“`html
Commission Delegated Regulation (EU) 2025/788 postpones the application date for the ‘Master UDI-DI’ solution for contact lenses to November 9, 2026, granting manufacturers and stakeholders more time to adapt to the new UDI requirements.
Commission Delegated Regulation (EU) 2025/1463 updates the Annex to Regulation (EU) 2024/1735, providing a more detailed list of final products and specific components for various net-zero technologies, with a new column ‘Final products’ added for clarity.
Commission Implementing Regulation (EU) 2025/1505 imposes definitive anti-dumping duties on imports of epoxy resins from China, Taiwan, and Thailand, based on the CIF Union border price, and finalizes the collection of provisional duties already in place, ending the investigation for imports from the Republic of Korea.
Commission Implementing Regulation (EU) 2025/1538 mandates customs authorities to register imports of new pneumatic tires made of rubber originating from China, enabling potential retroactive application of anti-dumping duties if the ongoing investigation finds evidence of dumping.
Commission Implementing Regulation (EU) 2025/1501 amends Implementing Regulation (EU) 2022/191 to include Moregood Hardware Technology (Nanjing) Co., Ltd. under the same anti-dumping duty rate as its related company, Shanghai Moregood Hardware Co., Ltd., for certain iron or steel fasteners.
Commission Implementing Regulation (EU) 2025/1504 renews the authorization of Lactiplantibacillus plantarum NCIMB 40027 as a technological feed additive for all animal species until August 17, 2035, outlining specific conditions for use and safety measures.
Commission Implementing Regulation (EU) 2025/1509 amends Implementing Regulation (EU) 2017/2470, increasing the maximum level of “other sterols/stanols” allowed in phytosterols/phytostanols derived from sunflower plants to less than 7.0 %, and grants Advanced Organic Materials SA exclusive marketing rights for five years for the modified product.
Council Implementing Regulation (EU) 2025/1559 updates Annex IX to Regulation (EU) No 267/2012, revising the list of persons and entities subject to restrictive measures against Iran due to their involvement in nuclear or ballistic missile activities and/or their association with the Iranian Revolutionary Guard Corps (IRGC).
Regulation (EU) 2025/1520 amends Regulation (EU) 2016/445, removing an option for the number of days past due for default classification and introducing a transitional arrangement allowing institutions to continue using ECAI credit assessments that incorporate assumptions of implicit government support until 1 January 2027.
“`
Review of each of legal acts published today:
Commission Delegated Regulation (EU) 2025/788 of 16 April 2025 amending Delegated Regulation (EU) 2023/2197 as regards the date of application
This Commission Delegated Regulation (EU) 2025/788 amends Delegated Regulation (EU) 2023/2197, specifically concerning the date of application for rules regarding Unique Device Identifiers (UDI) for contact lenses. The original regulation introduced the ‘Master UDI-DI’ solution for contact lenses. This new regulation defers the application date of the original regulation by one year.
The regulation consists of two articles. Article 1 amends Article 2 of Delegated Regulation (EU) 2023/2197, changing the application date from November 9, 2025, to November 9, 2026. Article 2 states that this regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and confirms that it is binding in its entirety and directly applicable in all Member States.
The most important provision of this regulation is the postponement of the application date for the ‘Master UDI-DI’ solution for contact lenses to November 9, 2026. This delay is intended to allow manufacturers and other stakeholders more time to implement the new system, taking into account guidance provided by the Medical Device Coordination Group (MDCG) and to adapt their internal systems and technologies for UDI assignment.
Commission Delegated Regulation (EU) 2025/1463 of 23 May 2025 amending Regulation (EU) 2024/1735 of the European Parliament and of the Council as regards the identification of sub-categories within net-zero technologies and the list of specific components used for those technologies
This Commission Delegated Regulation (EU) 2025/1463 amends Regulation (EU) 2024/1735, focusing on refining the identification of sub-categories within net-zero technologies and specifying the components used for these technologies. The regulation aims to provide a more detailed and accurate list of components primarily used in the production of net-zero technologies, enhancing the comprehensibility and applicability of the original regulation. This update is based on a comprehensive assessment of the supply chains of net-zero technologies, considering factors like commercial availability and technological developments.
