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    Review of the EU legislation for 22/07/2025

    Here’s a breakdown of the EU legislation you provided:

    Commission Delegated Regulation (EU) 2025/695

    This regulation sets harmonized standards for anchor devices and safety hooks used in construction. Manufacturers must declare essential performance characteristics like mechanical resistance via dynamic and breaking load tests. For products with safety hooks, a “hook base test” is also required. The regulation establishes minimum performance thresholds and a classification system for mechanical resistance, ensuring safety and reliability across the EU.

    Commission Directive (EU) 2025/1442

    This directive amends Directive 2006/111/EC by removing the obligation for Member States to submit annual financial reports on public undertakings operating in the manufacturing sector with a turnover exceeding EUR 250 million. It streamlines reporting requirements to reduce administrative burdens for national administrations and public undertakings.

    Council Implementing Regulation (EU) 2025/1474

    This regulation amends Regulation (EU) 2017/1770 by removing “MAÏGA, Choguel” from the list of individuals subject to restrictive measures related to the situation in Mali. Consequently, any sanctions like asset freezes or travel bans previously imposed on this individual are now lifted.

    Commission Implementing Regulation (EU) 2025/1467

    This regulation implements Regulation (EU) 2024/1938 by establishing technical specifications for the EU Substances of Human Origin (SoHO) Platform. The platform facilitates information exchange concerning SoHO for human application. It outlines rules for maintenance, accessibility, security, and usage, including personal data protection and contingency arrangements for system failures. The platform’s user interface will be in English.

    Commission Implementing Regulation (EU) 2025/1447

    This regulation amends Implementing Regulation (EU) 2019/627, updating official control arrangements for products of animal origin. Key changes include extending controls to game-handling establishments, clarifying responsibilities for checking food chain information, updating disease-free status references, refining post-mortem inspection procedures to reduce cross-contamination, and updating health mark requirements and abbreviations. It aims to ensure compliance with updated animal health rules.

    Commission Implementing Regulation (EU) 2025/1492

    This regulation classifies a lumbar support belt under CN code 6212 90 00, distinguishing it from orthopaedic appliances. This classification affects applicable tariffs and customs procedures for importers and exporters.

    Decision No 1/2025 of the EU-Ukraine Association Committee in Trade Configuration

    This decision modifies the Association Agreement between the EU and Ukraine by integrating Ukraine further into the EU’s internal market regarding roaming on public mobile communications networks. It grants Ukraine additional time to implement specific articles of Directive (EU) 2018/1972 due to the ongoing war with Russia. It also clarifies which EU legislation provisions are relevant for Ukraine’s regulatory approximation in the roaming service subsector, ensuring consistency and legal certainty, prioritising EU regulation texts in the event of discrepancies.

    Review of each of legal acts published today:

    Commission Delegated Regulation (EU) 2025/695 of 9 April 2025 supplementing Regulation (EU) No 305/2011 of the European Parliament and of the Council by establishing threshold levels and classes of performance for permanent anchor devices and safety hooks

    This Commission Delegated Regulation (EU) 2025/695 establishes specific requirements for permanent anchor devices and safety hooks used in construction. It defines the essential performance characteristics that manufacturers must declare when placing these products on the market, sets minimum performance thresholds, and establishes a classification system for mechanical resistance. This regulation aims to ensure the safety and reliability of these devices by providing clear and harmonized performance standards across the European Union.

    The Regulation consists of 5 articles and an annex. Article 1 defines the subject matter and scope of the regulation, linking it to the European Product Standard EN 17235:2024. Article 2 specifies the essential characteristics that manufacturers must declare in the declaration of performance, including ‘mechanical resistance – dynamic test’ and ‘mechanical resistance – breaking load test’ for all devices, and additionally ‘mechanical resistance – hook base test’ for products with safety hooks. Article 3 establishes threshold levels for ‘mechanical resistance – dynamic test’ and ‘mechanical resistance – hook base test’. Article 4 defines the classes of performance for ‘mechanical resistance – dynamic test’, with specific values detailed in the Annex. Article 5 states the entry into force of the regulation. The Annex provides tables that detail the threshold levels and classes of performance for different types of anchor kits (A, B, C, and D) based on EN 17235:2024.

