SANITARY REGISTRATION OF COSMETIC, HYGIENIC, AND CHEMICAL PRODUCTS IN EL SALVADOR.
REQUIREMENTS FOR SANITARY REGISTRATIONS:
- Special power of attorney granted by the person who will hold the sanitary registration, in our favor to appoint a Responsible Attorney and a Responsible Professional (Pharmaceutical Chemist). We provide the template. If this document originates from abroad, it must be submitted in original form, duly notarized and apostilled.
- Special power of attorney for distribution granted by the future holder of the sanitary registration, in favor of the company that will have the function of importing and distributing products once registered. If this document originates from abroad, it must be submitted in original form, duly notarized and apostilled. (A template is provided.) For cosmetic products, this is an essential requirement
- Certificate of Free Sale for each product, original, duly apostilled
- Certificate of Good Manufacturing Practices from the manufacturer, issued at least one year prior to submitting the procedures, original, duly apostilled
- Complete qualitative formula, indicating the quantities of restricted substances, if any, with the signature and seal of the manufacturer's responsible technical professional
- Finished product specifications, detailing important information, as the specifications must include:
- a) Organoleptic characteristics
- b) Physical and chemical tests
- c) Microbiological tests (which must be performed on all cosmetics, except those that are not susceptible to microbiological contamination by their nature)
- d) When the manufacturer Perform other tests; you must declare them.
Product Safety Data Sheet (MSDS)
Original packaging or legible drafts thereof.
If the holder is not the same as the product manufacturer, a manufacturing contract or manufacturing authorization document is required. We provide the template, and if it comes from abroad, it must be sent in original form, duly notarized and apostilled.
COSTS:
Our fees are USD 400.00 per product or group of products if they are from the same product family and only differ in scent or color.
Official Fees:
Registration Fees: USD 240.00
Registration of Power of Attorney, Responsible Professional, and Distributor: USD 96.00
Annual Renewal of Authorization and Maintenance Fee: USD 60.00 (Annual payment for the duration of the registration).
TIMEFRAME
The sanitary registration process for cosmetic products can take approximately 3-6 months.
REQUIREMENTS AND PRICE LIST FOR HYGIENIC PRODUCTS IN EL SALVADOR
REQUIREMENTS FOR SANITARY REGISTRATION:
- Special power of attorney granted in our favor to represent you, which must be submitted in original, duly notarized and apostilled (we will provide you with the template upon acceptance of our offer)
- Certificate of Free Sale issued by the health authority of the country of origin, duly legalized by apostille.
- Qualitative and quantitative formula signed and stamped by the Professional Responsible for registration
- Safety Data Sheet with the stamp of the health authority of the country of origin
- Legible packaging or plans
- Distribution power of attorney granted to a A national company will be listed as the importer of the product, which must be submitted in its original form, duly notarized and apostilled (we will provide the template upon acceptance of our offer).
COSTS:
Our fees are USD 400.00 per product.
Official Fees:
Registration Fees: USD 240.00
Registration of Power of Attorney, Responsible Professional, and Distributor: USD 96.00
Annual Renewal of Authorization and Maintenance Fee: USD 60.00 (Annual payment for the duration of the registration).
REQUIREMENTS AND FEES FOR CHEMICAL PRODUCTS IN EL SALVADOR
The requirements and fees for applying for sanitary registrations of chemical products are:
REQUIREMENTS:
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- Safety Data Sheet/Data Sheet for the product issued by the manufacturer or foreign supplier recently issued.
- Technical data sheet or technical or usage literature for the product issued by the national or foreign manufacturer or foreign supplier, when applicable, no more than five calendar years old.
- Clear and legible image of the product or its labeling where it is possible to identify the product name and the unit of volume or weight of each commercial presentation.
(In case, due to the characteristics of If the commercial presentation lacks labeling, a written explanation of the reasons for the lack of labeling must be attached for consideration.
Declaration of Chemical Composition including: product trade name, chemical names of components, CAS number, percentage of the substance, and sworn statement (not applicable for issuing certificates and attestations).
Technical information verifying the foreign supplier of the product (when applicable).
Certificate of Analysis (when applicable)
Manufacturer's Good Manufacturing Practices (when applicable)
NOTES:
- Substances controlled by the SRS (Sanitary Regulations) must be declared with their respective percentage and CAS number in the Declaration of Chemical Composition.
- If the information provided does not detail the chemical composition, a document issued by the manufacturer specifying it must be submitted.
- All documentation must be submitted in Spanish or with a translation.
COSTS:
Our fees are USD 400.00 per product.
Official Fees:
Registration Fees: USD 15.00 per product.
Registration of Power of Attorney, Responsible Professional, and Distributor: USD 96.00
Annual Renewal of Authorization and Maintenance Fee: USD 5.00 (Annual payment for the duration of the registration).
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Document Translations
At GOLD SERVICE we also provide translation services for simple and certified notarial documents
in English and Spanish, performed by accredited translators.
This service complements our services for company formation, trademark registration, health registration, ensuring compliance with the linguistic and legal requirements of national and international institutions.
