(fra kommisjonsforordningen)

(1) Commission Implementing Regulation No (EU) 1043/2012 approved the active substance phosphane and listed it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011. 

(2) The approval of the active substance phosphane, as set out in Part B of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 March 2027. 

(3) An application for the renewal of the approval of the active substance phosphane, under the name phosphine, which is the same substance and has the same CAS number as phosphane, was submitted to Spain, the rapporteur Member State, and Germany, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article. 

(4) The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State. 

(5) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 23 December 2021. In that draft renewal assessment report, the rapporteur Member State proposed to renew the approval of phosphine. 

(6) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. 

(7) On 10 December 2024, the Authority communicated to the Commission its conclusion on whether phosphine can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(8) The Authority identified a critical area of concern for the potential genotoxicity (clastogenicity) of phosphine. However, this concern does not preclude renewal of approval, because the implementation of risk mitigation measures eliminates the exposure of humans, animals and the environment to phosphine. 

(9) The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 10 December 2025 and 5 May 2026, respectively. 

(10) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration. 

(11) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance phosphine that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied, provided that the conditions and restrictions of use specified in Annex I to this Regulation are complied with. 

(12) It is therefore appropriate to renew the approval of phosphine. 

(13) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions to eliminate any exposure of humans, animals and the environment to phosphine. Phosphine, which is applied by fumigation, should only be used in gastight chambers or rooms, where gas tightness is verified and phosphine is supplied from outside, thus avoiding that operators come into contact with the active substance. After fumigation, the remaining phosphine should be removed using appropriate filter technology to ensure that no phosphine is released into the environment. The products on which phosphine is applies should be removed from the gas-tight chambers or rooms only after ventilation, and only if phosphine residue concentrations are at or below the limit of quantification (‘LOQ’). 

(14) Moreover, it is appropriate to require confirmatory information on the genotoxicity potential of phosphine to increase confidence in the decision that phosphine is unlikely to lead to genotoxic effects under relevant conditions of use. 

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

(16) Commission Implementing Regulation (EU) 2025/23166 extended the approval period of phosphine to 15 March 2027 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on the renewal of the approval of phosphine has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. 

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