    The most important provisions for manufacturers and users are those concerning the mandatory declaration of essential characteristics (Article 2), the threshold levels (Article 3), and the classes of performance (Article 4 and Annex). Manufacturers must ensure that their products meet the specified threshold levels and accurately declare the performance classes in their documentation. This information is crucial for users to select appropriate and safe anchor devices and safety hooks for their specific applications.

    Commission Directive (EU) 2025/1442 of 18 July 2025 amending Directive 2006/111/EC regarding reporting obligations

    This Commission Directive (EU) 2025/1442 amends Directive 2006/111/EC, focusing on reducing administrative burdens related to reporting obligations for Member States concerning the financial relations between public authorities and public undertakings. The key change is the deletion of Article 8 of the original directive, which required Member States to submit annual financial information on public undertakings operating in the manufacturing sector with a significant turnover. This amendment aims to streamline reporting requirements, aligning with the Commission’s objective of reducing administrative burdens by 25%.

    The directive consists of three articles. Article 1 deletes Article 2(c) (definition of public undertakings operating in the manufacturing sector) and Articles 8 and 9 of Directive 2006/111/EC. Article 2 states that the directive will enter into force twenty days after its publication in the Official Journal of the European Union. Article 3 specifies that the directive is addressed to the Member States. The main change compared to the previous version of Directive 2006/111/EC is the removal of the obligation for Member States to report financial information on public undertakings in the manufacturing sector, as well as the removal of the Commission’s obligation to regularly inform Member States on the application of the directive.

    The most important provision is the deletion of Article 8 of Directive 2006/111/EC. This means that Member States are no longer required to submit annual reports to the Commission on public undertakings operating in the manufacturing sector with a turnover exceeding EUR 250 million. This change directly impacts national administrations and public undertakings, as it eliminates a significant reporting obligation. Member States can also repeal any national measures that were adopted to transpose the now-deleted Article 8.

    Council Implementing Regulation (EU) 2025/1474 of 18 July 2025 implementing Article 12 of Regulation (EU) 2017/1770 concerning restrictive measures in view of the situation in Mali

    Council Implementing Regulation (EU) 2025/1474 amends Regulation (EU) 2017/1770 concerning restrictive measures against Mali. The new regulation removes one person from the list of individuals and entities subject to these measures. This adjustment follows a review of the existing list and a decision by the Council to delete the entry for the specified individual.

    The structure of the act is straightforward. It consists of two articles and an annex. Article 1 stipulates that Annex Ia to Regulation (EU) 2017/1770 is amended as per the new regulation’s annex. Article 2 indicates the regulation’s entry into force, which is the day after its publication in the Official Journal of the European Union. The annex contains the specific amendment, which is the deletion of the entry for “MAÏGA, Choguel” from the list of sanctioned individuals in Annex Ia of Regulation (EU) 2017/1770.

    The most important provision of this regulation is the removal of “MAÏGA, Choguel” from the list of individuals subject to restrictive measures related to the situation in Mali. This means that any sanctions, such as asset freezes or travel bans, that were previously in place against this individual are now lifted.

    Commission Implementing Regulation (EU) 2025/1467 of 18 July 2025 laying down rules for the application of Regulation (EU) 2024/1938 of the European Parliament and of the Council as regards the technical specifications for the EU SoHO Platform to exchange information concerning substances of human origin intended for human application

    This is a description of Commission Implementing Regulation (EU) 2025/1467.

    1. **Essence of the Act:** This regulation lays down the rules for implementing Regulation (EU) 2024/1938, specifically regarding the technical specifications for the EU Substances of Human Origin (SoHO) Platform. The platform is designed to facilitate the exchange of information concerning SoHO intended for human application. It outlines the maintenance, accessibility, security, and usage of the platform by various actors, including SoHO entities, competent authorities, and the general public. The regulation also addresses the protection of personal data processed through the platform and sets out contingency arrangements for system failures.

    2. **Structure and Main Provisions:** The regulation consists of 14 articles and two annexes.

