A product is considered to be a biocide if it falls within the scope of the Biocidal Products Directive. To determine whether the product falls within the scope of the legislation you should consult our law page for further information and advice.
If you want to place a biocidal product, which falls under the scope of the BPR and/or COPR, on to the UK market you must first apply to HSE for approval/authorisation.
To apply for BPR authorisation you will need to complete a R4BP application form. Details about the authorisation process are found on our BPR product application process page.
To apply for COPR approval you will need to complete a FEPA1 application form. Details about the approval process and the application form can be found on our COPR application process page.
If you are unsure which process(es) you need to follow, please consult our law page.
The costs and timescales will depend on whether your product requires authorisation under BPR or approval under COPR.
When HSE receive the application, an initial assessment of the information will be made to determine which type of application it is, whether any additional data is needed, how long it will take to process and how much it will cost.
HSE does not provide a ‘list’ of the substances available for formulators to use. It is your responsibility to check if the active substance you are considering for use in your product has been included onto Annex I of the Biocidal Products Directive in the relevant product type. If it hasn’t you need to ensure it is being supported for review under the BPD review programme. (i.e. has it been notified and in the relevant product type).
See question "How can I find out if a product is approved/authorised?" for further details.
Each biocidal product approved by HSE is given a unique reference, which must appear on the product label, e.g. HSE 1234 or BPR 5678. Therefore, check the label for an HSE/BPR number.
There is a list of products that currently hold an approval under COPR; this includes details such as the product name, active ingredient, marketing company, reference number and use (such as amateur and/or professional).
There is a similar list of products that have been authorised under BPR this includes details such as product name, product type active ingredient and authorisation holder/marketing company.
There is also a database of products for which a Certificate of Exemption has been issued. This allows you to search for product authorisation applications which are currently being evaluated, and for products withdrawn from the UK.
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.
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 on our placing biocidal product on the market page.
If the active substance in your product 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.
You must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by the Non Inclusion date.
A Certificate of Exemption (CoE) exempts an existing biocidal product from certain requirements of the Biocidal Products Regulations (BPR) to allow it to remain on the UK market until a decision is made on the application for product authorisation/registration.
An application for a Certificate of Exemption (CoE) should be made in writing at least three months before the active substance is included on Annex I/IA.
Details of the information we require to issue a CoE is outlined on our Transfer from UK webpage.
HSE, local authorities and several other bodies have roles in investigating incidents and carrying out enforcement for the Control of Pesticides Regulations (COPR) and the Biocidal Products Regulations (BPR). Depending on where the product has been used the use of biocidal products is usually enforced by either HSE inspectors or local authority environmental health officers. More detailed information on the specific enforcing authority for a particular situation is given on our Enforcement page.
If you, your family, your pets, or wildlife have been affected by exposure to biocides you are advised to seek medical advice and then to report the incident to the appropriate authorities. The department to contact depends on the type of incident that you wish to report.
Biocides are subject to a risk assessment to decide if they can be used without any undue risk to people, animals or the environment. The label on an approved/authorised product contains health and safety advice associated with the product.
If the advice given on the product label is followed, we would not expect any adverse effects to be experienced following the use of an approved/authorised product.
However, if somebody (human or animal) does become ill or is adversely affected after a biocide has been used please see the information and advice on our Reporting Incidents of Exposure page.
Your COPR approval may have been voided because the active substance(s) it contains is no longer being assessed under the Biocidal Products Directive (BPD) Active Substance Review programme.
Your notice and covering letter will provide details of the Non Inclusion decision that has been published for the active substance(s) in your product. This Non Inclusion decision will provide the date from which the active substance(s) can not be used in biocidal products placed on the EU market. This date will correspond to the cut off date on the COPR Notice of Approval you have received.
Revocation of approval may occur for a number of reasons, for example:
For the first three situations above, where possible, a "phased revocation'' will be implemented, but when safety considerations make it necessary immediate revocation may take effect.
