Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

1. Introductory Text

2. CHAPTER I SCOPE AND DEFINITIONS

   1. Article 1. Purpose and subject matter

   2. Article 2. Scope

   3. Article 3. Definitions

3. CHAPTER II APPROVAL OF ACTIVE SUBSTANCES

   1. Article 4. Conditions for approval

   2. Article 5. Exclusion criteria

   3. Article 6. Data requirements for an application

   4. Article 7. Submission and validation of applications

   5. Article 8. Evaluation of applications

   6. Article 8A. The GB List

   7. Article 9. Approval of an active substance

   8. Article 10. Active substances which are candidates for substitution

   9. Article 11. Technical guidance notes

4. CHAPTER III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

   1. Article 12. Conditions for renewal

   2. Article 13. Submission and acceptance of applications

   3. Article 14. Evaluation of applications for renewal

   4. Article 15. Review of approval of an active substance

   5. Article 16. Implementing measures

5. CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

   1. Article 17. Making available on the market and use of biocidal products

   2. Article 17A. NI Product Market Access

   3. Article 18. Measures geared to the sustainable use of biocidal products

   4. Article 19. Conditions for granting an authorisation

   5. Article 20. Requirements for applications for authorisation

   6. Article 21. Waiving of data requirements

   7. Article 22. Content of authorisation

   8. Article 23. Comparative assessment of biocidal products

   9. Article 24. Technical guidance notes

   10. Article 24A. The Simplified Active Substance List

6. CHAPTER V SIMPLIFIED AUTHORISATION PROCEDURE

   1. Article 25. Eligibility for the simplified authorisation procedure

   2. Article 26. Applicable procedure

   3. Article 27. Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure

   4. Article 28. Amendment of the Simplified Active Substance List

7. CHAPTER VI NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

   1. Article 29. Submission and validation of applications

   2. Article 30. Evaluation of applications

   3. Article 31. Renewal of a national authorisation

8. CHAPTER VII MUTUAL RECOGNITION PROCEDURES

   1. Article 32. Authorisation through mutual recognition

   2. Article 33. Mutual recognition in sequence

   3. Article 34. Mutual recognition in parallel

   4. Article 35. Referral of objections to the coordination group

   5. Article 36. Referral of unresolved objections to the Commission

   6. Article 37. Derogations from mutual recognition

   7. Article 38. Opinion of the Agency

   8. Article 39. Application for mutual recognition by official or scientific bodies

   9. Article 40. Supplementary rules and technical guidance notes

9. CHAPTER VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS

   1. SECTION 1 Granting of Union authorisations

      1. Article 41. Union authorisation

      2. Article 42. Biocidal products for which Union authorisation may be granted

      3. Article 43. Submission and validation of applications

      4. Article 44. Evaluation of applications

   2. SECTION 2 Renewal of Union authorisations

      1. Article 45. Submission and acceptance of applications

      2. Article 46. Evaluation of applications for renewal

10. CHAPTER IX CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

    1. Article 47. Obligation for notification of unexpected or adverse effects

    2. Article 48. Cancellation or amendment of an authorisation

    3. Article 49. Cancellation of an authorisation at the request of the authorisation holder

    4. Article 50. Amendment of an authorisation at the request of the authorisation holder

    5. Article 51. Detailed rules

    6. Article 52. Period of grace

11. CHAPTER X PARALLEL TRADE

    1. Article 53. Parallel trade

12. CHAPTER XI TECHNICAL EQUIVALENCE

    1. Article 54. Assessment of technical equivalence

13. CHAPTER XII DEROGATIONS

    1. Article 55. Derogation from the requirements

    2. Article 56. Research and development

    3. Article 57. Exemption from registration under Regulation (EC) No 1907/2006

14. CHAPTER XIII TREATED ARTICLES

    1. Article 58. Placing on the market of treated articles

15. CHAPTER XIV DATA PROTECTION AND DATA-SHARING

    1. Article 59. Protection of data held by the competent authority

    2. Article 60. Data protection periods

    3. Article 61. Letter of access

    4. Article 62. Data sharing

    5. Article 63. Compensation for data sharing

    6. Article 64. Use of data for subsequent applications

16. CHAPTER XV INFORMATION AND COMMUNICATION

    1. SECTION 1 Monitoring and reporting

