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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use.
Washington DC (Aug. 13)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use. SOCMA made its comments at the Asia-Pacific Economic Cooperation (APEC) Conference on Standards and Conformance held in Cuzco, Peru, earlier this month. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical 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 newly created European Chemicals Agency. Under REACH, companies will eventually be required to provide toxicity data for substances produced or imported into the EU in quantities above 1 metric ton per year. Companies will also be required to submit a comprehensive risk assessment, called a chemical safety report, covering the various uses of the materials they register. For approximately 1500–2000 chemical substances, companies will have to go through an authorization process to get permission to continue to use those substances.
SOCMA participated in APEC as part of the US delegation to the conference, which included the office of the United States Trade Representative and the United States Department of Commerce. Jim DeLisi, president of Fanwood Chemical (Fanwood, NJ) and chair of SOCMA’s International Trade Committee, represented SOCMA as a US Delegate to the APEC meeting. The forum took place to enhance technical cooperation and promote trade facilitation of APEC member countries, including a discussion on regulations as restrictions to trade.
One issue raised by SOCMA is in regards to provisions relating to the mandated use of a foreign-based “only representative” by a US-based company to comply with REACH. The “only representative” provision allows a manufacturer outside the European Union to appoint an EU-based company or individual to fulfill the registration obligations for products imported into the EU.
DeLisi commented on the high costs of having to use these representatives, their lack of availability and accountability, and the independence to which they are afforded to represent US businesses. Other concerns expressed about REACH were the disclosure of confidential business information, the potential to breach US antitrust laws, overall costs to companies to implement REACH, and doubts about the European Chemicals Agency’s ability to effectively administer REACH.
“As we expected, REACH has quickly become an unwieldy exercise on how not to regulate chemicals. It will continue to be so for many years, with millions of dollars having been spent and little or no conclusive public health data,” said SOCMA president Joseph Acker, in a prepared statement.