Argentina Overhauls Rules for Cosmetics and Hygiene Products

Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued Disposición 7939/2025, introducing a major reform to the authorisation process for cosmetic, personal care and hygiene product manufacturers.

Published in the Boletín Oficial de la República Argentina on 23 October 2025, the measure replaces the previous lengthy approval procedures with a digital sworn declaration system (Declaración Jurada), which confirms compliance with sanitary and manufacturing standards.

Simplified Authorisation

The new system applies to manufacturers or importers of

• Cosmetics and perfumes
• Personal hygiene products
• Oral hygiene items for dental use External disposable and intravaginal hygienic products
• Household cleaning goods (domisanitarios), except those considered high-risk

Companies will be authorised to operate once their sworn declaration is filed online, with ANMAT assigning a registration number. The declaration has no expiry date, but remains subject to inspection and compliance checks.

Updated Good Manufacturing Practices Rules

The reform introduces updated Good Manufacturing Practices (GMP) for disposable and intravaginal hygiene products, published as Annex II to the decree. The standards set out detailed requirements for infrastructure, hygiene, staff training, and record-keeping, covering every stage of production and storage. Manufacturers must ensure facilities are designed to minimise contamination, maintain strict environmental controls, and train staff in hygiene and safety protocols. Each product batch must undergo testing for microbiological safety, irritation, sensitisation and, where applicable, cytotoxicity.

Packaging must preserve product quality and include labelling in Spanish in line with national health rules. Claims of special product properties must be supported by scientific evidence. Companies outsourcing manufacturing processes must also formalise contracts detailing responsibilities and quality obligations, with both parties remaining subject to inspection.

Accountability and Oversight

While the new framework shifts Argentina towards self-declaration and digital compliance, ANMAT retains full authority to carry out audits and impose sanctions. Any false or incomplete declaration may result in suspension, fines, or legal penalties under Argentina’s public health laws. Existing companies must re-register under the new system within 180 business days, though they can continue using current packaging materials for up to three years. Activities involving higher-risk household chemical products will remain regulated under previous legislation.

Regulatory Renewal

The new framework repeals several older resolutions dating back to 1999, consolidating fragmented provisions into a single regulation.

Industry associations, including the Chamber of the Argentine Cosmetics and Perfume Industry (CAPA) and the Industrial Association of Personal and Household Care Products (ALPHA), were officially notified of the change.

ANMAT said the overhaul forms part of a broader government drive to modernise the public sector and align national standards with international best practice. The new regulation takes effect 60 working days after publication. For further details please consult the Decree here (in Spanish).