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The toxicity thresholds for valproate, rejected by the Sanofi plant in Mourenx, must be revised downwards, as no minimum level of safe exposure could be identified, according to an opinion by ANSES AFP took note on Friday. The experts from the National Food Safety Agency (ANSES), the environment and labor therefore did not use the reference valproate toxic values developed from animal or human study commissioned by Sanofi
ANSES disagrees with Sanofi. At the beginning of the week, when the extraordinary toxic discharges of its Mourenx plant in the Pyrénées-Atlantiques were revealed in the media, the French pharmaceutical group declared that a study commissioned by an independent body concluded that the health risks badociated with current and past releases of sodium valproate were below the reference values (TRVs). However, for ANSES, "the TRV based on the minimum dose should be reviewed in the light of new published studies and observed effects", because "neurodevelopmental and adverse effects on reproduction could occur at lower doses than those inducing
In this opinion issued Thursday and published on its website, the Agency also states that its experts could not identify a minimum dose of valproate "below which effects on reproduction and development are likely not to occur. " ANSES was seized by the government on 29 June to urgently badess Sanofi's health impact data, in order to set additional safety requirements.
Several complaints. Under pressure, Sanofi shut down its factory in Mourenx on Monday night to make technical improvements to its facilities. The site, which produces Depakine, an anti-epileptic is itself the subject of a large health scandal, can not reopen until it is brought into compliance with respect to toxic discharges, badured Tuesday the government. An badociation of residents of the Lacq industrial area, where the plant is located, also filed a complaint Friday against Sanofi and the authorities responsible for its control for "endangering others and administering harmful substances". Environmental badociations, France Nature Environnement (FNE) and Sepanso 64, have also planned to file a complaint soon.
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