Review of the EU legislation for 28/01/2025

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

1. EU School Scheme Amendment:
   Simplifies reporting requirements for Member States distributing fruit, vegetables, and milk in schools. Removes requirements to report average prices and stakeholder information while maintaining core reporting on funds used, participation numbers, and product quantities.
2. Geographical Indication Registrations:
   – ‘Trnavský slad’ from Slovakia receives Protected Geographical Indication status
   – ‘Ġbejna tan-nagħaġ’ from Malta receives Protected Designation of Origin status
   – Amendment approved for Spain’s ‘Espárrago de Huétor-Tájar’ PGI specification
3. Sanctions Updates:
   – Removal of one individual (Abdelhafiz ZLITNI) from Libya sanctions list
   – Addition of three Russian military officers to cyber-attacks sanctions list for attacks against Estonian systems
4. Technical Regulations:
   – Corrections to multiple language versions of regulation on analytical methods for detecting residues in food-producing animals
   – Amendment to approval conditions for plant protection substance from Lupinus albus seeds, setting new alkaloid limits
   – Establishment of procedural rules for joint scientific consultations on medical devices, including submission processes and expert selection
5. Transit Convention Amendment:
   Updates guarantee forms and adds Georgian language versions of customs terms in preparation for Georgia’s accession to the common transit procedure convention.

Review of each of legal acts published today:

Commission Delegated Regulation (EU) 2025/162 of 25 November 2024 amending Delegated Regulation (EU) 2017/40 as regards the monitoring of the implementation of the Union aid scheme for the supply of fruit and vegetables, bananas and milk in educational establishments

This Regulation amends the monitoring requirements for the EU school scheme that provides fruit, vegetables, bananas, and milk to educational establishments. The act simplifies reporting requirements for Member States by removing certain non-essential information from mandatory annual monitoring reports. It specifically modifies Article 9 of Delegated Regulation (EU) 2017/40.The structure of the act is straightforward, containing two main articles. Article 1 replaces paragraph 3 of Article 9 in the original Regulation, while Article 2 establishes the entry into force provisions. The key change is the removal of requirements to report on average prices of portions and information about authorities and stakeholders involved, while simplifying reporting on delivery frequency.The main provisions that remain mandatory for Member States’ annual monitoring reports include:

• Information about funds used for supply and distribution of product groups
• Number of participating educational establishments and children
• Average portion size and number of delivered portions
• Quantities of products supplied by product groups
• Information about additional products included in educational measures
• Types of communication and accompanying measures implemented

Commission Implementing Regulation (EU) 2025/131 of 21 January 2025 on the registration of the geographical indication Trnavský slad (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 ‘Trnavský slad’ (PGI – Protected Geographical Indication) in the EU register of geographical indications. The regulation implements Slovakia’s application for protecting this specific product name under the EU quality schemes system.The regulation consists of two main articles. Article 1 formally enters ‘Trnavský slad’ into the Union register of geographical indications, while Article 2 establishes that the regulation becomes effective twenty days after its publication in the Official Journal of the EU.The regulation follows a standard procedure for geographical indication registration: Slovakia submitted the application under the previous Regulation (EU) No 1151/2012, it was published in the Official Journal, and no opposition was received during the designated period. The registration is made under the new Regulation (EU) 2024/1143, which now governs geographical indications for wine, spirit drinks, agricultural products, and traditional specialties guaranteed.Key aspects of this regulation include:

• The successful completion of the application process without any opposition
• The transition from the old regulatory framework (Regulation 1151/2012) to the new one (Regulation 2024/1143)
• The formal protection of ‘Trnavský slad’ as a Protected Geographical Indication across the entire European Union

Council Implementing Regulation (EU) 2025/190 of 27 January 2025 implementing Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya

This is a Council Implementing Regulation that modifies the existing EU sanctions regime concerning Libya. The act removes one specific person from the list of individuals subject to restrictive measures, following a decision by the UN Security Council Committee.The regulation consists of two main articles and an annex. Article 1 introduces amendments to Annex II of the base Regulation (EU) 2016/44, while Article 2 establishes the entry into force provision. The Annex specifically deletes entry number 20, concerning an individual named Abdelhafiz ZLITNI, from Part A (‘Persons’) of Annex II to Regulation 2016/44.The key provision of this implementing regulation is the removal of one specific individual from the EU sanctions list related to Libya. This means that the restrictive measures previously applied to this person are no longer in effect. The regulation maintains the overall sanctions framework established by Regulation (EU) 2016/44 but updates the list of designated persons in line with UN Security Council decisions.

