An updated pesticide registration regulation was announced by the president of the republic of Brazil!

Law No. 14785, announced by Brazilian President Luiz Inácio Lula da Silva, established a comprehensive framework for the study, manufacturing, and use of pesticides and allied products, with the aim of streamlining and modernizing pesticide management. The repeal of Laws 7,802 and 9,974 by this comprehensive law represents a change in the regulatory environment for Brazil.

The new law addresses every stage of the pesticide lifecycle, from initial production and research to the ultimate disposal. Regulations pertaining to usage, labeling, packaging, storage, marketing, and transportation are made clearer. It also establishes regulations for these items exports, imports, and environmental restrictions.

The following deadlines, beginning from the time of submission, must be met for the completion of registration requests and their modifications:

1. New product - formulated: 24 months
2. New product - technical: 24 months
3. Formulated product: 12 months
4. Generic product, equivalent technical product, atypical product, pre-mix: 12 months
5. Identically formulated product: 60 days
6. Product for organic agriculture: 12 months
7. Product based on biological control agent: 12 months

To grant registrations for new products, as well as modifications in uses that involve an increase in dosage, inclusion of culture, application equipment, or in situations of reanalysis, risk analysis will be performed.

Efficiency and practicability studies for ‘formulated products’ and ‘products created based on an equivalent technical product’ shall not be required for items that, when compared to existing registered formulated products, have the characteristics like same type of formulation and same indications for use (cultures and dose) and methods of use already registered.

Pesticides, technical products, and similar items are registered with the federal body in charge of the agriculture sector, and environmental control products, technical products, and similar items are registered with the federal body in charge of the environment sector.

Unsafe products: Pesticide registration is prohibited if they pose an unacceptable risk to humans or the environment, even if risk management measures are implemented in accordance with the GHS, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), and the Codex Alimentarius.

Exempt from registration: Pesticides, environmental control products, and the like intended only for export will be excluded from registration with the registering authority, which will be replaced by an export production statement.

‘’ALL ABOUT REGISTRATION’’

1. Once registration for the pesticide, environmental control product, or similar product has been issued, the registration holder will have up to 2 (two) years to begin production and commercialization of the product, or the granted registration will be revoked.
2. Once registered, the registration holder must notify the registering authority of the start of manufacture and sale of the registered products.
3. If the product registration is revoked in line with the provisions of this article, the holder will be allowed to obtain a fresh registration after one (one) year.

Key Highlights of new law:

• New Law No. 14785 replaces outdated legislation for pesticide management.
• Covers research, production, use, and disposal of pesticides and related products.
• Creates new deadlines for pesticide registration.
• Introduces an "acceptable risk" category for previously banned substances.
• Sparked debate over potential risks and benefits.

Institutions that conduct operations covered by this law as of the law's publication date are required to adjust to its requirements within 360 days. This Law comes into force on the date of its publication December 27, 2023.

For more information, please reach out to?[email protected]?or?[email protected]

Visit to -?www.auxilife.com

Auxilife Scientific Services Pvt. Ltd. (a unit of GPC) Global Product Compliance (GPC)

Disclaimer: ''The information presented in this article is based on public data and reports collected from various authorities. We do not claim direct involvement in the events described."

#agochemical #pesticide #chemical #animalsafety #mrl #plantprotection #plantprotectionproduct #regulatorycompliance #regulatoryaffairs #goodagriculturalpractices #residue #field #guidance #guideline #updates #brazil #anvisa #mapa #ibama #efficacy #newlaw #new #regulation #January2024 #2024 #riskassessment #riskanalysis #import #export #regulatory