One of the reasons given for supporting the Colorado bill was that the targeted ingredients are more stringently restricted in Europe than in the USA. It’s true that the FDA has prohibited only 9 substances as cosmetic ingredients, compared to 1,233 currently prohibited in Europe. Well, clearly “no contest” in the legal stringency stakes. But, the great majority of the 1,233 are petroleum derivatives, and many are pharmaceutical drugs, industrial solvents, or poisons such as curare, strychnine and arsenic – you can read the full list here. Very few of them would ever be considered as cosmetic ingredients, unless your idea of a totally yummy facial cleanser includes aircraft fuel with a soupcon of antibiotics and a touch of TNT. Should the same substances be prohibited in cosmetics in the USA? It’s a good question, but remember that most potential cosmetic ingredients are already regulated in the USA too. Not prohibited, but controlled to specific maximum levels.
There is an assumption that safety legislation passed in Europe is somehow intrinsically right, of a higher standard, and deserving of our close attention. Some of it may indeed be, but the general assumption is misplaced. The bill that has created the most anguish, controversy and chaos –
in Europe – concerns allergens. It is regarded with skepticism by some dermatologists, and its scientific basis is seriously flawed, as I will explain momentarily. There is no evidence so far that it has done anything to reduce adverse reactions to cosmetics, but it has negatively affected essential oil production and availability. Many suspect that it has spurred the larger fragrance manufacturers to turn to alternative synthetic materials that have not been subject to such stringent safety testing. Even in Europe, fragrance ingredients do not have to be listed.
Linalool is one of the 26 fragrance materials listed as an allergen in the European Union. If present in a cosmetic product at over 100 ppm (0.01%) in a wash-off product or 10 ppm (0.001%) in a leave-on product, linalool must be declared on the ingredient list if sold in an EU member state. Doesn’t sound too bad, does it? The problem is, neither manufacturers nor retailers want to get sued, or branded as selling unsafe products, and most retailers will only carry cosmetics that have passed an independent safety assessment, which is almost entirely based on looking at the levels of “allergens”. So the de facto result is that very few manufacturers take the risk of having a “known allergen” in a product at over the declarable amount.
Linalool is a major constituent of ho wood, ho leaf, rosewood, coriander seed, neroli, lavender, lavandin, bergamot, ylang-ylang, clary sage and petitgrain, and is found in some 200 other essential oils. But the really strange part is, linalool is not a high-risk allergen. In fact, it’s superlatively safe on the skin. Between 1969 and 2007 (38 years), a total of thirteen dermatitis patients out of the 25,164 tested, (0.05%) were allergic to linalool when patch tested, and less than this actually had allergic reactions to products containing linalool. Yes, 0.05% is more than zero, but it’s pretty close to the 0.03% reaction rate for petrolatum, the least dermally allergenic substance known to mankind. One way of looking at this is that adding linalool to a product increases risk by about 0.02%. That’s probably less than almost any other known cosmetic ingredient.
So why did the EU list linalool as an allergen? Because – according to their own report – five dermatitis patients had allergic reactions to it over a five-year period on patch testing, and at the time, their criteria for listing a substance included two or more reports of allergic reaction. Incredible, but true. Considering that linalool is (or at least used to be) one of the most commonly-occurring fragrance materials, an average of one reported reaction per year, on planet earth, is about a negligible as it is possible to get.
So, I’m just saying… if you think European safety regulations are a shining example of how things should be done, I suggest you re-consider. This one, at least, has been a massively expensive and largely misdirected fiasco.
originally published 3/5/10