Research and development into biocidal products and active substances

The GB Biocidal Products Regulation (GB BPR) allows for experimental testing for the purposes of research and development (R&D) into non-authorised biocidal products and non-approved active substances, such as:

• testing whether the active substance and / or product is effective against target pests
• understanding how biocidal products are used
  • where they could be used
  • what happens to them after use
  • what are the environmental effects
• developing exposure scenarios for risk assessments
  • understanding the amount of a biocidal product that people and the environment will come into contact with
  • considering the potential harm that this amount of contact might do
  • what measures are needed to protect people and the environment

Research and development may also include the experimental testing of a biocidal product outside of the uses that are already authorised under GB BPR.

In certain situations, HSE may need to place conditions on the testing under GB BPR or issue experimental permits under the Control of Pesticides Regulations (COPR) before the testing can take place in Great Britain (GB).

Find out about conducting experimental testing in Northern Ireland (NI).

Action for experimenters

You can use our R&D flowchart to find out if you need to notify or apply to HSE. Each step in the flowchart is described in more detail below.

Step 1

If your testing involves vertebrates and the study report is intended, or has the potential, to be submitted to HSE as part of an application for active substance approval or product authorisation under GB BPR, you must first determine whether such studies have already been submitted to HSE. GB BPR prohibits the duplication of vertebrate studies which is expected to save costs and animal lives. Find out more about duplicate studies and what you need to do before testing with animals.

If you have confirmation from HSE that your proposed testing is not a duplicate, see step 2 next.

Step 2

Next you will need to check the status of the active substance(s) in your test formulation.

Your testing will fall under GB BPR if your test formulation fits either of the following options:

• it contains only active substances that are already approved under GB BPR for the relevant product type
• it contains one or more active substances that are, for the relevant product type:
  • new
  • non-Review Programme existing active substances
  • Article 93 active substances
  • not approved
  • not listed

See Step 3a next.

Your testing will not fall under GB BPR if your test formulation fits either of the following options:

• it contains only active substances that are under review under GB BPR for the relevant product type
• it contains a combination of active substances that are approved and under review under GB BPR for the relevant product type

See Step 3b next.

Step 3a

If your testing falls under GB BPR, next you will need to consider whether it will involve or be likely to result in the release of the biocide into the environment.

If the answer is yes, you will need to notify HSE before you begin testing. Find out how to notify.

Please note, if your testing involves GMOs, you must first notify DEFRA before notifying HSE.

If the answer is no, you do not need to notify HSE before you begin testing but you must:

• prepare a dossier containing all available information on the possible effects of the test formulation on people, animals and the environment
• prepare and maintain written records detailing:
  • the identity of the active substance and / or biocidal product
  • data supporting any information given on the active substance / biocidal product label
  • quantities supplied
  • names and addresses of the persons receiving it

This information must be made available to HSE on request.

You should also be aware of the requirements of other laws that may apply such as:

• Control of Substances Hazardous to Health Regulations (COSHH)
• environmental permitting legislation for England, Scotland and Wales
• Genetically Modified Organisms (Contained Use) Regulations (GMO(CU)) if your testing involves genetically modified organisms (GMOs)

Step 3b

If your testing does not fall under GB BPR, you will next need to determine whether your test formulation is in the scope of COPR.

If the answer is yes, you will need to apply to HSE for a permit before you begin testing. See Step 4 next.

If the answer is no, you do not need to notify or apply to HSE before you begin testing but you should be aware of the requirements of other laws that may apply such as:

• Control of Substances Hazardous to Health Regulations (COSHH)
• environmental permitting legislation for England , Scotland and Wales

Step 4

If your testing does not fall under GB BPR, but your test formulation is in the scope of COPR, next you will need to determine which type of permit you should apply for.

