The regulation amends EU sanctions against Belarus in connection with its involvement in Russia’s aggression against Ukraine. The key changes include:
– Removal of two entries from the sanctions list (one duplicate entry and one deceased person)
– Updates to the justifications for 10 natural persons, including officials, judges, and businesspeople supporting the Lukashenka regime
– Amendments to descriptions of two companies – Minsk Automobile Works (MAZ) and Belshina – detailing their involvement in supporting the regime and Russian military actions
– Extension of restrictive measures until February 28, 2026
The regulation provides detailed justifications for each listed person and entity, including their roles, activities, and specific reasons for being subject to sanctions. The descriptions emphasize connections to the Lukashenka regime, involvement in political repression, and support of Russian military actions in Ukraine.
Review of each of legal acts published today:
Council Implementing Regulation (EU) 2025/386 of 24 February 2025 implementing Article 8a of Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine
This Council Implementing Regulation amends the EU sanctions regime against Belarus in connection with its involvement in Russia’s aggression against Ukraine. The act primarily deals with updates to the list of sanctioned individuals and entities.
The structure of the regulation consists of two main articles and an annex. Article 1 implements changes to Annex I of Regulation 765/2006, while Article 2 sets the entry into force. The Annex contains detailed amendments to both the list of natural persons (Table A) and legal persons (Table B) subject to restrictive measures.
Key provisions:
1. Removal of two entries from the sanctions list – one duplicate entry and one deceased person
2. Updates to the statements of reasons for 10 natural persons, including officials, judges, and businesspeople involved in supporting the Lukashenka regime
3. Amendments to the descriptions of two legal entities – Minsk Automobile Works (MAZ) and Belshina – detailing their involvement in supporting the regime and the Russian military actions
4. Extension of restrictive measures until February 28, 2026
5. Specific focus on individuals and entities involved in repression of civil society, support of the regime, and cooperation with Russian military activities
The regulation provides detailed justifications for each listed person and entity, including their roles, activities, and specific reasons for being subject to sanctions. The descriptions emphasize connections to the Lukashenka regime, involvement in political repression, and support of Russian military actions in Ukraine.
Council Regulation (EU) 2025/407 of 24 February 2025 amending Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
This regulation amends the EU’s restrictive measures (sanctions) against Syria following the fall of the al-Assad regime. It introduces significant changes to the sanctions regime by suspending various restrictive measures and adding new humanitarian exemptions to support Syria’s transition, reconstruction, and stabilization efforts.
The structure of the regulation consists of two main articles. Article 1 contains 25 amendments to Regulation (EU) No 36/2012, while Article 2 deals with the entry into force. The amendments primarily focus on suspending various restrictive provisions, modifying asset freeze measures, and expanding humanitarian exemptions.
Key provisions include:
1. Suspension of multiple restrictive measures through the insertion of new Article 1a, affecting Articles 6-13a, 21a-b, and 26a
2. Introduction of broader humanitarian exemptions for various organizations delivering aid and supporting basic human needs
3. Modification of asset freeze provisions, particularly maintaining freezes on assets of entities listed in Annex IIb located outside Syria as of February 27, 2012
4. New exemptions for activities related to reconstruction, economic recovery, and basic services
5. Expanded provisions for humanitarian assistance delivery and support of civilian purposes
6. Modifications to provisions regarding crude oil, petroleum products, power plants, and other economic activities
The regulation maintains oversight mechanisms through regular review of the measures and emphasizes the importance of monitoring developments in Syria for potential adjustments to the suspensions and exemptions.
Council Implementing Regulation (EU) 2025/376 of 24 February 2025 implementing Regulation (EU) 2023/2147 concerning restrictive measures in view of activities undermining the stability and political transition of Sudan
This Council Implementing Regulation amends the EU’s restrictive measures (sanctions) regime concerning Sudan by removing two individuals from the sanctions list established in 2023.
The act consists of two main articles and an annex, implementing changes to Council Regulation (EU) 2023/2147 which established restrictive measures against persons and entities undermining stability in Sudan. The regulation follows a decision by the UN Security Council Committee to modify its sanctions list.