Commission Implementing Regulation (EU) 2025/127 of 27 January 2025 correcting certain language versions of Implementing Regulation (EU) 2021/808 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling

This Regulation corrects errors in various language versions of Implementing Regulation (EU) 2021/808, which deals with analytical methods for detecting residues of pharmacologically active substances in food-producing animals. The corrections are technical in nature and focus on specific definitions and calculations.The act addresses errors found in multiple language versions (Bulgarian, Croatian, Czech, Danish, Estonian, German, Irish, Polish, Portuguese, Slovak, Slovenian, and Spanish) of the original regulation. The corrections primarily concern the definition of ‘decision limit for confirmation (CCα)’ and calculations related to CCα and detection capability for screening (CCβ).The main provisions requiring correction are:

• Article 2, second paragraph, point (14) – definition of ‘decision limit for confirmation (CCα)’
• Article 5(2) – provisions concerning CCα
• Points 2.6 and 2.7 of Annex I – calculations related to CCα and CCβ

These corrections are crucial for ensuring accurate analytical methods and proper interpretation of results when testing for pharmacologically active substances in food-producing animals. The English language version remains unchanged, as it was not affected by these errors.

Commission Implementing Regulation (EU) 2025/136 of 21 January 2025 approving a non-minor amendment to the product specification of the protected geographical indication Espárrago de Huétor-Tájar pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council

This Regulation approves a non-minor amendment to the product specification of the protected geographical indication (PGI) ‘Espárrago de Huétor-Tájar’ (Huétor-Tájar Asparagus). The amendment was requested by Spain and processed under the new EU geographical indications framework established by Regulation (EU) 2024/1143.The Regulation consists of two articles: Article 1 approves the amendment to the product specification for the Huétor-Tájar Asparagus PGI, while Article 2 establishes that the Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.The key aspects of this legal act include:

• The amendment application was originally submitted under the previous Regulation (EU) No 1151/2012 but was processed under the new framework
• The amendment was published in the Official Journal of the European Union for potential oppositions
• No statements of opposition were received during the established period
• The amendment was approved without any modifications to the original request

Commission Implementing Regulation (EU) 2025/135 of 21 January 2025 on the registration of the geographical indication Ġbejna tan-nagħaġ (PDO) 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 ‘Ġbejna tan-nagħaġ’ as a Protected Designation of Origin (PDO) in the EU register of geographical indications. The regulation implements the registration process for this Maltese product under the new EU framework for geographical indications.The regulation consists of two main articles. Article 1 formally enters ‘Ġbejna tan-nagħaġ’ into the Union register of geographical indications, while Article 2 establishes that the regulation enters into force twenty days after its publication in the Official Journal of the European Union.The registration process followed the standard procedure where Malta submitted the application under the previous Regulation (EU) No 1151/2012, which was then processed under the new Regulation (EU) 2024/1143. No opposition to this registration was received during the designated period, allowing the Commission to proceed with the registration.Key aspects of this regulation include:

• The registration is based on the new EU framework for geographical indications (Regulation 2024/1143)
• The application was originally submitted under the previous regulation but processed under the new rules
• The registration process was completed without any opposition from other parties
• The protection applies across all EU Member States

Council Implementing Regulation (EU) 2025/173 of 27 January 2025 implementing Regulation (EU) 2019/796 concerning restrictive measures against cyber-attacks threatening the Union or its Member States

