Overview
If you’re exporting biocidal products or active substances outside of Great Britain (GB) or Northern Ireland (NI), you may be asked to provide a certificate of free sale (CFS) or an export statement.
A CFS is an official document confirming that the product complies with the relevant laws on biocides and may be freely sold across GB or in NI. They are usually requested when the country you are exporting to does not have its own regulatory regime.
An export statement may be able to be issued for:
- an active substance with current GB BPR approval
- an active substance which is currently under review in the GB review programme
- a product or active substance which does not comply with the relevant laws on biocides but is only intended for export from:
- GB – so is not made available on the GB market
- NI – so is not made available on the NI market
More about importing and exporting.
Issuing Certificates of Free Sale
HSE or the Department for Business and Trade (DBT) can issue a CFS for biocidal products, depending on the regulatory process and the approval or authorisation status of the product.
HSE can issue export statements for biocidal active substances.
HSE will only issue a CFS or export statement for companies that are based in the UK.
HSE can issue various CFS or export statements for biocidal active substances and for biocidal products (sometimes referred to as non-agricultural pesticides) that are regulated under the:
- Control of Pesticides Regulations (COPR)
- GB Biocidal Products Regulation (GB BPR)
- EU Biocidal Products Regulation (EU BPR)
HSE can issue a CFS for products that have reached the point where they would need to be authorised under the BPR. For example when all the active substances in the product have completed the BPR review process and are approved.
HSE can also issue various CFS or export statements for plant protection products (sometimes referred to as agricultural pesticide products).
How to get a CFS or export statement for a plant protection product.
DBT can issue a CFS for products that are within scope of GB BPR or EU BPR but do not yet require BPR authorisation, for example:
- where the active substance is still under review in the BPR review programme
- for products that contain a combination of actives where at least one active substance remains under review - as BPR product authorisation is only required when all of the review active substances within the product have been approved
DBT can also issue CFS or export documents for products that are not in the scope of biocides or plant protection product regulations.
Apply to the Department for Business and Trade for a Certificate of Free Sale.
Northern Ireland
In Northern Ireland, EU BPR or COPR (NI) applies.
If you are an NI based company wishing to export from Northern Ireland, HSE can issue CFSs and export statements on behalf of HSE NI.
Please use the relevant EU BPR or COPR (NI) template for your applicable situation.
Before requesting a certificate of free sale or export statement
Before you request a CFS or export statement:
- find out if your product or active substance is in scope of GB BPR or COPR
- check the status of the active substance in your product or the active substance you are exporting
- check if your product is already approved under COPR or authorised under GB BPR
- check if your product is being made available on the market in 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. Examples include:
- manufacturer to distributor
- distributor to retail store
- retail store to user
Using this information, choose the appropriate template below.
How to get a certificate of free sale or export statement from HSE
Complete a template with all of the relevant information you wish to appear on the CFS or export statement.
On some of the templates you can add information such as:
- manufacturing sites
- exporter
- distributor
This information is optional. As HSE cannot verify it, you can only put it under section ‘The following information has been supplied by the applicant to the Health and Safety Executive’.
Email the completed template to [email protected] along with:
- details of the product or active substance being exported – if the product is authorised or approved under one of the biocides regimes in GB, please provide the authorisation/ approval number
- a declaration that the information you are providing is true and correct by using this statement – ‘The contents of this request are true and correct, and the information provided is entirely the responsibility of the applicant company.’
HSE will issue the certificate or statement with the official HSE seal within 3 working days of your request.
