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According to No. 752 announcement issued on Sep. 7, 2018, China NHC opened 9 GB standards and 1 modification list for public feedback. The details are listed below.
GB 10766 National Food Safety Standard Older Infant Formula Food
GB 10767 National Food Safety Standard Young Children Formula Food
National Food Safety Standard Complete Nutrition Formula for Cancer
National Food Safety Standard Complete Nutrition Formula for Inflammatory Bowel Disease
National Food Safety Standard Complete Nutrition Formula for Diabetes
National Food Safety Standard Clinical Application Guidance of Food for Special Medical Purposes
National Food Safety Standard Operational Guidance For Student Meals
No. 1 Modification List For National Food Safety Standard General Rules for Sports Nutrition Food
GB 10765 Infant Formula Food (draft)
The draft states that GB 10765 infant formula food is applicable to formula food which are consumed by 0 to 6-months infants (stage 1), and here are some major amendments:
Choline is listed as an essential ingredient. (It was optional prior to revision)
The minimum and maximum limits of some nutrients are added
The minimum level of some nutrients are adjusted
The testing method for some nutrients are updated
Parts of revision to nutrient contents are listed below.
Nutrients
| Index | |||||||
per 100 kJ | per 100 kcal | |||||||
Minimum | Maximum | Minimum | Maximum | |||||
Before revision | After revision | Before revision | After revision | Before revision | After revision | Before revision | After revision | |
Vitamin A/(µg RE)a | 14 | 14 | 43 | 36 | 59 | 60 | 180 | 150 |
Vitamin D/(µg)b | 0.25 | 0.48 | 0.60 | 1.20 | 1.05 | 2.0 | 2.51 | 5.0 |
Vitamin E/(mg α-TE)c | 0.12 | 0.12 | 1.20 | 1.20 | 0.50 | 0.5 | 5.02 | 5.0 |
Vitamin K1/(µg) | 1.0 | 0.96 | 6.5 | 6.45 | 4.2 | 4.0 | 27.2 | 27.0 |
Folic acid /(µg) | 2.5 | 2.9 | 12.0 | 12.0 | 10.5 | 12 | 50.2 | 50 |
Pantothenic acid /(µg) | 96 | 96 | 478 | 478 | 402 | 400 | 2000 | 2000 |
Vitamin C/(mg) | 2.5 | 2.4 | 17.0 | 16.7 | 10.5 | 10 | 71.1 | 70 |
Choline /(mg) | / | 4.8 | / | 23.9 | / | 20 | / | 100 |
GB 10766 Older Infant Formula Food (draft)
The new GB standard for older infant formula food (Stage 2: 6-12 months) is now GB10766. Under previous regulation GB 10767 was an umbrella standard for both stage 2 and stage 3 formulae. GB10766 is only applicable to formula consumed by 6 to 12-months infants (Stage 2). Its major revision are listed below.
The proportions for whey protein and lactose are additionally required in the draft.
Item | Requirements |
whey protein (milk based) | ≥40% (calculated as the ingredient amount) |
lactose | ≥90% of the total carbohydrate |
The minimum or maximum level of most nutrients are adjusted or added for the sake of safety and nutritional suitability.
Manganese, Selenium and Choline are now essential ingredients for stage 2 infant formula due to infant’s nutritional demand
The list of amino acids allowed to be added in older infant formula food is included in an Annex
The testing method for some nutrients are updated
GB 10767 Young Children Formula Food (draft)
This standard only applies to formula food consumed by young children aged between 13 to 36 months. The minimum or maximum level of some nutrients are adjusted or added for the sake of safety and nutritional suitability, and lactose should account for over 50% of the total carbohydrate.
Besides, the revision to protein content is listed below.
Nutrients | Index | |||||||
Per 100 kJ | Per 100 kcal | |||||||
Minimum | Maximum | Minimum | Maximum | |||||
Protein | Before revision | After revision | Before revision | After revision | Before revision | After revision | Before revision | After revision |
0.7 | 0.43 | 1.2 | 0.96 | 2.9 | 1.8 | 5.0 | 4.0 | |
GB standards for FSMP
GB standards defining the technical requirements of FSMP for specific diseases have also been released. For the product standard (complete nutrition formula for cancer, inflammatory bowel disease and diabetics), it mainly stipulates the scope, terms and definition, technical requirements, such as the ingredients, nutrition composition, food additives and nutritional fortification substance and etc.
Impact on infant formula manufacturers
A higher production cost
GB standards for infant formula (stage 1) and older infant formula food (stage 2) mandate the use of lactose as the preferred carbohydrate source (minimum concentration requirements are specified by new standards) and that the use of fructose or saccharose is prohibited (because they may cause tooth decay and effect infants’ palate development). Based on this it is expected that the cost of milk powder may increase by at least 1000 yuan per ton.
Will formula registration be effected?
As most nutrient concentration requirements are adjusted in the new draft standards, some manufacturers are worried that it will impact previously registered infant formula. According to Lynn Chan, food regulatory expert from REACH24H Consulting Group, there will likely be at least a couple of years before these new GB standards are effective. Based on past experience there will also likely be an additional grace period to allow industry time to adjust formulations and submit new registration dossiers etc. We expect the new standards to impact market access requirements in about 5 years (2023) when it is time for most enterprise to renew their registration certificates.
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