USTR To Evaluate Trade Implications of REACH

February 26, 2009
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

The United States Trade Representative (USTR) is seeking documentation from chemical companies to identify possible non-tariff trade barriers, created by the European Union's Registration, Evaluation, Authorization and restriction of Chemicals (REACH) regulation, which would be inconsistent with the EU international trade obligations under World Trade Organization (WTO) rules, according to an informational release by the Synthetic Organic Chemical Manufacturers Association (SOCMA).

Washington DC (Feb. 18)-The United States Trade Representative (USTR) is seeking documentation from chemical companies to identify possible non-tariff trade barriers, created by the European Union’s Registration, Evaluation, Authorization and restriction of Chemicals (REACH) regulation, which would be inconsistent with the EU international trade obligations under World Trade Organization (WTO) rules, according to an informational release by the Synthetic Organic Chemical Manufacturers Association (SOCMA). SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceuticals ingredients and pharmaceutical ingredients.

REACH came into force in the European Union on June 1, 2007, with the goal of establishing a uniform system for assessing the risk posed by new and existing chemicals. REACH requires EU-based manufacturers and EU-based importers doing business, directly or indirectly in Europe, to register chemicals and their uses with the European Chemicals Agency. Under REACH, companies are required to provide toxicity data for substances produced or imported into the EU in quantities above 1 metric ton per year. Companies also are required to submit a risk assessment, called a chemical safety report, covering the various uses of the materials they register. Preregistration under REACH occurred between June 1 and Dec. 1, 2008, and full registration is required through 2018, depending on the tonnage produced or imported into the EU on an annual basis.

SOCMA reports that several sectors of the US industry, including the chemical industry, are asking the USTR to file a REACH-related WTO action based on the costs and trade impacts of the REACH regulation. In order to move forward on this action, the USTR must receive within six to eight weeks clear evidence that REACH trade impacts fall disproportionately on non-EU chemical companies.

To help with the coordination of this information gathering, an industry coalition is being formed to potentially address the matter as an industry sector and to provide support to the USTR’s efforts.

SOCMA suggests that for those companies that have had or anticipate encountering major disruptions to business operations as a result of REACH to provide documentation of their experiences to the USTR. For more information, see the SOCMA informational release.

See related articles:

REACH's Impact on the Pharmaceutical Industry

Will REACH Reach the US