Indian drugs and cosmetics law mum on trace presence of contaminants in products
Certain countries allow presence of trace metals in products like cosmetics provided it is technically unavoidable in good manufacturing practice and does not cause damage to human health. But this is not the case in India
“Trace” refers to very low levels of impurities/contaminants in a finished cosmetic product.
• Trace presence is likely to stem from impurities of natural or synthetic ingredients, the manufacturing process, storage and migration from packaging.
• Due to the ubiquitous nature of certain heavy metals that are otherwise prohibited, several countries such as the US, Canada, Germany and the EU recognise the non-intended presence of these prohibited substances in small quantities as “trace”.
• Such presence is allowed provided it is technically unavoidable in good manufacturing practice and does not cause damage to human health. There is no mention of trace or similar concept in the Indian Drugs and Cosmetics Act.
• Over and above recognising the trace presence of heavy metals, several countries have put a cap on the maximum allowable limit of certain heavy metals. Mercury, for example, is not allowed beyond 1 ppm in the US and Germany and 3 ppm in Canada.
• Colourants used in cosmetics are considered a key source of heavy metal presence as well as impurities in cosmetics. However, the final responsibility for ensuring the safety and regulatory compliance of a cosmetic product (including any trace substances it may contain) lies with the entity responsible for placing the product on the market.