Argentina Updates Cosmetic Regulation: ANMAT Incorporates MERCOSUR Standards

The Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) has taken a significant step toward updating national cosmetic regulations by incorporating the latest MERCOSUR standards into its legal framework. The move is formalized in Disposición 8067/2024, published on September 6, 2024, in the Official Gazette of Argentina, marking a crucial alignment with regional regulatory norms.

This regulatory update follows the approval of Resolution GMC No. 18/23, which establishes a new technical regulation for the classification of personal hygiene products, cosmetics, and perfumes within the MERCOSUR region. This resolution replaces the previous Resolution GMC No. 07/05, which had been in force since its incorporation into Argentine law in 2006 via ANMAT’s Disposición No. 345/2006. As a result of the new update, Disposición No. 345/06 has been officially revoked.

The new regulation provides an updated classification system for personal hygiene products, cosmetics, and perfumes, ensuring they meet current safety and efficacy standards. This aims to harmonize regulations across the MERCOSUR region, enhancing trade and compliance.

Under the Ouro Preto Protocol, the new MERCOSUR rule will take effect simultaneously in all member states. The regulation will enter into force 30 days after MERCOSUR’s Secretariat confirms that all member states have incorporated it into their respective legal systems.

The ANMAT has involved its Directorate for Monitoring Health Products, Directorate of Institutional Relations, and Directorate of Legal Affairs in the process. The relevant sectoral board and international relations programs will also be notified, ensuring that stakeholders are fully informed about the upcoming changes.

The new classification framework is expected to offer clearer guidelines for manufacturers and distributors in Argentina and throughout the MERCOSUR region. To this extent, Argentina positions itself in closer alignment with international standards, fostering smoother international trade and protecting consumers more effectively.

The full details of Resolution GMC No. 18/23 and its annexes are available on: Resolution GMC No. 18/23

This update highlights ANMAT’s commitment to maintaining rigorous standards in the health, safety, and efficacy of products in the marketplace while facilitating regional cooperation under MERCOSUR agreements. The cosmetics and personal care sectors can now look forward to improved regulatory clarity and market access across Argentina and its neighboring countries.