Commission Implementing Regulation (EU) 2025/2243
This regulation specifies how eFTI (electronic Freight Transport Information) platforms must function to ensure secure and interoperable exchange of regulatory transport data across the EU. Competent authorities can access data securely via eFTI Gates. The regulation requires robust user authentication using electronic identification (Regulation (EU) No 910/2014) and mandates data processing based on uniquely identified eFTI Consignment Movement Data Sets (CMDS), as defined by Delegated Regulation (EU) 2024/2024. eFTI platforms must connect securely with the digital waste shipment system (DIWASS) for waste shipment information exchange. The regulation also ensures data security and business users receive notifications on data access requests.
Commission Implementing Regulation (EU) 2025/2276
This regulation amends Council Regulation (EC) No 881/2002 by updating the identifying data for Abd El Kader Mahmoud Mohamed El Sayed, an individual listed for sanctions related to ISIL (Da’esh) and Al-Qaida. The key change is the inclusion of information that he was sentenced to 8 years imprisonment in Italy on 2.2.2004. EU member states must take this into account when implementing restrictive measures against him.
Commission Implementing Regulation (EU) 2025/2221
This regulation amends Implementing Regulation (EU) 2023/364, updating the Union authorization for Ecolab Deutschland GmbH’s ‘IPA Family 1’ biocidal products. It includes administrative changes to instructions for use, trade names, formulators, and active substance manufacturers. The updated Annex II provides a consolidated summary of product characteristics.
Commission Implementing Regulation (EU) 2025/2233
This regulation authorizes the placing on the market of *Clostridium butyricum* TO-A as a novel food in the EU. It amends Implementing Regulation (EU) 2017/2470 to include it in the Union list. It specifies that *Clostridium butyricum* TO-A can only be used in food supplements (excluding those for infants, young children, and pregnant or lactating women). Maximum levels vary by age group. The labelling must specify that it is a novel food and state that the food supplements should not be consumed by pregnant and lactating women, infants and children under 3 years of age, and other age groups depending on the target demographic.
Commission Implementing Regulation (EU) 2025/2235
This regulation amends Implementing Regulation (EU) 2025/1082, reinforcing plant health rules for unrooted cuttings of Calibrachoa spp., Petunia spp., and their hybrids imported from Kenya. It now includes non-EU isolates of Potato virus S and Potato virus X as specified pests, triggering stricter inspection and testing requirements. Importers and producers must include these viruses in their testing and inspection protocols.
Decision No 4/2025
This decision amends the Convention on a common transit procedure to include the Republic of Moldova as a contracting party. It updates the guarantee forms used in transit procedures to include Moldova and sets a transitional period for using older versions of these forms, which must be adapted geographically and with respect to addresses for service or authorized agents until the end of 2026. Ukraine is included in the list of countries covered by the guarantee forms.
Review of each of legal acts published today:
Commission Implementing Regulation (EU) 2025/2243 of 6 November 2025 laying down detailed specifications regarding the functional requirements for eFTI platforms in accordance with Regulation (EU) 2020/1056 of the European Parliament and of the Council
This is a description of the provisions of the Commission Implementing Regulation (EU) 2025/2243 of 6 November 2025 laying down detailed specifications regarding the functional requirements for eFTI platforms in accordance with Regulation (EU) 2020/1056 of the European Parliament and of the Council.
This regulation sets out the detailed functional requirements for eFTI (electronic Freight Transport Information) platforms, which are essential for the electronic exchange of regulatory transport information between economic operators and competent authorities within the EU. It aims to ensure interoperability, security, and transparency in the processing of freight transport data. The regulation facilitates the re-use of existing ICT solutions, promotes data security, and ensures seamless communication between eFTI platforms and the systems used by competent authorities.
The regulation is structured into five chapters and an annex:
* **Chapter I (General Provisions):** Defines key terms such as ‘ICT system’, ‘eFTI data’, ‘eFTI platform operator’, ‘business user’ and other terms relevant to the regulation.
