(1)

Commission Directive 2008/127/EC (2) included gibberellins 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 gibberellins as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 October 2026.

(4)

An application for the renewal of the approval of the active substance gibberellins was submitted to Slovenia, the rapporteur Member State, and Slovakia, the co-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 renewal 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.

(6)

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 26 April 2019. In its draft renewal assessment report, the rapportuer Member State proposed to renew the approval of gibberellins.

(7)

The Authority 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 and made the supplementary summary dossier available to the public.

(8)

On 13 July 2020, the Authority requested additional information from the applicant on the endocrine disrupting properties of gibberellins pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012. The applicant submitted information to allow the Authority to conclude the assessment as regards whether the scientific criteria for the determination of endocrine disrupting properties set out in point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation (EU) 2018/605 (6), are met.

(9)

In April 2023, the rapporteur Member State made an updated draft renewal assessment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered the additional information regarding the criteria to identify endocrine disrupting properties and proposed renewing the approval of gibberellins.

(10)

On 16 October 2024, the Authority communicated to the Commission its conclusion (7) indicating that, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing gibberellins can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(11)

The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 14 May 2025 and 9 July 2025, respectively.

(12)

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.

(13)

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

(14)

Although the risk assessment for the renewal of the approval of the active substance gibberellins is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing gibberellins may be authorised. It is therefore appropriate not to maintain the restriction to use as a plant growth regulator.

(15)

The Commission further considers that gibberellins is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Gibberellins is not a substance of concern and fulfils the conditions set in point 5 in Annex II to Regulation (EC) No 1107/2009 and, considering its intended uses, it is expected that plant protection products containing gibberellins will pose only a low risk to human and animal health and the environment.

(16)

It is therefore appropriate to renew the approval of gibberellins as a low-risk active substance.

(17)

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.

(18)

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

(19)

Commission Implementing Regulation (EU) 2025/787 (8) extended the approval period of gibberellins to 31 October 2026 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.

(20)

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