This document presents a summary of the most relevant aspects of Resolution No. 2310 of the General Secretariat of the Andean Community, published in the Official Gazette of the Cartagena Agreement No. 5095 of December 16, 2022. The Resolution includes the labeling requirements that cosmetic products must comply, if marketed in the countries of the Andean Community (Bolivia, Colombia, Ecuador and Peru).

1. Effective Date

December 16, 2024 (in two years)

2. Products regulated

Cosmetics

3. Who must comply?

Holders, manufacturers, and parallel importers of Mandatory Sanitary Notifications (NSO) issued in Colombia, Peru, Bolivia, and Ecuador.

4. What happens to an issued NSO that requires modifications, renewal, or recognition prior to the effective date?

The NSO must comply with the requirements of the new regulation.

5. What happens to an issued NSO that DO NOT require modifications, renewal, or recognition prior to the effective date?

The NSO will continue to comply with the requirements established in the community regulations with which the NSO code was issued until its respective expiration date.

6. Mandatory labeling requirements

• Product name
• Generic name
• Cosmetic group
• Commercial brand
• Holder´s name or Parallel importer´s name
• Country of origin
• Net content
• Ingredients and/or substances warnings
• Batch number.
• NSO code issued by the Competent Authority of the Country Member.
• INCI list of ingredients, preceded by the word "ingredients" in descending order according to their total weight.
• Expiration date or shelf life of the product.
• Directions for use, when applicable.
• Storage conditions, when applicable.
• Warnings, precautions, and restrictions established by the manufacturer, when applicable.

7. Mandatory labeling requirements in small containers or packages

• Product name
• Generic name
• Holder´s name or Parallel importer´s name.
• NSO code issued by the Competent Authority of the Country Member
• Net content
• Batch number
• INCI ingredients, which imply a health risk or warning.
• Expiration date or shelf life of the product.

8. Shelf life becomes mandatory

The cosmetic product must count with stability studies if:

• Shelf life is less than or equal to 24 months: At least the month and year must be declared on the product label or packaging preceded by the legend expiration or equivalents.
• Shelf life is greater than twenty-four (24) months: The expiration date will not be mandatory on the label or packaging, but the manufacturer must count with the stability studies for control.

9. How can the labeling requirements be placed on the container or packaging?

• Printed.
• On a firmly affixed label.
• A complementary affixed sticker will be allowed to complete the labeling requirements, except for the batch number.
• If the information of precautions, warnings and restrictions exceeds the size of the container or packaging, these must appear in a leaflet.
• The following information must be declared in Spanish: Generic name, ingredient precautions, instructions for use, storage, product warnings/restrictions.

10. Prohibitions

The following will not be allowed:

• Texts, images, or any other symbols that attribute therapeutic properties or that create confusion with another category of products.
• Benefits and claims that have not been justified with the appropriate technical and scientific studies.
• The use of a complementary label or sticker to correct misinformation printed in the original label.

11. Control and Surveillance

• The label of the product that is on the market must agree with the last submitted and notified in the NSO.
• The facilities must comply with operating permits to print and affix the complementary labels or stickers.
• The manufacturer, holder or parallel importer must keep the stability studies available for control and surveillance purposes.

For advice and further information please contact: agustin.acosta@dentons.com; oderay.andrade@dentons.com  and/or german.robayo@dentons.com