Numerous countries all around the world have recently instituted some form of cosmetic regulation, other than product registration with their ministries of health, with respect to protecting the consumers of their respective countries. The amount of information is massive and to simply list current activities would go far beyond the scope of this chapter. However, it should be noted that Australia (http://www. nicnas. gov. au/) as well as Canada (http://www. hc-sc. gc. ca/english/media/releases/2004/cosmetic_labelling. htm) have taken very proactive approaches to cosmetic regulation, and the Web sites noted above can be accessed for additional information if so desired. The European Union (EU) has probably been the most proactive globally in attempting to regulate cosmetics. New provisions made in the seventh amendment to the EU cosmetic directives are outlined below identifying some of the significant changes in how cosmetic manufacturers will need to do business in the EU as well as what information will need to be provided to consumers in order for the product to be sold in the various EU countries. These regulations are all in effect as of March 11,2005.
• A product information dossier on qualitative and quantitative composition of the product and existing data on undesirable effects must be made “easily accessible to the public by means including electronic means.” Companies can list themselves and this information in the European Cosmetic Toiletry and Perfumery Association (COLIPA) database (www. European-Cosmetics. info). Additionally, the dossier must include information on any animal testing relating to development or safety evaluation of a product or ingredient.
• A Quantitative Declaration of Ingredients containing any ingredient(s) listed in the Dangerous Substances Directive (67/548/EEC) must list the concentration or concentration range of the substance(s) in question.
• Information on Undesirable Effects on Human Health Resulting from Use of the Cosmetic Product. Undesirable effects are, essentially, irritant or allergic reactions that can in rare cases affect skin or eyes. It is also recommended that companies present the number of undesirable effects in context of the number of units placed in the marketplace (i. e., to date there have been zero undesirable effects per one million units placed in the EU market).
• A ban on animal testing went into effect immediately for finished products and for ingredients.
• Need exclusive exposure assessments for products intended for children under 3 years of age and for intimate hygiene products.
• Color additives for the entire range of decorative cosmetics may be listed at the end of the ingredient list after the term “may contain” or the symbol “ + /—.”
• Any ingredient identified as carcinogenic, mutagenic, and/or a reproductive hazard (CMR) Category 1 and 2 must not be intentionally added to cosmetic products. Any ingredient identified as CMR Category 3 must not be intentionally added unless evaluated by SCCNFP and found acceptable for use in cosmetic products.
• Products that have a durability (shelf life) over thirty months must have the a “Period After Opening” (PAO) symbolized by an open jar with the number of months which indicates how long after a product is opened it can be used without harm to the consumer (see example below under “How to Select the ‘Best’ Formulation of a Cosmeceutical.”
• Problem fragrance ingredients (26 fragrances ingredients with a history for contact dermatitis) need to be labeled by INCI name in the ingredient label if they are used in the formula at 0.001% in leave-on and 0.01% in rinse-off products.