ANMAT Provision 7939/2025 represents one of the most substantial regulatory updates for Argentina’s cosmetics, personal care, and household hygiene sectors. The new framework modernizes the process for authorizing establishments engaged in manufacturing, packaging, fractioning, conditioning, and importing these products. It removes outdated requirements and replaces them with a more agile system based on digital tools and strengthened responsibility for manufacturers and importers. The goal is to enhance administrative efficiency, reduce unnecessary delays, and reinforce oversight through documentary verification and post-market inspections.
At the core of the reform is the digital Sworn Statement, which acts as an immediate national authorization from the moment it is filed. Unlike the previous system, there is no prior approval stage and no expiration date: the authorization remains valid as long as the information remains accurate, updated, and backed internally by documentation demonstrating regulatory compliance. ANMAT retains authority to request information and conduct inspections at any time, ensuring robust oversight without hindering operational agility.
A sworn-statement-based system with ongoing responsibilities
The Sworn Statement requires establishments to maintain documentation supporting their facilities, processes, authorized activities, and compliance with Good Manufacturing Practices. Any significant modification—such as changes in corporate name, legal address, CUIT/CUIL, activities, additional plants, or Technical Direction—must be reported within 30 days through a new statement. This ensures transparency, up-to-date records, and continuous accountability for the accuracy of the information provided.
Companies already authorized must submit the new Sworn Statement within 180 business days from the regulation’s entry into force. Packaging printed with previous authorization data may continue to be used for up to three years, allowing a cost-efficient and orderly transition into the updated regulatory framework, which standardizes requirements and creates consistent traceability across the sector.
A more modern and efficient regulatory landscape
Provision 7939/2025 updates existing Good Manufacturing Practices and introduces new standards for disposable external-use and intravaginal hygiene products. Establishments remain subject to periodic inspections and must keep documentation available for review. The reform reduces bureaucracy, accelerates processes, digitizes regulatory procedures, and gives industry greater predictability while preserving ANMAT’s strong supervisory and enforcement capacity. The result is a more flexible framework aligned with the pace of innovation, yet rigorous enough to ensure product safety and consumer protection.
