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Document 32024R2711
Commission Regulation (EU) 2024/2711 of 22 October 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for thiacloprid in or on certain products
Commission Regulation (EU) 2024/2711 of 22 October 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for thiacloprid in or on certain products
Commission Regulation (EU) 2024/2711 of 22 October 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for thiacloprid in or on certain products
C/2024/7269
OJ L, 2024/2711, 23.10.2024, ELI: http://data.europa.eu/eli/reg/2024/2711/oj (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
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Official Journal |
EN L series |
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2024/2711 |
23.10.2024 |
COMMISSION REGULATION (EU) 2024/2711
of 22 October 2024
amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for thiacloprid 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), Article 18(1), and Article 49(2) thereof,
Whereas:
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(1) |
For the active substance thiacloprid, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. The European Food Safety Authority (the ‘Authority’) reviewed these MRLs in accordance with Article 12 of Regulation (EC) No 396/2005 and recommended MRLs which it found to be safe for consumers (2). Commission Regulation (EU) 2015/1200 (3) included these MRLs in Annex II to Regulation (EC) No 396/2005. |
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(2) |
In 2020, the approval of this active substance was not renewed (4) on the basis of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5), in view of the critical concerns identified by the Authority in the conclusions of the peer review in relation to the contamination of groundwater with potential carcinogenic metabolites of thiacloprid (6) and its classification, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7), as toxic for reproduction category 1B. Since the substance did not fulfil the approval criteria, the Authority did not consider it necessary to finalise the assessment of the possible endocrine disrupting properties of thiacloprid on the basis of the most recent criteria in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 (8). The Authority noted, however, that thiacloprid was considered to meet the criteria for endocrine disrupting properties set out in 2013 (9) and the WHO definition for endocrine disruptors (10), since it causes adverse effects on the reproductive and endocrine system through an endocrine mode of action. |
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(3) |
All existing authorisations for plant protection products containing thiacloprid have been revoked. It is therefore appropriate to delete the existing MRLs set out for this active substance in Annex II of Regulation (EC) No 396/2005 in accordance with Article 17 of that Regulation in conjunction with Article 14(1), point (a) thereof. In view of the new toxicological reference values, in particular a lower acute reference dose, as proposed in the conclusion of the peer review, the Commission requested the Authority to provide a statement under Article 43 of Regulation (EC) No 396/2005 containing a short-term (acute) dietary risk assessment for the MRLs that are based on non-EU uses, being those that are based on import tolerance requests and those that are based on Codex maximum residue limits (‘CXLs’) set in 2007. |
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(4) |
In its statement (11), the Authority identified a risk for consumers concerning the CXLs for peaches and sweet peppers/bell peppers. It is therefore appropriate to lower the MRLs for those products to the product-specific limits of determination (‘LODs’). For the MRLs for papayas and tea, which were derived from import tolerances, and for the MRLs for quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), plums, strawberries, ‘cane fruits’, ‘other small fruits and berries’, kiwis, potatoes, tomatoes, aubergines/eggplants, ‘cucurbits with edible peel’, melons, watermelons, rapeseeds/canola seeds, mustards seeds, rice, wheat, ‘animal (swine, bovine, sheep, horse, and other farm animals) products from tissues (muscle, liver, kidney and edible offal)’, poultry (muscle, liver and edible offal), milk and eggs, which are based on CXLs, the Authority did not identify an acute risk for the consumers but concluded that further consideration by risk managers was required. |
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(5) |
The risk assessment carried out by the Authority was based on existing toxicological reference values. These toxicological reference values do not necessarily reflect endocrine-related effects because they were not assessed according to the new EU criteria established in 2018 (8). Furthermore, endocrine-related effects frequently occur at low-dose levels and endocrine disruptor substances often do not have a safe threshold (12). As a result, there remain reasonable grounds for concern that the MRLs that are based on non-EU uses have potentially harmful effects on human health and are inconsistent with the high level of consumer protection in the Union. The Commission has therefore requested the Authority to carry out an additional assessment for thiacloprid taking into account the most recent criteria for endocrine disruptors. |
