Allergens in Cosmetics
Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some people. Many people suffer from allergies and anyone at any age can develop allergies. Allergic reactions are the immune system’s overreaction to substances that may otherwise be harmless. An allergen can trigger the immune system to release chemical substances such as antibodies that result in allergy symptoms. Many people are familiar with seasonal allergies brought on by pollen from blooming plants, or with food allergies. Allergic reactions to cosmetics most often appear as itchy, red rashes on the skin – or contact dermatitis.
Common Allergens Found in Cosmetic Products
The FDA has compiled the list below of common allergens found in some cosmetic products. These are allergens that cause most allergic reactions from the use of cosmetic products.
Common allergens fall into the five classes as detailed below: natural rubber, fragrances, preservatives, dyes, and metals.
As noted below, these specific ingredients may not be identified on the cosmetic product label. The European Commission, which has conducted extensive research on fragrance allergens, lists the following 26 fragrance ingredients listed as allergens in Annex III of the European Union Cosmetics DirectiveExternal Link Disclaimer:
Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), (also known as Lyral)
Oak moss extract
Tree moss extract
MethylisothiazolinoneExternal Link Disclaimer (MIT)
Formaldehyde and formaldehyde releasing ingredients:
DMDM hydantoin (1,3-dimethylol-5,5-dimethylhydantoin)
Quaternium-15 (Dowicil 200; N-(3-chloroallyl) hexaminium chloride)
What Consumers Can Do
Regarding possible allergens in cosmetics, the best way to prevent an allergic reaction is to know what you are sensitive to and how to avoid it. One way to accomplish this is by carefully reading the product ingredient panel and avoiding ingredients you know or think you are allergic to. It isn’t enough to check for terms like “hypoallergenic”, “fragrance-free” or “for sensitive skin,” as there is no federal standard or definition that governs the use of these terms in the U.S. However, under the authority of the Fair Packaging and Labeling Act (FPLA), the U.S. Food and Drug Administration (FDA) requires an ingredient declaration on cosmetic products sold at the retail level to consumers. However, certain ingredients may be listed generally as “fragrance,” or “perfume,” without identifying the specific ingredients.
If you have reviewed the product ingredient panel and still have questions regarding the substances in the product, you may contact the manufacturer listed in the product label. In addition, consumers should always check product labels and follow the manufacturer instructions before applying as directed. Reading the label on products is especially important as some products contain ingredients that may cause irritation, regardless of whether you have allergies or not. For example, manufacturers of certain hair dyes instruct users to test a small amount of product first – to see if they have a sensitivity to the ingredients in the product before applying it more broadly.
FDA Activities on Allergens in Cosmetics
To better understand allergens in cosmetics, the FDA focuses its efforts around three main areas:
Monitoring of adverse event reporting;
Conducting scientific research on the mechanisms of allergic reactions and how allergens interact with the body’s immune system; and
Conducting research on consumer practices, the frequency of adverse reactions, and consumer awareness of allergens in cosmetics.
Monitoring Adverse Event Reporting
Adverse event reports contain critical medical information and descriptions that help the FDA identify signals of potential safety issues with cosmetic products and ingredients. The FDA receives adverse event reports from healthcare professionals and consumers via MedWatch. The FDA reviews all adverse event reports and when necessary, takes action to address safety issues associated with cosmetic products and ingredients.
Scientific Research on Cosmetic Allergens
The FDA is interested in better understanding how allergens interact with the body’s immune system. To do this, FDA scientists are collaborating with scientists at the National Center for Natural Products Research at the University of Mississippi and University of Florida. Through these partnerships we can better understand how allergic reactions are induced, and we are identifying new ingredients capable of inducing allergic reaction. We are working with our research partners to develop animal-free testing methods to identify potential allergens and are exploring whether allergen testing data can help us further identify potential allergenic ingredients in cosmetic products. We are also exploring the existing data for quality and potential gaps.
The FDA is also engaged in research specific to fragrance ingredients. The study’s purpose is to identify the likelihood of an adverse reaction from the use of products containing fragrance ingredients. This project will help establish acceptable levels for multiple fragrance ingredients used in a variety of rinse-off and leave-on cosmetic products. The methodology established in this project may be used in future studies to perform similar assessments for additional cosmetics ingredients.
Enhancing our scientific understanding of allergens however, is only one area of interest for the agency. The FDA is also taking steps to learn more about consumer practices and use of cosmetics. We are conducting consumer surveys and focus groups to collect the following information:
How consumers use cosmetics;
How often consumers experience an adverse reaction from the use of cosmetics with potential allergens;
How aware are consumers of the presence of allergens in cosmetics; and
What actions (if any) do consumers take to avoid allergens in cosmetics.
In addition, the FDA intends to conduct interviews with the cosmetics industry to understand how manufacturing, marketing, and sale of cosmetic products is impacted by information on allergic reactions to cosmetic products. Furthermore, from interviews with state and local regulatory authorities, the FDA hopes to learn about their awareness of safety issues associated with cosmetic ingredients, including potential allergens, and how they monitor and address these issues.