Review of the EU legislation for 31/01/2025

Summary of the legal acts:

The reviewed acts can be grouped into several main categories:

Product Authorizations and Registrations:

– Authorization of new food additives and novel foods (glucosyl hesperidin, Lemna plants)
– Registration of geographical indications (‘Sussex’, ‘Aglonas maizes veistūklis’)
– Authorization of feed additives (various enzymes, microorganisms, amino acids)
– Renewal of existing feed additive authorizations

Safety and Health Measures:

– Amendments to maximum residue levels for pesticides
– Changes to veterinary medicinal product regulations
– Import restrictions due to avian influenza
– Updates to plant health requirements

Financial and Administrative:

– Changes to unemployment fund contributions
– Payment institutions’ identification numbers
– Business register interconnection requirements
– Shareholder rights and corporate governance rules

Trade and Customs:

– Common transit procedures
– Trade formalities simplification
– Import registration requirements
– Air service tender conditions

Sanctions and Restrictions:

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2025/163 of 30 January 2025 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

This Regulation amends Implementing Regulation (EU) 2021/17 which establishes a list of variations not requiring assessment for veterinary medicinal products. The act updates and clarifies which changes to marketing authorizations can be made without requiring additional assessment by regulatory authorities.The main changes include updates to provisions regarding changes in names/addresses of marketing authorization holders and manufacturers, modifications to manufacturing processes, specifications and testing procedures, as well as changes to packaging and product information.The Regulation consists of 2 articles and an extensive Annex that introduces detailed amendments to Parts A, B, C and D of the original regulation. The amendments provide more precise conditions and documentation requirements for various types of changes that do not require assessment.

Key provisions:

• Clarifies conditions for changes in names/addresses of various entities involved in manufacturing and testing
• Updates requirements for modifications to specifications, test procedures and manufacturing processes
• Revises provisions on changes to packaging materials and product information
• Introduces new provisions for changes related to flavoring and coloring systems
• Updates requirements for changes to Certificates of Suitability
• Provides more detailed documentation requirements for various types of changes

The Regulation maintains the general principle that only changes that do not affect the quality, safety or efficacy of the medicinal product can be implemented without prior assessment, while providing more clarity on specific conditions and requirements.

Commission Delegated Regulation (EU) 2025/212 of 13 September 2024 correcting Commission Delegated Regulation (EU) 2017/2055 supplementing Directive (EU) 2015/2366 of the European Parliament and of the Council with regard to regulatory technical standards for the cooperation and exchange of information between competent authorities relating to the exercise of the right of establishment and the freedom to provide services of payment institutions

This Regulation is a technical correction to the existing EU legislation regarding payment institutions’ identification numbers in Denmark. It modifies Commission Delegated Regulation (EU) 2017/2055, which deals with cooperation and information exchange between competent authorities concerning payment institutions.The Regulation consists of two articles and an annex. Article 1 introduces the correction to Annex I of the original Regulation, while Article 2 establishes the standard entry into force provision. The Annex contains the specific technical correction for Denmark’s identification numbers.The main change introduced by this Regulation is the correction of Denmark’s unique identification number format in Annex I. The new format specifies two types of identification numbers:

• For companies and sole proprietorships: an 8-digit CVR number (e.g., 12345678)
• For natural persons other than sole proprietorships: a 10-digit CPR number in the format 123456-7890

Commission Implementing Regulation (EU) 2025/167 of 30 January 2025 authorising the placing on the market of glucosyl hesperidin as a novel food and amending Implementing Regulation (EU) 2017/2470

This Commission Implementing Regulation authorizes the placing on the market of glucosyl hesperidin as a novel food in the European Union. The substance is a pale yellow to yellow-brown powder produced enzymatically from hesperidin, which is isolated from citrus fruits.The Regulation amends the Union list of novel foods by adding glucosyl hesperidin with specific conditions of use. The substance is authorized for use in soft drinks marketed in relation to physical exercise (525 mg/L), energy drinks (525 mg/L), and food supplements for the general population with specific dosages for different age groups (excluding infants).The structure of the act includes the authorization decision, conditions for market placement, data protection provisions, and detailed specifications in the Annex. Key changes include replacing the initially proposed use categories with more specific ones (functional drinks replaced by ‘soft drinks marketed in relation to physical exercise’ and ‘energy drinks’) and withdrawal of the request for use in food supplements for young children.The main provisions establish that:

• Only Nagase Viita Co., Ltd is authorized to place the product on the market for 5 years from February 20, 2025
• Scientific data supporting the authorization is protected for 5 years
• The product must meet specific compositional and purity criteria
• Clear labeling requirements apply, including warnings for certain age groups
• Maximum usage levels are set for different food categories

Council Regulation (EU) 2025/205 of 30 January 2025 amending Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism

This Regulation amends the EU’s framework for implementing restrictive measures (sanctions) against persons and entities involved in terrorist activities, specifically focusing on humanitarian exemptions to asset freezes. The amendment extends the duration of previously established humanitarian exemptions and updates relevant deadlines.The Regulation consists of two main articles that modify Council Regulation (EC) No 2580/2001. The changes primarily affect Article 6 of the original regulation, extending the humanitarian exemption period from 12 to 24 months and pushing the deadline from February 2025 to February 2027.The key provisions of this amendment include:
– Extension of the humanitarian exemption period to 24 months for organizations with Humanitarian Partnership Certificates and recognized humanitarian agencies
– Prolongation of the review period for these exemptions until February 22, 2027
– Maintenance of the derogation mechanism for humanitarian organizations that don’t qualify for automatic exemptionsThe amendment ensures continuity in the EU’s approach to balancing counter-terrorism measures with humanitarian needs, allowing legitimate humanitarian organizations to continue their operations while maintaining restrictions on terrorist financing.

