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Argentina Incorporates Mercosur Resolution No. 48/2010 into National Cosmetic Framework

On March 27, 2026, Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) issued Order No. 1612/2026, formally incorporating Mercosur/GMC/Resolution No. 48/2010 into the national legal framework. Even though this is a formal step in regional alignment, it does not alter the current technical requirements for products sold in Argentina.1

Under Mercosur/GMC/Resolution No. 48/2010, substances including lead acetate, pyrogallol, formaldehyde, and paraformaldehyde are subject to the mechanism set out in Article 8 of Mercosur/GMC/Resolution No. 51/2008. Pursuant to this provision, where Member States have not reached a consensus on the use or prohibition of certain substances, each country retains the authority to regulate their use at the national level, in accordance with its own established conditions.

At the national level, Argentina had previously established specific use conditions for these substances under existing regulations. The newly issued Order No. 1612/2026 primarily serves as a formal administrative alignment with regional requirements, and does not introduce substantive changes to Argentina's existing technical restrictions.

The following table summarizes the current use conditions and regulatory references for these substances in Argentina:

Substance

Use Conditions

Regulatory Reference

Lead acetate

Prohibited for use in cosmetic products

Order No. 5572/2005

Pyrogallol

Prohibited for use in cosmetic products

Order No. 1112/1999

Formaldehyde

Restricted for use in nail hardeners up to 5% (as formaldehyde). Mandatory labelling includes directions to protect cuticles with grease or oil, and—if the concentration is higher than 0.05%—the statement "Contains formaldehyde".

Order No. 7529/2013

Formaldehyde and paraformaldehyde

Restricted for use as a preservative in oral hygiene products up to 0.1%, and in other categories up to 0.2% (as free formaldehyde), excluding aerosols. The statement "Contains formaldehyde" is mandatory whenever the concentration exceeds 0.05%.


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