Ecuador Updates Registration Guidelines for Hygienic and Disinfectant Products

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, which contains updated requirements for the registration, re-registration, and modification of sanitary notifications for industrial hygienic products, hospital disinfectants, and food-grade disinfectants. 

Expanded Scope and New Product Categories

The latest version introduces additional product categories to the regulation:

• Hygienic disinfectants for hospital use.

• Food grade disinfectants. 

New Labeling and Reference Codes

To facilitate compliance, the guidelines now include a dedicated labeling guide for all regulated products:

• Industrial use: Reference Code N129PHI

• Hospital use: Reference Code N129PHHOP

• Food Grade use: Reference Code N129PHFV

This structured approach aims to simplify product identification and regulatory processes for manufacturers and importers.

Enhanced Compliance Requirements

Version 2.0 introduces more stringent standards for product efficacy and stability studies:

• Efficacy Studies: Applicants must substantiate the properties of their products with comprehensive efficacy data.

• Stability Studies: The document mandates stability testing for three different product batches, alongside accelerated stability studies adhering to the latest norms.

These changes reflect ARCSA's focus on ensuring product safety and maintaining quality standards throughout a product’s lifecycle.

Development of the Guidelines

The original guidelines were created in June 2020, but significant updates in December 2024 reflect ongoing efforts to improve regulatory oversight. Key changes include:

• Updated government branding on official documents.

• Clearer processes for modifying sanitary notifications.

• New labeling and study requirements to align with international best practice.

Regulatory Transparency and Accessibility

ARCSA emphasizes that this document is for its intended use only and that stakeholders must always consult the latest version available in the institutional repository. Printed or copied versions are considered uncontrolled and may not contain the latest updates.

A Step Forward in Hygiene and Safety

The revisions aim to streamline the registration process, enhance public safety, and provide clarity for stakeholders navigating the regulatory landscape. The Agency encourages manufacturers, importers, and distributors to familiarize themselves with the updated requirements and ensure full compliance by consulting the institutional repository. For further details, the External Instruction Document can be found here (in Spanish).