Cosmetics Safety Testing: A Path to Data Integrity and Traceability
Did you happen to see the discourse about Cosmetics Regulations last week in the news media?
- The New York Times published a news article (August 15, 2016) by Eric Lipton and Rachel Abrams entitled: “Their Hair Fell Out. Should the F.D.A. Have the Power to Act?“
- NPR’s news program On Point hosted by Tom Ashbrook interviewed Lipton among others in a segment (August 17, 2016) called: “The Battle to Regulate Cosmetics.”
- The New York Times Editorial Board published (August 17, 2016) an opinion piece entitled, “Is Your Lipstick Bad for You?“
Why all of the attention to Cosmetics Regulations?
There are currently two Bills introduced into the U.S Congress seeking to update the existing regulations on Cosmetics and Personal Care (CPC) products.
How could updated CPC regulations potentially impact analytical chemists working in the CPC industry? I don’t think I’m going out on a limb too much if I say that if the regulations are updated, the demand for analytical testing for existing products and for reformulations is going to go up. That’s probably intuitive enough, but one thing many people probably don’t think much about is: “How do I prove to the FDA (or other regulatory bodies) that I performed the analytical testing?”
After all, one adage I’ve often heard in reference to the FDA is: “If it isn’t documented, then it didn’t happen.” So, with that in mind, just how would you document your analytical tests? For example, what if you performed a liquid chromatographic separation for phthalates or parabens? Then you need to consider the chromatography data software (CDS) that you are using for your separation experiment. Make sure it has 21 CFR Part 11 technical controls for electronic documents – in other words, make sure your CDS is compliant-ready. Although, compliant-ready usually means that the CDS employs 21 CFR Part 11 (and Annex 11 in the EU) technical controls coming from the pharmaceutical regulations, the technical controls are simply good business practices for handling electronic records.
For example, a compliant-ready CDS would require unique login and passwords so that it can document who performed the test, when the test was performed, and the test itself. But, does this approach work in the Cosmetics and Personal Care industry?
If you consider that major Cosmetics and Personal Care companies use compliant-ready Empower 3 Chromatography Data Software (CDS) for their chromatography operations, then the answer is yes and it can probably help you, too.