(fra kommisjonsforordningen)

(1) Commission Delegated Regulation (EU) 2023/3612 supplements Regulation (EU) 2016/429 as regards rules on the use of certain veterinary medicinal products for the purpose of prevention and control of certain listed diseases. It provides among others for detailed and specific rules on the use in the Union of veterinary medicinal products with regard to prevention and control of the listed diseases referred to in Article 9(1)(a) (‘category A diseases’) of Regulation (EU) 2016/429 in kept and wild terrestrial animals. 

(2) Article 2 of Delegated Regulation (EU) 2023/361 set out definitions of terms used in that Regulation, including that of ‘recovery period’. After the completion of emergency protective vaccination an exit strategy should enable Member States to demonstrate the absence of infection before the restrictions to movements of animals and their products may be lifted. Such an exit strategy should consist of a specific reinforced clinical and laboratory surveillance during a pre-defined waiting period for each specific category A disease. There is no free status for category A diseases in EU rules, so the term ‘recovery period’, which refers to the recovery of a free status, should be replaced by ‘waiting period’. The definition thereof should be updated and Article 2 amended accordingly, as well as the title and point (1) of Article 16. 

(3) Moreover, the relevant disease-specific Annexes should describe in their Parts 4 respective conditions for this waiting period and not refer to animal health status, including status granted by WOAH. Therefore, all the disease-specific annexes should be amended accordingly to include this conceptual change. 

(4) Article 4 of Delegated Regulation (EU) 2023/361 lists the veterinary medicinal products prohibited for the prevention and control of category A and B diseases. Part 3 of Annex I lists the diseases for which some specific type of veterinary medicinal products allowed, and the conditions for their use; both the type and the use should comply with this Part 3 of Annex I, and it should be clearly stated in Article 4. 

(5) Article 7 of Delegated Regulation (EU) 2023/361 sets up vaccination strategies for prevention and control of Category A diseases and distinguishes between emergency and preventive vaccination strategies. Return of experience from vaccination plans applied in the field show that emergency protective vaccination may be applied when outbreaks of a listed disease occur in zones where preventive vaccination against that disease is already implemented. In order to avoid misunderstanding, implementation of emergency protective vaccination should be clarified in Article 7, and some explanatory text should be introduced to explain that preventive vaccination plan may continue to be implemented in a restricted zone, unless the competent authority decides to apply emergency vaccination. 

(6) During the review of Delegated Regulation (EU) 2023/361, Article 13 was considered unclear and should be amended for clarity: paragraphs 1 to 4 should not lay down in the detail which animals or products are prohibited and may be moved, and should clearly refer to the relevant parts of the annexes for the details, and paragraph 6 should be clarified to explain better the restrictions in accordance with paragraphs 1 to 5 of that Article, which apply simultaneously with the restricted zones in accordance with Delegated Regulation (EU) 2020/687. 

(7) During the review of Delegated Regulation (EU) 2023/361, it was noted that for clarity, Article 14(2)(a) should include a reference to the Article 13(1) that lists the animals and products subject to prohibition. 

(8) Delegated Regulation (EU) 2023/361 lays down specific conditions, in the respective disease-specific annexes, for each category A disease based on the experience and data that were available at the time of its adoption. For diseases for which sufficient experience and data were not available at the time of its adoption, disease specific measures could not be provided. 

(9) For Foot-and-Mouth Disease (FMD), recent outbreaks provided information relevant to the difficulties to use protective vaccination and the necessity to clarify in annex VII that all animals of listed species were concerned by prohibition, how surveillance was to be implemented and according which conditions derogations to prohibition could be granted. 

(10) For Lumpy Skin Disease (LSD), recent field experience and scientific data provided further information and evidence that should be taken into account in annex IX for the conditions related to the vaccination zones, and the related restrictions and waiting period before their lifting. 

(11) For Classical Swine Fever (CSF), up-to-date available scientific data should be used to update the conditions for vaccination of domestic pigs in annex XII and lay down specific conditions for vaccination of wild pigs in a new annex. 

(12) For Highly Pathogenic Avian Influenza (HPAI), recent experience of field implementation of vaccination of poultry, as well as scientific data on vaccination, risk-mitigation and surveillance, including a European Food Safety Authority (EFSA) scientific opinion , provided sufficient information to amend and update the specific conditions in annex XIII for restrictions, derogations, and surveillance, notably when preventive vaccination in applied. 

(13) For African Swine Fever (ASF), although currently no effective and safe vaccine is available, in view of recent EFSA reports and updated scientific data on vaccines included in the WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, new annexes should be added to describe the conditions for use of such vaccines, once available, respectively in domestic and in wild pigs. 

(14) For Sheep Pox and Goat Pox (SPGP), the scientific justifications for the modification of the relevant chapters of the WOAH Terrestrial Animal Health Code have provided sufficient data to lay down specific conditions in a new annex. 

(15) For consistency between the articles and the Annexes, the numbering should be amended due to additions or deletions of points, and to the addition of new Annexes. 

(16) Finally, editorial errors in Article 3(2) should be corrected,