If you think that your product is a biocide and you want to place it on the UK market the following information summarises the requirements with which you need to comply. You may find it helpful to check our definition of a biocidal product.
Biocidal products are regulated in the EU by the Biocidal Products Directive (BPD), which is implemented into UK law through the Biocidal Products Regulations (BPR) and the Biocidal Products Regulations (Northern Ireland).
There are 23 different biocidal product types covering disinfectants, preservatives, pest control and specialty biocides such as antifouling products and embalming and taxidermy fluids.
Further information about active substance assessment and product authorisation processes under the BPD/R can be found in the BPD/R section of the site.
Before you place a biocidal product on the UK market you must:
If the active substance(s) in your product has been reviewed under the BPD review programme for your product type and has been included onto Annex I/IA of the BPD then you need to get your product authorised before you place the product on the UK market.
A list of the active substances included onto Annex I/IA of the BPD can be found on the EU Commission website.
If the active substance(s) has not been Included onto Annex I of the BPD you need to check if it is still being supported for review under the BPD review programme, i.e. has it been notified and in the relevant product type and not withdrawn.
When a biocidal product contains more than one active substance the product cannot be authorised under BPR until all of the active substances are Included on to Annex I/IA of the BPD.
Until BPR authorisation is possible the product must continue to comply with existing UK national legislation and general requirements as outlined above.
To check if an active substance has been notified for review under the BPD review programme you need to go to the Fifth Review Regulations. Annex II of the Regulation lists all the active substances that were notified and the product type(s) they were notified in. Annex I of the Fifth Review Regulation, is the list of Identified and/or Notified active substances please note that this is not Annex I of the BPD.
To find out which product types an active substance was notified for we recommend that you check its status by searching using its CAS or EC number. However, it is important that the result found for the active substance relates to the relevant product type for your product. For example, if an active substance was notified for product type 18 there will be a number 18 in the relevant box in the table for its entry.
If the active substance hasn’t been notified in the relevant product type (the relevant number is not in the box) you cannot use it as an active substance in that type of biocidal product placed on the EU market. You could submit the relevant data to support the substance under the BPD but it could not be used as an active substance in biocidal products placed on the EU market until that assessment is complete.
If the active substance has been notified in the relevant product type (the relevant number is in the box) you need to check it is still in the BPD review programme before you can use it in biocidal products placed on the EU market. To do this you need to make sure it is not listed in a withdrawal notice and a non inclusion decision.
A withdrawal notice is published when all participants supporting the review of that active ingredient have withdrawn from the biocides review program. It gives other companies three months to take over the notification. If no one takes over the notification a non inclusion decision is published and this decision will give a date when all biocidal products containing the active substance, in the relevant product type, have to be removed from the EU market.
If the active substance is listed in a non inclusion decision, in the relevant product type, you can’t use it in biocidal products placed on the EU market after the date stated in the non inclusion decision.
If you find that the active substance, in the relevant product type, is listed in a withdrawal notice but not in a non inclusion decision please contact us.
Withdrawal notices and non inclusion decisions are found in the review of existing substance section of the Europa website. It is important that you check these lists as you may be affected.
If you find that the active substance isn’t listed in a withdrawal notice and non inclusion decision you can use it in biocidal products, in the notified product type, placed on the EU market (subject to any requirements under existing national legislation), until the review of that active substance has been completed.
Once the review of the active substance is complete and if successful, the substance will be included onto Annex I/IA of the BPD. It is following this Annex I/IA inclusion that products containing that active substance(s) need to be authorised under the BPR if they are to remain on the UK market.
Once you know the active substance status under the BPD you need to check if there is any existing legislation which applies to your product type, and comply with it until the BPD review is completed or until the date stated in the non inclusion decision.
Many product types covered under the BPD are currently regulated in the UK under legislation called the Control of Pesticides Regulations 1986 (COPR). These products are known generally as non-agricultural pesticides and include products such as wood preservatives, masonry/surface biocides, antifouling products, public hygiene insecticides, some repellents, rodenticides and other vertebrate control agents. These types of product will continue to be regulated and approved via HSE under this scheme until the BPD active substance review is completed. If your product falls under the scope of COPR you must apply and receive COPR approval before the product can be advertised, sold, supplied, stored or used in the UK.
Whilst disinfectants do not need approval under COPR, they are within scope of BPD, and whilst the review of the active substance is ongoing other specific legislation applies in certain situations.
There is a UK scheme in place for veterinary disinfectants for use against certain named pathogens. The Veterinary Laboratory Agency (VLA) on behalf of DEFRA are the body that 'approve' and list disinfectants (via results of laboratory based efficacy testing) under the Diseases of Animals (Disinfectants Approvals) Order 1978 against diseases such as foot-and-mouth disease, swine vesicular disease, tuberculosis etc.
There is also currently a regulatory scheme in place for substances and products used in drinking water from the source of the water, up to the point of delivery to the consumer’s building. Drinking water quality in England and Wales is regulated by the government through the Drinking Water Inspectorate (DWI).
The majority of other biocidal products are not currently regulated in the UK by specific legislation but are covered by general chemical legislation which continues to operate such as
In addition, the General Product Safety (GPS) Regulations may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. The responsibility for the GPS Regulations lies with the Department of Business, Innovation and Skills (BIS).
All biocidal products placed on the UK market must also comply with the following actions under BPR:
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