Regulatory Review: Regulations in Chemicals, Sunscreen Labeling and Nanotechnology

October 20, 2008 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Chemicals in the EU
Dangerous Substances Directive: In July 2007, a new adaptation to technical progress (ATP) was proposed to EU chemical regulations and was published. This ATP named approximately 379 chemicals classified as a Category 2 carcinogenic, mutagenic or toxic to reproduction (CMRs) that, if approved could potentially be added to Annex II, the List of Substances Which Must Not Form Part of the Composition of Cosmetic Products. Category 2 materials are mutagens. Following previous changes to the Cosmetic Directive in which the 7th amendment prohibited Category 1 and 2 CMRs from all cosmetics, it would be expected to see all of these chemicals added to Annex II. Annex II currently lists 1,243 prohibited chemicals. Adding another huge list to an already unworkable list will only add difficulty. Of the current 1,243 chemicals, only 10 to 15 are currently or were ever used in cosmetics; however, the new list does include six ingredients that are critical and commonly used in cosmetics including: boric acid, disodium and tetrasodium borate, EDTA, tetrasodium EDTA and isostearamide MIPA. The chemicals are, however, not in alphabetical order, creating extra search time for those looking for the chemicals that are used in cosmetics. Table 1 shows the new list’s chemicals’ frequency of use. (insert table 1 near here)

After an ATP is issued for the Cosmetics Directive, companies have nearly one year to comply. Because these ingredients will probably be prohibited in 2009, there is time to start reformulating. The loss of sodium borate or borax will mark the end of beeswax/borax emulsions. These types of emulsions were the original w/o facial cleansing creams or cold creams. They have been used since 150 A.D.1 It is unfortunate that the EU will force these emulsions to be reformulated and disregard close to 2,000 years of safe use when evidence of its negative effect on unborn children has yet to be proven.