565 A COMPARATIVE EVALUATION OF COSMETIC LEGISLATIONS IN INDIA enforced from December 15, 2020. The key amendments done in new Cosmetic Rules, 2020 are as follows. The concept of “new cosmetics.” The concept of new cosmetics is introduced in new Cosmetic Rules, 2020 and was not present in previous regulations. The term “new cosmetic” is defined as “a cosmetic which contains a novel ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature.” According to the rules, manufacturers or importers must seek the approval from the Central Licensing Authority before applying for a license or the registration of new cosmetics in India. The safety data information should made be available with Central Authority and the product must comply the safety standards specified by BIS. Table I (Continued) Comparison of Cosmetic Regulations in India and the EU India EU Manufacturing License Given By Manufacturing license is compulsory and given by SLA (CDSCO does not grant license to manufacture cosmetics in India) “Certificate of manufacture” equivalent to “Certificate of free sale” is given by state member country Registration License for Imported Cosmetic Products Required Registration Certificate is required for import of all cosmetic items and issued by CDSC Required ‘Certificate of free sale’ (equivalent to Certificate of Manufacture) is required to freely distribute throughout EU Validity of Registration Certificate 5 y unless canceled or suspended and remains valid in perpetuity — Animal Studies For Testing of Cosmetic Products And Ingredients Completely ban. Furthermore, any cosmetic product that is tested on animals is not allowed to import in India Completely ban (in vitro studies are allowed) Safety Warning/Cautions on Label On inner label only On inner and outer label Use of Lead and Arsenic Compounds in Cosmetics -Prohibited (for the purpose of coloring) -Allowed in traces with maximum limit when used as permitted synthetic organic colors and natural organic colors Prohibited, but traces are allowed if unavoidable by GMPs and does not pose any risk to human health Mercury Compounds in Cosmetics The manufacturing and import of cosmetics containing mercury compounds is prohibited in India Prohibited, but traces (≤1 ppm) are allowed does not pose any risk to human health How Are the Regulations Enforced? By state authority and the CDSCO By a competent authority appointed by each state member in its country with the cooperation of EU Commission Prohibited/Allowed Raw Materials Chemicals for Use in Cosmetic Products BIS has divided chemicals in two parts: Part I Colorants (generally recognized as safe and allowed) Part II enlist generally recognized as safe chemicals, allowed preservatives and UV filters 2,442 substances are banned and listed in Annexure II of cosmetic regulations Restricted and allowed ingredients (Colorants, conservative agents and UV filters) are listed in Annexure III and IV-VI, respectively

566 JOURNAL OF COSMETIC SCIENCE Import and registration of cosmetics. Though no major change was made to the registration process of imported items, a significant reduction in registration fees was made. Additionally, the new rules streamline the process for applying for a registration certificate. The importer can make a single license application and seek a single registration certificate for the import of one or more cosmetics manufactured by the same manufacturer in a single manufacturing unit. The new rules also prohibit the import of cosmetics if: 1. The manufacturing, sale, or distribution of the cosmetic in question is prohibited in the country of origin. 2. The “use before” or “use by” date is less than 6 mo. from the date of import. 3. The cosmetic contains hexachlorophene. 4. The cosmetic has been tested on animals after November 12, 2014. The manufacturing of cosmetics for sale or distribution. Under new rules, a self-declaration needs to be furnished by the applicant confirming compliance with GMPs and other prescribed requirements. The licensing process remain the same in the case of manufacturing of cosmetics for sale and distribution in India. Quality of cosmetics and recall. The new rule prohibits the manufacturing or import of cosmetics that do not comply with the safety and quality standards set by Cosmetics Rules, 2020 and BIS. If the manufacturer or responsible person believes that the product placed in the market is likely to pose a health risk to humans, the product must be recalled immediately, and the same information should be reported to the state or the Central Licensing Authority with valid reasons. CONCLUSION Despite the difference in Cosmetic Regulation of India, EU, or any other country, the main objective of all remains the same, human safety. Unlike in the EU, premarket approval is required for all the cosmetic products in the Indian market. The new cosmetics rules have consolidated, streamlined, and upgraded the safety and regulatory requirements to import or manufacture cosmetic products for sale and distribution. The new rules improved the accountability and responsibility of importers and manufacturers to ensure the safety and quality of their cosmetic products. The registration and licensing system became more user-friendly with reduced fees and more validity. SUGAM, an online portal for the registration to import and sell cosmetics in India, has made the overall process easy, more efficient, and more transparent with a tracking system. There have been continuous efforts to harmonize and align regulations globally through the International Cooperation on Cosmetic Regulation (ICCR), which is the continuation of CHIC. REFERENCES (1) S. K. Chaudhri and N. K. Jain, History of cosmetics, Asian J. Pharma., 3, 164–167 (2014). (2) S. Stewart, Painted Faces: A Colourful History of Cosmetics, (Amberley Publishing Limited, UK, 2017). (3) L. C. Parish and J. T. Crissey, Cosmetics: a historical review, Clin. Dermatol., 6(3), 1–4 (1988). (4) F. Blanco-Dávila, Beauty and the body: the origins of cosmetics, Plast. Reconstr. Surg., 105(3), 1196–1204 (2000). (5) J. A. Witkowski and L. C. Parish, You’ve come a long way baby: a history of cosmetic lead toxicity. Clin. Dermatol., 19(4), 367–370 (2001).