In the Expert Panel’s review of the effects of Chlorhexidine on the mucous membrane, there was concern about its implication in cases of anaphylactic shock reaction…
— Industry safety panel, the Cosmetic Industry Review, before discounting all but one case of anaphylactic shock and finding the cosmetic ingredient chlorhexidine “safe for use” in cosmetics (CIR 2003)
The cosmetic industry’s self-regulating safety panel, the Cosmetic Ingredient Review (CIR), considers allergic reactions the top health issue with cosmetics, judging from the weight placed on the topic in panel discussions and subsequent written reviews. The reactions can be severe, swift, and in rare cases even life-threatening including asthma attacks, for example, or anaphylactic shock or can appear as symptoms like hives, swelling, or blistering that can begin to heal when exposures end. Once sensitized, a person can remain so for a lifetime, enduring allergic reactions with every subsequent exposure.
A survey of approximately one-third of the reviews in CIR (2003) shows that the panel has chosen sensitization and the related effect of irritation as the basis for approximately 80% of its safety decisions, to the near total exclusion of other health impacts. Our analysis shows that of the ingredients approved by CIR for use in cosmetics based on irritation and sensitization data, 14 percent also had some data indicating cancer risks, yet the panel still chose sensitization as the health endpoint of concern, and the basis for recommended safe levels of use.
Sensitization affects product sales. Once a consumer develops an allergic response to a cosmetic ingredient, he or she can no longer use that product and will no longer buy it. And the sales impact of a consumer’s sensitization can extend beyond the original product that elicited the reaction. Based on their experience in treating people sensitized to cosmetics, the American Academy of Dermatology recommends that sensitized patients use only fragrance-free products, and avoid all perfumes, colognes, after-shaves, fingernail care products, and hair spray (AAD 2000).
Despite the potential financial impacts of sensitization to the cosmetic industry, our review of product labels shows that ingredients linked to sensitization are routinely used by the industry, dominated by fragrances, a leading cause of sensitization worldwide. EWG’s 2004 analysis of potentially sensitizing ingredients in cosmetics shows that:
- Skin sensitizing ingredients are frequently found in products that can contact the skin and that are not always rinsed off, including between five and 25 percent of all anti-aging creams, lip balms, acne treatments, anti-aging treatments, and nail polish remover.
- Approximately half of all products examined list the word “fragrance” on the label. Fragrances are considered to be among the top five known allergens (deGroot and Frosch 1997, cited in Jansson and Loden 2001). In a subset of asthmatics, attacks are specifically triggered by, and only by, cosmetic fragrances. This indicates that fragrances may not only be a trigger but also a cause of asthma in some cases, although more research is needed on this subject (Norback et al. 1995; Milqvist et al. 1996).
Sensitization reactions are common, protection for consumers is scant. The American Academy of Dermatologists suggests that up to 10 percent of the population will have an adverse reaction to a cosmetic product over the course of their lifetime (AAD 2000), and a recent review of fragrance allergies by the EU’s Scientific Committee on Cosmetic Products and Non-food Products estimated that as many as one of every 50 people is sensitized to fragrances (SCCNFP 1998). In 2003 an estimated three-quarters of all cosmetic injuries reported by consumers to FDA included symptoms consistent with sensitization — rash, redness, swelling, blisters, sores, lumps, inflammation, irritation, dryness, peeling, splitting, cracking, scars, choking, coughing, sneezing, shortness of breath, and wheezing (EWG analysis of FDA 2004).
Despite the importance of minimizing allergy potential to the financial health of the cosmetic industry, the industry’s safety panel places little to no margin of safety between safe levels of use for sensitizing ingredients in cosmetics, and levels shown to elicit allergic reactions in studies. A detailed survey of approximately one-third of the panel’s ingredient reviews in CIR (2003) shows that CIR has incorporated a safety margin into just 14 percent of its recommended safe values, and in one of every five cases endorsed limits of use higher than the safe levels determined in clinical studies. The industry panel places undue weight on sensitization to the exclusion of nearly every other effect, but they do it with little scientific rigor and inadequate safety margins for consumers. Their decisions may contribute to the high rates of allergic reactions to cosmetics across the population.
Assessments from the primary trade association for the fragrance industry, the International Fragrance Association (IFRA), also raise questions. For instance, the Code of Practice of the frgrance association recommends that the common fragrance compound isoeugenol be restricted to 200 ppm (parts per million) in products. But studies show that 20 percent of persons sensitized to this compound will react to isoeugenol at half that level (Jansson and Loden, 2001; Johansen et al., 1996).
Consumers should report allergic reactions and other injuries from cosmetics use to FDA. A more comprehensive accounting of reactions will give the agency a more complete picture of the scope of harm, and may ultimately result in safer products. FDA requests that consumers “send reports about adverse reactions to cosmetics, as well as problems such as filth, decomposition, or spoilage, to: FDA, Office of Cosmetics and Colors (HFS-106), 5100 Paint Branch Parkway, College Park, MD 20740-3835″ (FDA 2004).
American Academy of Dermatology (AAD) (2000). Allergies: The Culprit Could Be Hiding In Your Cosmetic Bag. Accessed online May 6 2004 at http://www.aad.org/PressReleases/allergies.html.
Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
de Groot AC, Frosch PJ (1997). Adverse reactions to fragrances. A clinical review. Contact Dermatitis 36:57-86, 1997.
EU chemical directive (2004). EU directive on classification and labeling of dangerous substances (Directive 67/548/EEC). Annex 1. Chemical compendium at http://europa.eu.int/comm/enterprise/chemicals/legislation/ markrestr/cmrlist.pdf.
Food and Drug Administration (FDA) (2004). How to Report Problems With Products Regulated by FDA. Accessed online May 6 2004 at http://www.fda.gov/opacom/backgrounders/problem.html#cosmetics.
Food and Drug Administration (FDA) (2004). Consumer Complaints About Cosmetic Products. Accessed online May 6 2004 at http://www.cfsan.fda.gov/~dms/cos-comp.html.
Jansson, T. and Loden, M. (2001) Strategy to decrease the risk of adverse effects of fragrance ingredients in cosmetic products. Am. J. Contact Dermatitis 12, 166-169.
Johansen, J.D., Andersen, K.E., Menne, T. (1996) Quantitative aspect of isoeugenol contact allergy assessed by use and patch tests. Contact Derm. 34, 414-418.
Norback D, Bjornsson E, Janson C, Widstrom J, Boman G. (1995) Asthmatic symptoms and volatile organic compounds, formaldehyde, and carbon dioxide in dwellings. Occup Environ Med. 52, 388-395.
Millqvist E, Lowhagen O. (1996) Placebo-controlled challenges with perfume in patients with asthma-like symptoms. Allergy 51, 434-439.
United Nations Economic Commission for Europe (UNECE) (2004). The Globally Harmonized System of Classification and Labelling of Chemicals (GHS). http://www.unece.org/trans/danger/publi/ghs/officialtext.html. (Part 3: Health and Environmental Hazards)