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Review of each of legal acts published today:
Commission Implementing Regulation (EU) 2025/1887 of 17 September 2025 granting a Union authorisation for the single biocidal product CLARMARIN® 350 LD in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is a description of Commission Implementing Regulation (EU) 2025/1887, which grants a Union authorisation for the single biocidal product ‘CLARMARIN® 350 LD’. This regulation confirms that ‘CLARMARIN® 350 LD’, containing hydrogen peroxide, meets the necessary conditions for use as a disinfectant and algaecide (product-type 2) according to Regulation (EU) No 528/2012. The authorisation is granted to Evonik Operations GmbH, ensuring the product can be made available on the market and used within the Union under specific conditions.
The regulation consists of two articles and an annex. Article 1 grants the Union authorisation to Evonik Operations GmbH for ‘CLARMARIN® 350 LD’ and specifies the authorisation number (EU-0033557-0000) and the validity period from October 8, 2025, to October 31, 2033. Article 2 states that the regulation will come into force twenty days after its publication in the Official Journal of the European Union. The annex provides a summary of the biocidal product characteristics, including administrative information, product composition, hazard and precautionary statements, authorized uses, and general directions for use. This regulation builds upon previous regulations, particularly referencing Implementing Regulation (EU) 2023/2183 for the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’.
The most important provisions for the use of ‘CLARMARIN® 350 LD’ are detailed in the annex, which outlines the authorized use for laundry disinfection in closed washing machines by dosing (application rate, frequency, contact time, temperature), specifies the categories of users (professional), and describes appropriate pack sizes and packaging materials. It also includes use-specific instructions, risk mitigation measures (requiring specific protective equipment), and first aid instructions. The annex also provides general directions for use, including measures for accidental release, safe disposal, and conditions for storage and shelf-life, ensuring the product is used safely and effectively.
Council Implementing Regulation (EU) 2024/2455 of 12 September 2024 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine
Here’s a breakdown of Council Implementing Regulation (EU) 2024/2455:
1. **Essence:** This regulation amends Council Regulation (EU) No 269/2014, which concerns restrictive measures against actions undermining or threatening the territorial integrity, sovereignty, and independence of Ukraine. The new regulation updates the list of individuals and entities subject to these measures, removes entries for deceased individuals and duplicate entries, and replaces existing entries with updated information. ****
2. **Structure and Main Provisions:**
* **Article 1:** States that Annex I of Regulation (EU) No 269/2014 is amended according to the Annex of this new regulation.
* **Article 2:** Specifies that the regulation comes into force the day after its publication in the Official Journal of the European Union and is binding in its entirety and directly applicable in all Member States.
* **Annex:**
* Deletes entries of deceased persons from the list.
* Deletes entries of persons from the list.
* Deletes duplicate entries.
* Replaces entries for several individuals and entities, providing updated identifying information, reasons for listing, and the date of listing. The reasons generally relate to actions and policies undermining Ukraine’s territorial integrity, sovereignty, and independence.
3. **Key Provisions for Use:**
* The updated list of sanctioned individuals and entities in Annex I is the core of this regulation. It’s crucial for ensuring compliance with EU sanctions.
* The “Reasons” column provides the justification for each listing, which is important for understanding the scope and application of the sanctions.
* The regulation directly affects individuals, entities, and member states, requiring them to adhere to the updated sanctions regime.
* The deletion of names from the list is also important, as it means that the sanctions no longer apply to these people.
Council Implementing Regulation (EU) 2024/849 of 12 March 2024 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine
Here’s a breakdown of Council Implementing Regulation (EU) 2024/849:
**1. Essence of the Act:**
This regulation amends Council Regulation (EU) No 269/2014, which concerns restrictive measures against actions undermining or threatening the territorial integrity, sovereignty, and independence of Ukraine. The new regulation updates the list of individuals and entities subject to these restrictive measures by amending information, deleting entries for deceased individuals and other persons, and replacing entries with updated details.
**2. Structure and Main Provisions:**
* **Article 1:** This article states that Annex I of Regulation (EU) No 269/2014 is amended according to the Annex of this new regulation.
* **Article 2:** This regulation comes into force the day after its publication in the Official Journal of the European Union and is binding in its entirety and directly applicable in all Member States.
* **Annex:**
* Deletes entries for 13 individuals.
* Replaces entries for 47 individuals and 6 entities with updated information. The updated information includes identifying information (DOB, POB, Gender), reasons for the restrictive measures, and the date of listing. The reasons typically involve direct or indirect support for actions undermining Ukraine’s territorial integrity, sovereignty, and independence.
**3. Main Provisions Important for Use:**
* **** The key aspect of this regulation is the updated list in Annex I. It is crucial for anyone dealing with individuals and entities potentially subject to EU sanctions to consult this updated list to ensure compliance.
* The reasons for listing provided for each individual and entity offer insights into why the EU has imposed sanctions, which can be helpful in assessing risks and understanding the scope of the restrictions.
* The regulation directly affects the application of asset freezes and the prohibition of making funds or economic resources available to those listed.
* The changes in identifying information (name, date of birth, etc.) are important for accurate identification and implementation of the sanctions.
Commission Implementing Regulation (EU) 2025/1876 of 16 September 2025 granting a Union authorisation for the single biocidal product Septihol IPA products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is a description of Commission Implementing Regulation (EU) 2025/1876, which grants a Union authorisation for the single biocidal product named ‘Septihol IPA products’. The product, manufactured by STERIS Ireland Limited, is authorized for use as a disinfectant and algaecide (Product Type 2) and in food and feed areas (Product Type 4). The regulation confirms that ‘Septihol IPA products’ meets the conditions outlined in Article 19(1) of Regulation (EU) No 528/2012, based on the assessment of the related reference biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’.
