Agrochemicals: Remedy or Poison?

There is still a lot of controversy regarding the safety and risks of pesticides. That is why it is important to ensure their quality and know how to use them.

There is still a lot of controversy regarding the safety and risks of pesticides. That is why it is important to ensure their quality and know how to use them.

Some have doubts about whether pesticides are drugs or poisons since they are strong substances used in food products.

In fact, everything will depend on the dose used! If the farmer uses too much pesticide in his plantation, the product will do harm and could harm the final consumer, who will have contact with residues in the food. However, if you do not use agrochemicals, you will be very likely to have a low total use of your crop and with shallow quality.

This means that agrochemicals are important for good crop yields, as they fight pests and avoid crop losses, but they need to be used to the right extent.

Just like water, which can do badly if ingested in excess, but which in the right amount brings more benefits than harm to the body, chemicals work in the same way. If the recommendations for use and the interval of safety on the label and package leaflet are followed, there will be no major concerns.

In an analogy with antibiotics, pesticides can save a crop from a pest infestation, just as the antibiotic can aid in the treatment of an infection. Both are controlled and require attention in their use.

That is why Bracci & Avila, a specialist in product registration, is concerned with the use of pesticides and enables the registration of these products, guaranteeing their quality and effectiveness in the plantations.

Why Outsource Product Registration Projects?

By outsourcing product registration projects, you facilitate your work and ensure the resolution of all points required by regulatory agencies.

Many companies question whether they should outsource their registration projects. It happens that a single professional with the capacity to handle the whole subject, due to his training, sometimes dominates only one aspect of the registry, failing to address other points required by MAPA, ANVISA, IBAMA.

This is common, considering that each professional is dedicated to their area, knows a lot about their product, but does not have enough time to manage all the bureaucratic issues that involve it. Hardly a regulatory department has professionals trained in law, agronomy, toxicology, pharmacy, veterinary and chemistry, in addition to all the analysis expertise of thousands of records.

For this reason, we recommend outsourcing product registration projects and provide trained professionals in different areas, facilitating this work and offering greater security for your company.

The importance of registration in Brazilian agriculture

Agricultural products need to be registered for safety in their use. To do so, we facilitate the work of your company, carrying out the entire process with the public agencies.

The registration of agricultural product results in safety for the use of the products in the crops for the indicated crop and pest, as well as tranquility for the applicators, provided that the Individual Protection Equipment provided in the label is used.

Due to the complexity and costs involved in registering an agricultural product, ranging from laboratory testing to field testing, it is rare to find companies that do not take the issue seriously, not least because current legislation is very strict.

Registration implies the certainty that there was a prior assessment of human health and applicators, soil contamination and water, as well as the agronomic effectiveness of the product.

In this way, registration is the guarantee and security for its quiet use, with the certainty that someone has invested a lot of time and resources for the product to reach the market.

Bracci & Avila specializes in product registration and enables your company to obtain all these benefits in a practical and fast way without worrying about bureaucratic issues.

What is the difference between raw material, active ingredient, technical product and product formulated?

To understand the difference between raw material, an active ingredient, technical product and product formulated from guidelines governed by law, according to decree 4.074 / 02.

To understand the difference between raw material, an active ingredient, technical product and formulated product, it is important to consider what Decree 4.074 / 02 says, in Art. 1:

XXIV – raw material – a substance, product or organism used to obtain an active ingredient, or a product containing it, by chemical, physical or biological process;

XVII – active ingredient or active ingredient – chemical, physical or biological agent that gives effect to pesticides and the like;

XXXVII – technical product – product obtained directly from raw materials by chemical, physical or biological process, intended to obtain formulated products or premixes and whose composition contains defined content of active ingredient and impurities, and may contain stabilizers and related products, such as isomers;

XXXV – formulated product – agro-toxic or related product obtained from technical product or premixture, by means of a physical process, or directly from raw materials by means of physical, chemical or biological processes;

Thus, we exemplify:

The raw material can be the substance found in nature that, after going through a chemical, physical or biological process, becomes an active ingredient.

