,"The Italian Ministry of Health has issued a comprehensive revision of the national Guidelines on Foods for Special Medical Purposes (AFMS), aiming to ensure clearer classification, stricter scientific validation, and safer use of these medically essential nutritional products. These AFMS are intended for a wide range of patient groups — infants, children, adolescents, adults, and elderly individuals depending on the specific medical condition being managed. The updated document was approved by the Technical Committee on Dietetics and Animal Health under the Department of Human, Animal, and Ecosystem Health.
Clearer Distinction Between AFMS and Dietary Supplements
The guidelines emphasize that AFMS are not regular foods nor dietary supplements, but specialized nutritional tools formulated exclusively to manage diseases or medical disorders. Unlike supplements intended for discretionary consumption, AFMS must be used under medical supervision.
To be classified as AFMS, a product must meet all three regulatory conditions:
Be specially formulated or processed.
Be used under medical supervision.
Meet nutritional requirements caused by a clinical condition that cannot be satisfied through normal diet or supplements.
Updated EU Framework Integration
The guidelines align with EU Regulation (EU) 2016/128 and Regulation (EU) 609/2013, which:
prohibit health and nutritional claims on AFMS,
apply infant formula-style rules to AFMS for infants and children,
extend pesticide limits applicable to infant formula.
In cases where Member States classify the same product differently, the European Commission may intervene or refer the issue to the Standing Committee to reach a common interpretation.
Stricter Composition Rules
The revision clarifies the three AFMS categories:
Nutritionally complete formulas (standard)
Nutritionally complete formulas (disease-specific)
Nutritionally incomplete formulas
For complete formulas, labelling must include guidance for use as the sole source of nutrition, including indicative intake quantities.
Vitamin and mineral levels must follow Regulation (EU) 2016/128, though higher levels may be justified when medically necessary. Novel foods may be used if authorized in the EU Novel Food Catalogue.
Mandatory Labelling Requirements
AFMS must include:
the statement “Indicato per la gestione dietetica di…” followed by the specific medical condition,
the “Important Notice” stating:
use under medical supervision,
suitability as sole nutrition source (or not),
target age group,
risks when consumed by healthy individuals.
Additional warnings apply to:
enteral formulas (osmolarity, “not for parenteral use”)
metabolic disorder products (e.g., PKU)
low-protein foods
renal conditions or dysphagia diets.
Scientific Evidence and Documentation
Manufacturers must provide scientific evidence demonstrating:
characterization of the disease and target population,
nutritional vulnerability caused by the condition,
why dietary modification or supplements are insufficient,
specific role of the AFMS,
necessity of medical supervision.
Human studies must follow ethical guidelines and good clinical practice.
Expanded List of AFMS Categories
The updated guidelines offer an extensive list of product types, including:
Nutritionally Complete AFMS
Special infant formulas (including for preterm infants)
Enteral nutrition formulas
Oral nutritional supplements (ONS)
Very Low-Calorie Diets (VLCD) / Low-Calorie Diets (LCD)
Products for impaired glucose metabolism
Nutritionally Incomplete AFMS
Milk fortifiers
Metabolic disorder formulas (e.g., amino acid mixtures)
Dysphagia products (thickeners, texture-modified foods, gelled water)
Low-protein or protein-free foods
Oral rehydration solutions (WHO/ESPGHAN standards)
High-vitamin formulations for specific diseases
Ketogenic diet products
MCT oils, triglyceride formulations
Bariatric surgery nutritional management products
Solutions for infant pain management (24% sucrose, hospital use)
Impact on Manufacturers and Healthcare Providers
The 2025 revision imposes stricter scientific, labelling, and composition requirements, providing clearer guidance for companies preparing AFMS dossiers. Healthcare professionals will benefit from better product clarity to ensure safe and effective medical nutrition therapy.
The overarching aim is to enhance patient safety, support proper clinical nutrition practices, and avoid misclassification of products as AFMS when they better fit the category of dietary supplements."
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