EU approval for seven new ais
By Jackie Bird
Published: 11 March 2014 10:30 AM
The European Commission has confirmed full EU approval, with effect from July 1st, for seven new active ingredients. The ais are: the fungicides, Nissan Chemical’s amisulbrom and Belchim’s valifenalate (developed by Isagro); Bayer CropScience’s herbicide, thiencarbazone-methyl; the insecticides, Sumitomo Chemical’s pyridalyl and Dow AgroSciences’ spinetoram; and the plant growth regulators, DormFresh’s 1,4-dimethylnaphthalene and Sumitomo’s S-abscisic acid. The process has taken between three and eight years (Agrow No 680, p 6).
Various conditions are attached to the authorisations, and member states have until December 31st 2015 to ensure that any existing provisional approvals comply with these conditions. The applicants are required to submit confirmatory information on specific aspects by June 30th 2016.
For amisulbrom, member states shall impose risk mitigation measures, where appropriate, to protect aquatic and soil organisms. Confirmatory information is required on specific metabolites regarding: their potential to contaminate ground and surface water; and the risk from secondary poisoning for birds and mammals. Further data on the potential for causing endocrine disrupting effects in birds and fish are to be submitted within two years after the EU adopts test guidelines on endocrine disruption.
When approving valifenalate-based products, member states must consider the risk to aquatic organisms. Confirmatory information is required on the potential of a metabolite to contaminate ground water.
For thiencarbazone, the risks to ground water and aquatic organisms must be considered. The applicant must submit the results of monitoring programme by June 30th 2018 on the potential for long-range atmospheric transport of the ai.
Pyridalyl may only be authorised for use in greenhouses with permanent structure, and member states must ensure that existing approvals comply with this restriction by December 31st 2014. Other conditions require appropriate measures to protect re-entry workers, ground water, birds, mammals and aquatic organisms. Confirmatory data on the toxicological and ecotoxicological relevance of specific impurities are required by the end of 2014. Other information is needed on: the relevance of metabolite HTFP to ground water; and the risk to aquatic invertebrates. Results of a monitoring programme must be submitted by June 30th 2018 on potential ground water contamination by HTFP.
Spinetoram approvals require member states to consider the risks to: aquatic and soil organisms; non-target arthropods in-field; and bees during application and subsequently. Further data are required on the equivalence between the stereochemistry of metabolites identified in the degradation studies and in the testing material.
For 1,4-dimethylnaphthalene, measures may be required to protect: operators and workers at re-entry and during inspection of the warehouse; and aquatic organisms and fish-eating mammals if the ai is discharged from warehouses into air and surface water without further treatment. Confirmatory information is required regarding the residue definition for the ai.
For S-abscisic acid approvals, member states must ensure the protection of aquatic organisms.