Decree modernizes inspection of plant-based products and consolidates agricultural and livestock regulations

On October 31, 2025, Decree No. 12,709 was published, unifying the regulation of plant-based products considering numerous sectoral laws, including Law No. 14,515/2022, which established self-control as the central axis of agricultural and livestock defense. The decree represents a regulatory advancement by consolidating regulations and aligning Brazil with international standards.

The primary details of the new decree are summarized as follows:

Identity, quality, and self-control standards

The decree establishes the technical criteria to ensure compliance of plant-based products, including:

• Regular sensory perception, quality, and quantity of components;
• Absence of harmful substances, contaminants, and deterioration;
• Compliance with microbiological and physicochemical limits;
• Implementation of good manufacturing practices and appropriate technological processes; and
• Conservation and presentation aligned with safe consumption.

Product quality and identity standards will be established in further normative acts and, in the absence of such standards, the Codex Alimentarius may be used as a reference.

The decree outlines the primary criteria for developing and implementing self-control programs, which must be implemented to monitor, verify, and correct the stages of both the production and distribution processes for plant-based products. The aspects considered will cover the assessment of physical, chemical, and biological risks, the control of suppliers and inputs, the compliance of facilities and equipment, hygiene procedures and fraud prevention, as well as proper management of transportation and logistics.

Those agents involved in primary agricultural and livestock production, as well as family farming, can voluntarily participate in these programs through private production protocols.

Compliance Incentive Program in Agricultural and Livestock Defense

Decree No. 12,709 establishes the Compliance Incentive Program in Agricultural and Livestock Defense as one of the pillars of the self-control system. The program offers benefits and incentives to facilities that voluntarily join the initiative, such as the opportunity to correct any irregularities before enforcement and exemption from penalties in cases of sanitary non-compliance, provided that the corrective measures outlined in the notice are implemented within the timeframe defined by the inspecting authority.

The main purpose of the program is to encourage preventive regularization, promoting an environment of cooperation between the production sector and the Ministry of Agriculture and Livestock (“MAPA”). The key objective is to provide transparency, stimulate the improvement of quality assurance systems, and optimize the flow of administrative processes, whose decisions must be made on the principles of risk analysis and risk-based management.

To remain in the program, agents must keep operational and quality data up-to-date, in compliance with regulatory specifications, and achieve the minimum performance established in a complementary act. Failure to comply with these obligations may result in a warning, suspension, or exclusion from the program.

Traceability and recall

Decree No. 12,709 established that all agents in the plant-based production chain, including producers, distributors, traders, and importers, must implement traceability mechanisms for each product batch, supported by systematized and auditable records that enable identification of the origin and monitoring of the handling process across the entire chain. Additionally, the data must remain available for inspection for 18 months after the product’s expiration date or shipment.

The decree establishes rules for the recall, which must occur if any deficiency or non-compliance is identified, posing a risk to consumer health, plant health, or animal health – in which case the person responsible for the product or the importer must, at their own expense, arrange for immediate withdrawal from the market. This obligation includes halting commercialization, segregating the corresponding batch, and implementing the corrective measures established, which may be taken at the agent’s initiative, by order of the inspection authority, or by administrative decision. MAPA must also publish a risk alert with information on the recall and the measures to be taken by the agents involved .

Finally, the decree defines violations and severe penalties for non-compliance with these obligations. Failing to keep auditable records for traceability constitutes a serious violation, whereas failing to carry out or incompletely carrying out the mandatory recall is considered a severe violation. Additionally, failure to execute a recall may result in an increase of up to 20% in the maximum level applicable within the relevant range.

Inspection and inspecting agents

The inspection system is based on risk and applies to all stages of production, processing, industrialization, transportation, commercialization, and export, including e-commerce. Within this context, ports, airports, borders, and other locations where products, documents, or systems involving the regulated activity are situated are encompassed.

During inspections, the competent authority may record images, audio, and video of products, facilities, equipment, and individuals involved for documentation purposes of any irregularities, while respecting the confidentiality of the information. Inspection may be carried out using a simplified procedure if non-compliance can be resolved immediately, as provided for in a complementary regulation.