Commission Delegated Regulation (EU) 2025/101 of 27 November 2024 adjusting the contributions for the financing of the Special Unemployment Fund set out under Articles 28a and 96 of the Conditions of Employment of Other Servants

This Regulation adjusts the financial contributions to the Special Unemployment Fund for temporary staff, contract staff, and accredited parliamentary assistants of EU institutions. The act establishes new contribution rates for the unemployment insurance scheme that provides benefits to former staff members after their service termination.The Regulation consists of two main articles. Article 1 sets the new contribution rate at 0.51% of the basic salary for both temporary and contract staff, with different standard allowance deductions (EUR 1,585.45 for temporary staff and EUR 1,189.08 for contract staff). Article 2 establishes the entry into force provisions.The key changes in this Regulation include:

• A unified contribution rate of 0.51% for all categories of staff
• Different standard allowance deductions for different staff categories
• Calculation of contributions without taking into account correction coefficients from Article 64 of the Staff Regulations

The most significant provisions for implementation are:

• The precise calculation method for contributions, based on basic salary minus standard allowance
• The exclusion of correction coefficients from the calculation
• The immediate applicability of the new rates following publication

Commission Implementing Regulation (EU) 2025/178 of 24 January 2025 on the registration of the geographical indication Aglonas maizes veistūklis (PGI) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council

This Commission Implementing Regulation registers the geographical indication ‘Aglonas maizes veistūklis’ as a Protected Geographical Indication (PGI) in the European Union register of geographical indications. The registration follows Latvia’s application and ensures legal protection of this traditional product name across the EU.The regulation consists of two main articles. Article 1 formally enters ‘Aglonas maizes veistūklis’ into the Union register of geographical indications as a PGI. Article 2 establishes that the regulation becomes effective on the twentieth day after its publication in the Official Journal of the EU.The key aspects of this regulation include:

• The application was originally submitted under the previous Regulation (EU) No 1151/2012 but was processed under the new Regulation (EU) 2024/1143
• No opposition was received during the prescribed period after the publication of the application
• The registration provides EU-wide protection for this Latvian geographical indication

Commission Implementing Regulation (EU) 2025/168 of 30 January 2025 concerning the renewal of the authorisation of a preparation of Limosilactobacillus fermentum NCIMB 30169 as a feed additive for all animal species and amending Implementing Regulation (EU) No 399/2014

This Commission Implementing Regulation concerns the renewal of authorization for Limosilactobacillus fermentum NCIMB 30169 as a feed additive for all animal species. The regulation extends the previous 10-year authorization period and updates safety requirements for the additive’s use. The preparation is classified as a technological additive in the functional group of silage additives.The regulation consists of four articles and an annex. Article 1 renews the authorization, Article 2 amends the previous regulation by deleting the old entry, Article 3 establishes transitional measures for existing stocks, and Article 4 sets the entry into force. The annex provides detailed technical specifications for the additive’s use.Key provisions include:

• The minimum concentration requirement of 2.5 × 10¹⁰ CFU/g in the additive
• Mandatory safety measures for handlers, including the use of protective equipment for skin, eyes, and respiratory tract
• Storage conditions must be indicated in the directions for use
• A minimum dose of 1 × 10⁸ CFU/kg fresh material when used alone
• The authorization is valid until February 20, 2035

The regulation maintains the previous safety standards while adding new protective measures based on the European Food Safety Authority’s assessment, which identified the additive as a potential skin and respiratory sensitizer. Products manufactured and labeled before February 20, 2026, may continue to be marketed until stocks are exhausted.

Commission Implementing Regulation (EU) 2025/191 of 24 January 2025 on the registration of the geographical indication Sussex (PDO) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council

This Regulation implements the registration of ‘Sussex’ as a Protected Designation of Origin (PDO) in the EU register of geographical indications. The registration follows an application from the United Kingdom that was submitted before the entry into force of the new EU Regulation 2024/1143 on geographical indications.The Regulation consists of two articles: Article 1 formally registers ‘Sussex’ as a PDO in the Union register of geographical indications, while Article 2 sets the standard entry into force provision (twentieth day following publication). The structure is simple and straightforward, focusing solely on the registration action.The key provisions to note are:

• The application was processed under transitional provisions, as it was submitted before the new geographical indications regulation came into force
• No opposition was received during the opposition period under Article 17 of Regulation 2024/1143
• The registration is binding and directly applicable in all EU Member States
• The protection granted is under the PDO (Protected Designation of Origin) category, which is the highest level of geographical indication protection in the EU system

Commission Implementing Regulation (EU) 2025/169 of 30 January 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for ruminants other than dairy (holder of authorisation: Mazzoleni S.p.A.)

This Commission Implementing Regulation authorizes the use of Saccharomyces cerevisiae DBVPG 48 SF (a specific yeast preparation) as a feed additive for ruminants other than dairy animals. The authorization is granted to Mazzoleni S.p.A. as the holder and is valid until February 20, 2035. The additive is classified as a zootechnical additive in the functional group of ‘other zootechnical additives’.The regulation consists of two main articles and an annex. Article 1 establishes the authorization of the preparation, while Article 2 sets the entry into force. The detailed technical specifications, conditions of use, and safety requirements are laid out in the comprehensive annex.Key provisions include:

• The minimum concentration requirement of 1 × 109 CFU/g in the additive
• The minimum content requirement of 4 × 109 CFU/kg in feedingstuff
• Mandatory storage conditions and stability information requirements
• Safety measures for handlers, including the use of protective equipment
• Specific analytical methods for identification and enumeration of the additive

Council Implementing Regulation (EU) 2025/206 of 30 January 2025 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2024/2055

This Council Implementing Regulation updates the EU’s list of persons and entities subject to restrictive measures in connection with combating terrorism. The act is a regular review and update of the existing sanctions list established under Regulation (EC) No 2580/2001.The regulation consists of three main articles and an extensive annex. Article 1 establishes a new list of sanctioned persons and entities, Article 2 repeals the previous implementing regulation (EU) 2024/2055, and Article 3 sets the entry into force provision. The Annex contains two parts: Part I listing 14 individuals and Part II listing 22 groups and entities.Key provisions of the act include:

