India mainly regulates cosmetic ingredients in accordance with seven lists in the three regulations:

1) IS 4707 (Part 1) Colorants

Table 1 Generally Recognized as Safe (GRAS) List of Colorants

Annex A List of Substances Excluded from the Scope of the Standard

2) Cosmetics Rules 2020

List of Colorants Permitted to be Used in Soaps

3) IS 4707 (Part 2) List of Raw Materials Generally Not Recognized as Safe for Use in Cosmetics

Annex A List of Substances Which Must Not Form Part of the Composition of Cosmetic Products

Annex B List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Condition Laid Down

Annex C List of Preservatives Which Cosmetic Products May Contain

Annex D List of Permitted U.V. Filters Which Cosmetic Products May Contain

GRAS and GNRAS are two classifications of ingredients in India. The former means "Generally Recognized as Safe", and the latter means "Generally Not Recognized as Safe".

In view of the large number of ingredients which were likely to be used for different intended purposes in cosmetics formulations, such as colorants, preservatives, U.V. filters, basic ingredients, adjuncts etc., the Bureau of Indian standards (BIS) has prepared GRAS list for colorants and GNRAS list for other ingredients and adjuncts to serve the intended purpose of safeguarding the interest of the consumer and simultaneously leaving enough scope for innovations in formulations.

The structure of India's cosmetic ingredients lists is the same as that of the E.U. and ASEAN, which are divided into five categories: prohibited ingredients list, restricted ingredient list, permitted preservatives list, permitted sunscreens list, and permitted colorants list. Most of the content in these lists is the same, but there are some differences. For example, both the E.U. and ASEAN have banned the use of pentylparaben, while India's prohibited ingredients list currently does not include this ingredient.

The limits on heavy metals in cosmetics are not included in the regulatory database of Indian cosmetic ingredients. But in the production process of cosmetics, there are restrictions on these substances. For example, the Cosmetics Rules 2020 stipulates that “The permitted synthetic and organic colorants used in cosmetics should not contain more than:

a) 2 ppm of arsenic calculated as arsenic trioxide

b) 20 ppm of lead calculated as lead

c) 100 ppm of heavy metals other than lead calculated as the total of the respective metals.”

For more details, please refer to our Cosme-list.

The microorganism limits are not included in the regulatory database of Indian cosmetic ingredients. However, there are limits on these substances during the production of cosmetics. For example, shampoos and powders are capped at 1000 CFU/g or CFU/ml for the total microbial count, while baby products and eye products are capped at 100 CFU/g or CFU/ml for that.

For more details, please refer to our Cosme-list.

The use requirements of cosmetic ingredients in this regulatory database are mainly based on India's general ingredient standard IS 4707. In addition to this, India has laid down specification standards for 37 finished products, including skin powders, tooth powder, toothpaste, hair creams, nail polish, lipstick, etc. Some of these finished product specification standards make additional requirements for cosmetic ingredients. For example, the tooth powder specification IS 5383: 2021 prescribed that the tooth powder ingredients shall comply with not only Part 1 and Part 2 of IS 4707 but also the "List of Ingredients Conventionally Used in the Manufacture of Tooth Powder" given in its appendix.

Therefore, cosmetic enterprises shall also pay attention to these specification standards to ensure that the corresponding ingredient requirements are met when importing or producing such cosmetics. For more details about these 37 specification standards, please refer to the Cosmetics Rules 2020 and BIS.