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Jürg Rupp, Executive Editor

The Rupp Report: To REACH, Or Not To Reach

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) has been one of the prominent and influencing issues in the chemical world for many years. It is a European Union regulation - 2006/1907, passed Dec. 18, 2006.

REACH covers the production and use of chemical substances. Its 849 pages took seven years to pass. It has been described as the most complex legislation in the European Union's history, and the most important in 20 years. It is the strictest law to date regulating chemical substances and will impact industries throughout the world.

Since coming into force in June 2007, REACH requires all chemicals of one metric ton or more in volume that are manufactured in or imported into the European Union each year to be tested for health and safety and to be registered with a new central European authority - the European Chemicals Agency (ECA), Helsinki, Finland. REACH encourages manufacturers and importers of such chemicals to preregister them during the six-month preregistration period from June 1, 2008, to Dec. 1, 2008. This will allow companies much more time before they have to test and fully register the chemicals.

Classification And Labeling
Classification and labeling involves an evaluation of the hazard of a substance or preparation in accordance with Directive 67/548/EEC (substances) and 1999/45/EC (preparations) and a communication of that hazard via the label. This evaluation must be made for any substance or preparation manufactured within or imported into the European Union and placed on the market and results in classification of the substance/preparation as dangerous for one or several end-points concerning physical-chemical properties, health or environmental effects.

Risk Management
Classification and labeling is therefore a useful tool for the risk management of chemicals. All marketed substances and preparations must be classified and labeled, irrespective of the quantity placed on the market. The labeling is the first and often the only chemical hazard information that reaches the user. In addition, the classification has a large number of downstream consequences within the EU legislation. The classification and labeling work area provides technical and scientific support to member state authorities and commission services (mainly DG Environment - Chemicals) concerning the hazard classification and labeling of pesticides, biocides, and new and existing chemicals.

Human Health Or The Environment
REACH also applies to all chemicals that are considered of very high concern to human health or the environment. These are called SVHC (substances of very high concern). Their use in products - articles, in REACH terminology - is regulated if they are in concentrations greater than 0.1 percent by weight of article or if they are intended to be released from the article, such as ink in a pen. The most hazardous chemicals only can be used if authorized by the ECA. REACH applies to all chemicals imported into or produced in the EU, in contrast to the US Toxic Substances Control Act, which only applies to chemicals newly coming into use.

Who Is Responsible?
The ECA will manage the technical, scientific and administrative aspects of the REACH system. ECA is also responsible for the Technical Committee on Classification and Labeling of Dangerous Substances. The group discusses classification and labeling of substances of special concern, which are then proposed for entry to the list of harmonized classifications of substances, which is legally binding.

The published list of substances with a harmonized classification and labeling at present contains approximately 2,700 existing and 1,100 new substance entries - covering approximately 8,000 substances in total. If a dangerous substance not yet listed is put on the market - as such or contained in a preparation - manufacturers, importers and distributors have to self-classify that substance.

Next Steps
The current classification and labeling directives will be replaced in the coming years by a Regulation that implements the United Nations Globally Harmonized System (GHS). The aim of the proposed regulation is to enable a judgment on a substance or mixture (preparation) with respect to its hazardous properties and to provide a hazardous chemical with pertinent hazard labeling and information on safety measures.

As with the current legislation, the proposed Regulation is intended to be primarily a self-classification system for enterprises. It stipulates that after entry into force, the deadline for substance reclassification is Nov. 30, 2010; and for mixtures, May 31, 2015. The current directives on classification, labeling and packaging, i.e. Council Directive 67/48/EEC and Directive 1999/45/EC, will be repealed on June 1, 2015.

May 6, 2008




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