Notifications for European Union (1104 notifications)

To establish an MRL for sodium salicylate in poultry, except turkeys.

Commission Implementing Regulation (EU) 2023/1709 authorises Lentilactobacillus diolivorans DSM 33625 as a feed additive belonging to the additive category ‘technological additives’ and in the functional group ‘silage additives, for all animal species.

Commission Implementing Regulation (EU) 2023/1455 concerns the urgent and provisional authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate and cobalt(II) sulphate, heptahydrate, as feed additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, for ruminants with a functional rumen, equidae and lagomorphs.

On 5 July 2023, the European Commission adopted a legislative proposal for a Regulation on plants produced by certain new genomic techniques (NGTs) and their food and feed. The proposal is part of a package of proposals to ensure resilient and sustainable use of the EU’s natural resources.The proposal sets out specific rules for the deliberate release into the environment for any other purpose than placing on the market of plants obtained by targeted mutagenesis and cisgenesis (including intragenesis) and for the placing on the market of food and feed containing, consisting of, or produced from such plants, and of products, other than food or feed, containing or consisting of such plants (‘NGT plants and products’). It is supported by an impact assessment and takes account of the scientific work from the European Food Safety Authority, the Commission’s Joint Research Centre and other scientific bodies (for further information see impact assessment, section 1.1. and Annex 6).The objectives of the proposal are to:Maintain a high level of protection of human and animal health and of the environment;Enable the development and placing on the market of plants and plant products contributing to the innovation and sustainability objectives of the European Green Deal and of the Farm to Fork and Biodiversity strategies;Ensure the effective functioning of the internal market and enhance the competitiveness of the Union agri-food sector at the Union and global levels.The main measures of the proposal include:The proposal (in Chapter I) makes the deliberate release and placing on the market of NGT plants and products subject to one of two procedures: verification procedure to establish equivalence with conventional plants/products or authorisation in accordance with EU legislation on GMOs;Chapter II of the proposal provides for a verification procedure and criteria to verify whether NGT plants/products obtained by targeted mutagenesis or cisgenesis could also have been obtained naturally or by conventional breeding techniques, based on the criteria laid down in Annex I (‘category 1 NGT plants’). Category 1 NGT plants/products are exempted from the requirements of the GMO legislation, and subject to the rules on conventionally bred plants. Transparency is ensured in a public database, through labelling of the seeds and through the relevant registers on plant varieties;Chapter III of the proposal applies to NGT plants/products which do not meet the criteria to consider that they could also be obtained naturally or by conventional breeding (‘category 2 NGT plants’). They remain subject to the rules on GMOs with adaptations as regards risk assessment, detection method, monitoring and renewal requirements. They are made subject to traceability and labelling requirements of the GMO legislation, with the possibility of a voluntary label to indicate the purpose of the genetic modification. The proposal includes regulatory incentives for Category 2 NGT plants/products featuring traits that could contribute to the overall performance of varieties as regards sustainability (Annex III to the proposal);The proposal provides that NGT plants/products are prohibited in organic production;The proposal includes provisions for the monitoring of economic, environmental and social impacts of NGT plants and products, supporting implementation reports and the future evaluation of the legislation.This Proposal for a Regulation will also be notified under the TBT Agreement

The substances covered by the Act were authorised as feed additives in the functional group of flavouring compounds. An application was submitted for the reauthorisation 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 reauthorised as feed additives for all animal species, under certain conditions. A transitional period is included for the interested parties to meet the new authorisation’s requirements.

The preparation specified in this Act was initially authorised for a period of 10 years as a feed additive for all animal species. An  application was submitted for the renewal of this authorisation. Further to the favorable assessment by the European Food Safety Authority, the authorisation of this preparation is renewed, subject to certain conditions.

The substance specified in this Act was initially authorised for a period of 10 years as feed additives for ruminants with a functional rumen. An application was submitted for the renewal of this authorisation. Further to the favorable assessment by the European Food Safety Authority, the authorisation of this substance is renewed, subject to certain conditions.

Commission Implementing Regulation (EU) 2023/1705 authorises riboflavin (vitamin B2) produced by Bacillus subtilis CGMCC 13326 as a feed additive belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, for all animal species.

The proposed draft Regulation concerns the review of existing MRLs for dithianon in certain food commodities. MRLs for these substances in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union.

The substance covered by the Act was authorised as a feed additive in the functional group of colourants. An application was submitted for the reauthorisation 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 a feed additive for cats, dogs, ornamental fish, grain-eating ornamental birds and small rodents, under certain conditions. A transitional period is included for the interested parties to meet the new authorisation’s requirements.

