180
Toxic Chemicals
REGISTRATION, EVALUATION AUTHORIZATION, AND RESTRICTION
OF CHEMICALS PROGRAM OF THE EUROPEAN UNION
Chemicals pose a quandary for the European Union (EU). Production of chemicals is the third largest industry in Europe, 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
the connection of asbestos 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. As its name implies, the EU program for Registration, Evaluation,
Authorization, and Restriction of Chemicals (REACH) has four basic components
for dealing with toxic chemicals.
The first part of the program, registration, is described in Chapter 2 of this book
as it focuses on composition reporting. The remaining three parts of the program
(evaluation, authorization, and restriction) are based on focusing on impact chemicals; therefore, these are described further in this chapter.
BASIS FOR PROGRAM
REACH is based on a number of council directives: 67/548/EEC of June 27, 1967,
is related to regulating classification, packaging, and labeling of dangerous substances; 76/769/EEC of July 27, 1976, is associated with restricting marketing and
use of dangerous substances; 1999/45/EC of May 31, 1999, is related to the classification, packaging, and labeling of dangerous preparations; and 793/93 of March 23,
1993, is 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
Evaluation
The evaluation component of the program will require manufacturers or importers
of chemicals to supply information on the toxicity of the chemicals. The goal is
to establish a single source for toxicity data on existing and new chemicals. The
information can be supplied by acceptable testing in countries outside the EU or
by evaluating toxicity of the chemical functional groups or toxicity of analogous
compounds. The program is also driven by a desire to limit new animal testing. The
goal of the program is to expand the knowledge of chemical toxicity and to place the
burden of testing and providing that information on the chemical manufacturer or
users of a chemical.
The EU wishes to maximize the use of nonanimal testing methods for determining
toxicity of new and existing chemicals, including the use of quantitative structureactivity (or structure-property) relationships (QSARs) to determine toxicity based on
knowledge of toxicity of similar chemicals or functional groups.
Toxic Chemicals
REGISTRATION, EVALUATION AUTHORIZATION, AND RESTRICTION
OF CHEMICALS PROGRAM OF THE EUROPEAN UNION
Chemicals pose a quandary for the European Union (EU). Production of chemicals is the third largest industry in Europe, 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
the connection of asbestos 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. As its name implies, the EU program for Registration, Evaluation,
Authorization, and Restriction of Chemicals (REACH) has four basic components
for dealing with toxic chemicals.
The first part of the program, registration, is described in Chapter 2 of this book
as it focuses on composition reporting. The remaining three parts of the program
(evaluation, authorization, and restriction) are based on focusing on impact chemicals; therefore, these are described further in this chapter.
BASIS FOR PROGRAM
REACH is based on a number of council directives: 67/548/EEC of June 27, 1967,
is related to regulating classification, packaging, and labeling of dangerous substances; 76/769/EEC of July 27, 1976, is associated with restricting marketing and
use of dangerous substances; 1999/45/EC of May 31, 1999, is related to the classification, packaging, and labeling of dangerous preparations; and 793/93 of March 23,
1993, is 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
Evaluation
The evaluation component of the program will require manufacturers or importers
of chemicals to supply information on the toxicity of the chemicals. The goal is
to establish a single source for toxicity data on existing and new chemicals. The
information can be supplied by acceptable testing in countries outside the EU or
by evaluating toxicity of the chemical functional groups or toxicity of analogous
compounds. The program is also driven by a desire to limit new animal testing. The
goal of the program is to expand the knowledge of chemical toxicity and to place the
burden of testing and providing that information on the chemical manufacturer or
users of a chemical.
The EU wishes to maximize the use of nonanimal testing methods for determining
toxicity of new and existing chemicals, including the use of quantitative structureactivity (or structure-property) relationships (QSARs) to determine toxicity based on
knowledge of toxicity of similar chemicals or functional groups.