The Crucial Role of the Private Sector in Sanitary Registration and Regulation in El Salvador

Our lawyer in El Salvador, expert in Healthcare Law and Life Science shares this article regarding the relevance of the private sector in sanitary registration and regulation. It highlights its participation in various technical regulation committees and the public consultations regarding the Central American Regulation, RTCA 67.01.60:23, on "Nutritional Labeling of Prepackaged Food Products for Human Consumption for the Population from 3 Years of Age."

Sanitary registration is a process through which a regulated product obtains authorization from a health authority to be marketed in a specific region. In El Salvador, different products are subject to regulation, such as processed and pre-packaged foods, pharmaceuticals, cosmetics and hygiene products, medical devices, chemicals, veterinary medicines, pet food, and fertilizers.

The importance of sanitary registration lies in guaranteeing the quality and safety of products on the market. In other words, if a product does not obtain its marketing authorization or is denied by the corresponding entity, it does not meet the technical standards that guarantee they are not a health risk.

The private sector mainly adheres to technical regulations since it produces and makes regulated products available to consumers. Therefore, the private sector plays a significant role in complying with sanitary norms and regulations and in their development.

The Salvadoran legal and regulatory framework is extensive and is based on general health regulations, such as the Health Code, the Medicines Pact, the Pact of Plant and Animal Health, the Pact of the Control of Pesticides, Fertilizers, and Products for Agricultural Use, different Salvadoran Technical Standards and Central American Technical Regulations (RTCA). Since 2011, the Salvadoran Technical Regulation Organization, OSARTEC, has been at the forefront of coordinating the adoption, adaptation, updating, and dissemination of technical regulations issued by various State institutions. OSARTEC also has the authority to create specific committees, such as the National Technical Regulation Committee, composed of professionals and experts in the relevant areas.

The private sector can participate in these committees, contributing with its knowledge and experience to developing Technical Regulations, especially in regulatory matters, which are essential for international trade. As part of the World Trade Organization's Agreement on Technical Barriers to Trade, ORSATEC submits proposed regulations to national and international public consultation. In these processes, the private sector can submit comments and suggestions, ensuring that the regulations benefit the industry without compromising quality and safety.

Currently, two Salvadoran Technical Regulations and one Central American Technical Regulation are in public consultation in El Salvador. The latter, "Nutritional Labeling of Pre-packaged Food Products for Human Consumption for the population from 3 years of age", RTCA 67.01.60:23, has been under review from March 15, 2024, until June 15, 2024. The private sector is invited to provide comments and suggestions to strengthen this regulation, which will establish the requirements for the nutritional labeling of food products, directly impacting the country's food industry. Among the significant changes are:

1. The mandatory inclusion of information about trans fats and total and added sugars.
2. More precise indications on non-addition property claims under specific requirements.
3. The prohibition of labeling foods as "healthy" or presenting them in a way that suggests they are.