Anvisa approves new regulatory framework for agrochemicals

Anvisa's Collegiate Board (Dicol) approved, this Tuesday (23/07), the new regulatory framework for agrochemicals, a measure that updates and clarifies the evaluation criteria and toxicological classification of products in Brazil. It also establishes important changes in labeling, with the adoption of the use of information, warning words and images (pictograms) that facilitate the identification of dangers to human life and health. 

The changes were proposed based on the standards of the Globally Harmonized System of Classification and Labeling of Chemicals – GHS, consolidating international regulatory convergence in this area. With this, Brazil will have rules harmonized with those of countries in the European Union and Asia, among others, strengthening the commercialization of national products abroad.   

The new regulatory framework is made up of three Collegiate Board Resolutions (RDCs) and a Normative Instruction (IN). Before evaluation by Dicol, the proposals were submitted to public consultations (CPs) in 2018. The rules will come into force from the date of publication in the Official Gazette of the Union (D.O.U).  

Director Renato Porto highlights that the review of the regulatory framework for pesticides involved carrying out several public consultations and that the topic is a long-standing priority for Anvisa. For him, one of the important points to be highlighted is the need for clarity of information placed on labels.   

“Labeling is what publicizes the risk assessment of products. Therefore, society needs to know the label”, says the director. For Porto, this way it will be possible to better communicate the dangers to farmers, who are vulnerable to substances, as they are the ones who work with the products and handle them. From publication in the D.O.U, companies will have one year to adapt the labeling standards.  

Changes in alerts for agrochemicals 

The new rules will bring more security to the consumer market because they facilitate identification regarding use. To this end, the toxicological classification categories were expanded from four to five, in addition to the inclusion of the “unclassified” item, valid for products with very low potential for harm, for example, products of biological origin. A color chart will further help identify risks.  

Therefore, the classification based on acute toxicity must be determined and identified with the respective category names and colors on the product label, as established below:

Category 1: Extremely Toxic Product – red band.

Category 2: Highly Toxic Product – red band.

Category 3: Moderately Toxic Product – yellow band.

Category 4: Low Toxic Product – blue band.

Category 5: Product Unlikely to Cause Acute Harm – blue band.

Unclassified – Unclassified Product – green band

The toxicological classification of a product may be determined based on its components, its impurities or other similar products. For each category, there will be an indication of damage in case of contact with the mouth (oral), skin (dermal) and nose (inhalation). Check it out in the example below:   

GHS Toxicological Classes 

In addition to the table with toxicological classes, it is planned to use other images (pictograms) from the GHS for use on agrochemical labels and leaflets.  

Wide discussion  

The proposals approved by Dicol were widely discussed and went through public consultations in 2018 – CPs 483, 484, 485 and 486. Before that, several Anvisa initiatives dealt with this topic, with consultations being held in 2011, 2015 and 2016, in addition to a public hearing. The result of this work was consolidated, between 2018 and 2019, in three proposals for RDCs and a Normative Instruction.   

The first RDC deals with toxicological information for labels and leaflets of agrochemicals, similar chemicals and wood preservatives. The second is focused on the criteria for evaluation, classification, prioritization of analysis and comparison of toxicological action. The third RDC provides for criteria for assessing dietary risk arising from human exposure to agrochemical residues. Finally, there is an IN that establishes and publicizes the list of components not authorized for use in agricultural pesticides.  

The rules also provide for the use of alternative methods to animal testing, with the removal of redundant animal testing requirements considered scientifically unnecessary for regulatory decision-making, among other measures.  

GHS  

Anvisa clarifies that the GHS defines the classification for product labeling purposes according to the outcome of death, analyzed in acute toxicological studies. The proposal is to follow this globally harmonized classification system and establish scientific criteria to compare toxicity (toxic action) between products based on mortality.  

The GHS was launched in 1992, during Eco-92, held in Brazil, and the harmonization of the classification and labeling of chemical products is one of the six programmatic areas endorsed by the General Assembly of the United Nations (UN) to strengthen international efforts relating to the environmentally safe management of chemicals. 

According to 2017 data from the Stockholm Environment Institute (Stockholm Environment Institute – SEI), currently 53 countries adopt GHS standards and 12 have partially implemented them, as is the case with Brazil, Australia and Mexico. In the Brazilian case, GHS rules are already applied to the use of chemical products and Ministry of Labor safety standards.  

Registration and reclassification   

It is important to highlight that the processes involving the registration and monitoring of agrochemicals in Brazil are carried out in a tripartite manner. Anvisa evaluates issues related to human health; the Ministry of Agriculture, Livestock and Supply (Mapa) takes care of agronomic issues and is responsible for registering products for agricultural use; and the Brazilian Institute of the Environment and Renewable Natural Resources (Ibama) is responsible for environmental issues.  

With the publication of the new regulatory framework, Anvisa will reclassify the agrochemicals that are already on the market. To this end, the body has already published a notice requesting information, which must be responded to by registration holders. Of the 2.300 agricultural pesticides registered in Brazil, Anvisa has already received data for reclassification of approximately 1.950 (85%) products.