Biocidal Products Regulations (Northern Ireland) 2001

  1. Introductory Text

  2. Part I General

    1. 1.Citation and commencement

    2. 2.Interpretation

    3. 3.Application

  3. Part II Active Substances

    1. 4.Placing on the market of active substances

    2. 5.Applications concerning new active substances

    3. 6.Assessment of applications concerning new active substances

    4. 7.Applications for variation or renewal of the inclusion of active substances in Annex I, IA or IB

  4. Part III Biocidal Products

    1. 8.Prohibitions

    2. 9.Authorisation of a biocidal product

    3. 10.Registration of a low-risk biocidal product

    4. 11.Mutual recognition of authorisations

    5. 12.Mutual recognition of registrations

    6. 13.Provisional authorisation

    7. 14.Provisional registration

    8. 15.Emergency authorisation

    9. 16.Research and development

    10. 17.Experimental authorisation

    11. 18.Frame-formulations

    12. 19.Revocation of authorisations and registrations

    13. 20.Modification and review of authorisations and registrations

    14. 21.Notification of new information

    15. 22.Emergency prohibition or restriction

  5. Part IV Use of Information

    1. 23.Data protection for active substances

    2. 24.Data protection for biocidal products

    3. 25.Co-operation in the use of information

    4. 26.Confidentiality

    5. 27.Treatment of confidential information

    6. 28.Exchange of information

    7. 29.Notification of information to the Poison Information Service

  6. Part V Packaging, Labelling and Advertisements

    1. 30.Packaging

    2. 31.Labelling

    3. 32.Samples, models and drafts

    4. 33.Advertisements

  7. Part VI Miscellaneous and General

    1. 34.General provisions on applications for authorisations and registrations

    2. 35.Files on applications

    3. 36.Appeals

    4. 37.Tests

    5. 38.Enforcement, offences and civil liability

    6. 39.Fees

    7. 40.Transitional provisions

    8. 41.Application within territorial waters

    9. 42.Amendments

  8. Signature

    1. SCHEDULE 1

      Biocidal product-types and their descriptions

    2. SCHEDULE 2

      Regulations relating to Biocidal products

    3. SCHEDULE 3

      Determinations of the Executive

      1. 1.Subject to paragraph 2, the Executive has determined that the...

      2. 2.In making the determinations referred to in paragraph 1, the...

      3. 3.The Executive has determined, according to the relevant requirements in...

      4. 4.The Executive has determined— (a) the physical and chemical properties...

    4. SCHEDULE 4

      Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product

      1. 1.The name and address of the applicant.

      2. 2.The name and address of the manufacturer of the biocidal...

      3. 3.The name and address of the manufacturer of the active...

      4. 4.The trade name of the biocidal product.

      5. 5.The name of each substance in the biocidal product, including...

      6. 6.The physical and chemical properties of the biocidal product relating...

      7. 7.The product-type and field of use of the biocidal product....

      8. 8.The intended category of users.

      9. 9.The intended method of use.

      10. 10.Efficacy data.

      11. 11.Analytical methods.

      12. 12.The classification, packaging and labelling of the biocidal product, including...

      13. 13.Where the biocidal product is a substance or preparation dangerous...

    5. SCHEDULE 5

      Matters in respect of which additional conditions may be imposed on the mutual recognition of an authorisation or a registration of a biocidal product

      1. 1.Directions for use of the biocidal product in question, including...

      2. 2.Particulars of any likely direct or indirect adverse side effects...

      3. 3.Directions for safe disposal of the biocidal product in question...

      4. 4.The period of time needed for the biocidal effect.

      5. 5.The interval to be observed between— (a) applications of the...

      6. 6.Particulars for adequate cleaning of equipment.

      7. 7.Particulars concerning precautionary measures during use, storage and transport, such...

      8. 8.Information on any specific dangers to the environment, including protection...

    6. SCHEDULE 6

      Non-confidential information

      1. 1.The name and address of the applicant for the authorisation...

      2. 2.The name of the biocidal product.

      3. 3.The name and address of the manufacturer of the biocidal...

      4. 4.The name and address of the manufacturer of the active...

      5. 5.The name and content of the active substance in the...

      6. 6.The name of any other substance in the biocidal product...

      7. 7.Physical and chemical data concerning the biocidal product and the...

      8. 8.Any ways of rendering harmless the biocidal product and the...

      9. 9.A summary of the results of the tests, referred to...

      10. 10.Recommended methods and precautions to reduce dangers from handling, storage,...

      11. 11.Safety data sheets.

      12. 12.Methods of analysis necessary to enable the Executive to make...

      13. 13.Methods of disposal of the biocidal product and its packaging....

      14. 14.Procedures to be followed and measures to be taken in...

      15. 15.First aid and medical advice to be given in the...

