Nařízení Komise v přenesené pravomoci (EU) 2026/322 ze dne 12. února 2026, kterým se mění a opravuje nařízení v přenesené pravomoci (EU) 2020/687, kterým se doplňuje nařízení Evropského parlamentu a Rady (EU) 2016/429, pokud jde o pravidla pro prevenci a tlumení určitých nákaz uvedených na seznamu

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law)OJ L 84, 31.3.2016, p. 1 , ELI: http://data.europa.eu/eli/reg/2016/429/oj. , and in particular Articles 55(2), 63, and 64(4), Article 67, and Article 68(3) thereof,

OJ L 84, 31.3.2016, p. 1 , ELI: http://data.europa.eu/eli/reg/2016/429/oj.

(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans, including rules on disease awareness, preparedness and control. That Regulation lays down, in particular, disease-specific rules for the prevention and control of the diseases listed in Article 5 thereof.

(2) Commission Delegated Regulation (EU) 2020/687Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64 , ELI: http://data.europa.eu/eli/reg_del/2020/687/oj). lays down rules supplementing Regulation (EU) 2016/429 as regards the prevention and control of certain listed diseases, namely category A, B and C diseases defined in Commission Implementing Regulation (EU) 2018/1882Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21 , ELI: http://data.europa.eu/eli/reg_impl/2018/1882/oj). . More particularly, Delegated Regulation (EU) 2020/687 lays down detailed rules concerning the establishment of a restricted zone in the event of an outbreak of a category A disease, and restrictions and conditions for movements of animals of listed species and their products within, to and from restricted zones, as part of the disease control measures required in order to prevent and control the spread of category A diseases.

(3) In addition, Article 7 of Delegated Regulation (EU) 2020/687 prohibits any movement of kept animals of non-listed species into and from an establishment where there is a suspicion of a category A disease. However, movements of certain animals of non-listed species into an establishment where there is a suspicion of a category A disease, or movements of such animals from such an establishment to a slaughterhouse, should be allowed, based on a risk assessment carried out, in each individual case, by the competent authority. Therefore, Article 7 of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(4) Cleaning and disinfection of the affected establishment is one of the basic disease control measures provided for in Article 61 of Regulation (EU) 2016/429 to minimise the risk of the spread of a confirmed category A disease, and to eliminate as soon as possible the category A disease pathogen. The requirements for cleaning and disinfection consist of several procedures set out in points A (General requirements), B (Preliminary cleaning and disinfection) and C (Final cleaning and disinfection) of Annex IV to Delegated Regulation (EU) 2020/687. However, Articles 15 and 16 of that Delegated Regulation, which lay down the rules and derogations for cleaning and disinfection, and, when necessary, the control of insects and rodents, refer only to preliminary cleaning and disinfection, that is only a part of the complete procedure of cleaning and disinfection. Therefore, Article 15 should be amended to regulate the complete procedure of cleaning and disinfection, consisting of both the preliminary and the final cleaning and disinfection procedures.

(5) Products from an establishment where an outbreak of category A disease has been confirmed may represent a risk for the spread of the category A disease. Therefore, those products that were moved from that establishment during a certain period are to be identified by tracing and treated or processed as required by Article 19(2) of Delegated Regulation (EU) 2020/687. However, that Article 19 does not clearly specify that the risk of the spread of the category A disease must be mitigated by the treatment or processing of those products. Therefore, Article 19 of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(6) Based on the provisions of Article 21 of Delegated Regulation (EU) 2020/687, the possibilities of the competent authority to extend or adapt the restricted zone established in accordance with that Article are limited to certain situations. The possibilities provided for by Article 21 of Delegated Regulation (EU) 2020/687 for the establishment of a further restricted zone or for the adaptation of the restricted zone are not sufficient to effectively prevent the spread of the category A disease, in particular when the category A disease is also present in the wild animals of listed species, or if it is a vector borne disease. Therefore, Article 21 of Delegated Regulation (EU) 2020/687 should be amended to allow for the adaptation of the restricted zones, as provided for by Article 64(2) of Regulation (EU) 2016/429, without any limitation to only certain possibilities.

(7) Regulation (EC) No 1069/2009 of the European Parliament and of the CouncilRegulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1 , ELI: http://data.europa.eu/eli/reg/2009/1069/oj). , lays down rules for the safe collection, transport and disposal of animal by-products. However, in the event of a widespread outbreak of a listed disease where disposal capacities in a concerned Member State are exceeded, Article 19(1) of that Regulation provides, by way of derogation the possibility for the competent authority to dispose animal by-products in exceptional cases by burning or burial on the site, under conditions which prevent the transmission of risks to public and animal health. That possibility should also be provided for in Delegated Regulation (EU) 2020/687. Therefore, Article 22 of that Delegated Regulation should be amended accordingly.

