Summary: Changes in Chinese Infant and Follow-Up Formula Draft Standards

Date: 2021-Feb-25 Source:Antion View: 857

On Sep. 7, the National Health Committee (NHC) revealed the drafts for infant formula and follow-up formula standards.

 

NHC made certain important revisions to the existing standards, for instance the older infant and young children formula standard was split to two standards. Coordinated with Chinese universities, the levels of nutrients were widely revised based on the breast milk studies, NHC said in the revision instruction. Antion will introduce the key changes and elaborate influences on formulation registration in this article.

 

Key changes

Draft of infant formula standard (draft GB 10765, for 0-6 months)

Ÿ   Choline is required as an essential nutrient and the required level is doubled while it is an optional nutrient in the existing standard

Ÿ   For carbohydrate source, in current standard, lactose, lactose and glucose polymer are preferred, and fructose is forbidden in case of potential life-threatening symptoms in young infants with unrecognized hereditary fructose intolerance. In the draft, Lactose is the preferred carbohydrate source and glucose polymer in proper level is acceptable while both sucrose and fructose are forbidden

Ÿ   The max and min level for nutrients are changed, especially vitamin D, please check the annex

Ÿ   Each strain of probiotics should reach a potency of 10^6 cfu/g (ml)

Ÿ   A small change* on mandatory warning may lead to label revision

* “對于0-6月的嬰兒最理想的食品是母乳,在母乳不足或無母乳時可食用本産品” is changed to “對于0-6月齡的......”

 

Draft of older infant formula standard (draft GB 10766, for 7-12 months)

Ÿ   Choline, manganese, selenium are required as essential nutrients while they are optional in the existing standard

Ÿ   Whey protein of milk-based product should be no less than 40% of total protein content

Ÿ   Ingredients and food additives should not contain gluten

Ÿ   In the draft, lactose is the preferred carbohydrate source and should be no less than 90%, glucose polymer in proper level is acceptable while both sucrose and fructose are forbidden

Ÿ   The max and min level for nutrients are changed, especially vitamin D, please check the annex

Ÿ   Each strain of probiotics should reach a potency of 10^6 cfu/g (ml)

Ÿ   A small change* on mandatory warning may lead to label revision

*suitable for 6-12 months is changed to 7-12 months

 

Draft of young children formula standard (draft GB 10767, for 13-36 months)

Ÿ   Lower protein level

Ÿ   In the draft, except the lactose-free or low lactose formula, lactose should be no less than 50% of total carbohydrate

Ÿ   The max and min level for nutrients are changed, especially vitamin D, please check the annex

Ÿ   Each strain of probiotics should reach a potency of 10^6 cfu/g (ml)

Ÿ   A small change* on mandatory warning may lead to label revision

*suitable for 12-36 months is changed to 13-36 months

 

Influences on formulation registration

The new drafts are still in consultation period. It may take 4 years for these standards to go through the publishment and transitional period, and finally get fully implemented. So for registered formulas, the influence is very limited. We just suggest the R&D to initiate the formula update. As for products haven’t obtain the registration, it would be better to get the registration quickly to avoid the situation that the standards are published before the completion of registration.

 

According to the draft of the guideline for changing application of formulation registration, we consider that any additions of new nutrients or NIP changes may be recognized as a new formula and need to apply for a new registration certificate.

 

Annex

Comparison of infant formula standard (draft GB 10765, for 0-6 months)

 S1-Energy & General Nutrition_副本.png

  S1-Mineral_副本.png                                           

1538044584190702.png

 S1-Optional_副本.png


 

Comparison of older infant formula standard (draft GB 10766, for 7-12 months)



S2-Energy & General Nutrition 2_副本.png 

1538044642393331.png



 S2-Vitamin_副本.png

S2-Optional_副本.png


Comparison of young children formula standard (draft GB 10767, for 13-36 months)

S3-Energy & General Nutrition_副本.png

S3-mineral_副本.png

1538044722482204.png

S3-optimal_副本.png


Relevant Reading

Introduction of Food Related Application & Registration Services