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Regulations on the use of toxins in cosmetics

The Food and Drug Administration (FDA) Handbook is the "bible" of regulations and standards laid down in the United States of America for the manufacture of food and drugs, including cosmetic and skin care products. It also forms the basis of regulations for Australia.

Below you will find excerpts from the FDA Handbook that allow for the use of known harmful ingredients in the manufacture of cosmetic and skin care products.

Almost any ingredient may be allowed in cosmetics and perfumes…

"With the exception of colour additives and a few prohibited ingredients, a cosmetic manufacturer may, on his own responsibility, use essentially any raw material as a cosmetic ingredient and market the product without approval." and . . . "Although not prohibited by law or regulation, in addition, the manufacturers of cosmetic fragrance products have voluntarily agreed to not use or to limit maximum use levels of certain selected ingredients which have been found to cause depigmentation, irritant, neurotoxic, or phototoxic or other allergic reactions."

Mercury in cosmetics…

"The use of mercury compounds as cosmetic ingredients is limited to eye area cosmetics at concentrations not exceeding 65 parts per million of mercury calculated as the metal (about 100 ppm or 0.01% phenylmercuric acetate or nitrate) and provided no other effective and safe preservative is available for use. Mercury compounds are readily absorbed through the skin on topical application and have the tendency to accumulate in the body. They may cause allergic reactions, skin irritation or neurotoxic manifestations."

Nitrosamines, known cancer-causing agents, allowed . . .

"Cosmetics containing as ingredients amines or amino derivatives, particularly di- or triethanolamine, may form nitrosamines if they also contain an ingredient which acts as a nitrosating agent as, for example, 2-bromo-2-nitropropane-1,3-diol (Bronopol, Onyxide 500), 5-bromo-5-nitro-1,3-dioxane (Bronidox C) or tris(hydroxymethyl)nitromethane (Tris Nitro), or if they are contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their derivatives are mostly present in creams, cream lotions, hair shampoos and cream hair conditioners. The nitrosation may occur during manufacture or during product storage.

. . . Many nitrosamines have been determined to cause cancer in laboratory animals... In surveys of cosmetic products conducted in 1991-92, NDELA (a nitrosamine) was found in 65% of the samples at levels up to 3 ppm."

Dioxane also … "Cosmetics containing as ingredients ethoxylated surface active agents, i.e., detergents, foaming agents, emulsifiers and certain solvents identifiable by the prefix, word or syllable ‘PEG’, ‘Polyethylene’, ‘Polyethylene glycol’, ‘Polyoxyethylene’, ‘- eth-’, or ‘-oxynol-’, may be contaminated with 1,4-dioxane. It may be removed from ethoxylated compounds by means of vacuum stripping at the end of the polymerisation process without an unreasonable increase in raw material cost. In rodent feeding studies conducted for the National Cancer Institute, 1,4-dioxane was found to produce cancer of the liver and the nasal turbinates. It also caused systemic cancer in a skin painting study. Skin absorption studies demonstrated that dioxane readily penetrates animal and human skin from various types of vehicles.

However, it was also determined that most of the dioxane applied to the skin in a vehicle evaporates into the environment and may not be available for skin absorption. The contamination of ethoxylated surface active agents with dioxane was first reported in 1978. Many of the raw materials analyzed since then have been found to contain dioxane; some contained as much as, or more than, 100 ppm."





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