11
Toxic Chemical Composition Reporting
EUROPEAN UNION’S REGISTRATION, EVALUATION,
AUTHORIZATION, AND RESTRICTION OF CHEMICALS PROGRAM
Chemicals pose a quandary for the European Union (EU). Production of chemicals
is Europe’s third largest industry, employing 1.7 million people directly. There are
over 100,000 different chemicals used in the European market, and a number of
these chemicals have been linked to certain health conditions, such as asbestos
connected to lung cancer and benzene to leukemia. Of the 100,000 chemicals used
in the market, only a small portion has adequate information on carcinogenicity or
other toxicity. In addition, new substances are introduced to the market annually.
The EU program for Registration, Evaluation, Authorization, and Restriction of
Chemicals (REACH) has four basic components for dealing with toxic chemicals,
as listed in its title.
The first part of the program, registration, is described further here as it focuses
on composition reporting. The remaining three parts of the program are based on
focusing on impact chemicals; therefore, these are described further in Chapter 11.
BASIS FOR PROGRAM
REACH is based on Council Directives 67/548/EEC of June 27, 1967, related
to regulating classification, packaging, and labeling of dangerous substances;
76/769/EEC of July 27, 1976, associated with restricting marketing and use of
dangerous substances; 1999/45/EC of May 31, 1999, related to the classification,
packaging, and labeling of dangerous preparations; and 793/93 of March 23, 1993,
related to the evaluation and control of the risks of existing substances. These directives identified problems of disparities in the laws of individual countries and the
need to do more to protect health and the environment from chemicals.
PROGRAM REQUIREMENTS
Registration
REACH proposes to require companies that wish to sell their products to EU
countries to provide composition information if
1. The substance is present in those products in quantities totaling over 1 metric
ton per producer or importer per year; and
2. The substance is present in those products above a concentration of 0.1 percent
by weight.
This regulation goes beyond the usual requirements of companies providing
Material Safety Data Sheets (MSDSs), which do not require composition information,
but rather general impacts of the chemicals such as flammability, toxicity, exposure
risks, and ranges of composition of certain toxic compounds.
Registration requires a manufacturer or importer to notify an authority in advance
of the intention to produce or import a substance and to submit required information
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