FSANZ approves Nestlé infant formula L-histidine level amendment

Nestlé Australia Limited and Nestlé New Zealand Limited filed the application in May 2012, seeking a reduction in the minimum requirement for L-histidine in all infant formula products.

They proposed amending the Australia New Zealand Food Standards Code – reducing minimum requirements from 12mg/100kJ to 10mg/100kJ.

L-histidine, which is naturally present in breast milk, is the chemical precursor to histamine, helps to maintain a healthy heart and circulatory system, and boosts the immune system.

In its application, Nestlé argued that the proposed reduction is “safe and will promote normal growth and development in infants.” ​It added that the amendment would promote international regulatory consistency, which would be beneficial for trade.

“Appropriate” reduction​

“Based on our assessment, FSANZ considers it is appropriate to reduce the minimum required level of L-histidine in infant formula products from 12mg/100kJto 10mg/100kJ, as requested by the Applicant,”​ said the FSANZ draft amendment.

“The reduced minimum level is comparable to the average L-histidine content of breast milk and is considered adequate to support the growth of formula-fed infants.”​

“Amending the Code would provide consistency between the Code and international and overseas food standards, and overall, would provide a net benefit to the community,” ​said the notification.

A Comparative Nutritional Safety Assessment (CNSA) was undertaken to review Nestlé’s application.

Through the assessment, FSANZ aimed to confirm whether or not the proposed reduction would be consistent with levels of L-histidine in breast milk and support normal growth in formula-fed infants.

The CNSA found that the average level of L-histidine in breast milk was 24 mg L-histidine per gram of crude protein – the equivalent of 10mg/100kJ.

Regulatory harmonisation ​

According to Nestlé, the current FSANZ regulations are not in line with relevant international standards.

The Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants states a minimum L-histidine requirement in infant formula of 41mg/100kcal – approximately 10mg/100kJ.

While European Commission (EC) Directive 2006/141/EC – Infant Formula and Follow-on Formulae – has a minimum L-histidine in infant formula and follow-on formula requirement of 10mg/100kJ.

The proposed reduction would bring the Australia New Zealand Food Standards Code in line with these standards.

“A reduction in the requirement for L-histidine is expected to benefit trade, support business competitiveness and innovation, and improve the range of products available to Australian and New Zealand consumers,”​ the FSANZ notification added.

FSANZ has now called for submissions to assist consideration of the draft food regulatory measure.

The deadline for submission is 20 December 2012.