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Nanomaterials 2020, 10, 979 7 of 16 should be accounted for. Apart from skin exposure, oral exposure—to NMs existing in toothpastes, Nanomaterials 2020, 10, x FOR PEER REVIEW 7 of 16 mouthwashes, and lipsticks—is also possible. Figure 3. Schematic outline for the nanomaterial safety assessment in cosmetics based (but modified) on Figure 3. Schematic outline for the nanomaterial safety assessment in cosmetics based (but modified) SCCS (Scientific Committee on Consumer Safety), Guidance on the Safety Assessment of Nanomaterials on SCCS (Scientific Committee on Consumer Safety), Guidance on the Safety Assessment of inCosmNeantoimcsat,erOialcst2o02b0e,1r0,2x0F1O9R,PSECERCRSE/V1I6E1W1/19[13]. 8of16 Nanomaterials in Cosmetics, October 2019, SCCS/1611/19 [13]. One of the most important aspects to take into consideration is the NMs’ routes of exposure. The primary route is skin exposure with the stratum corneum as the first layer of epidermis. There are still some uncertainties regarding the possibility of NMs penetrating through the stratum corneum into viable layers, where toxicological concerns may arise [55]. In Figure 4, a schematic of the structure of the human skin is presented. Although very small NMs still have much larger molecular weights compared to known molecules which penetrate the skin, further tests for every NM to be used in a cosmetic formula should be performed. Extra attention to safety assessment should be given to sprays or aerosols that may contain NMs, because exposure via inhalation is possible. The SCCS Notes of Guidance (SCCS/1602/18) included a non-exhaustive list of parameters that are required for an exposure scenario. For NMs, in addition to the weight-based concentration of the NM, the concentration should also be given in terms of particle number concentration and surface area. Also, changes in the aggregation and/or degradation/dissolution status of the NM during exposure should be accounted for. Apart from skin exposure, oral exposure—to NMs existing in toothpastes, mouthwashes, and lipsticks—is also possible. (a) (b) Figure4.(a)FiTgwuroem4.a(ian) Tpwoossmibalienspkoisnsipblensektirnatpieonnetpraatitohnwpaythswaaryesilalruesitlrluastteradt.edT.hTehenannanoomaterriaiall(i()i)entersvia enters via hair follicles (the follicular penetration pathway) and (ii) diffuses through the gaps hair follicles (the follicular penetration pathway) and (ii) diffuses through the gaps between corneocytes between corneocytes (the intercellular penetration pathway). Reproduced with permission from [80]. (the intercellular penetration pathway). Reproduced with permission from [80]. Copyright Springer Copyright Springer Nature, 2015; (b) Schematic of the structure of human skin. The epidermis Nature, 2015; (b) Schematic of the structure of human skin. The epidermis consists of five thin layers, consists of five thin layers, with the outmost layer, the stratum corneum, largely providing the vital withtheoubtmarroiesrtfulanycteiorn,tohfethsetsrkaintu.Rmepcrodruncedumwi,thlapregrmelisysiponrofrvoimd[i2n]g.CtohpeyrvigihtatEllbseavrireire,2r0f1u2.nctionoftheskin. Reproduced with permission from [2]. Copyright Elsevier, 2012. 4. Regulations 4. RegulationsIn the EU, the main regulatory framework for cosmetic products is the EC Regulation 1223/2009. Based on this framework, a list of all NMs that are in use in cosmetics should be available to all In the EU, the main regulatory framework for cosmetic products is the EC Regulation 1223/2009. consumers. The last updated catalogue consisted of 29 NMs. This catalogue is for consumer Based on thinifsorfmratmioen,wanodrkit,daoelsinsottonfecaesllsaNrilMy msetahnathtaat arell pinroduscets ilinstecdoisnmiteatreicasutshhooriuzeldNbMes.aVvearyilable to all recently (i.e., October 2019), the EC updated the existing guidance for nanomaterials in cosmetics with the Guidance on the Safety Assessment of Nanomaterials in Cosmetics, with the help of the SCCS (SCCS/1611/19). The SCCS provides guidance from industries to public authorities to ensure compliance with the EC No 1223/2009, regarding safety assessment of NMs intended for use as cosmetic ingredients. It should be noted that based on the Guidance SCCS/1484/12 from 2012, a complete animal testing ban has come in force under the Cosmetics Regulation since March 2013, and alternative methods for the safety assessment of cosmetic ingredients have been followed everPDF Image | Nanomaterials in Cosmetics: Recent Updates
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