Proposal to modify the Mexican Official Standard NOM-141-SSA1/SCFI-2012 for the correct handling and use of mineral UV filters in cosmetics, whose active ingredients contains nanoparticles of zinc oxide (ZnO) and titanium dioxide (TiO2)
Keywords:
mineral sunscreens, cosmetics, nanomaterials, nanomaterials regulation.Abstract
Nanotechnology has transformed the scientific and technological landscape in recent decades, enabling the manipulation of matter at the nanometric scale, which ranges from 1 to 100 nanometers. This has led to the creation and development of materials with unique physicochemical properties, which have applications in various industries, including pharmaceuticals, cosmetics, food, and electronics. However, its rapid and growing development has outpaced the creation of regulations to ensure the safe and ethical use of these nanomaterials. In Mexico, there has been very little regulation, causing concern at the academic and industrial levels, as there is no strong and solid regulatory framework that specifically regulates the interaction of nanomaterials, from their production to their final disposal. Current Mexican standards, such as NMX-R-13830-SCFI-2020, are voluntary and lenient, and have little impact on consumer health regulation and protection. On the other hand, the Official Mexican Standards, which are strict and mandatory, do not yet cover nanotechnology products, creating a regulatory vacuum that lacks the assessment of risks associated with exposure to nanomaterials. In the unique case of cosmetic products, particularly mineral sunscreens, the use of titanium dioxide and zinc oxide nanoparticles has become common due to their effectiveness against ultraviolet radiation. However, due to their higher chemical reactivity, these nanoparticles can interact inappropriately in biological systems, with the possibility of generating undesirable toxicological effects if not properly controlled. In regions such as the European Union, clear regulations have been established, such as Regulation (EC) No. 1223/2009, which requires the inclusion of the term [nano] on labeling, with characteristics such as concentration limits and pre-marketing safety assessments. In contrast, Mexico lacks similar regulations, causing competitive disadvantages and potential health risks. Therefore, this research work proposes to update NOM-141-SSA1/SCFI-2012 to include specific requirements for the use of nanomaterials in sunscreens for cosmetic use. It suggests the importance of incorporating the figure of a health officer, the obligation to notify Federal Commission for the Protection against Sanitary Risks (COFEPRIS) before marketing products with nanoparticles, and the detailed declaration of active ingredients such as TiO2 and ZnO [nano] on the label. Taken together, these measures can strengthen consumer safety by promoting industrial transparency in Mexico.
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