The Biocidal Products Directive (BPD), which is implemented into UK law through the Biocidal Products Regulations (BPR) and the Biocidal Products Regulations Northern Ireland (BPR (NI)), requires that biocidal products containing active substances listed in Annex I/IA of that directive for the uses specified (i.e. Product Types, (PTs)) be authorised or registered within 2 years of an active substance being formally included on to Annex I or IA.
Our database lists the active substances which have an Annex I/IA Inclusion decision. It presents important dates which now apply to products containing theses active substances, including those products already approved under the Control of Pesticides Regulations (COPR), and for applying for authorisation under BPR. Specific details on how various products are affected are provided below.
When the reviewed active substance is included into Annex I/IA, COPR no longer applies and consequently all conditions of approval issued under COPR for products containing that active as the sole active substance will be immediately revoked. At this stage products containing this active substance will require authorisation under BPR.
HSE will be issuing COPR revocation notices at least six months before the active is included into Annex I/IA for all products affected to give companies advanced notice of this change. This revocation notice will only take effect once the active substance is included on Annex I. Please note that for products with more than one active substance the COPR revocation notices will only apply/be issued when the last active substance in a product has been included on Annex I/IA of the BPD.
It is the approval holder’s responsibility to keep up to date with the progress through the review process of the active substance(s) in their product(s)
Some biocidal products that are currently on the UK market are not covered by COPR, for example disinfectants and some preservatives. When the reviewed active substance is included into Annex I/IA the full requirements of the BPR apply and these products will require authorisation under BPR if they are to remain on the UK market.
HSE uses our eBulletin alerts to let stakeholder know when an Annex I/IA Inclusion decision is published. It is at this point you should start making arrangements to apply for a BPR authorisation or remove the product from the UK market if you do not intend to apply for authorisation.
It is the company’s responsibility to keep up to date with the progress through the review process of the active substance(s) in their products(s).
Products that contain an active substance listed on Annex I/IA for the relevant PT as the only active substance must be authorised for sale on the market from the date of entry of the substance into Annex I/IA of the BPD. Where there is more than one active substance in the product, authorisation is need once the last active substance is included on Annex I/IA of the BPD.
Authorisations/registrations are issued by the Biocides Competent Authorities within each Member State (HSE in the UK). There is also a system of mutual recognition, where an authorisation/registration issued in one Member State is accepted in others.
Companies wishing to market biocidal products in the UK must submit by the date the active substance enters Annex I/IA either:
Please see the BPD/R Product Authorisation pages for further information about the product authorisation/registration process in the UK.
The authorisation process creates a period of up to two years where a product is under the scope of BPR/BPR(NI) but is not yet authorised to be placed on the market. If the applicants wishes to keep an existing product on the market during this period they must apply for a Certificate of Exemption (CoE) for that specific product which will exempt the product from certain requirements of BPR/BPR(NI) to allow it to remain on the UK market until a decision on the application for authorisation is made (in accordance with Schedule 13 of BPR and Schedule 12 of BPR(NI)).
A UK Certificate of Exemption (CoE) will exempt an existing product from certain requirements of BPR, to allow it to remain on the UK market until a decision is made on the application for authorisation/registration (in accordance with Schedule 13 of BPR and Schedule 12 of BPR(NI)). Regulations relating to NPIS (Reg. 29), Advertisement (Reg. 33), General Industry Charge (Reg. 39A) of BPR will still apply along with any other conditions or restrictions stated in the certificate.
An application for a 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 below.
CoE’s can only be issued for existing products. Should you wish to amend your current approval conditions, this can be done under COPR but you must inform us no later than 3 months prior to the Annex I/IA inclusion date to allow us to process the amendments and issue your CoE.
If any specifications of the product for which you are applying for BPR authorisation, differ from the current COPR approval such as formulation, technical specification, use pattern etc, this will be viewed as being a new product and a Certificate of Exemption will not be issued.
Any requests for new COPR products must also be made at no later than 3 months prior to the Annex I/IA inclusion date.
Some products that are currently on the UK market are not covered by COPR, for example disinfectants and some preservatives. If a company wishes to keep these products on the market while they seek authorisation under BPR/BPR(NI) they should request in writing a UK Certificate of Exemption (COE) 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 below.
As part of your request you must provide evidence that the product was on the UK market prior to the Annex I/IA inclusion date. This evidence could comprise of product labels, sales invoices, customer statements etc.
The COE will exempt the existing product from certain requirements of BPR, to allow it to remain on the UK market until a decision is made on the application for authorisation/registration (in accordance with Schedule 13 of BPR and Schedule 12 of BPR(NI) ). Regulations relating to NPIS (Reg. 29), Advertisement (Reg. 33), General Industry Charge (Reg. 39A) of BPR will still apply along with any other conditions or restrictions stated in the certificate.
Companies who decide not to submit a BPR product authorisation/registration application or notice of intention to the UK must ensure that the product is removed from the EU market before the date the active substance enters into Annex I/IA. However under BPR a phase-out period can be requested to allow them time to dispose of UK stocks appropriately.
A Phase Out COE will exempt an existing product from certain requirements of BPR, to allow it to remain on the UK market for a period of up to 18 months.
This certificate usually allows
Regulations relating to NPIS (Reg. 29), Advertisement (Reg. 33), General Industry Charge (Reg. 39A) of BPR will still apply along with any other conditions or restrictions stated in the certificate.
An application for a Phase Out 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 below.
For those products placed on the UK which also contain other active substances supported under BPD, these products can continue to be placed on the UK market, in accordance with existing national legislation, until all other active substances within these products are reviewed under BPD and entered into Annex I/IA. In these cases, an application, for product authorisation/registration is not required until all the active substances in the product are entered into Annex I.
Additional information to provide if the product is not approved under the Control of Pesticides Regulations
To process applications as effectively as possible applicants should provide all of the above information (where applicable). Incomplete/missing information may delay the processing of your CoE application.
Requests for CoE can be sent electronically to PA.biocides@hse.gsi.gov.uk or by post to:
Biocidal Product Authorisation Team
Chemicals Regulation Directorate
Health and Safety Executive
2.3 Redgrave Court
Merton Road
Bootle
L20 7HS
United Kingdom
HSE will issue the certificate before the date of Annex I/IA inclusion for the active in the product type and this will apply specifically to the product specified in the application for the certificate i.e. the application to which product authorisation/registration under BPR will be requested. It will not apply to any other products, for instance a product with the same name but different composition.
Simple administrative changes may be allowed - such as changing a marketing company if the original has gone out of business - if the COE holder can suitable justify that the change is essential.
Similarly, changes to the classification/labelling arising from CHIP/CLP requirements are allowed and companies should notify us of any such changes and the reasons behind them.
Non-administrative changes, such as amending the formulation, product name or conditions of use, are not allowed under the existing COE system.
Social media
Javascript is required to use HSE website social media functionality.
Follow HSE on Twitter:
Follow @H_S_E