(fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) No 993/20112 included 8-hydroxyquinoline (common name for quinolin-8-ol) as an active substance in Part B of the Annex to Implementing Regulation (EU) No 540/2011. 

(2) In the meantime, the Commission extended the approval period of quinolin-8-ol, originally expiring on 31 December 2021, four times in accordance with Article 17 of Regulation (EC) No 1107/2009. 

(3) The approval of the active substance quinolin-8-ol, as set out in Part B of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 December 2025. 

(4) An application for the renewal of the approval as a candidate for substitution of the active substance quinolin-8-ol was submitted by the applicant, to Spain, the rapporteur Member State, and the Netherlands, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 and within the time period provided for in that Article. 

(5) The applicant submitted the supplementary dossiers 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 9 July 2021. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of quinolin-8-ol. 

(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 28 February 2024, the Authority communicated to the Commission its conclusion indicating that, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing quinolin-8-ol can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.The conclusion of the Authority also indicated that quinolin-8-ol is not considered to meet the criteria for endocrine disrupting properties as laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009. 

(9) Commission Regulation (EU) 2017/776 amended Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council to include quinolin-8-ol (as 8-hydoxyquinoline) with classification as toxic for reproduction category 1B. 

(10) Active substances that are classified as toxic for reproduction category 1B can only be approved if it is demonstrated that exposure to humans is negligible. The representative uses of quinolin-8-ol, which include conditions and restrictions, showed that, under these conditions and restrictions, negligible exposure of humans can be demonstrated, through both dietary and non-dietary exposure routes. 

(11) The Commission communicated a renewal report to the Member States and the applicant on 13 June 2024 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 10 July 2024. 

(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 quinolin-8-ol 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 quinolin-8-ol is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing quinolin-8-ol may be authorised. It is therefore appropriate not to maintain the restriction to use this active substance as a fungicide and bactericide only. 

(15) Given that quinolin-8-ol is classified as toxic for reproduction category 1B, it fulfils the condition set in the sixth indent of point 4 of Annex II to Regulation (EC) No 1107/2009 to be approved as a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. 

(16) It is therefore appropriate to renew the approval of quinolin-8-ol as a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009.

 (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 and restrictions. In particular, only professional uses of plant protection products containing quinolin-8-ol in permanent greenhouses that allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment, by drip-irrigation, should be authorised, in order to ensure a negligible exposure of operators, workers, bystanders and residents. For the same reason, uses of quinolin-8-ol should be authorised only where a closed transfer system for loading and mixing the plant protection product into the application equipment is available. Additionally, a pre-harvest interval should be set and the reuse of soil in which crops treated with plant protection products containing quinolin-8- ol, are grown in permanent greenhouses should be restricted, in order to address the risk to soil macro-organisms identified by EFSA. 

(18) It is also necessary to require further confirmatory information from the applicant as regards the non-dietary exposure to the active substance, confined rotational crops metabolism data addressing the fate of the parent compound its in succeeding crops, as well as studies or information to confirm a lack of clastogenic and aneugenic potential for quinolin-8-ol. 

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

(20) Commission Implementing Regulation (EU) 2015/408 included 8-hydroxyquinoline (quinolin-8-ol) in the list of candidates for substitution. In the light of the renewal of approval of quinolin-8-ol as a candidate for substitution and the corresponding inclusion of quinolin-8-ol to Part E of the Annex to Implementing Regulation (EU) No 540/2011, the entry for quinolin-8-ol should be deleted from the Annex to Implementing Regulation (EU) 2015/408. 

(21) Commission Implementing Regulation (EU) 2024/2781 extended the approval period of quinolin-8-ol to 31 December 2025 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 that active substance has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. 

(22) This Regulation does not prevent the applicant from submitting additional information to amend the conditions of approval, as provided in Articles 7 and 14 of Regulation (EC) No 1107/2009. 

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