Research and development: biocidal products and active substances: Find out if you need to notify or apply to HSE

2. Find out if you need to notify or apply to HSE

Before carrying out testing for research and development purposes on non-authorised biocidal products and non-approved active substances, find out if you need to notify or apply to HSE.

Step 1

Does your testing involve vertebrates and are the data intended, or have the potential, to be submitted to HSE as part of an application for active substance approval or product authorisation under GB Biocidal Products Regulation (GB BPR)?

If yes, go to Step 2
If no, go to Step 4

Step 2

Follow the procedure on data sharing and vertebrate testing.

Then go to step 3.

Step 3

Do you have confirmation from HSE that your proposed testing is not a duplicate?

GB BPR prohibits the duplication of vertebrate studies which is expected to save costs and animal lives.

If yes, go to Step 4
If no, do not continue until you have confirmation from HSE - no further steps.

Step 4

Check the status of the active substance(s) in your test formulation.

If your test formulation contains:

only active substances that are already approved under GB BPR for the relevant product type, go to Step 5
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 or not listed, go to Step 5
only active substances that are under review under GB BPR for the relevant product type, go to Step 9
a combination of active substances that are approved and under review under GB BPR for the relevant product type, go to Step 9

Step 5

Will testing involve or be likely to result in the release of the biocide into the environment?

If yes, go to Step 6

If 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)

No further steps.

Step 6

Does your testing involve genetically modified organisms (GMOs)?

If yes, notify DEFRA (GOV.UK) before you notify HSE under GB BPR.

If no, notify HSE under GB BPR.

Go to step 7.

Step 7

Has HSE sent a response within 45 days of a compliant notification being submitted?

If yes, go to Step 8
If no, you may begin testing - no further steps.

Step 8

Conditions may be applied or the testing may be prohibited - for more guidance read ‘After you notify or apply’.

You may begin testing once formal confirmation has been issued and ensure you comply with any conditions and restrictions.

No further steps.

Step 9

Is your test formulation in the scope of COPR?

Check if your test formulation is in scope of COPR.

If yes, go to Step 10

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

No further steps.

Step 10

Can you meet all 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 (for example, wood) must not be sold on for use.
Where test sites include domestic premises, these must be unoccupied, meaning 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: