Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/697 (23 November 2023) is now adopted by Commission Regulation (EU) 2024/1342 of 21 May 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for deltamethrin, metalaxyl, thiabendazole and trifloxystrobin in or on certain products (Text with EEA relevance).The Regulation shall apply from 11 June 2024.

This Implementing Regulation amends and corrects Annex III to Implementing Regulation (EU) 2020/2235, as amended by Commission Implementing Regulation (EU) 2023/2744 (notified under G/SPS/N/EU/704 of 19 December 2023), i.e. restores, erroneously deleted by Commission Implementing Regulation (EU) 2023/2744, Part II of Chapter 29 (model EU-FISH) and updates references to new Union legislation on residues and public health requirements for the entry into the Union of products of animal origin and goods for human consumption in that Chapter; and corrects Chapter 28 (model FISH-CRUST-HC) by deleting erroneously inserted, by Implementing Regulation (EU) 2023/2744, footnotes (13) and (14) from its point II.2.6.2 (i) and (ii).

The notified document consists of a draft text updating the Listeria monocytogenes food safety criterion laid down in Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs. The objective of the draft text is to ensure an appropriate level of public health protection as regards the placing on the EU market of ready-to-eat foods, other than those intended for infants and for special medical purposes, that are able to support the growth of Listeria monocytogenes and for which the producing food business operator has not been able to demonstrate, to the satisfaction of the competent authority, that the level of Listeria monocytogenes will not exceed the limit of 100 cfu/g throughout their shelf-life.

The proposed draft Regulation concerns the review and update of existing MRLs for isopyrazam in certain food commodities. MRLs for these substances in certain commodities are lowered. MRLs for these substances in certain commodities are changed. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union as the approval of the use of the active substance withdrawn by Commission Implementing Regulation (EU) 2022/782[1][1]  Commission Implementing Regulation (EU) 2022/782 of 18 May 2022 withdrawing the approval of the active substance isopyrazam 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, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012            (OJ L 140, 19 May 2022, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2022/782/oj

The proposed draft Regulation concerns the review of existing MRLs for thiacloprid in certain food commodities following the non-approval of thiacloprid in the European Union. The proposed Draft Regulation proposes to provisionally lower to the limit of determination all the MRLs for thiacloprid, ensuring a precautionary approach towards consumer protection based on the indications that the substance may be an endocrine disruptor, while seeking to obtain additional information.

The text removes smoke flavouring primary products from the Union list of authorized smoke flavouring primary products. The European Food Safety Authority (EFSA), on 28 September 2023, adopted its scientific opinions on the safety of the smoke flavouring primary products SF-001, SF-002, SF-003, SF-004, SF-005, SF-006, SF-008 and SF-009. In its scientific opinions, the Authority concluded that a potential safety concern for genotoxicity for all the eight smoke flavouring primary products cannot be ruled out. For the smoke flavouring primary products SF-007 and SF-010 no application for the renewal of the authorization was submitted and the authorization expired on 1 January 2024. The use of smoke flavourings in or on foods should only be authorised if it is sufficiently demonstrated that it does not present risks to human health. Therefore, based on the scientific opinions of the Authority, the renewal of the authorization of smoke flavouring primary products SF-001, SF-002, SF-003, SF-004, SF-005, SF-006, SF-008 and SF-009 is refused.Since none of the ten products listed in the Union list of smoke flavouring primary products are authorized anymore, it is appropriate to remove the relevant references from the Annex of Commission Implementing Regulation (EU) No 1321/2013 and to adopt suitable transitional measures for the foods containing them.In order to allow for a smooth transition, the text lays down that foods containing smoke flavouring primary products SF-001, SF-002, SF-003, SF-004, SF-005, SF-006, SF-008 or SF-009 that comply with the provisions laid down for those smoke flavouring primary products in the Union list before the date of entry into force of the draft Regulation may continue to be placed on the market and remain on the market until their date of minimum durability or use by date if they are placed on the market until (i) 1 July 2029 for food categories 1.7 (cheese and cheese products), 8 (meat), 9.2 (processed fish and fishery products including crustaceans and molluscs), 9.3 (fish roe) and their corresponding sub-categories and (ii) 1 July 2026 for all other food categories.This notification includes, for information, eight Commission Implementing Decisions, addressed to the respective authorization holders, refusing the renewal of the authorizations for the smoke flavouring primary products for which the renewal of the authorization was requested.

The text removes the flavouring substance Benzene-1,2-diol (FL No. 04.029) from the Union list of flavourings and source materials approved for use in and on foods.The European Food Safety Authority (EFSA), on 28 September 2023, adopted opinions on the renewal of the authorizations for Zesti Smoke code 10 (SF‐002), Smoke Concentrate 809045 (SF‐003), SmokEz C‐10 (SF‐005) and SmokEz Enviro‐23 (SF‐006) as smoke flavouring primary products. The Authority concluded that these smoke flavouring primary products contain Benzene-1,2-diol (FL No. 04.029) for which a concern for genotoxicity has been identified in vivo upon oral administration. For this reason, it is appropriate to remove Benzene-1,2-diol (FL No. 04.029) from the Union list of flavourings.In order to allow for a smooth transition, the text lays down that foods, including foods imported into the Union, to which Benzene-1,2-diol (FL No. 04.029) has been added and which were lawfully placed on the market or dispatched from the third country before the entry into force of the draft Regulation may continue to be marketed until their date of minimum durability or use-by date.

