Search Legislation

Advanced Search

The Biocidal Products Regulations 2001

Help about what version

What Version

  • Latest available (Revised)
  • Original (As made)

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

  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 National Poisons 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. (8).In this regulation, “the appropriate person” means—

    5. 37.Tests

    6. 38.Enforcement, offences and civil liability

    7. 39.Fees

    8. 40.Transitional provisions

    9. 41.Extension outside Great Britain

    10. 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 MINISTERS

      1. 1.Subject to paragraph 2, the Ministers have determined that the...

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

      3. 3.The Ministers have determined, according to the relevant requirements in...

      4. 4.The Ministers have 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 Ministers 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 NATIONAL POISONS 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

      APPEALS

      1. PART I

        1. 1.In this Schedule— (a) “appeal” means an appeal under regulation...

        2. 2.The appropriate person shall direct that an appeal shall be...

        3. 3.Before the determination of an appeal, the appointed person shall...

        4. 4.An appointed person may give such directions as he thinks...

        5. 5.The appropriate person may pay to an appointed person such...

      2. PART II

        1. 6.An appeal brought pursuant to regulation 36(1)(j) shall be heard...

        2. 7.(1) Subject to the following sub-paragraphs of this paragraph, a...

        3. 8.(1) Not later than 28 days before the date of...

        4. 9.(1) The parties shall be entitled to appear at the...

        5. 10.(1) Where a government department has expressed in writing to...

        6. 11.(1) Except as otherwise provided in this Part of this...

        7. 12.(1) Where, after the close of the hearing, the appointed...

        8. 13.The appointed person shall notify the determination on the appeal,...

    11. SCHEDULE 11

      ENFORCEMENT, OFFENCES AND CIVIL LIABILITY

      1. 1.Interpretation

      2. 2.Application of the 1974 Act

      3. 3.Offences

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

      5. 5.Allocation of enforcement responsibility

    12. SCHEDULE 12

      FEES

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

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

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

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

      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...

    13. SCHEDULE 13

      TRANSITIONAL PROVISIONS

      1. 1.In this Schedule— “COPR 1986” 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 Ministers 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—

  10. Explanatory Note

Back to top

Options/Help

Print Options

You have chosen to open The Whole Instrument

The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open The Whole Instrument as a PDF

The Whole Instrument you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources

The data on this page is available in the alternative data formats listed: