Biocides vertebrate testing

To reduce in vivo testing on vertebrate animals, the GB Biocidal Products Regulation (GB BPR) requires that such tests should only be conducted as a last resort and that testing on vertebrates shall not be repeated for the purposes of GB BPR.

Determining if data exists

Before undertaking any in vivo testing on vertebrate animals for the purposes of GB BPR (for example to fulfil a data requirement), you must follow the steps on data sharing under GB BPR.[69]

This ensures that your proposed in vivo test on vertebrates will not duplicate an existing test.

If HSE holds the data you need, you should follow the required steps to allow that data to be used on your behalf.

If no vertebrate data exists

If HSE does not hold the data you need, new tests involving vertebrates should only be conducted as the last available option to meet data requirements for your GB BPR application.

You should ensure all the other data sources have been exhausted before you commission any new vertebrate tests.

HSE has developed detailed guidance on how to address the toxicology data requirements for the authorisation of biocidal products[70], in line with the provisions of Article 62 of GB BPR on minimising animal testing when unnecessary.

In addition, before commissioning new tests involving vertebrates, you must contact  HSE with a robust justification for the test. If the justification is found acceptable, the correspondence between you and HSE can be included in your GB BPR application.

If you submit an application containing new vertebrate data for active substance approval or product authorisation under GB BPR and we consider your justification is not acceptable, the data will not be accepted, and your application may be rejected.

Consulting HSE

To consult HSE about your proposed justification for conducting vertebrate studies for GB BPR, the prospective applicant or company acting on their behalf should submit a completed English language consultation form to biocidesapplications@hse.gov.uk.

Companies may wish to mark emails as confidential as appropriate. Please note that your form may be returned if it is incomplete.

Only the consultation form should be submitted by email.

All other relevant documentation and data must be submitted via the HSE Secure File Sharing Service, including:

  • evidence that you have contacted HSE to determine whether we already hold such studies
  • evidence that HSE confirmed we do not hold such studies

Using the HSE Secure File Sharing Service

  • Once we have received and processed your consultation form, you will be sent a link to upload the files associated with the relevant consultation - please do not use the link to upload files related to other consultations or applications.
  • Links will be sent out Monday to Friday and are valid for 5 working days. I the link expires before you are able to upload your files, please email biocidesapplications@hse.gov.uk to request a new link.
  • Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service, these will be included in the email alongside the link.
  • Please check the spam settings on your email account to ensure our emails are not going to your junk folder.

GB applications containing new vertebrate data

When submitting an application for active substance approval or product authorisation in GB that contains a test on vertebrate animals conducted after 1 September 2013, you must provide the following:

  • evidence that you contacted, prior to the commissioning of the test, either:
    • HSE - for tests commissioned after 31 December 2020
    • European Chemicals Agency (ECHA) - for tests commissioned prior to 01 January 2021
  • confirmation that HSE or ECHA, as applicable, did not hold such vertebrate tests
  • a robust justification demonstrating why the test was necessary, such as why it represented a last resort and that all other data sources had been exhausted. Where you have contacted us prior to commissioning the test you can provide the correspondence showing that HSE agreed with your justification

If there is no evidence that HSE or ECHA, as applicable, has been contacted regarding a test conducted after 1 September 2013, the data will not be accepted, and your application may be rejected.

Enforcement action[71] may also be taken as this is a breach of the law.

