Brazil: New Legislation for Foods for Special Purposes

Posted By: Selerant RSA


On 13 May 2015 Brazilian Health Surveillance Agency ANVISA published in the Official Journal new regulation regarding quality of tube feed - Resolution RDC 21/2015, which has replaced the former act from 1999. The new legislation has now been in force since 15 May 2015. It can be found here.

Tube feed is included among “Foods for special purposes” in the Brazilian regulatory acts. It is defined as foods “specially designed and prepared for use both orally or through tubes, industrialized, used solely or partially to replace or supplement the oral feeding in malnourished patients”, currently hospitalized.

The new regulation is more detailed in composition requirements and closer to international standards, notably the European ones.

Another novelty is the introduction of possible claims for the labeling of products in relation to the composition presented: “high energy”, “low protein formula”, “low sodium” and other.

The main differences between former and new act are presented below:


Resolution 449/1999

RDC 21/2015



Types of products

Foods nutritionally complete for tube feed

Standard formula for tube feed

Foods for supplementation of tube feed

Modified formula for tube feed*

Foods for special metabolic situations for tube feed



Modules of nutrients for tube feed

Nutrients modules

                    *replaces “supplementation” and “special metabolic” types.

Mandatory nutrient sources were described in an additional standard (Resolution RDC 22/2015), making it easier for food producers to choose from the raw material options available.

The new rules need to be taken into account by regulatory people when preparing registration dossiers for foods for special purposes . Companies importing the products in question should take the new rules into account in order to be able to legally place their products on the Brazilian market.

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