIVE SUBSTANCES

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. III. PHYSICAL AND CHEMICAL PROPERTIES

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

      4. IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION

        1. 1. . . . . . . . . . ....

      5. VI. TOXICOLOGICAL AND METABOLIC STUDIES

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

        5. 5. . . . . . . . . . ....

        6. 6. . . . . . . . . . ....

        7. 7. . . . . . . . . . ....

      6. VII. ECOTOXICOLOGICAL STUDIES

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

        5. 5. . . . . . . . . . ....

        6. 6. . . . . . . . . . ....

      7. VIII. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT

        1. 1. . . . . . . . . . ....

      8. XI. FURTHER HUMAN HEALTH-RELATED STUDIES

        1. 1. . . . . . . . . . ....

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

          3. 1.3. . . . . . . . . . ....

          4. 1.4. . . . . . . . . . ....

          5. 1.5. . . . . . . . . . ....

          6. 1.6. . . . . . . . . . ....

          7. 1.7. . . . . . . . . . ....

          8. 1.8. . . . . . . . . . ....

          9. 1.9. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

      9. XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT

        1. 1. . . . . . . . . . ....

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

          3. 1.3. . . . . . . . . . ....

          4. 1.4. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

          1. 2.1. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

      10. XIII. FURTHER ECOTOXICOLOGICAL STUDIES

        1. 1. . . . . . . . . . ....

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

          3. 1.3. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

          1. 2.1. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

          3. 2.3. . . . . . . . . . ....

          4. 2.4. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

          1. 3.1. . . . . . . . . . ....

          2. 3.2. . . . . . . . . . ....

          3. 3.3. . . . . . . . . . ....

          4. 3.4. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

          1. 4.1. . . . . . . . . . ....

        5. 5. . . . . . . . . . ....

    7. ANNEX IIIB

      ADDITIONAL DATA SET FOR BIOCIDAL PRODUCTS

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. 3. . . . . . . . . . ....

      4. XI. FURTHER HUMAN HEALTH-RELATED STUDIES

        1. 1. . . . . . . . . . ....

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

      5. XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

      6. XIII. FURTHER ECOTOXICOLOGICAL STUDIES

        1. 1. . . . . . . . . . ....

          1. 1.1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

          1. 2.1. . . . . . . . . . ....

            1. 2.1.1. . . . . . . . . . ....

            2. 2.1.2. . . . . . . . . . ....

            3. 2.1.3. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

          1. 3.1. . . . . . . . . . ....

          2. 3.2. . . . . . . . . . ....

          3. 3.3. . . . . . . . . . ....

          4. 3.4. . . . . . . . . . ....

          5. 3.5. . . . . . . . . . ....

          6. 3.6. . . . . . . . . . ....

          7. 3.7. . . . . . . . . . ....

            1. 3.7.1. . . . . . . . . . ....

            2. 3.7.2. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

    8. ANNEX IVA

      DATA SET FOR ACTIVE SUBSTANCES

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. 3. . . . . . . . . . ....

      4. 4. . . . . . . . . . ....

      5. 5. . . . . . . . . . ....

      6. Dossier requirements

        1. I. IDENTITY OF THE MICRO-ORGANISM

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

          3. 1.3. . . . . . . . . . ....

            1. 1.3.1. . . . . . . . . . ....

            2. 1.3.2. . . . . . . . . . ....

            3. 1.3.3. . . . . . . . . . ....

            4. 1.3.4. . . . . . . . . . ....

          4. 1.4. . . . . . . . . . ....

            1. 1.4.1. . . . . . . . . . ....

            2. 1.4.2. . . . . . . . . . ....

            3. 1.4.3. . . . . . . . . . ....

        2. II. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM

          1. 2.1. . . . . . . . . . ....

            1. 2.1.1. . . . . . . . . . ....

            2. 2.1.2. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

            1. 2.2.1. . . . . . . . . . ....

            2. 2.2.2. . . . . . . . . . ....

          3. 2.3. . . . . . . . . . ....

