(1)

Commission Directive 2004/71/EC (2) included Pseudomonas chlororaphis strain MA 342 as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

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 (4).

(3)

The approval of the active substance Pseudomonas chlororaphis strain MA 342, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2023.

(4)

An application for the renewal of the approval of the active substance Pseudomonas chlororaphis strain MA 342 was submitted to the Netherlands, the rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

(6)

The Netherlands prepared a draft renewal assessment report in consultation with Denmark, the co-rapporteur Member State, and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 11 January 2016. In its draft renewal assessment report the Netherlands proposed to renew the approval of Pseudomonas chlororaphis strain MA 342.

(7)

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.

(8)

On 9 December 2016, the Authority communicated to the Commission its conclusion (6) which indicated that Pseudomonas chlororaphis strain MA 342 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

Based on discussions at the Standing Committee on Plants, Animals, Food and Feed, the Commission requested the Authority on 3 February 2020 to provide scientific advice on the translocation potential by Pseudomonas chlororaphis strain MA 342 in plants after seed treatment of cereals and peas and, if applicable, for a revision of the assessment of the risk to humans by the metabolite 2, 3-deepoxy-2, 3-didehydro-rhizoxin (DDR). In response, on 23 September 2020, the Authority issued a statement on the translocation potential by Pseudomonas chlororaphis strain MA 342 in plants after seed treatment of cereals and peas and an assessment of the risk to humans (7).

(10)

The Commission presented the renewal report and a draft of this Regulation regarding Pseudomonas chlororaphis strain MA 342 to the Standing Committee on Plants, Animals, Food and Feed on 15 October 2022 and 8 December 2022, respectively.

(11)

The Commission invited the applicant to submit its comments on the conclusion and the statement of the Authority and, in accordance with the third paragraph of Article 14(1) 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 where appropriate.

(12)

It has been established, with respect to one or more representative uses of at least one plant protection product containing the active substance Pseudomonas chlororaphis strain MA 342, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(13)

It is therefore appropriate to renew the approval of Pseudomonas chlororaphis strain MA 342. In accordance with Article 14(1) of Regulation (EC) No 1107/2009, read in conjunction with Article 6 thereof, and in the light of current scientific and technical knowledge (8) and the outcome of the risk assessment, it is, however, necessary to set certain conditions. In particular, it is necessary to maintain the existing restriction to use Pseudomonas chlororaphis strain MA 342 only as fungicide for seed dressing in closed seed dressing machinery and to set the maximum content of the metabolite DDR in plant protection products containing Pseudomonas chlororaphis strain MA 342.

(14)

In addition, in order to increase the confidence in the conclusion that the risk for human beings and the environment following the exposure to Pseudomonas chlororaphis strain MA 342 is negligible or very low, the applicant should provide confirmatory information as regards the identification and characterisation of Pseudomonas chlororaphis strain MA 342, the metabolite DDR and the potential for gene transfer of antibiotic resistance from Pseudomonas chlororaphis strain MA 342 to other micro-organisms.

(15)

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

(16)

Commission Implementing Regulation (EU) 2022/378 (9) extended the approval period of Pseudomonas chlororaphis strain MA 342 to 30 April 2023 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 renewal 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,