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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’) (Text with EEA relevance)
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The scope of this Annex is to detail the criteria to be considered by the Commission when determining the disease prevention and control rules to be applied to the different categories of diseases listed in accordance with Article 5.
The process of categorisation shall take into account the profile of the disease in question, the level of the impact of that disease on animal and public health, animal welfare and the economy, and the availability, feasibility and effectiveness of the diagnostic tools and different sets of disease prevention and control measures provided for in this Regulation with respect to the disease.
The diseases for which the disease prevention and control rules referred to in point (a) of Article 9(1) apply shall be considered to have the most severe animal health, public health, economic, social or environmental impacts on the Union. Those diseases need to fulfil the following criteria:
the disease in question is:
not present in the territory of the Union;
present only in exceptional cases (irregular introductions); or
present in only in a very limited part of the territory of the Union;
and
the disease in question is highly transmissible; in addition to direct and indirect transmission, there may also be possibilities of airborne, waterborne or vector–borne spread. The disease may affect multiple species of kept and wild animals, or a single species of kept animals of economic importance, and may result in high morbidity and significant mortality rates.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria:
the disease in question has a zoonotic potential with significant consequences for public health, including epidemic or pandemic potential or possible significant threats to food safety;
the disease in question has a significant impact on the economy of the Union, causing substantial costs, mainly related to its direct impact on the health and productivity of animals;
the disease in question has a significant impact on one or more of the following:
society, with in particular an impact on labour markets;
animal welfare, by causing suffering to large numbers of animals;
the environment, due to the direct impact of the disease or due to the measures taken to control it;
in the long term, biodiversity or the protection of endangered species or breeds, including the possible disappearance of, or long-term damage to, those species or breeds.
The diseases for which the disease prevention and control rules referred to in point (b) of Article 9(1) apply shall be controlled in all Member States with the goal of eradicating them throughout the Union.
Those diseases need to fulfil the following criteria:
the disease in question is endemic in nature and is present in the whole or part of the Union territory. However, several Member States or zones of the Union are free of the disease; and
the disease is moderately to highly transmissible; in addition to direct and indirect transmission, there may also be possibilities of airborne, waterborne or vector–borne spread. It may affect single or multiple animal species and may result in high morbidity, with in general low mortality.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria:
the disease in question has a zoonotic potential with significant consequences for public health, including epidemic potential or possible significant threats to food safety;
the disease in question has a significant impact on the economy of the Union causing substantial costs, mainly related to its direct impact on the health and productivity of animals;
the disease has a significant impact on one or more of the following:
society, with in particular an impact on labour markets;
animal welfare, by causing suffering to large numbers of animals;
the environment, due to the direct impact of the disease or due to the measures taken to control it;
in the long term, biodiversity or the protection of endangered species or breeds, including the possible disappearance of, or long-term damage to, those species or breeds.
A disease to which the measures referred to in point (a) of Article 9(1) apply, which has not been successfully and promptly eradicated in a part of the Union, and has, in that part of the Union, obtained an endemic character, may be subject to disease prevention and control measures under point (b) of Article 9(1), in that part of the Union.
The diseases for which the disease prevention and control rules referred to in point (c) of Article 9(1) apply are of relevance to some Member States and measures are needed to prevent them from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease in question.
Those diseases need to fulfil the following criteria:
in terrestrial animals, the disease in question is endemic in nature and is present in the whole or part of the Union territory; or in aquatic animals, several Member States or zones of the Union are free of the disease; and
in terrestrial animals, the disease in question is moderately to highly transmissible, mainly through direct and indirect transmission. The disease mainly affects multiple or single animal species, usually does not result in high morbidity, and has a negligible or no mortality rate. Often the most observed effect is production loss;
in aquatic animals, the disease is moderately to highly transmissible, mainly through direct and indirect transmission. The disease affects multiple or single animal species and may result in high morbidity and usually low mortality. Often the most observed effect is production loss.
In addition to the criteria set out in points (a) and (b), those diseases need to fulfil one or more of the following criteria:
the disease in question has a zoonotic potential with significant consequences for public health, or possible threats to food safety;
the disease in question has a significant impact on the economy of parts of the Union, mainly related to its direct impact on certain types of animal production systems.
the disease in question has a significant impact on one or more of the following:
society, with, in particular, an impact on labour markets;
animal welfare, by causing suffering to large numbers of animals;
the environment, due to the direct impact of the disease or of the measures taken to control it;
in the long term, biodiversity or the protection of endangered species or breeds, including the possible disappearance of, or long-term damage to, those species or breeds.
The disease prevention and control rules referred to in point (d) of Article 9(1) shall apply to diseases that fulfil the criteria set out in Section 1, 2 or 3 and to other diseases fulfilling the criteria set out in Section 5 where the risk posed by the disease in question can be effectively and proportionately mitigated by measures concerning movements of animals and products in order to prevent or limit its occurrence and spread.
The disease prevention and control rules referred to in point (e) of Article 9(1) shall apply to diseases that fulfil the criteria set out in Sections 1, 2 or 3 and to other diseases where surveillance of the disease is necessary for reasons relating to animal health, animal welfare, human health, the economy, society or the environment.
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