• The Council has reviewed and verified that all listed persons and entities (except one removed person) have been involved in terrorist acts according to the competent authorities’ decisions
• The list includes detailed identification information for individuals, including aliases, dates of birth, places of birth, and passport numbers where available
• For groups and entities, alternative names and affiliated organizations are provided
• Notable entries include Hamas, Hezbollah Military Wing, PKK, and various other internationally recognized terrorist organizations
• The regulation maintains restrictive measures against Iranian individuals and entities, including members of Iranian intelligence services

Commission Implementing Regulation (EU) 2025/152 of 29 January 2025 concerning the authorisation of omicha tincture from Schisandra chinensis (Turcz.) Baill. and ginseng tincture from Panax ginseng C.A.Mey. as feed additives for certain animal species

This Regulation authorizes two feed additives – omicha tincture from Schisandra chinensis and ginseng tincture from Panax ginseng – for use in animal nutrition as flavoring compounds for specific animal species. The authorization is valid until February 19, 2035.The Regulation consists of three main articles and a detailed Annex. Article 1 establishes the authorization of the substances. Article 2 sets transitional measures for existing stocks of these additives. Article 3 determines the entry into force. The Annex provides detailed technical specifications for both additives.Key provisions include:

• The additives are authorized only for specific animals: horses, dogs, cats, and poultry for omicha tincture; horses, cats and dogs for ginseng tincture
• Maximum recommended content levels are established for each animal species
• The additives must be incorporated into feed in premixture form
• Specific labeling requirements are established
• Safety measures for handlers are required, including protective equipment
• The additives cannot be used in drinking water
• Detailed specifications for composition and analytical methods are provided

Commission Implementing Regulation (EU) 2025/161 of 29 January 2025 concerning the authorisation of a preparation of muramidase produced with Trichoderma reesei DSM 32338 as a feed additive for laying hens (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.)

This Commission Implementing Regulation authorizes the use of muramidase, an enzyme produced with Trichoderma reesei DSM 32338, as a feed additive for laying hens. The authorization is granted to DSM Nutritional Products Ltd and is valid until February 19, 2035.The regulation consists of two main articles and an annex. Article 1 provides the authorization itself, while Article 2 establishes the entry into force. The detailed technical specifications and conditions of use are laid out in the comprehensive annex.The key provisions include:

• The additive belongs to the category of ‘zootechnical additives’ and is intended to improve laying performance
• The preparation must have a minimum activity of 60,000 LSU(F)/g and is available in both solid and liquid forms
• The recommended dosage is between 30,000 and 60,000 LSU(F) per kg of complete feedingstuff
• Specific safety measures are required for handlers, including the use of protective equipment for skin, breathing, and eyes
• Storage conditions and heat treatment stability must be indicated in the directions for use

The authorization is based on a safety assessment by the European Food Safety Authority, which confirmed the additive’s safety for target species, consumers, and the environment, though with some precautions regarding its handling due to its potential as a respiratory sensitizer.

Commission Implementing Regulation (EU) 2025/160 of 29 January 2025 concerning the authorisation of L-threonine produced with Escherichia coli CGMCC 7.455 as a feed additive for all animal species

This Commission Implementing Regulation authorizes the use of L-threonine, produced with Escherichia coli CGMCC 7.455, as a feed additive for all animal species. L-threonine is classified as a nutritional additive in the functional group of amino acids, and the authorization is valid until February 19, 2035. The regulation establishes specific conditions for its use in animal feed and drinking water.The regulation consists of two main articles and a detailed annex. Article 1 establishes the authorization of L-threonine as a feed additive, while Article 2 sets the entry into force. The annex provides detailed technical specifications, including the composition requirements, analytical methods, and conditions of use.Key provisions include:
– The substance must contain a minimum of 98.5% L-threonine with maximum moisture content of 1%
– Special protection is required when fed to ruminants to prevent degradation in the rumen
– The additive can be used both in feed and drinking water
– Specific labeling requirements are established to prevent amino acid imbalances
– Safety measures for handlers are required, including the use of protective equipment
– Detailed analytical methods for substance identification and determination in various matrices are specified

Commission Implementing Regulation (EU) 2025/143 of 29 January 2025 concerning the authorisation of L-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 as a feed additive for all animal species

This Commission Implementing Regulation authorizes the use of L-isoleucine, produced with Corynebacterium glutamicum CGMCC 20437, 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 valid until February 19, 2035.The Regulation consists of two main articles and an extensive Annex. Article 1 establishes the authorization of L-isoleucine as a feed additive, while Article 2 sets the entry into force. The Annex provides detailed technical specifications, including the composition requirements, analytical methods, and conditions of use.Key provisions include:

• The additive must contain a minimum of 93.5% L-isoleucine on a dry matter basis with maximum 2% moisture content
• The substance can be used in both feed and drinking water
• When fed to ruminants, L-isoleucine must be protected against rumen degradation
• Special labeling requirements are imposed to prevent amino acid imbalances
• Safety measures for handlers include the use of protective equipment for skin, eyes, and breathing

The regulation establishes specific analytical methods for identifying and determining L-isoleucine content in feed additives, premixtures, compound feed, and water. Storage conditions, stability requirements, and safety precautions must be clearly indicated in the product documentation.

Commission Implementing Regulation (EU) 2025/203 of 28 January 2025 amending Annexes V and XIV to Implementing Regulation (EU) 2021/404 as regards the entries for Canada, the United Kingdom and the United States in the lists of third countries, territories or zones thereof authorised for the entry into the Union of consignments of poultry and germinal products of poultry, and of fresh meat of poultry and game birds

This Regulation amends the rules for importing poultry, poultry products and game birds from Canada, the United Kingdom and the United States into the European Union due to outbreaks of highly pathogenic avian influenza (HPAI) in these countries.The act modifies Annexes V and XIV of Implementing Regulation (EU) 2021/404, which contain lists of third countries and territories authorized to export poultry and poultry products to the EU. The changes reflect new restricted zones established around HPAI outbreaks in British Columbia (Canada), several counties in England (UK), and multiple US states.The main provisions include:
– Suspension of imports from newly affected zones in Canada (1 zone), UK (5 zones) and US (21 zones)
– Reauthorization of imports from certain previously restricted US zones where the disease situation has improved
– Detailed geographical descriptions of all new restricted zones
– Updated dates for when restrictions begin and end for specific zonesThe regulation provides precise coordinates and boundaries for each restricted zone, typically covering a 10km radius around infected establishments. It includes detailed tables specifying which types of poultry products are restricted from each zone and the applicable time periods.

