Regulatory Review: The Impact of REACH on the United States

By: David C. Steinberg, Steinberg & Associates

Posted: November 26, 2008, from the December 2008 issue of Cosmetics & Toiletries.

On Sept. 10, 2008, McKenna Long & Aldridge LLP, TSGE and Chemical Watch hosted a REACH conference in Arlington, Va., USA, for US businesses, titled “REACH in the Pre-registration Window and Beyond.” While this column will not focus on REACH legislation, it does report on several critical areas related to REACH that were discussed at this meeting.

US Exemption from TSCA
Rep. Diana DeGette, (D-Colorado), chief deputy whip of the House of Representatives’ majority party and vice-chair of the House Committee on Energy and Commerce (HCEC), was the keynote speaker. The HCEC is chaired by Rep. John Dingell (D-Michigan), who is in charge of the proposed US Food and Drug Administration (FDA) Globalization Act of 2008. Had this act been passed, it would have majorly impacted the cosmetics industry in a negative way.1 This bill is dead until 2009, at which time it may be reintroduced again to the subcommittee and, if approved, it would then move on to the full committee and forward to Congressional ratification.

The HCEC also oversees the Toxic Substance Control Act (TSCA) of 1976. Since all products regulated by the FDA are exempt from TSCA, this act has never been a major topic for the cosmetics and personal care industry, which is why pre-approval or preregistration of cosmetic ingredients in the United States is not required.

DeGette’s comments on the TSCA were of interest mostly to the chemicals industry, which represented the majority of attendees at the conference, though the cosmetics industry was represented (there may have been three of us). She discussed the globalization act, which, as noted, is on hold until 2009. However, of concern to the cosmetics industry and its ingredient suppliers is the review of the TSCA.

Reforming the TSCA is a top priority of the HCEC, and DeGette expects legislation to be resolved in 2009. Since cosmetic ingredients are currently exempt from the TSCA and its pre-notification requirements, new ingredients have been introduced with little cost or restriction; they merely have to be safe and have a target audience willing to buy them. In Canada and the EU where there is no such exemption, the introduction of new ingredients becomes more difficult. This is one reason why the United States has taken such an active role in developing new cosmetic materials. New ingredients are tried in the United States, and if successful, suppliers then invest in global approvals. The exemption of FDA-regulated industry from the TSCA may be on the committee’s agenda.