This Council Implementing Regulation amends the EU’s restrictive measures framework against cyber-attacks by adding three Russian military officers to the sanctions list. The regulation specifically targets individuals responsible for significant cyber-attacks against Estonia’s computer systems and classified information storage in 2020.The regulation modifies Annex I of Regulation (EU) 2019/796 by adding three new entries under the section ‘A. Natural persons’. The listed individuals are officers of military unit 29155 of the Main Directorate of the General Staff of the Armed Forces of the Russian Federation (GRU): Nikolay Alexandrovich Korchagin, Vitaly Shevchenko, and Yuriy Fedorovich Denisov.The key provisions detail that these individuals were involved in cyber-attacks aimed at collecting data from multiple Estonian institutions’ systems, targeting cyber security policy information, state cyber capabilities, sensitive personal data, and other classified information. The attacks were conducted with the intention of threatening Estonia’s security and affected its allies and partners.The regulation emphasizes that these cyber-attacks constitute a significant external threat to a Member State, warranting the implementation of restrictive measures. Each entry includes detailed identifying information about the individuals, including their date of birth, nationality, gender, and their association with the GRU, along with specific reasons for their listing.

Commission Implementing Regulation (EU) 2025/119 of 24 January 2025 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus

This Commission Implementing Regulation amends the conditions of approval for the low-risk active substance aqueous extract from germinated seeds of sweet Lupinus albus, which is used in plant protection products. The regulation specifically updates technical specifications regarding the maximum content of quinolizidine alkaloids and establishes lupanine as a marker compound.The regulation modifies Implementing Regulation (EU) No 540/2011 by updating two main aspects in Part D of its Annex. First, it sets specific requirements for purity, including a BLAD protein content of 195-210 g/kg and maximum levels for quinolizidine alkaloids (0.05 g/kg total, with lupanine specifically limited to 0.035 g/kg). Second, it updates provisions requiring Member States to ensure proper labeling instructions for foaming and stability of dilutions.Key provisions include:

• Establishment of specific maximum content levels for quinolizidine alkaloids
• Introduction of lupanine as a marker compound with defined limits
• Requirements for Member States to amend or withdraw authorizations for non-compliant products
• A grace period of up to 15 months for Member States to implement changes
• Detailed technical specifications for the manufactured substance

Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices

This Regulation establishes detailed procedural rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices in the EU. It sets up a framework for cooperation between Member States, health technology developers, and expert panels to exchange information and provide guidance on clinical studies and assessments.The Regulation’s structure includes three main components: rules for submitting consultation requests, procedures for selecting and consulting with experts and stakeholders, and provisions for information exchange between relevant parties when consultations are conducted in parallel with expert panels.Key provisions include:

• The Coordination Group must set at least three request periods per year for joint scientific consultations
• Health technology developers can submit requests through an IT platform during designated periods
• A detailed process for selecting and involving individual experts, including patients and clinical specialists
• Requirements for documentation and information exchange between parties
• Rules on handling personal data and maintaining professional secrecy
• Specific procedures for parallel consultations with expert panels

The most important operational aspects include:

• Mandatory use of standardized templates and the HTA IT platform for all communications
• Clear timelines for submission and review of documentation
• Detailed requirements for meetings between developers and experts
• Specific provisions for protecting confidential information and personal data
• 15-year retention period for relevant documentation

Decision No 3/2024 of the EU-CTC Joint Committee of 5 November 2024 as regards the amendment of Appendices III and IIIa to the Convention on a common transit procedure concerning the accession of Georgia [2025/174]

This Decision amends the Convention on a common transit procedure in connection with Georgia’s accession to it. The act primarily deals with updating guarantee forms and adding Georgian language versions of various customs-related terms and references used in the Convention.The Decision consists of two main articles and an extensive Annex. Article 1 introduces amendments to Appendices III and IIIa of the Convention. Article 2 establishes the application timeline and transition period for using existing forms.The Annex contains detailed modifications to several guarantee forms (C1, C2, C4) and adds Georgian translations to various customs terms in Appendix IIIa. The main changes include:

• Adding Georgia to the list of countries in guarantee forms
• Updating the maximum amounts and conditions for different types of guarantees
• Including Georgian language versions of standard customs terminology
• Setting transitional provisions for existing forms until June 30, 2026

Key provisions for practical implementation include:

• The Decision applies from the date Georgia becomes a contracting party
• Existing guarantee forms can be used until June 30, 2026 with necessary adaptations
• New guarantee forms must include Georgia in the list of participating countries
• All customs documentation must accommodate Georgian language versions