Regulatory update: 06/2007
Issued: 15 March 2007
Phase out of products containing Isoproturon
This update details the revocation action being taken with respect to all plant protection products containing isoproturon
Approvals Process for Pesticides
Plant protection products (agricultural pesticides) are considered under an EC review programme to ensure that the safety of all pesticides used throughout Europe is evaluated to modern standards. The basis of the EC review programme is set out in the pesticide authorisations directive (Directive 91/414/EEC). The Directive provides for the establishment of a positive list of active substances (Annex I), that have been shown to be without unacceptable risk to people or the environment. This decision is taken on the basis of a so-called ‘representative use’ of the substance.
Once an existing active substance is included in Annex I, each Member State has to “re‑register” products containing that active substance to ensure that they are safe to use under its specific conditions.
Isoproturon (IPU) has been reviewed under the EU review programme and has been included in Annex I (Directive 2002/18/EC). One of the conditions of inclusion in Annex I was that Member States, when authorising products containing IPU, are required to ‘pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures’.
The Pesticides Safety Directorate (PSD) has evaluated data presented by authorisation holders for the re-registration of products containing IPU. The applicants provided data specifically to address the concern of risk to aquatic organisms and, having evaluated these data, PSD sought the advice of the Advisory Committee on Pesticides (ACP).
ACP Conclusions
The risk assessment considered by the ACP identified that there is an unacceptable risk to aquatic life (algae, aquatic plants and invertebrates such as crustacea) arising from the movement of IPU into surface water-courses via land drains under treated areas. The ACP concluded that on the basis of the available evidence, exposure to IPU cannot be satisfactorily managed. The application of the relevant EC rules therefore means that the products considered should not be re-registered for use in the United Kingdom. The ACP minutes are available here.
Regulatory Action
As a result of these recommendations and following consultation with Ministers the advertisement, sale, supply, storage and use of all IPU containing products (including equivalent mixed products also containing other active substances) will be phased out by 30 June 2009. The following interim deadlines will apply:
(i) Sale by Approval Holders ending 30 September 2007
(ii) Sale by others ending 30 September 2008
(iii) Use and storage by all must end by 30 June 2009.
In addition, all existing approvals are being amended with immediate effect to restrict the maximum application rate to the rate considered for Annex I inclusion (i.e. 1.5 kg/ha) rather than the currently approved rates, during the above mentioned withdrawal period.
No new approvals will be granted during the withdrawal period apart from parallel imports against an existing product (at reduced rates) until 30 September 2007.
The extended phase out period has been implemented to allow the industry a period of adjustment to move to alternatives and to adopt the latest research findings on integrated approaches to weed control in cereals.
If any Approval Holder feels that their product (specifically a mixed active product) does not present an environmental risk, then the opportunity remains for them to submit a suitable risk assessment demonstrating safe and effective use.
Contact Details
If you have any questions regarding this issue, please contact either Darren Flynn (darren.flynn@hse.gsi.gov.uk) on 01904 455898 or Mark Curtis (mark.curtis@hse.gsi.gov.uk) on 01904 455834.