Product authorisation

Temporary changes to GB biocides application processing times - more information.

A biocidal product / biocidal product family must be authorised to be made available on the market in Great Britain (GB).

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

Requirements based on active substance status

For products containing active substances that have been supported under the review programme for the relevant product type, the authorisation requirements of the GB Biocidal Products Regulation (GB BPR) will apply to a product when the active substance(s) within the product is approved under GB BPR for the relevant product type.

For example, if an active substance is listed in the GB List of Active Substances as approved for use as a wood preservative (product type 8), products containing it may:

  • be authorised for use as wood preservative products
  • not be authorised for use as anti-fouling products (product type 21) until the active substance is approved for that product type

When a product contains more than one active substance, the biocidal product / biocidal product family cannot be authorised until all of the active substances in it are approved under GB BPR for the relevant product type ie authorisation is possible only when the last of the active substances in the biocidal product / biocidal product family is approved.

If your biocidal product / biocidal product family was made available on the market under other national law in GB prior to the active substance(s) being approved, transitional provisions will apply while your GB BPR application is ongoing or to allow you to phase out existing stocks if you are not applying for GB BPR authorisation.

If your biocidal product / biocidal product family was not on the GB market prior to the active substance(s) being approved, you must obtain GB BPR authorisation before the biocidal product / biocidal product family can be made available on the GB market.

If your biocidal product / biocidal product family contains a 'new active substance' or a 'non-review programme existing active substance' for your product type, you must obtain GB BPR authorisation before the biocidal product / biocidal product family can be made available on the GB market.

If your biocidal product / biocidal product family contains an active substance(s) that is a candidate for substitution, a comparative assessment will be made under Article 23 of GB BPR and you may need to provide additional information to support this assessment.

Authorisation types

Product authorisations can be granted for single products or product families.

Single product authorisations:

  • are for a fixed formulation
  • can include an unlimited number of trade names
  • can include products that are marketed by several different companies but have a single authorisation holder - that authorisation holder is legally responsible for all of those products

Product family authorisations:

  • are for a group of biocidal products that have:
    • similar uses
    • the same active substances
    • similar formulations within a defined range
    • similar levels of risk and efficacy
  • can include an unlimited number of trade names
  • can include products that are marketed by several different companies but have a single authorisation holder - that authorisation holder is legally responsible for all of those products
  • group products into different meta-Summary of Product Characteristics (meta-SPCs) depending on their properties and use patterns - every product within a meta-SPC must have the same classification
  • cover every product in the family under a single authorisation (each product will receive a unique suffix to the authorisation number)
  • allow changes to be made to the amounts of pigments, perfumes and dyes (PPDs) in any of the existing products within a family without HSE being notified, provided that the changes are within the ranges stated in the relevant meta-SPC and the product trade name remains the same

Application types

Both single product and product family authorisations may be able to be authorised by the following application types:

National authorisation

Allows biocidal products / biocidal product families that are not eligible for simplified authorisation to be made available on the market in GB.

Find out how to apply for national authorisation.

Simplified authorisation

Is only available to biocidal products / biocidal product families containing an active substance(s) on the GB Simplified Active Substances List and meeting certain other criteria.

Simplified product authorisation is intended to encourage the use of products with a more favourable environmental or human or animal health profile and they can therefore be granted based on a limited data package.

Find out if your product is eligible for simplified authorisation and how to apply.

Same biocidal product authorisation

Allows for the authorisation of a biocidal product / biocidal product family which is identical to another biocidal product / biocidal product family / part of a biocidal product family which is already authorised in GB, either by national or simplified authorisation.

You need to seek agreement from the authorisation holder of the biocidal product / biocidal product family that you want to base your application on before you apply.

Find out how to apply for same biocidal product authorisation.

Change or cancel an authorisation

Once your biocidal product / biocidal product family has been authorised, you can request to change or cancel the authorisation at any time.

Find out what types of changes you can make to your authorisation or how to cancel it.

Renewal of an authorisation

Biocidal products / biocidal product families with national authorisations will expire on the date specified on their Certificate of Authorisation unless renewed.

Find out how to renew your authorisation.

Guidance

Where there is no GB-specific guidance, HSE will use relevant technical guidance for the EU Biocidal Products Regulation (EU BPR), as the two sets of legislation are very similar. The European Chemicals Agency (ECHA) has published the following guidance documents to support the EU BPR:

Other requirements

Once you have received product authorisation, you will need to:

There are additional requirements placed on biocidal products by GB BPR which include (but are not limited to):

  • packaging and labelling requirements (Article 69)
  • advertising requirements (Article 72)
  • record keeping requirements (Article 68)
  • notification of unexpected or adverse effects (Article 47) - all authorisation holders must notify HSE without delay of any information they become aware of concerning the biocidal product, or the active substance(s) it contains, that may affect the authorisation, for example:
    • new data or information on the harmful effects of the active substance or biocidal product on humans, animals or the environment
    • any data indicating the potential development of resistance to the active substance or biocidal product
    • new data or information indicating that the product is not sufficiently effective

In addition to complying with GB BPR you should ensure you comply, where applicable, with general chemical and product safety law which continues to operate such as:

Calculating the actual costs

When you submit your application, we will estimate how much it may cost ("initial estimated fee") to process the application based on the information provided. As HSE operates on a cost recovery basis, at the end of the assessment we will calculate the actual cost for evaluating the application based on the total time spent. If the total cost has gone beyond the initial estimated fee, a top-up fee will be requested. Alternatively, if the cost is less than the initial estimated fee, an appropriate refund will be given.

Please note if a top if fee is required it must be paid prior to the product receiving the appropriate authorisation decision and the issuing of any associated GB legal documents.

Special Circumstances

There are alternative authorisation routes or derogations for specific special circumstances:

Unfettered access notification

Allows Northern Ireland (NI) businesses to access the GB market with biocidal products that have already been authorised under EU BPR in NI.

Find out if your product is eligible for an unfettered access notification and how to apply.

Research and development notice

Allows research and development into biocidal products that are not yet authorised under GB BPR or into active substances that are not yet approved.

Find out if your product is eligible for a research and development notice and how to apply.

Provisional product authorisation

Allows for the authorisation of a biocidal product / biocidal product family containing a new active substance before that active substance has been formally approved. This authorisation type is only available once HSE has completed its assessment of the active substance and allows the product to be made available on the GB market whilst the active substance goes through the formal approval decision-making process.

Contact HSE for advice on making an application for Provisional Authorisation.

Essential use authorisation

Allows for the authorisation of a biocidal product where the active substance has received an essential use derogation.

Find out how to apply for an essential use product authorisation.

Critical situation permit

Allows for the temporary and controlled use of a biocidal product, that does not meet the conditions for national or simplified authorisation, in the case of a danger to:

  • public health
  • animal health
  • the environment

It must be shown that the situation cannot be contained by any other means.

Find out how to apply for a critical situation permit.

Cultural heritage authorisation

Allows for the authorisation of a biocidal product containing a non-approved active substance if it shown to be essential for the protection of cultural heritage and no appropriate alternatives are available.

The protection of cultural heritage includes items or structures that are considered to:

  • have cultural significance
  • be national treasures
  • have artistic value
  • have historic value
  • have archaeological value

Contact HSE for advice on making an application for cultural heritage authorisation.

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Updated 2024-06-12