27 August 2009 21:49 [Source: ICIS news]
WASHINGTON (ICIS news)--The EU programme for the registration, evaluation and authorisation of chemicals (REACH) will cost six times more and need 20 times more test animals than projected, and thus it cannot be completed on time, two European scientists said in a study made available on Thursday.
In research done at and funded by Johns Hopkins University in Baltimore, Maryland, toxicologist Thomas Hartung of Germany and chemist Costanza Rovida of Italy said that animal testing of substances registered under REACH will cost $13.6bn (€9.5bn) over the next ten years, rather than the $2.3bn estimated by the EU when the programme was drafted.
Hartung and Rovida also contend that instead of requiring some 2.6m vertebrate animals to complete REACH testing, some 54m animals will be needed.
The study authors said that their estimates of much greater financial costs and test animal requirements are based on an analysis that uses a best-case scenario and the most optimistic assumptions.
The actual costs, both in terms of financial burden and the number of lab animals needed, could well be much higher, they said.
Noting that they both support the aims of REACH, Hartung and Rovida contend that EU legislators badly underestimated the scale of the testing challenge.
They said that when REACH was negotiated in 2001-2005, “it was expected that 27,000 companies would submit 180,000 pre-registrations on 29,000 substances”.
“Instead, some 65,000 companies made more than 2.7m pre-registrations for in excess of 140,000 substances,” they said, citing data from the European Chemicals Agency (ECHA).
The authors said that several factors contributed to the EU’s underestimation of costs and testing requirements.
They said the EU relied on chemical production data from 1991-1994, but the European chemicals industry has grown by about 5% annually since 1994, almost doubling production and sales by 2008.
In addition, they note that in 1994 the EU had 12 member nations, but it now contains 27 states - plus three non-EU countries - that will adhere to REACH. They said that the final REACH programme also requires more animal testing - such as second-generation evaluations - than first envisioned.
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To meet the testing and cost requirements of REACH, each year over the next decade the EU will require 60 times more lab animals (5.4m) at costs 16 times higher ($1.4bn) than current annual expenditures, the study suggests.
“The feasibility of the [REACH] programme is under threat,” the study said.
The authors recommend that REACH be refocused to concentrate on chemicals that pose the greatest risk to consumers and that the deadline for completing data collection be pushed beyond the current 2018 target date.
Hartung, a professor at the
Their report was published by the Trans-Atlantic Think Tank for Toxicology at Johns Hopkins, and they published a brief analysis of their research in the current issue of the weekly science magazine Nature.
($1 = €0.70)
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