Carbendazim toxicological revaluation about to be completed by ANVISA

In December 2019, ANVISA started the process of toxicological revaluation of the Active Ingredient (AI) Carbendazim, as signs of toxicity were identified that fit into prohibitive registration criteria: mutagenicity, carcinogenicity, and reproductive and developmental toxicity.

Carbendazim is a broad-spectrum systemic fungicide, belonging to the benzimidazole class and has, in Brazil, approved agricultural use for the foliar modality in cotton, barley, citrus, beans, apple, corn, soybean and wheat crops and for application in seeds in cotton, rice, beans, corn and soybean crops. In addition to agricultural use, Carbendazim is approved as a wood preservative and its use as a household cleaner is not permitted.

According to public data available on MAPA’s platform (Ministry of Agriculture, Livestock and Supply), there are 41 formulated products and 33 technical products based on Carbendazim with active registration in Brazil and 24 companies holding registrations of formulated and technical products.

The Collegiate Board of Directors of ANVISA, after an extraordinary public meeting, stipulated a schedule to be followed by the Agency that aims to comply with the judicial decision that determined a period of 60 days for the completion of the toxicological revaluation process (Public Civil Action No. 0051862-73.2013.4.01.3400), thus indicating immediate next steps.

In addition, the Agency appointed August 8^th, 2022 as the final date for the completion of the process regarding the active ingredient. ANVISA also adopted, in a decision of June 22, 2022, two measures in relation to Carbendazim, which aim to comply with the stipulated schedule: it approved the public consultation that deals with the banning of Carbendazim, as well as preventively suspending the importation, the manufacture, marketing and distribution of both the active ingredient Carbendazim and formulated products containing it, until the process is closed.

That is, until the revaluation process is completed (expected completion on August 8^th, 2022), the active ingredient will be suspended.

As defined by RDC No. 221/2018, which provides for the criteria and procedures for the process of toxicological revaluation of active ingredients of pesticides within the scope of ANVISA, the toxicological revaluation of active ingredients of pesticides must be carried out, at any time, when indications of changes in human health risks are identified.

In addition, the aforementioned RDC provides, in its art. 5, that the indication of active ingredients of pesticides for revaluation may also occur (i) when international organizations responsible for health or food, of which Brazil is a member or signatory of agreements, warn of risks or advise against the use of pesticides or (ii) when a technical-scientific basis, duly based on the active ingredient, is presented to ANVISA.

As a result of the revaluation process, it can be concluded:

1. For the maintenance of the active ingredient of the pesticide, its technical and formulated products, without additional restrictions beyond those already recorded in the respective registration;
2. By maintaining the active ingredient of the pesticide, its technical and formulated products, with the adoption of measures to mitigate health risks;
3. For the maintenance of the active ingredient of the pesticide, its technical and formulated products, with the need for changes in their records;
4. The suspension of the use of the active ingredient of the pesticide, its technical and formulated products; or
5. Prohibition of production, import, export, commercialization and/or use of the active ingredient of the pesticide, its technical and formulated products.

The following active ingredients of pesticides will be re-evaluated in the coming years, in addition to Carbendazim: (i) Methyl Thiophanate (being re-evaluated jointly with Carbendazim); (ii) Epoxiconazole; (iii) Procymidone; (iv) Chlorpyrifos; (v) Linuron; and (vi) Chlorothalonil.

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