Anvisa launches public consultation on updating rules for agrochemicals in Brazil

The National Health Surveillance Agency has put in discussion three proposals to update the rules for agrochemicals in Brazil. The first public consultation possesses the goal to define the criteria for the toxicological evaluation of components.

 

The proposal must establish minimal criteria and procedures for the adequate submission of the registration dossier, including the use of alternative methods; the requirement of the opinion of the technical analysis of the company, in which the company can present a critical technical evaluation over the product; the possibility of accepting the opinions of authorities of other countries for the approval of the product in the country (work sharing), which is understood as low-toxicity product; and the relation of banned components or components that should be discontinued in the country, considering the health-damaging characteristics.

 

The second public consultation is based on the guidelines and requirements related to the registrations, renovation of registration and extension of the use of related agrochemical products. The revision, according to Anvisa, is necessary due to an increase in knowledge of the matter within two decades of the ruling norm.

 

“The legislation establishes that labels and packaging inserts of agrochemicals should follow specifications approved by the federal agencies of agriculture, health and environment. This way, it is necessary to establish a comparison with other norms that are proposed for the evaluation and toxicological classification of agrochemicals,” informed Anvisa.

 

A guide for the elaboration of label and package insets will be launched, in which additional guidance for making those will also be published to help companies accept the label criteria of Globally Harmonized System of Labeling of Chemical Products and the mentioned proposal.

 

The last public consultation involves the criteria for the toxicological classification and comparison of toxic action of agrochemicals and related products. According to the agency, the revision is necessary because of an increase in knowledge of the matter during a period of over two decade of the ruling norm. With the revision, Anvisa intends to approach the criteria of toxicological classification of agrochemicals with the GHS system, which has already been adopted by Brazil for other chemical substances and by several countries on the toxicological classification of agrochemicals.

 

“Besides, it is intended to regulate the terms of the Decree 4,074/2002 with the parameters regarding the toxicity of new agrochemicals compared to those that are already in the market.”