Cosmetics - Ecuador

In Peru, Colombia and Ecuador, cosmetics are defined as any substance or formulation intended to be brought into contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucosa, with the exclusive or main purpose of cleaning, perfuming, modifying or improving their appearance, protecting them, keeping them in good condition, correcting body odors.

The previous definition is given by the sanitary regulation in cosmetics, enshrined in a supranational regulation, through Decision 516 of 2004 of the Andean Community of Nations, which was subject to changes and updates through Decision 833 of 2018, which began to govern as of March 2021 and which has the complementary technical regulations, one for BPM, Resolution 2206 of 2021 and another for Labeling, Resolution 2310 of 2022.

This regulation applies to all the countries of the CAN (Andean Community of Nations). Aruna has a team specialized in the registration and approval of its products, which, strategically, achieve parallel arrival in these markets.

In order to market cosmetic products, the Mandatory Sanitary Notification is required, a communication in which the Competent Sanitary Authority is informed, under sworn declaration, that a cosmetic product will be marketed in the country, fully complying with the corresponding regulations and guaranteeing that They do not harm human health when applied under normal or reasonably foreseeable conditions of use. This Mandatory Sanitary Notification may be modified, recognized or renewed, according to the interest of the Holder and aligned with the norm.

The Ecuadorian Competent Health Authority is ARCSA, in Peru it is DIGEMID and in Colombia it is INVIMA, these being the entities in charge of attending to all requests to natural or legal persons that carry out production, conditioning, storage, distribution, commercialization and import activities. of this type of products.

Aruna Asesores has a group of specialists with experience in the field, guaranteeing the adequate management of the different requests before the Competent Health Authorities belonging to the Andean Community, in the three countries, optimizing efforts by channeling the process with a single regulatory consultant.