(8) Article 23 of Delegated Regulation (EU) 2020/687 provides that the competent authority may grant derogations from the provisions set out in Chapter II of that Delegated Regulation concerning the measures to be applied in the restricted zones under certain circumstances, to the extent necessary and after carrying out a risk assessment. However, it is not clear that the outcome of the risk assessment must indicate that the risk of spread of the disease is negligible in order for the competent authority to grant a derogation. In addition, following the amendments made to Article 21(3) of Delegated Regulation (EU) 2020/687 by Commission Delegated Regulation (EU) 2023/751Commission Delegated Regulation (EU) 2023/751 of 30 January 2023 amending Delegated Regulation (EU) 2020/687 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the prevention and control of certain listed diseases (OJ L 100, 13.4.2023, p. 7 , ELI: http://data.europa.eu/eli/reg_del/2023/751/oj). regarding establishments keeping up to 50 captive birds, point (c) of Article 23 is no longer necessary as it is covered by Article 21(3), point (g) of Delegated Regulation (EU) 2020/687. Moreover, the derogation initially provided by Article 23, point (c), of Delegated Regulation (EU) 2020/687 only covers establishments keeping up to 50 captive birds where the outbreak of the category A disease occurred. However, as a result of the amendments made by Delegated Regulation (EU) 2023/751 to Article 21(3) of Delegated Regulation (EU) 2020/687, and based on Article 23, point (d) of that Delegated Regulation derogations are currently possible in establishments keeping up to 50 captive birds, which are not the establishments where the outbreak occurred. Therefore, Article 23 of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(9) Following the confirmation of a category A disease in an establishment with kept animals of listed species, Article 26 of Delegated Regulation (EU) 2020/687 requires that official veterinarians carry out visits to the establishments located in the protection zone. The scope of these visits is to perform the necessary checks and examinations, including sampling for laboratory testing, to detect early the possible spread of the category A disease to other establishments in that zone. The procedures for the taking of samples at the establishments to be visited, and for the clinical and laboratory examinations in the visited establishments, are laid down in Annex I to Delegated Regulation (EU) 2020/687. The clinical and laboratory examinations of animals of listed species kept in establishments locatedScientific Opinion on the assessment of the control measures for category A diseases of Animal Health Law: Foot and Mouth Disease, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6632. Assessment of the control measures of category A diseases of the Animal Health Law: Infection with rinderpest virus (Rinderpest), https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7071. Assessment of the control measures of the category A diseases of Animal Health Law: Rift Valley Fever, https://www.efsa.europa.eu/en/efsajournal/pub/7070. Assessment of the control measures for category A diseases of Animal Health Law: Lumpy Skin Disease, https://www.efsa.europa.eu/en/efsajournal/pub/7121. Assessment of the control measures for category A diseases of Animal Health Law: Contagious Bovine Pleuropneumonia, https://www.efsa.europa.eu/en/efsajournal/pub/7067. Assessment of the control measures of the category A diseases of Animal Health Law: sheep and goat pox, https://www.efsa.europa.eu/en/efsajournal/pub/6933. Assessment of the control measures of the category A diseases of Animal Health Law: peste des petits ruminants, https://www.efsa.europa.eu/en/efsajournal/pub/6708. Assessment of the control measures for category A diseases of Animal Health Law: Contagious Caprine Pleuropneumonia, https://www.efsa.europa.eu/en/efsajournal/pub/7068. Assessment of the control measures of the category A diseases of Animal Health Law: Classical Swine Fever, https://www.efsa.europa.eu/en/efsajournal/pub/6707. Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: African Swine Fever, https://www.efsa.europa.eu/en/efsajournal/pub/6402. Assessment of the control measures of the category A diseases of Animal Health Law: Burkholderia mallei (Glanders), https://www.efsa.europa.eu/en/efsajournal/pub/7069. Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: African Horse Sickness, https://www.efsa.europa.eu/en/efsajournal/pub/6403. Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: Highly Pathogenic Avian Influenza, https://www.efsa.europa.eu/en/efsajournal/pub/6372. Assessment of the control measures of the category A diseases of Animal Health Law: Newcastle disease, https://www.efsa.europa.eu/en/efsajournal/pub/6946. (the relevant scientific evidence) including recommended clinical and laboratory examinations and sampling procedures to detect those diseases. Therefore, Article 26(2), point (d), and Article 39(1), point (b), of Delegated Regulation (EU) 2020/687 should be amended to refer to the need to collect samples for laboratory examinations when the relevant scientific evidence recommends such measures. In addition, Annex I to Delegated Regulation (EU) 2020/687 should be amended to add the requirement that the sampling procedures laid down in point A of that Annex must be based on the relevant scientific evidence for the respective category A disease.

(10) Article 27 of Delegated Regulation (EU) 2020/687 provides, amongst other things, for prohibitions on movements of animals and products in the protection zone. Paragraph 3 of that Article allows for certain products to be exempted from that prohibition. An exemption is only possible for products that are safe and do not present a risk for the transmission of category A diseases to terrestrial animals. Paragraph 3 lists derived products as one such product. However, derived products may, in accordance with the rules on animal by-products, and in particular Commission Regulation (EU) No 142/2011Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1 , ELI: http://data.europa.eu/eli/reg/2011/142/oj). be treated by different methods and some of those methods may not be sufficient to mitigate the risk of a category A disease in terrestrial animals. Recent experiences with the application of disease control measures in the Union have highlighted that deficiency. It is, therefore, necessary to amend Delegated Regulation (EU) 2020/687 so as to require those treatments for the relevant derived products, as provided for in Regulation (EU) No 142/2011, which are considered to mitigate the risk of pathogens of those category A diseases. In addition, gelatine and collagen as defined in Annex I, points 7.7 and 7.8 to Regulation (EC) No 853/2004 of the European Parliament and of the CouncilRegulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55 , ELI: http://data.europa.eu/eli/reg/2004/853/oj). are, due to their production process, considered to be products of animal origin which do not represent a risk as regards transmissible animal diseases falling within the scope of Regulation (EU) 2016/429. It is, therefore, necessary to exempt gelatine and collagen from the prohibitions provided for in

