Commission Delegated Regulation (EU) 2025/1181: Protecting Picked Dogfish
This regulation introduces a measure to protect picked dogfish by requiring the release of any specimen longer than 100 cm if accidentally caught in Union waters or by Union vessels. This rule applies only to areas not under the sovereignty of a third countries. This is designed to protect mature female dogfish. The regulation is time-limited and will expire on December 31, 2025.
Commission Delegated Regulation: Adjusting Mesh Sizes for Squid Fishing
The new rule modifies Regulation (EU) 2019/1241 by increasing the minimum mesh size for fishing nets used when specifically targeting squid in the North Sea and North Western Waters. The minimum mesh size has been increased to 80 mm when using bottom trawls and seines. There are some exceptions for fishing in specified areas. This adjustment is meant to protect juvenile fish.
Commission Implementing Regulation (EU) 2025/2158: Penalties for Overfishing
This regulation details deductions from fishing quotas for 2025 for Member States that exceeded their allocated quotas in previous years. Specific deductions for each Member State, species, and area are listed in the Annex. These deductions are mandated by Article 105 of Regulation (EC) No 1224/2009. Overfishing involving quantities of less than one tonne is not considered.
Commission Implementing Regulation (EU) 2025/2149: Anti-Dumping Duty Amendment
This regulation updates Implementing Regulation (EU) 2021/1976 to reflect the acquisition of Equistar Chemicals, LP by INEOS Americas LLC. The anti-dumping duty and TARIC code previously assigned to Equistar Chemicals, LP now apply to INEOS Americas LLC, retroactive to 1 May 2024. Provision is made for reimbursement or remission of excess duties paid.
Commission Implementing Regulation (EU) 2025/2091: GMP for Veterinary Medicinal Products
This regulation establishes detailed Good Manufacturing Practice (GMP) requirements for veterinary medicinal products in the EU. It covers all aspects of manufacturing, control, and distribution, including specific requirements for sterile products, biological products, and herbal remedies. It emphasizes a comprehensive pharmaceutical quality system based on risk management. This regulation repeals Directive 2001/82/EC, aligning GMP requirements with Regulation (EU) 2019/6. Key aspects include the implementation of a pharmaceutical quality system, prevention of cross-contamination, the role of the qualified person, outsourced activities, and compliance with specific annexes for certain products.
Commission Implementing Regulation (EU) 2025/2154: GMP for Active Substances in Veterinary Medicinal Products
This regulation lays down rules for Good Manufacturing Practice (GMP) for active substances used in veterinary medicinal products. It focuses on ensuring high-quality standards throughout the manufacturing process, including quality management systems, personnel, premises, equipment, documentation, and controls. The regulation also specifies requirements for active substances produced by cell culture/fermentation or that are active substance gases, with a strong focus on robust documentation, validation, and change control systems. The regulation also contains an annex on defining the starting point of manufacture for different types of active substances.
Commission Implementing Regulation (EU) 2025/2156: Derogation from Tolerance Margins for Estimating Catches
The new regulation amends Implementing Regulation (EU) 2025/897 by adding Santa Eugenia de Ribeira and La Puebla del Caramiñal to the list of approved Spanish ports that can benefit from a derogation from standard margins of tolerance when estimating catches. These ports are added to the annex of the Implementing Regulation (EU) 2025/897. This exception applies to unsorted landings or transhipments of specific fisheries where the ports have alternative procedures ensuring accurate weighing comparable to remote electronic monitoring (REM) systems.
Commission Implementing Regulation (EU) 2025/2189: African Swine Fever Control Measures
This regulation amends Annex I of Implementing Regulation (EU) 2023/594, updating the lists of restricted zones (I, II, and III) for African swine fever (ASF) in various Member States. Changes are based on the evolving epidemiological situation. Anyone involved in the movement of live pigs or pig products needs to consult the updated annex to determine whether specific areas are subject to restrictions.The regulation includes Croatia, Estonia, Italy, Latvia, Lithuania, Poland and Slovakia.
