Review of the EU legislation for 04/02/2025

Here’s a concise review of the key legal acts:

Fishing Opportunities Regulation:

Sets fishing quotas and effort limits for Mediterranean and Black Seas for 2025, covering various species like European eel, red coral, and dolphinfish. Includes specific measures for different fishing zones and technical requirements like closure periods and gear restrictions.

Pesticide MRLs Amendment:

Modifies maximum residue levels for fenbuconazole and penconazole in food products. Lowers MRLs for certain fruits, sets new limits for tea, and adjusts values for berries and stone fruits. Includes transition period until August 2025.

Biofuels Certification Amendment:

Updates requirements for certification bodies verifying biofuel sustainability. Requires accreditation to specific ISO standards and establishes transition period until December 2026.

Food-borne Outbreak Investigation Rules:

Mandates Whole Genome Sequencing for specific food-borne pathogens and creates EU-wide data sharing system through EFSA. Applies to five specific pathogens and requires accredited laboratory analysis.

Feed Additives Regulations:

Multiple regulations covering:
– Increased nonanoic acid limits from 5mg/kg to 100mg/kg for specific poultry and pigs
– Technical corrections for acetic acid, sodium diacetate, and lactic acid specifications
– Authorization renewal for enzyme preparation in poultry feed
– L-tryptophan authorization for all animal species

Ukraine Facility Scoreboard:

Establishes monitoring system for Ukraine’s recovery and reconstruction funding, tracking reforms, investments, and financial disbursements. Requires transparency for recipients receiving over €100,000.

Review of each of legal acts published today:

Council Regulation (EU) 2025/… of 30 January 2025 fixing for 2025 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Mediterranean and Black Seas

This is a Council Regulation establishing fishing opportunities (quotas and effort limits) for certain fish stocks in the Mediterranean and Black Seas for 2025.The regulation sets detailed rules for fishing activities in different geographical areas of the Mediterranean and Black Seas, including:

• Maximum allowable catches and fishing effort for various species like European eel, red coral, common dolphinfish, demersal stocks, small pelagic stocks
• Specific measures for different fishing zones – Western Mediterranean, Adriatic Sea, Strait of Sicily, Ionian Sea, Levant Sea, Alboran Sea and Black Sea
• Technical measures like closure periods, gear restrictions, minimum sizes

The regulation’s structure includes:

• Title I – General provisions defining scope and key terms
• Title II – Fishing opportunities for EU vessels, divided into 7 chapters covering different sea basins
• Title III – Final provisions
• 9 detailed annexes specifying quotas, effort limits and technical measures for different areas and species

The main provisions establish catch limits, fishing effort restrictions, fleet capacity ceilings and technical conservation measures aimed at sustainable exploitation of fish stocks in line with scientific advice and international commitments. The regulation is particularly important for countries bordering these seas, including Ukraine in relation to Black Sea fisheries.

Commission Regulation (EU) 2025/195 of 3 February 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fenbuconazole and penconazole in or on certain products

This regulation amends Annex II to Regulation (EC) No 396/2005 regarding maximum residue levels (MRLs) for two pesticides – fenbuconazole and penconazole – in various food products. The changes are based on new scientific data and risk assessments by the European Food Safety Authority (EFSA).The regulation has a detailed structure consisting of 3 articles and an extensive annex that replaces the existing columns for fenbuconazole and penconazole in Annex II of Regulation 396/2005. The annex provides specific MRL values for different categories of food products including fruits, vegetables, cereals, spices, and products of animal origin.Key changes include lowering MRLs for fenbuconazole in certain fruits (grapefruits, oranges, peaches) to match Codex levels, setting new limits for tea, and adjusting MRLs for penconazole in berries and stone fruits based on new data. The regulation also removes footnotes requiring additional information for both substances.

Main provisions:

• Sets new MRLs for fenbuconazole and penconazole across different food categories
• Aligns certain MRLs with international Codex standards where deemed safe
• Lowers MRLs to the limit of determination (LOD) where data gaps were not addressed
• Maintains existing MRLs where supported by new data
• Removes requirements for additional data submission

Most important provisions:

• Detailed MRL values for hundreds of food products organized in categories
• Special provisions for animal products based on feed intake assessments
• Transition period until August 24, 2025 to allow adaptation to new requirements
• Continuation of previous rules for products placed on market before implementation

Commission Implementing Regulation (EU) 2025/196 of 3 February 2025 amending Implementing Regulation (EU) 2022/996 as regards the accreditation of certification bodies and correcting Annex VII to that Regulation

This Regulation amends the rules for certification bodies that verify sustainability and greenhouse gas emissions criteria for biofuels and other renewable fuels. It introduces changes to ensure proper accreditation of certification bodies and corrects technical values in the previous regulation.The Regulation consists of three main articles and an annex. Article 1 modifies the definition of ‘certification body’ and establishes new requirements for their accreditation. Article 2 introduces corrections to Annex VII regarding nitrogen fertilizer values. Article 3 contains entry into force provisions.Key provisions include:

• Certification bodies must be accredited to EN ISO/IEC 17065 standard, and when conducting verification activities, must meet requirements of EN ISO/IEC 17029 and EN ISO 14065
• The Commission will assess if methodologies and rules of voluntary and national schemes are suitable for accreditation, after consulting the European cooperation for Accreditation
• A transition period is established until December 31, 2026, allowing existing certification bodies to continue their activities without new accreditation requirements
• Technical correction of values for nitrogen and urea fertilizers in Annex VII

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 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 a standardized data sharing system.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 outbreaks
• Requirement for food and feed business operators to submit isolates and WGS results to competent authorities upon request
• Detailed requirements for data transmission to EFSA, including specific associated data points like unique reference numbers, sampling dates, and outbreak information
• WGS must be performed in accredited laboratories according to ISO 17025 standards
• The regulation will become applicable from August 23, 2026, allowing time for technical and financial adaptation

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

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) 2025/187 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 previous act: removes incorrect entries about non-volatile matter for certain additives, modifies the composition specifications for sodium diacetate, and adjusts the animal categories for which certain additives can be used. Additionally, it clarifies that for lactic acid, the maximum content should refer to the active substance rather than the additive itself.The key provisions include:

• Deletion of incorrect entries about non-volatile matter for calcium acetate
• New specifications for sodium diacetate composition (≥ 97% purity)
• Revision of animal categories for acetic acid, sodium diacetate, and calcium acetate use
• Clarification that maximum content for lactic acid refers to active substance
• Transitional measures allowing continued use of existing stocks until February 2026 for food-producing animals and February 2027 for non-food producing animals

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) 2025/182 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 correction ensures the accurate chemical description 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) 2025/220 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
• Mandatory transparency regarding recipients of substantial funding (over €100,000)
• Progress tracking must be broken down by specific reforms and investments
• The scoreboard must provide references to all relevant assessments of the implementation process

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) 2025/188 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
• 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 to protect users from endotoxin exposure
• The authorization is valid until February 23, 2035
• Feed business operators must establish operational procedures and organizational measures to address potential risks