The key provisions of the act are:
1. Removal of two specific individuals – Abdulrahman Juma Barakallah and Osman Mohamed Hamid – from Annex I of Regulation 2023/2147, which lists persons subject to EU restrictive measures
2. The changes take effect the day after publication in the Official Journal
3. The regulation is binding in its entirety and directly applicable in all EU Member States
The act represents a technical update to existing sanctions, removing specific targets from the restrictions rather than introducing new measures or changing the overall sanctions framework against Sudan. The changes align EU sanctions with UN Security Council decisions regarding Sudan.
Council Implementing Regulation (EU) 2025/408 of 24 February 2025 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
This Council Implementing Regulation amends the EU’s restrictive measures against Syria following the fall of al-Assad’s regime. The act suspends certain sanctions and removes six Syrian financial and aviation entities from the sanctions list, while maintaining asset freeze for the Central Bank of Syria.
The structure of the act is typical for EU implementing regulations, consisting of a preamble with 6 recitals explaining the context and reasons, two operative articles, and two annexes. The first annex lists the entities being removed from sanctions, while the second annex establishes a new list with the Central Bank of Syria remaining under asset freeze.
The main provisions include:
– Removal of five Syrian banks (Industrial Bank, Popular Credit Bank, Saving Bank, Agricultural Cooperative Bank, Central Bank of Syria) and Syrian Arab Airlines from the sanctions list
– Creation of a new Annex IIb containing only the Central Bank of Syria with frozen assets
– The changes aim to support Syria’s transition, humanitarian aid delivery, economic recovery, reconstruction and stabilization
– The regulation facilitates the return of Syrian nationals with their belongings
– The act maintains certain restrictions while encouraging inclusive political transition in line with UN Security Council Resolution 2254
: This act has implications for Syrian nationals, including those who may be in Ukraine, regarding their potential return to Syria and transfer of belongings. It also affects business relations between EU entities and Syrian financial institutions.
Commission Implementing Regulation (EU) 2025/356 of 21 February 2025 amending Implementing Regulation (EU) 2022/1941 as regards the prohibition of introduction, movement, holding, multiplication or release of certain pests
The essence of the act:
This Commission Implementing Regulation amends the previous Regulation (EU) 2022/1941 regarding the prohibition of certain plant pests in the EU territory. The main change is the removal of the pest Leucinodes pseudorbonalis from the list of prohibited pests, based on a scientific assessment that showed its very low risk to the EU territory. The regulation also introduces a more structured format for identifying pests by including EPPO (European and Mediterranean Plant Protection Organization) codes and expiry dates for prohibitions.
Structure and main provisions:
1. The regulation consists of two main articles and an annex:
– Article 1 amends the previous regulation by updating the prohibition rules and replacing the annex
– Article 2 sets the entry into force
– The Annex provides a new list of prohibited pests with their EPPO codes and prohibition expiry dates
2. The new annex lists four specific pests that remain prohibited until May 31, 2027:
– Chloridea virescens Fabricius
– Homona magnanima Dyakonov
– Resseliella citrifrugis Jiang
– Spodoptera ornithogalli Guenée
Most important provisions:
1. The prohibition applies to introduction, movement, holding, multiplication, and release of listed pests within the EU territory
2. Each pest in the list is now clearly identified with its EPPO code for better recognition
3. The prohibition period is explicitly stated with an end date of May 31, 2027 for all currently listed pests
4. The removal of Leucinodes pseudorbonalis demonstrates that the list is dynamic and based on scientific risk assessment
5. The regulation maintains a unified approach to pest control across all EU Member States through direct applicability
Commission Regulation (EU) 2025/351 of 21 February 2025 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, amending Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008, and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food as regards recycled plastic and other matters related to quality control and manufacturing of plastic materials and articles intended to come into contact with food
The essence of the act in 3-5 sentences:
This Commission Regulation amends three existing regulations related to plastic materials and articles intended for food contact: Regulation (EU) No 10/2011, Regulation (EU) 2022/1616, and Regulation (EC) No 2023/2006. It introduces more stringent requirements for the purity of substances used in plastic food contact materials, establishes clearer rules for reprocessing plastic manufacturing by-products, and updates provisions on compliance testing and quality control. The regulation also clarifies requirements for repeated use plastic articles and introduces new labeling requirements for consumer information about proper use and deterioration signs.