Commission Implementing Directive (EU) 2025/145 of 29 January 2025 amending Implementing Directive 2014/98/EU as regards the Union regulated non-quarantine pests Tobacco ringspot virus, Tomato ringspot virus, Pucciniastrum minimum (Schweinitz) Arthur and Fig mosaic agent and correcting that Implementing Directive as regards measures concerning Candidatus Phytoplasma prunorum Seemüller & Schneider

This Directive amends Implementing Directive 2014/98/EU regarding regulated non-quarantine pests (RNQPs) affecting fruit plant propagating material and fruit plants. The key changes include:The Directive updates the phytosanitary status and control measures for several pests:

• Tobacco ringspot virus and Tomato ringspot virus are now listed as RNQPs for certain fruit plants
• Pucciniastrum minimum is added as an RNQP for Vaccinium plants
• Fig mosaic agent is removed from the list of RNQPs

The Directive provides detailed requirements for:

• Visual inspections and testing protocols for different plant categories (pre-basic, basic, certified, CAC)
• Specific measures to prevent pest presence in production sites
• Sampling frequencies and procedures
• Actions required when pests are detected

The amendments aim to ensure appropriate phytosanitary protection while maintaining consistency with other EU plant health regulations. Member States must implement these changes by July 31, 2025.

Commission Implementing Regulation (EU) 2025/141 of 29 January 2025 making imports of screws without heads originating in the People’s Republic of China subject to registration

This Regulation introduces registration requirements for imports of specific types of screws without heads from China into the European Union. The measure is part of an anti-dumping investigation initiated following a complaint from the European Industrial Fasteners Institute. The registration requirement will last for nine months and aims to enable potential retroactive collection of anti-dumping duties if deemed necessary.The Regulation consists of three main sections and two operative articles. The first section defines the product subject to registration – specifically screws and bolts without heads made of iron or non-stainless steel. The second section establishes the legal basis and justification for registration, noting estimated dumping margins of 100-150% and injury elimination levels of 150-214%. The third section addresses personal data processing requirements.Key provisions include:
– Precise definition of affected products under CN codes 7318 15 42 and 7318 15 48
– Exclusion of specific screw types like wood screws, self-tapping screws, and railway track construction screws
– Nine-month duration of the registration requirement
– Requirement for customs authorities to implement appropriate registration procedures
– Protection of personal data under EU Regulation 2018/1725

Commission Regulation (EU) 2025/140 of 29 January 2025 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide in the Union list of flavourings

This Regulation amends the EU list of authorized food flavourings by adding a new substance – (E)-3-benzo[1,3]dioxol-5-yl-N,N-diphenyl-2-propenamide (FL No 16.135). The amendment follows a safety evaluation by the European Food Safety Authority (EFSA) which confirmed that this flavouring substance is safe for use in specified food categories at defined maximum levels.The Regulation consists of two articles and an annex. Article 1 introduces the amendment to Annex I, Part A of Regulation (EC) No 1334/2008, while Article 2 sets the entry into force. The Annex specifies the exact placement and details of the new flavouring substance in the Union list, including its FL number, chemical name, CAS number, and use restrictions for different food categories.Key provisions include:

• Maximum permitted levels vary by food category: up to 250 mg/kg in category 5 (with some exceptions), up to 500 mg/kg in category 5.3, and up to 150 mg/kg in category 5.4
• The substance was evaluated as safe both as a food flavouring and in combination with its use in toothpaste
• The authorization is based on EFSA’s scientific opinion from May 2022 which confirmed no safety concerns at the estimated levels of dietary exposure

Commission Implementing Regulation (EU) 2025/157 of 29 January 2025 concerning the authorisation of microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose as feed additives for all animal species

This Commission Implementing Regulation authorizes six cellulose-based substances (microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose) as feed additives for all animal species. The authorization is valid until February 19, 2035.The regulation is structured around the authorization of these substances in different functional groups including emulsifiers, stabilizers, thickeners, gelling agents and binders. For each substance, detailed specifications are provided regarding their composition, characteristics and purity criteria. The regulation includes an extensive annex with specific conditions for use of each additive.Key provisions include:
– All six substances are authorized for use in feed for all animal species without minimum or maximum content restrictions
– Specific storage conditions and heat treatment stability must be indicated in usage directions
– Safety measures for handlers are required, including protective equipment when risks cannot be eliminated through procedures
– Transitional periods are established allowing continued use of existing stocks: until August 19, 2025 for additives and premixtures, February 19, 2026 for food-producing animals’ feed, and February 19, 2027 for non-food producing animals’ feed

Commission Implementing Regulation (EU) 2025/142 of 29 January 2025 concerning the authorisation of a preparation of 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive for fin fish (holder of authorisation: AB Enzymes Finland Oy)

This Commission Implementing Regulation authorizes the use of 6-phytase, an enzyme produced with Trichoderma reesei CBS 126897, as a feed additive for fin fish. The additive is classified as a zootechnical additive in the functional group of digestibility enhancers, and the authorization holder is AB Enzymes Finland Oy.The regulation consists of two main articles and an annex. Article 1 establishes the authorization of the preparation, while Article 2 sets the entry into force. The detailed conditions of use are specified in the Annex, which includes technical specifications, dosage requirements, and safety measures.Key provisions include:

• The minimum activity requirement of 5,000 FTU/g for the preparation
• Specific dosage requirements: 500 FTU/kg complete feed for salmonids and ornamental fish, and 2,500 FTU/kg for other fin fish
• Safety measures requiring feed business operators to establish operational procedures and use protective equipment when necessary
• The authorization is valid until February 19, 2035
• Storage conditions and stability to heat treatment must be indicated in the directions for use

Commission Implementing Regulation (EU) 2025/151 of 29 January 2025 concerning the renewal of the authorisation of a preparation of Levilactobacillus brevis DSM 21982 as a feed additive for all animal species and repealing Implementing Regulation (EU) No 838/2012

