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Making biocidal products available on the UK market

If your product may be a biocide and you want to make it available on the UK market the following information summarises the requirements with which you need to comply. You may also find it helpful to look at our page on the EU BPR law as it gives information on the definition of a biocidal product and scope of the regulation, which will help you decide if your product is, or is not, a biocide.

From 1st September 2013, Biocidal products are regulated in the EU by the EU Biocides Regulation (EU BPR) which replaced the older Biocidal Products Directive (BPD) which applied to biocidal products prior to 1st September 2013.

The EU BPR includes 22 different biocidal product types covering disinfectants, preservatives, pest control and specialty biocides such as antifouling products and embalming and taxidermy fluids, and products are authorised for use and marketing following the assessment and Approval of the active substances in the product. Further information can be found in the active substance approval and product authorisation sections of this website.

I want to put a biocidal product on the UK market what do I need to do?

Check the Status of your Active Substance

Before you make a biocidal product available on the UK market for a particular type of product you will need to ensure that the active substance is Approved for that Product Type, is under review for that Product Type or listed in Annex I of the EU BPR (list of active substances that can be used in products that qualify for the simplified authorisation procedure). Please note that active substances that were previously included onto Annex I of the BPD were automatically Approved under the EU BPR for the relevant Product Type and are listed in EU BPR Article 9 Approved List of Active Substances (Union list). Annex I of the EU BPR is not the same as Annex I of the BPD. If your active is not

then you could not bring the product to the market at this time – instead, you would need to support your active substance through the Regulation’s active assessment and approval process or submit an application to Amend Annex I of the EU BPR and gain an authorisation for the product under the relevant process before you could market it in the UK. 

If you are unsure if your active is Approved or supported for review for your Product Type, details of how to check this are on our Active Substance Status page.

My active substance has been Approved for my Product type

If your active substance has been through the assessment process and has already been Approved (in the Union List) under the EU BPR for the relevant Product Type for your product, then you will need to get your product authorised before you make it available on the UK market.

My active substance has an Approval decision published for my Product Type but the approval date is in the future

Existing active substances

If your biocidal product contains an existing active substance that has been through the review programme assessment process and an approval decision (Commission Implementing Regulation) has been published under the EU BPR for the relevant Product Type for your product, then you need to apply for product authorisation by the active substance approval date. The active substance approval date can be found in the approval decision (Commission Implementing Regulation) published by the EU Commission. Under the transitional provisions of Article 89 of the EU BPR, until the active substance approval dated you can make the product available in the UK, complying where necessary with the requirements of other relevant national legislation, such as the Control of Pesticides Regulations (COPR) and also to the specific elements of EU BPR relating to:

To keep making your product available on the UK market after the approval date for the active substance/product type combination you must submit an EU BPR application for product authorisation by the approval date.

If you don’t submit an application or you submit an application and it is rejected or authorisation is granted/not granted, various phases out periods apply.

New active substances

If your biocidal product contains a new active substance that has been through the assessment process and an approval decision (Commission Implementing Regulation) has been published under the EU BPR for the relevant Product Type for your product, then you need to apply for product authorisation and obtain authorisation before the product can be made available on the market, as the transitional provisions of Article 89 of the EU BPR do not apply to new active substances.

My active substance is still under review for my Product Type

If your active substance is still under review for your Product Type, then products can be brought to the market without needing to be Authorised under the EU BPR – however, please note that once the review of the Active is completed you will need to seek Authorisation for the product or remove it from the market. 

Whilst the review is on-going, products still need to comply where necessary with the requirements of other relevant national legislation and also to the specific elements of EU BPR relating to:

My active substance is listed in Annex I of the EU BPR (list of active substances that can be used in products that qualify for the simplified authorisation procedure)

If your active substance listed in Annex I of the EU BPR (list of active substances that can be used in products that qualify for the simplified authorisation procedure), then you will need to get your product authorised under the Simplified product authorisation procedure before you make it available on the UK market.

If you have been granted a Simplified product authorisation in another EU Member State you must notify HSE via R4BP at least 30 days before placing the biocidal product on the UK market.

The biocidal product can be placed on the UK market in a manner consistent with the conditions and restrictions associated with the authorisation granted in the other EU Member State but the product label must be in English.  

If HSE believes that the product does not meet the criteria for simplified authorisation procedure or is not being made available on the UK market in accordance with conditions and restrictions associated with the authorisation granted, HSE may provisionally restrict or prohibit the making available and/or use of the biocidal product in the UK

My active substance isn’t Approved, isn’t in the Review programme and isn’t listed in Annex I of the EU BPR

If your active is not

then you could not bring the product to the market at this time – instead, you would need to support your active substance through the Regulation’s active assessment and approval process  or submit an application to Amend Annex I of the EU BPR and gain an authorisation for the product under the relevant process before you could market it in the UK. 

Updated 2015-06-26