The structure of the regulation is straightforward. It consists of two articles and an annex. Article 1 states that the Annex to Regulation (EU) 2024/1735 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 main body of the amendment is the updated Annex, which provides a detailed list of final products and specific components considered primarily used for the production of various net-zero technologies. This includes categories such as solar technologies, onshore and offshore wind technologies, battery and energy storage technologies, heat pumps and geothermal energy technologies, hydrogen technologies, sustainable biogas and biomethane technologies, CCS technologies, electricity grid technologies, nuclear fission energy technologies, sustainable alternative fuels technologies, hydropower technologies, and others. The updated Annex includes an additional column ‘Final products’ for explanatory purposes.
The most important provision of this act is the updated Annex, which provides a detailed list of final products and specific components considered primarily used for the production of various net-zero technologies. This list is crucial for project promoters, national competent authorities, and other stakeholders in determining whether specific components or machinery fall within the scope of Regulation (EU) 2024/1735. The inclusion of the ‘Final products’ column enhances the clarity and usability of the Annex, making it easier to understand the context in which these components are used.
Commission Implementing Regulation (EU) 2025/1505 of 25 July 2025 imposing a definitive anti-dumping duty and definitively collecting the provisional duty imposed on imports of epoxy resins originating in the People’s Republic of China, Taiwan, and Thailand and terminating the investigation on imports of epoxy resins originating in the Republic of Korea
This is Commission Implementing Regulation (EU) 2025/1505, which imposes a definitive anti-dumping duty on imports of epoxy resins originating from the People’s Republic of China, Taiwan, and Thailand. It also finalizes the collection of provisional duties already imposed and terminates the investigation into imports of epoxy resins from the Republic of Korea. The regulation aims to protect the Union industry from the injurious effects of dumped imports.
The regulation is structured into several sections, covering the procedure, product concerned, dumping, injury, causation, level of measures, Union interest, and definitive anti-dumping measures. It details the investigation process, including the initiation, imposition of provisional measures, and subsequent procedures. The regulation addresses comments from interested parties, clarifies the scope of the product concerned, and determines dumping margins for the countries involved. It also assesses the injury to the Union industry, establishes a causal link between the dumped imports and the injury, and sets the level of measures to counteract the dumping. Compared to the provisional regulation, this implementing regulation provides definitive anti-dumping duties.
The most important provisions of this act are the imposition of definitive anti-dumping duties on epoxy resins from China, Taiwan and Thailand, as specified in Article 1 and the Annex. These duties are applied based on the CIF Union border price and vary depending on the company of origin. The regulation also specifies the conditions for the application of individual duty rates, requiring a valid commercial invoice with a specific declaration.
Commission Implementing Regulation (EU) 2025/1538 of 25 July 2025 making imports of new pneumatic tyres, of rubber, of a kind used on motor cars, buses or lorries with a load index not exceeding 121 originating in the People’s Republic of China subject to registration
This Commission Implementing Regulation (EU) 2025/1538 concerns the registration of imports of new pneumatic tires made of rubber, typically used on cars, buses, or lorries with a load index not exceeding 121, originating from the People’s Republic of China. The regulation is initiated in response to an anti-dumping proceeding and aims to enable the potential retroactive imposition of anti-dumping duties if the investigation concludes that such measures are necessary. The regulation mandates customs authorities to register these imports, which will be in effect for nine months.
The regulation consists of a preamble outlining the reasons for the registration, followed by two articles. Article 1 directs customs authorities to register the specified tire imports from China and sets the registration period to expire after nine months. Article 2 stipulates that the regulation will take effect the day after its publication in the Official Journal of the European Union and confirms its binding and directly applicable nature in all Member States. There are no direct changes to previous versions since this is an implementing regulation related to an ongoing anti-dumping investigation.
The most important provision is Article 1, which instructs customs authorities to register imports of the specified tires from China. This registration is crucial because it allows for the possibility of retroactively applying anti-dumping duties if the ongoing investigation determines that these tires are being dumped on the EU market and causing injury to Union producers. Businesses importing these tires should be aware of this registration, as it could lead to additional financial liabilities in the future.
