Health and Safety
Executive / Commission
Biocides &
pesticides
All stakeholders of products containing active substances in the 2nd phase of the Biocidal Products Directive (BPD) review programme are reminded that certain biocidal products (those in product types 16, 18, 19 and 21) containing active substances for which:
cannot be placed on the EU market or subsequently stored for any purpose (except for export and disposal) from 21 August 2009. This is in accordance with Articles 11 (2) and 13 (5) of Regulation (EC) No 1451/2007 (the Fifth Review Regulation). For the purpose of this article, these actives will be called ‘unsupported’.
It is your responsibility to ensure that stocks of your biocidal products containing such active substances do not remain on the EU market by 21 August 2009. Therefore you should be considering how long your products will be in the supply chain and be taking the necessary action. There will be no phased withdrawal of products once the 21 August 2009 has been reached.
Current COPR products – what is the legal status?
All conditions of approval will expire on 21 August 2009, as COPR no longer applies to these products. In order to ensure that HSE records are consistent, you will receive a ‘notice’ voiding your COPR approval with effect from 21 August 2009. This notice will be sent to you in January 2009, but obviously will not impact until 21 August 2009.
The below list details those active substances contained in non-agricultural pesticides approved under COPR for which a notice has been published for the 2nd priority list that all participants have withdrawn or that no dossier was submitted or that none of the dossiers submitted could be considered as complete.
Please note that this list is for guidance purposes only and is not exhaustive as there are a small number of product types that are not regulated under COPR but contain active substances that are being reviewed under the 2nd and 3rd phases of the review programme under BPD.
| Active substance | EC No | CAS No | Product Type |
|---|---|---|---|
| Naphthalene | 202-049-5 | 91-20-3 | PT 19 Repellents and Attractants |
| Benzyl benzoate | 204-402-9 | 120-51-4 | PT 18 Insecticide |
| Boric acid | 233-139-2 | 10043-35-3 | PT 18 Insecticide |
| (RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl-(1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 2 isomers: 1R trans: 1RS only 1:1)/Bioallethrin/d-trans-Allethrin | Plant protection product |
- | PT 18 Insecticide |
Stakeholders should ensure that they check the DG Environment website regularly for updates/modifications to the status of active substances in the 2nd phase of the review programme. Stakeholders should also be aware that biocidal products containing these ‘unsupported’ active substances cannot be placed on the EU market or subsequently stored for any purpose (except for export and disposal) from 21 August 2009.
As already stated there are a small number of product types that are not regulated under COPR but which contain active substances that are being reviewed under the 2nd and 3rd phase of the review programme under BPD. Stakeholders should be aware that biocidal products containing these ‘unsupported’ active substances cannot be placed on the EU market or subsequently stored for any purpose (except for export and disposal) from 21 August 2009.
Go to the withdrawal notices webpage on Europa website, search the withdrawal notices using specific CAS numbers for the substances where appropriate. The website also contains lists of active substances, which have been taken over by a new participant, and active substances included in the review programme.
It is very important that you check the Europa website.
Comprehensive lists of Notified active substances as well as supported product types can be found in the Annex II of the EC Fifth Review Regulation (1451/2007/EC).
The HSE website also contains relevant background information on biocides.
Please note we are unaware of the progress of the completeness checks in other Member States and therefore cannot give you any definitive answer on the status of these active substances until the relevant Rapporteur Member State has notified us. We therefore suggest that you examine the European Commission’s website regularly and keep in contact with your active substance supplier.
HSE intends to inform Local Authority Trading Standards officers of this forthcoming deadline and its implications including a list of non-agricultural pesticides approved under COPR that are affected. It will be incumbent upon them to decide what, if any, enforcement action is required.
From the 1st January 2009, we will no longer be accepting applications for approval under COPR for non-agricultural pesticides containing ‘unsupported’ active substances. There is little point granting approval this close to the 21 August 2009 deadline considering the time needed to obtain approval and get a formulation packaged and ready for the market. All applications falling into this category will be sent back to the applicant with a note explaining that they cannot be processed.
It is the applicant’s responsibility to ensure that any new product applications made under COPR contain active substances that are being supported through the EU review program and applicants are advised to consult the Europa and European Chemicals Bureau website regularly.
If you wish to replace any products that are affected by the 21 August 2009 deadline, you need to complete and submit a FEPA 1 application form to HSE for each new product approval. Each proposed product will require a new name and once approved it be allocated a new HSE number. Due to the time required by staff to process these replacement product applications under COPR we cannot progress these applications as amendments. Each application will be fee-banded on a case-by-case basis.
UK Biocides Competent Authority
November 2008