The execution of inspection activities is the responsibility of agricultural and livestock tax auditors at the federal level. However, authorized technical staff can provide support. Auditors are responsible for the following actions: issuing notices and summonses, applying precautionary measures, auditing self-control programs and certification bodies, inspecting national and foreign establishments, and issuing health certificates, among others.

MAPA can also use technical, operational, and laboratory support from accredited companies for its inspections. The inspecting authority will have free access to the information and the places of business and may request police assistance if necessary. However, commercial confidentiality and data protection requirements must be observed.

In addition, Decree No. 12,709 provides for the creation of the Brazilian System for the Inspection of Plant-Based Products (“SISBI-POV”), aiming to ensure the identity, quality, compliance, integrity, as well as hygienic-sanitary and technological safety of plant-based products produced, manufactured, or commercialized across the national territory.

SISBI-POV will be implemented in line with the national agricultural policy, by the Federal Government, state and municipal governments, the Federal District, and public consortia – on a voluntary adherence basis – with the implementation of equivalent inspection systems.

Assisted by federal agricultural and livestock inspectors from the Department for the Inspection of Plant-based Products, MAPA is exclusively responsible for coordinating SISBI-POV and carrying out the following activities:

• Compliance and maintenance audits of inspection services for plant-based products to SISBI-POV;
• Facility and product registration;
• Management of agents’ self-control oversight;
• Inspection and certification of import and export of plant-based products;
• Management of the Compliance Incentive Program in Agricultural and Livestock Defense;
• Performance of other activities required to address risks to agricultural and livestock defense.

Violations and penalties

The violations outlined in Decree No. 12,709 can arise from irregular practices by the numerous agents involved in the production, commercialization, import, or export of plant-based products, including those conducted on e-commerce platforms, digital platforms, or social networks.

According to the regulation, minor violations involve irregular conduct that does not directly compromise the safety, harmlessness, or compliance of plant-based products. Some examples of minor violations include failure to submit mandatory documents, the use of non-compliant packaging, unreported changes to the industrial plant, and failures to document classification services.

Moderate, serious, or severe violations relate to conduct that poses increased regulatory, operational, or health risks. Examples of conduct that fall into this group include: omission of information by custodians; execution of activities with expired registrations; operation of facilities in disagreement with current regulations; improper use of labels and packaging; unauthorized change of the composition of registered products; absence or non-implementation of mandatory self-control programs; commercialization of products with contaminants above the permitted limits; product fraud; obstruction of inspection; and non-compliance with imposed penalties.

Agents who engage in any of the violations provided for in Decree No. 12,709 will be subject to the following penalties: warning; fine; product condemnation; suspension of registration, enrollment, or certification; revocation of registration, enrollment, or certification; and revocation of the professional license involving agricultural and livestock defense services.

However, minor violations whose irregularities are corrected before citation will not result in the issuance of a violation notice, as provided for in Law No. 14,515/2022.

Fines for violations of Decree No. 12,709 may range from BRL100.00 to BRL 150,000.00 and may be increased by 10% for each subsequent violation.

Additionally, the penalties of suspension of registration, enrollment, or certification, or the penalty of revocation of registration, enrollment, or certification may be converted into a fine, upon presentation of a request by the offender to enter into a Conduct Adjustment Agreement (“TAC”). If approved by MAPA, the agreement will serve as an extrajudicial enforcement order.

Sanction grading will be defined considering the risk associated with the violation committed by the agent, their background, and the mitigating or aggravating circumstances, thus ensuring proportional and effective accountability of the agents involved. 

Transition rules

Decree No. 12,709 came into force on the date of its publication and will take effect immediately, except in relation to:

• the guidelines for identifying facility and product registration records and the mandatory labeling description in online product offers, which will come into force 90 days after the publication of the decree, but still require complementary regulation; and
• the adjustments to the registration information of beverages whose designation has changed, which will come into force 730 days after the publication of the decree.

According to MAPA, any omissions or doubts that arise in relation to the new rules and requirements established in Decree No. 12,709/2025 will be resolved by the Department for the Inspection of Plant-Based Products.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.