Technical equivalence of an active substance: biocides

What technical equivalence is

The purpose of technical equivalence is to ensure that the active substance contained in a biocidal product does not have significantly more hazardous properties than the substance which was evaluated for the purpose of approval (the reference source).

When technical equivalence is assessed

Technical equivalence needs to be assessed when there has been a change in regard to the source of the active substance:

  • when the substance is produced from a source different to the reference source
  • when the substance is produced from the same reference source but following a change to the manufacturing process or location

Who assesses technical equivalence

HSE is responsible for assessing technical equivalence for Great Britain under the GB Biocidal Products Regulation (GB BPR).

If you need to have technical equivalence assessed for Northern Ireland, this is done by the European Chemicals Agency (ECHA) under the EU Biocidal Products Regulation (EU BPR).

Find out how to apply to ECHA.[67]

How to apply for an assessment

Companies interested in applying for technical equivalence assessment should email gb.biocides@hse.gov.uk.

The assessment is divided into 2 tiers.

In Tier 1, substance identity, chemical composition, analytical profile of 5 representative batches, description of the analytical method used for the determination of the substance and absorption spectra are assessed. If we cannot establish technical equivalence based on Tier 1, you may ask HSE to perform a Tier 2 assessment based on the hazard profile using toxicological and eco-toxicological data.

Normally we would expect to receive a Tier 1 application in the first instance. If you think that a Tier 2 assessment will be necessary, you should discuss this with us before carrying out any experimental work.

The approximate timeframe for a technical equivalence application is 90 days from payment of the fees[68]. However, this timeframe may be suspended if you are asked to submit additional information.

Please note that if we do not hold the relevant data for the reference source, we may not be able to process your application.

Once the assessment is complete, you will be given the opportunity to comment regarding the outcome before HSE takes the final decision. 

Technical equivalence and biocidal products

When you apply for product authorisation under GB BPR or EU BPR, if you are not using the reference source, you must make sure that the active substance you are using has technical equivalence.

For products that are already authorised, if the active substance source or manufacturing process changes, you must make sure that the active substance produced from this source or manufacturing process has technical equivalence before you start using it in your product. You must also notify us of these changes[69] before you start using the new or amended source in your product.

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. Find out how to apply to ECHA.https://echa.europa.eu/regulations/biocidal-products-regulation/technical-equivalence
  68. feeshttps://www.hse.gov.uk/biocides/fees.htm
  69. notify us of these changeshttps://www.hse.gov.uk/biocides/change/index.htm

Glossary of abbreviations/acronyms on this page

COPR
Control of Pesticides Regulations

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Updated 2025-03-12