/
A Spanish or EU brand that already sells food supplements under EU rules often assumes Latin America works the same way: get a Certificate of Free Sale (CLV), translate the label, and ship. It doesn’t. Argentina lets a CLV substitute for registration in most cases; Chile does not, and the same ingredient can be authorized in one country and unrecognized in the other. Treating the region as a single market is the single most expensive mistake we see exporters make, usually discovered only after a container is sitting in customs.
Why Latin America Is Not One Regulatory Market
Each country runs its own food and supplement authority, its own registration circuit, and its own list of authorized ingredients and maximum doses. There is no regional equivalent of the EU’s single market for food supplements, and a dossier built for one country rarely transfers to the next without rework. In our experience, the two most common failures are assuming a CLV always exempts the product from local registration, and carrying an ingredient limit from one country into another without checking the local ceiling.
A concrete example makes the point. Monk fruit extract is an authorized sweetener in Argentina under the Código Alimentario Argentino, but it is not a recognized ingredient in Chile. Biotin is capped at a maximum daily intake of 2,500 µg in Argentina, against a ceiling of just 150 µg in Chile — a difference large enough to force a full reformulation if the same dosage is exported to both markets. Neither gap shows up until someone checks the primary source for each country, which is exactly the step that gets skipped when a company applies «Latin America» as one label.
Argentina: a Fast Lane, but Only If Your Product Qualifies
Argentina is the one country in the region with a genuine shortcut. Under Decree 35/2025 and Disposition 537/2025, a supplement backed by a valid Certificate of Free Sale from the country of origin can be imported under the simplified Annex III regime: a sworn declaration (declaración jurada) instead of the full registration circuit — exempt from the RNE (establishment registration) and RNPA (product registration) that would otherwise apply under Article 1381 of the Código Alimentario Argentino, and administered by ANMAT through INAL.
That exemption comes with conditions. It only covers products that fit within the authorized ingredient list and the dose limits set by Joint Resolutions 3/2020 and 3/2026, and it does not remove the front-of-pack labeling obligation: Argentina’s Law 27.642 requires black octagonal warning seals («EXCESO EN…») on any supplement that exceeds the sugar, sodium, fat or calorie thresholds it sets, in Spanish, on the Argentine-market label — not the EU one. Skip that step and the product clears the sanitary review but gets stopped at the retail or customs stage anyway.
Chile: Full Supplement Registration, No Shortcut
Chile takes the opposite approach. There is no simplified regime comparable to Argentina’s Annex III, and a Certificate of Free Sale from the exporting country is accepted as supporting evidence but never substitutes for the local process. Every product needs its own file: a CDA (Certificado de Destinación Aduanera) to clear the shipment at the port of entry, followed by the Resolución de Uso y Disposición — the sanitary authorization — issued by the regional SEREMI de Salud, under the framework of the Reglamento Sanitario de los Alimentos (Decreto Supremo 977/96, articles 534 and 536–537) and the dose limits set out in Resolución Exenta 394/2002, with the Instituto de Salud Pública (ISP) providing the laboratory backing that supports the SEREMI’s review.
Labeling has its own logic too. Chile’s front-of-pack warning system (the black «ALTO EN» stop-sign seals under Law 20.606) is the best known feature of its food regulation, but food supplements are explicitly exempt from it — which is the reverse situation from Argentina, where supplements are inside the warning-seal net. An exporter who applies Argentina’s labeling logic to a Chilean shipment either adds seals that shouldn’t be there or misses an exemption they were entitled to use; both cost time and, in a private-label negotiation, money.
What EU Exporters Consistently Get Wrong
Across the files we’ve reviewed, five mistakes account for most of the delays. The first is assuming the CLV alone opens the market, when in fact it only exempts Argentina from full registration and nowhere else. The second is reusing an EU or Spanish label instead of building one in the target country’s own language and legal format. The third — the one that trips up even experienced exporters — is carrying an ingredient or dose approved in one Latin American country into another without checking the local ceiling, exactly as monk fruit and biotin illustrate above. The fourth is reaching for a health or disease-related claim, «reduces cholesterol,» «treats,» «prevents,» which reclassifies the product as a pharmaceutical in every country in the region; none of them allow therapeutic claims on a food supplement. And the fifth, specific to Peru, is shipping capsules or tablets without first confirming whether DIGESA or DIGEMID is the competent authority — the presentation format and any health claim decide which agency and which circuit applies, and the wrong choice restarts the whole file.
None of these five is a hard barrier. Each one has a legal, documented way through it — a reformulation that keeps the product inside the authorized dose, a label rebuilt in the target format, or a claim rewritten so it stays inside the food category. The real question isn’t whether your product can legally reach Argentina and Chile — it almost always can — but which fix applies to which country before it ships, not after it’s already held at the port.
How ASC Handles a Latin America Launch
We don’t hand a client a checklist and let them find their own way through ANMAT or the SEREMI. Our regulatory team builds the country-by-country legality file for the exact product and dosage — which ingredients and doses clear each authority, which registration or declaration route applies, and what the label must say — and then manages the registration or declaration itself with the relevant agency. Argentina and Chile are covered in full depth; the rest of the region (Mexico, Brazil, Colombia, Peru, Ecuador and the wider LATAM markets) follows the same rigor, verified against each country’s primary source rather than assumptions carried over from elsewhere.
After close to two decades advising importers and exporters through the EU’s own regulatory framework, we bring the same standard to Latin America: a licensed technical team signs off on the file, and if an authority raises a question about a submission we manage, we are the ones who answer it — not the exporter, working alone against a foreign agency in a language and a legal system they don’t operate in every day.
Frequently Asked Questions
Does a Certificate of Free Sale let me sell my supplement anywhere in Latin America?
No. It exempts a qualifying product from full registration only in Argentina, under the Annex III regime. In Chile and in most other Latin American countries, the CLV is supporting documentation, not a substitute for local registration or notification.
Can I use the same label across Argentina, Chile and the rest of the region?
No. Each country has its own labeling rules, its own front-of-pack warning system, and its own exemptions for supplements — Argentina applies its warning seals to supplements, Chile exempts them. The label has to be built for the destination country, not translated from the EU version.
What happens if my product contains an ingredient not authorized in the destination country?
The dossier gets rejected or held until the formulation is adjusted. This is why we verify every ingredient and dose against the country’s own primary source before filing, rather than assuming approval in one market carries over to another.
How long does registration take in Argentina versus Chile?
Argentina’s Annex III declaration route is materially faster when the product qualifies, since it replaces full registration with a sworn declaration. Chile’s process runs through the CDA at customs and the SEREMI’s Resolución de Uso y Disposición, which takes longer because there is no simplified alternative — timelines depend on the completeness of the file submitted.
If your catalogue is ready to move into Argentina, Chile or elsewhere in Latin America, get the country-by-country legality assessment done before you commit to a shipment — talk to our regulatory team about your specific product and destination markets.