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Regulations for cosmetics in EU and the US in comparison

  U.S. Food & Drug Administration (FDA) European Union (EU)
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
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.
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 Cosmetic Registration Program.

The FDA can inspect cosmetic manufacturing plants or offices at any time even without notice. These inspections do occur in case safety is questioned.

FDA also has authority to:

To ban or restrict cosmetics ingredients for safety reasons,
To mandate cosmetics warning labels,
To inspect cosmetics manufacturing facilities,
To issue warning letters,
To seize illegal products
To enjoin unlawful activities,
To prosecute violators
To work with manufacturers in implementing nationwide product recalls.

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 EU. Authorities must give 48hr. notice for inspection. The tech file contains:

Full product and formula specifications + manufacturing process + relevant micro/stability data
Proof of cosmetic safety
Proof of pack claims
Record of any type of health related consumer comments (e.g. allergy reactions), NOT normal consumer complaints

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.
Risk assessment is part of safety evaluation process? Yes Yes - the safety assessor report is a key part of the technical file mentioned above
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).
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).
Expert ingredient safety reviews publicly available? Yes; published in peer-reviewed International Journal of Toxicology and on Cosmetic Ingredient Review (CIR) website Yes; published on SCCP website
Banned Ingredients?

Yes

List of 9 cosmetic ingredients prohibited or restricted by FDA

9 additional cosmetics ingredients judged by the Cosmetic Ingredient 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.
Requirement to list ingredients on label?

Yes

Individual perfume ingredients don't have to be listed; lumped under "fragrance."

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.)