Regulations for cosmetics


Cosmetics products in India are regulated under the Drugs and cosmetics Act 1940 and Rules 1945 and Labeling Declarations by Bureau of Indian Standards (BIS). BIS sets the standards for cosmetics for the products listed under Schedule ‘S’ of the Drugs and cosmetics Rules 1945 .

Bureau of Indian Standards (BIS) has provided the specification for Skin Creams and Lipstick in the Indian Standards (IS) 6608:2004 and 9875:1990 respectively. IS 6608:2004 says that if all the raw materials requiring test for heavy metals have been so tested and comply with the requirements, then the manufacturer may not test the finished cosmetic for heavy metals and arsenic.

The Dyes colors (pigments lakes) if used in the manufacture of skin creams and lipstick shall comply with IS 4707 (Part I) subject to the provision of Schedule Q of Drugs and Cosmetics Act and Rules, issued by the Government of India, and as amended from time to time. Other ingredients shall comply with the provisions of IS 4707 (Part 2).

Rule 134 of Drugs and Cosmetics Rules has laid down restrictions on use of cosmetics containing Dyes, Colors and Pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q. The permitted Synthetic Organic Colors and Natural Organic Colors used in the Cosmetic shall not contain more than:

• 2 ppm (parts per million) of Arsenic calculated as Arsenic Trioxide.
• 20 ppm of lead calculated as lead.
• 100 ppm of heavy metals other than lead calculated as the total of the respective metals.

These coloring agents are generally recognized as safe (GRAS). For some of these, purity requirements are mentioned as laid down in the EEC directive of 1962. Maximum concentration in finished products is mentioned in some.

Rule 145 of the Drugs and Cosmetics Rules prohibits use of lead and arsenic compounds in cosmetics for the purpose of coloring. Rule 135 prohibits import of cosmetics in which a lead or arsenic compound has been used for the coloring purpose. Rule 145 D and 135 A prohibits manufacture and import respectively of cosmetics containing mercury compounds.