The technical product (PT) has the active ingredient plus other components, aimed at improving the product.

The formulated product (PF), which is marketed to farmers, is the Technical Product with some more ingredients. Always the PF has the lower concentration than the PT.

In short, these are steps in the process of obtaining the final product.

Transfer of agricultural registration by incorporation, merger or cison

Although the adjuvant contributes to the improvement of the application of the pesticide, how not to combat and control the pests, many do not consider it as a pesticide, in fact.

It is currently argued whether the adjuvant or adhesive spreader, which facilitates the dispersion and improves the application of the pesticide, can be classified as an agricultural defensive.

Initially, it should be noted that Article 1, II of Decree 4.074 / 02 provides the adjuvant as: “product used in mixture with products formulated to improve its application”. However, because it does not offer effective pest control and control, many do not consider it as a pesticide.

Such controversy was the subject of the CTA – Technical Committee for the Advising of Agrochemicals (an organ that gathers IBAMA, MAPA, and ANVISA) but has not yet reached a conclusion. There was a previous manifestation defending the maintenance of the registry for adjuvant, since its composition can alter the functioning of the pesticide, before the mixture that is made.

On 03/29/2017, there were some rejections of the adjuvant registration request under the claim “without registration provision in Law 7.809 / 89”.

The CTA through Act 104/2017 does not require registration of adjuvants if there is no proven agronomic effectiveness.

What is an atypical product?

Atypical products are based on copper, sulfur, adhesive spreader and oils and are exempt from having technical product registration

Atypical products are those that do not fall into the ordinary process of registration and may dispense with the registration of technical product (see what is a technical product in this article).
Thus, the IBAMA STANDARD NORMATIVE No. 84, OF OCTOBER 15, 1996, determines as atypical products those based on copper, sulfur, adhesive spreader and oils.

What is the difference between manufacturer and formulator of pesticide?

What differs from the manufacturer of the agrochemical formulator is that the former produces components, i.e. the technical product, and the latter manufactures the pesticide itself.

The difference between manufacturer and agrochemical formulator is provided in Decree 4.074 / 02, as in Art. 1, subsection XII and XIV:
XII – manufacturer – natural or legal person authorized to produce components;
XIV – formulator – natural or legal person qualified to produce agrochemicals and related products;
In short, the manufacturer is the industry that produces the technical product, since the formulator is the industry that produces the pesticide. It may be the same industry or formulator to purchase the technical product from another company, provided that it is previously authorized in the Product Registration Certificate issued by MAPA.

The PPA Maintenance Rate (IBAMA) must be paid?

The environmental hazard potential maintenance fee must be paid at the time of application for product registration and annually.

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 with the Ministry of Agriculture, Livestock and Supply – MAPA – depend on this classification to obtain their respective records.

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 NO. 812, OF SEPTEMBER 29, 2015, published in the Official Gazette of the Union on 09/30/2015, pages. 17, 18 and 19.

In order to obtain such a classification of environmental hazard potential, it is an indispensable requirement to pay a fee, instituted by Law 9,960, dated January 28, 2000 (provided for in Annex VII, item III, subitem 4.3 and 4.4).

Under this Law, not only the classification of environmental hazard potential is subject to fee payment, but also the simple maintenance of hazardous environmental hazard classification depends on payment of the fee.

In other words, when the taxpayer requires the registration of his product, he must pay the fee for the provision of the public agency’s service to classify the environmental hazard potential of the same.

And, once this classification has been granted for the required product, under the terms of Law 9.960 / 2000, the taxpayer must also pay an annual periodicity fee to maintain the environmental hazard classification already granted.

That is, the initial fee payment is made for a classification of the product and, after the registration is granted, it is subject to the annual payment for the maintenance of such classification granted.

