Notifications for European Union (1104 notifications)

This draft Commission Regulation aims to prohibit the use of monacolins from red yeast rice in food based on the scientific opinion of EFSA and following a period of Union scrutiny during which food business operators, or any other interested parties, may submit scientific data to demonstrate the safety of plant preparations in question.On 25 June 2018, EFSA adopted a scientific opinion on the safety of monacolins in red yeast rice. In that opinion, it considered that the available information on the adverse effects reported in humans was judged to be sufficient to conclude that monacolins from red yeast rice were of significant safety concern at intake levels as low as 3 mg/day. EFSA was unable to provide advice on a daily intake of monacolins from red yeast rice that does not give rise to concerns for human health. Considering the significant harmful effect on health associated with the use of monacolins at levels as low as 3 mg/day and that no safe daily intake level could be set, the use of the substance in food was restricted and at the same time placed under Union scrutiny by means of Regulation (EU) 2022/860 of 1 June 2022 for a period of four years from the entry into application of that Regulation. On 29 January 2025, EFSA adopted a scientific opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006. In its opinion, EFSA concluded that the data submitted by interested parties during the Union scrutiny period do not allow establishing the safety of monacolins from red yeast rice at intake levels below 3 mg/day or identifying a safe daily intake of monacolins from red yeast rice. Therefore, pursuant to the procedure of Article 8(5) of Regulation (EC) No 1925/2006, monacolins from red yeast rice should be included in Part A of Annex III to Regulation (EC) No 1925/2006, which means that their use in food will be prohibited.

The proposed draft Regulation concerns the review of existing MRLs for difenoconazole in certain food commodities. Some MRLs for this substance are increased and some MRLs in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union. The proposed draft Regulation also addresses import tolerances in various crops.

The content of the draft Regulation previously notified in G/SPS/N/EU/702 (12 December 2023) is partially changed.This new version of the proposed draft Regulation concerns the review of existing maximum residue levels (MRLs) for cypermethrins 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 anymore in the European Union. Additionally, corresponding MRLs are set separately for alpha-cypermethrin. This new version of the draft Regulation intends to set separate MRLs for the sum of cypermethrins and for alpha-cypermethrin, based on the latest EFSA Statement: EFSA Journal. 2025;23:e9386. Statement on MRLs for alpha-cypermethrin and screening of the existing EU MRLs for cypermethrin. https://doi.org/10.2903/j.efsa.2025.9386

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 Annex II to Implementing Regulation (EU) 2019/1793 by including arachidonic acid oil from China due to possible contamination by cereulide toxin (frequency set at 50%).

The proposal notified in G/SPS/N/EU/891 (31 October 2025) is now adopted by Commission Implementing Regulation (EU) 2026/318 of 12 February 2026 amending Annex III to Implementing Regulation (EU) 2020/2235 and Annex II to Implementing Regulation (EU) 2021/403 as regards model certificates for entry into the Union of consignments of certain products of domestic solipeds origin intended for human consumption and certain categories of equine animals (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.

Lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta were authorised for 10 years as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying by Commission Implementing Regulation (EU) 2020/1097. In addition, a preparation of lutein-rich extract of Tagetes erecta L. was authorised for 10 years as a feed additive for turkeys for fattening by Commission Implementing Regulation (EU) 2025/1928. Some amendments and corrections to the two Implementing Regulations are considered necessary to align their provisions based on the substantial similarities in the manufacturing process and composition of the authorised additives: mention of the presence of hexane as solvent and limit thereof in the additives, more accurate description of the additives authorised as preparations, removal of the reference to xanthophylls and update of the method of analysis of lutein in Implementing Regulation (EU) 2020/1097; and alignment of the identification number of the additive lutein-rich extract of Tagetes erecta in Implementing Regulation (EU) 2025/1928.

Commission Delegated Regulation (EU) 2020/692 supplements Regulation (EU) 2016/429 of the European Parliament and the Council as regards the animal health rules for entry into the Union and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin. Delegated Regulation (EU) 2020/692 applies from 21 April 2021. Since that date, that Delegated Regulation has been amended several times. Following these past amendments, some further minor errors have been detected in that Delegated Regulation. These mistakes and omissions should be corrected and changes introduced by amending Delegated Regulation (EU) 2020/692 accordingly. In addition, the experience gained on the application of that Delegated Regulation has shown the need to refine further several provisions related to the scope, application of specific conditions, animal identification, captive birds and their hatching eggs for conservation programmes, meat, dairy and egg products, eggs, composite products, vaccination programmes against highly pathogenic avian influenza, risk-mitigating treatments for milk and dairy products and egg products, aquatic and equine animals.

