,Chiles Ministry of Health (MINSAL) has published a technical proposal to amend Supreme Decree No. 977/96, introducing a comprehensive and explicit regulatory framework governing the internation (entry) of foods into Chile. The proposal aims to eliminate ambiguities in current procedures by formally embedding food entry requirements, documentation, and control mechanisms into the Food Sanitary Regulations themselves, rather than relying primarily on guidance manuals.
The initiative follows feedback from Regional Ministerial Health Secretariats (SEREMI), the National Customs Service, and private-sector stakeholders, who identified inconsistencies and a lack of legal clarity regarding documentation, responsibilities, timelines, and inspection criteria for imported foods. The amendments are aligned with Codex Alimentarius (CAC/GL 20-1995 and CAC/GL 47-2003) and FAO/WHO recommendations on risk-based food control systems.
Explicit Requirements for Entry of Foods Into Chile
Mandatory Documentation for Internation (New Article 94 bis)
Under the proposed Paragraph XIII, any request for food entry authorization must be accompanied, as applicable, by the following documents:
Commercial invoice, identifying the transaction and products
Packing list, detailing product description, brand, quantities, net and gross weights, lot numbers, and expiry dates
Declaration of the destination establishment, which must hold valid sanitary authorization; use of third-party facilities must be formally accredited
Estimated arrival date and transport route within Chile
Transport document, such as a bill of lading, airway bill, or waybill
Exporter identification details
Certificate issued by the competent authority of the country of origin, demonstrating suitability for human consumption (e.g. sanitary certificate or free sale certificate)
Technical file or monograph for each product, in Spanish (English also accepted), including composition, ingredients, nutritional profile, shelf life, manufacturing process, quality standards, conditions of use, and storage requirements
Photographs or artwork of labels, both from the country of origin and the Chilean market label in cases of re-labelling; bulk products may require photographs of the cargo
Delivery note or equivalent document confirming arrival at the declared warehouse
Customs entry declaration submitted to the National Customs Service
Depending on the nature and risk profile of the product, SEREMI may additionally request temperature records, analytical reports for allergens, contaminants, fortification, or microbiological, chemical, or physical quality indicators, as established under the RSA.
Risk-Based Evaluation and Control
The sanitary authority will determine the intensity and type of control based on:
Food composition and intended use
Epidemiological and public health risk
Compliance history of the product and importer
Validity and credibility of accompanying certifications
Controls may include documentary review, physical inspection, and/or laboratory analysis.
Obligations of Importers and Holders (Article 94 ter)
Applicants and holders of food consignments must:
Obtain prior authorization from SEREMI before release
Transport products only to the declared and authorized facility
Maintain consignments under custody, without use, sale, sampling, or distribution, until sanitary clearance is issued
Ensure full traceability and updated contact and facility information
SEREMI must issue a reasoned authorization or rejection decision within 40 working days once all required documentation has been completed.
Rejected, Returned, and Export-Only Products
Rejected consignments must remain under the custody of the holder until a final destination is approved, which may include destruction, re-export, or alternative authorized use, at the owners expense.
Special provisions apply to:
Re-imported foods, requiring proof of rejection abroad
Foods entering Chile exclusively for processing and re-export, which must be segregated from products for domestic consumption
Additional Institutional and Digital Controls
SEREMI may request technical opinions from the Institute of Public Health (ISP) in cases of regulatory classification uncertainty
A digital importer profile system will be introduced to characterize operators and assign risk profiles, improving inspection efficiency and traceability
Stricter Rules on Imported Food Labelling
The proposal reinforces that re-labelling of imported foods is only permitted if it does not involve opening or manipulating the primary packaging. Products requiring access to individual sealed units for label correction will be prohibited from entry unless explicitly authorized.
Regulatory Impact
If adopted, the amendments will significantly increase legal certainty, transparency, and predictability for food importers while strengthening Chiles risk-based sanitary control system. Businesses exporting food to Chile will need to reassess documentation readiness, labelling strategies, and importer compliance history to ensure uninterrupted market access