New registration procedures for microbiological products

On May 04, 2023, the Ministry of Agriculture, Livestock and Food Supply (MAPA) published  Joint Ordinance SDA/MAPA – IBAMA – ANVISA No. 1, of April 10, 2023, which establishes procedures for the registration of microbiological products.

The new rule aims to adapt the legislation to recent innovations, such as the permission for registration of inactivated microorganisms, which was previously allowed only for living microorganisms. It also clarifies and eliminatesred tape in certain registration procedures.

The new Joint Ordinance defines “microbiological products” as living or inactivated microorganisms, including viruses, as well as microorganisms created through techniques that involve modification of genetic material, and that are aimed at preventing, eliminating, repelling or mitigating pests, as well as being used as plant regulators, stimulants, defoliants or desiccants.

Regarding the registration procedure, the new Joint Oedinance establishes, among others:

• That the registration of technical products is not required for microbiological products.
• The simplified registration procedure for microbiological products. This procedure is requested only to MAPA and is applicable only in the event that the qualitative and quantitative composition and the microorganism isolate of the product are the same as those of another reference product that has already undergone analyses regarding potential environmental hazards, danger to the health of humans and agronomic efficiency.
• The list of all documents and information that must be submitted to MAPA, to the Brazilian Health Regulatory Agency (Anvisa), and to the Brazilian Environment and Natural Resources Institute (Ibama).
• The list of all documents and information (technical justification) for exemption, waiver or replacement of the required study.
• The situations in which microbiological products do not require toxicological and ecotoxicological studies.
• That the registration of microorganism-based products classified within biological risk groups 3 or 4 is prohibited.
• The exclusive and prioritized processing of applications for the registration of microbiological products.

Additionally, the Ordinance established that the sale of certain microbiological products does not require agronomic prescriptions and that such exemption must be informed on the label and on the leaflet of the product.

The new Ordinance repeals the Joint Normative Instruction Ministry of Agriculture, Livestock and Food Supply/Anvisa/Ibama No. 03 of March 10, 2006 and CGAA/DSV/SDA Act No. 06 of January 23, 2014.

Registration holders that have already carried out the registration of products that fall under the definition of “microbiological product” will have 180 days, from the publication of this Joint Ordinance, to adjust their labels and leaflets. In addition, registration holders must update the label and leaflet templates in the Phytosanitary Pesticides System (Agrofit) and inform MAPA of such adjustments.

The Normative Instruction will enter into force on June 01, 2023.

Demarest’s Life Sciences team is monitoring the updates of the industry and is available to provide any further clarifications that may be necessary.