The Colombian National Institute of Food and Drug Surveillance (Invima) has announced that the enforcement of the Andean Community's Cosmetic Labeling Regulation (Resolution 2310) will be extended to December 17, 2025, giving companies an additional year beyond the original deadline of December 17, 2024.
This regulation, proposed by the Andean Community Commission, aims to standardize cosmetic labeling across member states to prevent consumer confusion. It also requires companies to obtain a Mandatory Sanitary Notification (NSO) before launching their products.
Scope and Requirements of the Mandatory Sanitary Notification (NSO)
1. Mandatory Requirements
Companies marketing cosmetics in the Andean region must apply for the NSO and obtain an NSO code. Once canceled or invalidated, the code cannot be reassigned.
2. Manufacturer Qualifications
Manufacturers of cosmetics produced in the Andean region must hold a sanitary operating license, competency certificate, or operational permit to apply for the NSO.
3. Exemptions for Overseas Sales
Cosmetics manufactured in the Andean region but sold exclusively in third countries are exempt from the NSO requirement.
Responsibilities and Rights of NSO Holders
1. Qualifications and Obligations
NSO holders, whether individuals or legal entities, must have a legal address in the member country where the notification is submitted. They are responsible for reporting, modifying, updating, or renewing the NSO with the competent national authorities and ensuring compliance with all relevant regulations for cosmetics sold in the Andean region.
2. Voluntary Cancellation of NSO Code
NSO holders can voluntarily cancel their code through the competent national authorities and must indicate whether the product will remain on the market.
Application Process for the NSO Code
In accordance with Article 9 of the regulation, the NSO application must be submitted through a community-level form, accompanied by the following information:
1. General Information
- Name and representative capacity of the legal representative or agent.
- Name and address of the manufacturer and NSO holder.
- Name and address of the packager and adjuster (if applicable).
- Product name, generic name, cosmetic category, and brand.
- Commercial presentation.
- Cosmetic form.
- Name of the technical responsible person (pharmacist).
- Payment of applicable fees as determined by the member country.
2. Technical Information
- Product description, including qualitative formula.
- International or common nomenclature of ingredients (INCI).
- Sensory and physicochemical specifications of the finished product.
- Microbiological specifications (if applicable) based on product nature and Andean regulatory requirements.
- Technical, experimental, or scientific evidence supporting the cosmetic efficacy of the product.
- Draft label or labeling.
- Instructions for use (if applicable).
- Primary and secondary packaging materials.
- Description of the production batch coding system.
3. Translation Requirements
All information must be provided in Spanish, except for the INCI names of ingredients. For technical studies, translations of key objectives and conclusions are required.
4. Contract Manufacturing
In cases of contract manufacturing, a declaration from the manufacturer must also be included.
Review Process
- Once an application is submitted, it's reviewed by the national regulatory authority.
- The product undergoes evaluation for ingredients, uses, and safety, ensuring compliance with health and safety standards.
- Successful review leads to an NSO code assignment by the health regulatory body.
- This code is essential for product commercialization in the Andean Subregion market.
Subsequent Management
Once the NSO code is granted, the product is authorized for sale across the Andean region. Any modifications or updates to the product may necessitate a new application and potential revision of the NSO code.
Invima has emphasized that the delay is intended to provide additional time for manufacturers, importers, and other industry stakeholders to adapt. The institution will continue to offer guidance to facilitate a smooth transition and ensure compliance. Invima also calls on all relevant parties to stay informed about the regulatory changes and to uphold responsible practices within the industry to safeguard public health.
