Effective strategy within REACH

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Effective strategy within REACH

• ANTIDOTE EUROPE
• An European-wide board of reseach scientists
• President Claude Reiss PhD, former Professor
• and CNRS Research Director, Molecular Biology,
  Paris
• www.antidote-europe.org

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Mortality due to BRAIN cancer, France
(data INED)
Per 100,000
Age class
year
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The REACH project, as proposed by the EC in 2001

• Test of 100,000 chemicals
• Cost 11 B, to be supported by industry
• Completion by 2020-2050 (?)
• Test method animal models

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The REACH project, as proposed by the EC in
2001CRITICISM by Stakeholder parties

• Test of 100,000 chemicals
• Consumer protection MOST WELCOME, but
• Cost 11 B, to be supported by industry
• Chem. Industry NOT AFFORDABLE
• Completion 2020-2050 (?)
• Environ. Protection DELAY TOO LONG
• Test method animal models
• Animal Welfare ETHICALLY UNACCEPTABLE

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CRITICS ARGUMENTS the tests will involve gt
100,000,000 animals

• Cost Estimate 100 PER ANIMAL, average
• Hence total 11 B, to be charged to industry
• Animal testing per substance TAKES MONTHS
• Hence completion by year gt2050, perhaps 2100
• By far the largest MASS POISONING ever
• ..BUT the MAJOR CRITICISM is

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Animal tests unreliable for humansbecause

• A species is defined by its reproductive
  isolation, linked to its unique genetic make-up
• the genetic make-up in turn determines all
  biological activities, incl. response to a test
• Therefore, response to a test is
  species-dependent.
• Hence no species is a reliable biological model
  for another species

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CONCLUSION.COMMON OBSTACLE to the REACH PROJECT

• FLAWED ANIMAL TEST
• METHODOLOGY

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The way forwardScientific Toxicology

• Toxicology is biology in the presence of the
  toxic substance.
• Methods developped in modern biology apply to
  toxicology.
• The solution to any biological problem is to be
  earched ultimately at the cell level.
• DNA arrays allow to assess toxicity in human
  cells TOXICOGENOMICS

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TOXICOGENOMICSprinciple

• HUMAN cells in culture are exposed to substance
  to be tested.
• In response to toxic agression, cells express
  genes for security, damage repair
• Gene expression is monitored by DNA array.
• Known biological activity of affected genes allow
  unambigous, scientific assessment of toxic risk.
• Substance identified as toxic to human cells are
  toxic to humans.

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TOXICOGENOMICS respond to ALL CRITICS made to
REACH

• ReliableToxicity assessments valid for humans
• Cost lowered hundred-fold (estimate about 100M)
• Speed a few years for 100,000 products by
  large-scale, robotized set-up
• Can be easily expanded to test mixtures
• No animal involved

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TOXICOGENOMICSWORKS RIGHT NOW!

• We assayed a series of substances using
• DNA arrays, produced and processed by SCIENION
  GmbH, Berlin
• Cell culture and exposure to substance, made by
  BioTeSys GmbH, Esslingen
• Assay supervision Antidote-Europe, Paris
• We would be happy to present the results to
  interested MEPs

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Conclusions

• Reliable risk assessment means effective
  prevention of cancer, neurodegeneration...
• Spare Billion in Social Security Bill
• Pay consideration to futur generations!
• Authorities will be compelled to adopt
  Toxicogenomics within 2 or 3 years
• E.U. could take the lead for scientific toxicity
  testing world-wide

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