Review of the EU legislation for 03/02/2025

Here’s a concise review of the legal acts:

1. A regulation establishing a scoreboard system for the Ukraine Facility, requiring tracking of reforms, investments, and financial disbursements until 2027. The system must monitor progress percentages, financial support details, and publicly disclose recipients receiving over €100,000.
2. A technical correction maintaining the authorization of sodium bisulphate as a feed additive for aquatic animals until September 2025, which was erroneously removed in a previous regulation.
3. A regulation mandating Whole Genome Sequencing for specific food-borne pathogens during outbreak investigations, requiring analysis of five specific pathogens and establishing a data sharing system through EFSA, effective from August 2026.
4. A technical correction for feed additives specifications, adjusting requirements for acetic acid, sodium diacetate, calcium acetate, and lactic acid, including modifications to composition parameters and animal categories.
5. A regulation renewing and expanding authorization for an enzyme preparation containing xylanase, subtilisin, and alpha-amylase as feed additives for various poultry species, with specific activity levels and dosage requirements.
6. An amendment increasing the maximum content of nonanoic acid as a feed additive from 5 mg/kg to 100 mg/kg for specific poultry and pig categories.
7. Authorization of L-tryptophan produced with E. coli CGMCC 7.460 as a feed additive for all animal species, requiring 98% minimum purity and specific safety measures.
8. A technical correction to the chemical formula of riboflavin 5′-phosphate monosodium salt, changing it from C17H22N4O9Pna to C17H20N4O9Pna.
9. A regulation removing Kenya from the EU’s Generalised Scheme of Preferences beneficiary list, effective from January 2027, due to a new preferential market access arrangement.

Review of each of legal acts published today:

Commission Delegated Regulation (EU) 2025/220 of 29 November 2024 on supplementing Regulation (EU) 2024/792 of the European Parliament and of the Council establishing the Ukraine Facility by setting out the detailed elements of the scoreboard for the Ukraine Plan

This Regulation establishes detailed requirements for the scoreboard that will track the implementation of the Ukraine Facility – a financial instrument supporting Ukraine’s recovery, reconstruction, and modernization until 2027. The scoreboard serves as a transparent monitoring tool to display progress in implementing the Ukraine Plan, which constitutes Pillar I of the Facility.The Regulation consists of two main articles. Article 1 defines six key elements that must be included in the scoreboard: fulfillment of steps related to reforms and investments, progress of financial disbursements, components of disbursed funds, assessment references, implementation progress by chapters, and cross-reference to recipients of funding exceeding €100,000. Article 2 addresses the entry into force of the regulation.The most significant provisions include:

• The requirement to track and display the percentage of satisfactorily fulfilled steps compared to the total number of steps outlined in the Ukraine Plan
• Monitoring of both non-repayable financial support and loans disbursement
• Transparency requirements through mandatory references to assessments and progress tracking by specific chapters
• Public disclosure of major funding recipients (those receiving over €100,000 cumulatively over four years)

Commission Implementing Regulation (EU) 2025/181 of 31 January 2025 correcting Implementing Regulation (EU) 2024/2393 as regards the repeal of Implementing Regulation (EU) 2015/1416

This Regulation corrects an error in the previous Implementing Regulation (EU) 2024/2393 regarding the authorization of sodium bisulphate as a feed additive. The correction maintains the authorization of sodium bisulphate for aquatic animals until September 2025, which was erroneously repealed.The Regulation consists of two main articles. Article 1 replaces Article 3 of the previous Regulation and amends Implementing Regulation (EU) 2015/1416 by specifying that sodium bisulphate remains authorized for aquatic animals and food-producing aquatic animals. Article 2 establishes the entry into force and retroactive application from September 30, 2024.Key provisions include:

• Modification of animal categories in Annex I, replacing ‘All animal species other than cats and mink’ with ‘Aquatic animals’
• Deletion of categories ‘Cats’ and ‘Mink’ and their corresponding maximum content values
• Amendment of Annex II to specify ‘Food-producing aquatic animals’ as the authorized category
• Retroactive application to ensure market continuity and prevent negative impacts on operators

Commission Implementing Regulation (EU) 2025/179 of 31 January 2025 on the collection and transmission of molecular analytical data within the frame of epidemiological investigations of food-borne outbreaks in accordance with Directive 2003/99/EC of the European Parliament and of the Council

