April 26, 2009

Via Email Sanco-Sc8-Secretariat@ec.europa.eu

To: Scientific Committee on Health and Environmental Risks (SCHER)
The European Commission

Re: “Call for Information” – scientific papers, reports, etc., on fluoride and fluoridation
chemicals published after 2004.

Dear Committee Members,

In response to your “Call for Information” we submit the following list of papers, reports, and
relevant articles, published since 2004, on fluoride.

On April 23, I asked Takis Daskaleros for a week’s extension to submit the pdf copies of these
articles to which he kindly agreed. I will be submitting them no later than May 4.

An important report that we list below is the National Research Council of the National Academies
2006 study, Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (NRC, 2006).
This landmark report, with over 1100 references, provides an excellent review of the toxicology of
fluoride as reported prior to 2006. We urge the Committee members to avail themselves of the
wealth of information in this report.

When the NRC (2006) panel reviewed the studies on the brain they had only had five IQ studies
available to them. Since 2006, several more IQ studies have been published, one from Iran, one
from India and another from Mexico. In addition, the Fluoride Action Network arranged for 19
brain studies originally published in Chinese to be translated into English. Most of these have
since been published in the journal Fluoride. In total, there are now 23 studies which indicate a
possible association between the lowering of IQ in children and moderate to high exposure to
fluoride. The levels of fluoride in the studies involving drinking water ranged from a low of 0.88
ppm to a high of 9.4 ppm. The lowest level estimated to be associated with lowering of IQ was 1.8
ppm (Xiang et al., 2003 a and b) and 0.88 ppm in combination with moderately low iodine levels
(Lin, et al., 1991). Five of these studies have yet to be translated from Chinese. Various
combinations of these studies have been subjected to three meta-analyses (e.g. Tang et al.,
2008). In addition to the IQ studies three other newly translated studies from China have found
fetal brain damage in aborted fetuses in areas endemic for fluorosis (Han et al., 1989; Du et al,
1992; Yu et al., 1996).

In your evaluations on the fluoridation of drinking water we ask that you apply a margin of safety
analysis to those adverse end points associated with high dose levels, to determine a dose which
is protective for everyone – not just the average citizen. Normally toxicologists use a factor of 10
when extrapolating from an adverse effect, in order to protect for the usual range of sensitivity to
a toxic substance in a human population (intra-species variation). Some advocate a larger safety
factor than 10 for the protection of infants because of their extra vulnerability to toxic substances,
especially those substances known to interfere with development.

Furthermore when extending this analysis from a safe dose in mg/day, or a safe dosage in mg/kg
bodyweight /day, to a safe drinking water level another safety factor needs to be introduced to
take into account the full range of water consumption as well as the fact that people are getting
fluoride from numerous others sources in addition to fluoridated water. We would appreciate it if
you would provide the public with a very clear explanation and justification for the selection of the
safety factor(s) you use. We would also remind you that the level of fluoride in mothers milk is
0.004 ppm (NRC, 2006, page 40). This should be a helpful yardstick for what evolution deemed
was appropriate for consumption by a breast fed infant, and may help to determine a safe level
for babies.

Lastly, we were quite shocked at the November 2008 “scientific opinion” of the European Food
Safety Authority (EFSA) on their approval of adding sodium monofluorophosphate to food. EFSA
added, as a caveat to their approval, this statement: “The safety of fluoride itself, in term of
amounts that may be consumed, is outside the remit of this Panel” and that for children, ‘tolerable
upper intake levels would be exceeded in most cases’.

To avoid anything resembling EFSA’s inexplicable opinion on sodium monofluorophosphate, we
urge this Committee to take full advantage of the physiologists, neuroscientists, toxicologists,
biologists, and chemists, in your respective countries, to assist you in your work.

I wish you all the best in your deliberations,

Ellen Connett,
Fluoride Action Network

• See

— Part I. Rough categorization of studies, by subject. published since 2004

— Part II. List of studies by author