You should apply for an Automatic Experimental Permit (AEP) if you can meet all of the following conditions:

• the test formulation must be stored on the premises of the permit holder or their agent (the person, company or organisation acting on their behalf)
• testing must be carried out on the premises of the permit holder or their agent
• the permit holder must provide their agent with written information on all conditions relating to the use and safe disposal of the test formulation
• the experimenter(s) (permit holder or agent) must have appropriate training and equipment to carry out the testing safely
• the permit holder must keep full records of all testing carried out, including details of:
  • the specific sites treated
  • application rates
  • the amount of active substance used
• any treated materials (eg wood) must not be sold on for use
• where test sites include domestic premises, these must be unoccupied ie not lived in
• all reasonable precautions must be taken to prevent people, animals, the environment and food or feeding stuffs from exposure to the test formulation and treated items after testing
• testing must not involve a biocidal product that has been revoked or suspended by HSE under COPR except as a comparison when testing alternative products
• testing must not involve:
  • antifouling products
  • genetically modified organisms (GMOs)
  • products used in sewage treatment systems

Find out how to apply for an AEP.

If you cannot meet all of the conditions for an AEP, then you should apply for an Experimental Permit (EP).

If your testing involves GMOs, before you apply to HSE for an EP under COPR you must first separately notify:

• DEFRA, where the testing will involve deliberate release into the environment
• HSE under the Genetically Modified Organisms (Contained Use) Regulations (GMO(CU)), where the testing will involve contained use

Find out how to apply for an EP.

How to notify or apply

The prospective applicant or company acting on their behalf must submit, in English, a completed R & D form to [email protected] - companies may wish to mark emails as appropriate eg confidential. Please note that your R&D form may be returned if it is incomplete.

Only the R&D form should be submitted by email. All other relevant documentation / data must be submitted via the HSE Secure File Sharing Service, which may include:

• a dossier containing all available information on the possible effects of the test formulation on people, animals and the environment
• a copy of your COSHH assessment considering the level, type and duration of exposure to people (where applicable)
• evidence that your proposed vertebrate testing is not a duplicate study (where applicable)
• 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.

After you notify or apply

GB BPR R&D notification

What HSE will do:

• assess the information provided - you may be asked to provide further information
• provide an opinion within 45 days of a compliant notification (please note a compliant notification includes both the application form and all relevant data/attachments) - if HSE does not provide an opinion within 45 days of a compliant notification you may begin testing
• impose conditions on the testing where appropriate
• send the applicant a draft copy of any conditions HSE intends to set for the testing
• take into account the applicant's comments, where relevant
• assign a reference number to the testing
• issue confirmation that the testing can go ahead, either as described or under additional conditions, for a maximum period of 12 months, free of charge
• prohibit testing if it could have any unacceptable adverse effects on people, animals or the environment

What you should do:

• respond promptly and fully to any requests for further information - if the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your testing may be prohibited
• examine any draft conditions and return them to HSE (with comments if necessary) to indicate your agreement with the conditions
• wait until the formal confirmation has been issued and ensure you comply with any conditions and restrictions before beginning testing
• note the date by which the testing must be completed - if your testing is likely to go on beyond this, please contact us as soon as possible

COPR Automatic Experimental Permit

What HSE will do:

• check that the testing meets the necessary conditions based on the information provided
• assign a notice number to the permit
• issue a signed Notice of Approval for a maximum period of 12 months, free of charge

What you should do:

• wait until the signed Notice of Approval has been issued and ensure you comply with the conditions and restrictions before beginning testing
• note the date by which the testing must be completed - if your testing is likely to go on beyond this, please contact us COPR Automatic Experimental Permit as soon as possible about renewing your AEP

COPR Experimental Permit

What HSE will do:

• determine how much it will cost to process the application based on the information provided
• assess the information provided - you may be asked to provide further information
• impose conditions on the testing where appropriate
• send the applicant a copy of the draft conditions HSE intends to set for the testing - these are set out in a draft Experimental Permit Schedule
• take into account the applicant's comments, where relevant
• assign an approval number to the permit
• issue a signed Notice of Approval and Experimental Permit Schedule for a maximum period of 12 months, free of charge
• prohibit testing if it could have any unacceptable adverse effects on people, animals or the environment

What you should do:

• respond promptly and fully to any requests for further information - if the information you provide is not satisfactory, or you fail to provide the information within the specified deadline, your testing may be prohibited
• examine the draft Experimental Permit Schedule and return it to HSE (with comments if necessary) to indicate your agreement with the conditions
• wait until the signed Notice of Approval and Experimental Permit Schedule has been issued and ensure you comply with the conditions and restrictions before beginning testing
• note the date by which the testing must be completed - if your testing is likely to go on beyond this, please contact us COPR Experimental Permit as soon as possible about renewing your permit