(11) Articles 28 and 43 of Delegated Regulation (EU) 2020/687 lay down the general conditions for granting derogations from the prohibitions to be applied in the protection and surveillance zones, respectively as established following confirmation of a category A disease in kept animals of listed species. Commission Delegated Regulation (EU) 2024/2623Commission Delegated Regulation (EU) 2024/2623 of 30 July 2024 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for approval and recognition of disease-free status of compartments keeping terrestrial animals (OJ L, 2024/2623, 4.10.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2623/oj). lays down the rules for the approval and recognition of disease-free status of compartments keeping terrestrial animals as regards certain category A diseases. Therefore, Articles 28 and 43 of Delegated Regulation (EU) 2020/687 should be amended to allow movements of animals and products from a restricted zone if they originate from compartments approved for the relevant category A disease in accordance with Delegated Regulation (EU) 2024/2623, and listed in Annex XI to Commission Implementing Regulation (EU) 2021/620Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, p. 78 , ELI: http://data.europa.eu/eli/reg_impl/2021/620/oj). .

(12) Specific conditions for authorising movements of manure, including litter and used bedding, from protection and surveillance zones are laid down in Articles 35 and 51 of Delegated Regulation (EU) 2020/687. In addition, Articles 37(2) and 53(2) of Delegated Regulation (EU) 2020/687 lay down the specific conditions for authorising movements of products from protection or surveillance zones to an animal by-product approved plant. Manure, including litter and used bedding, are also products, and therefore they fall within the scope of Articles 37(2) and 53(2) of that Delegated Regulation. However, that is not clear, considering that movements of those products from establishments in the protection and surveillance zone are already referred to Articles 35 and 51 of that Delegated Regulation. Therefore, for clarity of Union rules on possibilities for movements of manure, including litter and used bedding from establishments located in the protection and surveillance zones, Articles 35 and 51 of Delegated Regulation (EU) 2020/687 should be amended so that they refer to all those provisions. Moreover, Point C, paragraph 1(a)(i), of Annex IV to Delegated Regulation (EU) 2020/687 provides for a treatment deemed to inactivate the category A disease pathogens in manure, litter and used bedding from an affected establishment. The same treatment should be deemed safe also for the manure, including litter and used bedding from establishments located in the protection zone. Therefore, Articles 35 and 51 of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(13) Moreover, it is important to ensure that the risk mitigating treatments used for animal-by products originating from protection and surveillance zones presenting an imminent risk for the transmission of the animal disease are safe to destroy the disease agent. This can only be ensured by processing those products with processing methods which are considered as safe in accordance with Regulation (EC) No 1069/2009 and therefore fully harmonised under that legislation. It is, therefore, necessary to refer to these safe methods in Delegated Regulation (EU) 2020/687 and amend Articles 37 and 53 accordingly.

(14) Article 46(1), point (b), of Delegated Regulation (EU) 2020/687 limits the possibility to authorise movements of day-old chicks originating in the surveillance zone to movements of such animals to establishments in the same Member State only. However, movements from establishments in the surveillance zone of day-old chicks obtained from hatching eggs originating outside the restricted zone may be deemed to be safe if those eggs and the day-old chicks have had no contact with other hatching eggs or day-old chicks from the restricted zone. Therefore, Article 46(1), point (b), of Delegated Regulation (EU) 2020/687 should be amended to permit, subject to certain conditions, movements of day-old chicks hatched from eggs originating outside the restricted zone to any establishment.

(15) A surveillance zone is considered to represent a lower risk for the spread of a category A disease pathogen than a protection zone. Therefore, feed materials of plant origin and straw produced in the surveillance zone represent a lower risk than those produced in the protection zone and may be used in the protection zone without increasing the risk of the spreading of the category A disease in that zone. Therefore, Article 52, point (c), of Delegated Regulation (EU) 2020/687 should be amended to permit the use of feed materials of plant origin and straw produced in the surveillance zone in both the protection and surveillance zones.

(16) Disease control measures must be applied in the restricted zone established for a category A disease until the final cleaning and disinfection has been carried out, as required by Article 68 of Regulation (EU) 2016/429. Therefore, Article 55 of Delegated Regulation (EU) 2020/687 should be amended to clearly refer to the completion of the final cleaning and disinfection as a condition to be fulfilled before lifting the disease control measures applied in the surveillance zone. However, in certain situations, such as force majeure or because of long period of unfavourable weather conditions, the completion of the final cleaning and disinfection in accordance with the procedures set out in Annex IV to Delegated Regulation (EU) 2020/687 might be delayed. As such delays might significantly extend the duration of the restrictions more than doubling the length of the minimum duration required in accordance with Annex XI to Delegated Regulation (EU) 2020/687, this can cause serious disturbances to the activity of the non-affected establishments located in the surveillance zone and significant economic losses for those operators. Therefore, it is appropriate to permit, in such exceptional circumstances, the lifting of the disease control measures in the surveillance zone before the completion of the final cleaning and disinfection in the affected establishment if certain conditions are fulfilled to ensure that the risk of spread of the category A disease from that establishment is negligible. Therefore, Article 55 of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(17) The restricted zone may also comprise a further restricted zone as established by the competent authority in accordance with Article 21 of Delegated Regulation (EU) 2020/687 when certain epidemiological situations warrant applying such measure to effectively control the spread of the category A disease. In those circumstances, it also might be necessary to maintain certain disease control measures in the entire restricted zone after the lifting of the disease control measures applied in the protection and surveillance zones. Therefore, Articles 39 and 55 of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(18) As a consequence of the prohibitions laid down in Articles 27 and 42 of Delegated Regulation (EU) 2020/687 movements of animals of listed species within and into a restricted zone cannot take place until the measures are lifted in accordance with Article 55 of Delegated Regulation (EU) 2020/687. Therefore, establishments in the restricted zone might not be able to restock and thus remain empty for the duration of the restrictions even if they were not affected by the disease. In certain exceptional circumstances, the duration of the measures in the restricted zone may be significantly extended even if no further outbreaks have been detected, exceeding significantly the minimum period set out in Annex XI of Delegated Regulation (EU) 2020/687. As a result, restocking of those establishments may be substantially delayed, potentially causing serious economic losses for those operators. This is especially relevant for certain production systems with high level of integration and relatively short turnover times. Therefore, in such exceptional situations, and under specific conditions, a derogation from the prohibition of moving animals of listed species into establishments located in a restricted zone should be provided for in Section 4 of Chapter II in Part II of Delegated Regulation (EU) 2020/687 and Article 56 of Delegated Regulation (EU) 2020/687 which already provides for certain derogations from prohibitions of movements of animals, but these need to be extended accordingly. These derogations are complementing the derogations laid down in Articles 28 and 43 of Delegated Regulation (EU) 2020/687. However, Article 56 makes incorrect reference to articles with derogations. Therefore, title of Section 4 of Chapter II in Part II of Delegated Regulation (EU) 2020/687 and Article 56 should be amended accordingly.