For the fourth situation above when an active substance(s) is Included into Annex I of the BPD, all conditions of approval under the Control of Pesticides Regulations (COPR) will expire. A notice to revoke approval is issued because COPR will no longer apply to the product.
If you wish to place your product on the UK market after the BPD Annex I Inclusion date or you require a phase out period to remove your product from the UK market you must comply with the requirements of the UK Biocidal Products Regulations (BPR).
The European Commission have took action to prohibit amateur use of creosote products and to restrict the use of creosote treated wood. You can find out exactly what action was been taken, and what you need to do to comply with this decision on the Revocation of approvals for amateur creosote/coal tar creosote wood preservatives page.
Since 21 April 2002 it has been illegal to advertise, sell or supply a range of insecticides containing dichlorvos, following the suspension of these conditions of approval. More information is located on the Results of review of pesticide products containing dichlorvos page.
A food and feed derogation is a time limited removal of the requirement that an active substance used in a biocidal product must be/have been evaluated under the Biocidal Products Directive (BPD). The derogation is given on a case by case basis at a national level, and can be applied only to repellents or attractants that only contain active substance (s) that are considered to be of food or feedstuffs.
Companies wishing to market repellents or attractants products in the UK containing foodstuffs or other food grade materials such as flavourings as the active substances will need to submit details to HSE.
The information we require is outlined on our food and feed derogation webpage.
To apply for a food and feed derogation in another EU member state you will need to contact the Competent Authority in that member state.
Our online searchable database lists the products that currently hold a UK food and feed derogation.
For details of food and feed derogation in other EU member state you will need to contact the Competent Authority in that member state.
All users of biocides must be trained and competent for the tasks they are required to perform. There is no requirement for a user of biocides (or non-agricultural pesticides as they are referred to under COPR) to have gained a 'certificate of competence'.
However, the law says that if a person is using a biocide in the course of their business then they must have received appropriate information, instruction and training in the use of biocides.
The type of training required/received would cover issues such as the legislation, the correct use of biocides and how to carry out a risk assessment under the Control of Substance Hazardous to Health Regulations (COSHH). Those using biocides have a duty to properly assess a situation before they use a biocide, and consider the options for treatment and the potential risks involved, to ensure that a product is used in a way that reduces any risks from its use.
There are numerous courses run around the UK on different aspect of biocide use, both by private consultants and firms and by trade associations and training bodies.
We cannot recommend any specific company, as we have a duty to remain impartial. However, we would recommend that you contact your local council to see if they will carry out the treatment you require or you could contact one of the Pest Control Trade Associations to see if they can recommend a pest control company.
We cannot recommend any specific products, as we have a duty to remain impartial to all companies that have products approved/authorised. However, there is a wide selection of products available and these may be found in local DIY/hardware stores and supermarkets.
There is a list of products that currently hold an approval/authorisation on the HSE website. This includes details such as the product name, active ingredient, marketing company, HSE number and use (such as amateur and/or professional).
See question "How can I find out if a product is approved/authorised?" for further details about our databases.
Honey bees, both feral (wild) and colonised, are important beneficial insects, not normally considered as pests. They live either in the wild in nests, or as colonies in hives kept by beekeepers. In either case, they will only sting people if strongly provoked.
Because of their beneficial role, every effort should be made to avoid carrying out control treatments against honey bees. Treatment with a pesticide should be considered only as the last resort.
If you are asked to treat a feral honey bee nest, you should assess the situation carefully. Have people been stung by honey bees from the nest, or are they at risk because of its location? If the nest is not causing any risk to public health then you should carefully consider the alternatives before carrying out a treatment.
If you consider treatment is the best option, make use of the British Beekeepers Association's spray liaison scheme. This will enable local beekeepers to be warned by their own Spray Liaison Officer. It is important for you to talk to local beekeepers in this way before treating a nest.
Remember, members of the British Beekeepers Association can provide advice and can sometimes remove accessible feral honey bee colonies, avoiding the need to use pesticides.
Only use an HSE approved insecticide. Always read the label and use the product safely.
Once the treatment is complete, you should take every reasonable action to prevent foraging honey bees from gaining access to the treated nest, by removing the combs or blocking the nest entrances.
