El Salvador’s Superintendence of Sanitary Regulation (SRS) published in the Official Gazette of October 20, 2025, the Regulations for the Operation of Small Regulated Businesses, a special framework aimed at facilitating the formalization and growth of microenterprises that manufacture, process, or market cosmetic products, hygienic products, prepackaged foods, and soft orthopedic and support products.
The purpose is to promote formalization and ensure minimum quality and safety standards in the production and sale of products for human and veterinary use, without imposing disproportionate administrative burdens.
Individuals or legal entities classified as microenterprises and duly registered with the National Commission for Micro and Small Enterprises (CONAMYPE) may operate under this regulatory framework.
Scope and classification of small businesses
The regulation applies to those who manufacture, process, package, repackage, label, store, distribute, or market the regulated products.
Establishments are classified according to their activity into:
- Small businesses manufacturing cosmetic products for human use.
- Small businesses manufacturing cosmetic products for veterinary use.
- Small businesses manufacturing hygienic products.
- Small businesses manufacturing prepackaged foods.
- Small businesses manufacturing soft orthopedic and support products.
Each business must obtain an annual operating license, which may cover one or several categories depending on the activities requested. The Superintendence will maintain an official registry of authorized small businesses.
Operating licenses for small businesses
The Regulations require that small businesses obtain an Operating License corresponding to the activities they perform: manufacturing, processing, packaging, wrapping, labeling, storage, distribution, and/or marketing of cosmetic products for human and veterinary use, hygienic products, prepackaged foods, and soft orthopedic and support products.
Obligations and good manufacturing practices
Business owners are responsible for ensuring the quality and safety of their products and must comply with several obligations, including:
- Denaturing or removing from the market any product that poses a health risk.
- Reporting any detected quality or safety failures to the SRS.
- Keeping detailed records of suppliers, raw materials, batches, and manufacturing and expiration dates.
- Ensuring adequate sanitary and hygienic conditions in facilities, equipment, and storage áreas.
- Training personnel in good manufacturing practices or food handling practices.
- Submitting to periodic sanitary inspections conducted by the authority.
The regulation also establishes explicit prohibitions, such as operating without proper authorization, using expired raw materials, or attributing therapeutic properties to non-pharmaceutical products.
Product commercialization licenses
In addition to the operating license, every regulated product must obtain a Product Commercialization Permit issued by the Superintendence.
This permit is valid for five years and authorizes the distribution and sale of products exclusively within El Salvador. The regulation clarifies that these permits are not eligible for Central American mutual recognition mechanisms, meaning the products cannot be exported under this simplified regime.
The SRS may deny commercialization if products fail to meet technical or sanitary requirements, contain prohibited substances, or pose a health risk.
Labeling requirements and sanitary control
The regulation requires that all information on product labels be provided in Spanish, be truthful and verifiable, and not mislead consumers regarding the nature or composition of the product. Additionally, cosmetic and hygienic products may not have an expiration date exceeding 12 months from their manufacturing and packaging.
The authority may conduct inspections, seizures, and permit suspensions when noncompliance is detected, in order to safeguard public health.
Preferential fees and technical support
Recognizing the special nature of this regulation, the SRS will establish preferential and proportional fees for small businesses in relation to the procedures and services regulated.
It will also provide training in good manufacturing practices to strengthen the technical capacity of the sector.
International references
The regulation incorporates international technical references such as the European Union’s CosIng cosmetic ingredient database, the Personal Care Products Council (PCPC) ingredient lists, and Codex Alimentarius standards, ensuring that locally manufactured products meet international safety standards.
