Resolution nº 16, of April 30, 1999 (*)
(republished on 03/12/1999)

The Director-Chairman of the Brazilian Sanitary Surveillance Agency in the use of the attributions vested in him,

WHEREAS

the need for constant enhancement of sanitary control actions related to food, with a view to protecting the health of the population and the need to establish REGULATION ON PROCEDURES FOR REGISTRATION OF FOOD AND OR NEW INGREDIENTS;

that registration of foods is a legal and obligatory procedure according to Decree n. 986/69;

the Basic Guidelines for Evaluation of Risk and Safety of Foods, decides:

Article 1 - To approve the TECHNICAL REGULATION ON PROCEDURES FOR REGISTRATION OF FOODS AND OR NEW INGREDIENTS, included in the annex of this Administrative Order.

Article 2 - Failure to comply with the terms of this Administrative Order constitutes a sanitary infraction subject to the provisions of Law n. 6.437, of August 20, 1977, and other applicable provisions.

Article 3 - This Administrative Order shall enter into force on the date of its publication, revoking all contrary provisions.
Gonzalo Vecina Neto

ANNEX

TECHNICAL REGULATION ON PROCEDURES FOR REGISTRATION OF FOODS AND OR NEW INGREDIENTS.

1. SCOPE OF APPLICATION.

The present regulation is applicable to the registration of new foods and or ingredients for human consumption, without a record of consumption in the Country, or foods containing substances already consumed that are added or begin to be used at levels much higher than those currently observed in the foods that make up a regular diet. The additives and coadjuvants of manufacturing technology are excluded from this regulation.

2. DEFINITION.
FOODS AND OR NEW INGREDIENTS: are the foods or substances without a record of consumption in the Country, or foods with substances already consumed, that are added or begin to be used at levels much higher than those currently observed in foods used in a regular diet.

3. DOCUMENTATION.
For the purpose of this regulation, the interested party must present, in addition to the documents required in compliance with specific legislation, the following documentation:

4. REGISTRATION OF FOOD AND OR NEW INGREDIENTS.

4.1. Technical Scientific Report containing the following information:

4.1.1. name of the product;

4.1.2. purpose of use;

4.1.3. recommended intake indicated by the manufacturer;

4.1.4. scientific description of the ingredients of the product, according to species of botanical, animal or mineral origin, when appropriate;

4.1.5. chemical composition with molecular characterization, when appropriate, and or formulation of the product;

4.1.6. description of the analytical methodology for evaluation of the food or ingredient that is the object of the petition;

4.1.7 applicable scientific evidences, as appropriate, to prove safety of use:

nutritional and or physiological and or toxicological assays in experimentation animals;

biochemical assays;

epidemiological studies;

clinical assays;

evidence of traditional use, observed in the population, without damage to health;

broad evidences from scientific literature, international health organizations and internationally recognized legislation on the characteristics of the food or ingredient.

4.2. The foods that start being commercialized in the form of capsules, pills or other pharmaceutical formulas, and that do not present scientifically proven functional or health claims, must display the following information on the label:

The Ministry of Health warns: There is no proven scientific evidence that this food prevents, treats or cures diseases.

4.3. Any information or functional or health claim of a food or ingredient, advertised by any media, cannot be different in meaning from the information approved for display on its label.

5. TECHNICAL EVALUATION.

The technical scientific evaluation report on risk and demonstration of safety shall be evaluated by a Technical Scientific Advisory Commission on Functional Foods and new Foods instituted by the Brazilian Sanitary Surveillance Agency.

6. GENERAL PROVISIONS

The Brazilian Sanitary Surveillance Agency shall revise this Regulation on Procedures for Registration of Foods and or New Ingredients, within a minimum of two years after it enters into force.