       1. Article 65. Compliance with requirements

       2. Article 66. Confidentiality

       3. Article 67. Electronic public access

       4. Article 68. Record-keeping and reporting

    2. SECTION 2 Information about biocidal products

       1. Article 69. Classification, packaging and labelling of biocidal products

       2. Article 70. Safety data sheets

       3. Article 71. Exchange of information

       4. Article 72. Advertising

       5. Article 73. Poison control

17. CHAPTER XVI THE AGENCY

    1. Article 74. Role of the Agency

    2. Article 75. Biocidal Products Committee

    3. Article 76. Secretariat of the Agency

    4. Article 77. Appeals

    5. Article 78. The budget of the Agency

    6. Article 79. Formats for submission of information to the competent authority

18. CHAPTER XVII FINAL PROVISIONS

    1. Article 80. Fees and charges

    2. Article 81. The competent authority

    3. Article 82. Committee procedure

    4. Article 83. Exercise of the delegation

    5. Article 83A. Regulation procedure

    6. Article 83B. The consent requirement

    7. Article 84. Urgency procedure

    8. Article 85. Adaptation to scientific and technical progress

    9. Article 86. Active substances included in Annex I to Directive 98/8/EC

    10. Article 87. Penalties

    11. Article 88. Safeguard clause

    12. Article 89. Existing transitional measures

    13. Article 90. Transitional measures concerning active substances evaluated under Directive 98/8/EC

    14. Article 91. Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC

    15. Article 92. Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC

    16. Article 93. Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC

    17. Article 94. Transitional measures concerning treated articles

    18. Article 95. Transitional measures concerning access to the active substance dossier

    19. Article 95A. Transitional measures for simplified notification procedure

    20. Article 95B. Transitional measures for mutual recognition applications

    21. Article 95C. Renewal of authorisations subject to mutual recognition under Regulation 492/2014

    22. Article 95D. Transitional measure for national authorisation applications

    23. Article 95E. Transitional measures simplified authorisation applications

    24. Article 95F. Transitional measures for applications for same biocidal product authorisations

    25. Article 95FA. Transitional measures for applications for same biocidal product authorisations under the simplified procedure

    26. Article 95G. Transitional measures for Regulation (EU) No 528/2012 authorisations

    27. Article 95H. Transitional measures for ongoing applications for Union authorisations

    28. Article 95I. Transitional measures for Article 95 List

    29. Article 95J. Transitional measure for active substance applications made to the United Kingdom competent authority before 30 March 2019 and subsequently reallocated

    30. Article 95K. Transitional measure for active substance applications made before IP completion day pursuant to Article 93 where the United Kingdom competent authority was not the evaluating competent authority

    31. Article 95L. Transitional measures for renewal of an approval of an active substance

    32. Article 95M. Transitional measures for ongoing applications to change or amend authorisations

    33. Article 95N. Interpretation of Articles 95A to 95M

    34. Article 96. Repeal

    35. Article 97. Entry into force

19. Signature

20. 1. ANNEX I

    2. ANNEX II

       INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES

       1. 1. This Annex sets out the information requirements for the preparation...

       2. 2. The data elements set down in this Annex comprise a...

       3. 3. A detailed and full description of the studies conducted or...

       4. 4. Dossiers must be formatted, prepared and submitted in accordance with...

       5. 5. Tests submitted for the purpose of the approval of an...

       6. 6. Tests performed should comply with the relevant requirements of protection...

       7. 7. Where testing is done, a detailed description (specification) of the...

       8. 8. Where test data exist that have been generated before 1...

       9. 9. New tests involving vertebrates shall be conducted as the last...

       10. TITLE 1 CHEMICAL SUBSTANCES

           1. Core data set and additional data set for active substances...

       11. TITLE 2 MICRO-ORGANISMS

           1. Core data set and additional data set for active substances...

    3. ANNEX III

       INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS

       1. 1. This Annex sets out the information requirements that shall be...

