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Toxicological reassessment and agrochemical security in Brazil.

The registration of pesticides in Brazil involves three independent Ministries: Agriculture, Livestock and Supply (MAPA), Health (Represented By ANVISA) and Environment (Represented by IBAMA), with each regulatory agency responsible for its area of ​​operation.

As knowledge does not stagnate after a product registration, science can identify new health risks at any time. To address these situations, the National Health Surveillance Agency - ANVISA promotes the toxicological reassessment of active ingredients when international organizations responsible for health and food warn of risks or advise against the use of pesticides and their components, or when there are indications of the occurrence of risks that advise against the use of registered products (Decree No. 4074 of 2002).


In 2008, ANVISA defined the administrative procedures for a toxicological reassessment of active ingredients of pesticides suspected of altering the risks to human health (RDC No. 48/2008, revoked by RDC No. 221/2018). The active ingredients of pesticides that presents evidence of risks to human health may be reassessed at any time. ANVISA has established criteria for selecting and prioritizing active ingredients that will be subjected to reassessment, generating a list of the following actives to be evaluated. At the beginning of the reassessment process, all companies with registered products with the active ingredient under revaluation are called, and ANVISA presents the motivation that placed the ingredient on the list.


Therefore, companies interested in defending the active ingredient must present the toxicological rationale to support this defense. For this, an evaluation of toxicological data is carried out, including proprietary information of the companies, data available in the literature, and data from other regulatory agencies. It is essential that an exhaustive review of the literature is carried out and all information is critically analyzed by experienced professionals in the light of current scientific knowledge and specific legislation as a criterion. In this case, the legislation was updated in 2019 (RDC No. 294/2019), bringing the GHS criteria for the evaluation. Based on toxicological data, the weight of evidence is evaluated to prepare a preliminary technical note submitted for public consultation.


The Agency only concludes after analyzing and compiling all the contributions received. An excellent theoretical foundation and consistent information from the contributions are of fundamental importance. Since 2006, ANVISA has completed the reassessment of 19 active ingredients, 12 of which are now banned in Brazil.


In this way, expertise in toxicology is fundamental in this reassessment process, which focuses on reducing the risks arising from exposure to chemical substances. Toxicology is a translational science based on scientific foundations constantly updated. However, the toxicologist must have experience in Risk Analysis to contribute to the pesticide reassessment process effectively. In addition, it is crucial to understand new methodologies such as NAMs (New Approach Methods), which are increasingly being used in the toxicological evaluation of products and which, in addition to the ethical issue, represent better tools for understanding the real risk to humans. Like a peer review assessment, an independent toxicological assessment is intended to maintain scientific integrity by critically analyzing information in an unbiased manner.


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Izabel Villela, PhD - CEO

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