Structure and main provisions:
1. Amendments to Regulation (EU) No 10/2011:
– New definitions and clarifications regarding additives and UVCB substances
– Introduction of “high degree of purity” requirements
– New provisions for reprocessing of plastic by-products
– Updated rules for repeated use articles
– Enhanced requirements for documentation and compliance testing
– Modified provisions for declaration of compliance
2. Amendments to Regulation (EU) 2022/1616:
– Clarification of requirements applicable to recycled plastic materials
– Specification of quality control measures
3. Amendments to Regulation (EC) No 2023/2006:
– New requirements for quality assurance systems
– Detailed rules for reprocessing of plastic materials
– Enhanced traceability requirements
Most important provisions for use:
1. High Purity Requirements:
– Introduction of specific criteria for determining high purity of substances
– Special provisions for naturally-derived substances (UVCB substances)
– Requirements for documentation of purity levels
2. Reprocessing Rules:
– Clear conditions for reprocessing of manufacturing by-products
– Requirements for separate collection and handling
– Traceability requirements throughout the process
3. Consumer Safety Measures:
– New labeling requirements for repeated use articles
– Information about proper use and deterioration signs
– Enhanced compliance testing procedures
4. Documentation Requirements:
– Expanded scope of information in declarations of compliance
– Enhanced requirements for supporting documentation
– New provisions for demonstrating compliance to authorities
The regulation will enter into force 20 days after publication, with an 18-month transition period for full compliance.
Commission Implementing Regulation (EU) 2025/354 of 21 February 2025 amending Implementing Regulation (EU) 2021/405 as regards the lists of third countries with an approved control plan and the lists of third countries authorised for the entry into the Union of certain fishery products
The essence of the act in 3-5 sentences:
This Regulation amends the EU rules regarding the lists of third countries authorized to export certain fishery products and food-producing animals to the EU. It updates the lists of countries that have approved control plans for monitoring pharmacologically active substances, pesticides and contaminants in food products. The act specifically modifies permissions for various countries regarding exports of milk, eggs, honey, aquaculture products and other animal-derived foods to the EU market.
Structure and main provisions:
1. The regulation modifies Implementing Regulation (EU) 2021/405 by:
– Replacing Annex -I with updated lists of authorized third countries
– Amending Annex IX regarding specific provisions for Armenia
2. Key changes include:
– Removal of authorizations for several countries (Belize, Cuba, Honduras, Nigeria, Tunisia) due to failure to provide required guarantees
– New approvals (Brazil for eggs, Kazakhstan for honey)
– Modifications of existing authorizations (Singapore for aquaculture products)
– Removal of authorizations for countries no longer interested in exports (UAE and Pitcairn Islands for honey)
Most important provisions for use:
1. The regulation establishes clear marking system for different types of authorizations:
– ‘X’ for full approval with control plan
– ‘O’ for conditional approval
– ‘Δ’ for specific restrictions
2. Each country’s authorization is product-specific and can include:
– Live animals (bovine, ovine/caprine, porcine, equine, poultry)
– Animal products (milk, eggs, honey)
– Aquaculture products
– Wild and farmed game
3. The authorization can be withdrawn if countries fail to maintain required control plans or provide necessary guarantees.
: The regulation includes specific provisions regarding Ukraine, maintaining its authorization for exports of bovine, porcine, poultry, aquaculture products, milk, eggs, rabbit, and honey to the EU.
Commission Implementing Regulation (EU) 2025/358 of 21 February 2025 amending Implementing Regulation (EU) 2022/1630 as regards the list of demarcated areas for containment of Grapevine flavescence dorée phytoplasma
Here’s a detailed analysis of Commission Implementing Regulation (EU) 2025/358:
1. Essence of the act (3-5 sentences):
This regulation amends Implementing Regulation (EU) 2022/1630 regarding the list of demarcated areas for containment of Grapevine flavescence dorée phytoplasma, a quarantine pest affecting grapevines. The regulation updates the list of areas where the pest is present and where containment measures must be applied. It extends several containment areas in Croatia, Portugal, and Slovenia, and adds new areas in France (Nouvelle-Aquitaine) and Italy (Tuscany and Lombardy) where eradication is no longer possible.
