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Resolution
nº 18, of April 30, 1999 (*)
(republished on 03/12/1999)
The Director-Chairman
of the Brazilian Sanitary Surveillance Agency, in the use of the
legal attributions vested in him, whereas the need for constant
enhancement improvement of the actions of sanitary control of
food with a view to protecting the health of the population and
the need to establish the BASIC GUIDELINES FOR ANALYSIS AND PROOF
OF FUNCTIONAL AND OR HEALTH CLAIMS ON FOOD LABELS, and whereas:
that several
motivating forces throughout the world have been strengthening
interest in the use of food as an important determiner of health;
that the consensus
on the close connection between food-health-disease, new concepts
on the need for nutrients in special physiological states, beneficial
effects of other non-nutrient compounds, factors linked to urbanization,
increase in life expectancy, are all factors that have been stimulating
the production of new foods;
that there
are many positive aspects demonstrated by scientific research
motivating the correct use of foods and the production of specific
foods for maintaining health;
that the consumer
is often confused by nomenclature and claims that have not been
scientifically proven;
the trend
of Codex Alimentarius and some countries to discipline the claims
regarding the functional properties of foods or their components,
as well as safety of use on the basis of scientific evidences;
that the general
principles of the Technical Regulation for Labeling of Packed
Foods already establish that:
a) the label
may not include claims of effects or properties that cannot be
demonstrated;
b) it is forbidden
to indicate that the food possesses medicinal or therapeutic properties,
decides:
Article 1
- To approve the TECHNICAL REGULATION ESTABLISHING THE BASIC GUIDELINES
FOR ANALYSIS AND PROOF OF FUNCTIONAL AND OR HEALTH CLAIMS ON FOOD
LABELS, 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 ESTABLISHING THE BASIC GUIDELINES FOR ANALYSIS AND
PROOF OF FUNCTIONAL AND OR HEALTH CLAIMS ON FOOD LABELS
1. SCOPE OF
APPLICATION.
This regulation
is applicable to the claims of functional and or health properties
of foods and ingredients for human consumption, displayed on the
labels of products that are prepared, packed and ready to be sold
to consumers.
This regulation
is applicable without loss to the other provisions contained in
legislation on food labeling.
2. DEFINITION.
For the purpose
of this regulation, the following definitions apply:
2.1. 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.
2.2. HEALTH
CLAIM: states, suggests or implies the existence of a connection
between the food or ingredient with disease or condition related
to health.
3. GUIDELINES
FOR USE OF FUNCTIONAL AND OR HEALTH CLAIMS.
3.1. The functional
and or health claim is allowed as an option.
3.2. The food
or ingredient that makes functional and or health claims may,
in addition to basic nutritional functions, in the case of a nutrient,
produce metabolic and or physiological effects and or beneficial
health effects, and must be safe for consumption without medical
supervision.
3.3. Claims
of function and or nutrient and non-nutrient contents are allowed,
and the claims describing the physiological role of the nutrient
or non-nutrient in the growth, development and normal functions
of the organism may be accepted, by means of demonstration of
effectiveness. For the nutrients with functions fully recognized
by the scientific community, the demonstration of effectiveness
or it effectiveness analysis shall not be necessary for functional
claim on the label.
3.4. In the
case of a new functional claim, there is need for scientific evidence
of the functional and or health claims and of safety of use, according
to the Basic Guidelines for Evaluation of Risk and Safety of Foods.
3.5. The claims
may mention general maintenance of health, the physiological role
of the nutrients and non-nutrients and reduction of risk of diseases.
Health claims that mention cure or prevention of diseases are
not allowed.
3. BIBLIOGRAPHICAL
REFERENCES.
3.1. FAO/WHO,
Codex Alimentarius, CAC/GL 23-1997, Guidelines for the Use of
Nutrition Claims.
3.2. FAO/WHO
Codex Alimentarius, ALINORM 97/22, Appendix II.
3.3. FAO/WHO
Codex Alimentarius, ALINORM 99/22, Appendix X.
4. PROOF OF
FUNCTIONAL AND OR HEALTH CLAIMS.
4.1. Proof
of functional and or health claims for foods and or ingredients,
must be conducted on the basis of:
estimated
or recommended intake provided by the manufacturer;
purpose, conditions
of use and nutritional value, when appropriate;
scientific evidence(s) described in item 4.2.
4.2. Scientific
evidences, as appropriate, applicable to proof of the functional
and or health claim:
chemical composition
with molecular characterization, when appropriate, and or formulation
of the product;
biochemical
assays;
nutritional
and or physiological and or toxicological assays in experimentation
animals;
epidemiological
studies;
clinical assays;
general evidence
from scientific literature, international health organizations
and internationally recognized legislation on the characteristics
of the food or ingredient;
evidence of
traditional use, observed in the population, without damage to
human health.
4.3. Documented
information on approval of use of the food or ingredient in other
countries, economic blocks, Codex Alimentarius and other internationally
recognized organizations.
5. GENERAL
PROVISIONS.
Although methodologies
are known for risk evaluation to prove the safety of foods and
ingredients, unforeseen situations can occur. Thus, the risk evaluation
must be managed, in each case, by a Technical Scientific Commission
on Functional Foods and New Foods instituted by the Brazilian
Sanitary Surveillance Agency.
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(*) Republished due to incorrectness in the original, in the Federal
Official Gazette on 3/5/99, Section 1, p 11.
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