2. Unit 4
• Design of cosmeceutical products:
• Sun protection, sunscreens classification and regulatory aspects.
• Addressing dry skin, acne, sun-protection, pigmentation, prickly heat,
wrinkles, body odor., dandruff,
• Dental cavities, bleeding gums, mouth odor and sensitive teeth through
cosmeceutical formulations
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38. REGULATORY ASPECTS FOR SUNSCREENS
• Considering the increasing attention to sun screen products and
globalization of their market, international harmonization of product
regulation would be useful.
• Two major international organizations have been working in this sense,
the International Organization for Standardization (ISO) and the
International Cooperation on Cosmetics Regulation (ICCR).
• The ICCR is composed of experts from the USA (FDA), Canada (Health
Canada), Europe (European Commission, DG Enterprise) and Japan (Ministry
of Health, Labour and Welfare).
• It is important to have stringent safety assessment of their potential to
produce local toxicity, such as irritation, sensitization, phototoxicity,
acute toxicity, dermal absorption/penetration, sub-chronic toxicity,
genetic toxicity, carcinogenicity and photo-carcinogenicity etc. for the
sunscreen chemicals in this country.
39. • SPF rating for cosmetic products and drugs needs to be fixed
and guidelines for label claims on these products should be
developed.
• SPF labelling should be made mandatory.
• Standard for sunscreen products should be fixed and made
statutory.
• There is need to redefine “cosmetic” in global perspective.
40. • The protection against UV radiation offered by sunscreens
was recently standardized in the European Union (EU) based
on international harmonization of measurement techniques.
• Four different categories of sun protection have been
implemented along with recommendations on how to use
sunscreen products in order to obtain the labelled
protection.
41. The UV filters in sunscreens have long been authorized for use
by the EU authority on the basis of data from studies on acute
toxicity, subchronic and chronic toxicity, reproductive toxicity,
genotoxicity, photogenotoxicity, carcinogenicity, irritation,
sensitization, phototoxicity and photosensitization as well as on
environmental aspects
42. New challenges with respect to the safety of UV filters have arisen
from the banning of animal experiments for the development of
cosmetics.
Future debates on sunscreens are likely to focus on nanoparticles
and environmental issues, along with motivation campaigns to
persuade consumers to protect their skin.
However, more efficient sunscreen use will also continue to raise
questions on the benefit in preventing vitamin D synthesis in the
skin induced by sunlight.