    * **Article 1** provides definitions for terms like “actor,” “authorised actor,” and “local administrator” to clarify roles within the platform.
    * **Article 2** mandates the Commission to maintain and optimise the EU SoHO Platform and specifies that actors and authorised actors must use the platform to comply with various requirements outlined in Regulation (EU) 2024/1938.
    * **Article 3** details the accessibility, modules, and functionalities of the platform, with specific modules listed in Annex I.
    * **Article 4** outlines the access control mechanisms for actors, authorised actors, and local administrators, ensuring appropriate access rights and permissions.
    * **Article 5** describes the access rights of the general public, allowing them to view publicly available information without registration.
    * **Article 6** assigns responsibilities for recording and verifying the accuracy of information exchanged through the platform, emphasizing the role of SoHO competent authorities.
    * **Article 7** specifies when data is considered submitted to the platform.
    * **Article 8** addresses the protection of personal data, including health data, processed through the platform, with categories and retention periods listed in Annex II.
    * **Article 9** mandates measures to safeguard the safety and security of personal data.
    * **Article 10** requires the Commission to set up a support team and provide manuals for platform users.
    * **Article 11** requires the Commission, in collaboration with SoHO national authorities, to develop contingency arrangements for prolonged platform failures.
    * **Article 12** outlines procedures for handling information technology security incidents, risks, or threats.
    * **Article 13** specifies that the user interface of the platform shall be in English and encourages the use of English for information exchange.
    * **Article 14** states the regulation’s entry into force and application date, which is 7 August 2027.

    * **Annex I** lists the modules and functionalities of the EU SoHO Platform, including modules for registration of SoHO entities, authorisation of SoHO establishments, a compendium of authorised SoHO preparations, a module on the SoHO Coordination Board, vigilance reporting, activity data, guidelines for implementation of standards, collaboration, and publication.
    * **Annex II** details the categories of personal data to be processed and their retention periods, including data identifying authorised actors, data related to SoHO donations and clinical evaluations, and data identifying SoHO Coordination Board members.

    3. **Main Provisions for Use:**

    * **Data Accuracy:** Actors and authorised actors must ensure the completeness and accuracy of the information they enter into the platform.
    * **Access Rights:** Access to the platform is controlled through authentication and authorisation tools, ensuring users have appropriate access rights.
    * **Personal Data Protection:** The regulation mandates measures to protect personal data, including health data, processed through the platform, with specific retention periods defined.
    * **Language:** The user interface is in English, and English should be used for information exchange on the platform.
    * **Contingency Arrangements:** Procedures are in place to ensure continuity of regulatory processes in case of platform failures.

    Commission Implementing Regulation (EU) 2025/1447 of 18 July 2025 amending Implementing Regulation (EU) 2019/627 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council

    This Commission Implementing Regulation (EU) 2025/1447 amends Implementing Regulation (EU) 2019/627, which lays down uniform practical arrangements for official controls on products of animal origin intended for human consumption. The amending regulation adapts the existing rules to include game-handling establishments, clarifies responsibilities for checking food chain information, updates references to disease-free status and disease control measures, and refines post-mortem inspection procedures to reduce the risk of cross-contamination. It also addresses health mark requirements and provides a transitional period for using older health mark abbreviations.

    The regulation modifies several articles and annexes of Implementing Regulation (EU) 2019/627. Key changes include: extending the scope of official controls to game-handling establishments; clarifying that the official veterinarian is primarily responsible for verifying food chain information during ante-mortem inspections; updating references to the list of Member States with disease-free status for tuberculosis; refining post-mortem inspection procedures to only include relevant incisions and palpations based on risk; updating references to Union notification and reporting of transmissible animal diseases; extending the application of rules regarding food chain information to slaughter at the holding of provenance and emergency slaughter outside slaughterhouses; clarifying actions to be taken in case of misleading food chain information; updating references to animal health rules and clarifying the link between health marks and special health marks for disease control; and updating abbreviations for the European Union in health marks, with a transitional period for older abbreviations.