The EU Biocides Regulation repeals and updates the Biocidal Products Directive 98/8/EC (BPD) and aims to simplify and streamline existing EU requirements without reducing the level of protection it offers to health and the environment.
It will bring in some changes in relation to the regulation of biocidal products, but the basic mechanics of requiring assessment of the active for efficacy and safety for humans and the environment, followed by authorisation of biocidal products containing that active remain the same as for the BPD.
It is our understanding that the date (1st September 2013) mentioned in Article 95 (1) of Regulation (EU) No 528/2012 is the date from which submission can be made - not by which the submission has to have been made.
Article 95 (3) of Regulation (EU) No 528/2012 mentions that after the 1st September 2015 biocidal products can not be made available on the EU market if the active substance manufacturer/importer etc isn't on the list.
We would expect that ECHA will be thinking about how they will be dealing with this issue, for example, when they will start publishing the list, whether they will want to set an administrative date by which applications have to be made so that they can get onto the list before 1st September 2015.
Under Biocides Regulation (EU 528/2012) biocidal products are classified into 22 biocidal product-types, grouped in four main areas. These product types are broadly similar to the product types under the Biocidal Products Directive (BPD) but the names and the descriptions for each product type have been updated.
Preservatives for food and feedstock (product type 20 under the BPD) are no longer under the scope of the Biocides Regulations so there is one less product type compared to the BPD. Product type 23, Control of other vertebrates, under the BPD is now product type 20 under the Biocides Regulation and has been moved to main group 3, Pest control.
Other notable changes are product type 16 now includes products to control worms and other invertebrates and product type 13 now includes other cutting fluid preservatives. Also the borderline between product types 1 and 2 is now clearer.
The full list of product types can be found in Annex V of the Biocides Regulation (EU 528/2012).
Biocidal products families are defined in Article 3 as “a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products”
Biocidal products families build on ‘Frame formulation’ concept under the Biocidal Products Directive (BPD) in that it allows for:
However biocidal products families also allow for the replacement of non-active substance with another with same or lower risk.
Classification, hazard and precautionary statements for all products within the biocidal product family have to be the same.
Under the Biocides Regulation all products within the biocidal product family are covered by one authorisation for the family as a whole rather than each individual product requiring authorisation.
No, all products within the biocidal product family are covered by one authorisation for the family as a whole rather than each individual product requiring authorisation.
Each product within the biocidal product family will have a suffix to the authorisation number (Article 17 (6)).
If the product falls within the existing ranges of the biocidal product family authorisation, Article 17(6) of the Biocides Regulation states, that company must notify the relevant Competent Authority 30 days before first placing the new product on to the market.
For variations in the dyes, perfumes or pigments within existing ranges do not need to be notified.
A Union authorisation allows access to the EU market through a single authorisation, so there is no need for mutual recognition of a national authorisation.
Union authorisations are for biocidal products with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and certain product-types (14, 15, 17, 20 and 21).
Depending upon the product types, Union authorisation will be available in three different stages:
Applications are made to the European Chemicals Agency (ECHA)
Article 3 defines a treated article as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.”
The below table gives the UK Competent Authority’s current view of what is a treated article and what is a biocidal product, this could be subject to change once further guidance is published at the European level.
| Type of article | Treated Article or Biocidal Product |
|---|---|
| Article treated with a biocide (e.g. a wooden bench painted with wood preservative) with the sole intention of controlling organisms harmful to the treated article/material itself | Treated Article must comply requirements in Article 58 |
| Article is treated with a biocide and the primary function of the article is not as a biocide (e.g. antibacterial sock) | Treated Article must comply requirements in Article 58 |
Article is treated with a biocide and the primary function of the article is as a biocide (e.g. antibacterial wipe) |
Biocidal Product which requires authorisation |
Yes Article 58(2) of the Biocides Regulation states “a treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met.”
The treated article cannot be placed on the EU market unless the active substance(s) in the biocidal product(s) used to treat the article is approved for that use in EU e.g. preserved wood can only be imported if active is allowed in EU.
