The new European Chemical Agency (ECHA), based in Helsinki , started its work on June 1, 2007 . The agency is tasked with implementing the new European Union chemical substances legislation known as Registration, Evaluation, and Authorizations of CHemicals (REACH) that will eventually replace the bulk of over 40 current European Community directives and regulations. REACH is a comprehensive regulatory system that applies to all chemicals, not just chemicals used in industrial processes but also chemicals used in articles such as clothing, furniture, and electrical appliances. REACH will impact manufacturers and importers within the EU and exporters who send products into the EU.

Chemicals in commerce before the close of 1981 are called existing chemicals and are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). One of the new agency’s tasks is to re-evaluate all of these 100,000+ chemicals. In the first 11–12 years of implementation, approximately 30,000 chemicals and substances will be re-evaluated and registered, and the regulatory division between existing and new (since 1981) chemicals will be removed.

The four key elements of REACH are:

• Classification and labeling
• Restriction on marketing and use
• Notification of “New” (after 1981) chemicals
• Regulation of “Existing” (before 1981) chemicals

All manufacturers and importers of chemicals must identify and manage the potential risks of their products. Substances of Very High Concern (e.g., carcinogens) must be identified and plans made to eliminate them from products or control exposure to them. Substances produced or imported annually in quantities of 1 metric ton or more per company must have a technical dossier or Chemical Safety Report submitted to the Agency. Companies that produce or import the same substance are encouraged to share data and cooperate to avoid redundant testing, requiring management of a cooperative process among competitors. Manufacturers and importers must provide their downstream users with the risk information they need to use the substance safely.

The professionals at Sciences International can assist companies who do business in Europe with a variety of tasks that will be required under the new program:

• Creating and maintaining an inventory of safety data
• Hazard evaluations and exposure assessments
• Preparing technical dossiers and Chemical Safety Reports
• Summaries of research and other technical data
• Management of cooperative data sharing between different companies
• Use of IUCLID5, the ECHA software
• “Only representative” services, permitting a non-EU company to export to the EU
• Identification and control of Substances of Very High Concern
• Evaluation and registration of “articles” (finished products that may or may not emit chemicals)
• Exposure scenarios and other requirements of downstream users

For information on our REACH services, call Herman Gibb 571-527-1701 or click the link to send an email hgibb@sciences.com.