Brazilian Pesticide Regulation Overview

Brazil’s current pesticide legislative framework was established under Law 7802 (Pesticide Law), which regulates the research, experimentation, production, packaging, labeling, transportation, storage, marketing, commercial-advertising, utilization, import, export, waste and package disposal, registration, classification, control of pesticide, components and similar products. Entities involved in the pesticide industry or service of pesticide application are mandatorily required to comply with a spectrum of obligations under this law, including:

Pesticide Registration-Enterprise involved in the production, importation, exportation, marketing and utilization of pesticides or similar products should register with the federal authorities of health, agriculture and environment. Activities associated with research and development, experimentation of pesticide and similar product should obtain the temporary special registration (RET);
Component Registration-The inert ingredient, additive for the production of pesticide and specific raw material for the synthesis of technical material should obtain the component registration by including into the SIC ( Component Information System);
Establishment Registration-The physical or legal entities of production, importation, exportation, marketing or providing application service of pesticide, component and similar product should obtain the establishment registration from the authorities at state level;
Recycle and Disposal-The users of pesticide, component and similar product should return the empty package or obsolete product to the designated establishment and the production and marketing entities are responsible for the disposal of the unrecyclable package and obsolete product returned from the users;
Agronomic Prescription-Marketing of pesticides requires a specific permission (known as agronomic prescription) issued by a legally authorized professional;

Implementing Regulation:
Fundamental Legislation:
Law 7802 Pesticide Law

Enacted on: 11 Jul 1989
Revised under Law 9974 on 6 Jun 2000
Decree 4074 on 4 Jan 2002
Updated by Decree 5549 of 2005
Decree 5981 of 2006
Decree 6913 of 2009
Main supporting legislation in force
MS Ordinance 3 on 1 Jan 1992
IBAMA Ordinance 84 on 15 Oct 1996
MAPA Ordinance 45 on 10 Dec 1990
MAPA IN 36 on 24 Nov 2009
MAPA/ANVISA/IBAMA INC 25 on 14 Sep 2005
MAPA/ANVISA/IBAMA INC 1 on 15 Apr 2008(INC No 2 on 15 Aug 2014)
ANVISA Resolution 4 on 18 Jan 2012
MAPA Normative Instruction on 19 on 8 Jul 2013
MAPA/ANVISA/IBAMA INC 49 on 20 Aug 2002
CTA Technical Guidance on 21 Sep 2011

Regulatory Scope

Pesticide and similar product are defined as: products or agents of chemical, physical, biological nature intended to defend and protect stored processed agricultural outputs, pastures, native or planted forests, urban and industrial environments from attack by a variety of creatures. Substances classified as pesticides also include defoliants, desiccant, growth stimulator and inhibitors. Component refers to the active ingredient, technical product (technical grade active ingredient), raw material, inert ingredient and additive used for the production of pesticide and similar products.

Regulatory Progress

large

Fig. 1 -Brazil Pesticide Legislation Timeline

After the amendment under the Law 9974, the collecting, recycling and “triple-washing” technology for empty container were covered under pesticide management. In 2002, the enactment of Decree 4074 specified more operational provisions on the involved authorities, procedures, category, data requirement, templates for pesticide registration. The Decree was revised three times and numerous supporting rules were established by the authorities under various forms, ranging from department/authority ordinance, rules, resolution (RDC), technical note and normative instruction (IN) by single authority to jointly normative instruction by multiple authorities (INC).

Authorities and Competences

Authorities from 3 federal ministries are involved in the registration management of pesticide, including the Ministry of Agriculture, Livestock and Supply (MAPA), the National Health Surveillance Agency (ANVISA) under the Ministry of Health (MS) and the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) under the Ministry of Environment (MMA). The Technical Advisory Committee of Pesticide (CTA) is made up of representatives from these ministries and there is considerable overlap in the responsibilities of these authorities during the registration process. Because of this Brazil has one of the most complex and inefficient registrations system in the world. The time required for registration can be up to 6 years. The common and exclusive competences of relevant authorities are summarized as follow:

Table 1- Competence of the Authorities Involved in Pesticide Registration

		MAPA	MS/ANVISA	MMA/IBAMA
Establishing : guidance and data requirement on pesticide registration; guidance and requirement to minimize pesticide risk; MRL and safety interval; Parameters for label and manual; Official method for the sampling and analytical determination of pesticide residue in product of animal and plant origin, in water and soil; Initiate pesticide reevaluation when Brazil is alerted by international organization of pesticide risk; Review the application for registration cancellation and impeachment; Authorized the repackaging and sub-packaging;		√	√	√
Monitoring pesticide residue in	product of plant origin	√	√
Monitoring pesticide residue in	Product of animal origin		√
Component Registration (under the guidelines jointly compiled by three ministries)		√		√
Toxicological evaluation, rating and preliminary evaluation for RET			√
Environmental impact evaluation, rating and preliminary evaluation for RET				√
Efficacy evaluation and grant registration(RET) to pesticide intended for (under the guideline and requirement established by other two ministries):		Agricultural and forestry use	Public health and water treatment use	Aquatic , native forest and other ecosystem use

Index of the Major Regulations

Code	Subject
Law 7802 on 11/07/1989	Brazil Pesticide Law (overarching legislation, amended by Law 9974 on 06/06/2000)
Decree 4074 on 04/01/2002	Implementing regulation of the Law 7802 on 07/11/1989(amended by Decree 5549 on 22/09/2005, Decree 5981 on 12/06/2006 and Decree 6913 on 23/07/2009)
Inter-ministerial Ordinance 127 31/05/2004	Internal regulation of the Technical Advisory Committee of Pesticide(CTA)
MAPA Ordinance 45 on 12/10/1990	Documents required by MAPA, minimal requirement on agronomic test, pesticide label, acceptable limits of difference in composition of formulated product and result of chemical analysis
ANVISA/MS Ordinance 3 on 16/01/1992	Directives and requirments of the MoH on the toxicological evaluation, toxicological classification and establishment of maximum residue level and labeling of pesticide.
IBAMA Ordinance 84 on 15/10/1996	Procedures and data required for the registration and evaluating the environmental hazard potential of pesticide as well as the detailed testing items required for the eco toxicological evaluation (amended by IBAMA Ordinance No. 6 17/05/2009)
IBAMA Ordinance No. 1 16/10/2009	Requirement that the physic-chemical, toxicological, eco-toxicological and other studies which support IBAMA’s pesticide evaluation should be performed in testing facilities monitored under GLP principles.
INC No. 25 on 14/09/2005	Procedures adopted by the MAPA, ANVISA and IBAMA for the preliminary assessment and obtaining the special temporary registration(RET) of technical product, pre mixture and pesticide for research and experimental purpose
INC No.3 19/08/2014	Amendment to the INC No. 25 on 14/09/2005
INC No. 49 on 20/08/2002	Procedures for the registration under equivalent technical product: required test items and criterion for the determination of equivalence
CTA document on 21/09/2011	Guidance on technical and administrative procedures for assessing the equivalence determination of technical product.
CTA document on 21/03/2007	Technical guidance on five batches study report and criterion for establishing the statement on minimal limit of active ingredient and maximal limits of impurities
INC No.1 on 15/04/2008	Toxicological and environmental relevant impurities to be studied in five batch study for the registration of technical product and their acceptable levels updated by INC No.2 on 15/08/2014
ANVISA RDC No.4 on 18/ 01/2012	Criterion for conducting residue tests for pesticide registration purpose in Brazil
IBAMA IN No.4 on 18/02/2009	Complementary administrative procedures for the environmental hazard evaluation of pesticide adopted by IBAMA
INC No.1 on 18/04/2013	Criterion and procedures for the alteration of formulation of registered pesticides and similar products.
MAPA IN No.19 on 08/07/2013	Technical and administrative procedures for licensing the importation of pesticide, component and similar product
MAPA IN No.36 on 24/11/2009	Guidelines and requirements for conducting research and experimentation, submission of registration/registration alteration regarding the report of agronomic efficacy, feasibility and phytotoxicity and field study for the residue of pesticides and similar products(Amended by IN No.15 707/07/2016)
INC No.2 27/09/2006	Condition and administrative procedures for the re-evaluation of pesticide
IBAMA IN No.17 on 29/05/2009	Administrative procedures for the environmental re-evaluation of pesticides, the components and similar products adopted by IBAMA
INC No.2 on 27/09/2006	Administrative procedures for the agronomic, toxicological or environmental re-evaluation of pesticides, their components and similar products
INC No.1 on 24/05/2011	Procedures for the registration of plant protection products approved for organic agriculture use
INC No.2 on 12/07/2013	Reference specification for plant protection products approved for organic agriculture use
INC No.1 16/06/2014	Guidelines and requirements for the registration of pesticides, their components and similar products for crops with insufficient plant health support and the permitted MRLs