This Regulation establishes new requirements for collecting and analyzing molecular data during food-borne outbreak investigations in the EU. It introduces mandatory Whole Genome Sequencing (WGS) for specific food-borne pathogens and creates a system for sharing this data between Member States through the European Food Safety Authority (EFSA).The Regulation consists of three main articles that outline: (1) the collection and WGS requirements for pathogen isolates, (2) the transmission of WGS results to EFSA, and (3) the implementation timeline. The act introduces new obligations compared to previous legislation by making WGS mandatory for specific pathogens and establishing detailed data sharing requirements.Key provisions include:

• Mandatory collection and WGS analysis of five specific pathogens (Salmonella enterica, Listeria monocytogenes, Escherichia coli, Campylobacter jejuni and Campylobacter coli) when associated with food-borne outbreaks
• Requirement for food and feed business operators to submit pathogen isolates and WGS results to competent authorities upon request
• Detailed requirements for data transmission to EFSA, including specific associated data such as unique reference numbers, sampling information, and outbreak details
• Implementation timeline with the regulation becoming applicable from August 23, 2026, allowing 18 months for adaptation to new requirements

Commission Implementing Regulation (EU) 2025/187 of 31 January 2025 correcting Implementing Regulation (EU) 2022/415 concerning the authorisation of malic acid, citric acid produced by Aspergillus niger DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic acid, sodium formate, calcium formate and ammonium formate, and lactic acid produced by Bacillus coagulans (LMG S-26145 or DSM 23965), or Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889) and calcium lactate as feed additives for certain animal species

This Regulation corrects several technical aspects of the earlier Implementing Regulation (EU) 2022/415 regarding feed additives for animals. The corrections mainly concern the specifications and use conditions of acetic acid, sodium diacetate, calcium acetate, and lactic acid as feed additives.The Regulation makes three main types of corrections to the original document: removes incorrect entries about non-volatile matter for certain additives, modifies the specifications for sodium diacetate’s composition and characteristics, and clarifies that maximum content limits for lactic acid should refer to the active substance rather than the additive itself. It also adjusts the categories of animals for which certain additives are authorized.Key provisions include:

• Deletion of incorrect entries about non-volatile matter for calcium acetate
• Updated specifications for sodium diacetate, including minimum content requirements (≥ 97%) and detailed chemical composition parameters
• Modification of animal categories for acetic acid, sodium diacetate, and calcium acetate use, specifically distinguishing between ruminants and other animals
• Clarification that maximum content limits for lactic acid should be measured in terms of active substance

The Regulation includes transitional measures allowing for the continued use of existing stocks of affected additives and feed materials, with different deadlines for food-producing animals (until February 2026) and non-food producing animals (until February 2027). These provisions ensure a smooth transition to the corrected requirements while avoiding market disruption.

Commission Implementing Regulation (EU) 2025/193 of 31 January 2025 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 as a feed additive for chickens for fattening, turkeys for fattening, ducks, and laying hens, and the authorisation of new uses of that preparation as a feed additive for all other poultry species and categories (holder of authorisation: Genencor International B.V.) and repealing Regulation (EC) No 1087/2009 and Implementing Regulation (EU) No 389/2011

This Regulation concerns the renewal of authorization and new uses of an enzyme preparation containing endo-1,4-beta-xylanase, subtilisin, and alpha-amylase as feed additives for various poultry species. The preparation is produced using specific strains of Trichoderma reesei, Bacillus subtilis, and Bacillus amyloliquefaciens.The Regulation consists of five articles and an annex. Article 1 renews the authorization for existing uses (chickens for fattening, turkeys for fattening, ducks, and laying hens), Article 2 authorizes new uses for additional poultry species, Article 3 repeals previous regulations, Article 4 establishes transitional measures, and Article 5 sets the entry into force. The Annex provides detailed technical specifications.Key provisions include:

• Specific minimum activity levels for each enzyme in the preparation: 1,500 U/g for endo-1,4-beta-xylanase, 20,000 U/g for subtilisin, and 2,000 U/g for alpha-amylase
• Different dosage requirements for various poultry categories: from 75 U xylanase for ducks to 300 U for laying species
• Safety measures for handlers, including the use of protective equipment when necessary
• Transitional periods allowing continued use of existing stocks produced under previous rules until February 2026

