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Biocides applications: information requirements, assessments and evaluation

Contents

Legislation

Regulation (EU) No 528/2012[67] (UK legislation website)

Please note that due to advances in testing since GB BPR came into force in 2012, the data requirements have been updated and amended by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024[68] Applications received after 6 October 2025 will be required to use the new data requirements.

Data requirements by specialist area

The guidance is divided into 5 volumes that:

  • describe how to fulfil the information requirements set by the BPR
  • describe how to perform the required assessments
  • explain the guiding principles for the evaluation of the applications

Technical agreements for biocides

The EU technical agreements for biocides provide the general agreements which have not yet been included in any other Biocidal Products Regulation related guidance documents.

You can still use the agreements when making an application for the market in Great Britain(GB). Any GB updates you need to consider will be listed below:

GB updates

No GB updates

EU technical agreements

EU technical agreements[85] (European Commission website).

Biocides competent authorities meetings documents

The EU Competent Authorities for Biocidal Products discuss implementation issues in their meetings and publishes all documents discussed. Some of the documents may be useful when making an application for the market in Great Britain(GB).

Any GB updates you need to consider will be listed below:

GB updates

Bridging the endocrine disruptor assessment of biocidal non-active substances with UK and EU REACH screening and assessment[86]

EU meetings documents

EU competent authorities meetings documents (European Circabc website)[87]

Resources

Regulation (EU) No 528/2012[88] (UK legislation website)