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(6) |
Pending the conclusion of this additional risk assessment by the Authority, and given the available pertinent information with regard to potentially harmful effects on human health, it is appropriate to provisionally lower the MRLs that are based on non-EU uses. These MRLs will be reviewed once the assessment by the Authority is concluded. |
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(7) |
The Commission consulted the European Union reference laboratories for residues of thiacloprid as regards the need to adapt certain LODs. Those laboratories proposed product specific LODs that are analytically achievable for all products. |
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(8) |
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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(9) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(10) |
To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been placed on the market in the Union before the new MRLs become applicable, except for pears, peaches, raspberries (red and yellow), sweet peppers/bell peppers, Chinese cabbages/pe-tsai and lettuces for which an acute risk to consumers was identified. This transitional measure is justified and proportionate given the limited range of products for which such a period would effectively apply (mainly long shelf life products and not fresh perishable products) and the low exposure of consumers from such products, as evidenced by recent monitoring data representative for the market collected by the Authority (13). |
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(11) |
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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(12) |
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 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 placed on the market in the Union before 12 May 2025, except for pears, peaches, raspberries (red and yellow), sweet peppers/bell peppers, Chinese cabbages/pe-tsai and lettuces.
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 12 May 2025.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 October 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/2005/396/2024-02-26.
(2) EFSA (European Food Safety Authority), 2014. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for thiacloprid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(3):3617, https://doi:10.2903/j.efsa.2014.3617.
(3) Commission Regulation (EU) 2015/1200 of 22 July 2015 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 amidosulfuron, fenhexamid, kresoxim-methyl, thiacloprid and trifloxystrobin in or on certain products (OJ L 195, 23.7.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/1200/oj).
(4) Commission Implementing Regulation (EU) 2020/23 of 13 January 2020 concerning the non-renewal of the approval of the active substance thiacloprid, 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 and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 8, 14.1.2020, p. 8, ELI: http://data.europa.eu/eli/reg_impl/2020/23/oj).
(5) 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, ELI: http://data.europa.eu/eli/reg/2009/1107/2022-11-21.
(6) EFSA (European Food Safety Authority), 2019. Conclusion on pesticides peer review. Peer review of the pesticide risk assessment of the active substance thiacloprid. EFSA Journal 2019;17(3): e05595, https://doi.org/10.2903/j.efsa.2019.5595.
(7) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/2023-12-01).
(8) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33, ELI: http://data.europa.eu/eli/reg/2018/605/2018-04-20).
(9) EFSA (European Food Safety Authority) Scientific Committee, 2013. Scientific Opinion on the hazard assessment of endocrine disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA Journal 2013;11(3):3132.84, https://doi: 10.2903/j.efsa.2013.3132.
(10) WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2002. Global Assessment of the State-of-the-science of Endocrine Disruptors. WHO/PCS/EDC/02.2, https://iris.who.int/bitstream/handle/10665/67357/WHO_PCS_EDC_02.2.pdf?sequence=1.
(11) EFSA (European Food Safety Authority) 2023; Statement on the short-term (acute) dietary risk assessment and evaluation of confirmatory data for certain maximum residue levels (MRLs) for thiacloprid. EFSA Journal 2023;21(3):7888, https://doi.org/10.2903/j.efsa.2023.7888.
(12) EFSA (European Food Safety Authority) 2010; Scientific report of the Endocrine Active Substances Task Force. EFSA Journal 2010;8(11):1932, https://doi.org/10.2903/j.efsa.2010.1932.
(13) EFSA (European Food Safety Authority) 2024; The 2022 European Union report on pesticide residues in food. EFSA Journal 2024;22:e8753, https://doi.org/10.2903/j.efsa.2024.8753.
ANNEX
Annexes II and V to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
in Annex II the column for thiacloprid is deleted. |
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(2) |
in Annex V the following column for thiacloprid is added: ‘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
ELI: http://data.europa.eu/eli/reg/2024/2711/oj
ISSN 1977-0677 (electronic edition)