Commission Directive 2008/125/EC

Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (OJ L 344, 20.12.2008, p. 78).

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

On 8 April 2010 one of the notifiers at whose request tebuconazole was included in Annex I to Directive 91/414/EEC, submitted an application for an amendment to the conditions of approval of the active substance tebuconazole to allow uses as a plant growth regulator to be authorised without restriction. That application was accompanied by information relating to the requested additional supported use as plant growth regulator in oilseed rape. It was submitted to Denmark, which had been designated rapporteur Member State by Commission Regulation No. 1490/2002

Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (OJ L 224, 21.8.2002, p. 23).

Denmark assessed the information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 23 July 2012.

The Commission consulted the Authority which presented its opinion on the risk assessment of tebuconazole on 9 December 2013

EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance tebuconazole. EFSA Journal 2014;12(1):3485, 98 pp. doi:10.2903/j.efsa.2014.3485.

The Commission invited the notifier to submit its comments on the review report for tebuconazole.

The Commission has come to the conclusion that allowing uses as a plant growth regulator to be authorised without restriction does not cause any risks in addition to those already taken into account in the approval of tebuconazole and in the Commission review report for that substance.

It is appropriate to extend the approval of tebuconazole to cover uses as a plant growth regulator without restriction. However, in order to take into account the remaining uncertainty on the potential for groundwater exposure of the metabolite 1,2,4-triazole for the representative spray uses on cereals, as a barley seed treatment and on grapes, Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole.

In January 2014, Denmark finalized the evaluation of the confirmatory information as regards the risk to birds and mammals. The Standing Committee on Plants, Animals, Food and Feed agrees that, on the basis of the current outcome, the risk to birds and mammals is acceptable. Therefore, the conclusions of the original risk assessment are not substantially affected by the evaluation of the submitted confirmatory data. No further review by the Authority has been considered necessary.

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,