    The most important provisions for practical use include the extension of official control requirements to game-handling establishments, the clarification of the official veterinarian’s role in verifying food chain information, and the adjustments to post-mortem inspection procedures to focus on relevant risks and minimize cross-contamination. Food business operators and competent authorities need to be aware of these changes to ensure compliance with the updated regulations. The transitional period for health mark abbreviations is also relevant for businesses to manage their labeling practices.

    Commission Implementing Regulation (EU) 2025/1492 of 14 July 2025 concerning the classification of certain goods in the Combined Nomenclature

    This is Commission Implementing Regulation (EU) 2025/1492 which classifies a specific article, a lumbar support belt, within the Combined Nomenclature (CN). The regulation aims to ensure uniform application of the CN, which is essential for customs and trade purposes within the EU. It specifies the correct CN code for the described goods based on their characteristics and intended use. The regulation also addresses the validity of previously issued binding tariff information that may conflict with this new classification.

    The regulation consists of three articles and an annex. Article 1 states that the goods described in column (1) of the annex table shall be classified under the CN code indicated in column (2) of that table. Article 2 allows for a three-month grace period during which binding tariff information that doesn’t align with this regulation can still be invoked. Article 3 specifies the date of entry into force. The annex contains a table detailing the description of the goods, the corresponding CN code, and the reasons for the classification. In this case, the article in question is a lumbar support belt, classified under CN code 6212 90 00.

    The most important provision is the classification of the lumbar support belt under CN code 6212 90 00. This classification is based on the determination that the belt’s primary function and characteristics do not qualify it as an orthopaedic appliance under CN code 9021 10 10. The reasoning provided in the annex details why the belt’s elasticity, the pressure pad, and the flexible steel strips do not meet the criteria for orthopaedic appliances as defined in the Combined Nomenclature and related explanatory notes and court rulings. This distinction is crucial for importers and exporters as it affects the applicable tariffs and customs procedures.

    Decision No 1/2025 of the EU-Ukraine Association Committee in Trade configuration of 13 March 2025 modifying Part A of Appendix XVII-3 (Rules applicable to telecommunication services) of Annex XVII to the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part [2025/1351]

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    This Decision No 1/2025 of the EU-Ukraine Association Committee in Trade Configuration aims to further integrate Ukraine into the EU’s internal market, specifically concerning roaming on public mobile communications networks. It modifies Appendix XVII-3 of Annex XVII to the Association Agreement between the EU and Ukraine, focusing on aligning Ukrainian legislation with EU standards in the telecommunications sector. The decision grants Ukraine additional time to fully implement certain articles of Directive (EU) 2018/1972, considering the difficulties caused by Russia’s ongoing war of aggression. It also clarifies which provisions of EU legislation are relevant for Ukraine’s regulatory approximation in the roaming service subsector and sets a new timetable for Ukraine to implement Directive (EU) 2018/1972.

    The act consists of a preamble that outlines the reasons and objectives for the decision, followed by three articles. Article 1 states that Part A of Appendix XVII-3 of Annex XVII to the Association Agreement is modified as set out in the Annex to the decision. Article 2 specifies the languages in which the decision is authentic. Article 3 states that the decision enters into force on the date of its adoption. The Annex contains the revised text of Part A of Appendix XVII-3, detailing the specific EU directives and regulations that Ukraine must implement, along with adaptations and timelines. Compared to previous versions, this decision introduces specific adaptations to the implementation deadlines for certain articles of Directive (EU) 2018/1972 and clarifies the scope of relevant provisions for roaming services.

    Several provisions of this act are particularly important. First, Ukraine is granted additional time to fully implement Article 7(2), Article 8(1), and Article 30(6) of Directive (EU) 2018/1972, which relate to the independence and accountability of the national regulatory authority. Second, the act specifies which articles of Directive (EU) 2018/1972, Regulation (EU) 2022/612, Regulation (EU) 2018/1971, Implementing Regulation (EU) 2016/2286, and Delegated Regulation (EU) 2021/654 are relevant for Ukraine’s obligations on regulatory approximation in the roaming service subsector. Finally, the act establishes that in the event of discrepancies between the text of EU regulations and their incorporation into Ukrainian law, the EU text prevails, ensuring consistency and legal certainty.

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