       2. 2. The data elements set down in this Annex comprise a...

       3. 3. A detailed and full description of studies conducted and of...

       4. 4 Dossiers must be formatted, prepared and submitted in accordance with...

       5. 5. Tests submitted for the purpose of authorisation shall be conducted...

       6. 6. Tests performed should comply with the relevant requirements of protection...

       7. 7. Where testing is done, a detailed quantitative and qualitative description...

       8. 8. Where test data exist that have been generated before 17...

       9. 9. New tests involving vertebrates shall be conducted as the last...

       10. TITLE 1 CHEMICAL PRODUCTS

           1. Core data set and additional data set for chemical products...

       11. TITLE 2 MICRO-ORGANISMS

           1. Core data set and additional data set

    4. ANNEX IV

       GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS

       1. This Annex sets out rules to be followed when the...

       2. The reasons for such adaptations to the data requirements must...

       3. 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

       4. 2. TESTING IS TECHNICALLY NOT POSSIBLE

       5. 3. PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING

          1. 3.1. Testing in accordance with some endpoints in Sections 8 and...

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

    5. ANNEX V

       BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE ...

       1. MAIN GROUP 1: Disinfectants

          1. Product-type 1: Human hygiene

          2. Product-type 2: Disinfectants and algaecides not intended for direct application to humans ...

          3. Product-type 3: Veterinary hygiene

          4. Product-type 4: Food and feed area

          5. Product-type 5: Drinking water

       2. MAIN GROUP 2: Preservatives

          1. Product-type 6: Preservatives for products during storage

          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: Construction material preservatives

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

          7. Product-type 12: Slimicides

          8. Product-type 13: Working or cutting fluid preservatives

       3. MAIN GROUP 3: Pest control

          1. Product-type 14: Rodenticides

          2. Product-type 15: Avicides

          3. Product-type 16: Molluscicides, vermicides and products to control other invertebrates

          4. Product-type 17: Piscicides

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

          6. Product-type 19: Repellents and attractants

          7. Product-type 20: Control of other vertebrates

       4. MAIN GROUP 4: Other biocidal products

          1. Product-type 21: Antifouling products

          2. Product-type 22: Embalming and taxidermist fluids

    6. ANNEX VI

       COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS

       1. TERMS AND DEFINITIONS

          1. Technical definitions

             1. (a) Hazard identification

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

             3. (c) Exposure assessment

             4. (d) Risk characterisation

             5. (e) Environment

       2. INTRODUCTION

          1. 1. This Annex sets out the common principles for the evaluation...

          2. 2. The principles set out in this Annex can be applied...

          3. 3. In order to ensure a high and harmonised level of...

          4. 4. A risk assessment on the active substance(s) present in the...

          5. 5. Additional risk assessments shall be carried out, in the same...

          6. 6. In order to carry out a risk assessment, data are...

          7. 7. The results of the risk assessments carried out on the...

          8. 8.

          9. 9. The application of these common principles shall, when taken together...

          10. 10. In the case of biocidal products containing active substances covered...

          11. 11. During the process of evaluation, applicants and the competent authority...

          12. 12. The judgments made by the competent authority during the evaluation...

       3. ASSESSMENT

          1. General principles

             1. 13. The data submitted in support of an application for authorisation...

             2. 14. A risk assessment on the active substance present in the...

             3. 15. In carrying out the assessment, the possibility of cumulative or...

             4. 16. For each active substance and each substance of concern present...

             5. 17. The results arrived at from a comparison of the exposure...

             6. 18. The risk assessment shall determine:

             7. 19. In certain cases it may be concluded that further data...

             8. 20. The information provided on the biocidal product family shall permit...

             9. 21. Where relevant the technical equivalence for every active substance contained...

          2. Effects on human and animal health

             1. Effects on human health

                1. 22. The risk assessment shall take account of the following potential...

                2. 23. The effects previously mentioned result from the properties of the...