Review of each of legal acts published today:
Commission Delegated Regulation (EU) 2025/1181 of 13 June 2025 on the implementation of the Union’s international obligations, as referred to in Article 15(2) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council, under the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, as regards picked dogfish
This Commission Delegated Regulation (EU) 2025/1181 aims to implement the EU’s international obligations under the Trade and Cooperation Agreement with the United Kingdom, specifically concerning the management and conservation of picked dogfish stocks. The regulation introduces a derogation from the standard landing obligation for picked dogfish exceeding 100 cm in length, requiring that such specimens, if caught accidentally, be released unharmed back into the sea. This measure is designed to protect mature female dogfish, which are particularly vulnerable to fishing, and to ensure the sustainable management of the shared stock. The regulation is set to expire on December 31, 2025, aligning with the timeline for ongoing technical discussions and scientific evaluations regarding the effectiveness of the size limit and potential alternative management measures.
The regulation consists of three articles. Article 1 defines the subject matter and scope, specifying that it applies to fishing activities in Union waters and by Union fishing vessels outside Union waters, within areas not under the sovereignty or jurisdiction of third countries. Article 2 outlines the core provision, prohibiting the targeting, retention, transhipment, landing, transport, storage, display, or sale of picked dogfish longer than 100 cm. It mandates the unharmed release of any accidentally caught dogfish exceeding this length. Article 3 sets the entry into force as the day following its publication and stipulates that the regulation will cease to apply on December 31, 2025. This regulation builds upon measures previously established in Annex IA of Council Regulation (EU) 2025/202, providing a more stable and legally defined framework for the protection of picked dogfish.
The most important provision of this regulation is Article 2, which directly impacts fishing practices. It creates a clear and enforceable rule regarding the handling of picked dogfish exceeding 100 cm. This provision is crucial for fishermen operating in the relevant waters, as it mandates a specific action (release) for accidentally caught dogfish above the specified size, with the aim of protecting the spawning population. The regulation ensures that the EU adheres to its commitments under the Trade and Cooperation Agreement with the UK, promoting sustainable fisheries management and conservation of vulnerable marine species.
Commission Delegated Regulation (EU) 2025/2169 of 16 June 2025 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards an increase of the minimum mesh size when fishing for squid in the North Sea and North Western Waters
This act is a Commission Delegated Regulation that amends Regulation (EU) 2019/1241 concerning the conservation of fisheries resources. The key change involves increasing the minimum mesh size for fishing nets used when targeting squid in the North Sea and North Western Waters. This adjustment aims to improve the selectivity of fishing gear, protecting juvenile fish and spawning populations, and to enhance enforcement of mesh size regulations.
The structure of the act is straightforward. It consists of two articles and an annex. Article 1 stipulates that Annexes V and VI of Regulation (EU) 2019/1241 are amended as detailed in 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. The Annex provides the specific amendments to the tables in Annexes V and VI of the original regulation, outlining the new minimum mesh sizes for squid fishing in various ICES (International Council for the Exploration of the Sea) areas. Compared to the previous version, this regulation introduces stricter mesh size requirements for squid fishing in specific regions, while maintaining some exceptions for particular fishing methods and areas.
The most important provisions for those affected are the changes to the minimum mesh sizes for directed squid fishing. Specifically, the increase to at least 80mm in ICES subarea 4 (North Sea) and divisions 7a, 7b, 7c, 7d, 7e, 7g, 7h, and 7k (North Western Waters) when using bottom trawls and seines. Exceptions are made for ICES subareas 5 and 6, ICES division 7e (within 12 nautical miles of the coast of France when using midwater otter trawls), and ICES division 7j, where a minimum of 40mm mesh size is maintained.
Commission Implementing Regulation (EU) 2025/2158 of 24 October 2025 operating deductions from fishing quotas available for certain stocks in 2025 on account of overfishing in the previous years
This is a description of Commission Implementing Regulation (EU) 2025/2158 of 24 October 2025, which concerns deductions from fishing quotas for certain stocks in 2025 due to overfishing in previous years. The Regulation identifies instances where Member States have exceeded their allocated fishing quotas and specifies the corresponding deductions to be made from their 2025 quotas. These deductions are mandated by Article 105 of Regulation (EC) No 1224/2009, which establishes a Union control system for ensuring compliance with the rules of the common fisheries policy. The aim of the regulation is to ensure that overfishing is penalized and that Member States adhere to the established fishing quotas to maintain sustainable fishing practices.