    7. SCHEDULE 7

      Information relating to Biocidal products to be given to the Commission and to the competent authorities

      1. 1.The name of the applicant for, or the person to...

      2. 2.The trade name of the biocidal product.

      3. 3.The name and amount of each active substance which the...

      4. 4.The name and amount of each substance which the biocidal...

      5. 5.The product-type for the biocidal product and the use for...

      6. 6.The type of formulation of the biocidal product, namely whether...

      7. 7.Any proposed limits on residues which have been determined by...

      8. 8.Any conditions subject to which the authorisation or registration was...

      9. 9.The reasons for the modification or cancellation of an authorisation...

      10. 10.Whether the biocidal product is a low-risk biocidal product or...

    8. SCHEDULE 8

      Information to be notified to the Poison Information Service

      1. 1.The name of the biocidal product.

      2. 2.If the biocidal product is authorised or registered under these...

      3. 3.The date on which the biocidal product was first placed...

      4. 4.The name, address and telephone number and any e-mail address...

      5. 5.A description of the packaging of the biocidal product, including...

      6. 6.The pH, physical state and colour of the biocidal product....

      7. 7.The identity of the ingredients of the biocidal product, and...

      8. 8.The effects on human health of contact with the biocidal...

      9. 9.Particulars of the likely direct or indirect adverse side effects...

      10. 10.Any other information relating to the health and safety of...

    9. SCHEDULE 9

      Information to be included on labels

      1. 1.The identity of the active substance in the biocidal product...

      2. 2.The authorisation or registration number allocated to the biocidal product...

      3. 3.The type of formulation of the biocidal product, namely whether...

      4. 4.The use for which the biocidal product is authorised or...

      5. 5.Directions for use of the biocidal product, including its dose...

      6. 6.Particulars of likely direct or indirect adverse side effects and...

      7. 7.Directions for safe disposal of the biocidal product and its...

      8. 8.The number or other reference assigned by the manufacturer of...

      9. 9.The period of time needed for the biocidal effect.

      10. 10.The interval to be observed between— (a) applications of the...

      11. 11.Instructions for adequate cleaning of equipment for use with the...

      12. 12.Instructions concerning precautionary measures during use, storage and transport, such...

      13. 13.Any restriction on the category of persons who may use...

      14. 14.Information on any specific dangers to the environment, including protection...

    10. SCHEDULE 10

      Enforcement, offences and civil liability

      1. 1.Interpretation

      2. 2.Application of the Health and Safety at Work (Northern Ireland) Order 1978

      3. 3.Offences

      4. 4.Limitation on entry to domestic premises in certain circumstances

      5. 5.Allocation of enforcement responsibility

    11. SCHEDULE 11

      Fees

      1. 1.On the making of an application to the Executive under...

      2. 2.There shall be payable by the applicant to the Executive...

      3. 3.The applications to the Executive referred to in paragraph 2...

      4. 4.There shall be payable by the applicant to the Executive...

      5. 5.There shall be payable by a person who provides information...

      6. 6.There shall be payable by a person who requests a...

      7. 7.On receipt of— (a) an application referred to in paragraph...

      8. 8.The amount estimated in accordance with paragraph 7 shall be...

      9. 9.On the determination of the application, completion of the evaluation...

      10. 10.If the cost referred to in paragraph 9 is greater...

      11. 11.If the cost referred to in paragraph 9 is less...

      12. 12.In estimating or stating the cost of carrying out any...

    12. SCHEDULE 12

      Transitional Provisions

      1. 1.In this Schedule— “COPR 1987” means the Control of Pesticides...

      2. 2.Subject to paragraphs 3 and 4, where a decision is...

      3. 3.These Regulations shall not apply to a biocidal product—

      4. 4.Where there is more than one unlisted active substance in...

      5. 5.Where— (a) there is made a decision referred to in...

      6. 6.Where— (a) there is made a decision referred to in...

      7. 7.During— (a) the period of time in which an application...

      8. 8.Where— (a) there is made a decision referred to in...

      9. 9.During— (a) the period of time in which an application...

      10. 10.Where— (a) no application is made in accordance with paragraph...

      11. 11.Where— (a) an application is made in accordance with paragraph...

      12. 12.Where— (a) there is made a decision referred to in...

      13. 13.Where— (a) there is made a decision referred to in...

      14. 14.The Executive shall— (a) notify in writing the holder of...

      15. 15.A certificate of exemption granted pursuant to paragraph 6, 7,...

      16. 16.An exemption certificate granted in accordance with paragraph 15—

    13. SCHEDULE 13

      Application within territorial waters

      1. 1.Interpretation

      2. 2.Offshore installations

      3. 3.Wells

      4. 4.Pipelines

      5. 5.Mines

      6. 6.Other activities

  10. Explanatory Note