2. Structure and main provisions:
– The regulation consists of two main articles and one extensive annex
– Article 1 replaces the entire Annex I of Regulation 2022/1630 with a new version
– Article 2 sets the entry into force
– The new Annex I provides detailed lists of demarcated areas in 8 countries:
* Austria (buffer zones due to Slovenia’s demarcation)
* Croatia (two infected zones and buffer zones)
* France (two infected zones and buffer zones)
* Hungary (buffer zones due to Croatia and Slovenia)
* Italy (two infected zones and buffer zones)
* Portugal (one infected zone and buffer zones)
* Slovenia (three infected zones and buffer zones)
* Spain (buffer zones due to Portugal)
3. Most important provisions:
– The regulation establishes precise geographical boundaries for infected zones and buffer zones in each affected country
– New areas are added in France (Nouvelle-Aquitaine region) and Italy (Tuscany and Lombardy regions) where the pest cannot be eradicated
– Buffer zones are extended in several countries to prevent further spread:
* Croatia’s containment areas are enlarged to include more municipalities
* Portugal’s buffer zones are extended into Spanish territory
* Slovenia’s buffer zones are extended into Austrian territory
– The regulation provides detailed municipality-level descriptions of all affected areas to ensure precise implementation of containment measures
Council Regulation (EU) 2025/395 of 24 February 2025 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine
1. Essence of the act:
The regulation establishes a comprehensive sanctions framework targeting Russian entities involved in military, defense, aviation, electronics and shipbuilding industries. It creates a detailed registry of 313 companies and organizations subject to restrictive measures, effectively limiting their access to European markets, technologies, and resources. The measures represent a coordinated effort to constrain Russia’s military-industrial capabilities through economic restrictions.
2. Structure and main provisions:
The act is organized as a detailed sanctions registry that includes:
– Full identification details of each sanctioned entity (official names in English and Russian, alternative names, legal addresses)
– Technical information including registration numbers, tax IDs, and contact details
– Temporal implementation data showing multiple waves of sanctions (March-December 2022)
– Industry-specific categorization focusing on strategic sectors
– Ownership structure information for subsidiary companies
– Specific restriction types applicable to each entity
3. Key provisions for implementation:
The most critical elements include:
– Asset freeze provisions affecting all listed entities’ property within EU jurisdiction
– Complete prohibition of business transactions with sanctioned organizations
– Extension of restrictions to subsidiaries where ownership exceeds 50%
– Detailed compliance requirements for EU member states
– Specific provisions for authorized transactions under special licensing
– Mechanisms for regular updates and amendments to the sanctions list
– Clear identification of prohibited goods, services, and technologies
– Requirements for financial institutions regarding transaction monitoring
– Reporting obligations for EU entities regarding sanctioned party contacts
The legislation provides comprehensive technical details necessary for practical implementation while maintaining flexibility for updates as circumstances evolve.
Council Regulation (EU) 2025/401 of 24 February 2025 amending Regulation (EU) No 692/2014 concerning restrictive measures in response to the illegal annexation of Crimea and Sevastopol
1. Essence of the act:
This regulation amends EU Regulation 692/2014 concerning restrictive measures related to the illegal annexation of Crimea and Sevastopol. It introduces new prohibitions on supplying banknotes, providing various professional services, and exporting certain goods and technology to Crimea and Sevastopol. The regulation also strengthens provisions against circumvention and establishes requirements for EU operators regarding entities they control outside the EU.
2. Structure and main provisions:
The regulation consists of 2 articles and 3 annexes:
– Article 1 introduces amendments to Regulation 692/2014, including new prohibitions and restrictions
– Article 2 sets the entry into force
– Annex I lists restricted goods and technology
– Annex II specifies prohibited software
– Annex III lists countries exempted from certain restrictions
Key changes compared to previous version:
– New ban on supplying EU member states’ banknotes
– Extended list of prohibited professional services (accounting, legal, IT, etc.)
– New restrictions on software for enterprise management and industrial design
– Enhanced anti-circumvention provisions
– New requirements for EU operators regarding controlled entities outside EU
3. Most important provisions:
– Prohibition to supply banknotes denominated in any official EU currency to Crimea/Sevastopol
– Ban on providing wide range of professional services including accounting, legal, IT consulting, engineering
– Restrictions on export of specific goods and technology in transport, telecommunications, energy sectors
– Requirement for EU operators to prevent circumvention through entities they control outside EU
– Detailed provisions on processing personal data for implementation purposes
– Enhanced enforcement mechanisms including penalties and self-disclosure provisions
The regulation significantly expands the scope of restrictions while providing certain humanitarian exemptions and establishing clearer implementation framework.
