(1)

Commission Implementing Regulation (EU) No 736/2011 (2) approved fluroxypyr as an active substance in accordance with Regulation (EC) No 1107/2009 subject to certain conditions requiring the Member States concerned to ensure that the applicant at whose request fluroxypyr was approved provide further confirmatory information on six points, one of which concerned the relevance of the impurities present in the technical specifications.

(2)

On 25 June 2012 and 5 September 2013 the applicant submitted additional information intended to address the confirmatory data requirements to the rapporteur Member State Ireland within the time period provided for its submission.

(3)

Ireland assessed the additional information provided by the applicant. It submitted its own 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 22 December 2014 and invited them to comment on the assessment.

(4)

The Authority published a Technical Report (3) summarising the outcome of this consultation process for fluroxypyr on 22 July 2015.

(5)

The draft assessment report, the addendum and the Technical Report were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 23 March 2017 in the format of the Commission review report for fluroxypyr.

(6)

The Commission invited the applicant to submit its comments on the Commission review report for fluroxypyr.

(7)

N-methyl-2-pyrrolidone (NMP) is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4) as toxic for reproduction category 1B and has a general concentration limit of 0,3 %. The presence of NMP in the technical material below 3 g/kg would be highly unlikely to pose any risk to consumers. Hence the Commission has concluded that the additional information provided showed that a maximum level for the toxicologically relevant impurity NMP should be set at less than 3 g/kg (< 0,3 %) in the technical material.

(8)

In order to ensure a high level of protection for consumers it is, therefore, appropriate to establish a maximum level for this impurity in the commercially manufactured active substance.

(9)

The Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should therefore be amended accordingly.

(10)

Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing fluroxypyr.

(11)

For plant protection products containing fluroxypyr, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 8 September 2018.

(12)

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