,The Chilean Ministry of Health has published a technical proposal to amend Supreme Decree No. 977/96, which establishes the Sanitary Regulation of Foods (RSA). The proposal introduces extensive changes aimed at clarifying, modernising, and strengthening the regulatory framework governing the internation (entry), importation, labelling, and sanitary control of foods entering the country. The draft amendments are being submitted for public consultation.
Background and Regulatory Gap
Following an internal review of food import procedures, authorities identified that the current RSA does not clearly define the documentation requirements, responsibilities, and control procedures applicable to foods entering Chile. This lack of clarity has created inconsistencies for importers, regional health authorities (SEREMI), customs officials, and other public agencies.
Observations from SEREMI, the National Customs Service, and the private sectorraised through productivity working groupshighlighted discrepancies between the RSA and the Manual for the Importation of Foods for Human Consumption. To address these issues and improve transparency, the Ministry has decided to formally incorporate import and internment requirements directly into the RSA, in line with Codex Alimentarius and FAO/WHO recommendations.
Objectives of the Proposed Amendment
The proposal aims to:
Harmonise Chilean food regulations with Codex Alimentarius guidelines (CAC/GL 20-1995 and CAC/GL 47-2003).
Improve administrative efficiency and standardise technical criteria.
Strengthen intersectoral coordination among health and customs authorities.
Explicitly define sanitary requirements and procedures for food internment.
Enhance traceability, risk-based controls, and regulatory certainty for all stakeholders.
Key Proposed Changes
1. Inclusion of Internation in the RSA Scope
Several articles are amended to explicitly include the term internación (internment) alongside importation, aligning the RSA with the Chilean Sanitary Code. This change clarifies that sanitary control begins from the physical entry of food into national territory, regardless of its customs destination.
2. Updated Institutional Responsibilities
References to Health Services are replaced with Secretarías Regionales Ministeriales de Salud (SEREMI), ensuring consistency with existing administrative law. SEREMI will remain the competent authority for food control, inspection, and enforcement.
3. New Definitions Added
The proposal introduces key definitions to avoid regulatory ambiguity, including:
Technical file or monograph: detailed product information such as composition, ingredients, shelf life, processing, storage conditions, and quality standards.
Importation: the legal process of bringing food into Chile for domestic consumption after customs and sanitary clearance.
Internation: the physical entry of food into Chile, regardless of customs regime, subject to sanitary verification.
Packing list: a detailed shipment document specifying product identity, quantities, weights, lot numbers, and expiry dates.
4. New Chapter on Food Internation Requirements
A new Paragraph XIII (Articles 94 bis to 94 quinquies) is introduced, formally establishing mandatory requirements for food internment.
Article 94 bis lists compulsory documentation, including:
Commercial invoice and packing list
Transport documents
Exporter and importer information
Declaration of authorised destination facility
Estimated arrival date and transport route
Sanitary or free-sale certificates from the country of origin
Product technical files
Label artwork (original and Chile-compliant versions)
Customs entry declaration
Additional documents may be required depending on product risk, such as allergen analysis, contaminant testing, fortification data, or temperature records.
5. Risk-Based Control Approach
Authorities will determine inspection intensity based on:
Product composition and epidemiological risk
Compliance history of the product and importer
Validity of supporting certification
Controls may include documentary review, physical inspection, and laboratory analysis.
6. Clear Rules for Rejected and Returned Products
The proposal clarifies procedures for:
Rejected imports
Re-exported foods returning to Chile
Products entering solely for processing and export
Rejected products must remain under custody, and their final destination (destruction, re-export, or other authorised use) must be formally communicated, with costs borne by the responsible party.
7. Defined Obligations and Timelines
Article 94 ter establishes importer obligations, including custody, traceability, and prohibition of use or sale prior to approval. SEREMI must issue an approval or rejection decision within 40 working days once all documentation is complete.
8. Role of the Institute of Public Health
Under Article 94 quater, SEREMI may request a binding opinion from the Institute of Public Health (ISP) when there are justified doubts regarding the sanitary classification of imported products, particularly where foodmedicine borderline issues arise.
9. Digital Risk Profiling of Importers
Article 94 quinquies introduces a digital importer profile, enabling authorities to characterise operators, identify risk profiles, optimise inspections, and strengthen enforcement actions.
10. Stricter Labelling Controls
Amendments to Article 109 reinforce labelling requirements for imported foods. Re-labelling is permitted only if it does not involve manipulation of the primary package or access to the product contents. Products requiring such manipulation will be prohibited from importation unless expressly authorised.
Overall Impact
The proposed amendments represent a structural reform of Chiles food import control system, embedding transparency, risk-based oversight, and international best practices directly into the Sanitary Regulation of Foods. If adopted, the changes will significantly enhance traceability, regulatory clarity, and consumer protection, while providing clearer obligations and procedures for food business operators.
The proposal is currently open for public consultation, allowing stakeholders to submit comments before final adoption.