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21 November 2023
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Objectives and Scope
Council Directive 414 of 15 July 1991 concerning the placing of plant protection products on the market relates to the authorization, placing on the market, use and control within the Community of plant protection products in commercial form and the placing on the market and control within the Community of active substances. A plant protection product includes active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to protect plants or plant products against all harmful organisms or prevent the action of such organisms, influence the life processes of plants, other than as a nutrient, (e.g. growth regulators), preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives, destroy undesired plants; or destroy parts of plants, check or prevent undesired growth of plants.
Tetraconazole was included as an active substance in Annex I to Directive 91/414/EEC. However, the inclusion of tetraconazole is limited to uses on field crops with a restricted rate and timing of application. Uses on apples and grapes are entirely excluded. Those restrictions were necessary because at the time of inclusion the information required for the groundwater assessment was insufficient, in particular as regards the risk of contamination by two metabolites which had not been identified by the notifier. As regards uses on apples and grapes, the information necessary for the assessment of the risk to consumers was incomplete.
The notifier Isagro has requested an amendment to the inclusion of tetraconazole extending its use as a fungicide by removing those restrictions and has submitted further scientific data in support of its request.
The new data submitted by the notifier and the new assessment carried out by the rapporteur Member State indicate that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for tetraconazole in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular as regards the risk of groundwater contamination, the rapporteur Member State considered that the new study submitted by the notifier identifies those metabolites and that there is no unacceptable leaching. Concerning use on apples and grapes, it concluded that, as completed by the new supervised and field trials, the residue data show that there are no risks as regards the acute and chronic intake by consumers.
2- phenylphenol was included as active substance in Annex I to Directive 91/414/CEE, by Commission Directive 2009/160/EU with the specific provision that Member States may only authorise indoor uses as a post-harvest fungicide in closed drench chambers.
The notifier submitted information on other application techniques, such as wax treatment, dipping treatment and foam curtain treatment, in order to remove the restriction to closed drench chambers.
The new information on the application techniques submitted by the notifier and the new assessment carried out by the rapporteur Member State indicate that plant protection products containing 2- phenylphenol may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the indoor uses as a post-harvest fungicide which were examined and detailed in the Commission review report. Consequently, it is no longer necessary to restrict the use of 2-phenylphenol to closed drench chambers.
Plant Protection Products containing the active substances napropamide, zinc phosphide, haloxyfop-P, fenbuconazole, quinmerac, pyridaben, metosulam, bromuconazole and 6-Benzyladenine can be authorized to be placed on the market. The authorizations and uses must be subject to the conditions laid down in the respective directives to ensure that their uses are safe for human health and the environment.
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