Food Supplement Regulations & Compliance Requirements in Chile

In Chile, health supplements are controlled as food or nutritional supplements. They come under food product regulations under the country’s Reglamento Sanitario de los Alimentos (RSA). Companies, prior to market entry, need to make sure that the classification of the product, ingredients, claims, and labeling are in accordance with Chilean requirements to prevent import delays or product changes.

This document provides an overview of the regulatory scenario, product labeling requirements, import controls, timelines, costs, and compliance requirements for these products in Chile.

Regulatory Authority for Food Supplements in Chile

The Food Sanitary Regulation (RSA) regulates food supplements in Chile. Other governing bodies include the following:

• MINSAL/Ministry of Health (Ministerio de Salud) – lays out the rules.
• SEREMI de Salud/Regional Ministerial Secretariat of Health (Secretaría Regional Ministerial de Salud) – Responsible for imports, inspections, and compliance.
• ISP/Public Health Institute (Instituto de Salud Pública de Chile) – Reviews products for medical classification or for pharmaceutical ingredients or therapeutic claims.

What Are Food Supplements Under Chilean Regulations?

Chile’s RSA uses the term “suplementos alimentarios.” Dietary supplements are products specially prepared to supplement the diet for health-related purposes and to help maintain or protect physiological states. Their composition may consist of a nutrient, a mixture of nutrients, or other components naturally present in foods. They may include vitamins, minerals, amino acids, fatty acids, fiber, or other approved nutrients. Their form can be capsules, tablets, dragees, granules, liquids, powders, or other conventional dosage forms.

Chilean Regulatory Framework for Food Supplements

Reglamento Sanitario de los Alimentos (Decreto 977/1996) provides the principal rules for dietary supplements. Articles 534-538 cover information about them and are as follows:

The Ministry of Health also issued Resolución Exenta No. 394/2002 (Exempt Resolution). It provides nutritional guidelines and minimum/maximum levels for vitamins and minerals used in food supplements. Its latest version was amended by Resolución 1225/2005.

Compliance Checklist for Food Supplement in Chile

When planning to market a food supplement in Chile, be sure to do the following:

• The product is a health supplement as per the RSA.
• Ingredients and levels are according to local requirements.
• Labels comply with Spanish Language requirements.
• Claims meet permitted nutrition claims and/or function claims.
• The manufacturing site is GMP (or equivalent) certified.
• Import documents are required and are available.
• Local importer is appointed.

Food Supplements Import Process in Chile

For imported food supplements, the regulatory pathway is centered on compliance with the RSA. They require a Chilean importer/responsible party to obtain a Certificate of Destination (CDA). With an authorization for use and disposal from the relevant SEREMI de Salud, companies must ensure compliance with applicable food-labelling, composition, and claims rules.

The US Department of Commerce’s current Chile nutritional-supplements guidance similarly states that Chilean importers, not the US company, are responsible for obtaining authorization to import the goods from the SEREMI of the province where the goods enter. It also identifies a Certificate of Free Sale among the documents the importer provides for US-origin supplements.

Let’s understand this step-by-step process in detail:

Step 1: Verify Product Classification

The product should be correctly classified as a food supplement and not a pharmaceutical product. Do so by reviewing the nutrient composition, formula, dosage form, its purpose, dietary ingredients, recommended use, claims, and labeling. Do not assume that a product sold as a “dietary supplement” in the United States or another market will automatically be classified identically in Chile.

Step 2: Review Ingredients & Nutrient Levels

Article 535 requires dietary ingredients to comply with applicable identity and purity specifications. Article 538 establishes that minimum and maximum levels for vitamins, minerals, and other components are set through Ministry of Health rules.

Resolución Exenta 394/2002 provides the specified minimum and maximum daily levels for various vitamins and minerals used as dietary ingredients in supplements. It also states that vitamins and minerals without defined permitted limits cannot be added to supplements.

Step 3: Prepare for Chilean Food Supplement Labeling Regulations

The supplement label must comply with the RSA requirements applicable to packaged foods and the additional provisions for food supplements. Article 537 specifically requires the product to display the classification “Suplemento Alimentario” prominently on the principal display area, immediately after the product name. It also requires the specified mandatory warning statement:

“Use is not recommended for children under 8 years of age, pregnant women, or breastfeeding women, except on the advice of a competent professional; it does not replace a balanced diet.”

The wider RSA labeling provisions cover the food supplement name, net quantity, Manufacturer/packer/importer information as applicable, country of origin, lot/date info, nutritional details, and other mandatory info. For products entering Chile, the consumer-facing and technical information required for the import process should be prepared in Spanish.

The official Chilean import procedure identifies a technical product sheet in Spanish for products imported for the first time or where the formulation has changed.

Step 4: Comply with Health Claims & Advertising Rules

Article 536 provides that health and nutrition-property declarations appearing on supplements must comply with the RSA’s rules. It expressly prohibits promoting supplements for purposes of diagnosis, prevention or treatment of diseases.

