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To date (July 27th 2018) China has granted approval to 152 infant formula manufacturers and 1156 formulae in total, including 47 overseas producers and their 204 formulae. Since the implementation of China’s infant formula registration requirements, remarkable progress has been made to improve product quality, safety and increase the efficiency of administrative oversight in this sector. After promulgation and implementation of the infant formula registration standard, several other changes to ingredient specific standards have also been released which have a major impact on market dynamics, exemplified by China’s new Lactoferrin standard, raw goat milk and goat whey requirements etc. precipitating the need for many manufacturers to change their registered infant formula.
The long anticipated guidance on altering a registered infant formula was finally released in draft format and if passed will have significant ramifications for relevant stakeholders.
The draft guidance specifies the application scope, documentation requirements and the conditions under which manufacturers need to apply for formula alteration and conditions under which it is necessary to conduct formula registration starting from scratch.
Alteration of Previously Registered Formula
Within the validity period of a registration certificate, if a change to a formula doesn’t involve changing original raw materials, ingredients sheet, nutrients information table then manufacturers are allowed to adjust the relative concentrations of raw materials and (or) food additives within a permitted range and are eligible for alteration of a previously registered infant formula
Conditions Under Which a New Infant Formula Registration Application is Necessary
If a change to a formula is obviously different from the originally registered formula and includes changes to the nutrient information table, ingredients list, raw materials, or the manufacturing techniques differ (wet processing/dry processing/combination of both) then a new formula registration application is necessary.
The draft also outlines changes that could undermine the likelihood of positive review by regulatory authorities during the assessment of a registration dossier based on a reduction in overall scientificness and safety of the infant formula.
According to the above provisions, to remove Lactoferrin from the formula, as we predicted, will require submission of a completely new registration dossier.
The draft guidance is another major blow to any international enterprise struggling with the complexity of maintaining market access and the unstable market conditions in China. The draft also further expands and clarifies the overall regulatory framework and administrative procedures of infant formula in China and will supplement the requirements released by the former CFDA last year when it detailed the requirements and criteria for changing the label of registered infant formula.
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