Review of Commission Delegated Regulation (EU) 2025/695
This regulation sets the safety standards for permanent anchor devices and safety hooks used in construction. Manufacturers must now declare the ‘mechanical resistance – dynamic test’ and ‘mechanical resistance – breaking load test’ for all devices. If the product includes a safety hook, they must also declare ‘mechanical resistance – hook base test’. The regulation establishes minimum performance levels (thresholds) for dynamic and hook base tests and defines performance classes for dynamic resistance, ensuring these crucial safety components meet EU-wide standards. Detailed specifications for these thresholds and classes are outlined in the Annex, categorized by anchor kit type based on European Product Standard EN 17235:2024.
Review of Commission Implementing Regulation (EU) 2025/1468
This regulation greenlights the use of a specific *Bacillus subtilis* and *Lentilactobacillus buchneri* blend as a silage additive for all livestock. Dubbed ‘1k1802’, this additive aims to improve silage quality by boosting aerobic stability. The regulation sets usage conditions, including a minimum concentration of viable cells, storage guidelines, and a specific minimum dosage for fresh plant material that is easy or moderately difficult to ensile. Importantly, it mandates labelling regarding the dry matter range of the plant material. Furthermore, feed businesses must implement safety protocols and provide protective gear to minimize any potential risks to users. This authorization is valid until August 12, 2035.
Review of Commission Implementing Regulation (EU) 2025/1465
This regulation authorizes two *Enterococcus faecium* preparations (ATCC 53519 and ATCC 55593) as silage additives suitable for all animal species. It defines these as technological additives improving silage quality. Key aspects include required storage conditions, minimum dosage levels, and a strong emphasis on safety. Feed business operators are obligated to have safety procedures in place and to provide personal protective equipment to minimize risks. A transitional period is also granted, allowing the sale and use of products produced and labelled before August 12, 2026, until existing stocks are depleted.
Review of Commission Implementing Regulation (EU) 2025/1466
This regulation revises existing rules (Implementing Regulation (EU) No 520/2012) governing how pharmaceutical companies monitor the safety of their drugs (pharmacovigilance). The update emphasizes clearer documentation within the pharmacovigilance system master file, specifically regarding any deviations from standard practice. It introduces detailed requirements for outsourcing pharmacovigilance tasks, stressing the need for well-defined roles, responsibilities, and audit protocols. Furthermore, the regulation clarifies the scope and content of quality system audits to improve oversight. Drug companies must now enhance their monitoring of the Eudravigilance database and include updates on risk minimization efforts in their periodic safety reports, along with registering details of post-authorization safety studies in a central electronic register.
Review of Commission Implementing Regulation (EU) 2025/1441
This regulation amends existing rules (Implementing Regulation (EU) 2019/1793) regarding increased checks on specific food and feed imports into the EU. Its aim is to protect public health by updating lists of products facing heightened scrutiny due to risks like mycotoxins or pesticide contamination. The regulation adjusts the frequency of controls for certain goods from specific countries based on recent risk data. Highlights include increased checks on granadilla and passion fruit from Colombia, vine leaves from Egypt, and yardlong beans from Sri Lanka. Mango from Egypt and bottle gourd from India are newly added to the list of products requiring increased controls due to pesticide concerns. It also sets special conditions for drumsticks and yardlong beans from India, requiring official certificates and analysis results for each shipment. The model official certificate has been updated to include specific guarantees for mycotoxin contamination.
Review of Commission Implementing Regulation (EU) 2025/1534
This regulation introduces a phased implementation of the Entry/Exit System (EES) across EU member states. It allows a progressive rollout over 180 days, giving Member States flexibility in how they implement the EES, but with minimum requirements and specified timeframes to ensure full implementation with biometric functionalities. Systematic stamping of travel documents continues during the rollout, with specific guidelines for resolving discrepancies. Certain automated functionalities, like the stay calculator and overstayer lists, are temporarily disabled. Member States must inform third-country nationals about the rollout and its implications. A key provision allows Member States to temporarily suspend EES operations in case of system failures or excessive traffic.
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 the rules for permanent anchor devices and safety hooks, specifically focusing on their mechanical resistance. It mandates manufacturers to declare certain essential characteristics of these products when placing them on the market and sets threshold levels and classes of performance for these characteristics to ensure safety and technical applicability. The regulation supplements Regulation (EU) No 305/2011, which lays down harmonized conditions for the marketing of construction products.
The regulation consists of 5 articles and an annex. Article 1 defines the subject matter and scope of the regulation. 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 permanent anchor devices and safety hooks, and additionally ‘mechanical resistance – hook base test’ for products including a safety hook. Article 3 sets the threshold levels for ‘mechanical resistance – dynamic test’ and ‘mechanical resistance – hook base test’. Article 4 establishes classes of performance for ‘mechanical resistance – dynamic test’. Article 5 defines the entry into force. The Annex provides tables detailing the threshold levels and classes of performance for different types of anchor kits based on the European Product Standard 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), as well as the tables in the Annex. Manufacturers must ensure that their products meet the specified threshold levels and accurately declare the performance classes to comply with EU law.