The substance covered by the Act was authorised for a period of ten years as a feed additive for all terrestrial animal species in the additive category ‘technological additives’, functional group ‘preservatives’ and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’. An application was submitted for the renewal of the authorisation of this substance 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 as a feed additive for all terrestrial 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 for a period of ten years as a feed additive for all animal species in the additive category ‘technological additives’ and in the functional groups ‘binders’ and ‘anticaking agents’. An application was submitted for the renewal of the authorisation of this substance 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 as a feed additive for all animal species is renewed under certain conditions detailed in the Annex to the Act.

The draft legal act prescribes the procedure to be followed to grant temporary derogations from import prohibitions or from special import requirements in particular, including the content and submission of the requests and their accompanying dossiers, as well as their assessment.

The proposal notified in G/SPS/N/EU/842 (19 March 2025) is now adopted by Commission Implementing Regulation (EU) 2025/1953 of 29 September 2025 amending Annexes VII, VIII, XI and XIII to Implementing Regulation (EU) 2019/2072 as regards measures against the entry into, and the presence in the Union territory of Anoplophora glabripennis (Motschulsky) and Anoplophora chinensis (Forster).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/801 (5 December 2024) is now adopted by Commission Regulation (EU) 2026/215 of 29 January 2026 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).The Regulation shall apply from 19 August 2026.

The proposal notified in G/SPS/N/EU/885 (17 September 2025) is now adopted by Commission Implementing Regulation (EU) 2026/187 of 28 January 2026 amending Implementing Regulation (EU) 2021/405 as regards the lists of third countries or regions thereof authorised for the entry into the Union of consignments of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (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 substance covered by the Act was still authorised without a time limit as a feed additive for all animal species other than ruminants for milk production or reproduction, weaned piglets of porcine species, porcine species for fattening, salmonids and chickens for fattening. An application was submitted for the reauthorisation of this substance for the species mentioned above 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 the species mentioned above in the additive category ‘technological additives’ and in the functional groups ‘binders’, under certain conditions detailed in the Annex to the Act.In addition, Implementing Regulation (EU) 2023/263 is amended to increase the maximum content of the additive in complete feed for salmonids and chickens for fattening.

The proposed draft Regulation concerns the lowering of existing MRLs for carbendazim and thiophanate‐methyl in certain food commodities.

The substance and the preparation covered by the Act are 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 preparation 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 preparation 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.

This Regulation authorises for the first time in the European Union and for a period of ten years tartrazine as a feed additive belonging to the category ‘sensory additives’ and in the functional group ‘colourants, (i) substances that add or restore colour in feedingstuffs’ for its use in baits for freshwater food-producing finfish. 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.

Amendment to Regulation (EC) No 999/2001: the proposal will make Regulation (EC) No 999/2001 more flexible to ensure that the control measures of that disease can be updated in a swifter and more proportionate manner to enable that it becomes more science-based and more aligned with the relevant Chapter 11.4 of the WOAH Terrestrial Code.Amendment to Regulation (EC) No 1829/2003: clarification of legal status of food and feed obtained using genetically modified organisms.Amendments to Regulation (EC) No 1831/2003: the draft act provides for 1/ unlimited duration of authorisation of feed additives (except coccidiostats and histomonostats) accompanied by safety safeguards, 2/ simplification and clarification of procedures for modification of feed additives authorisations and 3/ allowing digital labelling of feed additives and premixtures for certain non-safety information.Amendment to Regulation (EC) No 1099/2009: this part of the proposal removes the obligation in Article 18(4) of Regulation (EC) No 1099/2009 for Member States to submit a separate annual report on depopulation operations. Information on compliance with animal welfare requirements during depopulation activities will instead continue to be reported through the existing annual reports under Regulation (EU) 2017/625 on official controls.Amendment to Regulation (EC) No 396/2005: the proposed regulation allows for more flexible transitional measures in cases where Maximum Residue Limits (MRLs) are lowered, allows the setting of permanent MRLs based on monitoring data, aligns the terminology “limit of quantification (LOQ)”, and introduces the possibility on a case-by-case basis to set MRLs at the LOQ for the most hazardous pesticides (substances with mutagenic, carcinogenic, or reprotoxic properties as well as endocrine disruptors that may cause adverse effects in humans and in non-target organisms, persistent organic pollutants (POP), persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances).Amendment to Regulation (EC) No 1107/2009: the draft Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1107/2009 proposes a number of changes to lower administrative burden and allow for faster market access, without reducing the existing protection standards for health and the environment. The proposal aims to accelerate access to innovative biocontrol solutions. This will be achieved by, among others, tackling procedural inefficiencies, defining biocontrol substances, allowing provisional authorisations of products containing biocontrol substances, and reallocating or increasing resources in Member State authorities and the European Food Safety Authority. The possibility for certain active substances to have unlimited approval periods is proposed, alongside new provisions to allow for the renewal or targeted reassessment of those substances. Existing provisions concerning derogation from the approval criteria and grace periods are also amended. The proposal also intends to expand market access for plant protection products through stronger mutual recognition of product authorisations between Member States and strengthened support for minor uses. In addition, the proposal intends to clarify provisions related to basic substances, seed treatment and data protection to increase harmonisation of implementation across Member States. Amendment to Regulation (EU) No 528/2012: the draftProposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 528/2012 proposes to extend the data protection of data of existing active substances still under evaluation in the review programme due to delays in the completion of the review programme.Amendment to Regulation (EU) 2017/625: two amendments are proposed on the official controls Regulation (OCR): (a) Article 50(3) is amended to provide the possibility to competent authorities of border control posts to split the consignments of plant and plant products before completing the official controls on the entirety of the consignment, in order to release the parts for which official controls have been finalised while other parts still need further controls. (b) Articles 41, 93, 100 and 144 are amended so that the Commission is empowered to adopt delegated acts concerning the cases where, and the conditions under which, laboratories may be designated as official laboratories, national reference laboratories and EU reference laboratories, while operating and being accredited in accordance with similar laboratory standards to EN ISO/IEC 17025 and/or not being accredited for all the methods they use for official controls or other official activities.

