Anvisa's regulatory agenda for 2023


Source: Anvisa (12/14/2022), update annually

Original File

Regulatory ProjectsConclusion
Justifications for changes in the processRelated legislation Context and motivationExpected results
Occupational risk assessment for pesticidesUNCHANGED projectNo justificationNone indicatedNeed to establish criteria for establishing the assessment of occupational risk resulting from the use of pesticides (...)

This health risk assessment stage, carried out by Anvisa, must precede the registration of a pesticide or the authorization of alterations aimed at new uses for it.
The regulatory framework for pesticides does not establish criteria for risk assessment for rural workers, that is, occupational risk assessment. It is necessary to assess the health risks of rural workers who handle and/or apply pesticides, including also those who only enter the agricultural area where the application was made (eg, to harvest food treated with pesticides).

Therefore, it is expected to establish the criteria for carrying out the occupational risk assessment of pesticide products. In parallel, a proposal for a Guide was prepared with the aim of indicating the fundamental principles of this assessment and specifying the models, criteria and general parameters to be used and the information necessary for a more refined exposure assessment, so that the risk assessment conducted for products registered in Brazil is representative of the Brazilian reality.
Establishment of criteria and parameters for pesticide productsCHANGED projectNeed to complement the justification and expected results, considering that possible changes in RDC 294/19 will certainly result in the need to adapt 296/19, since if one deals with the toxicological classification of pesticides, the other determines how the communication of danger , arising from the classification, should happen.RDC No. 04, of January 18, 2012
INC 25/2005
INC 02/2008
Need to establish or review criteria to be evaluated by Anvisa prior to the registration of pesticide products. After the publication of the new regulatory framework for pesticides.
Having verified the need to harmonize the understandings observed in relation to the classification and communication of the danger of pesticides and the like (...)
Review and update criteria for toxicological evaluation and hazard communication performed by Anvisa for the purpose of registering pesticides with a view to simplification, international harmonization and safety of health products human.

The INCs to be reviewed are INC n. 25/2005, which establishes the criteria for the authorization of "Special Temporary Registration" (RET) of pesticides, provided for in Decree 4074/2002 intended exclusively for products for research and development purposes and INC n. 2/2008, which refers to the maximum limits of relevant impurities to be investigated in the studies of five batches to be presented in the post-registration petitions.

Another normative revision intended to work on in this regulatory project is the updating of the criteria for carrying out studies of pesticide residues for establishing the Maximum Residue Limit (MRL) of pesticides in food.

It is expected that the project can also cover other regulatory proposals worked together with the other bodies responsible for the regulation of pesticides in Brazil, such as, for example, the proposal that establishes guidelines for changes in the registration of pesticides and the like, regarding the inclusion or exclusions of registered Technical Product, formulator, manipulator and packaging in Formulated or Premixed product (INC Instruction) in progress, which will be conducted by Ibama in the Public Consultation phase and other regulations that may result from this review.

Inspection of Pesticide AdvertisingUNCHANGED projectNo justificationLaw No. 7802/1989 (Pesticides Law), Article 8;
Decree No. 4074/2002, Article 61;
Advertising of pesticides must comply with the provisions of Federal Law n. 9,294/96 (...)
The regulatory process was motivated by the presentation of a Public Civil Action promoted by the Public Ministry of Dourados in which it requires that Anvisa be determined to adopt emergency measures to curb the advertising and propaganda of pesticides in outdoor media or similar, as well as on the internet , with determination for ANVISA to be determined to the obligation to do, consisting in the edition of legal restrictions to the publicity of agrochemicals, through regulation of the legislation in force (...)Evaluate the need for regulation of pesticide advertising as well as structure the work process at Anvisa for the purpose of monitoring the advertising of these products.
Toxicological reassessment of active ingredients of pesticides.CHANGED projectChanges to the text contained in the "Expected results" field, with the inclusion of two more active ingredients of pesticides that will be prioritized for carrying out the toxicological reassessment and their respective motivation, namely: chlorpyrifos and procymidone.RDC 221/2018This topic aims to regulate Anvisa's decision on toxicological aspects and risk related to health resulting from exposure to the active ingredients of pesticides. The registration of pesticides in Brazil has an indefinite validity, with no legal provision for renewal. However, technical-scientific knowledge about these products is constantly evolving and, even after registration, new information on toxicity and health risks can be identified, requiring the reassessment of the active ingredient of the pesticide. During the reassessment of the registration of an active pesticide ingredient, Anvisa evaluates all available studies on the active ingredient and verifies its inclusion in the prohibitive characteristics of registration related to human health (...)In 2023, efforts will be focused on the toxicological reassessment of the active ingredients epoxiconazole, methyl thiophanate, chlorpyrifos and procymidone. Anvisa established the reassessment of active ingredients due to the following reasons:
. Epoxiconazole - Suspected endocrine disruption, carcinogenicity and reproductive toxicity (fertility and development).
· Methyl Thiophanate - Suspected mutagenicity and endocrine disruption.
. Chlorpyrifos: mutagenicity and reproductive toxicity (neurotoxicity).
. Procymidone: Carcinogenicity, Endocrine disruption and reproductive toxicity (fertility and development).
Thus, it is expected to review the safety profile of these substances as pesticides and propose measures to mitigate any risks identified during the reassessment process. From the reassessment, it can be concluded that the record of the active ingredient is maintained without changes; by changing the formulation, dose or method of application; by restricting production, importation, marketing or use; by prohibiting or suspending production, importation or use; or by canceling the registration. And the elaboration of the Guides referring to the subjects: mutagenicity, reproductive toxicity, Neutoxicity and carcinogenicity.

Regulation of products intended for amateur and professional gardeningUPDATED projectUpdate of the reference to Ordinance SVS/MS No. 322, of July 28, 1997, which was revoked by RDC 709/2022.RDC No. 709/2022 (revoked Ordinance SVS/MS No. 322 of July 28, 1997 and others)Need to establish and update the criteria for regularization for pesticide products intended for use in professional and amateur gardening (...)The regulatory proposal intends to deal with the revision of the technical requirements for products used in amateur gardening, as well as studying the possibility of regulating the use of pesticides intended for professional gardening.
Regulation of phytochemicals and biological productsUPDATED projectUpdate to complement information related to the existing regulatory proposal for a new phytochemical standard.Anvisa/MAPA/IBAMA Joint Normative Instruction No. 03/2006Need to establish criteria for regularizing phytochemical products and update requirements for registering microbiological products used in agriculture.
Currently, Joint Normative Instruction Anvisa/MAPA/IBAMA No. 03/2006 regulates the registration of microbiological products such as pesticides and the like. The regulation was elaborated 14 years ago, and the practice of daily work pointed out the need to update it in accordance with scientific advances and advances in legislation (...)
Regulate the registration of phytochemical products that are characterized as pesticides or the like, whose active ingredient(s) is(are) obtained exclusively from vegetable raw material.

Establish procedures to be adopted for the registration of microbiological products used in the control of a population or biological activities of another organism considered harmful or responsible for promoting plant growth and defense.