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Perguntas Frequentes

Frequently asked questions about product registration and company regulation

It is needed:
  1. Identify the active ingredient in ANVISA's monograph list.
  2. Obtain the Temporary Special Register (RET) for testing with the product.
  3. To enter with a lawsuit filed in the Ministry of Agriculture, Livestock, and Supply (MAPA) to analyze the agronomic effectiveness. The process is also analyzed by the National Sanitary Surveillance Agency (ANVISA) and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA). ANVISA issues the Toxicological Assessment Report (IAT), assuring the use of the product from the human point of view. On the other hand, IBAMA issues the certificate of Environmental Hazard Potential (PPA), concerned with water and soil pollution. Subsequently, the certificate of registration is issued by MAPA, aiming at commercialization or manufacturing.
  4. Perform the state registration in the federal units where it is intended to sell.
  5. Submit by January 31 and July the semi-annual reports to the MAPA, through the AGROFIT and IBAMA system, with the corresponding system, and to ANVISA, by e-mail, in a spreadsheet in Excel format.
  6. Pay annually IBAMA's environmental control and inspection fees (TCFA) and maintenance fees (PPA).
  7. Ensure that the company has all the current qualifications (environmental license, technical responsible, state registration, AVCB, among others).
It depends on the type of lawsuit, but normal processes can take up to 6 years after the protocol. There are faster processes that take 3 years, such as registration by equivalence.
Usually takes up to 4 months to be analyzed and deferred, if all relevant documents are presented and there are no requirements.
When one company buys the other (merger), two companies become one (merger), or when one company splits and forms another (spin-off), it may happen that it needs to pass the registration of one agrochemical product to another (transfer of ownership, provided for in Article 22 § 1 of Decree 4.074 / 02). To do so, it is necessary to change the license of operation before the city, obtain an environmental license, be registered with INPEV (National Institute for Processing Empty Packages) and obtain the State Register of the Establishment allowing the manufacturer/commercialization of pesticide.
If you have had your registration canceled based on Art. 22 of Decree 4.074 / 02, Bracci & Avila can help you have an adequate defense with a greater probability of success. The legislation considers the registration of the pesticide product to be canceled if an unauthorized change occurs, after an inspection by the registering agency in the company. The cancellation occurs with the publication in the Official Gazette (DOU) through an act. However, after the cancellation, there is still the possibility of presenting a defense, in order to keep the record suspended until the alleged alteration is regularized. It is offered a period to present the pertinent defense, assuring the right of the ample defense and contradictory provided for in Article 5, paragraph LV of the Federal Constitution and Article 2 of Law 9,784 / 99.
It depends on the type of license, but normally the licenses must be renewed before expiration so that they are already deferred upon expiration of the renewal. The deadlines are usually 30 to 180 days before the expiration of the license and can be filed until the last day of validity for most cases.
It depends on the type of record, the tests to be conducted, the quantities of pests and aborted crops, but the values can be from R$ 20,000.00 to R $ 500,000.00 and may exceed the complexity.
Yes. IBAMA's PPA maintenance fee must be paid annually, at the request of the interested party. The amount is in accordance with the class, ranging from R $ 8,669.38 to R $ 20,225.75 under the terms of INTERMINISTERIAL PORTFOLIO No. 812, OF SEPTEMBER 29, 2015, published in the Official Gazette of the Union on 09/30/2015, pages. 17, 18 and 19. The classification of the potential of environmental hazard is an activity of competence of the Ministry of the Environment, through the Brazilian Institute of Renewable Natural Resources - IBAMA. Products subject to registration in the Ministry of Agriculture, Livestock, and Supply - MAPA depends on this classification to obtain their respective records. And in order to obtain this classification, as well as its annual maintenance, it is indispensable to pay fees established by Law 9.960, dated 01/28/2000 (set forth in Annex VII, item III, subitems 4.3 and 4.4.
[[pb] A taxa oriunda da classificação do potencial de periculosidade ambiental é devida em face de uma prestação de serviço por parte do IBAMA, inquestionavelmente. No entanto, havia dúvidas quanto a taxa para MANUTENÇÃO de classificação do Potencial de Periculosidade Ambiental, pois não se caracteriza como uma nova prestação de serviço ao contribuinte. Sendo assim, passa-se a analisar o outro possível fato gerador, a saber: o poder de polícia. De acordo com o art. 78 do Código Tributário Nacional, poder de polícia é o conjunto de órgãos e atividades incumbidos de fiscalizar, controlar e deter as atividades individuais que se revelem contrárias à higiene, à saúde, à moralidade, ao sossego, ao conforto público e, porque não, até mesmo à ética urbana. Não se vislumbra, portanto, o poder de polícia como fato gerador da instituição da taxa de manutenção de potencial de periculosidade ambiental por parte do IBAMA, motivo pelo qual a cobrança em questão esteja mais vinculada ao conceito de imposto, uma vez que este tem por fato gerador uma situação independente de qualquer atividade estatal específica, relativa ao contribuinte, nos termos do art. 16 do Código Tributário Nacional. Não obstante, a Advocacia Geral da União (AGU), defendendo os interesses do IBAMA, obteve um posicionamento favorável na ação judicial que correu sobre o assunto, o qual decidiu-se pela legalidade da cobrança da taxa de manutenção do PPA, fazendo seu pagamento obrigatório.A taxa oriunda da classificação do potencial de periculosidade ambiental é devida em face de uma prestação de serviço por parte do IBAMA, inquestionavelmente. No entanto, havia dúvidas quanto a taxa para MANUTENÇÃO de classificação do Potencial de Periculosidade Ambiental, pois não se caracteriza como uma nova prestação de serviço ao contribuinte. Sendo assim, passa-se a analisar o outro possível fato gerador, a saber: o poder de polícia. The rate derived from the classification of the potential for environmental hazard is due to a service rendering by IBAMA, unquestionably. However, there were doubts as to the rate for MAINTENANCE of classification of the Environmental Hazard Potential, since it is not characterized as a new service provider to the taxpayer. Thus, we proceed to analyze the other possible generating event, namely: police power. According to art. 78 of the National Tax Code, police power is the set of bodies and activities tasked with supervising, controlling and stopping individual activities that are contrary to hygiene, health, morality, quiet, public comfort and, even to urban ethics. Therefore, it is not possible to envisage police power as a triggering factor for the institution of IBAMA's rate of maintenance of environmental hazard potential, which is why the charge in question is more closely linked to the concept of tax, since it event generating a situation independent of any specific state activity, relative to the taxpayer, under the terms of art. 16 of the National Tax Code. Nevertheless, the General Law of the Union (AGU), defending the interests of IBAMA, obtained a favorable position in the legal action that went on the matter, which was decided by the legality of the collection of the maintenance fee of the PPA, making its payment required.
It depends on the product, concentration, application and the purpose of the product to be controlled. Not every product that contains controlled product is controlled by the Army, Civil, and Federal Police. Some solvents, products for swimming pool, cleaning, among others, have in their formulation controlled products, but are not controlled, and can be purchased directly by the consumer.