Study on methylisothiazolinone in shampoo lacks a credible scientific basis

Dec 6 2004

Consumers can rest assured that their cosmetic products, including shampoos, are safe. The abstract on Methylisothiazolinone (MI), presented at the Cell Biology 2004 meeting of the American Society for Cell Biology, lacks a credible scientific basis in suggesting that MI could be a safety issue for consumers using personal care products. In determining the safety of any ingredient, a major factor is exposure.

Cosmetic exposure is so much lower than what is presented in this abstract as to make the study meaningless for safety evaluation purposes regarding cosmetic products.

The experiments conducted with MI on extracted rat nerve cells in laboratory containers do NOT remotely resemble the possible consumer exposure to this preservative. In fact, safety testing with animals has demonstrated that application of MI does NOT result in systemic toxicity to the preservative. Clinical and functional effects on the nervous system have NOT been observed in relevant safety tests.

MI is a preservative that has been specifically approved for use as a biocide by the U.S. Environmental Protection Agency (EPA), by Japan, and by the European Commission for use in cosmetics. It is used at very low levels, parts per million (one part per million = one drop in a 55 gallon drum) in cosmetic products, including shampoos and other products. MI was reviewed by the Cosmetic Ingredient Review (CIR) in 1992 as a component of a preservative mixture with methylchloroisothiazolinone (MCI) and found to be safe for use in cosmetics.

Cosmetics are regulated under the Food, Drug and Cosmetic Act, which is enforced by the U.S. Food and Drug Administration (FDA). The Food and Drug Administration (FDA) has abundant legal authority to regulate the safety of cosmetic products.

The charge to CIR, an independent scientific body, is to look at all available data and assess the safety of ingredients used in cosmetics. The deliberations are completely open and in public, and the Food and Drug Administration and the Consumer Federation of America both have liaison members who participate in the deliberations of the Panel. Additionally, anyone from the public who has information can offer it for consideration.

The Cosmetic, Toiletry, and Fragrance Association (CTFA) is the national trade association representing the cosmetic, toiletry, and fragrance industry. Founded in 1894, CTFA has an active membership of approximately 275 companies that manufacture or distribute the vast majority of finished personal care products marketed in the United States. CTFA also includes approximately 275 associate member companies, including manufacturers of raw materials, trade and consumer magazines, and other related industries.