Active Substances: How to Apply

Applications for biocidal active substance approval in Great Britain (GB) can be made to HSE for:

  • 'new active substances' to be used in biocidal products and biocidal product families under the GB Biocidal Products Regulation (GB BPR)
  • existing active substances for product types that have not been supported under the review programme – 'non-Review Programme existing active substances'
  • changes to 'Review Programme active substances', such as when a new company wants to take over support of the active substance in the review programme from the existing participant

New active substances (and non-Review Programme existing active substances) cannot be used in biocidal products / biocidal product families made available on the GB market until the active substance is approved and the biocidal product / biocidal product family 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 may be taken where a new biocidal active substance (or non-Review Programme existing active substance) that is not yet approved is made available on the GB market in a biocidal product / biocidal product family.

Notify your support for an active substance where it has a published  'open invitation'

You may notify HSE of your intention to support an active substance / product type combination if it has a published open invitation due to participant withdrawal, redefinition, or a compliant 'declaration of interest'.

Declare your interest in notifying an active substance / product type combination into the GB Review Programme

You may inform HSE of your intention to support an active substance / product type combination in the GB Review Programme, if you are able to meet the criteria given in points 1a or 1b and 2a or 2b and 3a or 3b below.

  1. You have placed a product on the GB market either:
    1. prior to 01 January 2021, based on published guidance or written advice from the EU Commission, and EU Competent Authority or HSE
    2. after 31 December 2020, based on published guidance or written advice from HSE
  2. That guidance or advice stated that either:
    1. the product was excluded from the scope of EU / GB BPR
    2. the relevant active substance / product type combination was one which was already notified
  3. That guidance or advice has subsequently been reviewed by either:
    1. new guidance published by the EU Commission prior to 01 January 2021, or HSE after 31 December 2020
    2. a decision published in accordance with Article 3 (3) of EU BPR prior to 01 January 2021, or Article 3 (3) of GB BPR after 31 December 2020

If your declaration of interest is determined to be valid, any person may then notify HSE of an intention to support the active substance / product type combination in the GB Review Programme within 6 months of the publication of the decision that the declaration is valid.

How to apply

Notifications

The prospective applicant or company acting on their behalf must submit, in English, a completed application form to [email protected] by the deadline of the open invitation – companies may wish to mark emails as appropriate eg 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 / data must be submitted via the HSE Secure File Sharing Service. Find out more about  using HSE Secure File Sharing Service below.

Declarations of interest

The prospective applicant or company acting on their behalf must submit, in English, a completed application form to [email protected] within 12 months of the publication of new guidance / an Article 3 (3) decision – companies may wish to mark emails as appropriate eg 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 / data must be submitted via the HSE Secure File Sharing Service, including:

  • substantial justification showing that the conditions above are fulfilled, including:
    • evidence of the published guidance or written advice you relied on
    • evidence of the new published guidance or Article 3 (3) decision
    • evidence that the active substance meets the definition of 'existing' as given in Article 3 (1) (d)

Find out more about using HSE Secure File Sharing Service below.

Active substance approval

The prospective applicant or company acting on their behalf must submit, in English, a completed application form to [email protected] – companies may wish to mark emails as appropriate eg 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 / data must be submitted via the HSE Secure File Sharing Service, including:

  • 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
  • if the active substance meets at least one of the exclusion criteria listed in Article 5 (1), evidence that Article 5 (2) is applicable
  • a draft Risk Assessment Report (RAR) for the active substance and representative product
  • Safety Data Sheet (SDS)
  • reference list of studies
  • any pre-submission correspondence with HSE

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 [email protected] 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.

Dossier guidance

  • Dossiers should be submitted in one of two formats:
  • 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
  • All documents / attachments should be included within your IUCLID dossier, where applicable
  • Guidance on information requirements for active substances and biocidal products – applicants should use this document when preparing dossiers for active substance approval
  • Biocides Submission Manual (BSM) series - describes how to build IUCLID dossiers with detailed and illustrative technical assistance
  • Guidance and training on IUCLID 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 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 and likely timelines

What HSE will do

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 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 ("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 the risks to health and the environment, intended use and efficacy of the active substance and representative biocidal product – 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 approved in GB
  • conduct regular checks on the actual cost of evaluating the application (including a final calculation at the end of the process) – invoices for "top up" fees may be issued at various points during the evaluation if the actual cost 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 evaluation being suspended or the approval 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 approval / non-approval decision

When the evaluation of an application is completed, a decision will be made as to whether the active substance can be approved. HSE will recommend that the active substance is not approved where:

  • unacceptable risks or effects to people, animals or the environment have been identified, or the active has not been shown to be sufficiently effective (ie the conditions given in Article 4 (1) of GB BPR cannot be met)
  • the active substance meets the 'Exclusion Criteria' outlined in Article 5 (1) of GB BPR (eg the active is classified as a category 1A or B carcinogen) and suitable evidence to derogate from exclusion has not been provided

Approval 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)
  • take into account the applicant's comments, where relevant
  • recommend to the Secretary of State and Devolved Authorities that the active substance be approved in GB
  • publish the Secretary of State's approval decision

You should:

  • examine the draft Competent Authority Report (CAR) and return it to HSE (with comments if necessary) to indicate your agreement with the approval conditions
  • wait until the approval decision has been published and ensure you apply for Product authorisation by the approval date – you must wait for product authorisation to be granted before making any products available on the market in GB
  • ensure you comply with any deadlines associated with the approval, such as for any post approval data requirements or the approval may be cancelled
  • note the approval expiry date – the approval will expire on the date shown unless a valid application for renewal is submitted at least 550 days before the expiry date
  • ensure you comply with general chemical and product safety law which continues to operate such as:

Approval 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)
  • take into account the applicant's comments, where relevant
  • recommend to the Secretary of State and Devolved Authorities that the active substance is not approved in GB
  • publish the Secretary of State's non-approval decision

You should:

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

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Updated 2024-11-14