Brazilian National Health Surveillance Agency (ANVISA) decides to ban Carbendazim

On August 8^th, 2022, during the 12^th Extraordinary Public Meeting of DICOL, ANVISA’s Collegiate Board of Directors announced the completion of the toxicological revaluation of the active ingredient Carbendazim, unanimously approving the draft Resolution (RDC) that provides for the prohibition of this active ingredient in pesticide products in the country. Therefore, ANVISA decided to ban the production, import, export, sale and use of Carbendazim in Brazil.

In addition, the RDC also defined the transitional measures to mitigate risks, establishing the plan for the gradual and continuous discontinuation of the import, production, commercialization and use of technical and formulated products based on Carbendazim. The approved Resolution determined the banning of Carbendazim in pesticide products in the country, covering all technical and formulated products based on this active ingredient. Carbendazim was approved in Brazil for foliar use in cotton, sugarcane, barley, citrus, beans, apple, corn, soybeans and wheat, as well as in relation to seed treatment of cotton, rice, beans, corn and soybeans. Its non-agricultural use is also foreseen, as a preservative for wood and paints.

The decision of August 8^th affects products already registered and also those that have a registration request in Brazil. It should be noted that the non-agricultural use of Carbendazim as a wood preservative is not within the scope of the toxicological revaluation carried out, so the RDC will not reach the non-agricultural use of Carbendazim.

ANVISA’s decision to ban the agricultural use of Carbendazim follows the understanding and is in line with the conclusions of other international agencies. Recent toxicological revaluations have been carried out by the US, Canadian, European and Australian agencies. In the United States and Canada, Carbendazim is not registered for food crops, as it has been considered carcinogenic, mutagenic and represents reproductive toxicity. In Europe, the active ingredient is not approved, as it has been considered mutagenic and also represents reproductive toxicity. In 2015, Carbendazim was included in the list of candidate pesticides for replacement because it fulfills prohibitive registration criteria under European legislation. In turn, in Australia the product is approved, having, however, some restrictions of use.

The Board based its final conclusion on the toxicological revaluation carried out by the General Management of Toxicology of ANVISA, which concluded that Carbendazim should be banned, due to its potential to cause mutagenicity, toxicity to reproductive physiology and toxicity to embryofetal and neonatal development and the impossibility of determining safe human exposure thresholds for these toxicological outcomes.

That is, the toxicological revaluation of Carbendazim concluded that the active ingredient should be classified as presumably mutagenic to human germ cells (Category 1B), presumably carcinogenic to humans (Category 1B) and presumably toxic for reproduction in humans (Category 1B), and that it is not possible to establish a safe threshold for mutagenicity and reproductive toxicity. These are prohibitive registration criteria established by Law No. 7,802/1989, Decree No. 4,074/2002 and RDC No. 29 of 2019.

Regarding the plan to discontinue the use of Carbendazim in the national territory, the gradual and continuous elimination of pesticides containing the active ingredient was agreed, with the aim of reducing risks and respecting the most appropriate destination of the products. IBAMA, after consultation by ANVISA, considered that the best solution from the environmental impacts’ point of view is the depletion of stocks (observing their expiration date), since incineration could generate many pollutants. In addition, the depletion of stocks would avoid the uncontrolled disposal or storage of the products and would allow the correct use, maintaining the indicated doses, thus avoiding the expansion of use to unauthorized cultures.

In order to comply with the Carbendazim discontinuation plan, it was determined the prohibition of

1. the importation of technical and formulated products and the production of technical products from the validity of the Resolution; and
2. the use of formulated products with backpack, semi-stationary, stationary and open-cab tractors manual application technologies from the validity of the Resolution.

However, it was allowed:

1. for a period of three months: the production of formulated products;
2. for a period of six months: the marketing of formulated products; and
3. for a period of twelve months: the export of technical and formulated products.

After this period, companies must provide, within two months, the proper disposal of any remaining technical and formulated products and, from then on, they will have three months to inform ANVISA about the disposal of technical and formulated products.

The Resolution will take effect immediately, as of its publication in the Official Gazette.

We remind that the toxicological revaluation of Carbendazim began on December 19, 2019. This active ingredient is a broad-spectrum systemic fungicide, belonging to the benzimidazole class, whose pesticidal action results from the inhibition of β-tubulin polymerization, which prevents the proper formation of the achromatic spindle and, consequently, impairs the process of cell division. It is a metabolite of the thiophanate-methyl fungicide, which is also registered in Brazil; and the compound Benomyl, whose monograph was excluded by ANVISA in 2002. It was the 16^th most commercialized pesticide in the country in 2019, with 33 technical and 41 formulated products based on Carbendazim registered with MAPA.

If you would like to be informed of further developments in this matter and/or need any assistance or clarification, especially with regard to active ingredient revaluation procedures in Brazil, do not hesitate to contact us via mail@kasznarleonardos.com.