Table 11.

Legislation on cosmetic products in India, USA, and Europe.

Contents	India	USA	Europe
Governing authority	Central Drugs Standard Control Organization (CDSCO)	Food Drug Administration (FDA)	European Union Regulatory Authority (EUMA)
Rules and regulations	Drugs and Cosmetics Act, 1940, and Rules 1945 Bureau of Indian Standards (BIS)	Food, Drug & Cosmetic Act (FD&C Act)	Council Directive 76/768/EEC, 1976 Revised Regulation EC 1223/2009
Purpose	BIS regulates the standards for cosmetics products described under Schedule “S” of the Drugs and Cosmetics Rules 1945	Enforcement of laws governing the marketing of cosmetics prohibits the marketing of adulterated or misbranded cosmetics in the market	Provides comprehensive categorization of cosmetic products on the basis of function, zone of application, and product constitution
Cosmetics	Any article envisaged to be poured, rubbed, sprinkled, or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, alluring, beautifying, or changing the appearance, and entails any article intended for use as a component of a cosmetic.	Any article envisaged to be poured, rubbed, sprinkled, or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, alluring, beautifying, or changing the appearance, and entails any article intended for use as a component of any such articles; except that such term shall not include soap.	Any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.
Registration	Required	Through Voluntary Cosmetic Registration Program (VCRP) (Not mandatory)	For market authorization, an applicant must provide a degree of information in the application form.
Pre-market approval	Required under state government licensing	Not required	Not required
GMP compliance	Yes	Yes Not mandatory	Yes ISO 22716 is the reference guide to GMP implementation and assessment
Level of microbial contamination		Follows the guidelines of the Personal Care Products Council (PCPC), formerly the Cosmetic, Toiletry and Fragrance Association (CTFA)	Scientific Committee on Consumer Safety (SCCS) Guideline “SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 9th revision”
Post-marketing survey and Reporting system	No specific guidelines	Follows Voluntary Cosmetic Regulation Program (VCRP) reporting system	No specific guidelines
References	[298,299,300]	[24,294,295,296,298,301,302,303]	[24,222,298,299,304,305]