The structure of the act is straightforward. It consists of two articles and an annex. Article 1 states that the fishing quotas fixed for 2025 in specified Council Regulations shall be reduced as detailed in the Annex. Article 2 indicates that the Regulation will enter into force seven days after its publication in the Official Journal of the European Union and that it is binding in its entirety and directly applicable in all Member States. The Annex provides a table listing the Member States, species codes, area codes, species names, area names, initial quotas for 2024, permitted landings for 2024, total catches for 2024, quota consumption related to permitted landings, overfishing related to permitted landing, multiplying factors, outstanding deductions from previous years, and deductions to be applied in 2025. The Regulation refers to previous regulations and communications, particularly those concerning fishing opportunities for 2023, 2024, and 2025, as well as guidelines for the deduction of quotas under Article 105 of Regulation (EC) No 1224/2009. It also takes into account recommendations from the International Commission for the Conservation of Atlantic Tunas (ICCAT) regarding specific stocks like blue marlin and swordfish.
The most important provisions for its use are those detailed in the Annex, which specifies the exact deductions to be applied to each Member State’s fishing quotas for specific species and areas. The Regulation also clarifies the application of multiplying factors, including additional factors for consecutive overfishing or stocks subject to multiannual plans. It addresses specific cases, such as Germany’s request to spread deductions for overfishing of other species in Norwegian waters over three years. The Regulation also notes that further updates or corrections may occur due to errors, omissions, or misreporting in catch figures declared by Member States. Finally, it states that overfishing involving quantities of less than one tonne should not be considered.
Commission Implementing Regulation (EU) 2025/2149 of 24 October 2025 amending Implementing Regulation (EU) 2021/1976 imposing a definitive anti-dumping duty on imports of mono ethylene glycol originating in the United States of America and the Kingdom of Saudi Arabia
This Commission Implementing Regulation (EU) 2025/2149 amends Implementing Regulation (EU) 2021/1976, which imposed definitive anti-dumping duties on imports of mono ethylene glycol from the United States of America and the Kingdom of Saudi Arabia. The amendment concerns a change of name of a company subject to these duties. Specifically, Equistar Chemicals, LP, a company from the United States of America, was acquired by INEOS Americas LLC, and this regulation updates the relevant annex to reflect this change.
The regulation consists of two articles. Article 1 updates the Annex to Implementing Regulation (EU) 2021/1976 by replacing “Equistar Chemicals, LP” with “INEOS Americas LLC” and clarifies that the TARIC additional code C682, previously assigned to Equistar Chemicals, LP, now applies to INEOS Americas LLC, effective from 1 May 2024. It also provides for the reimbursement or remission of any definitive duties paid in excess of the anti-dumping duty established for Equistar Chemicals, LP, for imports of products manufactured by INEOS Americas LLC from that date. Article 2 states that the regulation will enter into force on the day following its publication in the Official Journal of the European Union and confirms its binding and directly applicable nature in all Member States.
The most important provision is Article 1, which ensures that the anti-dumping duty applicable to Equistar Chemicals, LP, continues to apply to INEOS Americas LLC following the acquisition. This prevents any disruption in the application of the anti-dumping measures due to the change in company name and ensures that importers are not unfairly penalized or unduly benefited as a result of the acquisition. The retroactive application to 1 May 2024, and the provision for reimbursement or remission of excess duties paid, is also significant for ensuring fairness and accuracy in the application of the anti-dumping duties.
Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Okay, I can help you with that. Here’s a detailed description of Commission Implementing Regulation (EU) 2025/2091:
**1. Essence of the Act:**
This regulation establishes the requirements for Good Manufacturing Practice (GMP) for veterinary medicinal products within the European Union. It aims to ensure the quality, safety, and efficacy of these products by setting standards for their manufacturing, control, and distribution. The regulation addresses specific aspects like sterile products, biological and immunological products, herbal remedies, and products with unique administration methods. It emphasizes a comprehensive pharmaceutical quality system, risk management, and continuous monitoring throughout the product lifecycle.
**2. Structure and Main Provisions:**
The regulation is structured into two main parts:
* **Main Body (Chapters I-XI):** This part outlines the general principles and requirements applicable to all manufacturers of veterinary medicinal products.
* **Chapter I (General Provisions):** Defines the scope and subject matter, including specific annexes for certain product types.
* **Chapter II (Pharmaceutical Quality System):** Emphasizes the implementation of a comprehensive quality system based on risk management principles.
* **Chapter III (Personnel):** Sets requirements for personnel qualifications, training, and hygiene.
