To register new foods or new ingredients for human consumption in Brazil, applicant companies must submit to ANVISA (Brazilian National Health Surveillance Agency) a series of information about the product according to resolutions RDC No. 16/1999 and RDC No. 17/1999 (ANVISA, 1999a; 1999b).
ANVISA classifies as new foods or new ingredients foods or new substances those that do not have a history of use in Brazil or that are already consumed, but that will be used in quantities much higher than those currently found in foods used in the regular diet (ANVISA, 1999a).
Among the necessary information, there is evidence of safety, which aims to protect the population's health and reduce possible risks associated with the consumption of the product.
The security assessment involves a complete risk analysis that must compose the Technical Scientific Report of Safety Assessment according to Guide No. 23/2019 (ANVISA, 2019).
Risk analysis must follow scientific criteria and comprise four steps: hazard identification and characterization, exposure assessment, and risk characterization (ANVISA, 2019).
Hazard Identification
Hazard identification is based on information about the product and its manufacturers, such as denomination, nature, origin, chemical composition, molecular characterization, purity, formulation, procurement and manufacturing, and analysis methodologies. The information must be clear and detailed for identifying and detailed description of the product.
Hazard Characterization
In this step, the profile, nature, and extent of possible adverse health effects associated with the product are investigated. For hazard characterization, data on the product's toxicological and ADME (absorption/distribution/metabolism/excretion) profile in non-clinical and human models must be presented. However, the types and extent of toxicological tests may vary on a case-by-case basis. Toxicological evaluation in non-clinical experimental models (in vitro, in vivo) should consider genotoxicity and sub-chronic toxicity data. Depending on the observed outcome profile, additional studies of chronic toxicity, reproductive and developmental toxicity, carcinogenicity, neurotoxicity, immunogenicity, and sensitization are required. Studies must be carried out following the respective official protocols (such as OECD guides) and quality standards (Good Laboratory Practices - GLP). Complementary alternative approaches may be included in the analysis, as long as they are compatible with the scientific requirements for evaluating the effects of the product.
The results of human studies help to assess the relevance of data obtained from studies in non-clinical models and confirm established safety values. Human data can be obtained from studies of safety or tolerance, nutritional and functional characteristics, metabolism, and toxicokinetics, which must also be performed according to technical and ethical guidelines for clinical trials. In this item, evidence of product use history must also be presented.
It is important to emphasize that data obtained from a thorough and robust literature review can help characterize the hazard, contributing to the definition of necessary tests and refinement of experimental designs of the studies.
Based on the data set obtained from toxicology/safety and ADME, the determination of safety values for the product means an intake range that does not pose an appreciable risk to human health, such as the Acceptable Daily Intake (ADI).
Exposure Assessment
Exposure assessment is performed to estimate the population's likely intake of the product. From the analysis of food consumption data and the amounts of the product (food or ingredient) present in the foods used in the regular diet of the population, the probable intake of the product can be estimated.
Risk Characterization
With all the data from the three previous steps in hand, the risk characterization of the product must be carried out based on the probability of occurrence and the severity of an adverse effect. In general, the estimated intake is compared with the safety values , and a food exposure lower than the safety value supports the safety of users of the product (ANVISA, 2019).
If available, product safety assessment information by internationally recognized authorities and bodies may also be presented to complement the risk characterization.
Finally, the Technical-Scientific Safety Assessment Report must present the scientific rationale used at each stage. It must be prepared by professionals who are experienced and competent in product risk analysis.
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Miriana Machado, PhD