Yesterday, on December 17, 2024, ANVISA’s Rule #950, dated December 13, 2024 (RDC #950/2024), was published, through which the Brazilian FDA (ANVISA) establishes complementary requirements to optimize the analysis of petitions for the evaluation and toxicological classification of formulated agrochemicals products obtained from equivalent technical products (ETPs).

The RDC makes compulsory the submission, at the time of filing the registration request, of the Optimized Reading Tool Form for Agrochemical Registration, known as FLORA (Brazilian acronym), an algorithm tested by ANVISA since 2018, which is expected to automate the preliminary evaluation of the requests.

The debate and deliberation on the proposed text of RDC #950/2024 took place during ANVISA’s 24th Public Ordinary Meeting of the Collegiate Board, which was held on December 11, 2024. As explained by the Rapporteur Director, FLORA has been available, but its use was optional. The idea of making FLORA mandatory emerged to address a backlog of approximately 2,000 processes awaiting analysis by ANVISA, exceeding the analytical capacity of the General Management of Toxicology (GGTOX).

RDA #950/2024 also includes the creation and establishment of the same mandatory requirement for the Declaration of Constitution and Hazard Information for Agrochemicals, known as DCIPA (Brazilian acronym), which must contain detailed information about the qualitative and quantitative composition of formulated products, as well as toxicity data of active ingredients and non-active components. In the DCIPA, companies will provide basic product information, including hazard classification, and assume responsibility for the information provided.

Both FLORA and the DCIPA must be submitted by companies registering formulated products obtained from equivalent technical products at the time of filing. For registration requests filed before the rule takes effect, companies must comply with the submission of said documents by January 2, 2026. The RDC provides that failing to submit FLORA and DCIPA at the time of filing or to regularize the protocols within the given timeframe will result in the rejection of the request. Indeed, a provision was included in the RDC assigning the responsibility to the registrant company to inform ANVISA that their process is ready for analysis, after submission, through an amendment in the “Solicita” petitioning system, according to the document template provided in Annex 2 of the RDC.

Thus, the mandatory use of FLORA and the implementation of DCIPA are intended to accelerate the analysis processes, reduce lawsuits resulting from non-compliance with legal deadlines, improve alignment with the regulated sector, and foster a better work environment.

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