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This brochure provides the international background regarding Foods for Special Dietary Uses (FSDU) based on THE GENERAL STANDARD FOR THE LABELLING OF AND CLAIMS FOR PREPACKAGED FOODS FOR SPECIAL DIETARY USES — CODEX STAN 146-1985, which defines this category of products at international level.

The CODEX ALIMENTARIUS international food standards, guidelines and codes of practice contribute to the safety, quality and fairness of international trade. Codex standards are based on sound science provided by independent international risk assessment bodies or ad hoc consultations organised by FAO and WHO.

The brochure is for general information purpose and aims to facilitate the reading and understanding of THE GENERAL STANDARD FOR THE LABELLING OF AND CLAIMS FOR PREPACKAGED FOODS FOR SPECIAL DIETARY USES — CODEX STAN 146-1985.

The brochure can be used as a support for Food Business Manufacturers (e.g. internal trainings programs) or as a background element for discussions with national authorities regarding Foods for Special Dietary Uses.

The brochure does not consider the specific situation of FSDU or specialised nutrition products in each country and should not be considered in isolation.

Key messages
Foods for Special Dietary Uses are defined at Codex Alimentarius level as foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific diseases and disorders and which are presented as such (1). The composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist.
(1) This includes foods for infants and young children.

Codex Alimentarius also further defines specific FSDU through different texts that cover among others and in broad terms infant formula, follow-up formula for older infants and product for young children, complementary foods, foods for special medical purposes, meal replacement and total diet replacement, gluten free food, low sodium food.

Other FSDU exist and are recognised in some national regulations, but are not necessarily defined at Codex Alimentarius level. One example is the sports food category.

FSDU remain food products and should therefore comply with all the relevant Codex texts and requirements established by Codex Alimentarius, unless provided otherwise.

Standardised terminology should be used when defining or describing FSDU.

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– English: Print version; digital version
– French: Print version; digital version
– Spanish: Print version; digital version