Notifications for European Union (1104 notifications)

The measure concerns an amendment of the conditions of use concerning astaxanthin esters to the level up to 0.25 % for all population groups in food supplements. The increase in the astaxanthin esters in oil from Calanus finmarchicus is expected to result in intakes of astaxanthin which, in combination with the intake of astaxanthin from the normal diet, are not expected to exceed, in any population group, the acceptable daily intake of 0.2 mg of astaxanthin/kg body weight established by the European Food Safety Authority. There is also a need to amend the labelling requirements of the novel food Calanus finmarchicus oil in line with the proposed conditions of use, as the statement laid down in Commission Implementing Regulation (EU) 2022/966 that food supplements containing Calanus finmarchicus oil should not be consumed by children younger than 14 years if the ingredient contains ≥ 0.1 % astaxanthin does no longer apply.

The additive covered by this Act is currently authorised for a period of ten years as a feed additive for all animal species in the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’. An application was submitted for the modification the authorisation of this additive in accordance with article 13 of Regulation (EC) No 1831/2003. The modification consists of the addition of a new production strain, Corynebacterium glutamicum NRRL B-68248. Based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA), the authorisation of this additive is amended under certain conditions detailed in the Annex to the Act. In addition, the additive covered by this Act was erroneously referred to in Commission Implementing Regulation (EU) 2020/997 as an active substance, while it is actually a preparation. Implementing Regulation (EU) 2020/997 is therefore corrected accordingly by this Act.A transitional period is included for the interested parties to meet the requirements resulting from those amendment and correction.

The substance covered by the Act was authorised as a feed additive for all animal species. An application was submitted for the reauthorisation of this substance in accordance with article 10 of Regulation (EC) No 1831/2003. Based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA), this substance is reauthorised as a feed additive for all animal species in the additive category ‘sensory additives’ and in the functional groups ‘flavouring compounds’, under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation requirements.

The substances covered by the Act were authorised as  feed additives for all animal species. An application was submitted for the reauthorisation of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. Based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA), these substances are reauthorised as feed additives for all animal species in the additive category ‘sensory additives’ and in the functional groups ‘flavouring compounds’, under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation requirements.

Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country). This Implementing Regulation amends Annexes I and II to Implementing Regulation (EU) 2019/1793 by introducing the following changes:Inclusion in Annex I of mango (Mangifera indica) from Egypt, bottle gourd (Lagenaria siceraria) from India and tomatoes (Solanum lycopersicum L.) from Türkiye, due to risk of contamination by pesticide residues (frequency set at 20%);Decrease in the frequency of identity and physical checks laid down in Annex I for grapefruits from Türkiye (both commodities for pesticide residues from: 20% to 10%);Increase in the frequency of identity and physical checks laid down in Annex I for the following commodities:Granadilla and passion fruit from Colombia (pesticide residues: from 10% to 20%);Vine leaves from Egypt (pesticide residues: from 20% to 50%);Yardlong beans from Sri Lanka (pesticide residues: from 20% to 30%);Tahini and halva from sesamum seeds from Syria (Salmonella: from 20% to 30%);Removal from Annex I and inclusion in Annex II of drumsticks (pesticide residues 30%) and yardlong beans (pesticide residues 50%) from India; Removal from Annex II and inclusion in Annex I peppers of genus Piper, dried or crushed or ground fruit of the genus Capsicum or genus Pimenta and ginger, saffron, turmeric (curcuma), thyme, bay leaves curry and other spices from Ethiopia (aflatoxins: 30%);Increase in the frequency of identity and physical checks laid down in Annex II for the following commodities:dried figs and products derived from figs from Türkiye (aflatoxins: from 20% to 30%). In addition to extend and include additional hazard for that commodity – Ochratoxin A with the frequency set at 30%;cumin seeds from Türkiye (pyrrolizidine alkaloids: from 30% to 50%).In addition, several Articles updated in relation to references to the EU Regulations. Model of official certificate provided in Annex IV to Regulation (EU) 2019/1793 updated accordingly.

The substances covered by the Act were authorised as  feed additives for all animal species. An application was submitted for the reauthorisation of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. Based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA), these substances are reauthorised as feed additives for all animal species in the additive category ‘sensory additives’ and in the functional groups ‘flavouring compounds’, under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation requirements.

The substance and the preparations covered by the Act were authorised for a period of ten years as feed additives for all animal species in the additive 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 the authorisation of this substance and the preparations in accordance with article 14 of Regulation (EC) No 1831/2003. Based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA), the authorisation of this substance and the preparations as feed additives for all animal species is renewed under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation requirements.

The substance covered by the Act was authorised as a feed additive for all animal species. An application was submitted for the reauthorisation of this substance in accordance with article 10 of Regulation (EC) No 1831/2003. Based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA), this substance is reauthorised as a feed additive for all animal species in the additive category ‘sensory additives’ and in the functional groups ‘flavouring compounds’, under certain conditions detailed in the Annex to the Act. A transitional period is included for the interested parties to meet the new authorisation requirements.

The draft act concerns the withdrawal from the EU market of a series of feed additives, due to the lack of application for re-authorisation 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‑authorisation. 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.