Commission Implementing Regulation (EU) 2025/1468 of 22 July 2025 concerning the authorisation of a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species
This Commission Implementing Regulation (EU) 2025/1468 authorises the use of a preparation of *Bacillus subtilis* DSM 33862 and *Lentilactobacillus buchneri* DSM 12856 as a technological feed additive (specifically, a silage additive) for all animal species. The regulation is based on an application for authorisation and the subsequent assessment by the European Food Safety Authority (EFSA), which concluded that the additive is safe for animals, consumers, and the environment, and that it can improve the aerobic stability of silage. The regulation sets out the conditions for use, including the minimum content of the additive, and specifies certain labelling and safety requirements to protect users from potential sensitisation.
The regulation consists of two articles and an annex. Article 1 states that the preparation specified in the Annex is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 states that the regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The Annex specifies the identification number of the feed additive, its composition, the species or category of animal for which it is intended, and other provisions.
The most important provisions of this act are those specified in the Annex.
* The additive is identified as ‘1k1802’ and consists of a preparation of *Bacillus subtilis* DSM 33862 and *Lentilactobacillus buchneri* DSM 12856.
* It specifies the composition of the additive, including the minimum concentration of viable cells.
* It mandates that the directions for use of the additive and premixtures must include storage conditions.
* It sets a minimum dose of 1 × 108 CFU/kg fresh plant material when the additive is used alone.
* It restricts the use of the additive to fresh plant material that is easy or moderately difficult to ensile.
* It requires specific labelling regarding the dry matter range of the fresh plant material.
* It obliges feed business operators to establish operational procedures and organisational measures to address potential risks and, where risks cannot be eliminated, to ensure the use of personal protective equipment.
* The period of authorisation ends on 12 August 2035.
Commission Implementing Regulation (EU) 2025/1465 of 22 July 2025 concerning the authorisation of a preparation of Enterococcus faecium ATCC 53519 and a preparation of Enterococcus faecium ATCC 55593 as feed additives for all animal species
This Commission Implementing Regulation (EU) 2025/1465 authorises two preparations of *Enterococcus faecium* as feed additives for all animal species. These additives, *Enterococcus faecium* ATCC 53519 and *Enterococcus faecium* ATCC 55593, are classified as technological additives within the functional group of silage additives. The regulation specifies conditions for their use, including safety measures for users and storage requirements.
The regulation consists of three articles and an annex. Article 1 authorises the preparations as feed additives, subject to the conditions in the annex. Article 2 provides transitional measures, allowing the continued marketing and use of products produced and labelled before August 12, 2026, under the previous rules until stocks are exhausted. Article 3 states the regulation’s entry into force 20 days after its publication in the Official Journal of the European Union. The annex specifies the identification number, composition, analytical method, and conditions of use for each additive.
The most important provisions for users include the conditions of use specified in the Annex. These include the required storage conditions, minimum dosage of the additive, and the need for feed business operators to establish operational procedures and organizational measures to address potential risks. The regulation also mandates the use of personal protective equipment where risks cannot be eliminated through procedures and measures.
Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
This Commission Implementing Regulation (EU) 2025/1466 amends Implementing Regulation (EU) No 520/2012, which sets out measures for the performance of pharmacovigilance activities. The amendments aim to reflect practical experience, technical and scientific progress, and international harmonization in pharmacovigilance, while maintaining a high level of public health protection. The changes address the content of the pharmacovigilance system master file, subcontracting of pharmacovigilance activities, quality systems audits, monitoring of the Eudravigilance database, terminology updates, individual case safety reports, periodic safety update reports, and post-authorization safety studies.
The Regulation modifies several articles of Implementing Regulation (EU) No 520/2012. These modifications include clarifying the documentation of deviations in the pharmacovigilance system master file, detailing requirements for subcontracting pharmacovigilance activities (including audit and inspection arrangements), specifying the content of quality system audits, clarifying the monitoring of the Eudravigilance database by marketing authorization holders, updating terminology used for pharmacovigilance activities, and mandating the inclusion of updates on risk minimization measures in periodic safety update reports. It also requires marketing authorization holders to enter post-authorization study information into an electronic register maintained by the Agency.
Key provisions of this act include the enhanced requirements for documenting subcontracting arrangements for pharmacovigilance activities, emphasizing the need for clear roles, responsibilities, and audit/inspection arrangements. The clarification of the scope and content of quality system audits is also significant, ensuring a more effective oversight of pharmacovigilance activities. Furthermore, the updated requirements for monitoring the Eudravigilance database and the inclusion of risk minimization measures in periodic safety update reports are crucial for ongoing safety monitoring and risk management of medicinal products.
