Proven Experience
With extensive experience in the Chilean market, we have successfully developed and delivered food supplements that comply with the stringent regulations set forth by the Institute of Public Health (Instituto de Salud Pública, ISP) under the Ministry of Health. Our expertise encompasses every stage, from formulation to delivery, ensuring adherence to the Chilean Food Code (Reglamento Sanitario de los Alimentos, RSA), particularly Title XXIX, which governs dietary supplements and foods for athletes.
Definition of Food Supplements
In Chile, food supplements, known as “suplementos alimentarios,” are products formulated to supplement the diet for healthy purposes, contributing to the maintenance or protection of physiological states such as adolescence, adulthood, or old age. These products may contain nutrients like vitamins, minerals, amino acids, lipids, dietary fiber, or other components naturally present in food. They are typically presented in forms such as powders, liquids, granules, tablets, or capsules.
Registration Process.
Before marketing food supplements in Chile, obtaining an Authorization for Use and Disposal is mandatory. This authorization is issued by the Regional Ministerial Secretariat of Health (Secretaría Regional Ministerial de Salud, SEREMI) in the region where the products are imported.
Required Documentation
For imported products, the following documents must be submitted to SEREMI:
Customs Certificate (Certificado de destinación aduanera para alimentos).
Indicates the authorized warehouse and conditions for product transfer. The cost varies based on product volume, and its validity is indefinite.
Copy of the Sanitary Resolution.
Authorization of the warehouse where the products will be stored.
Health Certificate from the Country of Origin.
Valid for each import item or a certificate of free sale of products.
Technical Sheet.
Issued by the manufacturer in Spanish, required for products imported for the first time or with a formulation change compared to previously imported products.
Label or Draft Label.
Must comply with Chilean labeling regulations.
The authorization process typically takes about 15 working days, and the cost depends on the product’s volume. For example, fees for imports weighing between 1 and 500 kg are approximately 30,100 CLP (around 35 USD).
Labeling Requirements
Specific labeling requirements for food supplements include:
- Product Designation: Must be labeled as “suplemento alimentario” (food supplement).
- Warnings: Advisories concerning children, pregnant, and breastfeeding women.
- Usage Instructions: Method of use and the daily recommended dose.
- Nutritional Information: A full nutrition table must be provided, and all rules on nutritional declarations apply.
Additionally, since 2016, foods high in energy, salt, sugar, or saturated fat are required to display octagonal warning signs corresponding to the respective nutrient or energy value. Only foods intentionally high in energy and carbohydrates are exempted; those high in salt or saturated fat must carry the sign.
Compliance and Enforcement
Chile’s regulatory framework ensures that food supplements meet safety, quality, and labeling standards. Compliance with the RSA and guidelines issued by the ISP is mandatory for all food products, including dietary supplements.
We’re Certified.
Our company holds all necessary certifications, including BRC and NSF GMP, ensuring that our manufacturing processes meet the highest quality standards.
Multi-language Labelling
To enhance product appeal in Chile’s diverse market, we offer assistance in creating labels in Spanish, ensuring compliance with regional language requirements.