CHINA - FORMULA REGISTRATION IN THE PROCESS OF THE REVISION OF THE INFANTS & YOUNG CHILDREN FORMULA FOOD STANDARD

In recent years, infants & young children formula products have received extensive attention in both China and the world. As the study of nutrition science deepens, organizations have successively carried out the revision work for infants & young children formula product standards in recent years. For example, the Codex Alimentarius Commission started revision work for the older infants & young children formula food standard (Codex Stan 156-1987) in 2011, EU issued regulations to modify the nutritional ingredients in infants & young children formula food in 2016, the United States revised the selenium content in infants & young children formula food, Australia and New Zealand is also soliciting opinions on the revision related to infants & young children formula standard.

China released infants & young children formula food standards (GB 10765-2010, GB 10767-2010) very early. In order to promote infants & young children formula food to be more scientific and safer together with further implementation of the requirements of “most stringent standard” and enhancement of the scientificity and safety of our infants & young children formula food standards, the General Office of National Health and Family Planning Commission released the “National food safety standard project plan in 2016 (the second batch)” on December 22, 2016 including revision plan for infants, older infants and young children formula food standards.

According to the introduction of China National Center for Food Safety Risk Assessment, this revision work of infants & young children formula food standard mainly refers to the standards of Codex Alimentarius Commission, and also imitates the infants & young children formula food standards and regulations of EU, the United States and Australia, etc.. At present, the revision work of standard mainly includes the following aspects:

①     The standard framework is changed, and the original standard “Older infants and young children formula” (GB 10767) is divided into “Older infants formula food” standard and “Young children formula food” standard.

②     All nutrient contents were reevaluated.

For infants formula food, the majority of the nutrient content currently meets the needs of infants and will not incur excess risk, so it is recommended to maintain;

For older infants formula food, some data in the existing standards shall be revised according to the latest scientific evidence, the lower limit values of some nutrients need to be adjusted, and the upper limit values of most nutrients need to be set to meet the needs of infants at this age group;

For young children formula food, put forward scientific suggestive value as far as possible according to the present nutritional status of young children in China based on the existing evidence. For example, reduce the protein content range, and regulate the lower limit range of some certain nutrients (such as DHA).

③     Pay attention to the revision progress of International code and the standards of each country in real time. The Codex Alimentarius standard for nutrient contents in older infant formula food (6-12 months old) has been basically completed in revision, which reduces the content of energy and protein, and adjusts the content range of nutrients.

④     The standard revision matches with the current registration requirements;

Since many enterprises, taking into account the detection and shelf life attenuation and other factors, make the target nutrient content close to the larger value, China National Center for food Safety Risk Assessment pointed out that the minimum value in standard rather than the maximum value shall be taken as the designed goal in order to avoid potential security risks. Only the minimum value shall be set according to the requirements, while the maximum value is the index set to prevent excess and control safety.

Impact on infants & young children formula milk powder manufacturing enterprises:

In the perspective of the revision trend of new standard, the scope of some nutrient content will be changed, protein content will be reduced, and the upper or lower limit of some nutrients will also be defined, so many companies worry about whether it is needed to adjust the registered formula or reapply for formula registration. On August 26, 2017, China National Center for food Safety Risk Assessment said that the release and implementation of the new standards would be completed from the revision to administrative licensing of current standard in the next two years.

In view that overseas formula registration requires one year, the time for preparing the second declaration of formula may be shortened to half a year. The infants & young children formula food manufacturers shall follow the revision progress of standard, adjust the existing formulas in a timely manner, and rapidly response to the new standard, which is expected to register smoothly during the transition period of implementing the new standard. As overseas enterprises need a slightly longer time to declare, it will be better for them to do research on formula improvement based on the trend of standard revision in the next 2~3 years. While it may after all be accepted as a good plan for the infants & young children enterprises, which have not yet declared for formula registration to register formula after adjusting formula in accordance with the revision trend of new standards. In addition, there are a variety of micronutrients in infants & young children formula milk powder, and different testing methods may lead to differences in product quality determination results, so the detection bias in the formula design process shall be balanced.