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On February 13, 2023, China released an amendment draft to GB 25596-2010 General Rules of Infant Formula for Special Medical Purposes, along with other 37 GB food standard drafts. The proposed standard applies to food for special medical purposes (FSMP) of consumers from 1 to 12 months, which is the same as the current standard. The revision mainly involves definition, FSMP types and technical requirements. Any feedback can be sent back prior to March 20, 2023.
Major revisions
6 new FSMP types are proposed to be added.
The revised framework of FSMP types is summarized below. The draft improves the technical requirements for the current FSMP types and adds 6 new types (highlighted in yellow). Extensively hydrolysed milk protein formula and amino acid formula are in the same food category in the current framework but separated in the revised version.
The revised framework of FSMP types
The definition of FSMP for infants is proposed to be revised
The draft deletes the requirement for product forms, such as liquid and powder, so as to fit the technical development and consumer demand for diversity. To avoid misunderstanding, the draft cuts “the energy and nutrients shall meet the growth and development needs for 0-to-6-month-old infants”.
Additionally, “nutritional needs” is revised to “dietary nutritional needs”. For instance, in the formula for preventing gastroesophageal reflux disease, the product form is designed more thickened to avoid gastroesophageal reflux in consideration of the dietary demand of infants. The proposed and current definitions are shown in the table below, with the revised part remarked in red.
Proposed and current definitions
FSMP for Infants | Definitions |
In proposed standard | It refers to the formula which is designed to meet the dietary nutritional needs of infants in special medical conditions such as a particular disorder, disease or medical conditions. This food type shall be eaten alone or in combination with other foods under the guidance of doctor or clinical nutritionist. |
In current standard | It refers to the powder or liquid formula which is designed to meet the nutritional needs of infants in special medical conditions such as a particular disorder, disease or medical conditions. Under the guidance of doctor or clinical nutritionist, the energy and nutrients shall meet the growth and development needs for 0-to-6-month-old infants in special medical conditions while eating alone or in combination with other foods. |
The general requirements for nutritional ingredients are proposed to be revised.
The draft mainly revises the indicators in 3.4 Indispensable ingredients and 3.5 Optional ingredients. Notably, choline is proposed to be modified from optional ingredient to indispensable ingredient. Many content requirements for the indicators are modified. For instance, in the current GB standard, the energy coefficient of dietary fibre is calculated by 50% of the carbohydrate energy coefficient. According to the draft, it shall be calculated by 8kJ/g. In addition, the table below provides some examples of the revised indicators (in red).
Examples of the revised indicators:
Nutrients | Value per 100kj | |
Minimum value | Maximum value | |
Protein/g | 0.45→0.43 | 0.70→0.84 |
Fat/g | 0.84→1.05 | 1.40→1.43 |
Vitamin D/µg | 0.25→0.48 | 0.60→1.20 |
Manganese/µg | 1.2→0.24 | 24.0→23.90 |
Check this link to find more details about other 37 GB standard drafts: China Unveils 38 National Food Safety Standard Drafts
Please refer to FSMP Registration Database if you are interested in FSMP registration data.
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