In changes that will come into force from 5 November 2009, companies will not be able to use diethylene glycol (DEG) or phytonadione in cosmetics products.
DEG allowed at low trace levels
The changes in the regulation of DEG were prompted by the presence of high levels of the substance found in some toothpaste products from other markets, explained Emma Meredith from the UK trade body the CTPA.
“Reputable manufacturers do not use diethylene glycol as an ingredient in toothpastes and other oral care products, and none of the major brands sold through mainstream retail outlets were affected,” she said.
However, trace levels are often present due to low level contamination of some widely used ingredients including glycerol, she explained.
The amendments to the Directive clarify the level at which trace elements of DEG are tolerated (below 0.1 percent in the finished product), while clearly banning the substance as an ingredient.
Phytonadione, a form of vitamin K that is given to patients suffering from abnormal blood clotting diseases, has also been given the red card.
The Directive amendment states that topical application of phytonadione may illicit an allergic reaction and consequently those suffering may not be able to use the substance as a therapeutic agent, thus its use in cosmetics products has been banned.
Hair dye ingredients not for aerosols
In addition, restrictions have been placed on the use of diethylene glycol monobutyl ether (DEGBE) and ethylene glycol monobutyl ether (EGBE).
A maximum concentration of 9 percent has been placed on DEGBE when used as a solvent in hair dye products.
Similarly, the use of EGBE has been restricted to 4 percent as a solvent in oxidative hair dye products and 2 percent in non-oxidative hair dye products.
However, neither EGBE nor EGBE can be used in aerosols or spray products.
From 5 February 2010, companies will have to respect restrictions placed on the solvent toluene that will only be accepted for use in nail products up to 25 per cent. Regarding this substance, the Directive states that all inhalation buy children should be avoided.