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. Technical equivalence of an active substancehttps://www.hse.gov.uk/Biocides/technical-equivalence.htm
  27. Overviewhttps://www.hse.gov.uk/Biocides/product-authorisation-overview.htm
  28. National authorisationhttps://www.hse.gov.uk/Biocides/national-authorisation.htm
  29. Simplified authorisationhttps://www.hse.gov.uk/Biocides/simplified-product-authorisation.htm
  30. Same biocidal product authorisationhttps://www.hse.gov.uk/Biocides/same-biocidal-product.htm
  31. Change or cancel a biocidal product authorisationhttps://www.hse.gov.uk/Biocides/change/index.htm
  32. Renew an existing product authorisationhttps://www.hse.gov.uk/Biocides/renew.htm
  33. Research and developmenthttps://www.hse.gov.uk/Biocides/research.htm
  34. Essential use authorisationhttps://www.hse.gov.uk/Biocides/essential-use-authorisation.htm
  35. Critical situation permitshttps://www.hse.gov.uk/Biocides/critical-situation-permits.htm
  36. Food and feed derogationshttps://www.hse.gov.uk/Biocides/derogation.htm
  37. Unfettered access notificationhttps://www.hse.gov.uk/Biocides/unfettered-access-notification.htm
  38. Overviewhttps://www.hse.gov.uk/Biocides/uk-authorised-biocidal-products.htm
  39. Advertisement requirementshttps://www.hse.gov.uk/Biocides/advertisement-requirements.htm
  40. Packaging and labelling requirementshttps://www.hse.gov.uk/Biocides/packaging-labelling-requirements.htm
  41. Record keepinghttps://www.hse.gov.uk/Biocides/recording-keeping-reporting.htm
  42. Informing NPIShttps://www.hse.gov.uk/Biocides/informing-npis.htm
  43. Overviewhttps://www.hse.gov.uk/Biocides/data-protection.htm
  44. Access to documents: Biocidal active substances and productshttps://www.hse.gov.uk/Biocides/access-to-documents.htm
  45. Data sharing in GBhttps://www.hse.gov.uk/Biocides/data-sharing.htm
  46. Vertebrate testinghttps://www.hse.gov.uk/Biocides/vertebrate-testing.htm
  47. GB BPR feeshttps://www.hse.gov.uk/Biocides/fees.htm
  48. Biocides regulationshttps://www.hse.gov.uk/Biocides/regulations.htm
  49. Northern Irelandhttps://www.hse.gov.uk/Biocides/northern-ireland.htm
  50. Existing products: Transfer to GB BPRhttps://www.hse.gov.uk/Biocides/transfer-from-uk-national-law.htm
  51. Overviewhttps://www.hse.gov.uk/Biocides/copr/index.htm
  52. COPR approval: how to applyhttps://www.hse.gov.uk/Biocides/copr/application.htm
  53. COPR product approval typeshttps://www.hse.gov.uk/Biocides/copr/approvals.htm
  54. COPR approved productshttps://www.hse.gov.uk/Biocides/copr/approved.htm
  55. COPR feeshttps://www.hse.gov.uk/Biocides/copr/fees.htm
  56. COPR labellinghttps://www.hse.gov.uk/Biocides/copr/labelguidance.htm
  57. Conditions of approvalhttps://www.hse.gov.uk/Biocides/copr/conditions.htm
  58. Open invitations and notificationshttps://www.hse.gov.uk/Biocides/open-invitations-notifications.htm
  59. Consultations and surveyshttps://www.hse.gov.uk/Biocides/consultations.htm
  60. Consultations: Submitting informationhttps://www.hse.gov.uk/Biocides/consultations-submitting.htm
  61. Overviewhttps://www.hse.gov.uk/Biocides/information.htm
  62. Glossaryhttps://www.hse.gov.uk/Biocides/glossary.htm
  63. Useful linkshttps://www.hse.gov.uk/Biocides/links.htm
  64. Contacthttps://www.hse.gov.uk/Biocides/contact.htm
  65. Service standardshttps://www.hse.gov.uk/Biocides/servicestandards.htm
  66. Temporary changes to GB biocides application processing timeshttps://www.hse.gov.uk/Biocides/temporary-changes-application-processing-time.htm
  67. Regulation (EU) No 528/2012https://www.legislation.gov.uk/eur/2012/528/contents
  68. The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024https://www.legislation.gov.uk/uksi/2024/352/contents/made
  69. Introduction to information requirementshttps://www.hse.gov.uk/Biocides/applications/introduction.htm
  70. Parts A+B+C: information requirements, assessment and evaluationhttps://www.hse.gov.uk/Biocides/applications/volume1.htm
  71. Part A: information requirementshttps://www.hse.gov.uk/Biocides/applications/volume2-a.htm
  72. Parts B+C: assessment and evaluationhttps://www.hse.gov.uk/Biocides/applications/volume2-bc.htm
  73. Supplementary GB product type 19 efficacy guidancehttps://www.hse.gov.uk/Biocides/applications/supplementary-gb-pt19.htm
  74. Part A: information requirementshttps://www.hse.gov.uk/Biocides/applications/volume3-a.htm
  75. Parts B+C: assessment and evaluationhttps://www.hse.gov.uk/Biocides/applications/volume3-bc.htm
  76. Biocides human health exposure methodologyhttps://www.hse.gov.uk/Biocides/applications/human-health-exposure-methodology.htm
  77. Part A: information requirementshttps://www.hse.gov.uk/Biocides/applications/volume4-a.htm
  78. Parts B+C: assessment and evaluationhttps://www.hse.gov.uk/Biocides/applications/volume4-bc.htm
  79. Active substance suppliershttps://www.hse.gov.uk/Biocides/applications/volume5-active-substance-suppliers.htm
  80. Disinfection by-productshttps://www.hse.gov.uk/Biocides/applications/volume5-disinfection-by-products.htm
  81. Identification of endocrine disruptorshttps://www.hse.gov.uk/Biocides/applications/volume5-endocrine-distruptors.htm
  82. Identification of endocrine disruptors – consultations outcomehttps://www.hse.gov.uk/Biocides/applications/volume5-endocrine-distruptors-consultations-outcome.htm
  83. Micro-organismshttps://www.hse.gov.uk/Biocides/applications/volume5-micro-organisms.htm
  84. Technical equivalencehttps://www.hse.gov.uk/Biocides/applications/volume5-technical-equivalence.htm
  85. EU technical agreementshttps://webgate.ec.europa.eu/s-circabc/w/browse/4047dcc1-ff35-45e1-894c-8647639f9ae8
  86. Bridging the endocrine disruptor assessment of biocidal non-active substances with UK and EU REACH screening and assessmenthttps://www.hse.gov.uk/Biocides/applications/bridging-endocrine-disruptor-assessment.htm
  87. EU competent authorities meetings documents (European Circabc website)https://circabc.europa.eu/faces/jsp/extension/wai/navigation/container.jsp
  88. Regulation (EU) No 528/2012https://www.legislation.gov.uk/eur/2012/528/contents

Glossary of abbreviations/acronyms on this page

COPR
Control of Pesticides Regulations

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Updated 2025-03-12