Decree No. 12,709/2025: Where to Start? A Practical Guide to Compliance for Vegetable Products

Choose where to start:

1. Phase 1: Understanding and Strategic Planning 
2. Phase 2: Internal Diagnosis and Risk Assessment 
3. Phase 3: Plan Structuring and Effective Action 
4. Phase 4: Monitoring and Continuous Improvement (Post-June 1, 2026)
5. Neogen: A trustable Ally

The arrival of Decree No. 12,709, of October 31, 2025, marks a new era for companies operating with vegetable products. More than just a new obligation, this regulation from the Ministry of Agriculture and Livestock (MAPA) is a call for modernization and excellence.

With effect from June 1, 2026, preparation must begin now. To ensure a smooth transition and transform compliance into a strategic differential, your company needs a structured plan. This guide suggests the essential steps to start this journey.

Phase 1: Understanding and Strategic Planning

This initial step is crucial for understanding the scope of the decree and your company's position in the new regulatory landscape. If your company deals with any of these products or derivatives, the decree is applicable.

1. Identify Your Products: Does the Decree Apply to You?  The first step is to verify if your company deals with vegetable products covered by the regulation. The decree details a wide range of categories; correct identification is vital:
• Vegetable Product (VP): Broad category that includes everything "obtained directly or indirectly from any part of the plant," whether in natura or processed (Art. 4º, I).
• Vegetable in natura: Products with minimal processing that does not alter their essential characteristics (cleaning, washing, drying, refrigeration, freezing) (Art. 4º, IV).
• Vegetable Raw Material: Vegetable products used as input for others (Art. 4º, III).
• Processed Vegetable Product:Resulting from processes that "essentially alter" the characteristics of in natura vegetables (Art. 4º, V).
• Beverages: Broad category covering:
  • Fermented Beverages: Obtained by alcoholic fermentation of vegetable musts (Art. 4º, II, "a").
  • Non-Fermented Beverages That have not undergone fermentation (Art. 4º, II, "c").
  • Non-Alcoholic Beverages: Without ethyl alcohol (Art. 4º, II, "c").
  • Mixed Beverages: Mixture of fermented/non-fermented beverages with non-alcoholic ones, in natura vegetables, or processed vegetables (Art. 4º, II, "d").
• Other Notable Products: Include Semiprepared Vegetable Product (Art. 4º, VII), Bagasse/Pomace (Art. 4º, VIII), Vegetable By-product (Art. 4º, XII), Grain/Seed (Art. 4º, XI), Whole grain/seed raw material (Art. 4º, XIII), Compound Product (Art. 4º, IX), Concentrated Product (Art. 4º, X), Additives (Art. 5º, VIII), Processing Aid (Art. 5º, IX), Sugars/Sweeteners (Art. 5º, X), and Packaging (Art. 5º, XI).
• Fermented beverages and grape and wine derivatives: Specifically detailed, covering wines, ciders, meads, spirits, vinegars, grape juices, among others (Art. 182, §1º).
2. Form Your Multidisciplinary Strategic Team: Create a compliance committee with representatives from management, quality (technical leader), production, R&D, legal, and other relevant areas. This team will interpret the decree, map impacts, and coordinate the implementation of changes.
3. Delve into the Decree and Monitor Complementary Acts: Thoroughly study each article and annex of Decree No. 12,709, focusing on product definitions. Actively monitor MAPA's complementary normative acts, as they will detail crucial operational requirements.
4. Map Your Processes and Inventory Your Internal Products: Develop a detailed flowchart of your operations, from raw material to distribution. List all vegetable products, categorizing them according to the new definitions to ensure correct application of the norms.

Phase 2: Internal Diagnosis and Risk Assessment

With knowledge of the decree and its applicability, conduct a critical analysis of your operations.

