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French Regulations

Dear Dr Daniel,

Our report considered phytoestrogens specifically and soy only in second interest, therfore on the site www.afssa.com, you will find the reports at phytoestrogens and not at soy.

We set up a security limit beyond that we had no data to ascertain no adverse effect from isoflavone consumption, this limit is 1mg/kg bw/day of aglycon isoflavone for all consumers of soy derived products

We recommended to drastically decrease isoflavone in soy infant formulae to get it as low as possible, 1mg/liter of reconstituted formula being optimal. 1mg/L of soy formula is 1ppm, but in soy protein which is the raw material there is about 1mg of agycon isoflavone /g of protein. In France we have soymilk which contains 37g/L of protein which means 37mg of aglycon isoflavone content/L, thus we ask for an oprtimal reduction of about 30 to 40 times and not one million (as far as the protein content is the same in infant formula). And we know that some cultivar present 4xtimes less isoflavone, so we are at 4 to 5g!

We do not advise soy derived products for children below 3 years of age, because of insufficient nutritional value.

In France also, soy industry claims that such a reduction is impossible, but it is their problem, and if pediatricians do not recommend it anymore, they will have to change.
If it is true that soy industry has almost entirely isoflavone free products, they should use it. I know Archer did provide such a product which was used in an intervention assay in young women in UK, but not in children.

We do not know exactly when the new regulation will go into effect, the agency is working on it.

Regular products to be possibly consumed by all consumers but children below 3 years of age, children treated for hypothyroiditis, women with previous history of breast cancer and/or history of familial breast cancer will have a warning label with the security limits and the above restrictions

I hope I answered your questions, don't hesitate to call on me again if necessary
best regards

Dr. Mariette Gerber
Centre de Recherche en Cancérologie
INSERM-CRLC
34298 Montpellier Cedex 5
tel: (0)4 67 61 30 05
fax: (0)4 67 61 37 87