(fra kommisjonsforordninen)

(1) On 28 June 2018, Austria, as rapporteur Member State, received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from ADAMA Agriculture B.V. for the approval of the active substance elemental iron.
(2) On 9 August 2018, in accordance with Article 9(3) of Regulation (EC) No 1107/2009, the rapporteur Member State notified the applicant, the other Member States, the Commission and the European Food Safety Authority (“the Authority”) of the admissibility of the application.
(3) On 2 July 2021, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether elemental iron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(4) The Authority circulated the draft assessment report received from the rapporteur Member State to the applicant and the other Member States, in accordance with Article 12(1) of Regulation (EC) No 1107/2009.
(5) In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority requested the applicant to supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report on 25 April 2022.
(6) On 2 October 2024, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance elemental iron can be expected to meet the approval criteria provided for in Article 4 of Regulation
(EC) No 1107/2009. The Authority made its conclusion available to the public.
(7) The Commission presented a review report and a draft Regulation regarding elemental iron to the Standing Committee on Plants, Animals, Food and Feed on 4 December 2024 and 11 March 2025, respectively.
(8) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the review report. The applicant submitted its comments, which have been carefully examined.
(9) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(10) The Commission further considers that elemental iron is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Elemental iron is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.
(11) It is therefore appropriate to approve elemental iron as a low-risk active substance.
(12) In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Commission Implementing Regulation (EU) No 540/20113 should be amended accordingly.
(13) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,