Argentina Overhauls Rules for Cosmetics and Hygiene Products

Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has unveiled sweeping reforms to how cosmetic, personal care and hygiene product manufacturers are authorised. Under Disposición 7939/2025, published in the Boletín Oficial de la República Argentina on the 23rd of October 2025, companies will no longer need to undergo lengthy approval procedures to begin operations. Instead, they will be able to register through a digital sworn declaration system (Declaración Jurada), which confirms compliance with sanitary and manufacturing standards.

Simplified Authorisation

The new system applies to companies producing or importing cosmetics, perfumes, personal hygiene products, oral hygiene items for dental use, external disposable hygienic products, intravaginal hygienic products, and household cleaning goods (domisanitarios), except those considered high-risk.

Firms 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 inspections and compliance checks.

New Good Manufacturing 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 measure also repeals several earlier resolutions dating back to 1999, unifying rules that had become fragmented across multiple decrees. 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, you can consult the Decree here (in Spanish).