Build a solid foundation in science, formulation and product development—find out more!
Most Popular in:
Recent ATPs and Their Effect in the EU and Abroad
By: David C. Steinberg, Steinberg & Associates
Posted: April 14, 2009, from the June 2009 issue of Cosmetics & Toiletries.
page 3 of 6
Hair dye ingredients: On Sept. 23, 2008, another ATP added 41 hair dye ingredients to Annex II from Annex III. These substances were all delisted because no supporting safety data was available to support their use in hair dyes. Included were colors remaining in the Annex IV List of Coloring Agents Allowed for Use in Cosmetic Products. This list is shown in Table 4.The changes and additions to Annex II resulted in changes to Annex III, and included: the deletion of diaminophenols and hydroquinone as a hair care ingredient; and the delisting of the provisionally allowed status for Basic Blue 26 (CI 44045), FD&C Red No. 4 (CI 14700) as a colorant, and Basic Violet 14 (CI 42510) as a hair dye.
UV filters: This ATP went into effect on Dec. 12, 2008, and deals with sunscreens in the Annex VII List of UV Filters Which Cosmetic Products May Contain. It delists PABA, known as 4-aminobenzoic acid or the drug name aminobenzoic acid, which was permitted up to 5%. This required Annex II entry 167 to be changed from “Esters of 4-aminobenzoic acid with the free amino group, with the exception of that given on Annex VII,” to “4-aminobenzoic acid and its esters, with the free amino group.” This second and minor change was to eliminate a restriction of the UV filter diethylamino hydroxybenzoyl hexyl benzoate for use only as a sunscreen.
Toluene and hair dye ingredients: This ATP, dated Feb. 4, 2009, prohibited two ingredients and added four ingredients to Annex III. New inclusions on the prohibited list are EU ref. 1370, diethylene glycol; and ref. 1371 phytonadione, also known as vitamin K1. The four ingredients added to Annex III are shown in Table 5.
Comments: Regulation in the United States
In the United States, cosmetic regulations are simple—manufacturers are required to place safe products on the market. If they do not, the US Food and Drug Administration (FDA) can take action against them but usually the lawyers get there first. It is baffling how consumers will not buy cosmetics containing traces of allegedly “unsafe” ingredients (based on questionable science), yet they certainly buy unsafe foods that cause disease and even death-and nongovernmental organizations (NGOs) are not protesting this. However, when it comes to cosmetics, NGOs want either all cosmetics and ingredients pre-approved by the government before they are placed on the market or they want no cosmetics at all. The worst sin committed by the personal care industry is the false, exaggerated (“puffery”) or misleading promotion of products.
However, the industry has done severe damage to itself by basing advertisements for products on claims of what the products do not contain rather than the benefits they provide. This began in the early 1980s with “PABA-free” claims, and the industry will see the consequences of advertising in this manner. For example, a bill was introduced in the New York State Assembly on Mar. 13, 2009, that if passed will require all cosmetics sold in New York state to include the warning: “Caution—Use only as directed. Exposure to an ingredient contained in this product has been linked to health problems, including certain cancers, reproductive problems and hormone disruption. Keep out of the reach of children.”