The preparation covered by the Act was initially authorised by Commission Implementing Regulation (EU) No 1076/2014 for a 10-year period as a feed additive for cats and dogs, in the category of sensory additives and the functional group of flavouring compounds. An application was submitted for the renewal of the authorisation of this preparationin accordance with article 14 of Regulation (EC) No 1831/2003. The European Food Safety Authority (EFSA) conducted a scientific assessment of the dossier submitted by the applicant, showing that the preparation does not satisfy the conditions for the renewal of the authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Consequently, the proposed Act denies the renewal of the authorisation and includes transitional periods for the interested parties to adjust to the denial of this preparation.

This Regulation authorises for the first time in the European Union and for a period of ten years a preparation of riboflavin produced from Eremothecium ashbyi CCTCCM 2019833, in the form of a dried inactivated fermentation product as a feed additive belonging to the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ for all animal species. This authorisation is based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA). The terms of the authorisation are detailed in the Annex to the Act.

The proposal notified in G/SPS/N/EU/815 (5 March 2025) is now adopted: Commission Implementing Regulation (EU) 2025/1316 of 2 July 2025 on temporary measures to prevent the introduction into, establishment and spread within the Union territory of Curtobacterium flaccumfaciens pv. flaccumfaciens (Hedges) Collins and Jones, and amending Implementing Regulation (EU) 2019/2072.

This corrigendum corrects a typo in Annex II of draft Commission Regulation 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 dimoxystrobin, ethephon and propamocarb in or on certain products (Text with EEA relevance) notified on 5 December 2024. In the Annex II, the MRLs for tree nuts, except hazelnuts and walnuts, should read 0.02*.

The proposal notified in G/SPS/N/EU/808 (4 February 2025) is now adopted by Commission Implementing Regulation (EU) 2025/1105 of 3 June 2025 amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen 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 its publication in the Official Journal of the European Union.

Patent Blue V was authorised for a period of ten years as feed additive for non‐food producing animals, in the additive category ‘sensory additives’ and the functional group ‘colorants, substances that add or restore colour in feedingstuffs’. An application was submitted for the renewal of the authorisation of this substance in accordance with article 14 of Regulation (EC) No 1831/2003. Following an inconclusive EFSA opinion, the applicant chose not to submit supplementary information to address the issues raised in that opinion. Consequently, considering that the additive does not satisfy the necessary conditions, the renewal of its authorisation is denied. A transitional period is included to allow for the withdrawal of the additive from the market.

The substances covered by the Act were initially authorised as feed additives for cats and dogs, in the category of sensory additives and the functional group of flavouring compounds. Applications were later submitted for the reauthorisation of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. However, the applicant has withdrawn those applications in the course of the risk assessment evaluation of their safety and efficacy. Consequently, the authorisation of these substances as feed additives must be withdrawn. The proposed Act includes transitional periods for the interested parties to adjust to the withdrawal of these substances.

The draft act concerns the authorisation as “flavouring compound” of celery seed essential oil from Apium graveolens L. and caraway essential oil from Carum carvi L. within the scope of the EU legislation on feed additives, i.e. Regulation (EC) No. 1831/2003. The measure aims at authorising these additives for turkeys for fattening, chickens for fattening and minor poultry for fattening, all poultry reared for laying or breeding, ornamental birds, all poultry for laying or breeding, pigs for fattening, pigs for fattening of minor Suidae, piglets (suckling and weaned) of all Suidae, all Suidae for reproduction, calves for fattening, sheep and goats, cattle for fattening, other ruminants for fattening and all other ruminants, Camelidae for fattening and all other CamelidaeEquidaeLeporidae, salmonids, minor finfish, dogs and to withdraw the placing on the market of these additives for the rest of the animals.It is proposed to provide transitional periods for the different types of feeds: 12 months for existing stocks of the additives celery seed essential oil from Apium graveolens L. and caraway essential oil from Carum carvi L., 15 months for stocks of premixtures produced with the above mentioned additives and 24 months for compound feed and feed materials produced with the feed additives and premixtures mentioned before.

The draft act concerns the authorisation as “flavouring compound” of a tincture from the plant Eucalyptus globulus Labill. within the scope of the EU legislation on feed additives, i.e. Regulation (EC) No. 1831/2003. The measure aims at authorising this additive for turkeys for fattening, chickens for fattening and minor poultry for fattening, pigs for fattening, pigs for fattening of minor Suidae, calves for fattening, sheep and goats for fattening, cattle for fattening and other ruminants for fattening, Camelidae for fattening, rabbits for fattening, salmonids (except brood stock) and minor finfish (except brood stock), and to withdraw the placing on the market of the additive for the rest of the animals.It is proposed to provide transitional periods for the different types of feeds: 12 months for existing stocks of the additive eucalyptus tincture from Eucalyptus globulus Labill., 15 months for stocks of premixtures produced with the above mentioned additive and 24 months for compound feed and feed materials produced with the feed additive and premixtures mentioned before.

This Regulation authorizes for the first time in the European Union and for a period of ten years L-valine produced with Escherichia coli CGMCC 22721 as a feed additive belonging to the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’, for all animal species. This authorization is based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA). The terms of the authorization are detailed in the Annex to the Act.

This Regulation authorizes for the first time in the European Union and for a period of ten years a preparation of Lentilactobacillus buchneri DSM 32651 as a feed additive belonging to the additive category ‘technological additives’ and in the functional group ‘silage additives’, for all animal species. This authorization is based on the favourable conclusions of a scientific assessment of the dossier submitted by the applicant, conducted by the European Food Safety Authority (EFSA). The terms of the authorization are detailed in the Annex to the Act.