Registration Management

The registration application should be filed by an indigenous entity engaged in the production, formulation, repackaging, exportation, and importation, marketing and application service of pesticide. Depending on the business stage, ingredient and registration object, the registration can be classified into product registration, special temporary registration (RET), component registration and entity registration (a.k.a. Establishment Registration)

Product Registration

Procedures of Pesticide Registration in Brazil

large

Fig. 2 -Procedures of Pesticide Registration

The applicant should simultaneously file the application and attached dossiers to the above federal authorities of agriculture, health and environmental sectors in triplicate. The registration authority will evaluate the efficacy, toxicological and environmental review made by the different authorities and conclude whether to accept registration. Pesticide reevaluation is initiated when new health/environmental risks are uncovered or when Brazil is warned of new risks by international health or environmental organizations or when a new pesticide with a better safety/efficacy profile is developed which can replace an existing pesticide. The authorities may review the dossiers under similar procedures and decide whether to maintain, alter or cancel the registration. The validity of product registration can be unlimited or canceled due to a negative result during aperiodic reevaluation, violation of government imposed enterprise sanctions or breach of operating scope. Typically, an agricultural pesticide will be subjected to the following regulatory due diligence and administrative measures:

Although the Decree 7074 defines technical products (technical material) as components, they shall be registered under product registration. Depending on the product type, novelty and acceptance authorities, the requirements differ.

Table 2-different data packages for product type (traditional chemical pesticide)

To the Authority	Document and Data	Technical Product	Equivalent Technical Product	Formulated Product	Formulated Product based on Equivalent Technical Product
Three authorities in triplicate	Contact information and identification of applicant, legal representative, manufacturer(s), formulator(s); Registration purpose, use class, mode of action, active ingredient(s), product information and packaging; evidence document that the applicant and the indigenous manufacturer/formulator have been registered, as well as the legal representative of the applicant; certificate of the physical-chemical analysis of the product; information on the registration status, use authorization, prohibition/restriction in the origin and other country; detailed description on the deactivation method of the product attached with technical report, indicating the reduction power of the component and the identification method of the remaining residue;	√	√	√	√
	Unique statement on qualitative and quantitative composition of the product, which shall be established based on the accompanied five batch analysis of each manufacturer, declaring: the maximal limit of each impurities equal or greater than 0.1%(a.k.a. significant impurity); the minimal limit of the active ingredient; the maximal limit of byproduct or relevant impurities less than 0.1% and identification and proportion of the isomers; Description on the observed effect of the relevant impurities; Description on the analytical method for the qualitative and quantitative determination of active ingredient, significant impurities and relevant impurities less than 0.1%, as well as the main degradation product of active ingredient; Description on the manufacturing process of the technical product from the manufacturer, containing: flowchart of chemical reaction and output of each step; identity and purity of the reactants, solvents and catalysts; general description on the control condition, purification step and discussion on the theoretical formation of each possible impurity; Study report of physical-chemical properties;	√	√Phase I physical-chemical properties studies(vapor pressure, melting/boiling point, solubility in water and partition coefficient)
	Referenced product for equivalent determination, indicating the registration number;		√
	Acute oral toxicity; Acute inhalation toxicity; Acute dermal toxicity; Primary skin irritation; Eye irritation; Dermal sensitization; Gene and chromosomal mutagenicity;	√	√Phase II	√	√
	Repeated dosage toxicity test(sub-acute and chronic); Teratogenicity, carcinogenicity, neurotoxicity and hormonal impact; Eco-toxicological test on the toxicity to aquatic and terrestrial organisms(fish, daphnia, algae, birds, bees, microorganisms, soil organism),according to the intended use of the product;	√	√ Phase III	Partly conditional	Partly conditional
	Statement on the qualitative and quantitative composition of the product, indicating the minimal and maximal variation and specific function of each component, accompanied with the laboratorial report of each formulator; Printed label and manual in origin country if available; Use instruction; Special recommendation and use restriction; Safety interval; Reentry interval; Specification on personal protection equipment for the application and measures for public protection; Procedures for decontaminating the package and application device; The collection, storage and disposal of package; Template of label and manual; Proof or registration protocol of its component, including the technical material;			√	√
Authority for efficacy evaluation(in one copy)	Test and information on the efficacy and practicability for the intended use;¹ Test and information concerning the compatibility with other product; Information on product resistance development; Study report on residue, safety interval and extraneous residue limit if applicable;² Analytical method and sensibility for the residue determination; Quantitative analytical result on the residue persistence in plant, animal, water ,soil and air; Information on bioaccumulation, persistence and mobility; Other required data;			√	Items 6,7,8 are exempted
ANVISA/MS (in one copy)	Study report on the physical-chemical property; Study report on residue, safety interval and extraneous residue limit if applicable;² Analytical method and sensibility for the residue determination; Quantitative analytical result on the residue persistence in plant, animal, water ,soil and air; Reentry interval of people in the treated area; Biological study involved in biochemical , acute and chronic toxicological aspects; Antidote and treatment available for intoxication in the country; Test and information concerning the compatibility with other product; Information on bioaccumulation, persistence and mobility; Other required data;			√	Items 4,9,10 are exempted
IBAMA/MMA (in one copy)	Study report on the physical-chemical property; Study report on toxicity to microorganisms, micro-crustaceans, fish ,algae, soil, organisms, birds, non-target plants and insects; Study report on toxicity to higher animal; Study report on mutagenic, teratogenic and carcinogenic potential to animal; Analytical method and sensibility for the residue determination; Test and information concerning the compatibility with other product; Other required data;			√	Item 7 is exempted

