Cosmetic products are part of our daily life as they provide us with hygiene, we use them for the care of our skin, they give us satisfaction when we apply them to enhance the beauty of people, and they are also part of medical treatments that allow us to improve or recover our health.
Therefore, all cosmetic products must be subject to strict regulation to ensure their safety and quality. In El Salvador, the entity empowered to perform this activity is the National Directorate of Medicines (Art. 1 of the Law of Medicines), where they ensure accessibility, registration, quality, availability, efficiency, and safety of cosmetic products for the entire population, promote the best price for the public and private user as well as the rational use of the products.
As there are similarities in the Central American region in the registration criteria of cosmetic products, there is a Technical Committee for Standardization and Technical Regulation where the countries Guatemala, Honduras, Nicaragua, Costa Rica, and El Salvador meet. Which based on consensus, issue regulations that provide the requirements and necessary information that must be verified cosmetically and among which we can mention:
- RTCA 71.01.35:06 Cosmetic Products. Registration and Sanitary Registration
- RTCA 71.03.36:07 Cosmetic Products. Labeling
- RTCA 71.03.45:07 Cosmetic Products. Quality Verification
- Annex 5 of Resolution No. -2008 (COMIECO-L)
It is important to emphasize that for a product to be classified as cosmetic, it must comply with the definition given by the regulation: “It is any substance or preparation intended to be placed in contact with the various superficial parts of the human body (epidermis, hair, and capillary systems, nails, lips, and external genital organs) or with the teeth and oral mucous membranes, with the exclusive or main purpose of cleaning them, perfuming them, modifying their appearance and/or correcting body odors and/or protecting them or keeping them in good condition”. However, at the registration level the cosmetic product that, due to its composition, is attributed therapeutic properties, must be registered as a drug and comply with the specific requirements.
The information currently required to proceed with the registration of cosmetic products in El Salvador is:
Before registration:
- Registration of Importer and Authorized Distributor.
- Registration of Responsible Proxy and Responsible Professional.
For registration:
- Certificate of GMP or manufacturing authorization documents duly legalized.
- Complete qualitative formula, in INCI nomenclature, including the percentages of the substances included in the COSING annexes.
- Finished product specifications, according to RTCA 71.03.45:07.
- Original packaging or legible drafts, according to RTCA 71.03.36:07.
- Other technical information as desired.
In addition, it is vital to know that products with the same basic qualitative composition, use, cosmetic form, and generic name, which have different organoleptic properties (color, odor, and flavor), as well as dyes with the same qualitative composition of their colorants, may be registered as Cosmetic Group.
It is also feasible to request Mutual Recognition for cosmetic products manufactured in the Party States (Guatemala, Honduras, Nicaragua, and Costa Rica), provided that the following requirements are met:
- Power of Attorney granted to the Responsible Power of Attorney and Responsible Professional who will process the recognition of the product in the country, duly legalized.
Note: With the presentation of this requirement, the sanitary authority will grant the interested party an opinion number, which must be referred to when making other recognitions.
- Certificate of Free Sale or Certificate of Sanitary Registration issued by the Sanitary Authority of the first legalized country.
- Sheet stamped by the authority with the qualitative formula issued by the manufacturer declaring the quantities of the restricted or controlled substances.
- Specifications of the finished product.
Undoubtedly, for cosmetic product manufacturers having the registration in the due form will allow them to have the confidence of the general public since it is understood that the quality and safety comply with international standards.
If you need any advice, please contact our team of professionals in the area of Life Sciences-Regulatory Affairs at info@latinalliance.co