* **Chapter IV (Premises and Equipment):** Details the standards for manufacturing, storage, and quality control areas, as well as equipment qualification and maintenance.
* **Chapter V (Documentation):** Establishes a comprehensive documentation system to ensure traceability and data integrity.
* **Chapter VI (Production):** Outlines the requirements for manufacturing operations, handling of materials, and prevention of cross-contamination.
* **Chapter VII (Quality Control):** Defines the responsibilities of the quality control department, including sampling, testing, and on-going stability programs.
* **Chapter VIII (Certification and Batch Release):** Specifies the role of the qualified person in certifying and releasing batches of veterinary medicinal products.
* **Chapter IX (Outsourced Activities):** Sets requirements for outsourcing manufacturing and control activities.
* **Chapter X (Quality Defects and Recall of Products):** Establishes systems for handling complaints, investigating quality defects, and managing product recalls.
* **Chapter XI (Final Provisions):** States the entry into force and application date of the regulation.
* **Annexes (I-IX):** These annexes provide specific requirements and adaptations for particular types of veterinary medicinal products or processes.
* **Annex I:** Sterile Products and Aseptic Manufacturing
* **Annex II:** Biological and Immunological Products
* **Annex III:** Specific Requirements for Certain Veterinary Medicinal Products (herbal, medicated feedingstuffs, ectoparasitic, liquids/creams/ointments, medicinal gases, aerosols)
* **Annex IV:** Computerised Systems
* **Annex V:** Qualification and Validation
* **Annex VI:** Template for the Site Master File
* **Annex VII:** Use of Ionising Radiation
* **Annex VIII:** Model for Batch Release Certificate
* **Annex IX:** Real Time Release Testing and Parametric Release
**Changes Compared to Previous Versions:**
This regulation repeals Directive 2001/82/EC, aligning GMP requirements with Regulation (EU) 2019/6 on veterinary medicinal products. Key changes include:
* Emphasis on a comprehensive pharmaceutical quality system and risk management principles.
* Specific requirements for the manufacture of sterile, biological, and immunological veterinary medicinal products.
* Detailed guidelines for the use of computerised systems and outsourced activities.
* Focus on data integrity and traceability throughout the product lifecycle.
* Introduction of real-time release testing and parametric release concepts.
**3. Main Provisions Important for Use:**
* **Pharmaceutical Quality System (Chapter II):** Manufacturers must implement a comprehensive quality system that covers all aspects of the manufacturing process, from raw materials to finished products. This system should be based on risk management principles and regularly reviewed for effectiveness.
* **Prevention of Cross-Contamination (Article 29):** Manufacturers must implement measures to prevent cross-contamination between different products, including the dedication of equipment and facilities, the use of closed systems, and validated cleaning procedures.
* **Role of the Qualified Person (Article 38):** The qualified person is responsible for ensuring that each batch of veterinary medicinal product has been manufactured and tested in accordance with the requirements of the marketing authorisation and GMP. They must have access to all relevant documentation and data.
* **Outsourced Activities (Chapter IX):** Any outsourcing of manufacturing or control activities must be done under a written contract that clearly defines the responsibilities of each party. The manufacturer remains responsible for the quality of the product.
* **Annexes:** The annexes provide specific requirements for certain types of products or processes. Manufacturers must ensure that they comply with the relevant annexes for their products.
**:** While the act itself does not directly mention Ukraine, it is important to note that this regulation, as part of EU law, may have implications for Ukrainian manufacturers who export veterinary medicinal products to the EU market. Ukrainian manufacturers would need to comply with these GMP standards to ensure their products can be sold in the EU.
Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025 laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Here’s a breakdown of the Commission Implementing Regulation (EU) 2025/2154:
**1. Essence of the Act:**
This regulation establishes the rules for Good Manufacturing Practice (GMP) for active substances that are used as starting materials in veterinary medicinal products. It aims to ensure that these active substances are manufactured to a consistent and high-quality standard, regardless of whether the final product is for use within the EU or for export. The regulation covers various aspects of manufacturing, from quality management systems and personnel to premises, equipment, documentation, and controls. It also addresses specific considerations for certain types of active substances, such as those of biological or herbal origin, and those manufactured using cell culture or fermentation.
**2. Structure and Main Provisions:**
The regulation is structured into several chapters and an annex, covering a wide range of topics:
* **Chapter I (General Provisions):** Defines the subject matter and scope of the regulation, including exceptions for certain active substances like those used in parasiticidal products for bees or ectoparasiticidal products for external application.