* **Chapter II (Access to eFTI Platforms):** Specifies how competent authorities and business users can access eFTI platforms, emphasizing secure and authenticated connections. It details the functionalities required for user identification, authentication, and authorization.
* **Chapter III (Data Processing on eFTI Platforms):** Focuses on the management and processing of eFTI data, including the creation, editing, reading, and archiving of eFTI Consignment Movement Data Sets (CMDS). It also outlines the processing operations business users can perform and the necessary data validation checks.
* **Chapter IV (Availability, Security and Resilience Measures):** Sets out requirements for the availability, security, and resilience of eFTI platforms, including measures for data storage, protection against physical damage, and data recovery.
* **Chapter V (Final Provisions):** States that the regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
* **Annex:** Provides a detailed table describing the processing operations on eFTI data that business users can perform and the corresponding actions that eFTI platforms must execute to ensure the completion of those operations.
Key provisions of the regulation include:
* **Secure Access:** eFTI platforms must ensure that competent authorities can only access eFTI data via secure, machine-to-machine communication through eFTI Gates.
* **User Authentication and Authorization:** The regulation mandates robust mechanisms for identifying, authenticating, and authorizing business users, including the use of electronic identification means compliant with Regulation (EU) No 910/2014.
* **Data Processing Requirements:** eFTI platforms must manage data processing based on uniquely identified eFTI CMDS, complying with the definitions and technical characteristics established by Delegated Regulation (EU) 2024/2024.
* **Interoperability with DIWASS:** To facilitate waste shipment information exchange, eFTI platforms must establish secure connections with the digital waste shipment system (DIWASS).
* **Transparency and Notifications:** Business users are entitled to receive notifications and reports on requests for access to eFTI data by competent authorities and related follow-up communications.
* **Data Security:** eFTI platform operators must implement measures to ensure the security and preservation of stored data, adhering to international best practices and standards on data privacy and data security.
Compared to previous versions or the overarching Regulation (EU) 2020/1056, this implementing regulation provides much more specific and technical details on how eFTI platforms should function. It elaborates on the technical aspects of data exchange, security protocols, and user access management, which were not as thoroughly defined in the original regulation.
The most important provisions for users are those concerning access to eFTI platforms, data processing requirements, and security measures. These provisions ensure that data is securely exchanged, that users are properly authenticated and authorized, and that the data processed complies with the established standards. The requirements for interoperability with DIWASS are also crucial for economic operators involved in waste shipments, as they streamline the process of providing regulatory information.
Commission Implementing Regulation (EU) 2025/2276 of 5 November 2025 amending for the 352nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da’esh) and Al-Qaida organisations
This Commission Implementing Regulation (EU) 2025/2276 amends Council Regulation (EC) No 881/2002, which imposes specific restrictive measures against individuals and entities associated with ISIL (Da’esh) and Al-Qaida. The amendment updates the identifying data of one listed individual, Abd El Kader Mahmoud Mohamed El Sayed, to reflect new information regarding his legal status and reported death.
The regulation consists of two articles and an annex. Article 1 states that Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this regulation. Article 2 specifies that the regulation comes into force on the day following its publication in the Official Journal of the European Union. The Annex contains the specific amendment, replacing the previous identifying data for Abd El Kader Mahmoud Mohamed El Sayed with updated information. The key change is the inclusion of the fact that he was sentenced to 8 years imprisonment in Italy on 2.2.2004.
The most important provision is the updated information in the Annex regarding Abd El Kader Mahmoud Mohamed El Sayed. This updated information must be taken into account by EU member states when implementing the restrictive measures outlined in Council Regulation (EC) No 881/2002.
Commission Implementing Regulation (EU) 2025/2221 of 31 October 2025 amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA Family 1
This Commission Implementing Regulation (EU) 2025/2221 amends Implementing Regulation (EU) 2023/364, which granted a Union authorization to Ecolab Deutschland GmbH for the biocidal product family ‘IPA Family 1’. The amendment incorporates administrative changes regarding the product’s instructions for use, trade names, formulators, and active substance manufacturers. The Commission has reviewed the changes proposed by Ecolab Deutschland GmbH and agrees with the European Chemicals Agency (ECHA) that these are administrative in nature and do not affect the product’s compliance with safety requirements. To ensure clarity, the regulation replaces Annex II of Regulation (EU) 2023/364 in its entirety, providing an updated summary of the biocidal product characteristics.
