Field of Work
Agrochemicals
According to current legislation, available at SISLEGIS, Agrochemicals are products and agents of physical, chemical or biological agents for use in the cultivation, storage and processing of agricultural products, to change the composition of flora and fauna in order to preserve them from the harmful action of living beings.
Registration of Agrochemicals in Brazil is granted by the MAPA, the Agency that evaluate the agronomic efficacy of these products. However, during the process of registration, the consent is mandatory requirement of the ministries of Health (ANVISA) and the Environment (IBAMA) for which the product is registered.
ANVISA performs toxicological evaluation of the products, as the risk to the health of the population and establishes maximum residue limits in food as well as the tolerance period that means the time to be observed between the last pesticide application and harvest.
IBAMA performs the evaluation of the potential environmental hazard of agrochemicals, their components and related, taking into account the risks and impacts that offer these substances to the environment.
The AGROFIT is a database for public consultation on pests, active ingredients, formulated products, reports, and components registered formulas the Ministry of Agriculture, with information from the Ministries of Health and Environment.
In Brazil, the technical product registration can follow the principle of equivalence, following the criteria of FAO.
• Herbicides;
• Insecticides;
• Fungicides;
• Adjuvants;
• Atipical Products
• Biological and microbiological Products;
• Pheromones;
• State Registration of agrochemicals.
Our work includes:
• Development and follow-up of the product registration at the municipal, state and federal levels;
• Determination of necessary analyses, hiring of laboratories, follow-up of laboratory analyses, bibliography research, elaboration of the registration process, protocol and follow-up at the official regulatory bodies in charge of granting registration until the latter is granted;
• Expert and technical advice in the environmental, toxicological, pharmaceutical, agronomic, biological, regulatory and quality control areas.
• Toxicological Risk Evaluation.
• Planning and conduct of developmental studies or programs to comply with specific registration requirements and legislation.
• Deeply evaluation of all dossier studies including: 5-batch report, physical-chemical studies, toxicological studies, ecotoxicological studies.
• State registration that legalizes the products to be commercialized in all states of Brazil.
** Equivalence Registration process in Brazil:
Regulatory Affairs
In Brazil the various products are registered in accordance with the allocation of use of it. PROREGISTROS helps your company in the direction to be given to your product according to the allocation and use of relevant legislation.
Direct contact with the Brazilian authorities responsible for the registration and registration of products in different areas.
• Development and follow-up of the product registration at the municipal, state and federal levels;
• Determination of necessary analyses, hiring of laboratories, follow-up of laboratory analyses, bibliography research, elaboration of the registration process, protocol and follow-up at the official regulatory bodies in charge of granting registration until the latter is granted;
• Expert and technical advice in the environmental, toxicological, pharmaceutical, agronomic, biological, regulatory and quality control areas.
• Toxicological Risk Evaluation.
• Planning and conduct of developmental studies or programs to comply with specific registration requirements and legislation.
• Deeply evaluation of all dossier studies including: 5-batch report, physical-chemical studies, toxicological studies, ecotoxicological studies.
• State registration that legalizes the products to be commercialized in all states of Brazil.
Hosting of Processes
For product registration in Brazil it is mandatory that the registrant company is perfectly entitled to all Regulatory Agencies in accordance with the allocation of product use. This license includes entries from ANVISA, IBAMA, Ministry of Agriculture (MAPA), Secretaries of Agriculture, Health and Environment, Regional Councils and other Class Regulatory Agencies.
PROREGISTROS is enabled with these Agencies and can act as a registrant of your product until your company can be perfectly qualified to register your product. This way you can immediately start registering your product while your business is established and obtains all necessary records to import products in Brazil.
PROREGISTROS can keep this register while it is in the interest of your company, being transferred to the company of your choice when prompted.
Household Products
proregistros work on registration and notification of household products with ANVISA.
The household products must be proven efficacy and safety before the registration, ensuring its quality.
The RDC 59/2010 sets forth the procedures and technical requirements for reporting and record household products.
The notification and registration of household products are made taking into account the assessment and management of risk, purpose, category and must meet specific regulations.
The household products are classified according to risk, purpose, sales and use.
Household products:
• For general cleaning and related products (detergent, softener, ...);
• Microbicides (disinfecting, deodorizing, ...);
• Biological (degreasers, ...);
• Disinfestants (insecticides, herbicides, rodenticides, fungicides ...).
Fertilizers/Inoculants
proregistros works with the Ministry of Agriculture (MAPA) in fertilizers and related record.
Fertilizers, biofertilizers inoculants are basic inputs that employees correctly, increase agricultural production.
The Ministry of Agriculture oversees the production and trade of fertilizers, correctives and inoculants, as provided in Law No. 6894 of December 16, 1980, regulated by Decree No. 4954 of 14 January 2004. Establishments that produce, import, export and market inputs must be registered with the Ministry of Agriculture (MAPA), as well as products manufactured or imported.
Veterinary Products
PROREGISTROS works with the Ministry of Agriculture (MAPA) assisting in the registration of veterinary products defined as any chemical, biological, biotechnological, or preparation manufactured, whose management is applied individually or collectively, directly or mixed with food intended for prevention, diagnosis, cure or treatment of animal diseases, including additives, supplies, promoters, enhancers animal production, antiseptics, disinfectants or use environmental equipment, pesticides and all products used on animals and / or their habitat, protect, restore or modify their physiological and bodily functions. Comprise up, yet, this definition are products intended for animal beautification.
Veterinary Products:
• Feed and food supplements;
• Improvers animal production;
• Antiseptics and disinfectants;
• Products beautification animal;
• Pesticides;
• Vaccines;
• Veterinary drugs.
The Legal procedures for Registration of veterinary products can be verified at MAPA site.