The Brazilian National Surveillance Agency (ANVISA), Ministry of Agriculture, Livestock and Supply (MAPA) and Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) are pushing forward the simplification of toxicological evaluation during registration alteration, which includes the alteration, inclusion and exclusion of manufacturer of an existing registered technical.
According to Article 22 Decree n. 4074/2002, the assessment of these claims must be made by federal agencies of the agricultural health and environment sectors. However, the content to be reviewed by the three authorities are technically identical, thus, the Advisory Technical Committee for Pesticides (CTA) developed an operational procedure that if the decision on the alteration request was made by the first authority, the other two authorities should made the same decision.
To apply for the manufacturer alteration of a technical material of pesticide, the company should provide description on the production process of the technical product, the synthesis steps, the by-products and impurities, and below information provided by the manufacturer:
Flowchart of chemical reactions and yield of each step of the process;
Identity of the reactants, solvents and catalysts, with their degrees of purity respectively;
Overview of conditions that are controlled during the process (e.g. temperature, pressure, pH, humidity);
Description on purification steps (including those used to recover or recycle starting materials, intermediates generated or substances);
Discussion on the theoretical formation of all possible impurities generated in the production process;
The 5-batch studies and synthesis process are to be reviewed under technical criteria internally defined by respective area among the authorities. The alteration of the manufacture of technical pesticide can be made if:
The maximum limit of each impurity of the new sourced technical product should be less or equal than the constant of the qualitative and quantitative composition declaration of the registered technical product;
The new quantified impurities in the new sourced technical product should not be greater than 1g/kg relative to the declaration of the qualitative and quantitative composition existing in the technical product registered; and
The minimum limit of active ingredient must be equal or greater than the constant in the declaration of the qualitative and quantitative composition of the registered technical.