          4. 2.4. . . . . . . . . . ....

          5. 2.5. . . . . . . . . . ....

          6. 2.6. . . . . . . . . . ....

          7. 2.7. . . . . . . . . . ....

          8. 2.8. . . . . . . . . . ....

          9. 2.9. . . . . . . . . . ....

          10. 2.10. . . . . . . . . . ....

          11. 2.11. . . . . . . . . . ....

        3. III. FURTHER INFORMATION ON THE MICRO-ORGANISM

          1. 3.1. . . . . . . . . . ....

          2. 3.2. . . . . . . . . . ....

          3. 3.3. . . . . . . . . . ....

          4. 3.4. . . . . . . . . . ....

          5. 3.5. . . . . . . . . . ....

          6. 3.6. . . . . . . . . . ....

          7. 3.7. . . . . . . . . . ....

          8. 3.8. . . . . . . . . . ....

          9. 3.9. . . . . . . . . . ....

          10. 3.10. . . . . . . . . . ....

          11. 3.11. . . . . . . . . . ....

        4. IV. ANALYTICAL METHODS

          1. 4.1. . . . . . . . . . ....

          2. 4.2. . . . . . . . . . ....

        5. V. EFFECTS ON HUMAN HEALTH

          1. TIER I

            1. 5.1. . . . . . . . . . ....

              1. 5.1.1. . . . . . . . . . ....

              2. 5.1.2. . . . . . . . . . ....

              3. 5.1.3. . . . . . . . . . ....

              4. 5.1.4. . . . . . . . . . ....

            2. 5.2. . . . . . . . . . ....

              1. 5.2.1. . . . . . . . . . ....

              2. 5.2.2. . . . . . . . . . ....

                1. 5.2.2.1. . . . . . . . . . ....

                2. 5.2.2.2. . . . . . . . . . ....

                3. 5.2.2.3. . . . . . . . . . ....

              3. 5.2.3. . . . . . . . . . ....

              4. 5.2.4. . . . . . . . . . ....

              5. 5.2.5. . . . . . . . . . ....

                1. 5.2.5.1. . . . . . . . . . ....

              6. 5.2.6. . . . . . . . . . ....

              7. 5.2.7. . . . . . . . . . ....

          2. END OF TIER I

          3. TIER II

            1. 5.3. . . . . . . . . . ....

            2. 5.4. . . . . . . . . . ....

            3. 5.5. . . . . . . . . . ....

          4. END OF TIER II

            1. 5.6. . . . . . . . . . ....

        6. VI. RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED

          1. 6.1. . . . . . . . . . ....

          2. 6.2. . . . . . . . . . ....

            1. 6.2.1. . . . . . . . . . ....

            2. 6.2.2. . . . . . . . . . ....

          3. 6.3. . . . . . . . . . ....

        7. VII. FATE AND BEHAVIOUR IN THE ENVIRONMENT

          1. 7.1. . . . . . . . . . ....

            1. 7.1.1. . . . . . . . . . ....

            2. 7.1.2. . . . . . . . . . ....

            3. 7.1.3. . . . . . . . . . ....

          2. 7.2. . . . . . . . . . ....

          3. 7.3. . . . . . . . . . ....

        8. VIII. EFFECTS ON NON-TARGET ORGANISMS

          1. 8.1. . . . . . . . . . ....

          2. 8.2. . . . . . . . . . ....

            1. 8.2.1. . . . . . . . . . ....

            2. 8.2.2. . . . . . . . . . ....

            3. 8.2.3. . . . . . . . . . ....

            4. 8.2.4. . . . . . . . . . ....

          3. 8.3. . . . . . . . . . ....

          4. 8.4. . . . . . . . . . ....

          5. 8.5. . . . . . . . . . ....

          6. 8.6. . . . . . . . . . ....

          7. 8.7. . . . . . . . . . ....

            1. 8.7.1. . . . . . . . . . ....

            2. 8.7.2. . . . . . . . . . ....

            3. 8.7.3. . . . . . . . . . ....

