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Resolution
nº 17, 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 of 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 EVALUATION OF RISK
AND SAFETY OF FOODS, and whereas:
the scientific
consensus on the existing connection between food-health-disease
and that has been increasing the interest, throughout the world,
in the use of foods as an important factor in quality of life;
the new concepts
related to the need for nutrients in special physiological states
and the possibility of significant beneficial effects of other
non-nutrient compounds of foods;
the increase
in life expectancy, factors linked to urbanization, the influence
of the media and economic aspects regarding industrialization
of new foods;
the technological
innovations, the globalization of the economy, the intensification
of food importation and the need to harmonize legislation at international
level;
the possibility
that new foods or ingredients can contain nutrient or non-nutrient
components, with biological action, in amounts that may cause
adverse effects on health, decides:
Article 1
- To approve the TECHNICAL REGULATION ESTABLISHING THE BASIC GUIDELINES
FOR EVALUATION OF RISK AND SAFETY OF FOODS, 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 EVALUATION OF
RISK AND SAFETY OF FOODS.
1. SCOPE OF
APPLICATION.
The present
regulation is applicable to foods and ingredients for human consumption.
2. DEFINITION
AND CLASSIFICATION.
For the purpose
of this regulation, the following definitions apply:
2.1. Hazard:
biological, chemical or physical agent, or property of a food,
that may cause a harmful effect on health.
2.2. Risk:
function of the probability of occurrence of an adverse effect
on health and of the gravity of such effect, as a result of a
hazard or hazards in foods.
2.3. Risk
analysis: process including three components: evaluation of risk,
management of risk and communication of risk.
2.4. Evaluation
of risk: process based on scientific knowledge, involving the
following phases: identification of the hazard, characterization
of the hazard, evaluation of the exposure and characterization
of the risk.
2.5. Identification
of the hazard: identification of the biological, chemical and
physical agents that can cause adverse effects on health and that
may be present in a particular food or group of foods.
2.6. Characterization
of the hazard: qualitative and or quantitative evaluation of the
nature of the adverse effects on health associated with biological,
chemical and physical agents that may be present in foods.
2.7. Evaluation
of the exposition: qualitative and or quantitative evaluation
of the probable ingestion of biological, chemical and physical
agents through foods, as well as the exposures to other sources,
when relevant.
2.8. Characterization
of the risk: qualitative and or quantitative estimate, including
inherent uncertainties, of the probability of occurrence of an
adverse effect, known or potential, and of its severity for the
health of a particular population, on the basis of the identification
of the hazard, its characterization and evaluation of the exposure.
2.9. Risk
management: process of balance of the distinct normative options
in light of the results of the risk evaluation and, whenever necessary,
the selection and application of possible appropriate control
measures, including regulatory measures.
2.10. Communication
of risk: interactive exchange of information and opinions on risk,
among the persons responsible for the risk evaluation, for risk
management, the consumers and other interested parties.
3. REFERENCES.
3.1.FAO/WHO,
Codex Alimentarius Comission, Procedural Manual, 10th ed., Joint
FAO/WHO Food Standards Programme, FAO, Rome, 1997.
3.2. Risk Management and Food Safety, Report of a Joint FAO/WHO
Consultation, Rome, Italy, 27 to 31 January 1997.
3.3. The Safety Assurance of Functional Foods, Nutrition Reviews,
vol. 54, November 1996, nº 11 (part. II).
4. PROOF OF SAFETY.
4.1. Proof
of safety shall be conducted on the basis of:
information
of purpose and conditions of use of the food or ingredient;
risk evaluation
based, according to circumstances, on one or more scientific evidences.
4.2. Applicable
scientific evidences, according to circumstances, to prove safety
of use:
chemical composition
with molecular characterization, when appropriate, and or formulation
of the product;
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.
(*) Republished
due to incorrectness in the original, in the Federal Official
Gazette of 3/5/99, Section 1, p 11.
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