(19) The rules laid down in Chapter III of Part II of Delegated Regulation (EU) 2020/687 refer to repopulation of the affected establishment and lifting of the disease control measures in that establishment. Therefore, the title of that Chapter should be corrected accordingly.

(20) Article 58 of Delegated Regulation (EU) 2020/687 provides for derogations from the conditions required to authorise the repopulation of affected establishment as laid down in Article 57 of that Delegated Regulation. However, the title of Article 58 of Delegated Regulation (EU) 2020/687 incorrectly refers to Article 55 and therefore should be corrected.

(21) Repopulation of an affected establishment is to be performed in accordance with the requirements laid down in Article 59 of Delegated Regulation (EU) 2020/687, to ensure that repopulated animals are free of the relevant category A disease. Accordingly, the official veterinarian is to visit, at least once, the affected establishment and check the repopulated animals. The visits are to take place within a specific period that takes into account the date on which the animals were placed into the establishment and the last day of the monitoring period for the relevant category A disease. However, when the monitoring period, in accordance with Annex II to Delegated Regulation (EU) 2020/687, is longer than 30 days, the visit should be performed within 30 days from the date on which the animals were placed into the establishment. Therefore, Article 59(5) of Delegated Regulation (EU) 2020/687 should be amended accordingly.

(22) The lifting of the disease control measures applied in an establishment affected by an outbreak of a category A disease is linked with the finalisation of the repopulation of that establishment, as required by Article 61 of Delegated Regulation (EU) 2020/687. The requirements of Article 61 of Delegated Regulation (EU) 2020/687 do not cover cases where repopulation is not taking place in the affected establishment either due to the cessation of keeping of animals by the operator or in cases when the competent authority granted derogations from the killing of animals of listed species kept in certain affected establishments and of certain categories of animals, in accordance with Article 13(1) and (2) of Delegated Regulation (EU) 2020/687. Therefore, Article 61 of Delegated Regulation (EU) 2020/687 should be amended to lay down conditions for lifting the disease control measures in affected establishments, covering those situations as well as when repopulation is not intended in the affected establishment.

(23) Article 75 of Delegated Regulation (EU) 2020/687 provides for several circumstances to be taken into account by the competent authority when establishing temporary restricted zones. One of these circumstances provided for in point (b) of that Article is the movements of animals in the vicinity of the suspected establishment. As that Article of Delegated Regulation (EU) 2020/687 refers to disease control measures for category A diseases in aquaculture animals, it is appropriate to specify that the circumstance to be taken into account is the movement of aquatic animals. Article 75 Delegated Regulation (EU) 2020/687 should, therefore, be amended accordingly.

(24) Article 78(1), point (f) (i) and (ii), and Article 78(5) of Delegated Regulation (EU) 2020/687 lay down rules concerning animal by-products and products of animal origin, although there are already rules for those products laid down in Article 78(1), point (b), and Article 78(3) of that Delegated Regulation. Therefore, Article 78 should be amended to ensure that there is no duplication of rules for the same products in the same Article.

(25) When purification is required before molluscs can be processed from aquaculture establishments in the protection zone, such purification should be completed in a manner which does not create a risk for the spread of the disease. In order to simplify and harmonise certain elements of Delegated Regulation (EU) 2020/687, Article 83 thereof should be amended by deleting the reference to a bio-secure purification centre, to ensure that molluscs from infected aquaculture establishments, are only purified in a disease control aquatic food establishment. In addition, Article 83 should be revised to align the provisions referred to Article 78 with the amendments done to that Article.

(26) Article 90(2), point (b), of Delegated Regulation (EU) 2020/687, provides that exchanges and discharges of water during transportation in the protection zone, must be carried out in areas, establishments or water exchange points approved by the competent authority. Such discharges and exchanges often require vehicles to stop. Such stopping is, however, prohibited by Article 90(2), point (a), of Delegated Regulation (EU) 2020/687. To ensure that those provisions are logistically feasible, the reference to stopping should be updated accordingly in Article 90(2), point (a), of Delegated Regulation (EU) 2020/687.

