Colombia Cosmetics Registration and Labeling Standards
Starting in December 2024, a new technical resolution 2310 governing cosmetics sold in Colombia comes into effect, mandating that all packaging be labeled in Spanish from origin. Article 5 of the regulation states that the manufacturer can still use complementary stickers (in Spanish), but the stickers must be placed in a space of the packaging that does not cover any other information, it must be a completely free or empty space.
How this impacts U.S. Exporters to Colombia
Many U.S. products currently being shipped to Colombia would not satisfy the new regulation, as most U.S. products are completely covered by English text and marketing images. U.S. companies exporting cosmetic products to Colombia would need to ensure compliance with the resolution by either:
• Manufacturing containers with only Spanish language on the original packaging; or
• Changing labeling size and placement to ensure a wide enough space to put a Spanish sticker that does not cover any other information on the package.
Ensuring compliance with Colombian labeling regulations may cause U.S. companies to incur additional costs, including expenses related to packaging redesign, translation services, manufacturing alterations to labels, and other regulatory compliance efforts.
About Cosmetic Product Registration in Colombia
Product registration holds significant importance for U.S. companies as they navigate selling and exporting cosmetic products to Colombia. Cosmetics and personal care products must be registered with the Colombian National Institute for Surveillance of Medicines and Food – INVIMA.
It is necessary to obtain a Mandatory Sanitary Notification (Notificación Sanitaria Obligatoria-NSO). The registration form for the Mandatory Sanitary Notification requires that a local Pharmaceutical Chemist or equivalent review and certify (sign) the registration form. You will also need to submit all the technical data sheets of the product and the labeling (art. 9 of Decision 833 of2018). According to INVIMA, the process could take around seven to 10 days business days to be completed (however, in reality, the process may take more than that to be completed). The registration process is easier with the help of an expert on INVIMA sanitary registration and with the help of the appointed local distributor.
What is Legally Considered a Cosmetic in Colombia
According to INVIMA regulation, a cosmetic is any substance or formulation intended to be put in contact with the superficial parts of the human body (epidermis, hair, capillary system, nails, lips) or with the teeth and oral mucous membranes, with the exclusive or main purpose of cleaning them, perfume them, modify or improve their appearance, protect them, keep them in good condition or correct body odors. According to Decision 833 of 2018, the list of cosmetics products includes, cosmetics for children, eye area, skin, lip, grooming, and body hygiene (also includes wet wipes, and antibacterial gels with a concentration of less than 70% alcohol), deodorants and antiperspirants, hair, nails, perfumery, products for oral and dental hygiene, for and after shaving, tanning products, sun protection, and self-tanning products. Depilatories, skin-lightening products, insect repellent products that go on the skin, and others determined by the General Secretariat of the Andean Community through resolution, by request, and consensus of the Competent National Authorities of the Member Countries.
The following products are not considered cosmetic: injectable products, products that are ingested, permanent tattoos, permanent makeup, products with systemic action, those that claim therapeutic action, for prevention or treatment of diseases, products implanted in the body, that are inhaled, and slimming products.
How This Impacts Cosmetics in Colombia in 2024
INVIMA reserves the right to conduct inspection during the seven-year license validity period of the mandatory sanitary notification. If INVIMA judges there to be any deviation from their policy, they reserve the right to suspend any previously approved license. A company that receives a suspended license notification has four months to appeal the decision by providing additional information as requested by INVIMA. Unsuccessful appeals lead to license cancellation.
In 2024, the U.S. Commercial Service Colombia office has been informed of a rising number of U.S. product license suspensions in cosmetics and cleaning products. As an example, an acne cream that claims to ‘prevent acne’ can be considered a therapeutic claim, changing the category of the acne cream from cosmetic to drug under these regulations, resulting in a suspended and perhaps cancelled cosmetic license.
Cost to Register
The average fee for the Mandatory Sanitary Notification per cosmetic group is $800 and is valid for seven years. Decision 833 of 2018 explains what is considered part of the Cosmetic Group:
Article. 12 – “Cosmetic products with the same basic qualitative and quantitative composition, use and generic name, possessing different organoleptic properties (color, smell, and taste) will be considered cosmetic groups”.
For more information on the cosmetics industry, please contact the Commercial Specialist Norcia Ward.
* Resolution 2310, The labeling of Colombian cosmetics is regulated by the Andean Technical Regulation for the Labeling of Cosmetic Products.