The proposal notified in G/SPS/N/EU/617 (24 February 2023) is now adopted by Commission Regulation (EU) 2023/1783 of 15 September 2023 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 denatonium benzoate, diuron, etoxazole, methomyl and teflubenzuron in or on certain products (Text with EEA relevance) [OJ L 229, 18 September 2023, p. 63].The Regulation shall apply from 8 April 2024.

The proposal notified in G/SPS/N/EU/616 (23 February 2023) is now adopted by Commission Regulation (EU) 2023/2382 of 29 September 2023 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 carbetamide, carboxin and triflumuron in or on certain products (Text with EEA relevance).The Regulation shall apply from 25 April 2024.

The proposal notified in G/SPS/N/EU/618 (24 February 2023) is now adopted by Commission Regulation (EU) 2023/1753 of 11 September 2023 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 pyriproxyfen in or on certain products (Text with EEA relevance) [OJ L 224, 12 September 2023, p. 1].The Regulation shall apply from 2 April 2024.

The proposal notified in G/SPS/N/EU/666 (21 July 2023) is now adopted by Commission Regulation (EU) 2023/2108 of 6 October 2023 amending Annex II to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No. 231/2012 as regards food additives nitrites (E 249-250) and nitrates (E 251-252) (text with EEA relevance).The Regulation shall enter into force on 26 October 2023.

The purpose of this Delegated Regulation is to supplement Regulation (EU) 2019/4 (Medicated Feed Regulation) by establishing, as regards the 24 antimicrobial active substances, specific maximum levels of cross-contamination for these substances in non-target feed and methods of analysis for these antimicrobial active substances in feed.The maximum levels of cross-contamination are based on scientific risk assessments carried out by the European Food Safety Authority. The European Union Reference Laboratory for feed additives recommended methods of analysis for the above-mentioned 24 antimicrobial active substances in feed.A cross-contamination level in non-target feed of 1% of the active substance in the medicated feed is proposed, based on experiences gained and representing a good balance between:·       the control of antimicrobial resistance and the levels causing effects on growth promotion or increased yield, based on the scientific opinions of the Authority;·       feasibility for the feed industry;·       enforceability by competent authorities.Stricter limits are needed e.g. after the production of medicated feed for fish and to avoid residues in certain food. Furthermore, limits should apply in non-target feed in case of flushing with feed materials after production of medicated feed.

The proposal notified in G/SPS/N/EU/645 (22 June 2023) is now adopted by Commission Regulation (EU) 2023/2379 of 29 September 2023 amending Annex II to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No. 231/2012 as regards the food additive stearyl tartrate (E 483) (Text with EEA relevance).The Regulation shall apply from 23 April 2024.

This Regulation is a measure transposing Codex MRLs (CXLs), for which the EU has not reserved its position in the 53rd Codex Committee for Pesticides Residues (CCPR), into EU legislation

In accordance with Article 10(2) of Regulation (EC) No. 1831/2003 an application was submitted for the authorisation of a preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) as a feed additive for salmon and trout. Following an inconclusive EFSA opinion the Commission gave the applicant the opportunity to submit supplementary information but in the absence of any reply, the authorisation has to be denied as the additive does not satisfy the conditions for such authorisation.

The text limits the conditions of use of 2-Phenyl-2-butenal (FL No. 05.062), 5-Methyl-2-phenyl-2-hexenal (FL No. 05.099) and 4-Methyl-2-phenyl-2-pentenal (FL No. 05.100) to their current use, following an evaluation by the European Food Safety Authority that could not rule out an in vivo potential aneugenicity for these substances and pending the re-evaluation by the Authority of theadditional data from the interested business operators

The text removes from the Union List of flavourings as laid down in Annex I to Regulation (EC) No. 1334/2008 a number of flavouring substances for which when the European Food Safety Authority had requested additional scientific data in order to complete their assessment the operators responsible for placing the following eight substances on the market as flavouring substances did not submit the required data and withdrew their respective applications. The substances concerned are: 2-Phenylpent-2-enal (FL No. 05.175); 2-Phenyl-4-methyl-2-hexenal (FL No. 05.222); 2-(sec-Butyl)-4,5-dimethyl-3-thiazoline (FL No. 15.029); 4,5-Dimethyl-2-ethyl-3-thiazoline (FL No. 15.030); 2,4-Dimethyl-3-thiazoline  (FL No. 15.060); 2-Isobutyl-3-thiazoline (FL No. 15.119); 5-Ethyl-4-methyl-2-(2-methylpropyl)-thiazoline (FL No. 15.130); 5-Ethyl-4-methyl-2-(2- butyl)-thiazoline (FL No. 15.131)