                3. 24. The populations previously mentioned are:

                4. 25. The hazard identification shall address the properties and potential adverse...

                5. 26. The competent authority shall apply points 27 to 30 when...

                6. 27. For repeated dose toxicity and reproductive toxicity the dose-response relationship...

                7. 28. For acute toxicity, corrosivity and irritation, it is not usually...

                8. 29. For mutagenicity and carcinogenicity, a non-threshold assessment should be carried...

                9. 30. With respect to skin sensitisation and respiratory sensitisation, in so...

                10. 31. When carrying out the risk assessment special consideration shall be...

                11. 32. An exposure assessment shall be carried out for each of...

                12. 33. The exposure assessment shall be based on the information in...

                13. 34. When conducting the exposure assessment, special consideration shall be given...

                14. 35. Where, for any of the effects set out in point...

             2. Effects on animal health

                1. 36. Using the same relevant principles as described in the section...

          3. Effects on the environment

             1. 37. The risk assessment shall take account of any adverse effects...

             2. 38. The hazard identification shall address the properties and potential adverse...

             3. 39. A dose (concentration) — response (effect) assessment shall be carried...

             4. 40. The PNEC shall be determined from the data on effects...

             5. 41. An assessment factor is an expression of the degree of...

             6. 42. For each environmental compartment, an exposure assessment shall be carried...

             7. 43. A PEC, or where necessary a qualitative estimate of exposure,...

             8. 44. The PEC, or the qualitative estimation of exposure, shall be...

             9. 45. When conducting the exposure assessment, special consideration shall be given...

             10. 46. For any given environmental compartment, the risk characterisation shall, as...

             11. 47. If it has not been possible to derive a PEC/PNEC...

             12. 48. The competent authority shall conclude that the biocidal product does...

          4. Effects on target organisms

             1. 49. An assessment shall be made to demonstrate that the biocidal...

             2. 50. The competent authority shall, where relevant, evaluate the possibility of...

          5. Efficacy

             1. 51. Data submitted by the applicant shall be sufficient to substantiate...

             2. 52. Testing should be carried out according to Great Britain guidelines...

          6. Summary

             1. 53. In each of the areas where risk assessments have been...

             2. 54. For biocidal product containing more than one active substance, any...

       4. CONCLUSIONS

          1. General principles

             1. 55. The purpose of the evaluation is to establish whether or...

             2. 56.

             3. 57. The competent authority shall, when seeking to establish whether a...

             4. 58. If the conclusion arrived at by the competent authority is...

          2. Effects on human and animal health

             1. Effects on human health

                1. 59. The competent authority shall consider possible effects on all human...

                2. 60. The competent authority shall examine the relationship between exposure and...

                3. 61. Typically, the margin of exposure (MOEref) — the ratio between...

                4. 62. The competent authority shall, where appropriate, conclude that criterion (iii)...

                5. 63. If, for non-professional users, the wearing of personal protective equipment...

             2. Effects on animal health

                1. 64. Using the same relevant criteria as described in the section...

          3. Effects on the environment

             1. 65. The basic tool used in the decision-making is the PEC/PNEC...

             2. 66. For any given environmental compartment, if the PEC/PNEC ratio is...

             3. Water

                1. 67.

                2. 68.

                3. 69.

                4. 70. The proposed instructions for use of the biocidal product, including...

             4. Soil

                1. 71. The competent authority shall conclude that the biocidal product does...

             5. Air

                1. 72. The competent authority shall conclude that the biocidal product does...

             6. Non-target organisms

                1. 73.

                2. 74. The competent authority shall conclude that the biocidal product does...

          4. Effects on target organisms

             1. 75. Where the development of resistance or cross-resistance to the active...

             2. 76. A biocidal product intended to control vertebrates shall not normally...

          5. Efficacy

             1. 77. The level, consistency and duration of protection, control or other...

          6. Summary

             1. 78. In relation to the criteria set out in points (iii)...

       5. OVERALL INTEGRATION OF CONCLUSIONS

    7. ANNEX VII