Diario Oficial de la Unión Europea del 13/7/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
13.7.2023
EN
Official Journal of the European Union
L 178/3
10
For the active substance cymoxanil, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation EC No 1107/2009 was requested by the Authority pursuant to Article 133a of Implementing Regulation EU No 844/2012, with a deadline of 17 June 2024.
11
For the active substances gibberellic acid and gibberellins, additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation EC No 1107/2009, was requested by the Authority pursuant to Article 133a of Implementing Regulation EU No 844/2012 and was submitted by the applicants within the deadline given. However, additional time is needed for its evaluation and to adopt the related conclusion as well as the ensuing risk management decision.
12
For the active substances aluminium ammonium sulphate, aluminium silicate and fat distillation residues, the Authority has submitted its conclusion. The Commission has initiated discussions on those active substances in the Standing Committee on Plants, Animals, Food and Feed.
13
As regards the approval of the active substances fatty acids C7-C20 in particular, pelargonic acid and plant oils/rape seed oil, the Commission has presented the renewal report and a draft Regulation renewing their approval to the Standing Committee on Plants, Animals, Food and Feed. Pending the delivery of an opinion of this Committee on the draft Regulations, additional time is needed to adopt the ensuing risk management decision.
14
Given that it is likely that no decision on the renewal of the approval of these active substances can be taken before the expiry of their respective approval periods on 31 August 2023 and 30 September 2023, and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of the active substances should be extended in order to enable the completion of the assessments required and finalise the regulatory decision-making procedures on the respective applications for renewal of approval.
15
As the risk assessment has not yet been finalised by the respective rapporteur Member States, and in light of the remaining time required to complete each respective renewal procedure, the duration of the extension for the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aluminium phosphide, calcium carbide, dodemorph, ethylene, flonicamid IKI-220, iron sulphate, magnesium phosphide, metamitron, sulcotrione and urea should be set at thirty-nine months, for the active substances extract from tea tree, maltodextrin, plant oils/clove oil and plant oils/spear mint oil should be set at twenty-nine months, and for the active substance tebuconazole should be set at thirty-five months and a half.
16
As the Authority needs additional time to adopt a conclusion and, where appropriate, to organise a consultation of experts, the duration of the extension for the active substances hydrolysed proteins and pyrethrins should be set at nineteen months and a half and thirty-three months and a half, respectively. In particular, when additional information for the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation EC No 1107/2009 was requested by the Authority, the duration of the extension for the active substance cymoxanil is set at thirty-five months and a half, and considering additional time is needed for its evaluation, the duration of the extension for the active substances gibberellic acid and gibberellins should be set at twenty-two months and a half.
17
Under point 3.6.4 of Annex II to Regulation EC No 1107/2009 an active substance shall only be approved if it is not or has not to be classified, in accordance with the provisions of Regulation EC No 1272/2008 of the European Parliament and of the Council 10, as toxic for reproduction category 1B, unless the exposure of humans to that substance in a plant protection product under realistic proposed conditions of use is negligible. As provided by Article 41 of Regulation EC No 1107/2009, the assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. In view of Commission Delegated Regulation EU 2020/217 11, amending Annex VI to Regulation EC No 1272/2008, classifying halosulfuron-methyl as toxic for reproduction category 1B, the duration of the extension for the active substance should be set at eighteen months.
10 Regulation EC No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation EC No 1907/2006 OJ L 353, 31.12.2008, p. 1.
11 Commission Delegated Regulation EU 2020/217 of 4 October 2019 amending, for the purposes of its adaptation to technical and scientific progress, Regulation EC No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting that Regulation OJ L 44, 18.2.2020, p. 1.
