Health and Safety
Executive / Commission
Biocides &
pesticides
The Biocidal Products Directive (BPD), which is implemented into UK law through the Biocidal Products Regulations (BPR), 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. General details on the BPD and the active substances being reviewed for inclusion in Annex I/IA are available on the EU Commission’s website.
Several active substances in various product types have been reviewed under BPD and are to be included in Annex I. The consequence of this is that products containing these actives will, in the relatively near future, come under the scope of BPD and will require authorisation to be placed on the market in the EU. There are also implications for products containing these actives which are currently approved under UK national legislation the Control of Pesticides Regulations 1986 (COPR).
Appendix 1 lists these active substances and presents important dates which now apply to products containing them under COPR and BPD. Specific details on how these products are affected are provided below.
When the reviewed active substance is included into Annex I/IA, COPR immediately dis-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 the COPR revocation notices will only apply/be issued when the last active substance in the products has been included on Annex I/IA of the BPD.
Products that contain an active substance listed on Annex I/IA for this PT as the only active substance present must be authorised for sale on the market from the date of entry of the substance into Annex I/IA of the BPD see Appendix 1. Where there is more than one active substance in the product, authorisation is only needed 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 such products in the UK must submit within three months[1] of the date the active substance enters Annex I/IA either:
Applicants wishing to apply for product authorisation/registration in the UK should complete the UK biocidal product application form (please contact us for further details). As part of the application, applicants should also confirm that they have access to the full data package on the active concerned or include a letter of access from the data holder.
Contact details for the participants responsible for supporting the active substance through the review process can be found in Appendix 2
The application form can be sent electronically to PA.biocides@hse.gsi.gov.uk or by post to:
Biocidal Product Authorisation Team
Chemicals Assessment Schemes Unit
Health and Safety Executive
2.3 Redgrave Court
Merton Road
Bootle
L20 7HS
United Kingdom
This process creates a period of up to two years where a product is under the scope of BPR but is not yet authorised to be placed on the market. If the company wishes to place a 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 to allow it to be placed on the market until a decision on the application for authorisation is made (in accordance with Schedule 13 of BPR).
A Certificate of Exemption[3] (CoE) will exempt a product from certain requirements of BPR, to allow it to be placed on the market until a decision is made on the application for authorisation/registration (in accordance with Schedule 13 of BPR). Regulations relating to NPIS (Reg. 29), Advertisement (Reg. 33), General Industry Charge (Reg. 39A and Schedule 12A of BPR (Amendment) Regulation 2003) will still apply to the biocidal product whilst it is exempt from BPR.
An application for a CoE should be made in writing to HSE at least one month[1] before the active substance is included on Annex I/IA.
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
The information required by HSE to issue a CoE is as follows
Companies who decide not to submit a BPR product authorisation/registration application or notice of intention to the UK within 3 months[1] of the active substance actually being included into Annex I/IA must ensure that the product is removed from the UK market before the date the active substance enters into Annex I/IA. This is because COPR will no longer apply to these products after the deadline. However under BPR a six month phase-out period[1] can be requested to allow them time to dispose of stocks appropriately.
Companies wishing to request this six month phase-out period should inform HSE in writing at least one month before the active substance is listed on Annex I/IA. HSE will then issue a BPR certificate of exemption which will explicitly exempt the product from the requirements of BPR apart from those relating to NPIS (Reg. 29), Advertisement (Reg. 33), General Industry Charge (Reg. 39A and Schedule 12A of BPR (Amendment) Regulation 2003) for a period of six months. Please note that the BPR certificate of exemption will apply specifically to the product specified in the application for the certificate. It will not apply to any other products, for instance a product with the same name but different composition.
For those COPR approved products which also contain other active substances supported under BPD, these products can continue to be approved under COPR 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/IA.
Figure 1. Generic timescale for active substances entering Annex I or IA
UK CA
December 2008