Council Regulation (EU) 2025/398 of 24 February 2025 amending Regulation (EU) 2022/263 concerning restrictive measures in response to the illegal recognition, occupation or annexation by the Russian Federation of certain non-government controlled areas of Ukraine
The essence of the act:
This regulation amends EU Regulation 2022/263 concerning restrictive measures against Russian-occupied areas of Ukraine. It introduces new prohibitions on supplying banknotes, certain goods, technology, and services to non-government controlled areas in Donetsk, Kherson, Luhansk and Zaporizhzhia regions. The regulation also strengthens enforcement mechanisms and clarifies provisions on circumvention of sanctions.
Structure and main provisions:
1. The regulation expands existing restrictions by:
– Prohibiting supply of EU member states’ banknotes to occupied territories
– Banning export of specific goods and technology listed in detailed annexes
– Restricting provision of professional services like accounting, consulting, IT, legal and engineering services
– Adding new provisions on software for enterprise management and industrial design
2. Key changes compared to previous version:
– Introduces comprehensive lists of restricted goods and technology in new annexes
– Adds detailed provisions on circumvention and enforcement
– Clarifies responsibilities of EU operators regarding entities they control outside EU
– Strengthens reporting requirements for member states on penalties
Main important provisions:
– Detailed lists of prohibited goods, technology and services in multiple sectors
– Clear definition of circumvention including both intentional and unintentional actions
– Requirements for EU companies to prevent circumvention by entities they control
– Provisions for exceptions related to humanitarian needs, civil society support and critical infrastructure
– Enhanced enforcement mechanisms including self-disclosure of violations
– Specific provisions on data protection and information sharing between authorities
The regulation provides comprehensive framework for implementing restrictions while maintaining humanitarian exceptions and ensuring effective enforcement.
Council Regulation (EU) 2025/392 of 24 February 2025 amending Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine
– This regulation amends EU sanctions against Belarus and has implications for Ukraine.
Key points about the act:
1. Essence in 3-5 sentences:
The regulation strengthens restrictions on dual-use goods and technology exports to Belarus, particularly items that could enhance Belarus’s defense and security sector. It expands controls on items used by Russia in its war against Ukraine and items contributing to Belarus’s military systems. The regulation also imposes new restrictions on exports of industrial goods, construction services, and financial services to Belarus. It introduces enhanced due diligence requirements for EU operators exporting certain goods to prevent circumvention.
2. Structure and main provisions:
– Expands list of controlled dual-use items and technology
– Strengthens prohibition on export of goods that could enhance Belarusian industrial and military capabilities
– Introduces new restrictions on:
* Construction services
* Software for oil/gas exploration
* Financial services and crypto assets
* Road transport
– Adds new designation criteria for sanctions
– Enhances compliance and enforcement mechanisms
– Updates various technical annexes with detailed lists of restricted items
3. Key provisions for implementation:
– Detailed lists of restricted goods and technology in updated annexes
– New derogation procedures for humanitarian purposes
– Enhanced due diligence requirements for EU exporters
– Strengthened reporting obligations
– Expanded information sharing between authorities
– New provisions on jurisdiction and legal remedies
– Technical amendments to improve clarity and enforcement
The regulation significantly expands the scope of EU sanctions against Belarus while focusing on preventing circumvention of restrictions related to Russia’s war against Ukraine.
Council Regulation (EU) 2025/390 of 24 February 2025 amending Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine
The essence of the act:
This regulation amends EU Regulation 269/2014 concerning sanctions against Russia related to actions undermining Ukraine’s territorial integrity. It introduces new criteria for asset freezing, enhances measures against Russian oil shipping practices, strengthens information sharing between authorities, and provides additional protections for EU operators complying with sanctions.