(27) Article 99(1) of Delegated Regulation (EU) 2020/687, prohibits movements of aquaculture animals from within the surveillance zone for slaughter, further keeping or release into the wild outside the surveillance zone. Article 99(4) of that Delegated Regulation, however, allows the competent authority in agreement with the competent authority of the place of destination to authorise movements of aquaculture animals, provided that appropriate biosecurity measures are applied to prevent the spread of the category A disease. While this derogation is appropriate for many types of movements, it is not appropriate for animals which are to be released into the wild, where such release may result in the infection of natural waters, which may be very difficult to eradicate. The derogation laid down in Article 99(4) should, therefore, be limited to movements other than for the purpose of release into the wild.

(28) The EFSA issued scientific opinions concluding and recommending on the effectiveness of the disease control measures laid down in Delegated Regulation (EU) 2020/687 for each category A disease5 , in particular on the effectiveness of the monitoring period, of the radiuses of the protection and surveillance zones, and on the duration of the measures to be applied in those zones, as laid down in Annexes II, V, X and XI to Delegated Regulation (EU) 2020/687. In addition, prohibitions in restricted zones and risk-mitigating treatments for products of animal origin and other materials, as laid down in Annexes VI, VII and VIII to Delegated Regulation (EU) 2020/687 have been assessed by EFSA, and conclusions on the effectiveness of those measures and risk-mitigation treatments have been published in a scientific opinion on the Assessment of the control measures of the Category A diseases of the Animal Health Law: prohibitions in restricted zones and risk-mitigating treatments for products of animal origin and other materialsAssessment of the control measures of the Category A diseases of the Animal Health Law: prohibitions in restricted zones and risk-mitigating treatments for products of animal origin and other materials, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7443. . Therefore, Annexes II, V to VIII, X and XI to Delegated Regulation (EU) 2020/687 should be amended, to take account of the effective measures, prohibitions and risk-mitigating treatments relevant for each category A disease in accordance with EFSA recommendations. In addition, following the amendment of Article 27(3) of Delegated Regulation (EU) 2020/687, Annex VII to that Delegated Regulation should be amended to also include the methods for mitigating the risk of the derived products from the restricted zone.

(29) Annex IV to Delegated Regulation (EU) 2020/687 sets out the procedures for the cleaning, disinfection and when necessary, the control of insects and rodents, as referred in certain Articles of that Delegated Regulation. Therefore, the subtitle of that Annex IV should refer to the rules laid down in all the Articles of Delegated Regulation (EU) 2020/687 that require cleaning and disinfection in accordance with Annex IV. In addition, amendments should be made to Point B of Annex IV to that Delegated Regulation in relation to the required contact time of the disinfectant with the treated surfaces, to take account of situations when unnecessarily maintaining the disinfectant on the surfaces to be disinfected longer than the minimum required contact time indicated by the manufacturer may damage the disinfected materials. Moreover, the duration of steam treatment required for manure as part of the final cleaning and disinfection as laid down in Point C, paragraph 1(a)(i), of Annex IV should be clarified for its duration to ensure the effective inactivation of category A disease agents. Furthermore, the period of 7 days required by Point C, paragraph 3, of Annex IV aims to allow the buildings, surfaces and equipment that were cleaned and disinfected as required by paragraph 2 of that Point to dry before being cleaned and disinfected again. However, in certain circumstances or weather conditions the surfaces, buildings and equipment are dry earlier than 7 days. It is therefore correct to allow the cleaning and disinfection provided for in Point C, paragraph 3, to be carried out earlier than 7 days if the surfaces have dried.

(30) For the control of category A diseases, in the case of authorised movements of fresh meat obtained from animals of listed species kept in establishments located in the protection and surveillance zones, Annex IX to Delegated Regulation (EU) 2020/687 provides for the marking of fresh meat of poultry which is not intended to be dispatched to another Member State, as well as of fresh meat moved to a processing establishment to undergo one of the relevant risk-mitigating treatments, as required by Articles 33 and 49 of that Delegated Regulation. Different shapes of marks are described for marks to be applied to fresh meat of poultry and to fresh meat of other species. In addition, theCommission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (OJ L 131, 17.5.2019, p. 51 , ELI: http://data.europa.eu/eli/reg_impl/2019/627/oj). or in Section I of Annex II to Regulation (EC) No 853/2004. Therefore, to simplify the description of the marks as laid down in Annex IX to Delegated Regulation (EU) 2020/687, and to ensure harmonised marking of fresh meat, Annex IX to Delegated Regulation (EU) 2020/687 should provide a reference to health marks or, where relevant, identification marks, as laid down in Article 48 of, and Annex II to, Implementing Regulation (EU) 2019/627 or in Section I of Annex II to Regulation (EC) No 853/2004, respectively. In addition, when used for disease control purposes as laid down in Articles 33 and 49 of Delegated Regulation (EU) 2020/687, additional requirements should apply to the form of the health or identification marks (special health or identification marks). Therefore, Annex IX to Delegated Regulation (EU) 2020/687 should be amended accordingly.

(31) The changes to the description of the marks as laid down in Annex IX to Delegated Regulation (EU) 2020/687, as amended by this Regulation, might create an additional administrative burden for operators. A transitional period should, therefore, be provided for in this Regulation during which time the marks as described in Annex IX in the version of Delegated Regulation (EU) 2020/687 applicable before the amendments made by this Regulation, may continue to be used, and the fresh meat with such marks applied before the end of the transitional period may remain on the market.