The structure of the act is straightforward. It consists of a preamble that outlines the reasons for the amendment, followed by two articles. Article 1 states that Annex II to Implementing Regulation (EU) No 2023/364 is replaced by the text in the Annex to this Regulation. Article 2 specifies that the regulation will come into force twenty days after its publication in the Official Journal of the European Union. The Annex contains the updated summary of product characteristics for the biocidal product family ‘IPA Family 1’. The main provisions include the clarification of instructions for use, addition of new trade names, the removal and addition of biocidal product formulators and the addition of active substance manufacturers.
The most important provision is the updated Annex II, which provides a consolidated summary of the biocidal product characteristics, incorporating all the administrative changes. This includes detailed information on the product’s composition, authorized uses, hazard and precautionary statements, and instructions for safe disposal. For users and interested parties, this updated summary is crucial as it provides the most current and accurate information for the safe and effective use of the ‘IPA Family 1’ biocidal products.
Commission Implementing Regulation (EU) 2025/2233 of 6 November 2025 authorising the placing on the market of Clostridium butyricum TO-A as a novel food and amending Implementing Regulation (EU) 2017/2470
This Commission Implementing Regulation (EU) 2025/2233 authorises the placing on the market of *Clostridium butyricum* TO-A as a novel food within the European Union. It amends Implementing Regulation (EU) 2017/2470 to include this novel food in the Union list. The regulation specifies conditions of use, labelling requirements, and data protection measures for *Clostridium butyricum* TO-A.
The regulation consists of four articles and an annex.
* **Article 1** authorises the placing on the market of *Clostridium butyricum* TO-A within the Union and mandates its inclusion in the Union list of novel foods as set out in Implementing Regulation (EU) 2017/2470. It also states that the annex to Implementing Regulation (EU) 2017/2470 is amended according to the annex of this regulation.
* **Article 2** grants exclusive rights to TOA Biopharma Co. Ltd. to place the novel food on the market for five years, unless another applicant obtains authorisation without relying on TOA Biopharma’s protected data or with their agreement.
* **Article 3** protects the scientific data provided by TOA Biopharma Co. Ltd. for five years, preventing its use by subsequent applicants without the company’s consent.
* **Article 4** specifies that the regulation will enter into force twenty days after its publication in the Official Journal of the European Union.
* The **Annex** amends Implementing Regulation (EU) 2017/2470 by adding *Clostridium butyricum* TO-A to the list of authorised novel foods. It details the conditions of use, maximum levels, specific labelling requirements, and specifications for the novel food.
The most important provisions for practical use are those specifying the conditions of use and labelling requirements for *Clostridium butyricum* TO-A. It can only be used in food supplements, excluding infants and young children, and pregnant and lactating women. The maximum levels vary depending on the age group: 1.0 × 108 CFU/day for children (3 to < 10 years), 2.0 × 108 CFU/day for adolescents (10 to < 14 years), 2.8 × 108 CFU/day for adolescents (14 to < 18 years), and 3.2 × 108 CFU/day for adults, excluding pregnant and lactating women. The labelling must include the designation of the novel food and a statement that the food supplements should not be consumed by pregnant and lactating women, infants and children under 3 years of age, and other age groups depending on the target demographic.
Commission Implementing Regulation (EU) 2025/2235 of 6 November 2025 amending Implementing Regulation (EU) 2025/1082 as regards Potato virus S and Potato virus X as specified pests for unrooted cuttings for planting of Calibrachoa spp., Petunia spp. and their hybrids from Kenya
This Commission Implementing Regulation (EU) 2025/2235 amends Implementing Regulation (EU) 2025/1082 regarding specific plant health rules for importing unrooted cuttings of Calibrachoa spp., Petunia spp., and their hybrids from Kenya into the EU. The amendment is triggered by the European Food Safety Authority’s (EFSA) identification of Potato virus S and Potato virus X as relevant pests for these plants. The Regulation aims to protect the EU territory from the introduction and spread of these viruses by updating the list of specified pests and reinforcing inspection and testing requirements.
