A Changing Path in Global Sourcing - Pharmaceutical Technology

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A Changing Path in Global Sourcing
The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.


Pharmaceutical Technology
Volume 3, Issue 32

Impact on the supply chain

Industry members point to the potential impact that REACH may have on the chemical supply chain. "We believe the flow of products in general from the United States to Europe may decline because of REACH," says Helmes. "Manufacturers and suppliers may decide it's not worth the expense or hassle of trying to get them through the process for REACH compliance. US-based contract manufactures exporting to the EU will have the burden of REACH compliance unless their customers or importers want to take that on," he says.

The cost and time for implementing REACH, however, may also provide a benefit for US-based contract manufacturers supplying European drug makers. "A trend may be created for drugs currently manufactured in Europe to instead, now be manufactured in the US and then sold into Europe because of the need to register APIs and intermediates in REACH," explains Helmes. "This is a possible opportunity for US drug makers in the short term," he says.

SOCMA provides REACH assistance

To help its members understand compliance, SOCMA's ChemSortia program offers REACH assistance through its REACH partners. These partners provide "only representative" and other services related to REACH-compliance needs such as preparation of registration dossiers, read across, and representation to the European Chemicals Agency, explains Helmes.

"ChemSortia builds on over 30 years managing chemical-specific consortia and panels for the Toxic Substances Control Act Section 4 test rules, High Production Volume testing, and related programs," says Helmes. "In this way, ChemSortia offers services to manage REACH cost-sharing consortia among suppliers, common manufacturers, supply-chain actors, and other organizations needing to share data, testing, dossier preparation, registration packages, submissions, construction of exposure scenarios, risk assessments, and preparation of chemical safety reports."

SOCMA is preparing a guidance manual for its members and will elaborate on the guidance through a series of webinars.

Beyond REACH

Outside of REACH, SOCMAsupports a North American program for the risk characterization of chemicals.

"SOCMA is committed to the Security and Prosperity Partnership (i.e., Montebello Agreement)," says Helmes. "In this way, we will support efforts to gather and evaluate data on medium production volume chemicals, which are those produced at levels greater than 25,000 pounds per year but less than 1 million," he explains.

"This is a cooperative agreement to pursue a tiered, targeted, and risk-based approach to chemical risk management that SOCMA considers is a significant step forward to continue the innovation of new and safer chemicals in North America," he adds.

One of the fundamental goals of this project will be publicly available risk characterizations of all chemicals in commerce produced and imported at more than 25,000 pounds annually. The project will build on current work, such as the US High Production Volume Chemical Challenge, a voluntary testing partnership between the Environmental Protection Agency, the Environmental Defense, the chemical industry, and work under Canada's Chemical Management Plan.

"We strongly support a system that begins with a screening-level look at chemicals and focuses on where more refined studies may need to be conducted, rather than just testing everything for the sake of data collection," says Helmes.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, first floor, Iselin, NJ, 08830, tel. 732.346.3072,

References

1 Environment Directorate General, European Commission, "REACH in Brief," (Brussels, Belgium, October 2007).

2 European Chemicals Agency, Guidance for Downstream Users (Helsinki, Finland, January 2008).


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