Good Manufacturing Practices to manufacture cosmetic products in the Andean Community (CAN)
The Andean Technical Regulation sets clear guidelines to ensure the quality and safety of cosmetic
products manufactured, packaged, or processed in the member countries of the Andean Community.
This regulation applies to all companies and establishments involved in the production, packaging, or
processing of cosmetics, including imported products, which must comply with the established Good
Manufacturing Practices (GMP) or equivalent international standards.
Requirements for Sanitary Authorization
The National Competent Authorities (NCA) of each member country require strict compliance with the
Andean Technical Regulation as a prerequisite for granting the sanitary authorization for operation or
the capacity certificate. This compliance is a prerequisite for obtaining the Mandatory Sanitary
Notification (NSO) for cosmetic products, which permits the legal commercialization of these products in
the region.
Good Manufacturing Practices (GMP) Certification
While GMP certification is voluntary, it is valid for three years in Bolivia, Ecuador, and Peru, and for five
years in Colombia. It is important to note that even though this certification is not mandatory, imported
cosmetic products intended for sale in the Andean Subregion must comply with GMP according to the
regulation or equivalent international standards. Companies must be mindful of renewing this
certification, which must be requested at least three months before its expiration to avoid disruptions.
Consequences of Non-Compliance
The regulation, which came into effect on December 17, 2023, stipulates that in the event of non-
compliance with GMP or if inspections by the NCA are obstructed, these authorities can impose
sanctions ranging from fines to the suspension of the establishment's sanitary authorization. This
underscores the importance of strictly adhering to the established standards.
Documentation and Quality Control
Companies operating under this regulation are required to document and record all procedures related
to GMP. Any changes in production processes that may affect the quality of the product must be
approved by authorized personnel and properly recorded. This rigorous documentation control is crucial
for maintaining traceability and ensuring the quality of cosmetic products in the market.
Product Recall Plan
In the event that quality issues are detected in commercialized products, companies must have an
effective plan to quickly and efficiently recall such products from the market. Additionally, it is
mandatory to notify the relevant authorities about any product recalls, thereby ensuring consumer
safety and compliance with current regulations.
In summary, compliance with the Andean Technical Regulation is essential for companies that
manufacture, package, process, or import cosmetic products in the member countries of the Andean
Community. This regulatory framework not only ensures the quality and safety of the products but also
protects consumer health, promoting responsible and sustainable trade in the region.