In Chile, health supplements are controlled as food supplements. Companies, prior to market entry, need to make sure that the classification of the product, ingredients, claims and labelling are in accordance with Chilean requirements, to prevent import delays or product changes.
This document provides an overview of the regulatory scenario, approval process, product labelling requirements, import controls, timelines, costs and compliance requirements in Chile.
Regulatory Authority for Health Supplements in Chile
In Chile, health supplements are regulated by the Food Sanitary Regulation (RSA).
- MINSAL (Ministerio de Salud) – lays out the rules.
- SEREMI de Salud (Secretaría Regional Ministerial de Salud) – Responsible for imports, inspections and compliance.
- ISP (Instituto de Salud Pública de Chile) – Reviews products that contain pharmaceutical ingredients or therapeutic claims.
What Are Health Supplements Under Chilean Regulations?
The health supplements are dietary products that are used to supplement the diet and promote normal physiological functions. May include vitamins, minerals, amino acids, fatty acids, fibre or other approved nutrients, but cannot make therapeutic claims.
Also Read: Drugs vs Medicines: Understand The Key Differences
Compliance Checklist for Health Supplement Approval in Chile
When planning to market a health supplement to Chile, be sure to do so:
- 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.
Health Supplements Registration Process in Chile (Step-by-Step)
The process is around product classification, authorisation of imports and compliance with the RSA.
Step 1: Verify Product Classification
Check if the product is a health supplement and not a pharmaceutical product.
Step 2: Designate a Local Importer
Assign one Chilean importer who has responsibility for regulatory compliance.
Step 3: Prepare Documentation
Prepare Certificate of Free Sale, product specification, labelling and supporting documents.
Step 4: Get a Customs Destination Certificate (CDA)
Fill in a CDA application request with the appropriate SEREMI de Salud.
Step 5: Apply for Authorisation of Use and Disposal
Submit all the documentation to SEREMI de Salud for approval of the commercialisation process.
Step 6: Complete Authority Review
Satisfy document calls, inspections, and product sampling needs.
Step 7: Import and Market the Product
Providing authorisation, importing, distributing, and commercialising the product.
Documents Required for Health Supplements Registration in Chile
Health supplements imported to Chile are required to have documentation to prove compliance with the Food Sanitary Regulation (RSA) and import requirements.
- A certificate of free sale from the competent authority of the country of origin.
- The formula of a product or its qualitative and quantitative composition.
- Product specifications and technical information.
- Original and suggested label for the Chile market.
- Business documents, including business invoices and shipping documents.
- Details and production site of the manufacturer.
- Documents to import information and authorisation.
- Other information required by SEREMI de Salud in the product evaluation and/or import review.
ISP Labelling Requirements for Health Supplements in Chile
The labelling requirements set out in the RSA must be followed by health supplements that are to be marketed in Chile prior to commercialisation.
- Product information should be provided in Spanish.
- The label must contain details about the product’s name and the net content.
- The full list of ingredients shall be listed.
- Manufacturer/importer information is required.
- Lot # and EXP must be included.
- Daily recommended uses and/or consumption amounts shall be mentioned.
- Allergen statements have to be included (if applicable).
- No therapeutic, curative or disease prevention claims are allowed on labels.
ISP Licensing Requirements for Health Supplements in Chile
In Chile, the majority of health supplements are not registered as a separate product but as a food. Commercialisation is normally accepted if it complies with the Food Sanitary Regulation (RSA) and the import authorisation from SEREMI de Salud. When pharmaceutical ingredients are present or therapeutic claims are made in a product, the ISP could become involved.
- Most health supplements don’t have an exclusive ISP enrollment.
- The local importer is responsible for regulatory compliance.
- Products having medicinal properties may require ISP review.
GMP Requirements for Health 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.
Health Claims and Advertising Regulations in Chile
Only claims allowed by the Chilean food regulations are acceptable, and health supplements are not allowed to treat, prevent or cure diseases.
- Claims for therapeutic and medical benefits are not allowed.
- The advertising shall be consistent with product labelling.
- If not compliant, it could lead to enforcement action or product reclassification.
Import Regulations for Health Supplements in Chile
Health supplements that are imported need to meet the Food Sanitary Regulation (RSA) and authorisation from the corresponding SEREMI de Salud prior to market.
- Must be imported locally.
- Upon import, a Customs Destination Certificate (CDA) needs to be acquired.
- The product can be marketed only with the Authorisation of Use and Disposal issued by SEREMI de Salud.
- Product inspection and/or samples may be taken during import review.
Health Supplement Registration Timelines in Chile
The timelines are based on the type of product, the quality of the documentation and the need for further review.
- If the application is incomplete, it may be postponed until it is finished.
- Timelines can be extended due to classification reviews, inspections or product sampling.
- Delays are minimized by early checking of ingredients, claims and labelling.
Health Supplement Registration 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 labelling 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 labelling compliance, health claims and import authorisation, as the health supplements are mainly regulated as food products according to the Food Sanitary Regulation (RSA). A proactive compliance review can ultimately assist companies to overcome delays, risks of reclassification and challenges of commercialisation.
From a new product launch to expanding your supplement line, Artixio can assist your team with product classification assessment, labelling review, import compliance, and market entry planning for regulatory strategy and speeding up product approval and commercialisation in Chile. For more, connect with us at info@artixio.com.
FAQs
Do health supplements require ISP registration in Chile?
No. Most health 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 health 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 health supplements in Chile?
No. Health supplements should not provide a cure, prevention or treatment of disease.
Is Spanish labelling mandatory?
Yes. Product information for consumers shall be made in Spanish.
