Carbendazim is banned in Brazil

The active ingredient carbendazim in agricultural pesticides is banned in Brazil. The determination includes technical and formulated products. And it even covers those registered or with a request for registration. The determination came from ANVISA, through Resolution - RDC 739/2022, the result of the procedure developed through SEI Process 25351.919965/2022-32.

There was a precautionary suspension of the import, manufacture, sale and distribution of the active ingredient and technical products since June 22, 2022, according to Order no. 60/DICOL/ANVISA.

Information on the agricultural use of Carbendazim in the C24 monograph was maintained until 1/12/2024. This is for monitoring residues in food.

The prohibition on the import, sale and use of products based on the active ingredient follows the following timeline:

(a) from 8/8/2022: import (technical and formulated) and production (technical); use of products formulated through manual application and open cabin tractors;

(b) three months from 8/8/2022: production of formulated products;

(c) six months from 8/8/2022: marketing of formulated products;

(d) 12 months from 8/8/2022: export of technical and formulated products.

In turn, products purchased by farmers and seed treatment companies can be used until the expiration date stated on the packaging.

Reasons

Carbendazim was banned due to its carcinogenic potential. This despite there being no consensus on the topic. See information from Opinion no. 5/2021 /SEI /CREAV /GEMAR /GGTOX /DIRE3 /ANVISA:

The APVMA - Australian Pestides and Veterinary Medicines Authority concluded that there is no evidence that the active ingredient is carcinogenic.

A similar conclusion was expressed by EFSA - European Food Safety Authority.

The PMRA - Health Canada's Pest Management Regulatory Agency (Canadian Pest Control Regulatory Agency) concluded that exposure to CBZ produced tumors in cattle and ovaries in mice that received daily doses throughout their lives. Studies were negative in rats and dogs (PMRA, 2011). The PMRA evaluated the following studies: rats – Til et al, 1976; dogs – Sherman, 1972; Reuzel et al, 1976; mice – Beems et al, 1976; Wood et al, 1982; Donaubauer et al, 1982.

Finally, the EPA - United States Environmental Protection Agency (EPA) classified CBZ in group C – possible carcinogen for humans, based on the presence of adenoma and hepatocellular carcinoma in CD-1 mice (Wood et al, 1982 ) and the aneugenic potential observed in genotoxicity studies.

Discover Carbendazim

Carbendazim is a fungicide. It was registered in Brazil for use on various grains and fruits. Belonging to the class of benzimidazoles, it has a broad spectrum of control, acting systemically. The literature reports that they interfere with fungal mitosis. They inhibit the assembly of microtubules, preventing the formation of the mitotic spindle.

Cases of fungal resistance to this active ingredient have been reported in Brazil since at least the 1980s.

Agrofit contains 41 registered products containing carbendazim.

Impacts for producers

The research director at the Rio Verde Technological Research and Development Foundation, Fabio Pittelkow, states that there are efficient technologies to replace the molecule. 

“Today we have tools available on the market that have good agronomic efficiency, greater environmental safety and greater safety for the use of rural workers. If Carbendazim is being removed from the market for safety reasons, it is important to pay attention. Today, Brazil has one of the most modern laws for registering agronomic products in the world, supported by science”, points out Pittelkow.

Studies cited

For those who want to delve deeper, below is the list of studies cited by Anvisa:

APVMA. Human health risk assessment of Carbendazim. December 2009. Australian Pesticides and Veterinary Medicines Authority. Available in https://apvma.gov.au/sites/default/files/publication/14531-carbendazim-prf-vol2.pdf.

APVMA. Carbendazim. review findings report. August 2012. Australian Pesticides and Veterinary Medicines Authority. Available in: https://apvma.gov.au/search/google/Carbendazim

Beems R, Til H, Van der Heijden C. Carcinogenicity study with carbendazim in mice, Final report; report no. R4936, Unpublished report by Central Institute for Nutrition and Food Research, 1976.

Börzsönyi M, Pintér A, Surján A, Farkas I. Transplacental induction of lymphomas in Swiss mice by carbendazim and sodium nitrite. Int J Cancer. 1976 Jun 15;17(6):742-7. doi: 10.1002/ijc.2910170609. PMID: 988851.

Börzsönyi M & Csik M. Induction of malignant lymphomas in Swiss mice by n-nitroso compounds formed in vivo Int. J. Cancer. (1975) 15:830-838. doi: 10.1002/ijc.2910150515.

