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25.7.2022 |
EN |
Official Journal of the European Union |
L 196/74 |
COMMISSION REGULATION (EU) 2022/1290
of 22 July 2022
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 ametoctradin, chlormequat, dodine, nicotine, profenofos and Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) isolate BV-0004 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 5(1) and Article 14(1)(a) thereof,
Whereas:
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(1) |
For ametoctradin and dodine, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For chlormequat and nicotine, MRLs were set in Part A of Annex III to that Regulation. For profenofos, MRLs were set in Annex II and Part B of Annex III to that Regulation. For Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) isolate BV-0004 no specific MRLs were set in Regulation (EC) No 396/2005 nor was that substance included in Annex IV to that Regulation, so the default value of 0,01 mg/kg laid down in Article 18(1)(b) thereof applies. |
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(2) |
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance ametoctradin on crops that might be attractive to bees and that might result in residues in honey, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRL for honey was submitted. |
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(3) |
As regards dodine, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for citrus fruits. |
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(4) |
In accordance with Article 8 of Regulation (EC) No 396/2005, both of 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 the consumer 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) |
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 information on the toxicological properties of the substances. Neither the lifetime 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 that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. |
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(7) |
For chlormequat, temporary MRLs were set by Commission Regulation (EU) 2019/1561 (3) for oyster mushrooms and by Commission Regulation (EU) 2017/693 (4) for cultivated fungi at 6 mg/kg and 0,9 mg/kg respectively. Those temporary MRLs were set based on monitoring data showing that residues occurred on untreated cultivated fungi at a level higher than the limit of determination due to cross-contamination of cultivated fungi with straw lawfully treated with chlormequat. Those temporary MRLs were set until 13 April 2021, pending the submission of monitoring data on the occurrence of that substance in the concerned products. |
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(8) |
The Authority and food business operators submitted recent monitoring data showing that residues of chlormequat still occur in oyster mushrooms and cultivated fungi at levels higher than the limit of determination. Mushroom growers notified the Commission of one ongoing study to assess levels of contamination of oyster mushrooms and other cultivated fungi. Since the study will be concluded in 2022 and the collected data will then be submitted to the Commission, it is appropriate to continue to extend the validity of those temporary MRLs for one year from the publication of this Regulation. |
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(9) |
Temporary MRLs for chlormequat were also set by Regulation (EU) 2017/693 for pears at 0,07 mg/kg, due to monitoring data showing persistence in the trees as a consequence of former uses. The temporary MRL was set until 13 April 2021, pending the submission of monitoring data on the occurrence of this substance in the concerned product. The Authority, Member States and food business operators submitted recent monitoring data showing that residues of this substance at levels higher than the limit of determination still occur in pears. It is therefore appropriate to continue to monitor the levels of chlormequat in pears and to extend the validity of that temporary MRL for seven years from the publication of this Regulation. |
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(10) |
For nicotine, temporary MRLs were set by Commission Regulation (EU) 2017/978 (5) for wild fungi (dried ceps and dried wild mushrooms other than ceps) until 19 October 2021, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in the concerned products. Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned products and to elucidate the mechanism of formation. The Authority and food business operators submitted recent monitoring data showing that residues of this substance still occur in those products at levels higher than the limit of determination. It is therefore appropriate to continue to monitor the levels of nicotine in those products and to extend the validity of those temporary MRLs for seven years from the publication of this Regulation. |
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(11) |
For profenofos, a temporary MRL was set by Regulation (EU) 2017/978 for rose petals until 18 October 2021, pending the submission of monitoring data on the occurrence of this substance in the concerned product. The Authority and food business operators submitted recent monitoring data showing that residues of this substance still occur at levels higher than the limit of determination in rose petals. It is therefore appropriate to continue to monitor the levels of profenofos in rose petals and to extend the validity of that temporary MRL for seven years from the publication of this Regulation. |
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(12) |
An application for approval of the active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) isolate BV-0004 was submitted to a Member State in accordance with Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (6). The application was evaluated by the Member State concerned in accordance with Article 11(2) of that Regulation. The Authority assessed the application and delivered a conclusion on the peer review of the pesticide risk assessment of the active substance (7), where it indicated Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) isolate BV-0004 as eligible for inclusion in Annex IV of Regulation (EC) No 396/2005. It is therefore appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005. |
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(13) |
Based on the reasoned opinions and the conclusion 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 Regulation (EC) No 396/2005. |
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(14) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(15) |
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, III and IV 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, 22 July 2022.
For the Commission
The President
Ursula VON DER LEYEN
(2) EFSA scientific reports available online: http://www.efsa.europa.eu
Reasoned Opinion on the modification of the existing maximum residue level for ametoctradin in honey. EFSA Journal 2021;19(11):6943.
Reasoned Opinion on the modification of the existing maximum residue levels for dodine in citrus fruits. EFSA Journal 2021;19(11):6950.
(3) Commission Regulation (EU) 2019/1561 of 17 September 2019 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 chlormequat in cultivated fungi (OJ L 240, 18.9.2019, p. 1).
(4) Commission Regulation (EU) 2017/693 of 7 April 2017 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bitertanol, chlormequat and tebufenpyrad in or on certain products (OJ L 101, 13.4.2017, p. 1).
(5) Commission Regulation (EU) 2017/978 of 9 June 2017 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fluopyram; hexachlorocyclohexane (HCH), alpha-isomer; hexachlorocyclohexane (HCH), beta-isomer; hexachlorocyclohexane (HCH), sum of isomers, except the gamma isomer; lindane (hexachlorocyclohexane (HCH), gamma-isomer); nicotine and profenofos in or on certain products (OJ L 151, 14.6.2017, p. 1).
(6) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
(7) Conclusion on the peer review of the pesticide risk assessment of the active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV). EFSA Journal 2021;19(10):6848.
ANNEX
Annexes II, III and IV to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
in Annex II, the columns for ametoctradin and dodine are replaced by the following: ‘Annex II Pesticide residues and maximum residue levels (mg/kg)
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(2) |
Annex III is amended as follows:
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(3) |
in Annex IV, the following entry is inserted: ‘Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV) isolate BV-0004’. |
(*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
(*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
(*3) Indicates lower limit of analytical determination
(3) For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I