Regulatory Concerns for Nanomaterials in Sunscreen Formulations

Author(s): Kamla Pathak*, Satyanarayan Pattnaik, Amit Porwal.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 5 , Issue 2 , 2018

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Abstract:

Background: There has been a phenomenal rise in the nanomaterial-based cosmetic formulations in the market, raising serious concerns over the possible biological impact on humans, animals and the environment as a whole. However, scarce reports can be found on the safety assessment of nanomaterials incorporated in cosmetic formulations including sunscreens. Hence, uncertainties loom for their safe use in cosmetics including those applied dermatologically. Unfortunately, not much research has been devoted to assess the safety profile of nanomaterials in cosmetics and the possible health hazards. As a large number of nanotechnological sunscreen products containing diverse sun filters against UV exposure are penetrating the market, the importance of adequate assessment of nanomaterial exposure, its toxicokinetics including biodistribution, and other health risks is now widely recognized.

Objective: The write up presents an overview of the nanomaterials used in sunscreen products and discusses the various laws and regulations in force in various countries. The review focuses on the current safety and regulation of nanomaterials in sunscreens.

Conclusion: While many countries have their own set of regulatory guidelines, it is high time to have a globally acceptable guideline framework to protect both the consumers and manufacturers for safe use, manufacture and sale of nanotechnology-based cosmetics. Harmonization across the globe is desirable.

Keywords: Sunscreen, nanomaterials, nanoparticles, regulations, SPF, ultraviolet.

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Article Details

VOLUME: 5
ISSUE: 2
Year: 2018
Page: [99 - 111]
Pages: 13
DOI: 10.2174/2213476X05666180601103853

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