The recent Decree No. 224, which amends the Law of the Superintendency for Health Regulation of El Salvador, introduces a significant shift in health regulation by excluding products related to breast milk substitutes and complementary feeding from the general regulatory framework and returning them under the jurisdiction of the Ministry of Health. By adding a second paragraph to Article 3 of the aforementioned law, this decree has key implications for the way these products will be managed in the country.
1. Overview of the Reform
Decree No. 224 introduces a second paragraph in Article 3 of the Law of the Superintendency for Health Regulation, with the objective of transferring the exclusive authority for the sanitary registration of breast milk substitutes and complementary feeding products from the regulatory body, the Superintendency for Health Regulation, to the Ministry of Health. This transfer grants the Ministry of Health exclusive authority over the registration and import authorization of these products, in its role as the governing body of the National Integrated Health System.
2. Legal Basis
The reform is based on the Law of Love Transformed into Food for the Promotion, Protection, and Support of Breastfeeding, which aims to promote, protect, and support breastfeeding in El Salvador. Article 8 of this law establishes the definitions of breast milk substitutes and complementary feeding, key concepts that guide the scope of the reform.
This specific regulation defines the products considered as substitutes and establishes the conditions under which they may be used as alternatives to breastfeeding. The law also sets guidelines to ensure that these products are appropriate, safe, and healthy for child development.
3. Legal Implications
Positive Aspects:
- Centralization of the Registration Process: By transferring the authority for sanitary registration to the Ministry of Health, the reform optimizes the centralization of administrative procedures, allowing for more coherent and coordinated management of these products within the national health system. This measure ensures that the regulation of breast milk substitutes and complementary feeding products aligns with the public health policies implemented by the Government of El Salvador, enhancing child protection.
- Greater Specialization: In addition to the previous point, assigning the responsibility for sanitary registration to an entity with more experience and resources in public health leads to greater specialization in evaluating products related to breastfeeding. This is crucial to ensuring that such products are genuinely beneficial and do not pose a risk to children’s health.
- Potential Acceleration of Administrative Processes: With the centralization of responsibility within the Ministry of Health, the approval process for sanitary registration of these products could be expedited, as a single entity would be exclusively responsible for their evaluation and approval. This contributes to administrative efficiency and facilitates access to products that meet established standards for the population in need.
Potential Challenges:
- Need to Strengthen the Ministry of Health’s Technical Capabilities: The transfer of this authority to the Ministry of Health may require the reinforcement of its technical capacities to ensure the efficient evaluation and registration of these products based on the applicable regulations. This could imply the need for additional resources, both in terms of personnel and infrastructure.
- Possible Reduction in Multilateral Control Mechanisms: The exclusive transfer of the registration and import authorization authority to the Ministry of Health may limit the participation of other technical and regulatory bodies, potentially creating a perception of reduced multilateral oversight over these products. This concern could be mitigated by implementing appropriate verification and control mechanisms, not only during pre-registration but also—critically—during post-registration monitoring.
- Risk of Discretionary Decision-Making in the Registration Process: Concentrating the registration process within a single entity could make it more susceptible to discretionary decision-making if clear and transparent procedures are not established and publicly disclosed for all stakeholders involved, from manufacturing laboratories and importers to distributors, retailers, and end users. It is essential to ensure that the process is properly monitored and regulated to prevent potential transparency issues.
4. Constitutional Perspective
Decree No. 224 upholds the principle of the Ministry of Health’s authority, as established in the Constitution and related public health legislation. This principle grants the Ministry of Health the responsibility to ensure the health and well-being of the population, particularly in sensitive areas such as breastfeeding and infant nutrition.
The reform aims to optimize health protection processes, ensuring that the registration of breast milk substitutes and complementary feeding products is managed under strict criteria aligned with the recently approved national health policies. Through this centralization, greater efficiency and effectiveness in public health protection are expected, always respecting the fundamental rights of children and ensuring access to safe and appropriate nutrition.
Final Considerations
In conclusion, Decree No. 224 represents a significant advancement in the regulation of products related to breastfeeding and complementary feeding in El Salvador. While the centralization of the sanitary registration authority within the Ministry of Health offers benefits such as streamlined procedures and increased specialization in product evaluation, it also presents challenges that must be carefully addressed.
Aligned with the constitutional principles of the Ministry of Health’s authority, this reform seeks to optimize health regulatory processes and protect child health, reaffirming the country’s commitment to early childhood protection, promoting breastfeeding, and ensuring the well-being of the most vulnerable populations.
In El Salvador, we have over 25 years of regulatory experience, and we are ready to advise any entity interested in this industry.
For more information, contact us: info@central-law.com
Elena Isabella De Sabata
Senior Associate
El Salvador