The regulation consists of two articles and an annex. Article 1 grants the Union authorisation to STERIS Ireland Limited for ‘Septihol IPA products’ under authorisation number EU-0034093-0000, valid from October 7, 2025, to November 30, 2032. Article 2 states that the regulation will take effect twenty days after its publication in the Official Journal of the European Union. The annex contains the summary of the biocidal product characteristics, including administrative information, product composition, hazard and precautionary statements, authorized uses, and general directions for use.
The most important provisions for users include the authorized uses specified in the annex, detailing application methods, rates, frequency, and specific instructions for different scenarios (e.g., surface disinfection in healthcare or food processing areas). The hazard and precautionary statements, along with risk mitigation measures, are also crucial for ensuring safe handling and application of the product. Users should also take note of the expiration date of the authorization, November 30, 2032.
Commission Implementing Regulation (EU) 2025/1878 of 16 September 2025 granting a Union authorisation for the biocidal product family BPF Propanol in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is a description of Commission Implementing Regulation (EU) 2025/1878 granting a Union authorisation for the biocidal product family ‘BPF Propanol’. The regulation grants authorization for placing on the market and use of the biocidal product family ‘BPF Propanol’, which includes products like Sterillium and Bacillol, used for human hygiene, food and feed area disinfection. The authorization is valid from October 7, 2025, to September 30, 2035, across all Member States. The regulation specifies the conditions of use, risk mitigation measures, and disposal instructions for these products.
The structure of the act includes the main regulation text and an annex detailing the summary of the biocidal product characteristics. The main body consists of two articles: Article 1 grants the Union authorization to Bode Chemie GmbH for ‘BPF Propanol’ with a specific authorization number and validity period. Article 2 states the regulation’s entry into force. The annex provides an extensive summary of product characteristics, divided into three parts: administrative information, second information level meta SPC(s), and third information level individual products. The Meta SPC(s) section details the composition, hazards, authorized uses, and directions for use for different product types within the ‘BPF Propanol’ family.
The most important provisions for the use of this act are in the Annex, which describes in detail the authorized uses for each product type (PT01, PT02, PT04), including specific instructions for use, risk mitigation measures, and target organisms. It specifies application rates, contact times, user categories (industrial, professional, general public), and pack sizes. The Annex also provides critical information on hazard and precautionary statements, first aid instructions, and safe disposal methods, ensuring users are well-informed about the safe and effective use of ‘BPF Propanol’ products.
Commission Implementing Regulation (EU) 2025/1879 of 16 September 2025 renewing the approval of the low-risk active substance rape seed oil 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 (EU) 2025/1879 renews the approval of rape seed oil as a low-risk active substance used in plant protection products within the European Union. It confirms that rape seed oil meets the safety criteria outlined in Regulation (EC) No 1107/2009 and extends its approval for use until 31 October 2040. The regulation also amends Commission Implementing Regulation (EU) No 540/2011 to reflect this renewal.
The regulation consists of three articles and two annexes. Article 1 states the renewal of approval of rape seed oil. Article 2 amends Implementing Regulation (EU) No 540/2011, deleting the old entry for rape seed oil from Part A and adding a new entry to Part D. Article 3 defines the entry into force and application date of the regulation. Annex I details the specifications for the renewed approval of rape seed oil, including its chemical properties, purity standards, and specific provisions for its use. Annex II provides the specific amendments to Implementing Regulation (EU) No 540/2011, replacing the previous entry with an updated one.
The most important provisions of this regulation are those concerning the conditions of use for rape seed oil. Member States must consider the conclusions of the renewal report, particularly Appendices I and II, when implementing the uniform principles of Regulation (EC) No 1107/2009. Special attention must be paid to protecting aquatic organisms, honey bees, and non-target arthropods, and risk mitigation measures must be implemented where necessary. The regulation also specifies that the impurity erucic acid in rape seed oil must not exceed 2%.
Commission Regulation (EU) 2025/1891 of 17 September 2025 amending Regulation (EU) 2023/915 as regards maximum levels of inorganic arsenic in fish and other seafood
This regulation amends Regulation (EU) 2023/915, introducing maximum levels of inorganic arsenic in fish and other seafood. This measure aims to further reduce the population’s exposure to inorganic arsenic, a contaminant known to pose health risks. The regulation sets specific limits for various types of fish, crustaceans, and molluscs, considering their different arsenic accumulation levels.
The regulation modifies Article 10(1) of Regulation (EU) 2023/915 to include a new point (q), setting the date of application for the new maximum levels of inorganic arsenic in fish and seafood as 8 October 2025. It also amends Annex I of the principal regulation, specifically section 3.4 (Arsenic), by replacing the second row to clarify that the maximum level for inorganic arsenic applies to products listed in points 3.4.1 to 3.4.8. Furthermore, it replaces entry 3.4.5 and the row above, introducing detailed classifications and maximum levels for arsenic in different types of fish, crustaceans, bivalve molluscs, and cephalopods. These levels vary depending on the species and the specific part of the seafood (e.g., muscle meat).
The most important provisions for practical use are the newly established maximum levels for inorganic arsenic in fish and seafood (points 3.4.5 to 3.4.8 of Annex I). These levels are differentiated by species and type of seafood, with specific values for muscle meat of fish (ranging from 0.10 to 0.50 mg/kg), crustaceans (ranging from 0.10 to 1.5 mg/kg), bivalve molluscs (0.10 to 0.50 mg/kg), and cephalopods (0.050 mg/kg). The regulation also clarifies which part of the seafood the maximum levels apply to, such as muscle meat for crustaceans and the animal without viscera for cephalopods. Additionally, it includes a provision allowing products lawfully placed on the market before 8 October 2025 to remain on the market until their date of minimum durability or use-by date.
