ANH described sodium monofluorophosphate as “toothpaste toxin” and said EFSA’s verdict was “irresponsible”.
Dr Damien Downing, ANH’s medical director, said: “It’s bad enough brushing your teeth or rinsing your mouth with fluoride. But opening up its usage to food supplements when it’s very difficult to control how much other fluoride a person is being exposed to, especially in countries like Ireland and the UK where the public drinking water supplies might be fluoridated, is utterly irresponsible.”
An EFSA spokesperson said the ANH criticism was misplaced and noted the risk assessor was in the process of constructing a response to the accusations.
ANH said the two petitioners (Hungarian firm Beres Pharmaceuticals and Italian company Rottapharm) intended the chemical be used for treating tooth decay and therefore it should be classified under drug law.
“As this use is clearly medicinal, its evaluation should be undertaken by the European Medicines Agency in an application for a drug. This is simply not within EFSA’s legal remit,” said ANH legal director, Robert Collins.
He called for an independent review of EFSA’s risk assessment work.
ANH executive and scientific director, Dr Robert Verkerk, said political factors were influencing EFSA’s decision-making processes, and added both EFSA and the European Commission were as “opaque as each other”.
“How can the people of Europe have any confidence in EFSA’s decisions when the methods it uses seem to be more about political number shuffling than proper science?” said Verkerk.
“EFSA shouldn’t be surprised by this criticism—we’ve been outlining the many problems with its approach for over three years via public consultations. Yet we’ve not had one government authority ever come back to us to discuss our scientific concerns. We’re ready to send a team of scientists to Parma to dialogue with EFSA at any time—they need only ask.”
In its November 2008 opinion on the chemical, EFSA’s Panel on Food Additives and Nutrient Sources (ANS) stated: “The use of sodium monofluorophosphate as a food supplement would be of no safety concern provided that fluoride tolerable upper intake levels established in Europe are not exceeded by the combined exposure from food supplements and the diet.”