USA Regulation 740.10 Excerpts
Cosmetics With Unsubstantiated Safety Warning -- 21 CFR 740.10

"Warning - The safety of this product has not been determined." [Required Warning WITHOUT the Cosmetic Safety Dossier]

A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the conspicuous warning statement on the PDP.

The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse. The safety of a cosmetic can adequately be substantiated by: a. Reliance on available toxicological test data on its ingredients and on similar products, and b. Performance of additional toxicological and other testing appropriate in the light of the existing data.

EU Article Seven Excerpts

“... The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6 (1) (a) …

(a) the method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned;

The person responsible for manufacture or first importation into the Community must possess -

an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation ..

(b) assessment of the safety for human health of the finished product.

To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure.

It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended.

There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene control criteria of the cosmetic product...