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Document 32022R1406
Commission Regulation (EU) 2022/1406 of 3 August 2022 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 methoxyfenozide, propoxur, spinosad and thiram in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2022/1406 of 3 August 2022 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 methoxyfenozide, propoxur, spinosad and thiram in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2022/1406 of 3 August 2022 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 methoxyfenozide, propoxur, spinosad and thiram in or on certain products (Text with EEA relevance)
C/2022/5481
OJ L 215, 18.8.2022, p. 1–26
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
- Date of document:
- 03/08/2022; Date of adoption
- Date of effect:
- 07/09/2022; Entry into force Date pub. +20 See Art 3
- Date of effect:
- 28/02/2023; Application See Art 3
- Date of end of validity:
- No end date
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Responsible body:
- Directorate-General for Health and Food Safety, SANTE
- Form:
- Regulation
- Additional information:
- EEA relevance
- Treaty:
- Treaty on the Functioning of the European Union
- Legal basis:
-
- 32005R0396 - A14P1PTA) 32005R0396 - A18P1PTB) 32005R0396 - A49P2
- Link
- Link
- Link
- Select all documents mentioning this document No data available in the table
- Modifies:
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Relation Act Comment Subdivision concerned From To Modifies 32005R0396 Deletion annex II table column 07/09/2022 Modifies 32005R0396 Replacement annex II table column 07/09/2022 Modifies 32005R0396 Deletion annex III part B table column 07/09/2022 Modifies 32005R0396 Addition annex V table column 07/09/2022
No data available in the table
- Modified by:
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Relation Act Comment Subdivision concerned From To Corrected by 32022R1406R(01) (DE) - Instruments cited:
- Link
- EUROVOC descriptor:
- Subject matter:
- Directory code:
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18.8.2022 |
EN |
Official Journal of the European Union |
L 215/1 |
COMMISSION REGULATION (EU) 2022/1406
of 3 August 2022
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 methoxyfenozide, propoxur, spinosad and thiram 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)(a), Article 18(1)(b) and Article 49(2) thereof,
Whereas:
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(1) |
For methoxyfenozide and spinosad, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For propoxur and thiram, MRLs were set, in Annex II and Part B of Annex III to Regulation (EC) No 396/2005, depending on the product. |
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(2) |
For methoxyfenozide, in the context of the procedure for the renewal of the approval of that active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (2), the European Food Safety Authority (‘the Authority’) published a conclusion on the peer review of the risk assessment of that active substance (3), confirming the existing acceptable daily intake (ADI) and establishing a lower acute reference dose (ARfD). |
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(3) |
In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion, assessing the risks that the current MRLs for methoxyfenozide may pose to consumers, in light of the above-mentioned lower ARfD. |
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(4) |
In its reasoned opinion (4), the Authority identified unacceptable risks concerning the current MRLs for oranges, grapefruits, mandarins, pears, peaches, apples, tomatoes and broccoli. Member States were consulted and requested to report potential fall-back Good Agricultural Practices (GAPs) that would not lead to an unacceptable risk for consumers. Member States identified such a fall-back GAP only for tomatoes. The Authority then performed an exposure calculation considering the residue data of the fall-back GAP for tomatoes and the peeling factor for citrus fruits established during the peer review of the substance. Notwithstanding that, for citrus fruits (oranges, grapefruits, mandarins), the Authority nevertheless explained that the existing MRLs are safe when using the peeling factor established during the peer review. For all other concerned products, the MRLs should be set at the relevant limit of determination (LOD). |
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(5) |
For propoxur, the Commission requested the Authority, in accordance with Article 43 of Regulation (EC) No 396/2005, to assess toxicological properties, derive toxicological reference values and evaluate the existing MRLs, as the substance was never assessed in the EU and findings were recently reported. In its reasoned opinion (5), the Authority could not derive EU toxicological reference values for propoxur and, therefore, could not conclude on the safety of the MRLs for consumers. The Authority concluded that further consideration from risk managers was required. From a risk management perspective, in the absence of such data, for all products, a risk for consumers cannot be excluded. As uses for this substance are no longer authorised in the Union, the MRLs should be set in Annex V to Regulation (EC) No 396/2005 at the LOD. |
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(6) |
For spinosad, the Authority submitted, in the context of the procedure for the renewal of approval of that active substance in accordance with Regulation (EC) No 1107/2009, a conclusion on the peer review of the risk assessment of that active substance (6), establishing, for the first time, an ARfD. |
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(7) |
In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to assess the risks that the current MRLs for spinosad may pose to consumers in the light of that new ARfD. |
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(8) |
The Authority identified in its reasoned opinion (7) consumer risks for sweet peppers/bell peppers, lettuces, escaroles/broad-leaved endives, spinaches, chards/beet leaves and witloofs/Belgian endives. Member States were consulted and requested to report potential fall-back GAPs that would not lead to an unacceptable risk for consumers. Member States identified fall-back GAPs for all concerned products. The Authority therefore recommended lowering the MRLs for those products. For those products MRLs should be set at the level identified by the Authority. |
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(9) |
For thiram, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (8). Thiram is no longer approved in the Union and all authorisations for plant protection products containing this substance have been revoked. In accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof, the MRLs set out for thiram in Annex II and Part B of Annex III to Regulation (EC) No 396/2005 should therefore be deleted. The Authority also assessed the existing import tolerances for thiram but, in the absence of toxicological data for its metabolite M1, the Authority could not finalise the consumer risk assessment and concluded that further consideration by risk managers was required. From a risk management perspective, in the absence of such data and taking into account the reasons for the non-renewal of the approval of thiram, for all products, a risk for consumers cannot be excluded and MRLs should be set in Annex V to Regulation (EC) No 396/2005 at the LOD. |
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(10) |
As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or Codex maximum residue limits (‘CXLs’) exist, MRLs should be set at the specific LOD or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(11) |
The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific LODs. |
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(12) |
Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. |
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(13) |
Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
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(14) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(15) |
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. |
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(16) |
A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. |
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(17) |
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 V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 28 February 2023, except for methoxyfenozide in pears, peaches, apples and broccoli, for propoxur on all commodities and for thiram on all commodities.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 28 February 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 August 2022.
For the Commission
The President
Ursula VON DER LEYEN
(2) 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).
(3) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance methoxyfenozide. EFSA Journal 2017;15(9):4978.
(4) European Food Safety Authority; Focused assessment of certain existing MRLs of concern for methoxyfenozide. EFSA Journal 2020;18(12):6330.
(5) European Food Safety Authority; Reasoned opinion on the toxicological properties and maximum residue levels for propoxur. EFSA Journal 2021;19(1):6374.
(6) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance spinosad. EFSA Journal 2018;16(5):5252.
(7) European Food Safety Authority; Focused assessment of certain existing MRLs of concern for spinosad. EFSA Journal 2021;19(2):6404.
(8) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for thiram according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2021;19(1):6391.
ANNEX
Annexes II, III and V to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
in Annex II, the columns for methoxyfenozide and spinosad are replaced by the following: ‘Pesticide residues and maximum residue levels (mg/kg)
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(2) |
in Annex II, the columns for propoxur and thiram are deleted; |
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(3) |
in Annex III, Part B the columns for propoxur and thiram are deleted; |
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(4) |
in Annex V, the columns for propoxur and thiram are added: ‘Pesticide residues and maximum residue levels (mg/kg)
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(*1) Limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(*2) 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
