Foods for Special Medical Purposes (FSMPs) Current rules in the EU and future challenges 歐盟特殊醫(yī)學(xué)用途配方食品(FSMPs)現(xiàn)有法規(guī)和未來挑戰(zhàn) 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 歐盟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要服從歐盟特殊醫(yī)學(xué)用途配方食品指令1999/21/EC ?指令規(guī)定了如下FSMPs成分和標 簽的要求: 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. 一類滿足特殊營養(yǎng)使用的食品，經(jīng)過專門的加工或配制，用于病人的膳食管理，在醫(yī)生監(jiān)督下使用。 FSMP可單獨食用或與其他食品配合食用，可用于進食/消化/吸收/代謝或清除功能受限、障礙或紊亂而 不能食用普通食品，或含有特定營養(yǎng)素，或產(chǎn)生某些代謝產(chǎn)物的食品，或者有疾病特異性營養(yǎng)素需求的 人群，這些人群的膳食管理不能通過改變常規(guī)飲食，其他特定營養(yǎng)食品或兩者結(jié)合來實現(xiàn)。

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