Author: Jenna White | San Francisco Hairstylist
October 18th, 2021
October 18th, 2021
Over the last few years, there has been an increase in the annual variety of cosmetic products sold. According to the Compliance Program Guidance Manual for the USA Food and Drug Administration (FDA) "the cosmetic industry is undergoing rapid technological changes, the manufacturing base becoming more global, and the ingredients ever more diverse". For some of these ingredients, there is little information available to support safety and efficacy. To help categorize them, the FDA uses a system called the International Nomenclature of Cosmetic Ingredients (INCI).
Why care about the INCI labeling system?
All consumer groups are affected by the INCI labeling system. However, the FDA's Compliance Program Guidance Manual, along with an article published in June of 2021 by Vogue Business, cites the "number of products targeting [the] men’s market has increased significantly". It also cites upwards trends in products marketed to infants and children. More specifically, it cites that "ingredients, including nano-based chemicals, which may be subject to stringent drug and/or food pre-approval processes, are often incorrectly introduced into U.S. commerce through the cosmetic market due to its low regulatory barriers".
The European Union (EU) has been the first to enforce stricter ingredient guidelines. For example, parabens are a class of preservatives suspected of having adverse effects (also written about in my post DMDM Hydantoin). The EU has been phasing out long-chain parabens from cosmetics because of this concern. As a result, manufacturers are applying non-traditional preservative systems in order to assure the microbial safety of their products.
What is the INCI labeling system?
The International Nomenclature of Cosmetic Ingredients (INCI) is a list of cosmetic ingredients such as waxes, oils, pigments, and other chemicals that are present in our cosmetics. The INCI system was established in the early 1970’s by the Personal Care Products Council, and its names are used in the United States, the European Union, Japan, and China, and many other countries for listing ingredients on cosmetic product labels.
You can read an overview of the INCI Program here. Important characteristics about it are outlined below.
How does the INCI help consumers?
FDA approval is not required for a product to go-to-market in the USA (the exception being in the case of color additives), but products are regulated by the FDA, which means they can take something off the market that is deemed unsafe. It is also against the law to sell products with ingredients that are harmful to consumers when used as intended. Leveraging a system like the INCI helps the FDA prevent the distribution of unsafe products, and encourages the disclosure of ingredients on packaging to help consumers understand what is in the products they use, even if it was manufactured outside of the USA.
According to the FDA Compliance Program Guidance Manual "adverse events have been associated with a variety of cosmetic products for several reasons", which includes:
The manual also cites examples of "high risk cosmetic products that have been associated with serious adverse events" to include the following cosmetic product groups:
FDA Regulated Ingredients
As of October 2021, the FDA breaks cosmetic product ingredients that are prohibited or restricted into the categories below. Check out their page titled "Prohibited & Restricted Ingredients in Cosmetics", under the question "What ingredients are prohibited or restricted by regulation?" for more information on each category.
FDA Guidance on Cosmetic Products
As of October 2021, the FDA breaks cosmetic products that people have frequent questions about into the categories below. Check out their page titled "Cosmetic Products" for more information on each category.
FDA Guidance on Common Allergens Found in Cosmetic Products
As of October 2021, the FDA breaks common allergens found in cosmetic products into the classes below. Check out their page titled "Allergens in Cosmetics" for more information on each class. Many things can trigger allergies to cosmetic products, so it can be difficult to track down exactly which ingredient is causing irritation.
Why care about the INCI labeling system?
All consumer groups are affected by the INCI labeling system. However, the FDA's Compliance Program Guidance Manual, along with an article published in June of 2021 by Vogue Business, cites the "number of products targeting [the] men’s market has increased significantly". It also cites upwards trends in products marketed to infants and children. More specifically, it cites that "ingredients, including nano-based chemicals, which may be subject to stringent drug and/or food pre-approval processes, are often incorrectly introduced into U.S. commerce through the cosmetic market due to its low regulatory barriers".
The European Union (EU) has been the first to enforce stricter ingredient guidelines. For example, parabens are a class of preservatives suspected of having adverse effects (also written about in my post DMDM Hydantoin). The EU has been phasing out long-chain parabens from cosmetics because of this concern. As a result, manufacturers are applying non-traditional preservative systems in order to assure the microbial safety of their products.
What is the INCI labeling system?
The International Nomenclature of Cosmetic Ingredients (INCI) is a list of cosmetic ingredients such as waxes, oils, pigments, and other chemicals that are present in our cosmetics. The INCI system was established in the early 1970’s by the Personal Care Products Council, and its names are used in the United States, the European Union, Japan, and China, and many other countries for listing ingredients on cosmetic product labels.
You can read an overview of the INCI Program here. Important characteristics about it are outlined below.
- The INCI labeling program is managed by the International Nomenclature Committee (INC), which is comprised of scientists with backgrounds in consumer products, academia and government.
- There are more than 16,000 ingredients on the INCI list, which is broken into three classes: (1) General Conventions, (2) Specific Conventions (grouped primarily by chemical class), and (3) Miscellaneous Conventions.
- The INCI is multilingual, multinational, and based on Latin as well as binomial nomenclature, which is universally used and accepted among the scientific community.
- The Latin name for a plant or botanical is also know as its Botanical Name.
- The use of INCI names is mandatory in Canada for all manufacturers and retailers of cosmetics. It is not required, but is commonly used for US and EU packaging. You can read more about packaging requirements in the USA here and guidelines for labeling/marketing in the EU here.
- The organization managing the naming system is based in the USA, which influences its predominant use of English (over 80% of English words are influenced by Latin, with 90% influencing science and technology vocabulary). However, there are exceptions, an example being when there is an "EU Trivial Name" for an ingredient. In this case, the ingredient must be listed either: (1) "in Latin (e.g., 'aqua')", (2) "in both English and French (e.g., 'water/eau')", or (3) "in all three languages ('aqua/water/eau')", as cited in The Secret Language of Cosmetic Packaging by the Canadian translation and marketing agency LAT.
- According to the Personal Care Products Council, INCI nomenclature conventions "are continually reviewed and modified when necessary to reflect changes in the industry, technology, and new ingredient developments".
How does the INCI help consumers?
FDA approval is not required for a product to go-to-market in the USA (the exception being in the case of color additives), but products are regulated by the FDA, which means they can take something off the market that is deemed unsafe. It is also against the law to sell products with ingredients that are harmful to consumers when used as intended. Leveraging a system like the INCI helps the FDA prevent the distribution of unsafe products, and encourages the disclosure of ingredients on packaging to help consumers understand what is in the products they use, even if it was manufactured outside of the USA.
According to the FDA Compliance Program Guidance Manual "adverse events have been associated with a variety of cosmetic products for several reasons", which includes:
- color additive violations
- sensitivities to specific ingredients or the product formulation
- microbial contamination
- product misuse due to inadequate labeling
The manual also cites examples of "high risk cosmetic products that have been associated with serious adverse events" to include the following cosmetic product groups:
- low- or no-alcohol mouthwash
- eye area cosmetics
- tattoo inks including permanent makeup
- hair straighteners
- seasonal products
FDA Regulated Ingredients
As of October 2021, the FDA breaks cosmetic product ingredients that are prohibited or restricted into the categories below. Check out their page titled "Prohibited & Restricted Ingredients in Cosmetics", under the question "What ingredients are prohibited or restricted by regulation?" for more information on each category.
- Bithionol
- Chlorofluorocarbon propellants
- Chloroform
- Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide)
- Hexachlorophene
- Mercury compounds
- Methylene chloride
- Prohibited cattle material
- Sunscreens in cosmetics
- Vinyl chloride
- Zirconium-containing complexes
FDA Guidance on Cosmetic Products
As of October 2021, the FDA breaks cosmetic products that people have frequent questions about into the categories below. Check out their page titled "Cosmetic Products" for more information on each category.
- Aromatherapy
- Disposable Wipes
- EOS Lip Balm® Products
- Hair Products (Dyes, relaxers, removers, statement on Brazilian Blowout and WEN)
- Makeup
- Nail Products
- Soaps & Lotions (Soap makers' FAQs, anti-aging products, cellulite treatments, and more)
- Tanning Products
- Tattoos & Permanent Makeup
FDA Guidance on Common Allergens Found in Cosmetic Products
As of October 2021, the FDA breaks common allergens found in cosmetic products into the classes below. Check out their page titled "Allergens in Cosmetics" for more information on each class. Many things can trigger allergies to cosmetic products, so it can be difficult to track down exactly which ingredient is causing irritation.
- Natural Rubber
- Fragrances
- Preservatives
- Dyes, or chemicals in dyes and color additives
- Metals
