outlines the scientific aspects and the guidance on the design and conduct of presentation of information necessary to such studies. support applications for novel foods and novel food ingredients. EFSA is currently working on new scientific guidance on novel foods in view of the upcoming new novel food regulation. Must show evidence to Safe for particular use support safety Must show evidence of Shall be bioavailable for use by the human efficacy body, have a nutritional or physiological to effect and be suitable for whom the food is achieve stated intended purpose) Must show evidence of Systematic review of the available data for nutritional expected benefits considerations (including growth and development) Must be ~ ~ referenced to Not specifically, though expected that this Not specifically, though expected that human milk be considered when evaluating the this would be considered when suitability of a substance for use in infant evaluating the suitability of a formula substance for use in infant formula The Novel Food Catalogue lists products of Current permissions are listed in Annex III No publicly available list. Information Transparency of permissions animal and plant origin and other of Directive 2006/141/EC. can be obtained from national
outlines the scientific aspects and the presentation of information necessary to support applications for novel foods and novel food ingredients. EFSA is currently working on new scientific guidance on novel foods in view of the upcoming new novel food regulation. guidance on the design and conduct of such studies. Must show evidence to support safety Safe for particular use Must show evidence of efficacy to achieve stated purpose) Shall be bioavailable for use by the human body, have a nutritional or physiological effect and be suitable for whom the food is intended Must show evidence of nutritional considerations (including growth and development) Systematic review of the available data for expected benefits Must be referenced to human milk ~ Not specifically, though expected that this be considered when evaluating the suitability of a substance for use in infant formula ~ Not specifically, though expected that this would be considered when evaluating the suitability of a substance for use in infant formula Transparency of permissions The Novel Food Catalogue lists products of animal and plant origin and other Current permissions are listed in Annex III of Directive 2006/141/EC. No publicly available list. Information can be obtained from national