As stated in Article 92 of the EU Biocides Regulation, the authorisation/registration granted under the UK BPR is still valid and its conditions and restrictions still apply until its expiry date or until the authorisation/registration is revoked or cancelled.
From the 1 September 2013 the requirements of the EU Biocides Regulation will also apply.
Yes but it is our current understanding that your application for amended will be processed under the procedure/process outlined in Article 48 or 50 of the EU Biocides Regulation. You will then be issued with an authorisation under the EU Biocides Regulation.
As stated in Article 90, from the 1 September 2013 ECHA will be responsible for coordinating the evaluation of dossiers and the evaluations will continue.
If the UK CA has finished its assessment the evaluation will continue according to the requirements of the BPD & UK BPR.
If the UK CA has not finished its assessment the evaluation will continue according to the requirements of the EU Biocides Regulation.
Our current understanding of article 91 of the EU Biocides Regulation, is that the evaluation will continue according to the requirements of the BPD & UK BPR but authorisation will granted under the EU Biocides Regulation not UK BPR.
Our current understanding of Article 92 of the EU Biocides Regulation is that the authorisation/registration granted under the UK BPR is still valid and its conditions and restrictions still apply until its expiry date or until the authorisation/registration is revoked or cancelled.
From the 1 September 2013 the requirements of the EU Biocides Regulation will also apply
Application should still be submitted via Register for Biocidal Products (R4BP) and the data requirements for biocidal products are outlined in Annex III of the EU Biocides Regulation.
From the 1 September 2013 ECHA will be responsible for coordinating the evaluation of applications.
Yes and No.
Products containing active substances included in Annex I/IA of the BPD before 1 September 2013 may still be issued with CoE’s, according to HSE current process.
Products containing active substance included in Annex I/IA of the BPD or the EU BPR approved active substance list after 1 September 2013 will not be issued with CoE as the intention is that UK national law such as the Control of Pesticides Regulations (COPR) will still apply to such products until a decision is made to authorise the product under the EU Biocides Regulation.
Yes until its expiry date or until it is revoked, which ever is the sooner.
You must ensure that your product complies with the requirements of the Regulation.
If the active substance in your product is included in the approved list of active substances (previously Annex I of the BPD) for your product type or the list of substances eligible for simple authorisations (Annex I of EU Biocides Regulation) you must apply for authorisation under the relevant procedure and comply with the transitional measures in Article 93 of EU Biocides Regulation.
If the active substance in your product is an existing active substances, which is being evaluated under the review programme for your product type you can continue to place your product on the market but you must comply with the transitional measures in Article 89 of EU Biocides Regulation.
If the active substance in your product isn’t being evaluated under the BPD or the EU Biocides Regulation you must apply for product authorisation by 1 September 2017 as stated in Article 93 of EU Biocides Regulation. When you apply for product authorisation you must also submit the relevant data on the active substance in the product. Your product can “continue to be made available on the market and used until the date of the decision granting the authorisation” (Article 93 (2)).
No, Annex I of the EU Biocides Regulation is the list of active substances that can be used in product that qualify for the simplified authorisation procedure.
It does include some of the substance that were Included into Annex IA of the BPD.
The active substances currently listed in Annex I of the BPD will be included in the Union list of approved active substances (Article 9).
A biocidal product shall be eligible for the simplified authorisation procedure if all the following conditions (Article 25) are met:
If all of the conditions are met the applicant seeking the authorisation should submit an application to ECHA under the procedure/process outlined in 26 of the EU Biocides Regulation.
Recital 29 of the EU Biocides Regulation states simplified products are “products with a more favourable environmental or human or animal health profile”.
Article 27 of the EU Biocides Regulation states that once a simplified product is authorised in at least one Member State, the product can be made available on the market in all Member States without the need for mutual recognition, under certain conditions.
The list of active substances can be found in Annex I of the EU Biocides Regulation.
Yes, the process/procedure for amending Annex I is outlined in Article 28 of the EU Biocides Regulation.
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