Commission Implementing Regulation (EU) 2025/183 of 31 January 2025 amending Implementing Regulation (EU) 2017/53 as regards the recommended maximum content of the active substance in complete feedingstuff of a feed additive consisting of nonanoic acid for certain pig and poultry categories

This Regulation amends the maximum content limits of nonanoic acid as a feed additive in animal nutrition. The act modifies the previously established maximum content from 5 mg/kg to 100 mg/kg for specific categories of poultry and pigs. The change is based on the European Food Safety Authority’s safety assessment.The Regulation consists of two main articles. Article 1 introduces changes to Implementing Regulation (EU) 2017/53, specifically modifying the recommended maximum content of nonanoic acid in feedingstuff. Article 2 establishes the entry into force provisions. The act introduces differentiated maximum content levels: 100 mg/kg for fattening poultry, poultry reared for laying or breeding, piglets of all Suidae, and Suidae for fattening, while maintaining 5 mg/kg for other animal species.Key provisions include:

• New maximum content levels of 100 mg/kg for specific animal categories
• Maintenance of 5 mg/kg limit for other animal species
• Application to feedingstuff with 12% moisture content
• Confirmation of safety for consumers and environment at new levels
• Direct applicability in all Member States

Commission Implementing Regulation (EU) 2025/188 of 31 January 2025 concerning the authorisation of L-tryptophan produced with Escherichia coli CGMCC 7.460 as a feed additive for all animal species

This Commission Implementing Regulation authorizes the use of L-tryptophan, produced with Escherichia coli CGMCC 7.460, as a feed additive for all animal species. The substance is classified as a nutritional additive in the functional group of amino acids, their salts and analogues. The authorization is granted based on the safety assessment by the European Food Safety Authority (EFSA).The Regulation consists of two main articles and an extensive Annex. Article 1 establishes the authorization of L-tryptophan as a feed additive, while Article 2 sets the entry into force. The Annex provides detailed technical specifications, including the identification number, composition requirements, analytical methods, and conditions of use.Key provisions include:

• The additive must contain a minimum of 98% L-tryptophan on a dry matter basis and ≤0.5% water
• Special protection is required when fed to ruminants to prevent degradation in the rumen
• The additive may be used via water for drinking
• Specific safety measures must be implemented for users due to endotoxin content
• The authorization is valid until February 23, 2035
• Labeling must include warnings about amino acid balance when supplementing via drinking water

Commission Implementing Regulation (EU) 2025/182 of 31 January 2025 correcting Implementing Regulation (EU) 2019/901 to correct the chemical formula of riboflavin 5′-phosphate monosodium salt

This Regulation makes a technical correction to the chemical formula of riboflavin 5′-phosphate monosodium salt, which is used as a feed additive for animals. The correction changes the formula from ‘C17H22N4O9Pna’ to ‘C17H20N4O9Pna’ in the previously issued Implementing Regulation (EU) 2019/901.The structure of the act is simple and consists of two articles. Article 1 contains the specific correction to be made in the Annex to the previous Regulation, while Article 2 establishes the standard entry into force provision.The key provision of this act is the modification of two hydrogen atoms in the chemical formula of riboflavin 5′-phosphate monosodium salt (from H22 to H20). This change ensures the correct chemical composition of the substance that was authorized as a feed additive for all animal species. The authorization period of 10 years established in the original Regulation remains unchanged.

Commission Delegated Regulation (EU) 2025/214 of 28 November 2024 amending Annex II to Regulation (EU) No 978/2012 of the European Parliament and of the Council as regards Kenya

This Regulation amends the EU’s Generalised Scheme of Preferences (GSP) by removing Kenya from the list of beneficiary countries. The change is made due to Kenya entering into a separate preferential market access arrangement with the EU that provides the same or better tariff preferences.The act consists of two main articles. Article 1 specifically removes Kenya (code KE) from Annex II of Regulation (EU) No 978/2012, which lists GSP beneficiary countries. Article 2 sets the entry into force and implementation dates, with the changes becoming effective from January 1, 2027.The key provisions include:
– The removal is based on Kenya’s new preferential market access arrangement that started on July 1, 2024
– A two-year adaptation period is provided for the country and economic operators to adjust to the new status
– The removal will take effect from January 1, 2027, ensuring legal certainty and avoiding administrative burden
– The change only affects Kenya’s status under the GSP, while other beneficiary countries remain unaffected