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24.3.2023 |
EN |
Official Journal of the European Union |
L 86/6 |
COMMISSION REGULATION (EU) 2023/679
of 23 March 2023
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 pyridaben, pyridate, pyriproxyfen and triclopyr 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:
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(1) |
For pyridaben, pyridate and triclopyr, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For pyriproxyfen, MRLs were set in Part A of Annex III to that Regulation. |
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(2) |
As regards pyridaben, an application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 was submitted as regards the use of that substance on grapefruits in the United States. The applicant provided data showing that the authorised uses of that substance on this crop in the United States lead to residues exceeding the MRL contained in Regulation (EC) No 396/2005 and that a higher MRL for pyridaben is necessary to avoid trade barriers for the importation of this crop into the Union. |
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(3) |
As regards pyridate, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRL was submitted for chives. As regards pyriproxyfen, such an application was submitted for apricots and peaches. As regards triclopyr, such an application was submitted for oranges, lemons and mandarins. |
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(4) |
In accordance with Article 8 of Regulation (EC) No 396/2005, all those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
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(5) |
The European Food Safety Authority (‘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 those opinions to the applicants, the Commission and the Member States and made them available to the public. |
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(6) |
As regards pyridate, the Authority noted that the data gap concerning analytical methods for the determination of pyridate residues, which was identified in the framework of the MRL review for this active substance under Article 12 of Regulation (EC) No 396/2005 (3), was addressed in the EU pesticides peer review for the active substance pyridate (4), where a sufficiently validated method was provided. Therefore, it is appropriate to delete the respective footnotes in Annex II to Regulation (EC) No 396/2005 referring to the absence of the data. |
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(7) |
As regards the MRLs for triclopyr in oranges, lemons and mandarins, the Authority noted that the submitted data were sufficient to derive a lower MRL proposal of 0,07 mg/kg based on the intended use. Nevertheless, the Authority noted that confirmatory data supporting the existing MRL of 0,1 mg/kg were required in the MRL review under Article 12 for that active substance, which is still pending, and therefore concluded that further consideration by risk managers was necessary. Pending the assessment of confirmatory data, it was decided that it is appropriate to maintain the current tentative MRL of 0,1 mg/kg. |
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(8) |
As regards the modifications to MRLs requested by the applicants for all four substances, the Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety, on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded. |
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(9) |
Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of that Regulation. |
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(10) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(11) |
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, 23 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(2) EFSA scientific reports are available online: http://www.efsa.europa.eu.
Reasoned Opinion on the setting of an import tolerance for pyridaben in grapefruits. EFSA Journal 2022;20(9):7553.
Reasoned Opinion on the modification of the existing maximum residue level for pyridate in chives. EFSA Journal 2022;20(8):7537.
Reasoned Opinion on the modification of the existing maximum residue levels for pyriproxyfen in apricots and peaches. EFSA Journal 2022;20(9):7567.
Reasoned Opinion on the modification of the existing maximum residue levels for triclopyr in oranges, lemons and mandarins. EFSA Journal 2022;20(8):7545.
(3) Reasoned opinion on the review of the existing maximum residue levels (MRLs) for pyridate according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2012;10(4):2687.
(4) Conclusion on the peer review of the pesticide risk assessment of the active substance pyridate. EFSA Journal 2014;12(8):3801, 84 pp.
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
in Annex II, the columns for pyridaben, pyridate and triclopyr are replaced by the following: ‘ANNEX II Pesticide residues and maximum residue levels (mg/kg)
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(2) |
in Part A of Annex III, the column for pyriproxyfen is replaced by the following: ‘ANNEX IIIA Pesticide residues and maximum residue levels (mg/kg)
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(*) 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
(*) 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