563 A COMPARATIVE EVALUATION OF COSMETIC LEGISLATIONS IN INDIA REGULATIONS FOR THE USE OF HEAVY METALS IN COSMETICS In India, Cosmetics Rules, 2020 prohibit the manufacturing and importing of those cosmetics that contain mercury compounds as such lead or arsenic compounds as colorants. The dyes used in the manufacturing of skin creams and lipstick must comply with IS 4707 (Part I) as per the Schedule Q of Cosmetics Rules, 2020 and other ingredients are required to comply with IS 4707 (Part II). Cosmetics Rules, 2020 restricts the use of dyes, colors, and pigments other than those specified by the BIS (IS: 4707 Part I as amended) and Schedule Q. It also indicates the permissible limits for synthetic organic colors and natural organic colors used in the cosmetics as 2 ppm of arsenic (from arsenic trioxide), 20 ppm of lead, and 100 ppm of total heavy metals other than lead. Unfortunately, the IS 6608:2004 states that if all the raw materials have been tested for heavy metals and comply with the requirements, then the manufacturer need not test the finished cosmetic for heavy metals and arsenic. As per the European Regulations (EC) No. 1223/2009, the use of heavy metals enlisted in Annexure II of amended Regulation (EU) 2020/1683 is prohibited for use in the manufacturing of cosmetics for sale and distribution in EU market. These include heavy metals such as lead, mercury, cadmium, arsenic, antimony and its compounds (except those special cases included as preservatives in Annexure V). According to Article 17 of the regulation, the use of such heavy metals or compounds is allowed only to such an extent that is safe for human use and technically unavoidable under GMPs. The safety of the product must be demonstrated in the safety assessment part of the PIF. It is reported that if the content of lead, cadmium, mercury, and arsenic is more than 2.0, 0.1, 0.1, and 0.5 ppm in various cosmetic products and 0.5, 0.1, 0.1, and 0.5 ppm in toothpaste, then, technically, they are avoidable (11). SIMILARITIES AND DIFFERENCES There are a few similarities in cosmetic regulations of India and the EU: 1. The manufacturer or designated person would be fully responsible for the safety of the manufactured or imported product in both the markets. 2. Follow-up, observation, and verification of safety of the registered cosmetic product by the regulatory authority. 3. No restrictions on sales channels (12,13). However, a few differences also exist among the legislations of both the countries. For better understanding, a comparative view of Indian and European cosmetic regulations is summarized in Table I. HIGHLIGHTS OF NEW COSMETIC RULES, 2020 VERSUS DRUGS AND COSMETIC RULES, 1945 By keeping in mind the few shortcomings in Drugs and Cosmetics Rules, 1945 such as multiple licensing systems for imported products complex process for applying for registration or licenses lack of safety data information with state regulatory authorities a time consuming process of license grating etc., the Ministry of Health & Family Welfare, Govt. of India has issued a new set of rules named Cosmetic Rules, 2020 for the manufacturing and the import for the sale and distribution of cosmetics in India separately,

564 JOURNAL OF COSMETIC SCIENCE (Continued) Table I Comparison of Cosmetic Regulations in India and the EU India EU Regulating Authority CDSCO for import and registration State Licensing Authorities for manufacturing for sale and distribution in India. EMA Act and Regulations Drugs and Cosmetics Act, 1940, and Cosmetics Rules, 2020 wef. 15.12.2020 Council Directive 76/768/EEC (27th July 1976), replaced by Regulation (EC) No. 1223/2009 on November 30, 2009 Under/Created By Ministry of Health and Family Welfare European Parliament and Council Primary Objective To ensure the safety, efficacy, and conformity of cosmetic products to state quality standards High-level of protection for the safety and health of EU citizens Premarket Product Approval Required (from SLA) Products must be notified before marketing, but preapproval is not required (with the exception of color additives, sunscreen active ingredients, and preservatives) Premarket Assessment of Product for Safety Required Required Labeling Requirements Labeling should comply with the provisions of Cosmetics Rules, 2020 and the BIS Should comply declarations issued by Council Directive 76/768/EEC Post-Market Reporting Not applicable Not applicable Product’s Safety Report (Before Placing the Product in Market) Manufacturer or responsible person should maintain a report with himself and produce to authority, if required Should be prepared in two parts: Part A (detailed product’s information), & Part B (assessment report), and must be provided to authority upon request PIF A dossier file must be prepared by manufacturer or responsible person and should be submitted to State authority at the time of applying for a license Responsible person should maintain a PIF till at least 10 y after the dispatch of last batch in the market Is There Safety/ Technical Information Available to Regulatory Authorities? Complete technical information should be provided to SLA A full technical dossier on the cosmetic product must be kept available for inspection upon request of the local authorities Mode of Information of Any Change in Cosmetic Product/S By online portal and offline mode (SUGAM: an online portal for registration of imported items) By CPNP Language of Label English English and National Language Use By Date/Expiry of the Product Use before or use by date must be mentioned on label Date of minimum durability should be mentioned on label if durability is 30 mo. If durability is 30 mo., then duration should be mentioned after opening for which the product is safe to use