Regulations Governing the Management of the Review, Registration and Issuance of Permit Documents for Food and Related Products｜第 19 條｜Food and Drug Administration｜Regulation｜In Force
第 三 章｜衛生福利部｜v1.0
Effective Date: 2024-11-30｜Last Amended: 2023-11-30
Formula for certain disease referred to in this chapter is intended for the dietary management of patients who have impaired capacity to ingest, digest, absorb or metabolize ordinary foods or certain nutrients, or who, for any medically-proven reason, have special dietary requirements that cannot be easily met with re-balancing daily diet. The food products in this category are processed or formulated according to the needs of the target users. The scope of formula for certain disease as referred in the preceding paragraph is as follows: 1.Nutritionally complete food that may be used as the single source of nutrients: (1.Nutritionally complete food with balanced formula: The products in this category are designed to maintain caloric and nutritional sustenance of patients. The various nutrients contained in the product shall comply with the regulations provided in the Schedule 2, except for formulae for patient children aged one to eighteen. (2.Nutritionally complete food with customized formula: The products in this category are designed to maintain caloric and nutritional sustenance of patients by delivering complete nutrition with added or reduced nutrients to meet the patients’ specific needs. The nutrient addition or reduction shall be based on scientific evidence. For other nutrients, the regulations provided in Schedule 2 shall apply mutatis mutandis. 2.Nutrition supplement formula food that may not be used as the single source of nutrients: (1.Nutrition adjusted supplementary formula food: The products in this category are designed to be used as part of nutritional supplement for patients of specific nutritional needs and meet the following requirements: A.The specific nutrients to be supplemented shall be based on scientific evidence. For the non-customized nutrition portion of the product, every serving size (100 Kcal) shall reach the lower limit as specified in Schedule 2. The recommended daily nutrition allowance for the product shall not exceed the maximum allowance specified in the Standards for Specification, Scope, Application and Limitation of Food Additives. B.Where the non-customized nutrition portion of the product under application per 100 Kcal does not reach the lower limit as specified in Schedule 2, a domestic clinical study on the product is required to prove that the users of such product will be able to meet the nutritional requirements by following the recommended diet. (2.Special modular formula food: The products in this category are designed to deliver a specific nutrient or ingredient to meet the nutritional needs deriving from specific illness or metabolic needs and contain the element meeting the following requirements: A.The source food additives containing the modular formula are the nutritional additives within the same domain of nutrients. B.There is scientific evidence that this element is essential for the nutritional needs deriving from specific illness or metabolic needs. The products as referred in the preceding paragraph may use other food ingredients or additives to meet the flavoring or processing requirements.