U.S. and EU Cosmetic Regulation Similarities
There are numerous similarities between the way that the United States and the European Union regulate cosmetic products. As demonstrated by the following table, consumers in both regions can feel confident that the cosmetic products are safe.
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U.S. Food and Drug Administration (FDA)
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European Union (EU) |
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Relevant Cosmetic Regulation |
Federal Food, Drug & Cosmetic Act (1938 as amended) and the Fair Packaging and Labeling Act (1967) |
The 1976 EU Cosmetics Directive implemented in 1986 and amended for the 7th time in 2003 |
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Requires that cosmetics be safe for intended use prior to marketing? |
Yes, proof of cosmetic safety is a responsibility of the manufacturer or its distributor in the US. |
Yes, proof of cosmetic safety is a responsibility of the manufacturer or its distributor in the EU. |
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Requirement for pre-market submission of safety data and pre-market product approval? |
No. However, manufacturers encouraged to register their establishments and list their cosmetic products and ingredients through FDA's Voluntary Cosmetics regulation program The FDA can inspect cosmetic manufacturing plants or office at any time even without notice. These inspections do occur in case safety is questioned. FDA also has authority to:
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No. However, a full technical file on the cosmetic product must be kept available for inspection upon request of the local authorities at a specified address in the E.U. Authorities must give 48 hour notice for inspection. The tech file continues:
Record of any type of health related consumer comments (e.g. allergy reactions), NOT normal consumer complaints |
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Exceptions that require pre-market approval? |
Yes, for color additives. Also, OTC cosmetic drug active ingredients are regulated by the FDA under their monograph system (e.g. anti-dandruff, anti-cavity, anti-perspirant, sunscreens, etc.) that lists approved actives, conc., uses, etc. |
Yes, for colors (including hair dye colorants), sunscreen active ingredients and preservatives. In general all active cosmetic ingredients require pre-approval in the EU, for example anti-dandruff active ingredients, anti-tooth-caries fluoride compounds, anti-perspirant aluminum salts etc. are all listed in a special annex III of the Cosmetics Directive. |
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Risk assessment is part of safety evaluation process? |
Yes. |
Yes - the safety assessor report is a key part of the technical file mentioned above. |
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Mandatory label warning statement if safety of product has not been determined? |
Yes. Without safety substantiation, Title 21 CFR, Part 740.10 requires that cosmetic products carry the following: "Warning: The safety of this product has not been determined." |
No such option in Europe. Hence the "negative" list system enforced via the SCCP (see below). |
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Ingredient safety reviews by independent scientific body is part of cosmetic safety process? |
Yes (by the CIR)* * Cosmetic Ingredient Review Expert Panel |
Yes (by SCCP)** ** EU Scientific Committee on Consumer Products This body in the EU is responsible of reviewing all special and active cosmetic ingredients and declaring whether they are safe or not. Hence there is a "negative list" type of system. For perspective, there are today over 1,100 substances listed in annex II (list of "banned" ingredients) and the list keeps growing largely with substances that are not used in cosmetics anyway but are published by the SCCP simply for enforcement reasons. |
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Expert ingredient safety reviews publicly available? |
Yes, published in peer-reviewed International Journal of Toxicology [LINK] and on Cosmetic Ingredient Review (CIR) website [LINK] |
Yes, published on SCCP website [LINK] |
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Requirement to list ingredients on label? |
Yes. Individual perfume ingredients don't have to be listed; lumped under "fragrance."
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Yes. Additionally, as per 7th Amendment, starting March 2005 the cosmetic ingredient list must include 26 specific perfume ingredients if % exceeds predetermined limits. These 26 ingredients are those that have been identified by the SCCP as potential allergens. There is an exemption from labeling for technical impurities that cannot be eliminated - these should not be present at a level that raises the cosmetics safety concerns. (e.g., carry-over ingredients such as preservatives of raw materials are labeled if present at significant levels that could trigger allergy in people who are pre-sensitized.) |
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Banned Ingredients? |
Yes. List of nine cosmetic ingredients restricted or prohibited by the FDA. Nine additional cosmetic ingredients judged by the Cosmetic International Review Expert Panel to not be safe for use in cosmetics. International Fragrance Association also establishes usage guidelines for fragrance materials. IFRA recommends against the use of over 30 substances and advises limiting the use of many others. |
Yes. Annex II includes over 1,100 ingredients and the list keeps growing as the SCCP continues to publish lots of ingredients that are not used in cosmetics anyway, for example CMR 1 & 2 classified substances.
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It is clear that within the United States, cosmetics are regulated under the Food, Drug and Cosmetic Act, which is enforced by the U.S. Food and Drug Administration (FDA). The FDA has abundant legal authority to regulate the safety of cosmetic products. The FDA, however, has had comparatively little need to use its authority, because cosmetics are composed of safe ingredients and because, when necessary, the cosmetics industry has acted voluntarily to prevent safety problems. The bottom line for American consumers is that they can have complete confidence that the cosmetic products they use are safe.