BIS Standards with Respect to Cosmetics -CliniExperts

BIS standards with respect to cosmetics

Cosmetics market is not regulated in India and it is growing at a rate of 20% annually. It is twice as fast as the US and European markets. The quality and safety of the cosmetics products are taken care of by Central Drugs Standard Control Organisation (CDSCO).

As per Drugs and Cosmetics Act 1940 and Rules 1945, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

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

The cosmetics which come under Schedule S are:

Skin Powders
Skin Powder for infants
Tooth Powder
Toothpaste
Skin Creams
Hair Oils
Shampoo, Soap-based
Shampoo, Synthetic-Detergent based
Hair Creams
Oxidation hair dyes, Liquid
Cologne
Nail Polish (Nail Enamel)
After Shave Lotion
Pomades and Brilliantines
Depliatories chemicals
Shaving Creams
Cosmetic Pencils
Lipstick
Toilet Soap
Liquid Toilet Soap
Baby Toilet Soap
Shaving Soap
Transparent Toilet Soap
Lipsalve IS:10284
Powder Hair Dye IS: 10350 26. Bindi (Liquid) IS: 10998
Kum Kum Powder IS: 10999 28
Henna Powder IS: 11142

All the above cosmetics should follow the updated BIS.

Bureau of Indian Standards (BIS) has provided the specifications for skin Creams and lipstick in the Indian Standards (IS) 6608:2004 and 9875:1990.

Standards for heavy metals in cosmetics:

According to IS 6608:200, if all the raw materials requiring a 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. There should be a declaration for Heavy Metal and Hexachlorophene content for registration of cosmetics products. The test report including result of lead, arsenic, mercury, other heavy metals and if any microbiological test. Undertaking from the manufacturer stating compliance of all raw materials/pigments used, heavy metals (with specified limits) and Hexachlorophene contents in products with BIS and Drugs & Cosmetic Rules, 1945.

Standards for Colouring Agent in Cosmetics:

While manufacturing skin creams and lipstick if dyes colour (pigments lakes) are used then they shall comply with IS 4707 (Part I). It should be according to the Schedule Q of Drugs and Cosmetics Act and Rules by CDSCO and as amended from time to time. The other ingredients shall comply with the provisions of IS 4707 (Part 2).

Rule 134 of Drugs and Cosmetics Rules prohibited on use of cosmetics containing Dyes, Colours, and Pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q.

According to Rule 145 of the Drugs and Cosmetics Rules, the use of lead and arsenic compounds in cosmetics for the purpose of colouring is prohibited. The import of cosmetics in which a lead or arsenic compound has been used for the colouring purpose is not allowed under Rule 135. Cosmetics containing mercury compounds are not manufactured and imported under Rule 145 D and 135 A.