🚨 New 2025 Regulation: A Game Changer for Cosmetic and Hygiene Brands
The Dominican Republic has adopted a comprehensive new technical regulation for cosmetics, personal care products, and household cleaners. A broad swath of consumer products is impacted by the new rules – including even household pesticides used to control insects and rodents. The rule provides definitions for the categories as well as lists of covered products.
The regulation applies to all stages of the life cycle of cosmetics, personal care products, and household cleaners: import, export, manufacturing, packaging, storage, distribution, transport, marketing, and commercialization. From how to file for the Mandatory Sanitary Notification to new Good Manufacturing Practices (GMP), it’s comprehensive.
Notable features:
- Products must use INCI ingredient nomenclature, and their labels must be in Spanish, with clear instructions and warnings (set out in detail in the rule).
- GHS labeling required for hazardous consumer products!
- International ingredient lists adopted as official reference (principally EU and US sources) – helping harmonization with EU and US markets.
The technical regulation was adopted by Resolution 0017-2025 on September 8, 2025.
If you are active in any of these consumer product categories (cleaners, cosmetics, or personal care), this new regulation will be impacting your business on the island.
Link to Regulation:
https://digemaps.gob.do/wpfd_file/reglamento-tecnico-de-productos-cosmeticos
GHS for Consumer Products: Growing Trend
Quietly, tucked into a regulation on cosmetics, personal care, and household cleaners, the Dominican Republic – a country that has not yet formally adopted the GHS – jumped ahead in Latin America by requiring GHS labeling for these consumer products. Specifically, “depending on the nature and hazardousness of the products, containers must incorporate, as appropriate … warning labels with safety pictograms and precautionary statements in accordance with applicable international regulations (such as the Globally Harmonized System, GHS).”
Given the breadth of products covered by this regulation – from household pesticides and drain cleaners to cosmetics and personal care – many companies will need to take a look a their labels for products going into the Dominican Republic.
🔑 Key Insight: Expect GHS to come for consumer labels in other countries in the region – Chile and Colombia next.
Link to Regulation:
https://digemaps.gob.do/wpfd_file/reglamento-tecnico-de-productos-cosmeticos
Brazil’s Regulatory Flexibility: Artisanal Personal Care Products
Brazil’s FDA-analog, ANVISA, has posted for public comment rules that implement the earlier law requiring a special regulatory registration process for “artisanal” cosmetics. What started out almost ten year ago as a bill to include artisanal soap makers into a law on recognized “artisans” morphed into a law that requires ANVISA to create this alternative process for legally bringing these handmade products to market.
The proposal could be seen as a weakening of consumer protections and a bold move to reduce regulatory burdens on bringing cosmetics to market in Brazil – a country with complex requirements. Instead, though, it is best seen as a limited scope measure really intended to apply to handmade (not mechanized, non-industrial), low-risk products in limited categories.
The draft includes a separate draft list of product categories – with specific limitations for each – that includes alcohol-based perfume products, solid bath products, solid body soaps, solid shampoos, body oils, and deodorant bars. The draft standard sets out the modified regulatory pathway – and labeling requirements – for covered products.
While industry cannot benefit from the proposal (even products made from industrialized kits don’t qualify), it does show ANVISA’s ability to strike a balance between public safety and commercial opportunities for craftspeople. Such regulatory flexibility may be a plus for industry in other cases – such as the regulatory sandbox (below).
Comments are due by November 26, 2025.
Link to Draft Rule:
https://anexosportal.datalegis.net/arquivos/1918369.pdf
Link to Draft List of Covered Products:
https://anexosportal.datalegis.net/arquivos/1918373.pdf
Brazil’s Regulatory Innovation: Cosmetics and Personal Care
As we previously covered, ANVISA is proving innovative in its approach to new cosmetic products through a program it calls the “regulatory sandbox.” We expect the formal publication of the call for submissions any day now.
In this first pilot project, ANVISA will be looking to select five projects focused on personalized cosmetics solutions at point of sale. Think products with formulations that can be adjusted at the time of sale to meet individual needs or desires like adjusting to your skin tone for a base or mixing lipstick colors to match your coloring.
The projects selected through the process will benefit from temporary, flexible regulatory conditions under Anvisa’s close supervision. The goal is to generate real-world evidence to inform future permanent regulatory frameworks.
🔑Key Insight: This initiative hopefully signals a new era of agile regulation in Brazil — one that embraces innovation without compromising consumer safety.
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