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Ecuador’s health regulator, ARCSA, has updated its external guidance on the documentation companies must submit to obtain, renew, recognise or modify the Notificación Sanitaria Obligatoria, or NSO, for cosmetic products, household hygiene products and absorbent personal hygiene products.

The document, External Instruction IE-B.3.1.1-COS-01, Version 2.0, dated 14 April 2026, replaces the original version issued in December 2025. It provides a practical roadmap for companies preparing NSO-related submissions through ARCSA’s electronic systems.

The update is mainly procedural, but it is important for manufacturers, importers, distributors and regulatory representatives placing these product categories on the Ecuadorian market. The NSO is the Andean Community notification mechanism used to authorise commercialisation of cosmetics, household hygiene products and absorbent personal hygiene products.

The guidance covers five main procedures: obtaining a new NSO, using an existing NSO as a parallel importer, renewing an NSO, recognising an NSO issued by another Andean Community member country, and modifying information already notified under an existing NSO. Cosmetic applications are submitted through ARCSA’s transitional “Sistema 833” or a future designated platform. Household hygiene and absorbent hygiene product applications are submitted through Ecuador’s VUE system on ECUAPASS, or another ARCSA-designated platform.

For new cosmetic NSO applications, companies must submit documents such as proof of legal representation, the completed application form, manufacturer declaration, product description, INCI-based formula information, details of restricted substances and nanomaterials where applicable, finished product specifications, microbiological specifications, label or artwork, packaging material information, batch coding system, proof of payment and a sworn declaration. For household hygiene and absorbent hygiene products, similar documents are required, with additional information where relevant on maquila, product claims, warnings, presentation format and disinfectant or bactericidal properties.

The instruction also clarifies labelling expectations. Cosmetic labels must include information such as product name, generic denomination, brand, NSO holder or importer details, country of origin, nominal content, warnings, batch number, NSO code, INCI ingredient list, expiry date or shelf life where required, instructions for use and storage conditions. Household hygiene and absorbent hygiene product labels must include equivalent information adapted to those categories, including qualitative composition and expiry date for certain absorbent products.

Two provisions are worth flagging. For renewals, cosmetic NSO holders are encouraged to begin the process at least 90 days before expiry; if renewal is not submitted, the NSO code will be considered expired and cannot be renewed or assigned again. For household hygiene and absorbent personal hygiene products, renewal applications should be submitted up to 60 days before expiry, and the NSO validity period is seven years from the date the code is assigned.

The parallel importer route is also important. A cosmetic parallel importer relying on an existing NSO must submit legal representation documents, the FNSOC-004 form, labelling with the importer’s data, manufacturer authorisation, sworn declaration, proof of payment and supporting documents. Although the apostille requirement has been removed for the manufacturer authorisation, the importer assumes the same responsibilities as the NSO holder for product safety and quality and cannot make modifications or reformulations reserved for the NSO holder.

The document further explains how companies may request recognition of an NSO already issued in another Andean Community member country. Applicants must provide the valid NSO code and copies of the documents submitted in the first country, including formula, specifications, label, supporting studies and previous modifications where applicable.

The guidance also reinforces documentary formality. Documents signed by the technical or legal representative must be electronically signed and submitted as verifiable PDFs, while manually signed documents must be notarised. For cosmetics, the technical representative must be a qualified pharmaceutical chemist or biochemical pharmacist; for household hygiene and absorbent hygiene products, ARCSA also accepts chemical engineers.

In practical terms, the update gives companies a clearer compliance roadmap for managing NSO procedures in Ecuador. While it does not create an entirely new product safety regime, it clarifies submission routes, documentation expectations, renewal timing, parallel importer obligations, recognition procedures and post-notification changes.