(32) Annex XII to Delegated Regulation (EU) 2020/687 should be amended to ensure that three separate options exist concerning the types of samples that may be considered for clinical and laboratory examinations of aquatic animals, rather than those options being linked to each other. In addition, the table in point 1(b) of that Annex is missing information and certain inconsistencies concerning the samples to be collected from crustaceans and fish, under certain circumstances. The European Union Reference Laboratory (EURL) for fish and crustacean diseases has been consulted and that table should be amended according to the recommendations of that EURL.

(33) In Annex XV to Delegated Regulation (EU) 2020/687, in the interest of clarity, it is necessary to harmonise the terminology to ensure that the term health visits is used throughout, rather than using both the terms health visits and health inspections, when they are intended for the same disease surveillance purpose.

(34) After publication in the Official Journal of the European Union , some errors were noticed in Part III of Delegated Regulation (EU) 2020/687. Those errors should be corrected.

(35) Delegated Regulation (EU) 2020/687 should therefore be amended and corrected accordingly,

Delegated Regulation (EU) 2020/687 is corrected as follows:

By way of derogation from the prohibitions provided for in Article 89(1), the competent authority may authorise the movement and transport of aquatic animals and products thereof in the cases referred to in Articles 91, 92 and 93 under the specific conditions provided for in those Articles and the general conditions laid down in paragraph 2 of this Article.

The competent authority shall ensure that any transport of aquaculture animals of listed species within or into the surveillance zone shall be carried out in accordance with the conditions laid down in Article 90(2), points (a) to (e), and in Article 91.

Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64 , ELI: http://data.europa.eu/eli/reg_del/2020/687/oj).

Article 2 Article 2 Corrections to Delegated Regulation (EU) 2020/687

Article 3 Article 3 Transitional provisions

Article 4 Article 4 Entry into force

(1) the title of Chapter III of Part II is replaced by the following:Repopulation of the affected establishment with terrestrial animals and lifting of disease control measures in the affected establishment ;

Article 15 Article 15 Cleaning and disinfection and control of insects and rodents in the affected establishment 1.The competent authority shall order and supervise the cleaning and disinfection and, where relevant, the control of insects and rodents, in the affected establishment, as follows: (a) a preliminary cleaning and disinfection, and where relevant, control of insects and rodents, immediately after the completion of the disease control measures accordance with Article 12, 13 and 14; and(b) a final cleaning and disinfection, and, where relevant, control of insects and rodents as provided for in Article 68(1), point (b) of Regulation (EU) 2016/429, immediately after the completion of the preliminary cleaning and disinfection. 2.The preliminary and final cleaning, disinfection and control of insects and rodents, referred to in paragraph 1 shall be: (a) performed in accordance with the general requirements set out in point A of Annex IV and the relevant procedures set out in points B and C of that Annex, using the appropriate biocidal products to ensure the destruction of the relevant category A disease agent; and(b) adequately documented. 3.If the competent authority has granted one of the specific derogations from the disease control measures laid down in Article 12(1), point (a), provided for in Article 13(2) and (4), it shall adapt the procedures laid down in Annex IV to the specific situation, without detriment to the control of the spread of the category A disease from the affected animals and affected establishments and locations to other unaffected animals or to humans. 4.In addition to the measures referred to in paragraphs 1 and 2, the competent authority shall order and supervise that the means of transport used for the transport of animals to and from the affected establishment are properly cleaned and disinfected and, where relevant, subjected to measures ensuring the control of insects and rodents.

Article 16Derogations and special rules for the cleaning and disinfection and control of vectors;

(2) the title of Article 58 is replaced by the following:Derogation from the requirements provided for in Article 57(1), point (b) ;

Article 23 Article 23 Derogations from measures to be applied in the restricted zone

(3) the title of Section 2, Chapter I of Part III is replaced by the following:Disease control measures in the event of official confirmation of a category A disease in aquaculture animals ;

Article 35 Article 35 Specific conditions for authorising movements of manure, including litter and used bedding, from establishments located in the protection zone

(4) in Article 85(4), point (b) is replaced by the following:(b) establish a restricted zone consisting of a protection zone without any adjacent surveillance zone; or;

(b) establish a restricted zone consisting of a protection zone without any adjacent surveillance zone; or;

(5) in Article 90, paragraph 1 is replaced by the following:1.By way of derogation from the prohibitions provided for in Article 89(1), the competent authority may authorise the movement and transport of aquatic animals and products thereof in the cases referred to in Articles 91, 92 and 93 under the specific conditions provided for in those Articles and the general conditions laid down in paragraph 2 of this Article. ;

Article 51 Article 51 Specific conditions for authorising movements of manure, including litter and used bedding, from establishments in the surveillance zone 1.The competent authority may authorise the movements of manure, including litter and used bedding, from establishments located in the surveillance zone: (a) without processing, to a landfill, previously authorised for that purpose by the competent authority, located in the same surveillance zone; or(b) following processing, to a landfill, previously authorised for that purpose by the competent authority, located in the territory of the same Member State. 2.The competent authority may authorise movements of manure, including litter and used bedding, from establishments and other locations in the surveillance zone to a plant approved for the processing or disposal of animal by-products where they are disposed of or processed in accordance with Regulation (EC) No 1069/2009 by the methods relevant for processing of manure provided for in Part II of Annex VII to this Regulation.