* **Chapter II (Quality Management System):** Requires manufacturers to implement a comprehensive quality management system, based on risk management principles, to ensure the quality of active substances.
* **Chapter III (Personnel):** Sets out requirements for personnel qualifications, training, and hygiene.
* **Chapter IV (Premises):** Specifies the requirements for premises used in the manufacture of active substances, including layout, ventilation, water quality, and containment measures.
* **Chapter V (Equipment):** Covers the design, construction, maintenance, cleaning, calibration, and use of computerised systems related to manufacturing equipment.
* **Chapter VI (Documentation):** Establishes requirements for a comprehensive documentation system, including specifications, records, and instructions.
* **Chapter VII (Materials Management):** Addresses the handling of materials, including receipt, quarantine, testing, and supplier qualification.
* **Chapter VIII (Production and In-Process Controls):** Specifies requirements for production operations, time limits, in-process controls, blending, and contamination control.
* **Chapter IX (Packaging and Labelling):** Sets out requirements for packaging materials, containers, label issuance, and packaging operations.
* **Chapter X (Storage and Distribution):** Covers storage conditions, warehousing procedures, and distribution procedures.
* **Chapter XI (Laboratory Controls):** Specifies requirements for laboratory testing, reference standards, certificates of analysis, stability monitoring, and retention of samples.
* **Chapter XII (Validation):** Establishes requirements for validation policies, documentation, qualification, process validation, cleaning validation, and validation of analytical methods.
* **Chapter XIII (Change Control):** Requires a formal change control system to evaluate changes that may affect the production and control of active substances.
* **Chapter XIV (Rejection and Re-Use of Materials):** Covers the rejection, reprocessing, reworking, and recovery of materials and solvents.
* **Chapter XV (Complaints and Recalls):** Sets out procedures for handling complaints and recalls.
* **Chapter XVI (Outsourced Activities):** Specifies requirements for outsourcing activities related to the manufacturing or control of active substances.
* **Chapter XVII (Entities Involved in Repackaging and Relabelling):** Addresses specific requirements for entities involved in repackaging and relabelling active substances.
* **Chapter XVIII (Specific Requirements for Active Substances Manufactured by Cell Culture or Fermentation):** Provides additional requirements for active substances manufactured by cell culture or fermentation.
* **Chapter XIX (Specific Requirements for Active Substance Gases):** Provides additional requirements for active substance gases.
* **Chapter XX (Final Provisions):** Sets out the entry into force and application date of the regulation.
* **Annex:** Defines the starting point of manufacture for different types of active substances.
**3. Main Provisions for Practical Use:**
* **Quality Management System (Chapter II):** Manufacturers must establish and maintain a robust quality management system that covers all aspects of the manufacturing process.
* **Documentation (Chapter VI):** Comprehensive and accurate documentation is crucial for demonstrating compliance with GMP requirements.
* **Validation (Chapter XII):** Validation of processes, equipment, and analytical methods is essential to ensure consistent quality.
* **Change Control (Chapter XIII):** A formal change control system is necessary to manage any changes that may affect the quality of the active substance.
* **Specific Requirements (Chapters XVIII & XIX):** Manufacturers of active substances produced by cell culture/fermentation or those that are active substance gases must adhere to the additional requirements outlined in these chapters.
Commission Implementing Regulation (EU) 2025/2156 of 24 October 2025 amending Implementing Regulation (EU) 2025/897 as regards the approval of the listing of ports in accordance with Chapter II of Implementing Regulation (EU) 2024/1474
This Commission Implementing Regulation (EU) 2025/2156 amends Implementing Regulation (EU) 2025/897 to include two additional Spanish ports, Santa Eugenia de Ribeira and La Puebla del Caramiñal, on the list of approved ports that meet the conditions for derogation from the standard margins of tolerance when estimating catches. This derogation applies to unsorted landings or transhipments of small pelagic fisheries, industrial fisheries, and tropical tuna purse seine fisheries. The inclusion of these ports follows an application by Spain and an assessment by the Commission, which confirmed that they meet the requirements outlined in Chapter II of Implementing Regulation (EU) 2024/1474.
