Your Guide to Cosmetic Regulations in Costa Rica

Category: Health

Costa Rica's cosmetics market offers lucrative opportunities for international brands due to the growing demand for personal care products. However, companies looking to enter this market must navigate the country's regulatory framework to ensure their products are safe and compliant. Cosmetics regulations in Costa Rica are primarily enforced by the Ministry of Health (Ministerio de Salud), which oversees product registration, labeling, safety, and post-market surveillance. This blog provides a detailed overview of Costa Rica's most important cosmetics regulations and introduces the essential steps for compliance. Regulatory Authorities and Key Laws In Costa Rica, the Ministry of Health is responsible for regulating cosmetics to ensure they meet safety and quality standards. The main law governing cosmetics is Presidential Decree No. 34482-S, which sets out the requirements for the importation, production, registration and distribution of cosmetics. This decree emphasizes consumer safety and mandates that only approved products can enter the Costa Rican market. Product Registration Process Mandatory Registration: All cosmetic products, whether produced locally or imported, must be registered with the Ministry of Health before being placed on the market. The registration process ensures that the product meets Costa Rican safety standards, including ingredient safety, proper labeling and packaging requirements. Application: To register a product, companies must submit a detailed application to the Ministry of Health that includes: Product information Ingredient list (according to the International Cosmetic Ingredients Guideline) Example product label (including statements, warnings and manufacturer information) Safety and efficacy data Good Manufacturing Practice (GMP) certification or equivalent documentation Evaluation and Approval: Once the application is submitted, the Ministry of Health evaluates the document and may request additional information or clarification. If the product meets the required standards, a Certificate of Registration is issued. This certificate is valid for five years and is renewable. Labeling Requirements Cosmetics in Costa Rica must meet certain labeling standards to ensure transparency and consumer protection. The label must include: Product name and description Full ingredient list (using the International Nomenclature of Cosmetic Ingredients, INCI) Net weight/volume Manufacturer's name and address Country of origin Instructions for use and warnings (if applicable) Batch number and expiration date Label information must be in Spanish, but bilingual labels are permitted as long as they include Spanish. Safety and Ingredient Regulations Costa Rica follows international cosmetic safety guidelines, including adherence to ingredient lists from recognized authorities such as the European Union and the U.S. Food and Drug Administration (FDA). The Ministry of Health prohibits the use of harmful substances and certain ingredients are restricted or banned. Manufacturers must ensure that their products are free of banned ingredients and that all banned substances are used in permitted concentrations. Conclusion For companies looking to enter this growing market, it is important to understand Costa Rica's cosmetic regulations. Adhering to legal standards is crucial to successfully market your cosmetics in Costa Rica. Working with Freyr's experts will ensure your brand's launch goes smoothly. Our experts will guide you through the registration process and keep you up to date on local requirements. Contact us today to learn how we can help streamline legal compliance in Costa Rica.