GB Templates
Within scope of GB BPR
Product with current GB BPR authorisation - CFS Template E
Product without current GB BPR authorisation but an application for product authorisation has been made and is currently under evaluation under GB BPR - CFS Template F
Product that does not have current GB BPR authorisation and is not currently under evaluation under GB BPR but the date of approval of the last active substance in the product was no more than 180 days ago - CFS Template G
Product that does not have current GB BPR authorisation and is for export only (not made available on the GB market) - Export Statement Template I
Active substance with current GB BPR approval or which is currently under review in the GB review programme - Export Statement Template H
Within scope of COPR
Product with current COPR approval - CFS Template A
Product without current COPR approval - Export Statement Template B
Active substance used in approved COPR products - Export Statement Template C
NI Templates
Within scope of EU BPR
Product with current EU BPR authorisation - NI CFS Template E
Product without current EU BPR authorisation but an application for product authorisation has been made and is currently under evaluation under EU BPR - NI CFS Template F
Product that does not have current EU BPR authorisation and is not currently under evaluation under EU BPR but the date of approval of the last active substance in the product was no more than 180 days ago - NI CFS Template G
Product that does not have current EU BPR authorisation and is for export only (not made available on the NI market) - NI Export Statement Template I
Active substance with current EU BPR approval or which is currently under review in the EU review programme - NI Export Statement Template H
Within scope of COPR (NI)
Product with current COPR (NI) approval - NI CFS Template A
Product without current COPR (NI) approval - NI Export Statement Template B
Active substance used in approved COPR (NI) products - NI Export Statement Template C
Additional information for importing countries’ regulatory authorities
The regulatory authorities in countries who have received a certificate of free sale or export statement sometimes have additional questions about the requirements in place in the United Kingdom. To help those authorities, and UK exporters, we have summarised below how products are regulated, as well as addressing specific issues that have been raised in the past.
Detailed information on the regulatory system.
Biocidal products regulations
Biocidal products are controlled in:
- Great Britain (England, Scotland and Wales) under the GB Biocidal Products Regulation (GB BPR)
- Northern Ireland under the EU Biocidal Products Regulation (EU BPR)
The Chemicals Regulation Division within the Health and Safety Executive carries out the duties of the Competent Authority for BPR.
BPR covers a wide range of products, including:
- disinfectants
- pest control
- preservatives
- specialist biocides such as embalming and taxidermy fluids
List of product types that fall under BPR.
Products exempt from BPR requirements
Some types of products with biocidal activity have other specific legislation that applies to them in the UK. For example:
- plant protection pesticides
- human medicines
- medical devices
- veterinary medicines
- cosmetics
Where a product falls under one of those pieces of legislation, it’s exempted from the requirements of BPR.
Details of the scope of BPR and exempting legislation.
Products only for export from the UK
Where a product is only ever intended for export from the UK, so is never supplied or used within the UK, that product does not need a BPR authorisation (and is also exempt from the requirements of COPR).
For export only products we may provide the exporting company with an ‘export statement’ rather than a certificate of free sale.
Product authorisation under BPR
Many products do not currently require authorisation under BPR. This is because the BPR works in a two-stage process
Stage 1 - first the active substances used in products are assessed for their suitability to be used in biocidal products – where they are found to be suitable, they gain ‘approval’ under the BPR.
Stage 2 - this approval triggers the second stage, where products containing the active substance have to be assessed for their safety and effectiveness – where they are found to be suitable, the product gains ‘authorisation’ under BPR.
A review programme was established to assess existing active substances. Whilst an active substance is being assessed within this review programme, products can continue to be supplied and used without the need for BPR product authorisation. The BPR review programme will not be completed for several more years, so there may be products that do not yet require BPR authorisation which are legally allowed to be made available.
How to check if an active substance is under review, and what it means for products.
Where a product has already been authorised, our authorised products database provides details.
Other national rules – the Control of Pesticides Regulations (COPR)
For some biocides, whilst the active substance is still under BPR review, the products continue to be regulated under older national rules, the Control of Pesticides Regulations (COPR). Once the active substance gains BPR approval, and the products are authorised under BPR, COPR ceases to apply to the product. COPR does not cover all the types of products that are within scope of BPR, so for example, disinfectants are usually exempted from COPR.
Kinds of products regulated under COPR.
BPR and good manufacturing practice
BPR does not require that biocidal products comply with the requirements of good manufacturing practice (GMP).
Licences to manufacture biocidal products
BPR does not require a licensing system for the manufacturing of biocidal products. Instead, BPR regulates the supply of products and how those products are used.
Certificates of manufacture
BPR does not require certificates of manufacture. HSE cannot verify or authenticate details contained within such documents.