Article 56 Article 56 Derogations from prohibitions of movements of animals within and into the restricted zones when restriction measures are maintained 1.Where prohibitions of movement of animals provided for in Articles 27 and Article 42 are maintained significantly beyond the period set out in Annex XI, the competent authority may, under exceptional circumstances, authorise the movement of kept animals of listed species from and into establishments within the restricted zone in cases not covered by derogations provided for in Articles 28 and Article 43, if: (a) the operator has submitted a reasoned application for that authorisation;(b) the risks derived from authorising such movements have been assessed prior to the authorisation and the assessment indicates that the risk of spreading of the category A disease is negligible;(c) reinforced biosecurity measures are applied in the establishment of destination to prevent the risk of the spread of the category A disease.(d) official veterinarians have, in case of movements from establishments within the restricted zone, carried out clinical examinations and have collect samples for laboratory examinations from animals of listed species, including those to be moved, which have yielded favourable results. 2.Where movements of animals are authorised pursuant paragraph 1, the competent authority shall ensure that the transport complies with the requirements laid down in Article 24.

(6) in Article 99, paragraph 2 is replaced by the following:2.The competent authority shall ensure that any transport of aquaculture animals of listed species within or into the surveillance zone shall be carried out in accordance with the conditions laid down in Article 90(2), points (a) to (e), and in Article 91. ;

(7) the title of Article 103 is replaced by the following:Measures in the event of official confirmation of a category A disease in wild aquatic animals of listed species ;

(8) in Article 104(1), point (e) is replaced by the following:(e) prohibit bringing into establishments keeping aquaculture animals of listed species, within the infected zone, any parts of aquatic animals of listed species whether fished, caught, collected or found dead in the infected zone, as well as any product, material or substance, which is likely to be contaminated with a category A disease..

(e) prohibit bringing into establishments keeping aquaculture animals of listed species, within the infected zone, any parts of aquatic animals of listed species whether fished, caught, collected or found dead in the infected zone, as well as any product, material or substance, which is likely to be contaminated with a category A disease..

Article 83 Article 83 Placing on the market of products of animal origin from aquaculture animals of listed species produced in infected establishments 1.When granting a derogation in accordance with Article 78(3), the competent authority may allow the placing on the market of products of animal origin from aquaculture animals only if the following conditions are fulfilled: (a) fish must be slaughtered and eviscerated before dispatch;(b) molluscs and crustaceans must be fully traceable and processed to non-viable products unable to survive if returned to the water, before dispatch. When purification is required before processing and placing on the market, it shall be conducted at a disease control aquatic food establishment. 2.The products of animal origin referred to in paragraph 1 shall be intended for: (a) direct supply to the final consumer; or(b) further processing in a disease control aquatic food establishment.

The marks to be applied to fresh meat referred to in Annex IX to Delegated Regulation (EU) 2020/687, as laid down in the version of that Delegated Regulation, before the amendments made by this Regulation, may continue to be used until 31 December 2028 , and fresh meat with such marks applied before that date may remain on the market.

Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21 , ELI: http://data.europa.eu/eli/reg_impl/2018/1882/oj).

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1 , ELI: http://data.europa.eu/eli/reg/2009/1069/oj).

Commission Delegated Regulation (EU) 2023/751 of 30 January 2023 amending Delegated Regulation (EU) 2020/687 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the prevention and control of certain listed diseases (OJ L 100, 13.4.2023, p. 7 , ELI: http://data.europa.eu/eli/reg_del/2023/751/oj).

Scientific Opinion on the assessment of the control measures for category A diseases of Animal Health Law: Foot and Mouth Disease, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6632. Assessment of the control measures of category A diseases of the Animal Health Law: Infection with rinderpest virus (Rinderpest), https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7071. Assessment of the control measures of the category A diseases of Animal Health Law: Rift Valley Fever, https://www.efsa.europa.eu/en/efsajournal/pub/7070. Assessment of the control measures for category A diseases of Animal Health Law: Lumpy Skin Disease, https://www.efsa.europa.eu/en/efsajournal/pub/7121. Assessment of the control measures for category A diseases of Animal Health Law: Contagious Bovine Pleuropneumonia, https://www.efsa.europa.eu/en/efsajournal/pub/7067. Assessment of the control measures of the category A diseases of Animal Health Law: sheep and goat pox, https://www.efsa.europa.eu/en/efsajournal/pub/6933. Assessment of the control measures of the category A diseases of Animal Health Law: peste des petits ruminants, https://www.efsa.europa.eu/en/efsajournal/pub/6708. Assessment of the control measures for category A diseases of Animal Health Law: Contagious Caprine Pleuropneumonia, https://www.efsa.europa.eu/en/efsajournal/pub/7068. Assessment of the control measures of the category A diseases of Animal Health Law: Classical Swine Fever, https://www.efsa.europa.eu/en/efsajournal/pub/6707. Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: African Swine Fever, https://www.efsa.europa.eu/en/efsajournal/pub/6402. Assessment of the control measures of the category A diseases of Animal Health Law: Burkholderia mallei (Glanders), https://www.efsa.europa.eu/en/efsajournal/pub/7069. Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: African Horse Sickness, https://www.efsa.europa.eu/en/efsajournal/pub/6403. Scientific Opinion on the assessment of the control measures of the category A diseases of Animal Health Law: Highly Pathogenic Avian Influenza, https://www.efsa.europa.eu/en/efsajournal/pub/6372. Assessment of the control measures of the category A diseases of Animal Health Law: Newcastle disease, https://www.efsa.europa.eu/en/efsajournal/pub/6946.

Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1 , ELI: http://data.europa.eu/eli/reg/2011/142/oj).

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55 , ELI: http://data.europa.eu/eli/reg/2004/853/oj).

Commission Delegated Regulation (EU) 2024/2623 of 30 July 2024 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for approval and recognition of disease-free status of compartments keeping terrestrial animals (OJ L, 2024/2623, 4.10.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2623/oj).

Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, p. 78 , ELI: http://data.europa.eu/eli/reg_impl/2021/620/oj).

Assessment of the control measures of the Category A diseases of the Animal Health Law: prohibitions in restricted zones and risk-mitigating treatments for products of animal origin and other materials, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7443.

Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (OJ L 131, 17.5.2019, p. 51 , ELI: http://data.europa.eu/eli/reg_impl/2019/627/oj).

Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1 , ELI: http://data.europa.eu/eli/reg/2011/142/oj).;

The competent authority shall order and supervise the cleaning and disinfection and, where relevant, the control of insects and rodents, in the affected establishment, as follows:

(a) a preliminary cleaning and disinfection, and where relevant, control of insects and rodents, immediately after the completion of the disease control measures accordance with Article 12, 13 and 14; and

(b) a final cleaning and disinfection, and, where relevant, control of insects and rodents as provided for in Article 68(1), point (b) of Regulation (EU) 2016/429, immediately after the completion of the preliminary cleaning and disinfection.

The preliminary and final cleaning, disinfection and control of insects and rodents, referred to in paragraph 1 shall be:

(a) performed in accordance with the general requirements set out in point A of Annex IV and the relevant procedures set out in points B and C of that Annex, using the appropriate biocidal products to ensure the destruction of the relevant category A disease agent; and

(b) adequately documented.

If the competent authority has granted one of the specific derogations from the disease control measures laid down in Article 12(1), point (a), provided for in Article 13(2) and (4), it shall adapt the procedures laid down in Annex IV to the specific situation, without detriment to the control of the spread of the category A disease from the affected animals and affected establishments and locations to other unaffected animals or to humans.

In addition to the measures referred to in paragraphs 1 and 2, the competent authority shall order and supervise that the means of transport used for the transport of animals to and from the affected establishment are properly cleaned and disinfected and, where relevant, subjected to measures ensuring the control of insects and rodents.

Commission Delegated Regulation (EU) 2024/2623 of 30 July 2024 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for approval and recognition of disease-free status of compartments keeping terrestrial animals (OJ L, 2024/2623, 4.10.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2623/oj).

Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, p. 78 , ELI: http://data.europa.eu/eli/reg_impl/2021/620/oj).;

The competent authority may grant derogations from the rules laid down in this Chapter concerning the measures to be applied in restricted zones, to the extent necessary and after carrying out a risk assessment that indicates that the risk of the spread of the category A disease is negligible:

(a) in the further restricted zones referred to in Article 21(1), point (c);

(b) where the competent authority decides to establish a restricted zone when an outbreak of a category A disease occurs in establishments and locations referred to in Article 21(3);

(c) in establishments and locations referred to in Article 21(3), points (a) to (f), located in a restricted zone.

The competent authority may authorise movements of manure, including litter and used bedding, from:

(a) establishments located in the protection zone for the purpose of their disposal in a designated landfill located within the same Member State only after it has been treated in accordance with the treatment set out in Point C, paragraph (1)(a)(i), of Annex IV, or after processing in accordance with Article 13, point (c), of Regulation (EC) No 1069/2009;

(b) establishments and locations in the protection zone to a plant approved for the processing or disposal of animal by-products, in which the products are disposed of or processed in accordance with Regulation (EC) No 1069/2009 by the methods relevant for the processing of manure provided for in Part II of Annex VII to this Regulation.

The competent authority may authorise the movements of manure, including litter and used bedding, from establishments located in the surveillance zone:

(a) without processing, to a landfill, previously authorised for that purpose by the competent authority, located in the same surveillance zone; or

(b) following processing, to a landfill, previously authorised for that purpose by the competent authority, located in the territory of the same Member State.

The competent authority may authorise movements of manure, including litter and used bedding, from establishments and other locations in the surveillance zone to a plant approved for the processing or disposal of animal by-products where they are disposed of or processed in accordance with Regulation (EC) No 1069/2009 by the methods relevant for processing of manure provided for in Part II of Annex VII to this Regulation.

Where prohibitions of movement of animals provided for in Articles 27 and Article 42 are maintained significantly beyond the period set out in Annex XI, the competent authority may, under exceptional circumstances, authorise the movement of kept animals of listed species from and into establishments within the restricted zone in cases not covered by derogations provided for in Articles 28 and Article 43, if:

(a) the operator has submitted a reasoned application for that authorisation;

(b) the risks derived from authorising such movements have been assessed prior to the authorisation and the assessment indicates that the risk of spreading of the category A disease is negligible;

(c) reinforced biosecurity measures are applied in the establishment of destination to prevent the risk of the spread of the category A disease.

(d) official veterinarians have, in case of movements from establishments within the restricted zone, carried out clinical examinations and have collect samples for laboratory examinations from animals of listed species, including those to be moved, which have yielded favourable results.

Where movements of animals are authorised pursuant paragraph 1, the competent authority shall ensure that the transport complies with the requirements laid down in Article 24.

When granting a derogation in accordance with Article 78(3), the competent authority may allow the placing on the market of products of animal origin from aquaculture animals only if the following conditions are fulfilled:

(a) fish must be slaughtered and eviscerated before dispatch;

(b) molluscs and crustaceans must be fully traceable and processed to non-viable products unable to survive if returned to the water, before dispatch.

When purification is required before processing and placing on the market, it shall be conducted at a disease control aquatic food establishment.

The products of animal origin referred to in paragraph 1 shall be intended for:

(a) direct supply to the final consumer; or

(b) further processing in a disease control aquatic food establishment.

HAS ADOPTED THIS REGULATION: