EU Cosmetics Law Restricts the Use of Several Substances
The European Commission's Official Journal published a new Commission Directive (2009/6/EC) on February 5th of this year, amending Directive 76/768/EEC on Cosmetics. This directive bans two substances (one of which may be present only in trace amounts) and allows the use of three substances, subject to certain conditions. Directive 2009/6/EC will be implemented in all 27 EU member states, and traders selling cosmetics in any member state must comply with the new regulations. According to EU Cosmetics Law, "cosmetics" consist of any substance or preparation that comes into contact with multiple external parts of the human body (including skin, hair, nails, lips, and external genitalia) or teeth and mouth, and is intended specifically for cleansing, fragrance, altering appearance, eliminating body odor, and protecting the affected areas. Annex 1 to Directive 76/768/EEC lists cosmetics, including creams, lotions, lotions, gels and emollients for the skin, soaps, deodorants, perfumes, hair or nail care products, whitening and anti-wrinkle skin care products, and oral care products. The EU's "List of Cosmetic Ingredients" includes diethylene glycol (DEG), a solvent that controls viscosity and provides a covering effect. In July 2007, the Spanish government notified the European Commission that they had found toothpaste products containing up to 8.3% diethylene glycol. The EU Scientific Committee on Consumer Products considered the use of diethylene glycol in cosmetics to be dangerous, but safe at concentrations below 0.1%. Therefore, the new Cosmetic Directive added diethylene glycol to Annex 2 (which lists substances generally prohibited for use in cosmetics) and to Annex 3 (which lists substances permitted for use under special conditions), allowing cosmetics to contain trace amounts of diethylene glycol up to 0.1%.
Vitamin K1 is a type of vitamin K, known for its blood-clotting properties. It's also an ingredient in skincare products, used topically to improve dark circles or increase skin radiance. France has banned cosmetics containing vitamin K1 after a study found it could cause allergic reactions. Vitamin K1 was subsequently included in Annex 2 of the Cosmetics Directive, prohibiting its use in cosmetics sold in the EU market.
Toluene is a solvent used in nail products and is classified as a Group 3 substance, a carcinogen, mutagenizer, or fertility hazard, because it may harm unborn children. According to EU law on the prohibition of hazardous substances (Directive 76/769/EEC), toluene concentrations above 0.1% are prohibited in public products such as glues and spray paints. However, from a general toxicological perspective, toluene concentrations of no more than 25% in nail products are considered safe, but children should be prevented from inhaling toluene. Therefore, toluene is listed in Annex 3 of the Cosmetics Directive, with a maximum permitted concentration of 25% in nail products. However, products must bear warning labels stating that they must be kept out of reach of children and are for adult use only. France restricts the use of diethylene glycol monobutyl ether (DEGBE) in cosmetics, with a maximum concentration limit of 9%. DEGBE has a wide range of uses, including as a solvent in hair dyes, paints, dyes, inks, detergents, and cleaning agents. In Europe, nearly 60% of DEGBE is used in cleaning agents, and approximately 35% in paints and surface coatings. Based on the conclusions of the Scientific Committee on Consumer Products, the new Cosmetics Directive 2009/6/EC added DEGBE to Annex 3, with a maximum permitted concentration of 9% in finished products, but prohibiting its use in aerosol sprays (such as hairspray). Ethylene glycol monobutyl ether (EGBE), used as a solvent in hair dyes, is also listed in Annex 3, and its use must comply with maximum concentration limits: 4% for oxidative hair dyes and 2% for non-oxidative hair dyes. Like diethylene glycol monobutyl ether, ethylene glycol monobutyl ether is prohibited from use in sprayers sold in the EU market. All EU member states were required to transpose Commission Directive 2009/6/EC into their national law by August 5, 2009. The provisions of the directive came into effect on November 5, 2009, except for the provisions concerning toluene, which came into effect on February 10, 2010. The directive is available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:036:0015:0017:EN:PDF
– Reference source: Hong Kong Trade Development Council website, March 2009
