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Laws and regulations

The CIR to review the safety of calendula in cosmetics

The safety of Calendula officinalis (Pot Marigold) in cosmetics is set for discussion at the upcoming meeting of the Cosmetic Ingredient Review (CIR) board, scheduled September 22-23. Calendula flower extracts are widely used in cosmetics, including topical preparations for children.

The CIR expert panel, which gathers scientists, dermatologists, pharmacologists and toxicologists, under the aegis of the U.S. Personal Care Products Council (formerly the Cosmetics, Toiletries and Fragrance Association) will review unpublished data for inclusion in its forthcoming report. The CIR currently classifies calendula as a substance for which available data are “insufficient to support safe use in cosmetics”.

The panel has expressed several concerns about data gaps regarding the safety of Calendula officinalis. During its June 4 meeting, the CIR panel had asked interested parties to provide feedback and data on this issue.

Actually, the CIR is looking to gain insight in the following areas:

  • How much of the catechol component in calendula would be pyrocatechol?
  • How much of the material derived from calendula are quinones?
  • How much of the material derived from calendula are coumarins?

Indeed, the panel previously determined pyrocatechol is unsafe for use in leave-on cosmetic products and has restricted the concentration of quinones in cosmetics. The CIR panel is also concerned about the limited evidence in animals regarding coumarins carcinogenicity.

“If data is not available regarding these areas, limits on the concentration of these components may be established to assure that calendula extracts are safe for use in cosmetics,” the panel noted in a release.

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