Structure and main provisions:
1. New listing criteria for sanctions targeting:
– Entities involved in high-risk shipping of Russian oil (“shadow fleet”)
– Persons/entities supporting Russia’s military-industrial complex
2. Enhanced cooperation mechanisms:
– Information sharing between EU authorities and partner countries
– Strengthened role of Financial Intelligence Units
– Commission’s authority to process personal data for sanctions implementation
3. Additional provisions:
– Derogations for Budapest metro system maintenance
– Extended divestment possibilities for certain listed individuals
– New requirements for EU operators to prevent sanctions circumvention by their non-EU subsidiaries
– Enhanced protection for EU operators facing third-country claims
Key important provisions:
1. Specific focus on combating “shadow fleet” operations transporting Russian oil through high-risk shipping practices
2. New obligation for EU companies to ensure their non-EU subsidiaries don’t undermine sanctions
3. Enhanced information sharing between authorities to prevent sanctions circumvention
4. Additional legal protections for EU operators facing claims in third countries related to sanctions compliance
5. Extended authority for competent authorities to authorize certain transactions under specific conditions
Council Implementing Regulation (EU) 2025/389 of 24 February 2025 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine
1. Essence of the Act:
This is Council Implementing Regulation (EU) 2025/389 which adds new sanctions against individuals and entities supporting Russia’s war against Ukraine. The regulation adds 48 persons and 35 entities to the EU sanctions list, including military industry executives, propagandists, and companies providing military equipment to Russia. The sanctions include asset freezes and travel bans for listed individuals and entities.
2. Structure and Main Provisions:
– The regulation consists of 2 articles and an extensive annex listing the sanctioned persons and entities
– Article 1 amends Annex I of Regulation 269/2014 by adding new entries
– Article 2 establishes immediate entry into force upon publication
– The annex provides detailed information about each sanctioned person/entity including:
– Identifying information (names, DOB, nationality, etc.)
– Reasons for listing
– Date of listing (24.2.2025)
3. Key Provisions:
– Targets high-level executives of Russian military companies producing weapons used in Ukraine
– Sanctions Chinese and Turkish companies involved in supporting Russia’s military capabilities
– Includes Belarusian electronics manufacturer JSC Integral for supplying components to Russian military
– Lists media outlets and individuals involved in Russian propaganda
– Sanctions companies operating in occupied Ukrainian territories
– Targets entities involved in the deportation of Ukrainian children
– Includes crypto exchange Garantex for helping sanctioned Russian banks access global financial system
– Sanctions companies producing drones and electronic warfare systems used against Ukraine
– Lists entities involved in circumventing existing EU sanctions
The regulation represents a significant expansion of EU sanctions against entities supporting Russia’s war effort through military production, propaganda, or financial services.
Commission Implementing Regulation (EU) 2025/353 of 21 February 2025 concerning the renewal of the authorisation of a preparation of Levilactobacillus brevis DSM 16680 as a feed additive for all animal species and amending Implementing Regulation (EU) No 399/2014
The act concerns the renewal of authorization for using Levilactobacillus brevis DSM 16680 as a feed additive for all animal species. This is a technological additive specifically used as a silage additive, which has been previously authorized for 10 years under different identification (formerly Lactobacillus brevis DSMZ 16680).
Structure and main provisions:
1. The regulation consists of 4 articles and an annex, which details the specific conditions for the additive’s use.
2. The main changes include:
– Renewal of authorization until March 16, 2035
– Updated safety requirements for users
– Deletion of the previous entry in Implementing Regulation (EU) No 399/2014
– Transitional measures for existing stocks until March 16, 2026
Key provisions for practical use:
1. The additive must contain a minimum of 2.5 × 10¹⁰ CFU/g
2. When used alone (not in combination with other microorganisms), the minimum dose is 1 × 10⁸ CFU/kg of fresh material
3. Storage conditions must be clearly indicated
4. Safety measures require personal protective equipment for skin, eyes, and breathing when risks cannot be eliminated through operational procedures
5. Specific analytical methods are prescribed for enumeration and identification of the additive
6. The additive is considered safe for animals, consumers, and environment, but is classified as an eye irritant and potential skin and respiratory sensitizer
Commission Implementing Regulation (EU) 2025/355 of 21 February 2025 amending Implementing Regulation (EU) 2022/2389 concerning the establishment of frequency rates for identity checks and physical checks on consignments of plants, plant products and other objects entering the Union
The act establishes new rules for checking plants, plant products, and other objects entering the European Union through border control posts. It modifies the frequency rates for identity and physical checks of various agricultural products, focusing on specific categories like cut flowers, fruits, vegetables, and used machinery from different countries. The regulation aims to ensure proper phytosanitary control while optimizing the inspection process based on risk assessment.