Note:

1&2: if the proposed formulated product or formulated product based on equivalent technical product has the same formulation type, dosage, targeted crop and application method with a formulated product previously registered, the efficacy study for the intended use can be exempted(phytotoxicity study is still required ). If a formulated product is identical to a registered product in formulation type, dosage, targeted crop and application method while possessing equal/less dosage during the crop cycle and equal/longer safety interval, the residue study can be exempted. The formulation type of wettable powder, suspension concentrate, emulsifiable concentrate and water granule are considered identical;
Phase I, II and III: if the proposed technical product was not determined equivalent to the designated reference technical product, phase II data will be required. If it was not possible to determine the equivalence with the data provided in phase II, phase III data will be required. If it was not possible to determine the equivalence with the data in phase III, the applicant may continue the registration by providing all requirements for technical product registration;

Special Temporary Registration

The research and experimentation of technical product, pre-mixture and formulated product should obtain the special temporary registration (RET). Pesticide with RET can be produced or imported under limited volume for the efficacy, toxicology, environment, residue and chemical studies. The agriculture product in the treated area cannot be utilized for food or feed purpose. If a pesticide contains active ingredients already registered in Brazil, the RET can be automatically granted by the registration authorities. According to the condition, area of the activity, study plan, the research and experimentation are classified in to three stages.

Table 3-Condition, validity, permitted area and volume of different stages under RET

	Phase I (Technical product and pre-mixture are framed at this stage at all times)	Phase II	Phase III
Condition	Preliminary implementation in laboratory, vegetation room, greenhouse, water box, water tank by an accredited experimentation station;	Scale-up implementation in pond, closed lake and plot by an accredited experimentation station;	Final implementation in accredited experimentation station or area of a third party by contract agreement, assignment or technical cooperation;
Valid Term	up to 3 years depending on study plan	up to 3 years depending on study plan	defined case by case depending on the study plan;
Area	up to 1000 square meter per crop or 100 square meter on water surface;	up to 5000 square meter per crop/ 1000 square meter on water surface;	defined case by case depending on the study plan;
Volume	defined case by case depending on the study plan	5 L/5kg per crop	defined case by case depending on the study plan;

Component Registration

The inert ingredient , additive and specific raw material for the synthesis of technical material can be utilized for pesticide production only if previously registered in the Component Information System(SIC). The application for component registration can be submitted prior to or simultaneously with the application for product registration. The applicant may apply multiple components in a single application and the import, production and utilizing company of a component should register the component even if the component was previously registered by other company.

