By lobbyism, one multinational infant formula manufacturer achieved a competitive advantage during the creation of Regulation (EU) No 609/2013 of the European Parliament. This regulation focused on the specific compositional and information requirements for infant formula and follow-on formula. The manufacturer successfully introduced very specific protein and manufacturing demands for infant formulas made from protein hydrolysates. As a result, the regulation now requires the same protein source and processing parameters as used by this particular player.
The impact of this regulation was significant for other players in the market. Despite several other companies already having their hydrolysate infant formula products on the European market (some for years), these products were no longer considered safe by the European Union. Consequently, clinical documentation was now required for all these existing products to gain approval. This meant that a huge number of clinical trials had to be executed, and a large number of infants had to be recruited for these trials, to fulfil new requirements by the European Food Safety Authority (EFSA) where each formula needed to go through a so-called nutritional safety and suitability assessment.
The situation created by the regulation was deemed unethical and lacking in safety justification. Due to industrial pressure, the European Food Safety Authority (EFSA) realized the need for a better practice. On July 17, 2020, EFSA issued an explanatory note to address the issue: “EFSA would like to emphasise that the Panel will conclude on the specific protein hydrolysate used to manufacture the formula for which the dossier has been submitted rather than on the formula itself. This is justified as the composition of the formula with respect to substances other than the protein hydrolysate fraction should comply with the compositional requirements laid down in Commission Delegated Regulation (EU) 2016/127 in order to ensure the nutritional safety and suitability for use by infants.”
In simpler terms, this means that clinical testing is not required for each formula but for each protein hydrolysate used in different formulas. Consequently, the number of clinical tests needed is reduced to some extent, as different manufacturers may use protein hydrolysate from the same supplier in their respective formulas. However, protein hydrolysate ingredient suppliers must now undergo clinical trials and the time-consuming EFSA approval process to have their ingredients approved, even for ingredients that have been on the European market for more than 15 years. Ultimately, these costs will be borne by consumers, specifically the parents of infants who rely on these formulas. It is hoped that all parents can afford these products and will not be forced to choose potentially less safe alternatives.
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Tag: Sven Hogh Peterson Eric Blanchard
#NutriXperts #InfantFormulaRegulation #ProteinHydrolysate #FoodSafety #NutritionSafety #EFSAApproval