Let’s see what the Art has. 77 of the CTN:

“The fees charged by the Union, the States, the Federal District or the Municipalities, within the scope of their respective attributions, have as a generator the regular exercise of police power or the actual or potential use of a specific and divisible public service, provided to the taxpayer or made available to him. “(emphasis added)

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. Maintaining a classification resulting from an analysis that has already been completed does not lead to a new service provided to the taxpayer and, therefore, some claim that it does not result in a new levy.

This fact, once there are doubts about the characterization of the provision of services in the institution of the rate of maintenance of environmental hazard potential, we proceed to analyze the other possible generating fact, namely: police power.

In accordance with art. 78 of the National Tax Code:

“Public police activity is the activity of the public administration which, by limiting or disciplining law, interest or freedom, regulates the practice of deed or de facto absolution, in the public interest concerning safety, hygiene, order, customs, the discipline of production and the market, the exercise of economic activities dependent on the concession or authorization of the Public Power, public tranquility or respect for property and individual or collective rights.

In other words, it is the police power of the body of organs and activities charged 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 decided by the legality of the collection of the maintenance fee of the PPA, made its mandatory payment.

Registration of agrochemical product canceled by amendment of formula

When there is a change in the product formula without prior authorization, the pesticide registration is canceled. However, it is possible to appeal with the assistance of Bracci & Avila.

Article 22 of Decree 4.074 / 02 is expressed in stating that the registration of pesticide product will be canceled if an unauthorized change occurs. The cancellation occurs after a survey of the registering agency in the company.

Art. 22. The registration of agrochemicals, its components and the like will be canceled whenever it is verified modification by federal agencies of the agriculture, health and environment sectors in terms of formula, dose, manufacturing conditions, indication of application and specifications stated in the label and package leaflet, or other modifications not in accordance with the registration granted.

It is offered time to manifest itself by presenting the pertinent defense, assuring the right of the ample defense and contradictory as foreseen in the Article 5, paragraph LV of the Federal Constitution as foreseen in the Art. 2 of Law 9,784 / 99.

The cancellation occurs with the publication in the Official Gazette of the Union – DOU through an act. After the cancellation is still possible to present the defense with the objective of keeping the record suspended until the alleged change is regularized.

If you have had your registration canceled based on Art. 22 of Decree 4.074 / 02, consult us to have an adequate defense with a greater probability of success.
transfer of agricultural registration by incorporation, merger or cison
Bracci & Avila assists in the transfer of ownership of the product registration, dealing with the change and obtaining the necessary licenses.

In a globalized world, more and more companies have adopted more commercial strategies aimed at their permanence in the market. Among these strategies, there is the incorporation, when one company buys the other; the merger, when two companies become one, joining efforts for a common goal; and the split, when a company divides and forms another company.
It happens that whenever the registration of the agrochemical product is in the name of one company and needs to pass to another, we call transfer of ownership, as provided in the Art. 22 § 1 of Decree 4.074 / 02.

However, prior to filing for title transfer, we must change or obtain other licenses for the company that takes over the registration.

TRANSFER OF AGRICULTURAL REGISTRATION BY INCORPORATION, MERGER OR CISON

In a globalized world, more and more companies have adopted more commercial strategies aimed at their permanence in the market.

Among these strategies, there is the incorporation, when one company buys the other; the merger, when two companies become one, joining efforts for a common goal; and the split, when a company divides and forms another company.

It happens that whenever the registration of the agrochemical product is in the name of one company and needs to pass to another, we call transfer of ownership, as provided in the Art. 22 § 1 of Decree 4.074 / 02.

However, prior to filing for title transfer, we must change or obtain other licenses for the company that takes over the registration.

Thus, it is necessary to change the license of operation before the city, environmental license, be registered at INPEV (National Institute for Processing Empty Packages) and obtain the State Register of the Establishment allowing the manufacturer/commercialization of pesticide.

Please contact us for more details on the subject.