Simplified active substances

To encourage the use of products with a more favourable environmental, human health or animal health profile, the GB Biocidal Products Regulation (GB BPR) establishes a list of active substances that may be used in products that are eligible for simplified product authorisation[68] in Great Britain (GB).

Substances already identified as presenting a "low risk", are included on the GB Active Substance List[69] as simplified active substances, it currently includes substances in the following categories:

  • category A – equivalent to categories 1-5 of Annex I of the EU Biocidal Products Regulation (EU BPR) – includes substances such as food additives, weak acids and pheromones
  • category B – equivalent to category 6 of Annex I of EU BPR – includes substances for which an active substance dossier has been validated in accordance with Article 7 (3) of GB BPR
  • category C – equivalent to category 7 of Annex I of EU BPR – includes substances other than those in categories A and B

Applications can be made to HSE to include a substance in the GB Active Substance List[70] as a category A or category B simplified active substance. Products using simplified active substances may be eligible for the simplified authorisation procedure[71].

If an active substance was not supported in the GB Review Programme, but might meet the criteria to be included as a simplified active substance on the GB Active Substance List, the active substance cannot be used in biocidal products made available on the GB market until the active substance is formally included on the GB Active Substance List[72] and the biocidal product is authorised.

Making available on the market means any supply of a biocidal product, whether in return for payment or free of charge, at all stages of the supply chain. Some examples of this could include:

  • manufacturer to distributor
  • distributor to retail store
  • retail store to user

Enforcement action[73] may be taken where a simplified biocidal active substance that is not yet included on the list is made available on the GB market in a biocidal product.

For category B simplified active substances, the active substance must be sourced from a GB Article 95[74] supplier (this is because for category B a full data dossier will have been submitted). If the category B simplified active substance supplier is not on the GB Article 95 List, then the biocidal product containing that active substance cannot be made available on the GB market.

Biocidal products containing categories A and C simplified active substances do not need to source their active substance from a GB Article 95 list supplier and the suppliers of these do not need to be included on the GB Article 95 list.

Check the criteria

Before considering supporting a simplified active substance for inclusion on the list in GB, you should check if it meets the criteria. To be considered for inclusion as a simplified active substance on the GB Active Substance List[75], there must be evidence that the substance does not give rise to concern.

An active substance  is considered to give rise to concern (and therefore would not meet the criteria for inclusion on the GB Simplified Active Substance List) where:

  • it meets the criteria for classification according to GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP[76]) Regulation as:
    • explosive / highly flammable
    • an organic peroxide
    • acutely toxic (category 1, 2 or 3)
    • corrosive (category 1A, 1B or 1C)
    • respiratory sensitising
    • skin sensitising
    • germ cell mutagenic (category 1 or 2)
    • carcinogenic (category 1 or 2)
    • toxic for reproduction (category 1 or 2 or with effects on or via lactation)
    • toxic for specific target organs (single or repeated exposure)
    • toxic to aquatic life (acute category 1)
  • it fulfils any of the substitution criteria set out in Article 10 (1) of GB BPR:
    • it meets the criteria for classification according to GB CLP[77] as:
      • carcinogenic (category 1A or B)
      • mutagenic (category 1A or B)
      • toxic for reproduction (category 1A or B)
    • it meets the criteria to be considered to have endocrine disrupting properties
    • it meets the criteria for being Persistent, Bio-accumulative and Toxic (PBT) or very Persistent and very Bio-accumulative (vPvB) according to UK REACH[78]
    • it meets the criteria for classification according to GB CLP[79] as respiratory sensitising
    • the acceptable daily intake / acute reference dose / acceptable operator exposure level is significantly lower that the majority of approved active substances for the same product type and use
    • it meets two of the criteria for being PBT according to UK REACH[80]
    • there are concerns linked to the nature of the critical effects even with very restrictive risk mitigation measures
    • it contains a significant proportion of non-active isomers or impurities
  • it has neurotoxic or immunotoxic properties
  • a level of concern equivalent to that described in any of the above points can be reasonably demonstrated based on reliable information

How to Apply

The prospective applicant or company acting on their behalf must submit, in English, a completed application form(.docx) (.docx) [81] to biocidesapplications@hse.gov.uk.

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

Only the application form should be submitted by email. All other relevant documentation and data must be submitted via the HSE Secure File Sharing Service.

