On March 10, 2021, Exempt Resolution No. 199, dated February 26, 2021, of the Ministry of Health was published in the Official Gazette, which declares that products intended for hand sanitizing, with antibacterial action ingredients, correspond to a special cosmetic, called “hand sanitizer”, considering that, due to the sanitary emergency caused by the outbreak of COVID-19, the use of this type of products by the population increased.
In this regard, it should be noted that, according to the Regulation of the National Cosmetics Control System, a special cosmetic corresponds to those that carry a risk in its use due to its formulation, concentration of active ingredients or its purpose, requiring a special indication of use.
On this basis, the new Resolution establishes the ingredients that this new special cosmetic may contain in its formulations.
Likewise, the margins under which such products may be promoted are determined, which, among other things, may not make reference to actions of sanitary products or biocides for human hygiene, make recommendations for use as cleaning and/or disinfection of inanimate surfaces, or directly or indirectly attribute therapeutic properties, or include certain words in its labeling.
For those holders of cosmetic registrations or notifications of products intended for hand hygiene that contain the ingredients indicated in the Resolution, a term of 120 days from the publication in the DO of this resolution is established, to carry out the modifications in the formulations, labeling, promotion and registration of the same.
The same term is established for those “hand sanitizers” that have cosmetic registration and are promoted with the phrase “eliminates 99.9% of bacteria” or other similar ones, to submit the scientific-technical support studies to the ISP.