Reglamento (UE) 2024/1439 de la Comisión, de 24 de mayo de 2024
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Reglamento (UE) 2024/1439 de la Comisión, de 24 de mayo de 2024, que modifica los anexos II y III del Reglamento (CE) nº 396/2005 del Parlamento Europeo y del Consejo por lo que respecta a los límites máximos de residuos de fenazaquina, mepicuat y propamocarb en determinados productos.
| Official Journal | EN L series |
| 2024/1439 | 27.5.2024 |
COMMISSION REGULATION (EU) 2024/1439
of 24 May 2024
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fenazaquin, mepiquat and propamocarb in or on certain products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1), point (a), thereof,
Whereas:
| (1) | For the active substances fenazaquin and propamocarb, maximum residue levels ('MRLs') were set in Annex II to Regulation (EC) No 396/2005. For the active substance mepiquat, MRLs were set in Part A of Annex III to that Regulation. |
| (2) | As regards fenazaquin, an application for import tolerances for use of that substance on hops in the United States, was submitted to the Member State concerned pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005. The applicant provided evidence that the uses of fenazaquin on hops authorised in the United States would lead to residues that exceed the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs would be needed to avoid trade barriers when importing that crop. |
| (3) | As regards propamocarb, an application requesting a modification of the existing MRLs for honey was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005. |
| (4) | In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. The Commission forwarded the applications, the evaluation reports, and the supporting dossiers to the European Food Safety Authority (the 'Authority'). |
| (5) | The Authority assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs (2). It forwarded its reasoned opinions to the applicants, the Commission and the Member States and made them available to the public. |
| (6) | As regards mepiquat, temporary MRLs were set for cultivated fungi by Commission Regulation (EU) 2019/50 (3) and for oyster mushrooms by Commission Regulation (EU) 2019/1791 (4), to be revised considering new information to be submitted by 31 December 2022, to address a cross-contamination that affected untreated cultivated fungi with straw lawfully treated with mepiquat. |
| (7) | An application requesting a modification of the existing temporary MRLs for mepiquat in cultivated fungi and oyster mushrooms was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005. |
| (8) | In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, that application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report, and the supporting dossiers to the Authority. |
| (9) | The Authority assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLs (5). It forwarded its reasoned opinion to the applicant, the Commission and the Member States and made it available to the public. |
| (10) | As regards the modification to the temporary MRL for mepiquat in cultivated fungi requested by the applicant, the Authority assessed the monitoring data provided with the application and those deriving from the Union monitoring programme, which showed that the existing MRL is sufficient to account for the residue uptake in cultivated fungi. |
| (11) | It is therefore appropriate not to modify the existing temporary MRL for mepiquat in cultivated fungi. |
| (12) | As regards the modification to the temporary MRL for mepiquat in oyster mushrooms requested by the applicant, the Authority assessed the monitoring data provided with the application and those deriving from the Union monitoring programme and concluded that further consideration by risk managers was required concerning whether to establish the new MRL at the level of 1 mg/kg, as derived by the Authority based on the 95th percentile of the data population, or at the level of 3 mg/kg, as derived by the Authority based on 95th percentile of the data population at the 95 % confidence level. |
| (13) | As pursuant to Commission Regulation (EU) No 283/2013 (6) temporary MRLs proposals based on monitoring data are to cover the 95th percentile of the data population at the 95 % confidence level, it is appropriate to set the temporary MRL for mepiquat in oyster mushrooms at the level of 3 mg/kg. |
| (14) | It is appropriate to continue to monitor the levels of mepiquat in cultivated fungi and oyster mushrooms and to review those MRLs based on monitoring data submitted to the Commission by 31 December 2030. |
| (15) | As regards all the other modifications to MRLs for fenazaquin, mepiquat and propamocarb requested by the applicants, the Authority concluded that all data requirements had been met and that such modifications were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of those substances. Neither the lifetime exposure to those substances via consumption of all food products that may contain them nor the short-term exposure due to high consumption of the relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded. |
| (16) | Based on the opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the proposed modifications to the MRLs are acceptable. |
| (17) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| (18) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 May 2024.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj.
(2) EFSA 2023. Setting of an import tolerance for fenazaquin in hops. EFSA Journal, 21(12), e8424. https://doi.org/10.2903/j.efsa.2023.8424.
EFSA 2023. Modification of the existing maximum residue level for propamocarb in honey. EFSA Journal, 21(11), e8422. https://doi.org/10.2903/j.efsa.2023.8422.
(3) Commission Regulation (EU) 2019/50 of 11 January 2019 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorantraniliprole, clomazone, cyclaniliprole, fenazaquin, fenpicoxamid, fluoxastrobin, lambda-cyhalothrin, mepiquat, onion oil, thiacloprid and valifenalate in or on certain products (OJ L 10, 14.1.2019, p. 8, ELI: http://data.europa.eu/eli/reg/2019/50/oj).
(4) Commission Regulation (EU) 2019/1791 of 17 October 2019 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 1-decanol, 2,4-D, ABE-IT 56, cyprodinil, dimethenamid, fatty alcohols, florpyrauxifen-benzyl, fludioxonil, fluopyram, mepiquat, pendimethalin, picolinafen, pyraflufen-ethyl, pyridaben, S-abscisic acid and trifloxystrobin in or on certain products (OJ L 277, 29.10.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1791/oj).
(5) EFSA 2024. Modification of the temporary maximum residue levels for mepiquat in cultivated fungi and oyster mushrooms. EFSA Journal, 22(1), e8476. https://doi.org/10.2903/j.efsa.2024.8476.
(6) Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1, ELI: http://data.europa.eu/eli/reg/2013/283/oj).
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
| (1) | in Annex II, the columns for fenazaquin and propamocarb are replaced by the following: ' Pesticide residues and maximum residue levels (mg/kg)
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| (2) | in Part A of Annex III, the column for mepiquat is replaced by the following: ' Pesticide residues and maximum residue levels (mg/kg)
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(*1) Indicates lower limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I
((+)) Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.
(*2) Indicates lower limit of analytical determination
(2) For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I
((+)) Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.
ELI: http://data.europa.eu/eli/reg/2024/1439/oj
ISSN 1977-0677 (electronic edition)
