the European Union (E.U.) gets its way, toxicology will soon be
booming in Europe. And, to hear chemical manufacturers tell it,
their industry will be in decline.
week, officials from the European Commission, Europe's executive
body, met with industry and environmental groups here to discuss
proposed legislation that would require chemical manufacturers to
run extensive safety tests over 11 years on the 30,000 most common
chemicals on the market, many of which have been used for decades.
The proposal would also severely restrict the use of an estimated
1500 chemicals considered the most hazardous to humans and the environment.
"The new policy introduces a radical paradigm shift,"
E.U. environment commissioner Margot Wallström told the conference.
"It is high time to place the responsibility where it belongs,
chemical industry, understandably, is up in arms. It estimates that
testing will cost at least $7.5 billion, and the policy could "impose
a regulatory stranglehold on our industry," says Alain Perroy,
director-general of the European Chemical Industry Council.
the root of this ideological fight is the so-called "precautionary
principle." This concept, codified in the E.U. charter, states
that governments should base regulatory policy on the significant
possibility of risk, taking action even before all the data are
compiled. In contrast, U.S. regulations are not imposed until there
is concrete evidence of harm. "The United States is usually
reactive when it takes steps to protect citizens against toxic chemicals,"
says Mary Graham, co-director of the John F. Kennedy School of Government's
Transparency Policy Project in Cambridge, Massachusetts. The E.U.
chemicals legislation, she adds, "is a remarkable effort because
it is very expensive and it isn't in response to a public crisis."
Perroy maintains that industry already has safety data on its products
and that if the E.U. legislation goes too far, it will be a "totally
bureaucratic approach to build a knowledge base without use."
Industry also predicts that the increased costs of testing, and
the possibility that hundreds of chemicals could be taken off the
market, could result in major job losses. Lobbyists cite a study
commissioned by the Federal Association of German Industry, which
predicts that in Germany alone more than 2 million jobs would disappear,
a figure that E.U. officials say is hugely overblown.
proposed legislation does, however, contain some good news for the
research community: It would significantly loosen existing regulations
on R&D. Under the current system, quantities of experimental
substances of less than 1 metric ton are exempt from registration
with the E.U. for a year. The proposed rules would lift the weight
restriction and waive registration for 5 years, with the possibility
of a 5-year extension. "This is good news," says Patrick
Peuch, a director of product stewardship at BP Chemicals-Europe.
The existing deadlines are often so tight they constrain evaluation
and testing, he says.
in the industry do see a positive side to the legislation. Horst
Mensel, a lobbyist at Bayer AG, believes that the new policy will
encourage innovation by forcing companies to develop substitutes
for chemicals deemed hazardous. Michael Warhurst of the environmental
pressure group World Wide Fund for Nature argues that the proposed
rules will create new markets for safer products and spur the creation
of innovative safety testing and risk assessment tools.
final draft of the proposed legislation is not expected before the
end of this year, so industry is still lobbying hard. But the European
Parliament, which must approve the new directive, has a strong environmental
leaning so will likely try to strengthen it. Final approval by a
council of ministers from E.U. member countries is expected in 2005
at the earliest, and individual members must then incorporate it
into their national laws.