Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/695 (16 November 2023) is now adopted by Commission Implementing Regulation (EU) 2024/859 of 18 March 2024 amending Regulation (EU) No 37/2010 as regards the classification of the substance sodium salicylate with respect to its maximum residue limit in foodstuffs of animal origin (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/682 (28 September 2023) is now adopted by Commission Implementing Regulation (EU) 2024/752 of 29 February 2024 concerning the denial of authorisation of a preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) as a feed additive for salmon and trout (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/679 (13 September 2023) is now adopted by Commission Implementing Regulation (EU) 2024/824 of 8 March 2024 concerning the authorisation of gentian tincture from Gentiana lutea L. 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 measure concerns an amendment of the conditions of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae', which was underpinned by a scientific opinion by EFSA. This measure was subsequently corrected by another legal act, which addresses an error identified with regard to the transitional measures established for the novel food complying with the previous labelling requirements.

The measure concerns the authorization of dried nuts of Canarium ovatum Engl. as a traditional food from a third country.

The draft Regulation establishes maximum levels for nickel in tree nuts, vegetables, seaweed, pulses, oilseeds, cereals, cocoa and chocolate products, food for infants and young children, fruit and vegetable juices. Taking into account the outcome of the EFSA risk assessment of nickel in food and drinking water (available at: https://doi.org/10.2903/j.efsa.2020.6268), the maximum levels for nickel are established to ensure a high level of human health protection.

The measure concerns an amendment of the Union list of novel foods in order to correct some errors identified in the Union list of novel foods (Implementing Regulation (EU) 2017/2470)

This draft Commission Implementing Regulation provides that the approval of the active substance acibenzolar-S-methyl is withdrawn in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorizations for plant protection products containing acibenzolar-S-methyl as an active substance. This decision only concerns the placing on the market of this substance and plant protection products containing it. Following withdrawal and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/997.

The text revises the conditions of use of the authorized food additives tartaric acid (L(+)-) (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354). These food additives are currently authorized for use at quantum satis and included in Group I, in Annex II, Part C of Regulation (EC) No 1333/2008, which covers food additives, other than colours and sweeteners, with an ‘acceptable daily intake not specified’ or for which the most recent risk assessment concluded that ‘there is no need for a numerical acceptable daily intake’. In addition, tartaric acid (L(+)-) (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354) are authorized for use in specific food categories with a numerical maximum level or at quantum satisThe European Food Safety Authority (EFSA) re-evaluated these food additives in 2020 and established a group acceptable daily intake (ADI) of 240 mg/kg bw per day, expressed as tartaric acid, for tartaric acid-tartrates (E 334 - 337 and E 354). Following the EFSA re-evaluation, it is appropriate to remove those food additives from Group I, create a new group for them, review their conditions of use and establish numerical maximum use levels.In order to allow for a smooth transition, the text lays down a transitional period for food business operators to adapt to the new more stringent conditions of use.

This draft Commission Implementing Regulation provides that the approval of the active substance metconazole is renewed in accordance with Regulation (EC) No 1107/2009. It is, however, necessary to include certain conditions and restrictions including in particular a restriction to use only by professional users. Existing authorized plant protection products containing metconazole will be reviewed in accordance with the conditions and restrictions set in this act. The outcome of the assessment is based on the first evaluation of the substance for use as a pesticide active substance in the European Union under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/EEC. This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned active substance. Any action on MRLs will be subject to notification under the SPS procedure. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/1049.

Commission Implementing Regulation (EU) 2023/2646 authorizes Lentilactobacillus buchneri DSM 32650 as a feed additive belonging to the additive category ‘technological additives’ and in the functional group ‘silage additives’, subject to certain conditions.

The draft act concerns the withdrawal from the EU market of a series of feed additives, due to the lack of application for re-authorization of those products submitted before the deadline laid down in Article 10(2) of Regulation (EC) No 1831/2003 – or the withdrawal by the applicant of a submitted application for re-authorization. This measure is required by the regime set out in Article 10 of Regulation (EC) No 1831/2003 with regard to the status of ‘existing products’, i.e. additives which were allowed under the previous Directive 70/524/EEC. Transitional periods are laid down for the interested parties to prepare themselves to meet the requirement concerning the withdrawal from the market of the products concerned.

Commission Implementing Regulation (EU) 2023/2644 authorizes lactic acid produced by Weizmannia coagulans DSM 32789 as a feed additive belonging to the additive category ‘technological additives’ and in the functional group ‘preservatives’, subject to certain conditions.

Commission Implementing Regulation (EU) 2023/2632 authorizes disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80235 as a feed additive belonging to the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’, subject to certain conditions.

The substances covered by the Act were authorized as feed additives in the functional group of flavouring compounds. Applications were submitted for the reauthorization of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. Further to the positive assessment by the European Food Safety Authority, these substances are reauthorized as feed additives for certain animal species, under certain conditions. A transitional period is included for the interested parties to meet the new authorisation’s requirements.

The preparations specified in this Act were initially authorized for a period of ten years as feed additives for all animal species. Several applications were submitted for the renewal of these authorizations. Further to the favourable assessment by the European Food Safety Authority, the authorization of these preparations is renewed, subject to certain conditions. A transition period is laid down for the interested parties to prepare themselves to meet the new requirements resulting from the authorization.

Commission Implementing Regulation (EU) 2024/265 authorises zinc(II)– betaine complex as a feed additive belonging to the additive category ‘nutritional additives’ and in the functional group ‘compounds of trace elements’, subject to certain conditions.

Commission Implementing Regulation (EU) 2023/2583 authorises L-isoleucine produced by Corynebacterium glutamicum KCCM 80185 as a feed additive belonging to the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’, subject to certain conditions.

The substance covered by the Act was authorized as feed additive in the functional group ‘flavouring compounds’. The application was submitted for the reauthorization of this substance in accordance with article 10 of Regulation (EC) No 1831/2003. Further to the positive assessment by the European Food Safety Authority, this substance is reauthorized as feed additive for all animal species, under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The preparation specified in this Act was initially authorized for a period of ten years as feed additive for all animal species. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of this preparation is renewed, subject to certain conditions.