Using the HSE Secure File Sharing Service

Once we have received and processed your application form, you will be sent a link to upload the files associated with the relevant application. Please do not use the link to upload files related to other applications.

Links will be sent out Monday–Friday and are valid for 5 working days. If 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.

For category A of the GB Simplified Active Substance List

Submit via the HSE Secure File Sharing Service:

  • evidence to show that the substance fits within the relevant category
  • evidence of a robust consensus of expert opinion or data to show that the substance does not give rise to concern against the criteria in Article 28 (2) of GB BPR
  • Safety Data Sheet (SDS) where applicable
  • any pre-submission correspondence with HSE

For category B of the GB Simplified Active Substance List

Submit via the HSE Secure File Sharing Service:

  • a dossier, in IUCLID format, that satisfies the requirements of Annex II of GB BPR - this dossier will include information about the active substance's:
    • physical, chemical, technical and, where appropriate, biological properties
    • physical hazards and respective characteristics
    • methods of detection and identification
    • effectiveness against target organisms
    • intended uses and exposure
    • toxicological profile for humans and animals, including metabolism
    • ecotoxicology
    • fate and behaviour in the environment
    • risk mitigation measures
    • classification, labelling and packaging
  • a dossier, in IUCLID format, that satisfies the requirements of Annex III of GB BPR for a representative biocidal product containing the active substance, including:
    • formulation details
    • physical, chemical, technical and, where appropriate, biological properties
    • effectiveness against target organisms
    • intended uses and exposure
    • toxicological profile for humans and animals
    • ecotoxicology
    • fate and behaviour in the environment
    • risk mitigation measures
    • classification, labelling and packaging
  • a draft Risk Assessment Report (RAR)(.docx) (.docx) [82]for the active substance and representative product
  • Safety Data Sheet (SDS)
  • reference list of studies (.xlsx) (.xlsx) [83]
  • any pre-submission correspondence with HSE

Dossier guidance for category B simplified active substances

Dossiers should be submitted in one of two formats:

  • IUCLID (International Uniform Chemical Information Database)[84]
  • structured file system consisting of word, excel and PDF documents etc – it is expected that this kind of submission will only be applicable to applicants who already have a dossier in this format and do not have a current IUCLID version

Paper dossiers (or partial paper dossiers) must not be submitted.

Dossiers should consist of three main sections:

  • data in the form of study reports
  • summaries of those data – either in IUCLID or word documents
  • assessments of the hazard, exposures, risks and efficacy of the active substance in a representative product, including an overall summary – using this Risk Assessment Report (RAR) template (.docx) (.docx) [85]

All documents and attachments should be included within your IUCLID dossier.

Guidance on information requirements[86] for active substances and biocidal products. Applicants should use these documents when preparing dossiers for active substance approval.

Biocides Submission Manual (BSM) series[87] - describes how to build IUCLID dossiers with detailed and illustrative technical assistance

Guidance and training on IUCLID[88] is also available – please note that HSE is unable to provide support on IUCLID

Things to note

HSE encourages pre-submission meetings with applicants to discuss:

  • the simplified active substance dossier structure
  • potential issues
  • the basis of data waiving arguments – to reduce potential problems later in the process
  • the proposed timescale for submission – to allow better work scheduling
  • fees[89] and likely timelines

What HSE will do

Applications for category A

After receiving your application HSE will:

  • conduct a brief initial check of the information to confirm that it meets the requirements for the application type
  • estimate how much it may cost[90] ("initial estimated fee") to process the application based on the information provided
  • issue an invoice to the applicant which must be paid within 30 days of the date of the invoice. Failure to pay the requested fees will result in your application being rejected
  • evaluate the application (once the initial estimated fee has been paid) to assess whether there is evidence that the substance does not give rise to concern. This will take approximately 180 days from the payment of the fees
  • make a recommendation to the Secretary of State and Devolved Authorities as to whether the active substance can be included as a simplified active substance on the GB Active Substance List[91]
  • issue an invoice for a "top up" fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice. Failure to pay the requested fees will result in the substance's inclusion in the list being withheld

You may be asked to provide further information at various stages of the process. When such requests are made, the indicative timeframes given above will be suspended.

Please noteif the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your application may be rejected.