Article 110 of the RSA also prohibits labeling or advertising from containing wording, illustrations, or other representations that could mislead consumers or create a false impression about the nature, composition, or quality of the product. It also prohibits suggesting therapeutic, curative effects or treatment dosages.

Nutritional and health claims are not simply prohibited across the board; they must comply with the applicable RSA rules and should not cross into prohibited disease-related or therapeutic positioning.

Step 5: Designate a Local Importer & Warehouse

Chile’s import system relies on the importer and the destination storage location. The official CDA procedure requires information about the importer, customs, warehouse, and transporter. It also requires evidence of the sanitary authorization of the storage warehouse. Businesses operating food establishments, including facilities that produce, package, store, distribute or sell food, require the applicable food sanitary authorization.

Thus, the importer must have the appropriate operational and sanitary arrangements for the imported food.

Step 6: Get the CDA

It identifies where imported food will be stored after it arrives in Chile. It also specifies the route and transport conditions between the customs facility and the destination warehouse. This certificate is obtained from the SEREMI de Salud and is required by the Chilean Customs service as part of the import process.

The latest ChileAtiende procedure can be requested online through the SEREMI platform. It requires information including the importer, customs location, warehouse, and transporter.

Step 7: Apply for the Authorization for Use and Disposal

Once the imported food arrives at the authorized destination warehouse, the importer must apply for the Autorización de Uso y Disposición from the relevant SEREMI de Salud. This is the authorization that permits the imported food to be used, consumed, and disposed of commercially after completion of the sanitary assessment.

Depending on the product and risk factors, the procedure can involve documentary evaluation, inspection without sampling, and inspection with sampling and laboratory analysis.

Step 8: Import Review & Sampling

The sanitary authority may review the shipment and request additional information. The review depends on factors such as epidemiological risk, product composition, import history, and records of violations. This means that the import process is not necessarily identical for every shipment.

Documents Required for Food Supplements Compliance in Chile

The importer must present a Certificado de Destinación Aduanera (CDA) and applicable sanitary certificates for specified products, such as those derived from bovines.

The SEREMI may additionally request:

• Commercial invoice from the supplier/manufacturer
• Sanitary certificate of origin
• Certificate of Free Sale
• Results of analyses conducted in the country of origin
• Technical product sheet in Spanish
• Product label or proposed label demonstrating compliance with the RSA.

The current SEREMI Metropolitana import procedure is even more specific, identifying the following:

• CDA
• Copy of purchase invoice
• Copy of sanitary resolution for the authorised warehouse/deposit
• Sanitary certificate of origin or Certificate of Free Sale
• Manufacturer-issued technical data sheet in Spanish for first-time imports or formulation changes
• Label/proposed label complying with Decree 977/96
• Additional information if required by the sanitary authority.

GMP Requirements for Food Supplements in Chile

Manufacturers have to have products made under appropriate sanitary and quality controls. Manufacturing and quality documentation may be requested during import reviews and/or inspections.

• Ensure implementation of GMP or equivalent quality systems.
• Maintain manufacturing and quality records.
• Supply quality documents to support when called upon by authorities.

Food Supplement Compliance Timelines in Chile

There’s no fixed timeline. They are based on the type of product, the quality of documentation, and the need for further review.

• An incomplete application may be postponed until it is finished.
• Timelines can be extended due to classification of reviews, inspections, or product sampling.
• Delays are minimized by early checking of ingredients, claims, and labeling.

Food Supplement Compliance Costs in Chile

The costs vary based on the product, documentation needs, and import channel. Some of the key cost elements are:

• Healthcare Services fees by SEREMI de Salud.
• Label translation and adaptation.
• Technical documentation.
• Product testing (if necessary).
• Customs clearance charges.
• Regulatory support services.

Classifications or labeling problems can result in higher costs to enter the market.

Conclusion

The main regulatory considerations prior to market entry in Chile are product classification, product labeling compliance, health claims, and import authorization, as the food supplements are mainly regulated as food products according to the Food Sanitary Regulation (RSA). A proactive compliance review can ultimately assist companies in overcoming delays, risks of reclassification, and challenges of commercialization.

From a new product launch to expanding your supplement line, Artixio can assist your team with product classification assessment, labeling review, import compliance, and market entry planning for regulatory strategy and speeding up product approval and commercialization in Chile. For more, connect with us at info@artixio.com.

FAQs 

Do food supplements require ISP registration in Chile? 

No. Most food supplements are not subject to separate ISP registration; instead, they are treated as food products. Products that have pharmaceutical properties, however, may be considered by the ISP. 

Can foreign companies directly import food supplements into Chile? 

No. Import authorisation and regulatory compliance are generally managed by a Chilean importer or a local responsible entity. 

Are therapeutic claims allowed for food supplements in Chile? 

No. Food supplements should not provide a cure, prevention, or treatment of disease. 

Is Spanish labeling mandatory? 

Yes. Product information for consumers shall be made in Spanish.