Over the coming months, I will present elements of the new EU Regulation 1223/2009 (Cosmetics Regulation) with a discussion of differences between the U.S. and E.U. rules. This first installment pertains to prohibited substances and provides a glance at some recently enacted or pending legislation pertaining to chemicals.
The EU Cosmetics Directive (76/768/EEC) bans or restricts over 1,300 chemicals from use in cosmetics (listed in Annex II and III); at the federal level, the U.S. has banned or restricted only 11. Earlier in 2014, the European Commission amended Annex II of the EU cosmetic Regulation to ban an additional five chemicals and changing the permitted concentrations of other specific substances. Per the amendment, October 30, 2014, marked the last day for which cosmetics containing the prohibited chemical substances could be introduced into the market in the EU. All products already circulating in the market must then comply with the Annex II by July 30, 2015.
Specifically, the five parabens added to the amended Annex II of substances prohibited in cosmetic products are:
- benzylparaben; and
In addition, triclosan was restricted to a maximum concentration of 0.2% in mouthwashes, and 0.3% in other cosmetic products such as toothpastes, hand soaps, body soaps, shower gels, deodorants (non-spray), face powders and blemish concealers, as well as nail products for cleaning the fingernails and toenails before the application of artificial nail systems. Furthermore, hydroxybenzoic acid and its salts and esters (other than the esters of isopropyl, isobutyl, phenyl, benzyl and pentyl) are limited to a maximum concentration of 0.4% as acid for a single ester in ready for use preparation and 0.8% as acid for mixtures of esters.
Despite what some consider a lag in the United State’s federal rules and regulations, a number of U.S. states are taking matters into their own hands and have either enacted or are in the process of considering rules banning or restricting certain chemicals in specific categories of products.
California’s Green Chemistry Initiative and the Safer Consumer Products (“SCP”) program. In September 2014, California’s Dept. of Toxic Substances Control’s SCP Program released its Safer Consumer Products DRAFT Priority Product Work Plan. The Draft Work Plan identifies Beauty, Personal Care, and Hygiene Products as one of the seven priority product categories in the Department’s outline for the direction of the program. The Draft Work Plan is available at this link. Potential candidate chemicals include: Aldehydes, formaldehyde, alkyl phenols & ethoxylates, azo dyes, coal tars, lead, and lead acetate, phthalates, triclosan, and toluene.
California’s Safe Cosmetics Act (SB 484): The Act requires companies that manufacture cosmetics to report any cosmetics products that contain ingredients known or suspected to cause cancer, birth defects, or other reproductive harm. The California Safe Cosmetics Program (CSCP) collects this data and makes it available to the public through this website.
California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65): Requires the state to maintain a list of chemicals known to the State of California a list of chemicals known to the state to cause cancer or reproductive toxicity and for businesses to provide a Prop 65 warning to consumers that they are being exposed to chemicals that are known to cause cancer and/or reproductive toxicity. Penalties of up to $2,500 per day per item of commerce for each violation.
In addition, a number of states have enacted or proposed legislation that either restrict or ban certain chemicals from various categories of products such as cosmetics and/or children’s toys (e.g., California (Health & Safety Code §§ 108935-108939); Connecticut (Conn. Gen. Stat. § 21a-335, et seq.); Maine (Toxic Chemicals in Children’s Products Title 38, Chapter 16-D of ME Rev. Stat.); Minnesota (Minn. Stat. 2010 116.9401-116.9407); Oregon (Bill Relating to Chemicals in Children’s Products SB 1569); Vermont (An Act Relating To The Regulation Of Toxic Substances [SB 239 Signed into law on June 10, 2014]); and Washington (Children’s Safe Products Act, Chapter 70.240 RCW). (This list is not intended to be exhaustive.)
There has also been serious debate and proposed legislation at the federal level looking to reform the 1976 federal Toxic Substances Control Act (TSCA), the U.S.’s primary statute regulating the manufacture, import, and use of chemicals in the U.S.
Take away… The regulatory landscape is changing. Quickly for some, not quickly enough for others. One thing however is certain– failing to participate in the discussion or failing to stay apprised of the changes ahead can land cosmetic companies in costly legal hot water. In addition, with all this activity at the state level, it is becoming more and more difficult for companies to stay compliant. With such an array of state laws, we are left waiting to see what reforms will occur at the federal level and to what extent courts will deem various state laws preempted by the Federal TSCA.