          8. 8.8. . . . . . . . . . ....

        9. IX. CLASSIFICATION AND LABELLING

        10. X. SUMMARY AND EVALUATION OF SECTIONS I TO IX INCLUDING CONCLUSIONS...

    9. ANNEX IVB

      DATA SET FOR BIOCIDAL PRODUCTS

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. 3. . . . . . . . . . ....

      4. 4. . . . . . . . . . ....

      5. 5. . . . . . . . . . ....

      6. Dossier requirements

        1. I. IDENTITY OF THE BIOCIDAL PRODUCTS

          1. 1.1. . . . . . . . . . ....

          2. 1.2. . . . . . . . . . ....

          3. 1.3. . . . . . . . . . ....

          4. 1.4. . . . . . . . . . ....

          5. 1.5. . . . . . . . . . ....

          6. 1.6. . . . . . . . . . ....

        2. II. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT

          1. 2.1. . . . . . . . . . ....

          2. 2.2. . . . . . . . . . ....

            1. 2.2.1. . . . . . . . . . ....

            2. 2.2.2. . . . . . . . . . ....

          3. 2.3. . . . . . . . . . ....

          4. 2.4. . . . . . . . . . ....

          5. 2.5. . . . . . . . . . ....

          6. 2.6. . . . . . . . . . ....

          7. 2.7. . . . . . . . . . ....

            1. 2.7.1. . . . . . . . . . ....

            2. 2.7.2. . . . . . . . . . ....

            3. 2.7.3. . . . . . . . . . ....

            4. 2.7.4. . . . . . . . . . ....

            5. 2.7.5. . . . . . . . . . ....

            6. 2.7.6. . . . . . . . . . ....

            7. 2.7.7. . . . . . . . . . ....

          8. 2.8. . . . . . . . . . ....

            1. 2.8.1. . . . . . . . . . ....

            2. 2.8.2. . . . . . . . . . ....

            3. 2.8.3. . . . . . . . . . ....

          9. 2.9. . . . . . . . . . ....

        3. III. DATA ON APPLICATION

          1. 3.1. . . . . . . . . . ....

          2. 3.2. . . . . . . . . . ....

          3. 3.3. . . . . . . . . . ....

          4. 3.4. . . . . . . . . . ....

          5. 3.5. . . . . . . . . . ....

          6. 3.6. . . . . . . . . . ....

          7. 3.7. . . . . . . . . . ....

          8. 3.8. . . . . . . . . . ....

          9. 3.9. . . . . . . . . . ....

          10. 3.10. . . . . . . . . . ....

          11. 3.11. . . . . . . . . . ....

          12. 3.12. . . . . . . . . . ....

        4. IV. FURTHER INFORMATION ON THE BIOCIDAL PRODUCT

          1. 4.1. . . . . . . . . . ....

          2. 4.2. . . . . . . . . . ....

          3. 4.3. . . . . . . . . . ....

          4. 4.4. . . . . . . . . . ....

          5. 4.5. . . . . . . . . . ....

          6. 4.6. . . . . . . . . . ....

            1. 4.6.1. . . . . . . . . . ....

            2. 4.6.2. . . . . . . . . . ....

          7. 4.7. . . . . . . . . . ....

        5. V. ANALYTICAL METHODS

          1. 5.1. . . . . . . . . . ....

          2. 5.2. . . . . . . . . . ....

        6. VI. EFFICACY DATA

        7. VII. EFFECTS ON HUMAN HEALTH

          1. 7.1. . . . . . . . . . ....

            1. 7.1.1. . . . . . . . . . ....

            2. 7.1.2. . . . . . . . . . ....

            3. 7.1.3. . . . . . . . . . ....

          2. 7.2. . . . . . . . . . ....

            1. 7.2.1. . . . . . . . . . ....

            2. 7.2.2. . . . . . . . . . ....

            3. 7.2.3. . . . . . . . . . ....

          3. 7.3. . . . . . . . . . ....

          4. 7.4. . . . . . . . . . ....

          5. 7.5. . . . . . . . . . ....

