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Pesticides and crop protection products in Brazil: who registers, statutory review deadlines and generic and equivalence routes

Last verified: 2026-10-27 · Status: Stable

Brazil's 2023 pesticides law makes the Ministry of Agriculture the registering body for agricultural pesticides, with the health and environment authorities assessing toxicological and environmental risk, and products with unacceptable risk banned. It sets maximum review times running from 24 months for new active ingredients down to 12 months for generics and equivalents, 60 days for identical products and 30 days for research permits. For an agribusiness or chemicals investor the registration route and timeline drive time to market.

Key facts

Maximum review time for a new active ingredient product	24 monthsLei nº 14.785 art. 3 § 1 I and II, as of 2026-10-27 · in force
Maximum review time for a generic product	12 monthsLei nº 14.785 art. 3 § 1 IV, as of 2026-10-27 · in force
Maximum review time for an identical formulated product	60 daysLei nº 14.785 art. 3 § 1 V, as of 2026-10-27 · in force
Maximum review time for a special temporary research registration	30 daysLei nº 14.785 art. 3 § 1 VIII, as of 2026-10-27 · in force

The rule

1. Pesticides, environmental control products, technical products and related products may be researched, produced, exported, imported, sold and used only if previously authorized or registered with the federal body.Lei nº 14.785 (pesticides law), Art. 3 caput, 2023-12-27 official text · verified 2026-10-27

2. The federal agriculture body registers pesticides and their technical products; the federal environment body registers environmental control products. The health authority sets toxicology dossier requirements and approves the toxicological risk assessment; the environment authority sets ecotoxicology requirements and approves the environmental risk assessment. Registration requirements follow the GHS, the WTO SPS Agreement and Codex Alimentarius, and products with unacceptable risk cannot be registered.Lei nº 14.785, Arts. 4 caput and §§ 1 to 3, 5 IV, 6 III and IV, and 7 II and III, 2023-12-27 official text · verified 2026-10-27

3. Registration applications and changes must be concluded within, from submission: 24 months for new formulated and new technical products; 12 months for formulated, generic, equivalent technical, atypical, organic farming, biological control and pre mix products; 60 days for identical formulated products; 30 days for the special temporary registration for research and for listed sets of changes; and 180 days for other changes.
Cost to do it: Registration fees and studies are set in regulation; the law fixes only review times.Lei nº 14.785, Art. 3 § 1 I to XIII, 2023-12-27 official text · verified 2026-10-27

4. A special temporary registration (RET) covers new products for research and experimentation, decided within 30 days, with audits after issue. Public and private teaching, technical assistance and research entities may run trials and issue reports.Lei nº 14.785, Art. 3 §§ 2 to 5, 2023-12-27 official text · verified 2026-10-27

5. Where no maximum residue limits exist in the health authority's active ingredient monographs, the limits of FAO or Codex Alimentarius, or from studies by laboratories supervised by an official monitoring authority of an OECD member, apply. When international bodies Brazil belongs to warn against a product, the authority must start a risk re analysis weighing economic and phytosanitary aspects and substitutes.Lei nº 14.785, Art. 3 §§ 6, 7 and 9, 2023-12-27 official text · verified 2026-10-27

6. An identical product, with the same qualitative and quantitative composition and the same manufacturers as one already registered, is registered within 60 days using the existing data, by the same holder or authorized third parties.Lei nº 14.785, Art. 15, 2023-12-27 official text · verified 2026-10-27

7. Applicants must answer requests for complementary information within 30 days, or the application is archived and rejected unless a technical justification is accepted. Companies must report changes to their bylaws or contracts to the registering and inspecting bodies within 30 days of registration.Lei nº 14.785, Arts. 12 § 5 and 23, 2023-12-27 official text · verified 2026-10-27

Application	Deadline
New product, formulated or technical	24 months
Formulated, generic, equivalent technical, atypical, organic, biological, pre mix	12 months
Identical formulated product	60 days
Special temporary registration (research)	30 days
Set of changes under art. 26	30 days
Other changes	180 days

Maximum review times from submission (Lei nº 14.785 art. 3 § 1).

Worked example

A foreign crop protection company planning a Brazilian launch: a biological control product can be filed on a 12 month review clock, a generic of an off patent molecule also 12 months, while a new active ingredient faces up to 24 months (Lei nº 14.785 art. 3 § 1). Trials can start sooner under a special temporary registration decided within 30 days (art. 3 § 4).

Step by step

1. Classify the product: new, generic, equivalent, identical, biological, organic or pre mix.
2. Prepare the agronomic, toxicology and ecotoxicology dossiers to the health and environment authority requirements.
3. File with the Ministry of Agriculture and track the statutory review clock.
4. Answer every information request within 30 days to avoid archiving.
5. Report corporate changes within 30 days and plan label updates after approved changes.

Common traps

Missing a 30 day information request deadline archives the application.
Risk based review does not override the ban on products with unacceptable risk (art. 4 § 3).
International alerts can trigger a re analysis of an approved product (art. 3 § 9).

Sources

Lei nº 14.785 (pesticides law), Congress normas.leg.br

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