Heavy metal analysis in Raw materials and Finished products are very crucial, The Bureau of Indian Standards (BIS) specifies permissible limits for heavy metals in cosmetics to ensure their safety. These limits are outlined in standards such as IS 4707 (Part 2): 2021, which covers the list of raw materials generally not recognized as safe for use in cosmetics.
Heavy metal Contamination
Tested Heavy metals: Lead, Cadmium, Mercury, Arsenic, Chromium, cobalt, nickel, and antimony.
Test Standards:
- IS 4707 (Part 2): 2021: Details prohibited and restricted raw materials, including heavy metals, in cosmetics.
- IS 6608:2004: For skin creams, mentions heavy metal limits indirectly.
- IS 9833:2018: heavy metal impurities in pigments and dyes.
- Permissible Limits for Heavy Metals in Cosmetics
- Lead (Pb): Not more than 20 parts per million (ppm).
- Arsenic (As): Not more than 5 ppm.
- Mercury (Hg):
- General use: Not more than 1 ppm.
- In eye-area cosmetics: Prohibited except for specific purposes like eye-area antiseptics.
- Cadmium (Cd): Typically not allowed or extremely limited as an impurity.
Preservative Efficacy Test
Preservatives are added in to cosmetic formulations to protect them from microbial contamination during Manufacturing, storage or consumer usage over the shelf life of the product. PET Test is used to demonstrate the efficacy of the preservatives. It ensures that the product remains free from microbial contamination during its shelf life and usage.
Regulatory Guidance and Standards
- IS 14648:2011: Microbiological Examination Of Cosmetics And Cosmetic Raw Materials- PET TEST.
- ISO 11930:2019: Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product.
- USP <51>: Antimicrobial Effectiveness Testing.
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