The Government of Paraguay, through the Ministry of Public Health and Social Welfare, has issued Decree No. 2942, which establishes regulations for personal hygiene, cosmetic, and perfume products. This decree replaces Decree No. 3636/2020 and aligns national legislation with international health and safety standards.

Background and Legal Framework

Decree No. 2942 is enacted under Article 39 of Law No. 1119/1997 on health products and Article 5 of Law No. 6788/2021, as amended by Law No. 7361/2024. These laws mandate the National Directorate of Health Surveillance (DINAVISA) to regulate, inspect, and ensure the quality and safety of health-related products, including cosmetics and hygiene items.

Key Provisions of the Decree

1. Regulatory Authority and Oversight

DINAVISA is designated as the primary regulatory body responsible for enforcing compliance with hygiene and cosmetic product regulations. The agency has the power to:

• Oversee registration, licensing, and monitoring of manufacturers, importers, and distributors.

• Implement sanitary control measures to ensure product safety.

• Enforce penalties for non-compliance.

2. National Registry for Hygiene and Cosmetic Products

The decree mandates the continuation of the National Registry of Hygiene, Cosmetic, and Perfume Products, which records all authorized products. This database will be publicly accessible, ensuring transparency and regulatory oversight.

3. Product Classification and Registration Requirements

Products are classified into two categories:

• Grade 1: Basic hygiene and cosmetic products with minimal safety concerns, requiring a simplified notification process (Notificación Sanitaria Obligatoria - NSO).

• Grade 2: Products with specific safety and efficacy requirements, requiring a more stringent sanitary registration process.

Both categories must comply with Good Manufacturing Practices (GMP) and submit safety documentation to obtain regulatory approval.

4. Prohibited and Restricted Substances

The decree strictly regulates ingredients in hygiene and cosmetic products. It prohibits:

• Substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) according to International Agency for Research on Cancer (IARC) standards.

• Ingredients banned under the EU Regulation No. 1223/2009 and MERCOSUR regulations.

5. Labeling and Packaging Regulations

DINAVISA will establish guidelines for labeling, packaging, and advertising, ensuring that product information is clear, accurate, and does not mislead consumers.

6. Inspection, Market Surveillance, and Penalties

To maintain quality control, DINAVISA is empowered to:

• Conduct random inspections and collect product samples for testing.

• Revoke or suspend registrations if safety risks are identified.

• Impose sanctions and penalties for regulatory violations.

Implications for Businesses

Manufacturers, importers, and distributors operating in Paraguay’s hygiene and cosmetics sector must comply with the new regulations by:

• Ensuring product registration with DINAVISA.

• Adhering to approved formulations and safety standards.

• Complying with labeling and marketing regulations.

Implementation and Enforcement

Decree No. 2942 will take effect on the 2nd of January 2025. Businesses must align their operations with the new requirements to avoid penalties and ensure continued market access.

This regulatory update reinforces Paraguay’s commitment to consumer safety and international regulatory harmonization, ensuring that hygiene and cosmetic products sold in the country meet high-quality standards. For more details, Decree 2942 can be found here (in Spanish)