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European Commission Provides Additional Guidance on Classification of Food for Special Medical Purposes

放大字体  缩小字体 Date:01 Dec 2017  Views:99
 The Notice is intended to help national authorities interpret what is to be classified as Food for Special Medical Purposes (FSMP) or not. Although rules covering FSMP are fully harmonized, notification may still be required at member state level. To ascertain harmonized classification and application of EU rules it is crucial that member states correctly interpret whether the concerned products are in fact FSMP. Food for Special Medical Purposes (FSMP) is regulated in the EU under Regulation (EU) No 609/2013 of the European Parliament and of the Council. The specific regime may provide for certain benefits when compared to the general food law framework, including the possibility for reimbursement under national health security schemes and the inclusion of statements referring to the dietary management of a disease, disorder or medical condition. For normal foods the latter is not permitted under the Nutrition and Health Claims Regulation (Regulation 1924/2006) and might even lead to the reclassification as a medicinal product.
Though these benefits must not lead to the effect that operators individually classify the product either as a food or a FSMP as such would potentially create discrepancies in the enforcement of different member states. For that reason the Commission notice aims to clarify the aspects that need to be considered for the classification as a FSMP. FSMP must in fact be specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; be intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone. Please find the following link to the notice which discusses the aspects of the definition in more detail; Commission Notice on the classification of Food for Special Medical Purposes (2017/C 401/01).



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