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Resolution
nº 19, of April 30, 1999 (*)
(republished on 10/12/1999)
The Director-Chairman
of the Brazilian Sanitary Surveillance Agency, in the use of the
legal attributions vested in him, whereas the need for constant
improvement of the actions of sanitary control of food, with a
view to protecting the health of the population and the need to
establish REGULATION ON PROCEDURES FOR REGISTRATION OF FOODS WITH
FUNCTIONAL AND OR HEALTH CLAIMS ON THEIR LABELS, and whereas:
the 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;
the Basic
Guidelines for Analysis and Proof of Functional and Health Claims
on Food Labels, decides:
Article 1
- Approve the TECHNICAL REGULATION ON PROCEDURES FOR REGISTRATION
OF FOODS WITH FUNCTIONAL AND OR HEALTH CLAIMS ON THEIR LABELS.
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, August 20, 1977, and other applicable provisions.
Article
3 - This Administrative Order enters into force on the date of
its publication, revoking contrary provisions.
GONZALO VECINA NETO
ANNEX
TECHNICAL
REGULATION ON PROCEDURES FOR REGISTRATION OF FOODS WITH OF FUNCTIONAL
AND OR HEALTH CLAIMS ON THEIR LABELS
1. SCOPE OF
APPLICATION
The present
regulation is applicable to the procedures for registration of
foods with functional and or health claims on their labels, without
loss to other legal provisions pertaining to the registration
of foods.
2. BIBLIOGRAPHICAL
REFERENCES.
2.1. FAO/WHO
Codex Alimentarius, ALINORM 97/22, Appendix II.
2.2. FAO/WHO Codex Alimentarius, ALINORM 99/22, Appendix X.
2.3 Code of Practice assessing the scientific evidence for Health
Benefits stated in Health Claims on food and drink 1998, Voedingscentrum
Informatie, Nutrition Centre, The Netherlands.
2.4 Guidance for Industry, Notification of a Health Claim or Nutrient
Content Claim based on a Authoritative Statement of a Scientific
Body, US Food and Drug Administration, Center for Food Safety
and Applied Nutrition, Office of Food Labelling, June 11, 1998.
2.5. FAO/WHO,
Codex Alimentarius, CAC/GL 23-1997, Guidelines for Use of Nutrition
Claims.
.
3. DEFINITION.
3.1. FUNCTIONAL
CLAIM: is related to the metabolic or physiological role that
the nutrient or non-nutrient plays in the growth, development,
maintenance and other normal functions of the human organism.
3.2. HEALTH
CLAIM: states, suggests or implies the existence of a connection
between the food or ingredient with disease or condition related
to health.
4. DOCUMENTATION.
For the purpose
of this regulation, the interested party must present, in addition
to documents required in compliance with specific legislation,
the following documentation:
4.1. REGISTRATION
OF FOODS WITH FUNCTIONAL AND OR HEATH CLAIMS ON THEIR LABELS.
4.1.1. Technical
Scientific Report containing the following information:
4.1.1.1. 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;
4.1.1.7. text
and copy of wording layout of the product in compliance with the
regulations on labeling and the BASIC GUIDELINES FOR ANALYSIS
AND PROOF OF FUNCTIONAL AND OR HEALTH CLAIMS ON FOOD LABELS;
4.1.1.8. Any
information or functional or health claim related to a food or
ingredient, advertised by any media, cannot be different in meaning
from the information approved for display on its label.
4.1.1.9. applicable
scientific evidences, as appropriate, of the functional and or
health claim:
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 regarding the characteristics
of the product.
NOTE: in the
case of registration of food and or new ingredient with functional
and or health claim on its label, the company may, if interested,
request in a single application the registration for food and
or new ingredient and the registration of food with functional
and or health claim on the label.
4.2. FOODS
THAT ARE ALREADY REGISTERED.
The foods
that are already registered and for which functional claims are
to be made, in addition to adopting the administrative procedures
for formulation and or label modification, must present the technical
scientific report described in item 4.1.1 of this regulation.
5. TECHNICAL
EVALUATION
The technical
scientific evaluation report of 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 of Procedures
for Registration of Foods with Functional and or Health Claims
on their Labels, within a minimum of two years after it enters
into force.
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(*)Republished due to incorrectness in the original, in the Federal
Official Gazette nº 41-E, of 3/5/99, Section 1, p 11.
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