On April 19, 2022, Decree 125-22 came into force, which regulates processes related to the registration of cosmetics and personal and household hygiene products, as well as the control and supervision procedures related to their commercialization, whose provisions in summary are shown below:
1) It provides a definition of Cosmetic Product and Personal Hygiene Product, broader to that contained in the General Health Law No. 42-01, by stating:
a. Cosmetic Product: Any substance or preparation intended to be put in contact with the various superficial parts of the human body or with the teeth and oral mucous membranes, with the exclusive or main purpose of cleaning, protecting or maintaining them in good condition, modifying their appearance or perfuming them or correcting odors.
b. Personal hygiene product: Any substance or preparation intended to be applied to healthy skin or mucous membranes, with the exclusive or main purpose of combating the growth of microorganisms, preventing or eliminating parasites or eliminating sanitary risks.
2) On the other hand, instead of a sanitary registration, the reference category will be processed by obligatory sanitary notification (NSO) defined as: “Procedure through which the holder or legal representative requests to the General Directorate of Medicines, Food and Sanitary Products (DIGEMAPS), -an agency attached to the Ministry of Public Health (MSP)- the authorization to commercialize a cosmetic product or a personal hygiene product in the national territory”; which must be verified and authorized before its commercialization.
3) It ratifies the attributions of DIGEMAPS to monitor, control and verify the information contained in the NSO and the other related processes, which guarantee the safety and quality of the product.
4) Without further content, the Decree grants a term of 4 months from the publication of the Decree for the MSP to issue a technical regulation for cosmetics and hygiene products, and 6 months for surveillance controls.
5) The decree repeals all provisions for cosmetics and hygiene currently provided for in the Regulation of Medicines 246-06, so that, from the provisions of this Decree, the new technical regulation is the one that regulates all cosmetic processes.
Finally, it states that the certificates of good practices and certificates of free sale of local emission, without specifying a particular category, will have a duration of 2 years of validity instead of only one year as it was until now.
Please do not hesitate to contact us for any clarification or comments that may arise from this information.
Contact our expert lawyers in Sanitary Registrations – Intellectual Property and New Technologies Department. [email protected]/ [email protected].