          6. 7.6. . . . . . . . . . ....

        8. VIII. RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED

        9. IX. FATE AND BEHAVIOUR IN THE ENVIRONMENT

        10. X. EFFECTS ON NON-TARGET ORGANISMS

          1. 10.1. . . . . . . . . . ....

          2. 10.2. . . . . . . . . . ....

          3. 10.3. . . . . . . . . . ....

          4. 10.4. . . . . . . . . . ....

          5. 10.5. . . . . . . . . . ....

          6. 10.6. . . . . . . . . . ....

          7. 10.7. . . . . . . . . . ....

            1. 10.7.1. . . . . . . . . . ....

            2. 10.7.2. . . . . . . . . . ....

            3. 10.7.3. . . . . . . . . . ....

          8. 10.8. . . . . . . . . . ....

        11. XI. CLASSIFICATION, PACKAGING AND LABELLING OF THE BIOCIDAL PRODUCT

        12. XII. SUMMARY AND EVALUATION OF SECTIONS I TO XI INCLUDING CONCLUSIONS...

    10. ANNEX V

      BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)(a) OF THIS DIRECTIVE

      1. . . . . . . . . . ....

      2. MAIN GROUP 1: Disinfectants and general biocidal products

        1. Product-type 1: Human hygiene biocidal products

        2. Product-type 2: Private area and public health area disinfectants and...

        3. Product-type 3: Veterinary hygiene biocidal products

        4. Product-type 4: Food and feed area disinfectants

        5. Product-type 5: Drinking water disinfectants

      3. MAIN GROUP 2: Preservatives

        1. Product-type 6: In-can preservatives

        2. Product-type 7: Film preservatives

        3. Product-type 8: Wood preservatives

        4. Product-type 9: Fibre, leather, rubber and polymerised materials preservatives

        5. Product-type 10: Masonry preservatives

        6. Product-type 11: Preservatives for liquid-cooling and processing systems

        7. Product-type 12: Slimicides

        8. Product-type 13: Metalworking-fluid preservatives

      4. MAIN GROUP 3: Pest control

        1. Product-type 14: Rodenticides

        2. Product-type 15: Avicides

        3. Product-type 16: Molluscicides

        4. Product-type 17: Piscicides

        5. Product-type 18: Insecticides, acaricides and products to control other arthropods...

        6. Product-type 19: Repellents and attractants

      5. MAIN GROUP 4: Other biocidal products

        1. Product-type 20: Preservatives for food or feedstocks

        2. Product-type 21: Antifouling products

        3. Product-type 22: Embalming and taxidermist fluids

        4. Product-type 23: Control of other vertebrates

    11. ANNEX VI

      COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS

      1. CONTENTS

        1. Definitions

        2. Introduction

        3. Evaluation

        4. Decision-making

        5. Overall integration of conclusions

      2. DEFINITIONS

        1. (a) Hazard identification

        2. (b) Dose (concentration) — response (effect) assessment

        3. (c) Exposure assessment

        4. (d) Risk characterisation

        5. (e) Environment

      3. INTRODUCTION

        1. 1. . . . . . . . . . ....

        2. 2. . . . . . . . . . ....

        3. 3. . . . . . . . . . ....

        4. 4. . . . . . . . . . ....

        5. 5. . . . . . . . . . ....

        6. 6. . . . . . . . . . ....

        7. 7. . . . . . . . . . ....

        8. 8. . . . . . . . . . ....

        9. 9. . . . . . . . . . ....

        10. 10. . . . . . . . . . ....

        11. 11. . . . . . . . . . ....

        12. 12. . . . . . . . . . ....

        13. 13. . . . . . . . . . ....

      4. EVALUATION

        1. General principles

          1. 14. . . . . . . . . . ....

          2. 15. . . . . . . . . . ....

          3. 16. . . . . . . . . . ....

          4. 17. . . . . . . . . . ....

          5. 18. . . . . . . . . . ....

          6. 19. . . . . . . . . . ....