Implementing Regulation 2019/2072 contains the list of Union quarantine pests, protected zone quarantine pests and regulated non-quarantine pests (RNQPs). Furthermore, it lays down phytosanitary import and internal movement requirements for plants, plant products and other objects that may pose a phytosanitary risk to the European Union. The draft amendment of Implementing Regulation 2019/2072 stipulates:Addition of new pests in the list of Union quarantine pests (Neoceratitis asiatica (Becker), Neoceratitis cyanescens (Bezzi) and Neotephritis finalis (Loew), Rose Rosette Virus, Phyllocoptes fructiphilus (Germar));Deregulation of Union quarantine pests (Melampsora medusae f. sp. tremuloidisRipersiella hibisci Kawai and Takagi, Tobacco ringspot virus, Tomato ringspot virus, Sweet potato chlorotic stunt virus and Sweet potato mild mottle virus);Changes in scientific names of pests;Addition of new pests in the list of RNQPs (Pucciniastrum minimum (Schweinitz), Tobacco ringspot virus and Tomato ringspot virus);Deregulation of RNQPs (Fig mosaic agent);Deletion of a Protection Zone for Gonipterus scutellatus Gyllenhal;Addition of new import and internal movement requirements;Deletion of existing import movement requirements;Revision of import and internal movement requirements;Addition/Revision in CN codes.

The proposal notified in G/SPS/N/EU/684 (6 October 2023) is now adopted by Commission Delegated Regulation (EU) 2024/1229 of 20 February 2024 supplementing Regulation (EU) 2019/4 of the European Parliament and of the Council by establishing specific maximum levels of cross-contamination of antimicrobial active substances in non-target feed and methods of analysis for these substances in feed (Text with EEA relevance).The Regulation shall apply from 20 May 2025.

The preparations specified in this Act were initially authorized for a period of 10 years as a feed additive for all animal species in the category “technological additives” and in the functional group “silage additives”. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of these preparations is renewed, subject to certain conditions.

The proposal notified in G/SPS/N/EU/716 (6 February 2024) is now adopted by Commission Implementing Regulation (EU) 2024/1201 of 26 April 2024 withdrawing from the market star anise terpenes from Illicium verum Hook.f. as a feed additive (Text with EEA relevance).This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/700 (12 December 2023) is now adopted by Commission Implementing Regulation (EU) 2024/1195 of 24 April 2024 concerning the authorization of cassia essential oil from Cinnamomum aromaticum Nees as a feed additive for certain animal species (Text with EEA relevance).This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/699 (12 December 2023) is now adopted by Commission Implementing Regulation (EU) 2024/1186 of 24 April 2024 concerning the authorisation of cinnamon bark essential oil and cinnamon leaf essential oil from Cinnamomum verum J. Presl as feed additives for certain animal species (Text with EEA relevance).This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The proposed Commission Delegated Regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of 'engineered nanomaterials' (Text with EEA relevance) notified in G/SPS/N/EU/747 (4 April 2024) was withdrawn.

Commission Implementing Regulation (EU) 2024/1199 authorises manganese(II) – betaine complex as a feed additive in the category ‘nutritional additives’ and in the functional group ‘compounds of trace elements’, subject to certain conditions.

Commission Implementing Regulation (EU) 2024/1104 authorises Lactiplantibacillus plantarum DSM 11520 as a feed additive in the category ‘technological additives’ and in the functional group ‘acidity regulators’, subject to certain conditions.

The preparation specified in this Act was initially authorized for a period of ten years as a feed additive for chickens for fattening, turkeys for fattening, other poultry and pigs in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. An application was submitted for the renewal of this authorization and another one for the authorization of a new use of that preparation for ruminants. Further to the favourable assessment by the European Food Safety Authority, the authorization of these preparations is renewed, subject to certain conditions.

Commission Implementing Regulation (EU) 2024/1056 authorizes riboflavin 5’-phosphate monosodium salt (vitamin B2), produced by Bacillus subtilis KCCM 10445 as a feed additive in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, subject to certain conditions.

The proposal notified in G/SPS/N/EU/633 (26 April 2023) is now adopted by Commission Delegated Regulation (EU) 2024/1141 of 14 December 2023 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards specific hygiene requirements for certain meat, fishery products, dairy products and eggs (Text with EEA relevance).The Regulation applies from 9 May 2024, except Point (3)(a)(iv)(1) of the Annex which shall apply from 9 November 2024.

Commission Implementing Regulation (EU) 2024/1068 authorises rosemary extract as a feed additive in the category ‘technological additives’ and in the functional group ‘antioxidants’, subject to certain conditions.