Link URLs in this page

  1. Biocideshttps://www.hse.gov.uk/biocides/index.htm
  2. Biocides: Introductionhttps://www.hse.gov.uk/biocides/introduction.htm
  3. Overviewhttps://www.hse.gov.uk/biocides/regulated/index.htm
  4. Biocides: active substance statushttps://www.hse.gov.uk/biocides/checking/index.htm
  5. Importing and exportinghttps://www.hse.gov.uk/biocides/importing.htm
  6. Certificates of Free Sale and Export Statementshttps://www.hse.gov.uk/biocides/certificates-of-freesale.htm
  7. Treated articleshttps://www.hse.gov.uk/biocides/treated-articles.htm
  8. Monitoring trapshttps://www.hse.gov.uk/biocides/monitoring-traps.htm
  9. Article 3(3) decisions on scopehttps://www.hse.gov.uk/biocides/decisions-on-scope.htm
  10. In situ generationhttps://www.hse.gov.uk/biocides/in-situ-generation.htm
  11. Get product on UK markethttps://www.hse.gov.uk/biocides/market.htm
  12. Overviewhttps://www.hse.gov.uk/biocides/using.htm
  13. Honey beeshttps://www.hse.gov.uk/biocides/honey-bees.htm
  14. Rodenticideshttps://www.hse.gov.uk/biocides/rodenticides.htm
  15. Reporting exposurehttps://www.hse.gov.uk/biocides/reporting.htm
  16. Biocides enforcementhttps://www.hse.gov.uk/biocides/enforcement.htm
  17. Authorities and activitieshttps://www.hse.gov.uk/biocides/enforcement-authorities.htm
  18. Overviewhttps://www.hse.gov.uk/biocides/active-substance-approval.htm
  19. UK Review Programmehttps://www.hse.gov.uk/biocides/review-regulation.htm
  20. Active substances: How to applyhttps://www.hse.gov.uk/biocides/how-to-apply.htm
  21. Simplified active substanceshttps://www.hse.gov.uk/biocides/simplified-actives.htm
  22. The GB List of Active Substanceshttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  23. GB Article 95: The basicshttps://www.hse.gov.uk/biocides/uk-article-95-basics.htm
  24. GB Article 95: How to applyhttps://www.hse.gov.uk/biocides/uk-article-95-how-to-apply.htm
  25. The GB Article 95 Listhttps://www.hse.gov.uk/biocides/uk-article-95-list.htm
  26. Planned removal of entries from GB Article 95 Listhttps://www.hse.gov.uk/biocides/article-95-removal.htm
  27. Entries due for removal from the GB Article 95 Listhttps://www.hse.gov.uk/biocides/uk-article-95-removal-list.htm
  28. Technical equivalence of an active substancehttps://www.hse.gov.uk/biocides/technical-equivalence.htm
  29. Overviewhttps://www.hse.gov.uk/biocides/product-authorisation-overview.htm
  30. National authorisationhttps://www.hse.gov.uk/biocides/national-authorisation.htm
  31. Simplified authorisationhttps://www.hse.gov.uk/biocides/simplified-product-authorisation.htm
  32. Same biocidal product authorisationhttps://www.hse.gov.uk/biocides/same-biocidal-product.htm
  33. Change or cancel a biocidal product authorisationhttps://www.hse.gov.uk/biocides/change/index.htm
  34. Renew an existing product authorisationhttps://www.hse.gov.uk/biocides/renew.htm
  35. Research and developmenthttps://www.hse.gov.uk/biocides/research.htm
  36. Essential use authorisationhttps://www.hse.gov.uk/biocides/essential-use-authorisation.htm
  37. Critical situation permitshttps://www.hse.gov.uk/biocides/critical-situation-permits.htm
  38. Food and feed derogationshttps://www.hse.gov.uk/biocides/derogation.htm
  39. Unfettered access notificationhttps://www.hse.gov.uk/biocides/unfettered-access-notification.htm
  40. Overviewhttps://www.hse.gov.uk/biocides/uk-authorised-biocidal-products.htm
  41. Advertisement requirementshttps://www.hse.gov.uk/biocides/advertisement-requirements.htm
  42. Packaging and labelling requirementshttps://www.hse.gov.uk/biocides/packaging-labelling-requirements.htm
  43. Record keepinghttps://www.hse.gov.uk/biocides/recording-keeping-reporting.htm
  44. Informing NPIShttps://www.hse.gov.uk/biocides/informing-npis.htm
  45. Overviewhttps://www.hse.gov.uk/biocides/data-protection.htm
  46. Access to documents: Biocidal active substances and productshttps://www.hse.gov.uk/biocides/access-to-documents.htm
  47. Data sharing in GBhttps://www.hse.gov.uk/biocides/data-sharing.htm
  48. Vertebrate testinghttps://www.hse.gov.uk/biocides/vertebrate-testing.htm
  49. GB BPR feeshttps://www.hse.gov.uk/biocides/fees.htm
  50. Biocides regulationshttps://www.hse.gov.uk/biocides/regulations.htm
  51. Northern Irelandhttps://www.hse.gov.uk/biocides/northern-ireland.htm
  52. Existing products: Transfer to GB BPRhttps://www.hse.gov.uk/biocides/transfer-from-uk-national-law.htm
  53. Overviewhttps://www.hse.gov.uk/biocides/copr/index.htm
  54. COPR approval: how to applyhttps://www.hse.gov.uk/biocides/copr/application.htm
  55. COPR product approval typeshttps://www.hse.gov.uk/biocides/copr/approvals.htm
  56. COPR approved productshttps://www.hse.gov.uk/biocides/copr/approved.htm
  57. COPR feeshttps://www.hse.gov.uk/biocides/copr/fees.htm
  58. COPR labellinghttps://www.hse.gov.uk/biocides/copr/labelguidance.htm
  59. Conditions of approvalhttps://www.hse.gov.uk/biocides/copr/conditions.htm
  60. Open invitations and notificationshttps://www.hse.gov.uk/biocides/open-invitations-notifications.htm
  61. Consultations and surveyshttps://www.hse.gov.uk/biocides/consultations.htm
  62. Consultations: Submitting informationhttps://www.hse.gov.uk/biocides/consultations-submitting.htm
  63. Overviewhttps://www.hse.gov.uk/biocides/information.htm
  64. Glossaryhttps://www.hse.gov.uk/biocides/glossary.htm
  65. Useful linkshttps://www.hse.gov.uk/biocides/links.htm
  66. Contacthttps://www.hse.gov.uk/biocides/contact.htm
  67. Service standardshttps://www.hse.gov.uk/biocides/servicestandards.htm
  68. Temporary changes to GB biocides application processing timeshttps://www.hse.gov.uk/biocides/temporary-changes-application-processing-time.htm
  69. follow the steps on data sharing under GB BPR.https://www.hse.gov.uk/biocides/data-sharing.htm
  70. detailed guidance on how to address the toxicology data requirements for the authorisation of biocidal productshttps://www.hse.gov.uk/biocides/article-62.htm
  71. Enforcement actionhttps://www.hse.gov.uk/biocides/enforcement.htm
  72. The lawhttps://www.hse.gov.uk/biocides/information.htm#law
  73. UK authorised biocidal productshttps://www.hse.gov.uk/biocides/uk-authorised-biocidal-products.htm
  74. The GB List of Active Substanceshttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  75. Vertebrate testing consultation formhttps://www.hse.gov.uk/biocides/assets/docs/form-vertebrate.docx
  76. Brexit: Implications for Northern Irelandhttps://www.hse.gov.uk/biocides/northern-ireland.htm
  77. Product authorisation overviewhttps://www.hse.gov.uk/biocides/product-authorisation-overview.htm
  78. Data protection overviewhttps://www.hse.gov.uk/biocides/data-protection.htm
  79. Data sharing in GBhttps://www.hse.gov.uk/biocides/data-sharing.htm

Glossary of abbreviations/acronyms on this page

COPR
Control of Pesticides Regulations

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Updated 2024-06-05