El Salvador Cosmetic Product Registration

COSMETIC REGISTRATION IN EL SALVADOR Regulatory Authority

Imports, Exports, and Donations Unit of the National Medicine Directorate (DNM)

Link for Regulatory Authority

https://www.medicamentos.gob.sv/

Regulations of the Medicines Law of April 2012

Who can Register? 

• Local legal representative 
• Importer,
• Pharmaceutical chemical representative 

If necessary, a power of attorney must be in Spanish or translated into Spanish if essential and notarized or apostille.

The DNM requires the following documentation for sanitary registration of cosmetic products:

1.   Form for Sanitary Registration (which requests information on the product name, manufacturer, importer, legal representative, etc.)
2.  A Good Manufacturing Practices Certificate from the nation where the manufacturer is located, issued by a regulator, or recognised entity.
3.  Power of attorney on the Legal Representative’s behalf.
4.  A qualitative full formula supplied by the producer that specifies the quantity of banned chemicals and is signed and approved by the local pharmaceutical chemical representative.
5.  The manufacturer’s specifications for the finished product
6.  The item’s original packaging. It is not acceptable to submit a copy. The labels must be written in Spanish.
7.  Payment receipts for the registration process, which will contain the fees for the various analyses.

Once all the documents are submitted, the DNM will issue a sanitary certificate within ten business days. All documents should be authenticated or apostille. The registration is valid for five years. The registration fee is US$75 per product, and the renewal fee is US$25.

Labelling:  The Ministers Council of Economic Integration (COMIECO) in Central America has approved Resolution No. 467-2022 to introduce the new Central America Technical Regulation for the Labelling of Cosmetic Products (RTCA71.03.36:21).

Under the new regulation, cosmetic products manufactured or imported without secondary packaging must incorporate labelling requirements directly on the primary package. Additionally, if the labelling is not in Spanish, supplementary labelling must be provided, with the option of using inserts.

The minimum labelling requirements for cosmetic products include:

• Product’s commercial name
• Cosmetic form
• Sun protection factor.
• Declared net quantity.
• Name of the holder of sanitary registration and country of origin
• List of ingredients
• Lot declaration.
• Safety information
• Product expiration date, and
• Any additional information deemed necessary.

Castilian/Spanish language is required, with translations as necessary. Among the modifications directly addressed by this section is a change of manufacturer, a change of ownership, a formulation change, a change of either the manufacturing company name or the owner’s name, a product name change, the addition of an alternate manufacturing facility, a change in packaging/presentation, adding or removing shade(s), variants or fragrance(s), change/addition/removal of a distributor, and a change of legal representative.