Establishment Registration

Entities engaged in the production, formulation, sub-packaging, exportation, importing marketing and providing application service of pesticide should register their establishment with the competent authorities at state, federal district or municipal level. The agricultural cooperatives are considered as commercial enterprise. The establishment should be operated under the assistance of legally qualified technicians. Each establishment should be separately registered even if additional establishments are located in the same place and owned by the same enterprise. The importing, exporting, production and formulating enterprises should report the quantity of the pesticide they marketed, imported, exported, produced or formulated to the competent authorities at state level by 31 January and 31 July each year.

Industry Obligation

Labeling

The Annex VIII and Annex IX of Decree 7074 provide the mandatory material requirement, label format and layout, element and text content of pesticide label and product manual. A color band should be placed on pesticide label to communicate the product hazard to the user. The color corresponds to the toxicological rating determined under ANVISA’s guidance:

Acute Toxicity/Rating	Class I-Extremely Toxic	Class II- Highly Toxic	Class III - Moderately Toxic	Class IV - Low Toxic
Oral(mg/kg)	Liquid: LD50≤20; Solid: LD50≤5	Liquid:20<LD50 ≤200; Solid: 5＜LD50≤50	Liquid:200<LD50≤2000; Solid: 5＜LD50≤500	Liquid: LD50>2000; Solid: LD50>500
Dermal (mg/kg)	Liquid: LD≤40; Solid: LD≤10	Liquid:40<LD50 ≤400; Solid: 10<LD50≤100	Liquid:400＜LD50 ≤4000; Solid: 100＜LD50≤1000	Liquid:LD > 4000; Solid:LD > 1000
Inhalation (mg/L, 1 hour)	LC50≤0.2	0.2<LC50≤2	2＜LC50≤20	LC > 20
Eye Irritation	Causing reversible/irreversible cornea opacity within 7 days, or persistent irritation to ocular mucous membranes	Causing no cornea opacity, but reversible irritation ocular mucous membranes within 7 days	Causing no cornea opacity, and reversible irritation ocular mucous membranes within 72 hours	Causing no cornea opacity and reversible irritation ocular mucous membranes within 24 hours
Skin Irritation	Causing ulceration or corrosion	causing severe irritation or Draize Test score ≥5;	causing moderate irritation or 3≤Draize Test score＜5;	causing mild irritation: Draize Test score ＜3;

The rating of substance or formulation into the above toxicological class does not depend on all toxicological parameters in the same classification but is selected on the highest risk classification principle. Pesticides with the same composition and usage as a previously registered pesticide may not be approved if they are more toxic.

Agronomic Prescription

Brazil implements specific traceability requirements for pesticide use to maximize the safety of pesticide and to facilitate authorities in ascertaining the accountability for pesticide related health and safety incidents. Pesticide may be directly sold to terminal users only after specific permission is granted, which should be issued by legally authorized professionals. Permission is issued in two copies: one is issued to the user and the other one will be kept by the marketing establishment. Each copy contains detailed information on:

Specified pest, target and crop to be treated;
Users name, state and location;
Agronomic diagnosis;
Product name and possible alternative;
Crop and area to be treated;
Application rate and volume to be purchase;
Application method;
Time of application;
Signature, personal ID number of the issuing the professional and identification for the registration with the professional management authority;

Pesticide should be used within the recommended scope as outlined on its label and product manual, which is previously reviewed and approved during its registration. Under the criteria by the agriculture, health and environmental authorizes, low risk pesticide can be exempted from agronomic permission requirements.

Package Recycling

Pesticide empty packages are mandatorily recycled and reutilized in Brazil. Users should return the packages to the original retail enterprise or any collecting center which was accredited by the purchase establishment and licensed by the competent authority of environmental management. The registrant, production and marketing companies are required to collect and dispose the empty packages and disused pesticides gathered from the users. For imported pesticide, the importing enterprise should be responsible for the collection and disposal.

Future Prospects

According statistics from ANVISA, the number of registration application pending review is almost 6 times the number of applications evaluated. The legislative system is considered outdated and incompatible with global best practices. A proposal to replace Brazil’s Pesticide Law (Law 7802) was drafted in late 2015 and is now being considered by Brazil's Chamber of Deputies. The establishment of a new organization, the National Technical Commission of Plant Protection was proposed with the aid of providing a centralized authority to administrate the registration of new pesticide, including technical product, pesticide for plant protect and environmental control purposes. Several powers now conferred to IBAMA, ANVISA and MAPA will also be centralized to the Commission. A new system of evaluation and registration similar to that implemented in the United States and Canada is expected to be implemented in Brazil.