Applications for category B

After receiving your application HSE will:

  • conduct a brief initial check of the information to confirm that it meets the requirements for the application type
  • issue an invoice to the applicant for the validation fee[92] which must be paid within 30 days of the date of the invoice. Failure to pay the requested fees will result in your application being rejected
  • conduct an initial assessment (validation) of the submitted information. This will take approximately 30 days from receiving the application and includes:
    • determining if there are any significant data gaps – additional information may be requested
    • estimating how much it may cost[93] ("initial estimated fee") to evaluate the full application based on the information provided
  • issue an invoice to the applicant for the initial estimated fee once the application has been validated
  • evaluate the application to assess whether there is evidence that the substance does not give rise to concern. This will take approximately 365 days from validating the application
  • make a recommendation to the Secretary of State and Devolved Authorities as to whether the active substance can be included as a simplified active substance on the GB Active Substance List[94]
  • issue an invoice for a "top up" fee if the cost of evaluating the application has gone beyond the initial estimated fee, which must be paid within 30 days of the date of the invoice. Failure to pay the requested fees will result in the substance's inclusion in the List being withheld

You may be asked to provide further information at various stages of the process. When such requests are made, the indicative timeframes given above will be suspended.

Please note:if the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your application may be rejected.

Active substance inclusion or non-inclusion decision

When the evaluation of an application is completed, a decision will be made as to whether the active substance can be included as a simplified active substance on the GB Active Substance List. HSE will recommend that the active substance is not included on the list where:

  • it cannot be suitably demonstrated that the substance does not give rise to concern (such as where it cannot be shown that the substance does not meet the criteria for concern given in Article 28 (2) of GB BPR)

Inclusion recommended

HSE will:

  • send the applicant a copy of the draft conditions HSE intends to set for the active substance – these are set out in a draft Competent Authority Report (CAR) or Opinion
  • take into account the applicant's comments, where relevant
  • recommend to the Secretary of State and Devolved Authorities that the active substance be included as a simplified active substance on the GB Active Substance List
  • publish the Secretary of State's decision
  • add the simplified active substance onto the GB Active Substance List[95]
  • for category B; include the supplier on the GB Article 95 list[96]

You should:

  • examine the draft Competent Authority Report (CAR) or Opinion and return it to HSE (with comments if necessary) to indicate your agreement with the conditions
  • wait until the inclusion decision has been published, and the simplified active substance is included on the GB Active Substance List, then ensure you apply for and gain product authorisation[97] before making any products available on the market in GB
  • ensure you comply with any deadlines associated with the inclusion, such as for any post inclusion data requirements or the substance may be removed from the list
  • ensure you comply with general chemical and product safety law which continues to operate such as GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulation[98]

Inclusion not recommended

HSE will:

  • send the applicant a copy of HSE's assessment and conclusions. These are set out in a draft Competent Authority Report (CAR) or Opinion
  • take into account the applicant's comments, where relevant
  • recommend to the Secretary of State and Devolved Authorities that the simplified active substance is not included on the GB Active Substance List
  • publish the Secretary of State's non-inclusion decision

You should:

  • examine the draft Competent Authority Report (CAR) or Opinion and return it to HSE with comments if necessary
  • ensure that you do not use or supply biocidal products containing the active substance in GB

Rejecting applications

An application can be rejected at any stage if the relevant fees or requested information / data are not submitted or are unacceptable.

