Advisory Committee on Pesticides Annual Report 2001

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Section C: Inclusion of new active substances in Annex I of Directive 91/414/EEC teratogenicity screening test had not been validated. The ACP was content with the environmental risk assessment, particularly as the use was largely in glasshouses, and agreed with the comments on appropriate disposal of benzoic acid. D-Carvone Carvone is a naturally occurring terpenoid compound and is the main ingredient of caraway oil, which is prepared by fractional distillation of caraway seed oil. Carvone is a racemic mixture of D and L stereoisomers. Carvone is used as a plant growth regulator, possibly acting by reversible enzyme inhibition in the plant terpenoid (mevalonic acid) biosynthetic pathway. The partially resolved isomer, D-carvone (>4:1 D:L enantiomers), was regarded as a new active substance within the remit of EU Directive 91/414/EEC. The EU application had been evaluated by Netherlands, the Rapporteur Member State (RMS), and a Draft Assessment Report (DAR) prepared. The DAR assessed the product ‘Talent’ a liquid containing 950 g/l carvone applied by fogging equipment in enclosed potato stores to suppress potato sprouting. There had been no UK applications for use of carvone, although a future application was possible. The DAR had been distributed to all Member States for consideration in the EU peer review process. 33 The ACP considered the DAR and draft comments prepared by PSD. The <strong>Committee</strong> noted that carvone was a natural product and a zero exposure level was not achievable. It was accepted that information based on experience of use could be extrapolated to human exposure scenarios. The ACP noted that estimated consumer exposures exceeded the proposed ADI, but that the estimates were likely to err on the high side. The <strong>Committee</strong> also observed that there were no teratogenic effects. However, overall the <strong>Committee</strong> agreed that the logic of the safety assessment was not well presented and derivation of the end points was largely unsubstantiated, and supported the conclusions and shortcomings that PSD had identified. Profoxydim Profoxydim (also previously known as clefoxydim) is a new cyclohexanone herbicide. It is racemic mixture of four (E/Z-R/S) stereoisomers, each purportedly having equal biological activity. The mode of action is inhibition of the acetyl coenzyme A carboxylase (ACCase) activity in the lipid biosynthetic pathway of sensitive plant species. It is a new pesticide to the EU.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 The EU application had been evaluated by Spain, the Rapporteur Member State (RMS), and a Draft Assessment Report (DAR) prepared. The DAR assessed the product ‘Aura’ an emulsifiable concentrate (EC) containing 200 g/l profoxydim. It is a contact herbicide to be used in combination with an adjuvant for the control of Echinochloa crus-galli, an annual grass weed, in rice crops. No other uses had been notified and there were no applications for approval for use of profoxydim-containing products in the UK. The DAR had been distributed to all Member States for consideration in the EU peer review process. 34 The ACP was invited to consider the DAR and provide written comments. It was noted that the toxicological implications of there being four enantiomers had not been considered and the method of analysis did not distinguish individual enantiomers. Anaemia had been identified as an adverse effect but had not been fully characterised and discussed. The carcinogenicity identified in the liver and urinary tract was regarded as non-genotoxic but a nongenotoxic mechanism had not been proposed. The reasoning for setting an ARfD (based on the ADI) was considered unclear, and the appropriateness of basing the AOEL on a 12-month dog study, was also questioned. It was noted that incomplete uptake by the gut (66 percent) may not have been taken into account in deriving the proposed AOEL. Dimethenamid-p Dimethenamid, a racemic mixture of P and M enantiomers, belongs to the chloroacetamide class of herbicides. The molecular mode of action of chloroacetamides has not been fully elucidated but growth of germinating and developing seedlings is severely inhibited apparently due to effects on cell division in meristematic tissue, possibly mediated via interaction with protein thiol (SH) groups. The resolved isomer, dimethenamid-P (approximate 96:4 P:M enantiomer ratio) is considered to be a new active ingredient within the remit of EU Directive 91/414/EEC. The EU application had been evaluated by Germany, the Rapporteur Member State (RMS), and a Draft Assessment Report (DAR) prepared. The DAR assessed an emulsifiable concentrate (EC) formulation containing 720 g/l active substance, which is used to control broad-leaved and grass weeds in maize and sugar beet. Uses were proposed both in northern and southern European Member States, but no applications for use in the UK had been made.
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Advisory Committee on Pesticides Annual Report 2001

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