Following the review of Dichlofluanid in Product Type 8 (Wood preservatives) under the Biocidal Products Directive 98/8/EC (BPD), the European Commission has agreed that this active substance will enter into Annex I of the Directive on 1 March 2009 and that all applications for PT 8 product authorisations containing Dichlofluanid as the sole active substance must be completed by 28 February 2011.
To ensure a consistent approach is taken across Europe, harmonised timelines and procedures following Annex I inclusion of an active substance have been agreed between the European Commission and Member States. HSE as the UK Competent Authority for biocides is using these, along with the Biocidal Products Regulations as amended (BPR) to develop UK post-annex I procedures.
When Dichlofluanid is included into Annex I on 1st March 2009, all conditions of approval under the Control of Pesticides Regulations 1986 (COPR) for wood preservative products containing Dichlofluanid as the sole active substance will expire, this is because COPR no longer applies to these products. In order to ensure that HSE records are consistent, we will be issuing COPR revocation notices, in October 2008, for all products affected. Please note that we will only be issuing COPR revocation notices for wood preservative products which contain Dichlofluanid as the sole active substance.
In accordance with the BPR, applications for product authorisation of wood preservative products containing Dichlofluanid as the sole active substance must be received by HSE 3 months after Dichlofluanid is included onto Annex I i.e. by 1st June 2009.
Companies wishing to market such wood preservative products in the UK after the 1st March 2009 will have to submit by 1st June 2009 either:
Applicants wishing to apply for product authorisation in the UK should first contact the Chemical Assessment Schemes Unit (CASU) in writing to express an interest in having a product authorised. In this letter, applicants should confirm that they have access to the full data package on Dichlofluanid.
The participant responsible for supporting Dichlofluanid through the review process is LANXESS DEUTSCHLAND GMBH, D-51369 Leverkusen, Germany.
CASU will then explain the next steps applicants need to take. These letters should be sent to:
Chemicals Assessment Schemes Unit
Health and Safety Executive
2.3 Redgrave Court
Merton Road
Bootle
L20 7HS
United Kingdom
In order to market such wood preservative products in the UK after the 1st March 2009, companies will also need to inform HSE (in writing) before 31st January 2009 that they intend to submit a BPR product authorisation application/notice of intention for mutual recognition by the 1st June 2009. HSE will then issue such companies with a certificate of exemption (in accordance with Schedule 13 of BPR) which will allow the product to be legally placed on the UK market while the BPR assessment of the product authorisation application is taking place/requests for mutual recognition are pending. Such certificates of exemption will be issued before 1st March 2009 and 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
Companies who decide not to submit a BPR product authorisation application/notice of intention to the UK by 1st June 2009 must take steps to ensure the product is removed from the UK market by 1st March 2009. This is because COPR will no longer apply to these products after 1st March 2009. However, in line with the harmonised timelines and procedures agreed across Europe, such companies can request under BPR an additional 6 month removal period after the 1st March 2009. If companies wish to take advantage of this 6 month phase out period they must inform HSE before 31st January 2009 (in writing). HSE will then issue a BPR certificate of exemption which will allow until 1st September 2009 to remove the product from the UK market. 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 wood preservatives which also contain other active substances supported under BPD (in addition to Dichlofluanid), these products can continue to be approved under COPR until all other active substances within these products are reviewed under BPD. In these cases, new applications for product authorisation will not be required until the European Commission agrees the official date when the last active substance within the product is reviewed and entered into Annex I.
1 Refer to Technical Notes for Guidance on 'Dossier Preparation and Study Evaluation' Part II, section 9 on the European Chemical Bureau website at: http://ecb.jrc.it/biocides/ for further guidance with regards product dossier structure.
UK CA
July 2007
Updated August 2008