Food & Beverage

Law 20,606 on the nutritional composition and advertising of food reshaped Chile's labelling regime by introducing the black "Alto en" warning labels for calories, sodium, sugars and saturated fat. We advise on compliance across the board: analysing the nutritional profile against the per-100-gram limits set out in the Food Sanitary Regulation (Decree 977), designing compliant labelling (mandatory particulars, nutritional claims, allergens, expiry date, directions for use, manufacturer identification, Spanish language), the nutrition table in the current format, visible warning labels where required, and the mandatory statements for specific products.

We also advise on reformulation to avoid warning labels where that is viable, which changes how the product sits against its competitors. The ISP and the regional health authority inspect actively: a defective label can trigger a product recall and significant fines.

Selling food, food supplements, pharmaceuticals, cosmetics and medical devices in Chile requires specific sanitary registrations before the Instituto de Salud Pública (ISP) and, for agricultural products, the Servicio Agrícola y Ganadero (SAG). We advise on obtaining the registration: the correct regulatory classification (food, supplement, food for special purposes), the technical dossier (composition, process, labelling, stability and efficacy studies where required), manufacturer documentation (GMP, certifications), the filing before the ISP or the SAG, responses to observations, the final authorisation and its maintenance afterwards.

For imports we also handle sanitary certificates and the import authorisation. Regulatory planning for a new product should start at least 6 to 12 months before launch to avoid commercial delays.

Law 20,606 prohibits advertising products carrying "Alto en" warning labels to children under 14, and the health authority applies that restriction broadly: television scheduling, digital platforms, on-pack content, mascots, promotions, gifts, sponsoring athletes, and placement in schools.

We help brands review campaigns, digital content, packaging and sponsorships proactively to avoid breaches, draft internal advertising compliance manuals, and respond to inspections by the Ministry of Health and SERNAC. For international companies we work with their global teams on adapting to the Chilean rules, which are markedly stricter than in other Latin American markets. A breach can trigger the withdrawal of a campaign, fines and significant reputational harm.

Food production in Chile requires compliance with Good Manufacturing Practice and, depending on the product, HACCP systems (Hazard Analysis and Critical Control Points). We advise on designing the documentation: the GMP manual, standard operating procedures, and the HACCP plan with its hazard analysis, critical control points, critical limits, monitoring, corrective actions and verification.

We support external audits (BRC, IFS, FSSC 22000) where these are needed to export to demanding markets. For inspections by the ISP or the local health authority, we prepare the supporting documentation, attend inspection visits and respond to any sanitary proceedings. A robust GMP and HACCP system substantially reduces the risk of recalls, which can cost millions and destroy consumer trust.

Exporting Chilean food abroad means complying with both local rules and those of the destination market. We advise on certification for the main markets: the United States (FDA, FSMA, facility registration, FSVP), the European Union (Regulation 178/2002, listing as an approved plant, EU-compliant labelling), China (GACC and plant registration), Japan (JAS and specific certifications), and other Latin American markets with their own requirements.

For imports into Chile we coordinate sanitary registrations, certificates of origin, the rules on international data transfers where they apply, and any bilateral sanitary protocols. International regulatory compliance is one of the main blockers to export growth and should be planned as soon as target markets are chosen.