The Regulation consists of two articles and one annex. Article 1 details the amendments to Implementing Regulation (EU) 2025/1082, specifically: updating the definition of ‘specified pests’ to include non-EU isolates of Potato virus S and Potato virus X; modifying the requirements for official inspections of plants grown from the specified cuttings, including sampling and molecular testing for the newly identified viruses; and adjusting Annex I to include molecular testing for Potato virus S and Potato virus X in the exporting country (Kenya) before the first lot of unrooted cuttings is exported to the EU. Article 2 states that the Regulation will enter into force twenty days after its publication in the Official Journal of the European Union and is binding in its entirety and directly applicable in all Member States.
The most important provisions for practical use are those that impose new obligations concerning sampling, molecular testing and inspections of the specified plants to address the risk of Potato virus S and Potato virus X. Specifically, the inclusion of Potato virus S and Potato virus X in the list of ‘specified pests’ in Article 1(1), the updated inspection requirements in Article 3(4) of the amended regulation, and the new testing requirements outlined in points 1(b)(vi) and 1(c)(i) of Annex I. These changes mean that importers and producers dealing with unrooted cuttings of Calibrachoa and Petunia from Kenya must ensure that these viruses are included in their testing and inspection protocols to comply with EU law.
DECISION No 4/2025 OF THE EU-COMMON TRANSIT COUNTRIES JOINT COMMITTEE of 19 September 2025 as regards the amendments of Appendix III to the Convention on a common transit procedure for the accession of the Republic of Moldova [2025/2255]
Here’s a breakdown of the key aspects of Decision No 4/2025:
**1. Essence of the Act:**
This decision amends Appendix III of the Convention on a common transit procedure to include the Republic of Moldova as a contracting party. It updates the guarantee forms used in transit procedures to include Moldova and sets a transitional period for using older versions of these forms. The decision ensures that guarantees are valid in Moldova and that existing forms can be adapted for continued use.
**2. Structure and Main Provisions:**
* **Article 1:** Formally amends Appendix III of the Convention as detailed in the Annex.
* **Article 2:**
* Specifies that the decision takes effect when Moldova becomes a contracting party to the Convention.
* Allows the use of older versions of guarantee forms (Annexes C1, C2, C4, C5, and C6) until December 31, 2026, provided they are adapted geographically and with respect to addresses for service or authorized agents.
* **Annex:**
* Replaces Annex C1 with a new version of the “Guarantor’s Undertaking – Individual Guarantee” form, which now includes the Republic of Moldova in the list of countries where the guarantee is valid.
* Replaces Annex C2 with a new version of the “Guarantor’s Undertaking – Individual Guarantee in the Form of Vouchers” form, which now includes the Republic of Moldova in the list of countries where the guarantee is valid.
* Replaces Annex C4 with a new version of the “Guarantor’s Undertaking – Comprehensive Guarantee” form, which now includes the Republic of Moldova in the list of countries where the guarantee is valid.
* Amends Annex C5 by adding “MOLDOVA” in box 7, which likely pertains to a list of countries or regions relevant to the form.
* Amends Annex C6 by adding “MOLDOVA” in box 6, which likely pertains to a list of countries or regions relevant to the form.
**3. Main Provisions for Practical Use:**
* **Inclusion of Moldova:** The most significant change is the inclusion of the Republic of Moldova in the list of countries covered by the guarantee forms. This means that the common transit procedure now applies to goods moving to, from, or through Moldova.
* **Transitional Period:** The allowance to use older versions of the forms until the end of 2026 provides flexibility for businesses and customs authorities to adapt to the new requirements without immediately needing to replace all existing forms.
* **Adaptation Requirements:** Users must ensure that older forms used during the transitional period are adapted to include Moldova geographically and that the address for service or authorized agent information is updated as necessary.
**** This act is directly related to Ukraine because it includes Ukraine in the list of countries covered by the guarantee forms.
