Ecuador publishes Draft Rules Aiming to Tighten Cosmetic Safety and Labeling Standards

A new draft proposal published by the National Health Regulation Agency (ARCSA) in Equador sets out stricter requirements for cosmetics, aiming to boost consumer safety and ensure products on the market meet higher technical and scientific standards. The draft outlines obligations for companies seeking to sell cosmetic products, household hygiene products and personal hygieneabsorbent produtcs  whether manufactured locally or imported to Ecuador. This framework is designed to protect public health while aligning with international practices.

Clearer Rules for Companies

Under the proposal, firms would need to provide detailed technical files for every product. These must include manufacturing processes, ingredient specifications, stability testing, and toxicological assessments. Authorities would also require proof that any claims, such as “anti-aging”, “moisturising”, or “UV protection”, are backed by scientific evidence. The draft also reinforces responsibilities for businesses to register officially and designate a legally responsible person for product compliance.

Safety at the Forefront

Regulators highlight that safety is a core pillar of the new requirements. Companies would need to demonstrate that products do not contain banned or restricted substances, and to carry out risk assessments for vulnerable groups such as children and pregnant women. Toxicological profiles of each ingredient would form part of the mandatory dossier, providing authorities with a clearer picture of potential risks.

Labels Under Scrutiny

Labels are also set to face tighter controls. Products must display full ingredient lists using the international INCI system, expiry dates, instructions for safe use, and details of the responsible company. A batch number will be mandatory to improve traceability in the event of recalls.

Next Steps 

The draft remains open for consultation until the 8th of October 2025, with regulators expected to refine the proposals before they come into force. If adopted, the rules would mark a significant shift for the cosmetics industry, placing greater emphasis on transparency, safety, and accountability. The proposa can be found here (in Spanish).