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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1.
Helsinki (June 3)-The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1. REACH is a new EU policy on chemicals and their safe use that establishes a uniform system for assessing the risk posed by new and existing chemicals.
Under the REACH regulation, EU-based manufacturers and EU-based importers doing business directly or indirectly into Europe are required to register with the ECHA. These companies are required to go through an authorization process to get permission to continue to use those chemicals. Manufacturers and importers are required to submit a technical dossier for substances in quantities of 1 metric ton or more or a chemical safety report for substances in quantities of 10 metric tons or more (1).
The REACH regulation exempts substances used in medicinal products that fall within the scope of Regulation 726/2004 (centralized procedures), Directive 2001/82/EC (veterinary use), and Directive 2001/83/EC (human use) (1). Although a given substance used in a pharmaceutical may be exempt, if the same substance is used in a nonpharmaceutical application, registration under REACH for that substance is required. It is the responsibility of the producer or importer to assess if the substance is used for medicinal or nonmedicinal products. Pharmaceutical companies must consider the risk to their supply chain as a producer’s or importer’s failure to preregister or register given substances could affect the continuity of supply of ingredients (1).
From June 1 to Dec. 1, 2008, the ECHA will handle pre-registration of substances and intermediates. About 200,000 pre-registration files are expected. Beginning June 1, companies also began submitting notifications, inquiries, and registrations. More than 2000 such submissions are expected before the end of the year. Evaluation of registrations will also start this year, and ECHA is expected to make its first evaluation decisions by 2009.
ECHA launched the REACH-IT portal and has started to accept pre-registration and other data submissions. Data submission procedures are established for pre-registration, product and process-oriented research and development (PPORD) notifications, inquiries, and registration. The REACH-IT system that will form the basis of ECHA data management will be used for company sign-up, online entry, and submissions of pre-registrations. During and initial period, PPORD, inquiry, and registration submissions need to be carried out using temporary data submissions.
On an organizational level, the agency has expanded its staff to 200. ECHA began providing guidance and helpdesk service on June 1. Also, the management board, the Forum on REACH enforcement, and three scientific committees (Risk Assessment Committee, Socioeconomic Analysis Committee, Member State Committee) have been established and are fully functioning.
ECHA plans to publish the list of preregistered substances and the first candidate list of substances of very high concern by the end of the year.
1. P. Van Arnum, “Will REACH Reach the US,” Pharm. Technol. Sourcing and Management, May 9, 2008,