Donaubauer et al (1982) apud EFSA. Draft Re-Assessment Report 16 July 2009. Carbendazim. Volume 3 (B6). Report and Proposed Decision. Rapporteur Member State: Germany. Available in: https://www.efsa.europa.eu/en/search/site/CARBENDAZIM

EFSA. Draft Re-Assessment Report 16 July 2009. Carbendazim. Volume 3 (B6). Report and Proposed Decision. Rapporteur Member State: Germany. Available in: https://www.efsa.europa.eu/en/search/site/CARBENDAZIMIARC.

International Agency for Research on Cancer, World Health Organization, IARC Monographs on the Identification of Carcinogenic Hazards to Humans. Preamble, Lyon, France, 2019.

Igarashi M, Setoguchi M, Takada S, Itoh S., Furuhama K. Optimum conditions for detecting hepatic micronuclei caused by numerical chromosome aberration inducers in mice. Mutation Research, vol. 632, p. 89-98. 2007.

Lynch AM, Eastmond D, Elhajouji A et al. Targets and mechanisms of chemically induced aneuploidy. Part 1 of the report of the 2017 IWGT workgroup on assessing the risk of aneugens for carcinogenesis and hereditary diseases, Mutat Res Gen Tox En, 847, 2019. doi.org/10.1016/j.mrgentox.2019.02.006.

McCarroll NE, Protzel A, Ioannou Y, Frank Stack HF, Jackson MA, WatersMD, Dearfield KL. A survey of EPA/OPP and open literature on selected pesticide chemicals. III. Mutagenicity and carcinogenicity of benomyl and carbendazim. Mutat Res. 2002 Sep;512(1):1-35. doi: 10.1016/s1383-5742(02)00026-1. PMID:12220588.

Peyre L, Zucchini-Pascal N, de Sousa G, Luzy AP, Rahmani R. Potential involvement of chemicals in liver cancer progression: an alternative toxicological approach combining biomarkers and innovative technologies. Toxicol In Vitro. 2014 Dec;28(8):1507-20. doi: 10.1016/j.tiv.2014.06.009. Epub 2014 Jul 2. PMID: 24997295.

Pfeil R, Dellarco V. Carbendazim –1 JMPR 2005. Inventory of evaluations performed by the Joint Meeting on Pesticide Residues (JMPR). Available in: https://apps.who.int/pesticide-residues-jmpr-database/pesticide?name=CARBENDAZIM

PMRA. Carbendazim. Proposed Registration Decision. PRD2011-04. Health Canada Pest Management Regulatory Agency, 2011. Available at: http://publications.gc.ca/site/eng/397259/publication.html

PubChem. Carbendazim C9H9N3O2 – PubChem. Available in: https://pubchem.ncbi.nlm.nih.gov/compound/25429

Reuzel et al (1976) apud EFSA. Draft Re-Assessment Report 16 July 2009. Carbendazim. Volume 3 (B6). Report and Proposed Decision. Rapporteur Member State: Germany. Available in: https://www.efsa.europa.eu/en/search/site/CARBENDAZIM

Sherman (1972) apud EFSA. Draft Re-Assessment Report 16 July 2009. Carbendazim. Volume 3 (B6). Report and Proposed Decision. Rapporteur Member State: Germany. Available in: https://www.efsa.europa.eu/en/search/site/CARBENDAZIM

Til KP, Kollen C, van der Heijden CA. Combined chronic toxicity and carcinogenicity study with Carbendazim in rats. Report no R5133. Unpublished report by Central Institute for Nutrition and Food Research, 1976.

Thomas P, Holland N, Bolognesi C et al. Buccal micronucleus cytome assay. Nature Protocols 4(6):825-837, 2009. doi:10.1038/nprot.2009.53.

USEPA. Methyl Thiophanate and Carbendazim (MBC). Human Health Assessment Scoping Document in Support of Registration Review. United States Environmental Protection Agency. March 20, 2014. Available at: https://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1

USEPA. Thiophanate-Methyl and Carbendazim: Draft Human Health Risk Assessment for Registration Review. United States Environmental Protection Agency. March 24, 2020.

Vela-Corcía D, Romero D, de Vicente A et al. Analysis of β-tubulin-carbendazim interaction reveals that binding site for MBC fungicides does not include residues involved in fungicide resistance. Sci Rep 8, 7161 (2018). https://doi.org/10.1038/s41598-018-25336-5

Wood et al (1982) apud EFSA. Draft Re-Assessment Report 16 July 2009. Carbendazim. Volume 3 (B6). Report and Proposed Decision. Rapporteur Member State: Germany. Available in: https://www.efsa.europa.eu/en/search/site/CARBENDAZIM

Further information can be obtained at the link below: