Food and Dietary Supplements Registration Chile

In Chile, food supplements registration and dietary supplements registration are overseen by the Institute of Public Health (Instituto de Salud Pública, ISP). The ISP is responsible for evaluating and approving products to ensure they meet Chile Food Supplement Safety and quality standards before they can be marketed and sold in Chile.

Several key regulations govern the registration process for food and dietary supplements in Chile:

• Food Health Regulations (Chile Food Health Regulations, Reglamento Sanitario de los Alimentos): These regulations set standards for food safety, labeling, and marketing practices in Chile. Compliance with these standards is mandatory for all food products, including dietary supplements.
• Supplementary Food Regulations Chile (Reglamento de Alimentos Complementarios): This regulation provides guidelines for the registration and control of dietary supplements and health foods in Chile, outlining requirements and procedures for product registration, labeling, and quality control.
• ISP Resolutions: The ISP issues specific resolutions and guidelines related to food and dietary supplements. These resolutions supplement existing regulations and provide further clarification on specific requirements and procedures for Chile dietary supplement compliance.

Understanding product classifications is essential for determining the regulatory pathway for Chile food product approval:

• Food Products: General consumables, including food items and beverages, must comply with the Chile Food Health Regulations and meet safety and labeling requirements.
• Dietary Supplements: Dietary supplements, including vitamins, minerals, and herbal products, are classified separately under the Supplementary Food Regulations Chile. These products must meet specific requirements for composition, labeling, and health claims. ISP dietary supplement approval is mandatory before marketing and distribution.

Compliance with labeling requirements is critical for Chile dietary supplement labeling and Chile Food Supplement market entry:

• Mandatory Information: Labels for food and dietary supplements must include essential information such as product name, ingredients list, nutritional information, net content, manufacturer details, and expiration date.
• Health Claims: Any health or nutritional claims made on product labels must be supported by scientific evidence and approved by ISP to avoid misleading consumers.
• Language: Labels must be in Spanish and comply with ISP’s labeling standards for legibility and clarity.

Navigating Chile's regulatory requirements presents several challenges:

• Complex Regulatory Framework: Understanding and complying with the diverse set of regulations from ISP can be complex and time-consuming.
• Documentation Requirements: Preparation and submission of extensive documentation, including product formulation, safety assessments, and labeling materials, can be resource-intensive.
• Labeling Compliance: Ensuring labels meet ISP Food Registration requirements for content, format, and health claims requires meticulous attention to detail.
• Market Access Delays: Delays in the registration process can impact product launch timelines and market entry strategies, affecting business profitability and competitiveness.