The structure of the act consists of two main articles and an annex. Article 1 amends the previous Regulation 2022/2389 by modifying Article 4(4) regarding exceptions to frequency rates and replacing Annex I with new frequency rates. Article 2 sets the entry into force date (March 1, 2025). The annex provides detailed tables with specific frequency rates for different products and their countries of origin.
Key provisions:
1. New frequency rates are established for various products, with some rates decreased (e.g., cut flowers from Ecuador, fruits from European countries) and others increased (e.g., Citrus from Morocco and USA).
2. Plants intended for planting are excluded from reduced frequency rates.
3. The regulation introduces a risk-based statistical method considering factors like pest mobility, previous non-compliance cases, and overall phytosanitary risks.
4. Specific attention is given to different product categories with varying inspection rates:
– Cut flowers: rates from 1% to 50%
– Fruits: rates from 1% to 75%
– Vegetables: rates from 1% to 15%
– Used machinery: 5% for all third countries
: The regulation includes specific provisions for products from Ukraine, treating it as a European third country with specific frequency rates for certain fruits.
Commission Implementing Regulation (EU) 2025/359 of 21 February 2025 concerning the authorisation of a preparation of Lactococcus lactis DSM 34262 as a feed additive for all animal species
This Commission Implementing Regulation authorizes the use of Lactococcus lactis DSM 34262 as a feed additive for all animal species. The preparation is classified as a technological additive in the functional group of silage additives, which helps improve the production of silage from fresh plant material.
Structure and main provisions:
1. The regulation consists of two main articles and a detailed annex specifying the conditions of use:
– Article 1 establishes the authorization
– Article 2 sets the entry into force
– The Annex provides detailed technical specifications and conditions
The key provisions include:
– The preparation must contain a minimum of 3 × 10¹¹ CFU/g of Lactococcus lactis DSM 34262
– The minimum dose when used alone is 1×10⁸ CFU/kg fresh material
– The additive is approved for use with plant material having 30% to 35% dry matter content
– The authorization is valid until March 16, 2035
– Specific safety measures for handlers are required due to potential skin and respiratory sensitization risks
Most important provisions for use:
1. The additive is authorized for all animal species without age restrictions
2. It must be used only with easy and moderately difficult to ensile fresh plant material
3. Specific storage conditions must be indicated on the product
4. Users must implement safety procedures and use protective equipment
5. When used as a cryoprotectant, polyethylene glycol (PEG 4000) concentration must not exceed 0.025 mg/kg silage
Commission Regulation (EU) 2025/350 of 21 February 2025 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health
The essence of the act:
This Commission Regulation refuses to authorize a specific health claim related to Appethyl® (a spinach leaf extract) and its alleged ability to help reduce body weight. The decision is based on the European Food Safety Authority’s (EFSA) scientific assessment, which found no established cause-and-effect relationship between the product’s consumption and weight reduction under the proposed conditions of use.
Structure and main provisions:
1. The regulation consists of two articles and an annex:
– Article 1 states that the health claim will not be included in the EU list of permitted claims
– Article 2 establishes the entry into force
– The Annex contains details of the rejected claim
2. The regulation’s preamble includes 10 recitals explaining:
– The legal basis for health claims regulation
– The application process
– The EFSA assessment procedure
– The specific case of Appethyl®
– The consultation process with Member States
Most important provisions for use:
1. The regulation explicitly prohibits the use of the specific health claim “Appethyl® helps your body weight reduction during mild caloric restriction” on food products in the EU market.
2. While EFSA acknowledged that Appethyl® as a food constituent is sufficiently characterized, they found no scientific evidence supporting the claimed weight reduction effect.
3. The decision demonstrates the strict scientific substantiation requirements for health claims in the EU, where claims must be based on proven cause-and-effect relationships supported by scientific evidence.
4. The regulation applies directly in all EU Member States, meaning food business operators across the EU must comply with this prohibition.
Commission Implementing Regulation (EU) 2025/364 of 21 February 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening (holder of authorisation: S.I. Lesaffre) and amending Regulation (EC) No 316/2003
The Commission Implementing Regulation (EU) 2025/364 authorizes the use of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle fattening. This yeast preparation is classified as a zootechnical additive in the functional group of gut flora stabilizers, with S.I. Lesaffre as the authorization holder. The regulation also amends the previous Regulation (EC) No 316/2003 regarding this additive.
