欧盟特殊医学用途配方食品(FSMPs)现有法规和未来挑战.pdf
Foods for Special Medical Purposes (FSMPs) Current rules in the EU and future challenges 欧盟特殊医学用途配方食品(FSMPs)现有法规和未来挑战 Basil Mathioudakis Head of Unit Directorate General for Health and Consumers FSMPs Forum, Beijing, October 2014 Health andHealth and ConsumersConsumers Legal framework for FSMPs in the EU 欧盟FSMPs法律框架 FSMPs are subject to: Commission Directive 1999/21/EC on dietary foods for special medical purposes compositional and labelling requirements for FSMPs as defined in the Directive and presented as such FSMP要服从欧盟特殊医学用途配方食品指令1999/21/EC 指令规定了如下FSMPs成分和标 签的要求: a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two. 一类满足特殊营养使用的食品，经过专门的加工或配制，用于病人的膳食管理，在医生监督下使用。 FSMP可单独食用或与其他食品配合食用，可用于进食/消化/吸收/代谢或清除功能受限、障碍或紊乱而 不能食用普通食品，或含有特定营养素，或产生某些代谢产物的食品，或者有疾病特异性营养素需求的 人群，这些人群的膳食管理不能通过改变常规饮食，其他特定营养食品或两者结合来实现。
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