Anvisa launches guidelines for registration of phytochemical products

The Brazilian Health Regulatory Agency (Anvisa) has launched new guidelines for the registration of phytochemical products, which are pesticides whose ingredients are obtained exclusively from vegetable raw materials.

According to Anvisa, these products can be used as an option in integrated pest management (IPM), to favor the cultivation of agricultural production with more sustainable means of control and lower risk.

The technical note published by the Brazilian agency provides provisional guidance on the procedures to be followed for the registration of phytochemical products.

Meanwhile, Anvisa is working with the Ministry of Agriculture, Livestock and Supply (Mapa) and the Brazilian Institute for the Environment and Renewable Resources (Ibama) to standardize specific requirements for regulating the registration of these herbal products in Brazil.

While the standards have not been published, companies should check the guidelines published in the technical note.

The document was prepared based on the common queries of the regulated sector and the current gaps that exist related to herbal products.

THE RULES

Depending on the characteristics of the product, the filing of registration requests must be in line with specific codes.

If the origin of the substance and its mode of action follow the classification, the product may be registered as a ″biochemical.″

Otherwise, it must be submitted as a formulated product under conventional pesticides.

The options currently available today:

• Biochemical Product – Toxicological evaluation of a product with an active ingredient (biochemical) already registered in the country.

• New Biochemical Product – Toxicological evaluation of a product with an active ingredient (biochemical) not yet registered in the country.

• Formulated Product – Toxicological evaluation of a product with an active ingredient already registered in the country.

• New Formulated Product - Toxicological evaluation of the product with Active Ingredient not yet registered in the country.

″The registration dossier must detail the process for obtaining the plant derivative. The part of the plant used must be specified and the production process described, highlighting all the steps, substances and equipment used, from the starting material to obtain the vegetable derivative to be used in the formulated product,″ the technical note stated.

According to Anvisa, at least one phytochemical marker, which are substances used as a reference in quality control and correlation, preferably through biological activity, must be identified.

″The company must carry out a literature review on the components of the vegetable derivative used in the product and reveal the presence of any substance classified in the prohibited registration categories,″ the provisional note said.

″The declaration of the qualitative and quantitative composition of the formulated product must include the part of the plant used, identify the vegetable derivative and phytochemical markers, as well as the nominal concentrations of the vegetable derivative, which has the function of the active ingredient. The markers must also be specified, along with the chosen phytochemicals and their minimum and maximum limits,″ the agency added.

″In the monograph of the vegetable derivative, there will always be information regarding the part of the plant used and the extraction process, including the solvent used, as this is fundamental information for the toxicological characterization of the fraction. General information about the toxicity of the plant will also be included,″ Anvisa said in conclusion.

(Editing by Leonardo Gottems, reporter for AgroPages)