This Commission Implementing Regulation concerns the renewal of authorization for Levilactobacillus brevis DSM 21982 as a feed additive for all animal species. The regulation extends the authorization for another 10 years while maintaining safety standards and introducing specific protective measures for users. It replaces the previous Implementing Regulation (EU) No 838/2012.The regulation consists of 4 articles and an annex. Article 1 renews the authorization, Article 2 repeals the previous regulation, Article 3 establishes transitional measures, and Article 4 sets the entry into force. The Annex provides detailed technical specifications for the additive’s use.Key provisions include:

• The additive remains classified as a ‘technological additive’ in the functional group ‘silage additives’
• The preparation must contain a minimum of 8 × 10¹⁰ CFU/g of the additive
• A minimum dose of 1 × 10⁸ CFU/kg fresh material when used alone
• Mandatory storage conditions must be indicated in the directions for use
• Users must implement safety measures and use protective equipment due to potential skin and respiratory sensitization risks
• A transitional period until February 19, 2026, allows for the use of existing stocks produced under previous rules

Commission Implementing Regulation (EU) 2025/154 of 29 January 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae DSM 34246 as a feed additive for dogs and cats (holder of authorisation: ACEL pharma s.r.l.)

This Commission Implementing Regulation authorizes the use of Saccharomyces cerevisiae DSM 34246 as a feed additive for dogs and cats. The preparation is classified as a zootechnical additive in the functional group of gut flora stabilisers. The authorization holder is ACEL pharma s.r.l.The regulation consists of two main articles and an annex. Article 1 establishes the authorization of the preparation, while Article 2 sets the entry into force. The detailed technical specifications, conditions of use, and safety requirements are laid out in the comprehensive annex. This is a new authorization, not an amendment to previous regulations.Key provisions include:

• The minimum content requirement is 5 × 109 CFU/kg of complete feedingstuff
• The preparation must contain a minimum of 2 × 1010 CFU/g of viable Saccharomyces cerevisiae cells
• Storage conditions and heat treatment stability must be indicated in usage directions
• Safety measures require personal protective equipment for breathing and skin when risks cannot be eliminated through operational procedures
• The authorization is valid until February 19, 2035

Commission Regulation (EU) 2025/147 of 29 January 2025 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of the flavouring substance 4-Methyl-2-phenylpent-2-enal (FL No 05.100) from the Union list

This Commission Regulation amends the EU list of authorized food flavourings by removing the substance 4-Methyl-2-phenylpent-2-enal (FL No 05.100) from the Union list. The removal is based on safety concerns related to potential aneugenicity that could not be ruled out by scientific evaluation.The regulation consists of three main articles and an annex. Article 1 introduces the amendment to Regulation (EC) No 1334/2008, Article 2 establishes transitional measures for foods containing the substance, and Article 3 sets the entry into force. The Annex specifies the deletion of the entry for 4-Methyl-2-phenylpent-2-enal from Part A of Annex I to Regulation (EC) No 1334/2008.Key provisions include:

• Complete removal of 4-Methyl-2-phenylpent-2-enal from the Union list of flavourings
• Transitional measures allowing foods containing this substance that were already placed on the market to be sold until their expiry date
• Special provisions for imported foods in transit before the regulation’s entry into force
• Exclusion of the substance itself and preparations containing it from transitional measures

Commission Implementing Regulation (EU) 2025/153 of 29 January 2025 authorising the placing on the market of Lemna minor and Lemna gibba plants as novel food and amending Implementing Regulation (EU) 2017/2470

This Commission Implementing Regulation authorizes the placing on the market of two aquatic plants – Lemna minor and Lemna gibba – as novel food in the European Union, following their safety assessment by the European Food Safety Authority (EFSA). The regulation also amends the Union list of novel foods established by Implementing Regulation (EU) 2017/2470.The regulation consists of two main articles and an annex. Article 1 authorizes the placing of Lemna minor and Lemna gibba plants on the EU market and provides for their inclusion in the Union list of novel foods. Article 2 establishes the entry into force. The Annex contains detailed specifications for these novel foods, including their characteristics, composition limits, contaminant levels, and microbiological criteria.The key provisions include:

• The plants can be used as vegetables similar to other leafy vegetables, either cooked or added to ready-to-eat products
• A maximum specification level for manganese is set at 6 mg/kg fresh weight
• Detailed specifications for moisture (91-95%), protein (1-4%), carbohydrates (1-3%), dietary fiber (0.5-3%), and other components
• Strict limits for contaminants like nitrates, heavy metals, and microcystins
• Specific microbiological criteria ensuring food safety

Commission Regulation (EU) 2025/158 of 29 January 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in or on certain products

This regulation amends the maximum residue levels (MRLs) for acetamiprid, a pesticide substance, in various food products. The changes are based on a new assessment by the European Food Safety Authority (EFSA) which established lower acceptable daily intake and acute reference dose values for acetamiprid and included its metabolite IM-2-1 in residue definition for fruit and leafy crops.The regulation consists of two articles and an extensive annex that replaces the existing column for acetamiprid in Annex II to Regulation (EC) No 396/2005. The annex provides detailed MRL values for hundreds of different food products grouped into categories like fruits, vegetables, cereals, spices, and animal products.The main changes include lowering MRLs for many products where EFSA identified risks of exceeding safe levels, including various fruits (currants, bananas, cherries, peaches, grapes), vegetables (lettuces, spinaches, tomatoes, peppers), and some animal products. For some products like apples, pears and cucumbers, temporary MRLs were set pending further review within two years.Key provisions include:

• New lower MRLs for many fruits and vegetables where previous levels were found to pose potential risks
• Special provisions for products marked with (+) where additional data is required
• Different residue definitions for animal products versus plant products
• Specific MRLs for processed foods and animal feed products
• Implementation date set for August 19, 2025 to allow adaptation period

Commission Regulation (EU) 2025/146 of 29 January 2025 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for zoxamide in or on certain products

