Carcinogenic, Mutagenic, or toxic for Reproduction (CMR) substances in cosmetic and personal care ingredients and products: Risk analysis and Safety assessment

In day to day life we as humans use lots of personal care products in form of cosmetics for beautification that indirectly leads to personality enhancement, and devices for personal hygiene like toothbrush, dental floss, sanitary napkins, adult diapers for urinary inconsistency patients or baby diapers for babies etc. All are made of many chemicals that are further made of many individual chemicals. While processing they are passed through various downstream process that involves usage of processing aids or metabolites are generated that are harmful to life. From good manufacturing practice, full care is taken to remove them all; however some entities are left over due to trace quantities that are below limit of quantification or are not detected in analytical system. One of them is CMRs. European Union (EU) classified and harmonized CMRs are those chemical ingredients that cause carcinogenicity (H340), mutagenicity (H350) and reproductive (H360) toxicity in humans when exposed for long time. These are classified under CMR substances from Annex VI of the CLP Regulation registered under REACH and/or notified under CLP with limit specified in Part 3 of Annex I of CLP Regulation (EC) No 1272/2008. They sometimes can be both genotoxic-carcinogenic or may be non-genotoxic carcinogenic or can be in either of any category 1A, 1B or 2. Since one can’t fully avoid them, so various regulatory bodies have set limits and methods to derive limits for them. The general usage limit is 0.1% for carcinogen or mutagen and 0.3% for reproductive toxicant.

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Author(s):

Jaideep Sarkar

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