1. Conduct a Gap Analysis: Compare your current practices and documentation with the decree's requirements. Identify areas of compliance and, more importantly, where gaps exist in procedures, records, or infrastructure.
2. Assess and Prioritize Risks According to MAPA's New Philosophy: The decree is based on risk assessment and management (Art. 22). Implement a methodology for each product and process step, considering:
   • Inherent Risk (Art. 22, Subsection I): Product characteristics.
   • Operational Risk (Art. 22, Subsection II): Risks associated with your processes.
   • Compliance Risk (Art. 22, Subsection III): Your history of adherence to norms.
   • Economic Fraud Risk (Art. 22, Subsection IV): Product's susceptibility to adulteration. This assessment will prioritize your actions, focusing where the impact (on health, reputation, finances) and the probability of non-compliances (especially Economic Fraud or Food Safety Risks) are highest, defining your "most critical foods."

Phase 3: Plan Structuring and Effective Action

With the diagnosis complete, plan and execute the changes. This phase culminates on the eve of the decree's effective date, June 1, 2026.

1. Develop a Detailed Action Plan: For each gap and risk, create a robust plan with goals, specific actions, responsibilities, deadlines, and resources. Define KPIs to monitor progress in implementing each mandatory control.
2. Structure or Revise Your Self-Control Program (P.A.): This is the heart of compliance and a mandatory control (Art. 20). The P.A. must be a robust and documented management system, covering: o Product Safety Policy: Formal commitment from top management. o Integrated Management System: Including GMP, GAP, HACCP, pest control, hygiene, traceability (Art. 24, II, "c"), monitoring, verification, and corrective actions. o Supplier Management: Rigorous qualification and auditing, especially for "Vegetable Raw Materials."
3. Review and Adapt Facilities and Equipment: Verify and adapt your infrastructure and equipment to hygiene and processing requirements for various products, preventing non-compliances related to contaminants.
4. Invest Heavily in Comprehensive Training and Capacity Building: Train all staff on the new decree, the importance of self-control, new SOPs, and their responsibilities in mandatory controls. Focus on most critical foods and economic fraud prevention.
5. Adapt Labeling and Communication: Review all product labeling (Art. 34), ensuring clarity, completeness, and truthfulness of information, preventing non-compliances due to misleading information.
6. Strengthen Non-Compliance Management: Create an agile system to identify, investigate, and apply effective corrective and preventive actions (CAPAs) for any type of non-compliance, from deterioration to economic fraud. Establish communication protocols with MAPA for notification or recall (Art. 51 and 52).
7. Ensure Analytical Capacity (Laboratory) for Compliance Verification: Prepare for inspection (Art. 148). Your internal laboratory or external partners must be capable of performing the required analyses (Art. 149): physical, physicochemical, microbiological, microscopy, molecular biology, and others. Prepare for counter-analysis (Art. 150) and for "simplified procedures" of inspection (Art. 151).

Phase 4: Monitoring and Continuous Improvement (Post-June 1, 2026)

Compliance is an ongoing commitment.

1. Implement a Robust Audit and Review Cycle: Conduct periodic internal audits and management reviews to ensure the effectiveness of your P.A. and adherence to the decree.
2. Actively Monitor Legislation: Maintain constant vigilance over new MAPA publications to proactively update procedures.
3. Conduct Simulations and Exercises: Test the readiness of your procedures and team with recall simulations or other crisis situations.
4. Cultivate a Food Safety Culture: Foster an environment where compliance and engagement are essential values, evaluated and encouraged.
5. Transparent Relationship with Inspection Authorities: Maintain organized documentation and be prepared for inspections, demonstrating the company's compliance.

This guide outlines the main topics of the Decree and suggests a starting point. It is crucial to emphasize that this material is an initial guide and does not replace a critical and detailed analysis of Decree No. 12,709/2025 by your legal and technical team. Preparation is vital, and proactivity will be your greatest ally to thrive in this new regulatory scenario.

To access the full content, visit: DECRETO Nº 12.709, DE 31 DE OUTUBRO DE 2025 - DECRETO Nº 12.709, DE 31 DE OUTUBRO DE 2025 - DOU - Imprensa Nacional

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