Instructions Given by Experts on Infant Formula Registration in Hainan Offline Seminar

On March 31, 2021, ChemLinked attended an offline seminar given by infant formula review experts and SAMR officials in Hainan island. The seminar mainly interpreted the requirements of infant formula registration under the new GB standards, covering technical review of recipes, onsite inspection and subsequent supervision. Here are the keynotes.

Requirements of documents

• Disclosed by the previous SAMR notice, when applicants want to apply for recipe registration, alteration and renewal under the new standards, they should provide relevant materials and documents based on the requirements specified in “Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial) (2017 Revised Edition)”. Materials and documents without any changes are exempted from the submission. But it is still necessary to submit the commercial production process validation reports of 3 batches.

• When applying for the recipe re-registration, enterprises need to provide the basis for the setting of feeding suggestions (preparation method, intake amount, etc.). In addition, plans and measures to prevent and control contaminants, such as chloropropanol esters, perchlorates, etc., should be provided as well.

• Documents are encouraged to submit once. For example, it is not suggested to submit the majority of materials first and then submit the documents of stability test for the second time. 

Label & Claim requirements

• The labeling of based powder and ingredient list should strictly follow GB 7718 Standard for the Labeling of Prepackaged Foods.

• For stage 1 infant formula, it is not suggested to label the nutrient function claims of mandatory ingredients according to GB 28050 General Rules for Nutrition Labeling of Prepackaged Foods. Claims of optional ingredients are allowed. 

Re-registration and alteration issues

• The major differential point for alteration and re-registration lies in whether the ingredient species and nutrition fact table are both adjusted. The aforementioned SAMR notice revealed that, if ingredient (including food additives) species and the nutritional facts of recipes were both adjusted, which becomes a new product recipe virtually, then applicants should annul the original recipe first and register the recipe as a new one. However, the deletion of ingredient like vanillin will not be regarded as a substantial change, because it is not a necessary ingredient in the recipe and such deletion is good for consumers. This principle also applies to the deletion of maltodextrin, etc.

• It is noteworthy that SAMR official also pointed out enterprises should not be struggling with the registration or alteration issues. It is very likely that registration and alteration are subject to the same requirement, including the requirement of on-site inspection.  

Supervision requirements

• For recipes that get the alteration approval, the registration number will remain unchanged. A new registration number will be given for registration approval.

• For the labeling of products granted registration approval based on new GB standards, the applicable executive standard should also include the year of publication, e.g. GB 10765-2021 (at present, products only label “GB 10765” as the product standard), which could bring convenience of the follow-up supervision during the grace period.

• As for the on-site inspection of overseas infant formula manufacturers, undoubtedly it will be carried out in future but SAMR is considering innovative ways for the implementation such as the cooperation with competent authorities in overseas countries. 

Prediction and trend

Jiang Yujun, a review expert of infant formula recipe, predicted that the application spike of infant formula registration will appear in November this year and last to February next year. Besides, compared to the registration requirements in 2017 and 2018, the review work will have more detailed and stringent requirements from now on. For example, along with the finding of new risks, the control measures of contaminants will be subject to more requirements accordingly. SAMR official in the seminar also said the grace period would not be further extended, because it is rational for enterprises to cope with the formula registration issue within 2 years. She unveiled that lots of domestic enterprises had been preparing for the recipe adjustment before the official release of the new standards.

For more interpretation and updates of requirements under the new infant formula standards, remember to join our webinar on April 8th! Click here to register.