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: Strawberries from Egypt due to the risk of pesticide residues (frequency set at 20%). Decrease in the frequency of identity and physical checks laid down in Annex I for: Oranges from Egypt (pesticide residues from: 20% to 10%);Lemons from Türkiye (Citrus limon, Citrus limonum) (pesticide residues from: 30% to 20%).Increase in the frequency of identity and physical checks laid down in Annex I for the following commodities:Seem beans and helmet beans (Lablab purpureus) from Bangladesh (pesticide residues: from 20% to 30%);Palm oil from Côte d’Ivoire (Sudan dyes: from 20% to 30%) and limit official controls only for packed products for direct human consumption;Peppers of the genus Capsicum (other than sweet) from Rwanda (pesticide residues: from 30% to 50%);Peppers of the genus Capsicum (other than sweet) from Thailand (pesticide residues: from 30% to 50%);Sesamum seeds from Türkiye (Salmonella: from 20% to 30 %).Removal from Annex II and inclusion in Annex I for the following commodities:Peppers of the genus Piper, dried or crushed or ground fruit of thegenus Capsicum or of the genus Pimenta from India (ethylene oxide – frequency of checks staying at 20%);Calcium carbonatefrom India (ethylene oxide – frequency of checks staying at 30%).Decrease in the frequency of identity and physical checks laid down in Annex II for: Black pepper (Piper nigrum) from Brazil (Salmonella: from 50% to 30 %);Mandarins (including tangerines and satsumas), clementines, wilkings and similar citrus hybrids from Türkiye (pesticide residues from: 20% to 10%);Oranges from Türkiye (pesticide residues from: 30% to 20%).Increase in the frequency of identity and physical checks laid down in Annex II for the following commodities:Pistachios, mixtures and products produced from pistachios originating from Türkiye, (aflatoxins: from 30% to 50 %);Pistachios, mixtures and products produced from pistachios originating from the United States and dispatched to the Union from Türkiye (aflatoxins: from 30% to 50 %). Delisting from Annex I (and thus, from the Regulation) of the following commodities:Rice from India (aflatoxins and Ochratoxin A (rice remains listed for pesticide residues));Nutmeg (Myristica fragrans) from India (aflatoxins);Vanilla from India (ethylene oxide);Cloves (whole fruit, cloves and stems) from India (ethylene oxide);Turnips (Brassica rapa ssp. rapa) from Lebanon (Rhodamine B);Mixtures of food additives containing locust bean gum from Malaysia (ethylene oxide);Grapefruits from Türkiye (pesticide residues);Mixtures of food additives containing locust bean gum from Türkiye (ethylene oxide);Okra from India (ethylene oxide (okra remains listed for pesticide residues)).

The proposal notified in G/SPS/N/EU/857 (23 May 2025) is now adopted by Commission Implementing Regulation (EU) 2026/178 of 23 January 2026 concerning the authorisation of eucalyptus tincture from Eucalyptus globulus Labill. 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.