Executive Decree No. 45224-S establishes the procedure for simplified sanitary registration by notification and third-party import authorization for low-risk processed foods and cosmetics, streamlining their commercialization in the country. It also regulates the recognition of registrations, control, and monitoring through the digital platform REGÍSTRELO.
The simplified registration applies only to foods listed in Annex I and to cosmetics that do not belong to the categories in Annex II. It does not apply to foods with health claims, products intended for children under three years of age, foods for special diets, energy drinks, dietary supplements, or products containing cannabis. It also does not apply to high-risk cosmetics such as sunscreens, anti-dandruff products, chemical exfoliants, hair dyes, and intimate products.
The simplified sanitary registration is valid for a period of five years. It is processed quickly through the REGÍSTRELO platform, with a sworn declaration and payment as required by current regulations. Third-party import authorization is granted for all foods and cosmetics not included in the restricted categories, and its validity depends on the original registration. The Ministry of Health will conduct subsequent verifications, canceling registrations or authorizations in cases of non-compliance, false information, health risks, or commercialization under conditions different from those registered. Sanctions include seizure, market withdrawal, product destruction, and criminal complaints.
Annex I contains 83 categories of low-risk foods, such as oils, dressings, water, cereals, cookies, juices, flours, dehydrated soups, and frozen vegetables. Annex II lists 21 categories of cosmetics that are not considered low-risk, including products for children under three years of age, eye contour products, sunscreens, antiperspirants, hair dyes, and hair products.
Fee Update for Sanitary Registration Procedures
According to the amendment of Article 1 of Executive Decree No. 30103-S, the fee for procedures related to the registration, inspection, monitoring, and control of food products and infant formulas has been updated.
New established amount: ₡55,000.00 (fifty-five thousand colones)
The fee, updated each January, is based on the accumulated inflation percentage over the previous twelve months, according to data from the National Institute of Statistics and Census.