Commission Implementing Regulation (EU) 2025/1501 of 25 July 2025 amending Implementing Regulation (EU) 2022/191 imposing a definitive anti-dumping duty on imports of certain iron or steel fasteners originating in the People’s Republic of China
This Commission Implementing Regulation (EU) 2025/1501 amends Implementing Regulation (EU) 2022/191, which imposed a definitive anti-dumping duty on imports of certain iron or steel fasteners originating in the People’s Republic of China. The amendment concerns the addition of Moregood Hardware Technology (Nanjing) Co., Ltd. to the list of companies subject to a specific anti-dumping duty rate. This addition is due to the company’s relationship with Shanghai Moregood Hardware Co., Ltd., which was already subject to the duty. The regulation ensures that the same anti-dumping duty rate applies to both companies.
The regulation consists of a preamble outlining the reasons for the amendment and three articles. Article 1 amends the Annex to Implementing Regulation (EU) 2022/191 by adding Moregood Hardware Technology (Nanjing) Co., Ltd. as a related exporting producer to Shanghai Moregood Hardware Co., Ltd. under TARIC additional code C837. Article 2 clarifies that the TARIC additional code C837, previously attributed only to Shanghai Moregood Hardware Co., Ltd., now applies to both companies. Article 3 states that the regulation will enter into force on the day following its publication in the Official Journal of the European Union. The main change is the inclusion of Moregood Hardware Technology (Nanjing) Co., Ltd. under the same anti-dumping duty rate as its related company.
The most important provision is the amendment to the Annex of Regulation (EU) 2022/191, specifically the inclusion of Moregood Hardware Technology (Nanjing) Co., Ltd. under TARIC additional code C837. This means that imports of certain iron or steel fasteners produced by Moregood Hardware Technology (Nanjing) Co., Ltd. will now be subject to the same anti-dumping duty rate as those produced by Shanghai Moregood Hardware Co., Ltd. This is significant for importers and exporters dealing with these companies, as it clarifies the applicable duty rate for these fasteners.
Commission Implementing Regulation (EU) 2025/1504 of 25 July 2025 concerning the renewal of the authorisation of a preparation of Lactiplantibacillus plantarum NCIMB 40027 as a feed additive for all animal species and amending Implementing Regulation (EU) No 1113/2013
This Commission Implementing Regulation (EU) 2025/1504 concerns the renewal of the authorization for the feed additive Lactiplantibacillus plantarum NCIMB 40027, used for all animal species, and amends Implementing Regulation (EU) No 1113/2013 accordingly. The regulation extends the authorization for another 10 years, classifying the additive as a technological additive within the functional group of silage additives. It addresses safety concerns by requiring measures to protect users from potential skin and respiratory sensitization.
The regulation consists of four articles and an annex. Article 1 renews the authorization of Lactiplantibacillus plantarum NCIMB 40027, outlining the conditions specified in the annex. Article 2 amends Implementing Regulation (EU) No 1113/2013 by deleting the entry for Lactobacillus plantarum NCIMB 40027, as it is being replaced by the new authorization. Article 3 provides transitional measures, allowing the continued marketing and use of products produced and labeled before August 17, 2026, under the previous regulations until stocks are exhausted. Article 4 states that the regulation will come into force twenty days after its publication in the Official Journal of the European Union. The annex specifies the conditions of use, including the composition, analytical methods, and other provisions for the feed additive.
The most important provisions for users include the extended authorization period until August 17, 2035, and the specific conditions for use outlined in the annex. These conditions include storage requirements, minimum dosage based on the type of material being ensiled, permissible cryoprotectants, and the requirement for feed business operators to implement operational procedures and protective measures to mitigate potential health risks to users, including the use of personal protective equipment.
Commission Implementing Regulation (EU) 2025/1509 of 25 July 2025 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food phytosterols/phytostanols
This Commission Implementing Regulation (EU) 2025/1509 amends Implementing Regulation (EU) 2017/2470, specifically concerning the specifications for the novel food phytosterols/phytostanols. The key change involves increasing the maximum level of “other sterols/stanols” allowed in phytosterols/phytostanols derived from sunflower plants, from 3.0 % to less than 7.0 %. This adjustment is based on an application by Advanced Organic Materials SA and a scientific opinion from the European Food Safety Authority (EFSA), which deemed the change safe.
