Beta Help us improve this guidance - give your feedback.

Active Substances: How to Apply

Important deadlines: Brexit implications for businesses

To get or maintain access to the GB market you should check what you need to do >

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

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:

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 for a notification of support of an active substance into the UK Review Programme 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:

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 for active substance approval, or re-submission of data, under the UK Biocidal Products Regulation (UK BPR) 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:

Using the HSE Secure File Sharing Service

Dossier guidance

Things to note

What HSE will do

After receiving your application HSE will:

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:

Approval recommended

HSE will:

You should:

Approval not recommended

HSE will:

You should:

Rejecting applications

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

Updated 2021-04-22