Business, not science, driving infant milk formulations say doctors

The standards for infant formulations, a topic of continued discussion with the Codex Committee, is being driven by commercial interests and not science say two paediatricians, claims that have been refuted by the industry.

The Codex Committee on Nutrition and Foods for Special Dietary Uses met in Germany late last year, with standards for infant milk formula high on the agenda. A scientific expert report was compiled and presented to the Committee, with recommendations on protein and nutrients levels.

In an editorial in the British Medical Journal, published today (Vol. 332, pp. 621-622), Professors Berthold Koletzko from the Dr von Hauner Childrens Hosptial in Munich and Raanan Shamir from the Meyer Childrens Hospital in Haifa, Israel, indicate that the scientific recommendations were being questioned and challenged by parties with commercial interests.

The Codex Committee meeting was attended by 315 delegates from 68 countries as well as observers from 33 different non-governmental organisations (NGOs), including the International Dairy Federation.

The main bones of contention from the paediatric doctors come from the standards used for the determination of infant formula protein, and the levels of water-soluble vitamins in the formulas.

The official report from the Codex Committee November meeting states: "The nutritional safety and adequacy of infant formula shall be scientifically demonstrated to support growth and development of infants."

This is being undermined, say Koletzko and von Hauner, by pressure from the International Dairy Federation, and delegates from strong dairy-producing countries.

"The International Dairy Federation demanded that the proportion of protein in formula derived from cows milk should be determined with a conversion factor of 6.38 even though modern infant formulas contain modified milk protein fractions for which this factor is not appropriate," said the paediatricians.

Koletzko and von Hauner, say that scientific experts in three separate reviews to the FDA, the EU and to the Codex Alimentarius Commission all agreed that a conversion factor of 6.25 should be used.

The paediatricians report that the International Dairy Federations demands were supported by several delegates from unnamed countries with big dairy industries.

By demanding the higher nitrogen conversion factor for cows milk would suggest that the milk has a higher biological value than human breast milk, say Koletzko and von Hauner, "which is clearly not the case."

The industry argued that changing to the lower conversion factor would result in massive losses for the dairy industry. The German dairy industry is said to have estimated losses of about 80m ($96m, 55m) in Europe alone from such a policy.

The International Dairy Federation (IDF) have hit back at the proposed changes, saying that the conversion factor of 6.38 is a well-established standard for whole cows milk and that it "is" based on science.

Quoting an array of scientific studies in a document entitled, "Comprehensive review of scientific literature pertaining to nitrogen protein conversion factors," the IDF stated: "There exists no scientific justification to support the change of the original protein source from 6.38 to 6.25. Any such modifications (both prior and proposed) are not supported by the conclusions drawn from the scientific studies reviewed herein."

A spokesman for the IDF expanded on these statements, telling FoodNavigator.com: "The proposed introduction of one single arbitrary conversion factor of 6.25 would understate the protein content of products based on milk and overstate the protein contents of products based on soya.

IDF retains its viewpoint that Codex must be based on science but not on simplicity. The choice of conversion factors has commercial implications but the reality is that the drivers for setting this standard are scientific and nutritional."

In terms of water-soluble vitamins, scientific recommendations to the Codex Committee said that the levels should not be greater than five times the minimum level of each vitamin.

"Delegates from some member states requested that maximum values should be established only for levels of nutrients with documented adverse effects in infants.

Moreover, the US delegation requested that both maximum values and guidance values should not be lower than values used for formulas already on the market, even if such levels have not been subjected to systematic evaluation, of their effects and safety," said Koletzko and von Hauner.

These two controversies from the meeting have led the authors to suggest that we question the basis of decisions of the Codex Alimentarius under such commercial pressures.

Koletzko and von Hauner called for paediatricians around the world to rise to reject such commercial pressure and should only recommend infant formulas whose composition is based on science.

The next meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses is scheduled for the end of October 2006 in Chiang Mai, Thailand.