This regulation amends the maximum residue levels (MRLs) for zoxamide, a pesticide substance, in various food products. The main focus is on setting new MRLs for several vegetables, particularly onions, garlic, shallots, and various types of fruits and vegetables. The regulation is based on the European Food Safety Authority’s assessment of consumer safety and agricultural practices.The regulation consists of three main parts: the legal basis and considerations (recitals), the operative part with three articles, and a detailed annex containing specific MRL values for different food products. The changes include new MRL values for potatoes (0.02 mg/kg), tomatoes (2 mg/kg), cucumbers and similar vegetables (2 mg/kg), and specific values for onions, garlic, and shallots (0.7 mg/kg).Key provisions include:

• Setting specific MRLs for various fruits, vegetables, and animal products
• Maintaining existing MRLs for certain products like aubergines/eggplants where additional data review is needed
• Setting default MRLs at the limit of determination (LOD) for products where specific values are not established
• Implementation date of August 19, 2025, with provisions for products already on the market

The regulation provides detailed tables with specific MRL values for hundreds of different food products, organized by categories such as fruits, vegetables, cereals, and animal products. Each product is assigned either a specific MRL value or a default limit of determination (*0.01 mg/kg in most cases).

Commission Implementing Regulation (EU) 2025/150 of 29 January 2025 renewing the approval of the active substance mepiquat chloride in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

This Commission Implementing Regulation concerns the renewal of approval for mepiquat chloride, an active substance used in plant protection products. The regulation extends the approval period for this substance until February 29, 2040, with new conditions for its use and manufacturing specifications.The regulation amends previous legislation by moving mepiquat chloride from Part A to Part B of the Annex to Implementing Regulation (EU) No 540/2011, with updated specifications and conditions. The key changes include removing the restriction to use mepiquat chloride only as a plant growth regulator and eliminating the requirement for Member States to pay special attention to food residues, as consumer risk assessment showed acceptable risk levels.The main provisions include:

• Technical specifications for the substance, requiring ≥990 g/kg purity for dry technical material and 615-665 g/L for technical concentrate
• Specific limitations on the impurity N-methylpiperidine (maximum 3 g/kg or 2 g/L)
• Requirements for Member States to pay particular attention to:
  • The specification of commercially manufactured technical material
  • Operator protection through adequate personal protective equipment
• Implementation of risk mitigation measures where appropriate

Commission Implementing Regulation (EU) 2025/148 of 29 January 2025 concerning the renewal of the authorisation of a preparation of Enterococcus lactis NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation: Chr. Hansen A/S) and repealing Implementing Regulation (EU) No 797/2013

This Commission Implementing Regulation concerns the renewal of authorization for using Enterococcus lactis NCIMB 11181 as a feed additive for calves and weaned piglets. The regulation extends the previous authorization granted in 2013 for another 10 years, until February 2035.The regulation consists of 4 articles and an annex. Article 1 renews the authorization, Article 2 repeals the previous regulation, Article 3 establishes transitional measures, and Article 4 sets the entry into force. The detailed technical specifications are provided in the annex.Key provisions include:

• The additive is classified as a zootechnical additive in the functional group of gut flora stabilisers
• Minimum content requirements are set at 1 × 10¹⁰ CFU/kg feed for piglets and 2 × 10⁹ CFU/kg for calves
• The additive is available in two forms: solid and solid water-soluble
• Specific safety measures are required for handlers, including personal protective equipment for eyes, breathing, and skin
• Transitional periods are established until August 2025 for premixtures and February 2026 for compound feed

The regulation maintains most conditions from the previous authorization but adjusts minimum contents to match effective doses and introduces additional protective measures for users. The European Food Safety Authority confirmed the safety of the additive for target animals, consumers, and the environment.

Commission Implementing Regulation (EU) 2025/159 of 29 January 2025 concerning the renewal of the authorisation of a preparation of Pediococcus pentosaceus DSM 14021 as a feed additive for all animal species and repealing Implementing Regulation (EU) No 84/2014

This Commission Implementing Regulation concerns the renewal of authorization for Pediococcus pentosaceus DSM 14021 as a feed additive for all animal species. The regulation extends the authorization period for this additive, which is used as a silage additive in animal feed, while also repealing the previous Implementing Regulation (EU) No 84/2014.The regulation consists of three main articles and an annex. Article 1 renews the authorization of the preparation, Article 2 repeals the previous regulation, and Article 3 establishes the entry into force. The detailed technical specifications and conditions of use are laid out in the comprehensive annex.Key provisions include:

• The additive must contain a minimum of 1 × 10¹¹ CFU/g
• It can be used for all animal species without age restrictions
• The minimum dose when used alone is 1 × 10⁸ CFU/kg fresh material
• Specific storage conditions must be indicated in the directions for use
• The additive can only be used in easy and moderately difficult to ensile fresh material
• Safety measures require the use of protective equipment for skin, eyes, and breathing when handling the additive
• The authorization is valid until February 19, 2035

Judgment of the Court (Second Chamber) of 30 January 2025.Caronte & Tourist SpA v Autorità Garante della Concorrenza e del Mercato (AGCM).Reference for a preliminary ruling – Competition – Article 102 TFEU – Abuse of dominant position – Empowering national competition authorities to enforce the rules on competition – Directive (EU) 2019/1 – Independence of national competition authorities – Article 4(5) – Setting priorities for the proceedings for the enforcement of Articles 101 and 102 TFEU – Fines on undertakings and associations of undertakings – Article 13 – Procedures for infringement of the rules of competition law – Compliance with a reasonable time limit – National legislation requiring the national authority to issue a statement of objections within a time limit of 90 days of knowledge of the essential elements of the infringement – Automatic annulment in its entirety of the decision of the national competition authority in the event of failure to comply with that time limit – Principle ne bis in idem – Revocation of the power to initiate new infringement proceedings in respect of the same facts – Principle of effectiveness – Rights of defence of undertakings.Case C-511/23.

This judgment concerns the interpretation of EU competition law regarding procedural time limits for national competition authorities. The key points are:1. The case examines whether Italian legislation requiring competition authorities to issue statements of objections within 90 days of discovering potential infringements is compatible with EU law.2. The Court analyzed the relationship between national procedural autonomy and the need for effective enforcement of EU competition rules. The main provisions examined were Article 102 TFEU on abuse of dominant position and Directive 2019/1 on empowering national competition authorities.3. The Court ruled that EU law precludes national legislation that:

• Requires competition authorities to start investigation proceedings within 90 days of discovering potential infringements
• Automatically annuls decisions if this deadline is missed
• Prevents authorities from initiating new proceedings on the same facts

The Court found such rules would undermine competition authorities’ operational independence and create a systemic risk of anti-competitive practices going unpunished, contrary to the effective enforcement of EU competition law.

Judgment of the Court (Eighth Chamber) of 30 January 2025.Giovanni Frajese v European Commission.Appeal – Public health – Medicinal products for human use – Marketing authorisation – Spikevax – Comirnaty – Action for annulment – Independence and impartiality of the Courts of the European Union – Failure to comply with procedural rules – Failure to give adequate reasons, and contradictory reasoning – Legal interest in bringing proceedings – Locus standi – Fourth paragraph of Article 263 TFEU – Right to effective judicial protection.Case C-586/23 P.

This is a judgment of the Court of Justice of the European Union (CJEU) from January 2025 concerning an appeal against a General Court order that dismissed an action seeking annulment of two Commission decisions granting marketing authorizations for COVID-19 vaccines (Spikevax and Comirnaty). The judgment addresses an appeal brought by Giovanni Frajese, a doctor, who challenged the General Court’s order dismissing his action as inadmissible. The CJEU examined four grounds of appeal concerning: (1) alleged lack of independence/impartiality of the General Court judge, (2) procedural issues regarding timing of objections, (3) alleged errors in finding lack of legal interest and standing to bring the case, and (4) alleged violation of right to effective judicial protection. The Court rejected all grounds of appeal, finding that: the judge’s impartiality was not compromised by prior Commission service; procedural objections were timely; the appellant lacked both legal interest and standing as the marketing authorizations did not directly affect his legal position as a doctor; and his right to judicial protection was not violated as other legal remedies remained available through national courts. Key provisions examined included Article 263 TFEU regarding standing requirements for annulment actions, Article 47 of the EU Charter of Fundamental Rights on effective judicial protection, and procedural rules regarding admissibility of actions before EU courts.

Judgment of the Court (Second Chamber) of 30 January 2025.Trenitalia SpA v Autorità Garante della Concorrenza e del Mercato (AGCM).Reference for a preliminary ruling – Consumer protection – Unfair business-to-consumer commercial practices in the internal market – Directive 2005/29/EC – Measures intended to combat such practices – Articles 11 and 13 – Procedures for infringement of the rules of consumer law – Compliance with a reasonable time limit – National legislation requiring the national authority to issue a statement of objections within a time limit of 90 days of knowledge of the essential elements of the infringement – Automatic annulment in its entirety of the decision of the national authority in the event of failure to comply with that time limit – Principle ne bis in idem – Revocation of the power to initiate new infringement proceedings in respect of the same facts – Principle of effectiveness – Rights of defence of undertakings.Case C-510/23.

This judgment concerns the interpretation of EU consumer protection legislation, specifically Directive 2005/29/EC on unfair commercial practices.The case arose from a dispute between Trenitalia and the Italian competition authority (AGCM) regarding penalties imposed for unfair commercial practices in online ticket sales. The key issue was whether Italian law requiring AGCM to issue objections within 90 days of discovering an infringement was compatible with EU law.The Court analyzed the following main aspects:

• Member States have discretion in establishing procedural rules for consumer protection enforcement, but these must not make EU law implementation impossible or excessively difficult
• National authorities need operational independence to prioritize cases and cooperate with other EU authorities
• Time limits must be reasonable and allow proper investigation while respecting defense rights

The Court ruled that EU law precludes national legislation that:

• Requires authorities to start investigation within 90 days of discovering infringement elements
• Automatically annuls decisions if this deadline is missed
• Prevents new proceedings on the same facts

Such rules would undermine effective enforcement of consumer protection and create systemic risk of unfair practices going unpunished.

Decision No 1/2024 of the EU-CTC Joint Committee of 18 October 2024 as regards the amendment of Appendices I and IIIa to the Convention of 20 May 1987 on a common transit procedure [2025/137]

This Decision amends the Convention of 20 May 1987 on a common transit procedure, specifically making changes to Appendices I and IIIa. The key aspects include:1. The Decision adapts the transit procedures to increasing digitalization by:

• Allowing the person presenting goods at departure to request a transit accompanying document
• Removing the obligation to print transit accompanying documents once NCTS is upgraded to version 5
• Allowing transhipments of containers and intermodal transport units without customs intervention under certain conditions

2. The main changes to data requirements include:

• Harmonizing data formats and codes for transit declarations
• Updating data element requirements to align with amendments to EU regulations
• Modifying requirements for customs electronic systems interoperability

3. The Decision also:

• Makes comprehensive guarantee certificates optional and issued only upon request
• Corrects a typographical error in Article 111a(1)
• Updates references to implementing decisions and regulations

The changes aim to modernize and simplify transit procedures while maintaining proper customs control and security measures.

Decision No 1/2024 of the EU-Common Transit Countries Joint Committee established by the Convention on the simplification of formalities in trade in goods of 21 October 2024 as regards an invitation to Georgia to accede to that Convention [2025/198]

This Decision concerns the invitation of Georgia to join the Convention on the simplification of formalities in trade in goods. The Convention aims to simplify procedures and documentation in international trade between participating countries. The Decision was adopted by the EU-Common Transit Countries Joint Committee on October 21, 2024. The Decision consists of two articles. Article 1 formally invites Georgia to accede to the Convention starting from December 1, 2024. Article 2 establishes that the Decision enters into force on the date of its adoption. The key provisions indicate that Georgia’s accession would facilitate trade relations between Georgia and other participating countries, including the European Union, Iceland, North Macedonia, Norway, Serbia, Switzerland, Türkiye, Ukraine, and the United Kingdom. The simplification would affect various formalities related to the movement of goods between these countries. The Decision is based on Article 11(3) of the original Convention from May 20, 1987, which provides the legal basis for inviting new countries to join. This represents an expansion of the geographical scope of the simplified trade formalities system that has been in place since 1987.

