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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.
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The industry should watch this TSCA reform so that the United States maintains its exemption. Of particular concern to DeGette was the need to anticipate and stop any and all state legislation that controls chemicals, such as California’s Proposition 65.
As for the food safety bill, to which the new cosmetics regulation was attached, it will be on the Congressional agenda as soon as the incoming electorate convenes in January. DeGette feels that a consensus bill will be reached that deals strictly with foods, much to the cosmetic industry’s relief. Again, the industry must be on top of this because nongovernmental organizations (NGOs) will likely propose more regulations for cosmetics and cosmetic ingredients with the ultimate goal being the pre-approval of all chemicals and cosmetics. This would have devastating effects on the industry and innovation.
Registration of Non Phase-in Substances
Jeffrey Weiss, senior director of the Technical Barriers to Trade Committee of the Executive Office of the President, noted that REACH is a barrier to trade. Cosmetic ingredients used in non-EU countries that are exported into the EU in the form of finished cosmetics were specifically noted by Weiss. These chemicals are not required to obtain European List of Notified Chemical Substances (ELINCS) registrations, but also do not meet the definition of existing chemicals, which requires they have EINECS numbers.2
The Personal Care Products Council brought it to Weiss’s attention that these chemicals are legally allowed in the EU and should therefore be eligible for preregistration. Negotiations are continuing and hopefully will be resolved by Nov. 1, 2008, the deadline for pre-registration under REACH, although an extension is possible. It was proposed in June 2008 that manufacturers of these chemicals sign up on REACH-IT to send an inquiry with supporting information, demonstrating that the substances were lawfully on the EU market before June 1, 2008. The European Chemicals Agency (ECHA) will determine whether the chemicals are eligible for preregistration and if not, registration will be required immediately.
This produces a dual burden; first on the ingredient manufacturer, then on the company exporting the cosmetic containing the ingredient to the EU. Chemical suppliers must ask their customers if their non-EU ingredients are used outside the EU, whether the finished goods are shipped into the EU, and in what volume the ingredients are shipped (taking a three-year average of the amount placed on the EU market). Manufacturers must know how much of the non-EU produced chemical is used in its products that are shipped into the EU and inform its vendors.