Introduction
Article 13 | Article 14 | ||
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Article 13.1 | Article 13.5 | ||
Referring to | the role of a nutrient or other substance in growth, development and the functions of the body | the role of a nutrient or other substance in growth, development and the functions of the body based on newly developed scientific evidence and/or which include a request for the protection of proprietary data. | the reduction of disease risk and claims relating to children's development and health |
Application based on | generally accepted scientific evidence | submission of an extensive scientific dossier | submission of an extensive scientific dossier |
Methods
Results
Pre-clinical models
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➢to deliver the food product in the manner in which it will be delivered in a human setting;
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➢to utilize a site of delivery and/or assessment site that is as closely matched as possible to the settings in which it will be used;
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➢to utilize an animal that provides a metabolic background and physiological responsiveness comparable to humans;
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➢to utilize a formulation of active agent that has the same composition, release, retention, and degradation properties as the formulation that will be used in humans.