The regulation consists of a preamble outlining the reasoning behind the amendment and two articles that detail the specific changes to the Annex of Implementing Regulation (EU) 2017/2470. The Annex is amended to include a new entry for phytosterols/phytostanols extracted from sunflower plants with a specific composition of sterols and stanols, including the increased level of “other sterols/stanols”. It grants Advanced Organic Materials SA exclusive rights to market phytosterols/phytostanols with this specific composition for five years, based on proprietary data.
The most important provisions of this regulation are:
1. The increase in the allowable level of “other sterols/stanols” in phytosterols/phytostanols derived from sunflower, which allows for a broader range of natural compositions to be used in food products.
2. The temporary protection of proprietary data belonging to Advanced Organic Materials SA, which prevents other companies from using their data to market similar products for five years.
3. The clarification that the existing authorization for phytosterols/phytostanols with less than 3.0 % of “other sterols/stanols” remains unaffected, ensuring that other sources and compositions of this novel food can still be legally marketed.
Council Implementing Regulation (EU) 2025/1559 of 25 July 2025 implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran
This Council Implementing Regulation (EU) 2025/1559 amends Annex IX to Regulation (EU) No 267/2012 concerning restrictive measures against Iran. The regulation updates the list of persons and entities involved in nuclear or ballistic missile activities and those providing support to the Government of Iran. It also updates the list of persons and entities related to the Iranian Revolutionary Guard Corps (IRGC) who are subject to restrictive measures.
The regulation consists of two articles and an annex. Article 1 states that Annex IX to Regulation (EU) No 267/2012 is amended in accordance with the Annex to this Regulation. Article 2 specifies that the regulation will enter into force on the day following its publication in the Official Journal of the European Union. The Annex details the specific amendments to Annex IX of Regulation (EU) No 267/2012, including replacing entries for individuals and entities involved in Iran’s nuclear and ballistic missile activities, as well as those associated with the Iranian Revolutionary Guard Corps (IRGC). One person is removed from the list.
The most important provisions for practical use are the updated lists of designated persons and entities in Annex IX. These lists are crucial for ensuring that the restrictive measures against Iran are properly implemented by EU member states, particularly concerning the freezing of assets and restrictions on providing funds or economic resources to those listed.
Regulation (EU) 2025/1520 of the European Central Bank of 15 July 2025 amending Regulation (EU) 2016/445 on the exercise of options and discretions available in Union law (ECB/2016/4) (ECB/2025/24)
Regulation (EU) 2025/1520 amends Regulation (EU) 2016/445, addressing changes introduced by Regulation (EU) 2024/1623 to Regulation (EU) No 575/2013 regarding prudential requirements for credit institutions. The amendment removes a previously available option concerning the number of days past due for considering a credit obligation in default and introduces a transitional arrangement regarding the use of External Credit Assessment Institution (ECAI) credit assessments that incorporate assumptions of implicit government support. This transitional arrangement allows institutions to continue using such ECAI credit assessments under specific conditions until 1 January 2027.
The regulation consists of two articles. Article 1 outlines the amendments to Regulation (EU) 2016/445, specifically deleting Article 4 and inserting a new Article 24a. The deleted Article 4 likely pertained to the option regarding the number of days past due for default classification, now removed to align with changes in Regulation (EU) No 575/2013. The newly inserted Article 24a introduces a derogation allowing institutions to continue using ECAI credit assessments that incorporate assumptions of implicit government support until 1 January 2027, despite changes in Article 138 of Regulation (EU) No 575/2013. Article 2 contains final provisions, specifying that the regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union and is binding in its entirety and directly applicable in the Member States.
The most important provision for practical use is the newly inserted Article 24a, which provides a transitional arrangement for the use of ECAI credit assessments incorporating assumptions of implicit government support. This allows institutions to continue using these assessments until 1 January 2027, even if they would otherwise be required to treat exposures to institutions with such assessments as exposures to unrated institutions under the amended Article 138 of Regulation (EU) No 575/2013. This transitional period provides institutions with time to adjust their practices in response to the changes in Regulation (EU) No 575/2013.
