Published in early January by the Ministry of Agriculture and Livestock (Mapa), the Brazilian Institute of the Environment and Renewable Natural Resources (Ibama) and the National Health Surveillance Agency (Anvisa), Joint Ordinance 737 submits to public consultation a proposal to regulate the procedures to be adopted for the distribution of pending proceedings for registration of equivalent technical products, premixes and formulated products of pesticides and related products.
As a mechanism for social participation, the objective of the public consultation is to receive suggestions and proposals to give greater effectiveness to the registration proceedings of products that are pending consideration by the agencies and have been initiated by October 8, 2021. The deadline for the public consultation is 60 days and ends in early March 2023.
The proposal presented is another attempt to speed up the analysis of proceedings of this nature that await procedural protocol in the registration bodies. According to industry data, the analysis of applications for pesticide registration can take up to ten years, if we consider the applications for new products and active ingredients not yet approved.
Under the proposal, the analysis of registration applications should consider the same active ingredients – which must necessarily be identical – of a product for each group of 20 proceedings, giving greater speed to the registration process for this set of products. The proposal indicates as the main process of the group the one who is in the first position of the analysis queue.
Another measure provided for by the ordinance is to make it possible for the application for registration of a new product to benefit from the most advanced stage of a product reanalysis proceeding already registered, provided that the products have identical active ingredients. In such cases, the new application proceeding will follow its own procedure, and the applicant will need to present the documents provided for in the annexes of the joint ordinance: the declaration of assignment of studies and the comparative table.
By means of the declaration of assignment, the legal representatives of the company holding a certain product already registered in the process of reanalysis and of the one whose application for registration will be filed declare, in consensus, that they allow the assignment of the dossier of information and studies already produced by the competent bodies.
To subsidize the declaration, the applicant must fill out the comparative table that indicates the numbers of the proceedings, in the three bodies, of the product to be registered and of the one with the dossier already complete.
The measure aims to avoid the double issuance of opinions by the competent bodies during the assessment of the different applications for registration.
Suggestions and contributions can be made through the Monitoring System of Normative Acts (Sisnam), of the Secretariat of Agricultural Defense (SDA).
After the deadline for the public consultation, the contributions will be analyzed by a technical group coordinated by the General Coordination of Pesticides and Related Products, with representation of the other competent bodies for the registration of pesticides.