The regulation consists of two articles and an annex. Article 1 stipulates that the Annex to Implementing Regulation (EU) 2025/897 is amended according to the Annex of this new regulation. Article 2 specifies that the regulation will come into force seven days after its publication in the Official Journal of the European Union. The Annex lists the two newly approved ports, specifying their names, locations, status as Union ports, and the applicant Member State (Spain). The main change is the addition of these two ports to the existing list of approved ports under Implementing Regulation (EU) 2025/897.
The most important provision is the inclusion of Santa Eugenia de Ribeira and La Puebla del Caramiñal in the list of approved ports. This means that landings and transhipments of specific fisheries products in these ports can benefit from a derogation from the standard margins of tolerance when estimating catches, provided that the conditions set out in Implementing Regulation (EU) 2024/1474 are met. Specifically, these ports, although not equipped with remote electronic monitoring (REM) systems with closed-circuit television (CCTV), have alternative procedures in place that ensure the accurate weighing of catches, providing a level of accuracy and reliability equivalent to that of a REM system.
Commission Implementing Regulation (EU) 2025/2189 of 23 October 2025 amending Annex I to Implementing Regulation (EU) 2023/594 laying down special disease control measures for African swine fever
Here is a description of the provisions of the act:
**1. Essence of the Act:**
This Commission Implementing Regulation (EU) 2025/2189 amends Annex I to Implementing Regulation (EU) 2023/594, which lays down special disease control measures for African swine fever (ASF). The amendment involves updating the lists of restricted zones (I, II, and III) in various Member States based on the evolving epidemiological situation of ASF. The goal is to adjust the geographical areas under specific control measures to effectively prevent the further spread of the disease within the Union.
**2. Structure and Main Provisions:**
* **Title:** Commission Implementing Regulation (EU) 2025/2189 amending Annex I to Implementing Regulation (EU) 2023/594 laying down special disease control measures for African swine fever.
* **Legal Basis:** The regulation is based on the Treaty on the Functioning of the European Union and Regulation (EU) 2016/429 (Animal Health Law), specifically Article 71(3).
* **Main Content:**
* Amends Annex I of Implementing Regulation (EU) 2023/594, which lists restricted zones I, II, and III for African swine fever.
* Updates the restricted zones for several Member States, including Croatia, Estonia, Italy, Latvia, Lithuania, Poland and Slovakia, based on recent outbreaks and improvements in the epidemiological situation.
* Reclassifies certain areas from one restricted zone to another (e.g., Zone I to Zone II or Zone II to Zone III) or removes them from the list altogether.
* The changes are based on notifications from Member States, scientific principles, and international standards, such as the Terrestrial Animal Health Code of the World Organisation for Animal Health (WOAH).
* **Amendments Compared to Previous Versions:**
* The regulation responds to new outbreaks of ASF in both kept and wild porcine animals in several Member States.
* It also reflects improvements in the epidemiological situation in certain areas, allowing for the relaxation of restrictions in those zones.
* The changes ensure territorial continuity and are in line with the zoning principles outlined in the ASF guidelines and international standards.
* **Structure:** The regulation consists of two articles:
* Article 1: Specifies that Annex I to Implementing Regulation (EU) 2023/594 is replaced by the text set out in the Annex to this regulation.
* Article 2: States the regulation’s entry into force, which is the day following its publication in the Official Journal of the European Union.
**3. Main Provisions Important for Use:**
* **Geographical Scope:** The key aspect of this regulation is the updated lists of restricted zones in Annex I. Anyone involved in the movement of live pigs or pig products needs to consult the updated annex to determine whether specific areas are subject to restrictions.
* **Restricted Zone Classifications:** The regulation reclassifies certain areas, meaning that the applicable disease control measures may change for those regions. Stakeholders need to be aware of the specific measures in place for each zone (I, II, and III).
* **Entry into Force:** The regulation takes effect immediately after its publication, so it is essential to implement the changes without delay.
* **Impact on Member States:** The regulation directly affects the Member States listed in Annex I, requiring them to implement the updated zoning and apply the corresponding disease control measures.
* **Reference to Other Legislation:** The regulation refers to Regulation (EU) 2016/429 (Animal Health Law) and Delegated Regulation (EU) 2020/687, which provide the broader legal framework for animal health and disease control.
* **** This regulation has implications for Ukraine, as African Swine Fever is a significant concern in Eastern Europe, and the measures outlined in this regulation aim to prevent its spread, which could indirectly affect Ukraine’s trade and animal health situation.
