(1)

Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

(3)

Fluazuron is already included in that table as an allowed substance for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

(4)

An application for the extension of the existing entry for fluazuron to fin fish has been submitted to the European Medicines Agency (‘EMA’).

(5)

The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for fluazuron in fin fish.

(6)

According to Article 5 of Regulation (EC) No 470/2009, EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

(7)

The EMA has considered that the extrapolation of the entry for fluazuron to tissues of all ruminants except ovine species and to bovine milk is appropriate.

(8)

Regulation (EU) No 37/2010 should therefore be amended accordingly.

(9)

It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

(2)

The approval periods of the active substances mepanipyrim, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, thiacloprid, thiram and ziram were last extended by Commission Implementing Regulation (EU) 2016/2016 (3). The approval periods of those substances will expire on 30 April 2018.

(3)

The approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, metrafenone, pirimicarb, rimsulfuron, spinosad, thiamethoxam, tolclofos-methyl and triticonazole were extended by Commission Implementing Regulation (EU) No 487/2014 (4). The approval periods of those substances will expire on 30 April 2018.

(4)

The approval periods of the active substances clopyralid, cyprodinil, fosetyl, pyrimethanil and trinexapac were extended by Commission Implementing Regulation (EU) No 678/2014 (5). The approval periods of those substances will expire on 30 April 2018.

(5)

The approval periods of the active substances dichlorprop-P, metconazole and triclopyr were extended by Commission Implementing Regulation (EU) No 878/2014 (6). The approval periods of those substances will expire on 30 April 2018.

(6)

Applications for the renewal of the approval of the substances referred to in recitals 2 to 5 were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (7).

(7)

Due to the fact that the assessment of the substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

(8)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

(9)

Taking into account that the approvals of the active substances expire on 30 April 2018, this Regulation should enter into force as soon as possible.

(10)

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

(11)

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