Through Resolution No. 2310 from the General Secretariat of the Andean Community, published in the Official Gazette of the Cartagena Agreement No. 5095 on 16 December 2022, the Andean Technical Regulation for the Labeling of Cosmetic Products ( "Regulation") was approved, containing the labeling requirements that cosmetic products that are marketed in the Andean Community (Bolivia, Colombia, Ecuador and Peru) must comply with.
The most relevant aspects of the Regulation are the following:
- It applies to the cosmetic products indicated in Decision 833 of the Commission of the Andean Community (Harmonization of Legislation on Cosmetic Products, "Decision 833").
- It contains additional definitions to those established in Decision 833 (among others, "complementary label", "origin label" and "parallel importer").
- The information that should be on the packaging of a cosmetic product can be incorporated through a printed version or through stickers ("firmly attached label").
- Among the information that must be included in the packaging is, among others, the following:
- Expiration date or shelf life of the product.
- Special precautions for its use.
- Product warnings, precautions and restrictions, where applicable.
- The changes in the label that do not imply any modification in the information of the notified labeling will not require a notification to be made to the General Directorate of Medicines, Supplies and Drugs (DIGEMID).
- DIGEMID will allow cosmetics to be marketed whose labels contain additional information that are required by the Regulation, as long as they do not contravene it.
- DIGEMID may allow the Mandatory Health Notification code not to be printed on the label. In this case, it must inform the General Secretariat before the Regulation enters into force.
- Cosmetic products must have stability studies.
- The Regulation will not require a conformity assessment procedure; that is, it is assumed that the information declared on the labels complies with the Regulation.
- The Regulation will enter into force on 16 December 2024.
The provisions of the Regulation can be reviewed in detail here.
We hope that this information will be of relevance to you and your company. If you require further information on the subject, do not hesitate to contact us.
