Updated Regulations By Bis For Finished Cosmetics

By Author: CliniExperts Pvt Ltd
Total Articles: 5
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The cosmetics market in India is growing exponentially. The estimated growth rate of this industry per year is about 20 %.

The Central Drugs Standard Control Organization (CDSCO) is the Indian authority that is concerned with putting in place all the protocols for the safety and quality of the finished cosmetic products before they are launched in the Indian market.

According to the Drug and Cosmetics Act 1940 and Rules 1945, a cosmetic is defined as any article that is intended for the purpose of rubbing, pouring, sprinkling or spraying on, or introduced into, or otherwise applied to the human body or any part of it for cleansing, beautifying, enhancing attractiveness, or altering, modifying or changing the appearance, and includes any article intended for use as a component of a cosmetic product.

The Bureau of Indian Standards (BIS) sets the standards that all cosmetic products must adhere to in India. As per the new Ninth Schedule in Cosmetic Rules, 2020 published by the BIS, the IS codes have been elaborated for each cosmetic product. All manufacturers and importers must adhere to these.

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... The cosmetics which are included in this are listed in the table below.

Table 1: Cosmetics that are included in the Schedule ‘S’ of Drugs and Cosmetic Rules, 1945

1. Skin Powders IS: 3959
2. Skin Powder for infants IS: 5339
3. Tooth Powder IS: 5383
4. Toothpaste IS: 6356
5. Skin Creams IS: 6608
6. Hair Oils IS: 7123
7. Shampoo, Soap-based IS: 7669
8. Shampoo Specification IS: 7884
9. Hair Creams IS: 7679
10. Oxidation hair dyes, Liquid IS: 8481
11. Cologne IS: 8482
12. Nail Polish (Nail Enamel) IS: 9245
13. Aftershave Lotion IS: 9255
14. Pomades and Brilliantines IS: 9339
15. Depilatories Chemicals IS: 9636
16. Shaving Creams IS: 9740
17. Cosmetic Pencils IS: 9832
18. Lipstick IS: 9875
19. Toilet Soap IS: 2888
20. Liquid Toiled Soap IS: 4199
21. Baby Toilet Soap IS: 10523
22. Shaving Soap IS: 5784
23. Transparent Toilet Soap IS: 11303
24. Lipsalve IS: 10284
25. Powder Hair Dye IS: 10350
26. Bindi (Liquid) IS: 10998
27. KukKum Powder IS: 10999
28. Henna Powder IS: 11142
29. Bathing Bars IS: 13498
30. Sindoor IS: 14649
31. Liquid Foundation Make-up IS: 14318
32. Coldwax-Hair remover IS: 15152
33. Face Pack IS: 15153
34. Kajal IS: 15154
35. Oxidation Hair Dyes (Emulsion type) IS: 15205
36. Cream Bleach IS: 15608
37. Hair Shampoo for Babies- Specification IS: 17117

All these cosmetic products mentioned should strictly be in adherence to the norms put forth by the BIS after 6 months from date of publication of this notice. Bureau of Indian Standards has already put forth certain specifications for lipstick & skin creams in the Indian Standards (IS) 9875:1990 & 6608:2004.

BIS standards for cosmetics: Presence of heavy metals

As per the Indian Standard 6608:2004, there is no requirement to subject the finished cosmetic goods to heavy metals & arsenic testing, if it has been tested in the pre-production stage.

The test report should include the contents of the cosmetic product clearly declared. The composition of the cosmetic should constitute only the permitted amounts of heavy metals such as lead, arsenic, mercury, etc and hexachlorphene. The manufacturers of the cosmetic have to comply with all the regulations set up by the Bureau of Indian Standard in regards to all the pigments and raw materials used in the said product.3

Standards related to the Colouring Agents present in Cosmetics

If there are dyes or colours present in the composition of the skincare products & lipstick, then such products must comply with Indian Standard IS 4707 (Part I). It should conform with the Schedule Q of Drugs and Cosmetics Act and should follow the rules laid down by CDCSO and as amended from time to time. The rest of the ingredients in such items must comply with the norms of IS 4707 (Part 2).3

Rule 39(1) and 39(3) of Cosmetics Rules has enforced a prohibition on the use of cosmetic items containing colours, dyes, and pigments other than those cited by the BIS (IS 4707 Part 1 as amended) as well as Part II Tenth Schedule.3

Rule 36 of the Cosmetics Rules 2020 encompasses the following: the use of heavy metals, including lead & arsenic compounds in cosmetics items for colouring, is not allowed. The import of cosmetic items that contain lead or arsenic compounds for colouring purposes is also banned.

The manufacturing, as well as the import of Cosmetic items containing mercury compounds, are prohibited.

In conclusion, all of the regulations formulated by the BIS have to be complied with by the manufacturers of cosmetic products in India.

Looking to get the Cosmetic License to import, contact CliniExperts Pvt Ltd via phone +91 7672005050 or email contact@cliniexperts.com.

CliniExperts is an Indian and global regulatory solutions provider catering to a vast array of services lines and products to simplify, familiarize and support our clients through every step of the regulatory process. CliniExperts offers 360 degree regulatory solutions to – Pharmaceutical, Food, Nutraceutical, Cosmetic, Medical Device, Diagnostic Kits, Biologicals and Vaccine Industry.