Anvisa Brazil Rejects Almost 5% of Pesticide Formulated Product Evaluations

Anvisa Pesticide

“Anvisa has publicly expressed its opposition to the Pesticides Bill…”

Carlos Alexandre Oliveira Gomes is the general manager of the General Management of Toxicology – GGTOX, at the Brazilian Health Regulatory Agency – Anvisa. Gomes is an agronomist, with a master’s degree in food science and technology from the Rural University of Rio de Janeiro.

Carlos Gomes, general manager of GGTOX, Anvisa

AgriBrasilis – What is the role of Anvisa in relation to pesticide products?

Carlos Gomes – Pesticides are regulated by Law No. 7802/1989, that conditions manufacturing, commercialization and use in Brazil to be authorized by the Federal Government. This is called registration, a complex administrative act carried out by agencies linked to the Ministries of Health, Environment and Agriculture.

Anvisa controls and supervises products and services that present risks to public health, among them “…limits of organic contaminants, residues of pesticides and veterinary drugs…”, according to Law No. 9782/1999, that defined the National Health Surveillance System and created Anvisa.

In the current pesticide control system, Anvisa is the federal administrative entity responsible for the regulation of pesticides and assessment of the health impacts resulting from the use of pesticides.

Anvisa performs the toxicological evaluation of pesticides for registration and post-registration purposes, responsible for defining the toxicological classification and for assessing the health risks arising from occupational exposure and exposure through residues in food.

Anvisa’s methodology for the toxicological evaluation of pesticides is in line with the best international regulatory practices.

AgriBrasilis – What is the time required for the toxicological evaluation of a product? How is the prioritization of processes carried out?

Carlos Gomes – Average time required for toxicological evaluation for registration, including waiting time in queue, is 04 to 05 years, depending on type of product, formulated or technical. Formulated Products are those sold to farmers and Technical Products are used as raw material for the manufacture of pesticides.

Decree No. 10833/2021 amended Decree No. 4074/2002, adjusting analysis deadlines, as per the excerpts below:

  1. a) 36 months in the case of a new technical product, counted from the date of the application protocol;
  2. b) 24 months for equivalent technical products, counted from the date of the application protocol;
  3. c) 24 months for formulated products whose technical product is already registered, counted from the date of the protocol of the formulated product;
  4. d) 24 months for formulated products, whose technical product is not registered, counted from the date of registration of the technical product;
  5. e) 12 months for new formulated products, counted from the registration date of the respective new technical products;

Art. 3 The federal agencies involved in the registration of pesticides will have a period of four years, counted from the date of publication of this Decree, to analyze pending processes for registration of technical products, premixes, pesticides, and similar products, through specific procedures to be established by the agriculture, health and environment agencies.

Prioritizing the analysis of these processes is the responsibility of the Ministry of Agriculture. There is a legal provision, based on articles 17 and 18 of Anvisa’s Resolution No. 294/2019, so that low toxicity and less dangerous products can be prioritized within the scope of Anvisa.

AgriBrasilis – What stages of the registration process are harmonized between MAPA, Anvisa and Ibama and why?

Carlos Gomes – Each agency operates in its own area of ​​competence. Aiming to eliminate bureaucratic dysfunctions, Decree No. 10833/2021 was published, addressing a series of necessary updates to Decree No. 4,074/2002, arising mainly from the international advancement of science and the need for harmonization with internationally adopted criteria and guidelines. This allowed the rationalization of processes, to avoid rework between the agencies, establishing obligations in line with the competence of each agency, providing more work effectiveness.

AgriBrasilis – What proportion of the filed processes are approved, rejected, or must undergo corrections?

Carlos Gomes – The following are the percentages of toxicological analyzes for registration purposes deferred by Anvisa between 2020 and 2022, depending on the type of pesticide evaluated:

Type of Product Percentage of deferral
Formulated Product 94.72%
Formulated Product Based on Equivalent Technical Product 95.94%
New Formulated Product 100%

AgriBrasilis – What is the reason for the lawsuits for the evaluation of registration processes? What percentage of these actions are upheld by the judiciary?

Carlos Gomes – Most of these lawsuits are related to allegations of administrative delay.

Article 15 of Decree No. 4074/2002 required federal agencies to carry out the technical evaluation of registration within 120 days, a period considered insufficient for this type of analysis. Therefore, Decree No. 10833/2021 amended Decree No. 4074/2002, adjusting deadlines.

The 120-day period was not compatible with the complexity and specificity inherent to the evaluation for the registration of pesticides and resulted in a huge liability and in frequent lawsuits against the federal agencies responsible for pesticide registration. The publication of Decree No. 10833 established feasible deadlines.

AgriBrasilis – What is Anvisa’s position in relation to the Pesticide Bill No. 1459/2022?

Carlos Gomes – Anvisa has publicly expressed its opposition to the Pesticide Bill. In Anvisa’s view, the Bill’s propositions eliminate, annul, or give to other agencies the responsibilities concerning health in the regulatory process of pesticides.

AgriBrasilis – In 2023, Anvisa will perform the toxicological reassessment of active ingredients epoxiconazole, methyl thiophanate, chlorpyrifos and procymidone. Under what circumstances can a ban on these products occur, as happened with carbendazim in 2022? Is this situation likely?

Carlos Gomes – Reassessment of these active ingredients is in progress, following the regulatory steps provided by law. They have already gone through the disclosure of the start of the reassessment, with the opening of the public notice and holding a meeting with the registrant companies, and the protocol of documents and studies by these companies. At this moment, technical analysis is in progress, focusing on toxicology.

After the technical analysis, documents for conclusion, or final decisions, must be prepared, that will be analyzed by the Collegiate Board of Anvisa, to approve the Public Consultation, for contributions from society. Afterwards, the contributions will be analyzed, and the Collegiate Board will deliberate again.

Reassessment may result in allowing commercialization with measures to reduce risks arising from use or even in banning the products. It could also lead to the decision to keep the product in circulation without further recommendations.

Conclusion of the reassessment process depends on the available evidence, the need to contribute with studies developed by the companies that hold the product registration, etc. There is no time duration standard, precisely because of the complexity of the process and the characteristics of each active ingredient, including toxicological aspects and relevance for agriculture.

Only after analyzing the evidence and completing the planned regulatory steps can a conclusion be made for the prohibition, maintenance of the active ingredient record without changes, or changes aimed at adapting and establishing risk mitigation measures.

AgriBrasilis – Another topic on the regulatory agenda is updating the regulation of phytochemicals and biological products. Why is this necessary? What changes are expected?

Carlos Gomes – On this subject, there are two regulations in the process of being created.

First is the Joint Ordinance on Microbiological Products. Given the obsolescence of the current Joint Regulatory Instruction 03, from 2006, and considering the advances of biotechnology, it was necessary to update the regulation. The said current Joint Regulatory Instruction is outdated in several points, making it impossible to register several products with biological activity to control diseases and pests. The Instruction’s review, with the expansion of regulated points, will create a framework for the specific analysis of microbiological products.

Second, in the process of consolidating contributions from public consultation, is the new standard for phytochemical products. Proposing regulations for these products is necessary because, although some phytochemicals are registered in Brazil, there is still no specific legislation for the correct classification and registration of products made from plant extracts.

Legislation for registration of conventional chemical products is not adequate. This is because of the characteristics of phytochemical compounds. To overcome this, the construction of the new phytochemical standard is essential to enable and expand the registration of natural products, that can be used as an option in the integrated management of pests and favor the development of agriculture with new, more sustainable, and less dangerous ways of control.



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