ON 11 JULY 2022 THE GUIDELINES REGARDING FOODS FOR SPECIAL MEDICAL PURPOSES WERE UPDATED.
THESE GUIDELINES ARE INTENDED TO PROVIDE INTERPRETATIVE ELEMENTS FOR THE CORRECT CLASSIFICATION OF A PRODUCT AS FSMP, CONSIDERING IN PARTICULAR THE NEED FOR ITS DISTINCTION FROM FOOD SUPPLEMENTS.
One of the key elements for this purpose is the product definition, given by the legislation: the “FOODS FOR SPECIAL MEDICAL PURPOSES” (FSMP) are “expressly developed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the complete or partial feeding of patients with limited capacity, disturbed or impaired in taking, digesting, absorbing, metabolizing or eliminating common foods or certain nutrients contained in them or metabolites, or with other nutritional needs determined by clinical conditions and whose dietary management cannot be carried out exclusively by modifying the normal diet.” – definition from Regulation (EU) 609/2013 (art. 2.2.g).
THIS MEANS THAT FSMP ARE FOODS SPECIFICALLY FORMULATED TO ADDRESS NUTRITIONAL VULNERABILITY CAUSED BY A SPECIFIC DISEASE OR MEDICAL CONDITION.
THE FSMP ARE CURRENTLY GOVERNED BY REGULATION (EU) 2016/128 OF THE COMMISSION AND BY THIS (IN ART. 2.1) THEY ARE DIVIDED INTO 3 DIFFERENT CATEGORIES:
- nutritional complete foods with a standard nutrient formulation;
2. nutritionally complete foods with a nutrient formulation adapted to a specific disease, disorder or disease state;
3. nutritionally incomplete foods with a standard formulation or adapted to a specific disease, disorder or disease status, which are not the only daily dietary source.
OTHER INNOVATIONS INTRODUCED BY REGULATION (EC) 2016/128 ARE:
- THE PROHIBITION FOR ALL FSMP TO USE NUTRITIONAL AND HEALTH CLAIMS;
- THE EXTENSION OF THE LABELLING AND PESTICIDE PROVISIONS FOR INFANT FORMULA AND FOLLOW-ON FORMULAE TO FSMP FOR INFANTS AND YOUNG CHILDREN.
SEE THE FULL PDF DOCUMENT BY THE ITALIAN MINISTRY OF HEALTH HERE.
THE COMPLIFE TEAM IS ALWAYS UP TO DATE WITH CURRENT LEGISLATION AND AVAILABLE TO ITS CUSTOMERS FOR HIGHLY SPECIALIZED REGULATORY SUPPORT AS WELL AS FOR TESTING THE SAFETY, EFFICACY, TOLERABILITY AND CHEMICAL AND MICROBIOLOGICAL FEATURES OF THEIR PRODUCTS, EVEN IN THE NUTRACEUTICALS FIELD.
WITH THIS AIM IN FACT, AT THE END OF 2021 NUTRATECH WAS BORN: THE COMPLIFE COMPANY FOCUSED ON THE FOOD SUPPLEMENTS MARKET.
SILVIA GIAMBUZZI
Nutraceutical Regulatory Manager
COMPLIFE. COMMITTED TO SCIENCE, COMMITTED TO YOU.