Decision No 2/2024 of the EU-Common Transit Countries Joint Committee established by the Convention on a common transit procedure of 21 October 2024 as regards an invitation to Georgia to accede to that Convention [2025/197]

This Decision concerns the invitation of Georgia to join the Convention on a common transit procedure, which establishes unified rules for transporting goods between participating countries. The Decision was adopted by the EU-Common Transit Countries Joint Committee on October 21, 2024.The Decision consists of two articles. Article 1 formally invites Georgia to accede to the Convention starting from December 1, 2024. Article 2 establishes that the Decision enters into force on the date of its adoption.The key provisions of this Decision are straightforward:

• Georgia is officially invited to become a party to the Common Transit Convention
• The accession will facilitate the movement of goods between Georgia and other participating countries (EU, Iceland, North Macedonia, Norway, Serbia, Switzerland, Türkiye, Ukraine, and the United Kingdom)
• The invitation takes effect from December 1, 2024

This Decision expands the geographical scope of the common transit procedure, which allows goods to move more easily between the participating countries under a single transit declaration and a single guarantee. Georgia will become part of this unified customs transit system alongside other non-EU countries that are already members of the Convention.

EFTA Surveillance Authority communication pursuant to Article 17(5) of Regulation 1008/2008 of the European parliament and of the Council on common rules for the operation of air services in the Community – Invitation to tender in respect of the operation of scheduled air services in accordance with public service obligations

This is a communication from EFTA Surveillance Authority regarding a tender for scheduled air services between Reykjavík and Hornafjörður in Iceland. The document outlines the conditions for operating air services under public service obligations according to Regulation 1008/2008.The act consists of several key elements: identification of the route subject to tender (Reykjavík – Hornafjörður – Reykjavík), the contract duration (September 2025 to August 2028 with possible two-year extension), and submission requirements. The document also provides contact information for obtaining detailed tender documentation.The main provisions that are crucial for potential participants include:

• The tender submission deadline is set at two months from the publication date in the Official Journal of the European Union
• The contract includes a possibility of a two-year extension beyond the initial three-year term
• All relevant documentation can be obtained from Vegagerðin (The Icelandic Road and Coastal Administration)
• The tender is managed under the framework of Regulation 1008/2008 on common rules for air services operation in the Community

Judgment of the Court of 22 October 2024 in Case E-5/24 – EFTA Surveillance Authority v Iceland (Failure by an EFTA State to fulfil its obligations – Failure to implement – Regulation (EU) 2018/1212 – Shareholder identification – Transmission of information – Facilitation of the exercise of shareholders rights)

The judgment concerns the failure of Iceland to implement Commission Implementing Regulation (EU) 2018/1212 into its national legislation. This Regulation establishes minimum requirements for shareholder identification, information transmission, and facilitation of shareholders’ rights exercise in the context of corporate governance.The Court’s judgment consists of two main operative parts. First, it declares that Iceland has failed to fulfill its obligations under Article 7 of the EEA Agreement by not incorporating the Regulation into its internal legal order. Second, it orders Iceland to bear the costs of the proceedings.The Regulation in question (2018/1212) implements the provisions of Directive 2007/36/EC and sets minimum standards for three key areas of corporate governance:

• Procedures for identifying shareholders
• Systems for transmitting information between companies and their shareholders
• Measures to facilitate the exercise of shareholders’ rights

The judgment specifically addresses Iceland’s failure to implement these requirements, which are designed to enhance corporate transparency and shareholder engagement in companies listed on regulated markets. The Court’s decision emphasizes the binding nature of EEA Agreement obligations and the requirement for EFTA states to properly implement agreed-upon regulations.

Judgment of the Court of 22 October 2024 in Case E-4/24 – EFTA Surveillance Authority v Iceland (Failure by an EFTA State to fulfil its obligations – Failure to implement – Directive (EU) 2017/828 – Encouragement of long-term shareholder engagement)

This judgment concerns a case where the EFTA Surveillance Authority took legal action against Iceland for failing to implement Directive (EU) 2017/828 on long-term shareholder engagement. The Court found Iceland in breach of its obligations under the EEA Agreement.The judgment consists of two main operative parts: first, declaring Iceland’s failure to implement the Directive within the prescribed timeframe, and second, ordering Iceland to bear the costs of the proceedings. The case was decided by a three-judge panel of the EFTA Court.The underlying Directive 2017/828 that Iceland failed to implement is aimed at amending the previous Directive 2007/36/EC to encourage long-term shareholder engagement in European companies. The judgment represents a straightforward declaration of non-compliance with implementation obligations.Key provisions of the judgment focus on Iceland’s specific breach of its obligations under point 10g of Annex XXII to the EEA Agreement and Article 7 of the EEA Agreement. The Court’s decision was unequivocal in finding that Iceland had failed to adopt the necessary implementation measures within the required timeframe.

Judgment of the Court of 22 October 2024 in Case E-6/24 – EFTA Surveillance Authority v Iceland (Failure by an EFTA State to fulfil its obligations – Failure to implement – Regulation (EU) 2021/1042 – System of interconnection of registers)

This judgment concerns the implementation of EU regulations regarding the interconnection of business registers across European countries. The Court found that Iceland failed to incorporate Commission Implementing Regulation (EU) 2021/1042 into its national law as required by the EEA Agreement.The structure of the judgment is straightforward, containing two main operative parts: the declaration of Iceland’s failure to fulfill its obligations and the order regarding costs. The regulation in question replaces the previous Implementing Regulation (EU) 2020/2244 and provides technical specifications for connecting national business registers.The key provisions of this judgment are:

• Iceland’s violation of Article 7 of the EEA Agreement by not implementing Regulation 2021/1042 into its domestic legal system
• The regulation itself concerns technical specifications and procedures for interconnecting business registers across EEA member states
• Iceland is ordered to bear all costs associated with the legal proceedings