        2. Effects on humans

          1. 20. . . . . . . . . . ....

          2. 21. . . . . . . . . . ....

          3. 22. . . . . . . . . . ....

          4. 23. . . . . . . . . . ....

          5. 24. . . . . . . . . . ....

          6. 25. . . . . . . . . . ....

          7. 26. . . . . . . . . . ....

          8. 27. . . . . . . . . . ....

          9. 28. . . . . . . . . . ....

          10. 29. . . . . . . . . . ....

          11. 30. . . . . . . . . . ....

          12. 31. . . . . . . . . . ....

          13. 32. . . . . . . . . . ....

          14. 33. . . . . . . . . . ....

          15. 34. . . . . . . . . . ....

        3. Effects on animals

          1. 35. . . . . . . . . . ....

        4. Effects on the environment

          1. 36. . . . . . . . . . ....

          2. 37. . . . . . . . . . ....

          3. 38. . . . . . . . . . ....

          4. 39. . . . . . . . . . ....

          5. 40. . . . . . . . . . ....

          6. 41. . . . . . . . . . ....

          7. 42. . . . . . . . . . ....

          8. 43. . . . . . . . . . ....

          9. 44. . . . . . . . . . ....

          10. 45. . . . . . . . . . ....

          11. 46. . . . . . . . . . ....

          12. 47. . . . . . . . . . ....

        5. Unacceptable effects

          1. 48. . . . . . . . . . ....

          2. 49. . . . . . . . . . ....

          3. 50. . . . . . . . . . ....

        6. Efficacy

          1. 51. . . . . . . . . . ....

          2. 52. . . . . . . . . . ....

        7. Summary

          1. 53. . . . . . . . . . ....

          2. 54. . . . . . . . . . ....

      5. DECISION MAKING

        1. General principles

          1. 55. . . . . . . . . . ....

          2. 56. . . . . . . . . . ....

          3. 57. . . . . . . . . . ....

          4. 58. . . . . . . . . . ....

          5. 59. . . . . . . . . . ....

          6. 60. . . . . . . . . . ....

          7. 61. . . . . . . . . . ....

          8. 62. . . . . . . . . . ....

          9. 63. . . . . . . . . . ....

          10. 64. . . . . . . . . . ....

          11. 65. . . . . . . . . . ....

          12. 66. . . . . . . . . . ....

          13. 67. . . . . . . . . . ....

        2. Effects on humans

          1. 68. . . . . . . . . . ....

          2. 69. . . . . . . . . . ....

          3. 70. . . . . . . . . . ....

          4. 71. . . . . . . . . . ....

          5. 72. . . . . . . . . . ....

          6. 73. . . . . . . . . . ....

          7. 74. . . . . . . . . . ....

          8. 75. . . . . . . . . . ....

        3. Effects on animals

          1. 76. . . . . . . . . . ....

          2. 77. . . . . . . . . . ....

        4. Effects on the environment

          1. 78. . . . . . . . . . ....

          2. 79. . . . . . . . . . ....

          3. 80. . . . . . . . . . ....

          4. Water

            1. 81. . . . . . . . . . ....

            2. 82. . . . . . . . . . ....

            3. 83. . . . . . . . . . ....

            4. 84. . . . . . . . . . ....

          5. Soil

            1. 85. . . . . . . . . . ....

          6. Air

            1. 86. . . . . . . . . . ....

          7. Effects on non-target organisms

            1. 87. . . . . . . . . . ....

            2. 88. . . . . . . . . . ....

            3. 89. . . . . . . . . . ....

        5. Unacceptable effects

          1. 90. . . . . . . . . . ....

          2. 91. . . . . . . . . . ....

        6. Efficacy

          1. 92. . . . . . . . . . ....

          2. 93. . . . . . . . . . ....

        7. Summary

          1. 94. . . . . . . . . . ....

      6. OVERALL INTEGRATION OF CONCLUSIONS

        1. 95. . . . . . . . . . ....

        2. 96. . . . . . . . . . ....

        3. 97. . . . . . . . . . ....