Structure and main provisions:
1. Authorization framework based on Regulation (EC) No 1831/2003 for feed additives
2. Safety assessment by the European Food Safety Authority confirming the preparation’s safety for cattle, consumers, and environment
3. Specific requirements for the additive:
– Minimum concentration of 5 × 109 CFU/g in the preparation
– Usage rate of 4 × 109 CFU/kg in complete feed
– Valid until March 16, 2035
4. Transitional measures allowing:
– Previously produced additive and premixtures to be used until September 16, 2025
– Compound feed and materials containing the additive to be used until March 16, 2026
Key provisions for implementation:
1. Storage conditions and heat treatment stability must be indicated in usage directions
2. Feed business operators must establish safety procedures and organizational measures
3. Personal protective equipment for eyes and skin is required when risks cannot be eliminated
4. Specific analytical methods are prescribed for enumeration and identification of the additive
5. The preparation must meet minimum content requirements while no maximum limit is established
Commission Regulation (EU) 2025/352 of 21 February 2025 amending Directive 2002/46/EC of the European Parliament and of the Council as regards calcidiol monohydrate used in the manufacture of food supplements
The Commission Regulation (EU) 2025/352 amends Directive 2002/46/EC by adding calcidiol monohydrate to the list of permitted vitamin and mineral substances that can be used in food supplements. This amendment follows the European Food Safety Authority’s scientific opinion confirming the safety of calcidiol monohydrate as a source of vitamin D in food supplements.
Structure and main provisions:
– The regulation consists of two main articles and an annex
– Article 1 introduces the amendment to Annex II of Directive 2002/46/EC
– Article 2 establishes the entry into force
– The Annex specifically adds calcidiol monohydrate as entry (c) under point A.2. (VITAMIN D) in Annex II of the Directive
– The change builds upon previous authorization of calcidiol monohydrate as a novel food ingredient under Implementing Regulation (EU) 2024/1052
Key provisions for use:
1. Calcidiol monohydrate is now officially permitted as a source of vitamin D in food supplements
2. Its use must comply with conditions set out in Implementing Regulation (EU) 2024/1052
3. The substance must be listed in the Union list of novel foods according to Regulation (EU) 2017/2470
4. The regulation is directly applicable in all EU Member States
5. The amendment takes effect 20 days after publication in the Official Journal
Decision No 2/2025 of the Joint Committee established by the Agreement between the European Union and Ukraine on the carriage of freight by road of 17 January 2025 as regards the recognition of smart tachographs for the enforcement of the Agreement and the provision by the European Commission of smart tachograph certification services to Ukraine [2025/409]
The essence of the act:
This Decision establishes the recognition and use of smart tachographs under the EU-Ukraine Agreement on freight road transport. It allows vehicles registered in both the EU and Ukraine to use advanced smart tachograph systems that provide more detailed monitoring capabilities than traditional digital tachographs. The Decision also establishes the European Commission’s role in providing certification services and cryptographic materials to Ukraine for tachograph implementation.
Structure and main provisions:
The Decision consists of 5 articles covering definitions, use of smart tachographs, type-approval procedures, installation and enforcement requirements. The key changes include allowing Ukrainian vehicles to use smart tachographs compliant with EU regulations while maintaining the option to continue using digital tachographs under AETR. The act establishes technical adaptations to include Ukraine in the EU’s smart tachograph system and recognizes the European Commission as the Root Certification Authority.
Most important provisions:
1. Smart tachographs must comply with specific requirements including automatic position recording, remote early detection of manipulation, and interface with Intelligent Transport Systems.
2. The European Commission becomes responsible for providing Ukraine with cryptographic materials for issuing tachograph cards for drivers, workshops, companies, and control authorities.
3. Installation, inspection, and enforcement provisions of EU Regulation 165/2014 apply equally to both EU member states and Ukraine.
4. Ukraine recognizes the European Commission as the single European Root Certification Authority and accepts its interoperability certificates.
5. Vehicles can use either smart tachographs or continue using digital tachographs under AETR, providing flexibility during implementation.
