Dominican Republic Adopts Regulation on Cosmetic, Hygiene and Household Products

By Susana Planas MunGavin BSc., MSc, Senior Regulatory Specialist, Supply Chain Team, UL Solutions

On Sept. 8, 2025, the General Directorate of Medicines, Food and Health Products (Dirección General de Medicamentos, Alimentos y Productos Sanitarios – DIGEMAPS) of the Ministry of Health and Social Welfare (Ministerio de Sanidad Pública y Asistencia Social), of the Dominican Republic, adopted Resolution No. 0017-2025 approving the Technical Regulation on the marketing of Cosmetic, Personal Hygiene and Household Products.

This Regulation aims to strengthen the regulatory controls on cosmetic, personal hygiene and household products to guarantee the quality of products made available on the market of the Dominican Republic.

The growing demand for cosmetics, personal hygiene, and household products requires a comprehensive and robust regulatory framework to guarantee product safety and prevent human health risks.

This Technical Regulation is based on the principles of good practice, in accordance with applicable international and regional standards, serving as a regulatory instrument for the harmonization of product safety requirements with international regulatory frameworks. For example, the Global Harmonized System (GHS) rules are taken into account when labeling products containing hazardous substances, including pictograms, thus promoting trade, responsible innovation and consumer protection.

DIGEMAPS recognises international lists of approved ingredients for the manufacture of cosmetic, personal hygiene and household products as established under the following international standards:

• European Union ingredient lists approved by the European Chemicals Agency, as provided in the European cosmetics ingredient database, Cosing.
• Recommendations on the safety of cosmetic ingredients issued by the Scientific Committee on Consumer Safety (SCCS).
• United States Food and Drug Administration (FDA) approved list of ingredients.
• Any other compiled lists of approved substances published by the Environmental Protection Agency (EPA) of the United States of America and the Personal Care Products Council of the United States of America (PCPC).
• Any further revisions and assessments approved by the Cosmetic Ingredient Review (CIR) of the United States of America.

Registration of all cosmetic, hygiene and household products manufactured in the Dominican Republic as well as those being imported and/or exported is required under the Regulation.

For this purpose, manufacturers, importers and/or exporters of products are required to submit a Mandatory Sanitary Notification (Notificación Sanitaria Obligatoria – NSO) to DIGEMAPS before the start of their activities.

A declaration of ingredients is required for each product according to the nomenclature of the International Nomenclature of Cosmetic Ingredients in English, or in Spanish, identifying the use and application intended for each ingredient. Therefore, in the event of modifying product composition, the applicable NSO must be updated.

Each NSO has a unique identification code and is valid for five years. To renew its validity, the relevant registration application form must be submitted to DIGEMAP, at least 3 months prior to its expiration.

Product registration fees vary from DR$5,000 for an ordinary registration procedure and DR$9,000 for simplified procedure for lower risk products, which are registered on the same day of application.

Products placed on the market are required to display applicable labels written in Spanish, with information, such as product name, composition, manufacturer’s and distributor’s contact details, expiration date, use and storage instructions, NSO identification code, hazard pictogram, if applicable, precautionary statements, as well as instructions in the event of a spill or accident. The Regulation provides an exhaustive, but not limiting, list of precautionary statements in Spanish that are required on the product label according to associated risks for each type of product.

In addition, all economic activities, including the manufacture, import or export of any products are subject to obtaining an authorization. DIGEMAPS maintains a register of all authorizations granted, which must be renewed every 5 years.  Authorizations are subject to a fee ranging from DR$7,000 for manufacturing sites and DR$6,000 for import and/or export activities.

Good Manufacturing Practice (GMP) must be implemented at registered sites. Manufacturing sites must hold a GMP certificate, which must be renewed every 2 years. Registered distribution sites are required to implement Good Storage Practice (GSP) procedures, and hold a GSP certificate, renewable annually, to ensure compliance and guarantee product safety during handling and storage.

References

Resolution No. 0017-2025 on the Technical Regulation of September 8, 2025 on the marketing of Cosmetic, Personal Hygiene and Household Products

General Law on Health 42-01

European Union Cosmetic ingredient database Cosing