论文辅导-欧洲兽药残留控制的讨论分析

论文辅导-欧洲兽药残留控制的讨论分析。在欧洲联盟，每项兽药规例均受欧盟指令2001/82/EC规管，因此兽药评核工作是全面进行的。用于兽医的药物主要是通过标准和质量来评估的。将用作食品的动物体内的残留限量将保持在适当的水平。根据欧盟的指示，还提供了一种剂量制度和一个退出时间。与中国监管机构一样，欧盟指令明确规定了设立最高残留限量的监管指令。该指示的附件一为已建立的MRLs(中国农业部，2011)提供了规则。这些都是已经在实践中，并在大多数国际VPH残留药物安全列表中得到确认。

The second Annex II are for those material substances for which MRLs are not necessary. This is because any form of residue that is collected from these substances are not considered a threat for the public health and hence these residual substances do not require any form of monitoring at present. The provisional MRLs are included in Annex III. Some substances do not have fully established MRL status, however might need to be monitored for some times, these are included under the provisional MRL. These substances might not have all the requirements for being considered as a MRL. On the other hand, Annex IV includes those elements for which MR cannot be established (neither provisionally nor permanently) because the residual risk uncertainty is not clearly established. The risk the residue might pose to humans, its specific toxicological profile and more might not be clearly established. These are substances that would need to be researched further before they could be recommended for MRL status (Turnipseed and Anderson, 2008). According to the EU directives, the Annex I, II and III are allowed for medicinal product usage in animals that would be used as food. However, there are still some very specific conditions that are imposed for the type of animal that these medicinal products could be used for. Secondly there are prescription rules that are established for the veterinarians that different member states of the European Union will have to adhere to (Calabro et al, 2011). Yet another European Union regulation in connection with the residual medicines and VPH is the Council Directive 96/23/EC. This directive ensures the residual control of pharmacologically active groups. This includes such elements as contaminants in the environment, dyes and other chemical products. The directive broadly divides the elements as Group A and B compounds (Sanders, 2007). The Group A compounds contains those drugs that are prohibited for the use in animals and the Group B contains those compounds that are present in Annexes I and III. These are veterinary drugs that are registered and are considered to be conformant to the Annexes. Most antibacterial drugs and their residues are present under B1 and in B2 those drugs that are sedatives, Non-steroidal anti-inflammatory NSAID’s are included as so are the other pharmacologically active substances (Heitzman, 1992; Aguilera et al, 2008). Dyes belonging in this group are also included under veterinary drugs because of their usage as therapeutics (example: malachite green). In addition to regulating the food producing animals, the primary product production such as meat and aquacultures are also commissioned under these regulatory requirements. EU Directive 97/747/EC helps define the management regulation for sampling food products such as milk eggs, rabbit meat and farmed game for veterinary residue. Sampling is not restricted to the meats as in the animal carcasses alone, it would also be done on live animals (Sanders, 2007). The EU directive 96/23/EC provides the regulatory management required for the Group A products in specific because these products are more critical. For the Group A products, the management is hence provided in such a way that more samples are included and they are analyzed in a more stringent manner. Since non-compliance results in severe implications for public health, legal action is taken when there is any form of breach in the EU directives. Sampling is done using the matrices too. The EU directive 96/23/EC ensures that veterinary residual control starts from the basics such as good agricultural practices (EMA, 2015).

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