Salami S A, Guinguina A, Agboola J O, Omede A A, Agbonlahor E M, Tayyab U
1Department of Animal Sciences,Wageningen University,De Elst 1,6708WD Wageningen,The Netherlands.
2Department of Animal Sciences,Aarhus University,DK-8830 Tjele,Denmark.
Animal. 2016 Aug;10(8):1375-90. doi: 10.1017/S1751731115002967. Epub 2016 Jan 14.
The pivotal roles of regulatory jurisdictions in the feed additive sector cannot be over-emphasized. In the European Union (EU), antioxidant substances are authorized as feed additives for prolonging the shelf life of feedstuffs based on their effect for preventing lipid peroxidation. However, the efficacy of antioxidants transcends their functional use as technological additives in animal feeds. Promising research results have revealed the in vivo efficacy of dietary antioxidants for combating oxidative stress in production animals. The in vivo effect of antioxidants is significant for enhancing animal health and welfare. Similarly, postmortem effect of dietary antioxidants has been demonstrated to improve the nutritional, organoleptic and shelf-life qualities of animal products. In practice, dietary antioxidants have been traditionally used by farmers for these benefits in livestock production. However, some antioxidants particularly when supplemented in excess could act as prooxidants and exert detrimental effects on animal well-being and product quality. Presently, there is no exclusive legislation in the EU to justify the authorization of antioxidant products for these in vivo and postmortem efficacy claims. To indicate these efficacy claims and appropriate dosage on product labels, it is important to broaden the authorization status of antioxidants through the appraisal of existing EU legislations on feed additives. Such regulatory review will have major impact on the legislative categorization of antioxidants and the efficacy assessment in the technical dossier application. The present review harnesses the scientific investigations of these efficacy claims in production animals and, proposes potential categorization and appraisal of in vivo methodologies for efficacy assessment of antioxidants. This review further elucidates the implication of such regulatory review on the practical application of antioxidants as feed additives in livestock production. Effecting these regulatory changes will stimulate the innovation of more potent antioxidant products and create potential new markets that will have profound economic impacts on the feed additive industry. Based on the in vivo efficacy claims, antioxidants may have to contend with the legislative controversy of either to be considered as veterinary drugs or feed additives. In this scenario, antioxidants are not intended to diagnose or cure diseases as ascribed to veterinary products. This twisted distinction can be logically debated with reference to the stipulated status of feed additives in Commission Regulation (EC) No 1831/2003. Nonetheless, it is imperative for relevant stakeholders in the feed additive industry to lobby for the review of existing EU legislations for authorization of antioxidants for these efficacy claims.
监管辖区在饲料添加剂领域的关键作用再怎么强调都不为过。在欧盟(EU),抗氧化物质被批准作为饲料添加剂,用于延长饲料原料的保质期,这是基于它们预防脂质过氧化的作用。然而,抗氧化剂的功效不仅限于其在动物饲料中作为技术添加剂的功能用途。有前景的研究结果表明,日粮抗氧化剂在生产动物体内具有对抗氧化应激的功效。抗氧化剂的体内作用对于增强动物健康和福利具有重要意义。同样,日粮抗氧化剂的宰后效应已被证明可以改善动物产品的营养、感官和保质期品质。在实践中,养殖户传统上就因这些益处而在畜牧生产中使用日粮抗氧化剂。然而,一些抗氧化剂,特别是过量添加时,可能会作为促氧化剂,对动物健康和产品质量产生有害影响。目前,欧盟没有专门的立法来证明批准抗氧化剂产品用于这些体内和宰后功效声明的合理性。为了在产品标签上标明这些功效声明和适当剂量,通过评估欧盟现有的饲料添加剂立法来扩大抗氧化剂的批准范围很重要。这样的监管审查将对抗氧化剂的立法分类和技术档案申请中的功效评估产生重大影响。本综述利用了对生产动物中这些功效声明的科学研究,并提出了对抗氧化剂功效评估的体内方法的潜在分类和评估。本综述进一步阐明了这种监管审查对抗氧化剂作为饲料添加剂在畜牧生产中的实际应用的影响。实现这些监管变革将刺激更有效的抗氧化剂产品的创新,并创造潜在的新市场,这将对饲料添加剂行业产生深远的经济影响。基于体内功效声明,抗氧化剂可能不得不应对被视为兽药还是饲料添加剂的立法争议。在这种情况下,抗氧化剂并非如兽药那样用于诊断或治疗疾病。这种复杂的区别可以参照欧盟委员会第1831/2003号法规中规定的饲料添加剂地位进行合乎逻辑的辩论。尽管如此,饲料添加剂行业的相关利益攸关方必须游说对欧盟现有立法进行审查,以便批准具有这些功效声明的抗氧化剂。