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. Existing NI products: transfer to EU BPRhttps://www.hse.gov.uk/biocides/existing-products-northern-ireland.htm
  52. Overviewhttps://www.hse.gov.uk/biocides/copr/index.htm
  53. COPR approval: how to applyhttps://www.hse.gov.uk/biocides/copr/application.htm
  54. COPR product approval typeshttps://www.hse.gov.uk/biocides/copr/approvals.htm
  55. COPR approved productshttps://www.hse.gov.uk/biocides/copr/approved.htm
  56. COPR feeshttps://www.hse.gov.uk/biocides/copr/fees.htm
  57. COPR labellinghttps://www.hse.gov.uk/biocides/copr/labelguidance.htm
  58. Conditions of approvalhttps://www.hse.gov.uk/biocides/copr/conditions.htm
  59. Open invitations and notificationshttps://www.hse.gov.uk/biocides/open-invitations-notifications.htm
  60. Consultations and surveyshttps://www.hse.gov.uk/biocides/consultations.htm
  61. Consultations: Submitting informationhttps://www.hse.gov.uk/biocides/consultations-submitting.htm
  62. Overviewhttps://www.hse.gov.uk/biocides/information.htm
  63. Glossaryhttps://www.hse.gov.uk/biocides/glossary.htm
  64. Useful linkshttps://www.hse.gov.uk/biocides/links.htm
  65. Contacthttps://www.hse.gov.uk/biocides/contact.htm
  66. Service standardshttps://www.hse.gov.uk/biocides/servicestandards.htm
  67. Temporary changes to GB biocides application processing timeshttps://www.hse.gov.uk/biocides/temporary-changes-application-processing-time.htm
  68. simplified product authorisationhttps://www.hse.gov.uk/biocides/simplified-product-authorisation.htm
  69. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  70. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  71. simplified authorisation procedurehttps://www.hse.gov.uk/biocides/simplified-product-authorisation.htm
  72. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  73. Enforcement actionhttps://www.hse.gov.uk/biocides/enforcement.htm
  74. GB Article 95https://www.hse.gov.uk/biocides/uk-article-95-basics.htm
  75. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  76. GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLPhttps://www.hse.gov.uk/chemical-classification/index.htm
  77. GB CLPhttps://www.hse.gov.uk/chemical-classification/index.htm
  78. UK REACHhttps://www.hse.gov.uk/reach/index.htm
  79. GB CLPhttps://www.hse.gov.uk/chemical-classification/index.htm
  80. UK REACHhttps://www.hse.gov.uk/reach/index.htm
  81. application form(.docx)https://www.hse.gov.uk/biocides/assets/docs/form-active-substance.docx
  82. draft Risk Assessment Report (RAR)(.docx)https://www.hse.gov.uk/biocides/assets/docs/template-active-substance.docx
  83. reference list of studies (.xlsx)https://www.hse.gov.uk/biocides/assets/docs/template-reference-list-of-studies.xlsx
  84. IUCLID (International Uniform Chemical Information Database)https://iuclid6.echa.europa.eu/
  85. Risk Assessment Report (RAR) template (.docx)https://www.hse.gov.uk/biocides/assets/docs/template-active-substance.docx
  86. Guidance on information requirementshttps://www.hse.gov.uk/biocides/applications/index.htm
  87. Biocides Submission Manual (BSM) serieshttps://echa.europa.eu/web/guest/support/dossier-submission-tools/r4bp/biocides-submission-manuals
  88. Guidance and training on IUCLIDhttps://iuclid6.echa.europa.eu/
  89. feeshttps://www.hse.gov.uk/biocides/fees.htm
  90. how much it may costhttps://www.hse.gov.uk/biocides/fees.htm
  91. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  92. validation feehttps://www.hse.gov.uk/biocides/fees.htm
  93. how much it may costhttps://www.hse.gov.uk/biocides/fees.htm
  94. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  95. GB Active Substance Listhttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  96. GB Article 95 listhttps://www.hse.gov.uk/biocides/uk-article-95-list.htm
  97. product authorisationhttps://www.hse.gov.uk/biocides/product-authorisation-overview.htm
  98. GB Classification, Labelling and Packaging of Substances and Mixtures (GB CLP) Regulationhttps://www.hse.gov.uk/chemical-classification/index.htm
  99. ECHA Guidance Documentshttps://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-legislation
  100. ECHA Biocides Submission Manualshttps://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals
  101. Guidance and training on IUCLIDhttps://iuclid6.echa.europa.eu/
  102. The lawhttps://www.hse.gov.uk/biocides/information.htm#law
  103. Active substance approval application formhttps://www.hse.gov.uk/biocides/assets/docs/form-active-substance.docx
  104. draft Risk Assessment Report (RAR)https://www.hse.gov.uk/biocides/assets/docs/template-active-substance.docx
  105. reference list of studieshttps://www.hse.gov.uk/biocides/assets/docs/template-reference-list-of-studies.xlsx
  106. The GB List of Active Substanceshttps://www.hse.gov.uk/biocides/uk-list-active-substances.htm
  107. Brexit: Implications for Northern Irelandhttps://www.hse.gov.uk/biocides/northern-ireland.htm
  108. Active substance approval overviewhttps://www.hse.gov.uk/biocides/active-substance-approval.htm
  109. Biocides feeshttps://www.hse.gov.uk/biocides/fees.htm

Glossary of abbreviations/acronyms on this page

COPR
Control of Pesticides Regulations

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Updated 2025-03-12