Commission Implementing Regulation (EU) 2025/1441 of 18 July 2025 amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council
This is a description of Commission Implementing Regulation (EU) 2025/1441, which amends Implementing Regulation (EU) 2019/1793 regarding increased official controls and emergency measures for certain goods entering the EU from specific third countries. The regulation aims to protect human health by updating the lists of food and feed subject to increased controls due to contamination risks like mycotoxins, pesticide residues, and microbiological contamination. It adjusts control frequencies for specific products from certain countries based on recent risk data and updates references to relevant legal acts.
**Structure and Main Provisions:**
The regulation amends several articles and annexes of Implementing Regulation (EU) 2019/1793. Key changes include:
* **Article 3:** Updates the regulation regarding sampling and analysis methods for mycotoxin contamination, referencing Implementing Regulation (EU) 2023/2782. Deletes a point concerning pentachlorophenol and dioxins.
* **Article 9:** Modifies the derogation concerning identification codes on consignments with multiple small packages.
* **Article 10:** Updates compliance requirements for mycotoxins and plant toxins, referencing Regulation (EU) 2023/915 and Directive 2002/32/EC. Deletes a paragraph related to pentachlorophenol and dioxins.
* **Article 14:** Introduces a transitional period for drumsticks (Moringa oleifera) and yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata) from India, allowing entry under certain conditions until October 12, 2025.
* **Annexes I and II:** Replaces the existing annexes with updated lists of food and feed subject to increased official controls and special conditions, respectively, including changes in control frequencies and the addition/removal of specific commodities and countries.
* **Annex IV:** Replaces the model official certificate, updating references to legal acts and modifying requirements for mycotoxin contamination guarantees.
**Main Provisions for Use:**
* **Increased Control Frequencies:** The regulation increases the frequency of identity and physical checks for several products from specific countries. For example, granadilla and passion fruit from Colombia, vine leaves from Egypt, and yardlong beans from Sri Lanka will face more frequent checks.
* **New Inclusions:** Mango from Egypt and bottle gourd from India are added to the list of products requiring increased controls due to pesticide residue concerns.
* **Special Conditions:** Drumsticks and yardlong beans from India are now subject to special conditions, requiring an official certificate and attached analysis results for each consignment.
* **Commodity Transfers:** Certain spices from Ethiopia are moved from Annex II (special conditions) to Annex I (increased controls), while drumsticks and yardlong beans from India are moved from Annex I to Annex II.
* **Updated Certificate Requirements:** The model official certificate (Annex IV) is updated, requiring specific guarantees for mycotoxin contamination.
Regulation (EU) 2025/1534 of the European Parliament and of the Council of 18 July 2025 on temporary derogations from certain provisions of Regulations (EU) 2017/2226 and (EU) 2016/399 as regards the progressive start of operations of the Entry/Exit System
Here’s a breakdown of Regulation (EU) 2025/1534:
1. **Essence of the Act:**
This regulation introduces temporary adjustments to the Entry/Exit System (EES) to allow for a phased implementation across EU member states. It addresses concerns about the EES’s resilience and potential border congestion by enabling a progressive rollout over 180 days. During this period, member states can gradually introduce the EES at different border crossing points or lanes. The regulation also includes temporary exceptions to certain rules in the Schengen Borders Code and the EES Regulation to accommodate this progressive implementation.
2. **Structure and Main Provisions:**
* **Roll-out Plans and Reporting (Article 3):** eu-LISA will develop a high-level roll-out plan, and each Member State must create a national roll-out plan in consultation with the Commission and eu-LISA. Member States will provide monthly reports on their progress.
* **Progressive Start of Operations (Article 4):** Member States must progressively implement the EES, starting with at least one border crossing point and reaching full implementation with biometric functionalities at all border crossing points by the 170th day. Specific percentages of estimated border crossings must be registered in the EES within certain timeframes.
* **Other Derogations (Article 5):** During the progressive start, border authorities will systematically stamp travel documents. The regulation specifies how national authorities should reconcile discrepancies between stamps and EES data. It also suspends certain functionalities, such as the automated stay calculator and the automatic generation of lists of overstayers.
* **Access to EES Data (Article 6):** National authorities and Europol must consider the potential incompleteness of EES data during the progressive rollout. Carriers must continue to verify stamps in travel documents and may start using the web service after a certain period.
* **Suspension of the EES (Article 7):** Member States can temporarily suspend EES operations at border crossing points in case of system failures or excessive traffic.
3. **Main Provisions for Use:**
* **Phased Implementation:** Member States have flexibility in how they roll out the EES, but must meet minimum requirements within specified timeframes.
* **Stamping of Travel Documents:** Systematic stamping continues during the progressive rollout, and authorities must follow specific guidelines to resolve discrepancies between stamps and EES data.
* **Limited Functionality:** Certain automated functionalities of the EES, such as the stay calculator and overstayer lists, will be disabled during the progressive rollout.
* **Information to Third-Country Nationals:** Member States must provide specific information to third-country nationals about the progressive rollout and its implications.
* **Suspension Option:** Member States have the option to suspend EES operations in certain situations, providing flexibility in managing the system.
