A Brief Discussion on Raw Materials of FSMP in China

FSMP, which is used for nutrition supplement and support for target population, has been widely recognized over the international community, while this kind of product has been in a relatively short history in application in China, and the development has been relatively slow at the early time. Currently, the nation and the major domestic medical institutions have paid increasing attention to FSMP, its development has been gradually on the right track. However, it is undeniable that the domestic market still has a relatively low awareness of FSMP, because consumers and enterprises are just entering this industry. Last year, CIRS Group released an article concerning How to Distinguish General Food, Health Food, FSMP and Drug in China. Now, CIRS Group carries out a more systematic discussion on what, or what kind of ingredients are permitted to be used in FSMP in China. This discussion will focus on the raw materials (excluding food additives) for the products aiming at the population over 1 year old.

1. Detailed explanation of the three FSMP categories’ definitions

More detailed and clearer descriptions on the three FSMP product categories defined in GB 29922-2013 Food Safety National Standard General Rules for Foods for Special Medical Purposes are listed below:

Table 1. FSMP definition

Category	Definition	Example
Nutritionally complete foods	Meet all the nutritional needs of the target population when consumed individually. Thus, they contain all the necessary nutrients required by the human body, including protein, fat, carbohydrate, vitamins and minerals, etc.	/
Specific nutritionally complete foods	Applied for the patients under specific disease conditions, and can meet all their nutritional needs when consumed individually. Thus, based on nutritionally complete foods, the content of some nutrients are appropriately adjusted according to the specific metabolic changes of different diseases, so as to more applicable for the target population.	Low GI (≤55) carbohydrates shall be used for specific nutritionally complete food for diabetes patients
Nutritionally incomplete foods	Provide some kinds of nutrients, thus, they cannot meet all the nutritional needs when consumed individually, and shall be consumed together with other foods, such as general food and other FSMP.	Protein (amino acid) component, which is mainly applied for the patients demanding protein support/ supplement, such as wound (burn) injury, or surgery patients

Therefore, FSMP are essentially the combination of the nutrients (required by the target population) and food additives (necessary for manufacturing, maintaining product characteristics and facilitating preparation). Based on this perspective, we are going to discuss the permitted raw materials separately based on the different sort of nutrients.

2. Permitted raw materials for the sources of nutrients in FSMP

The following information is related to the permitted raw materials of FSMP in China based on relevant regulation, standard and notice, etc.:

1) Protein:

Requirement in GB 29922 regarding the source of protein: referring to nutritionally complete food, high quality protein shall account for more than 50% of protein gross. Generally, the nutritional value of animal sourced protein is better than that of plant sourced protein.

Example: high quality protein commonly presented in FSMP: casein, whey protein, soy protein.

2) Fat (fatty acid):

Different from protein, plant sourced fatty acids are generally healthier than animal sourced fatty acids as the level of unsaturated fatty acids in plant sourced fatty is higher. In terms of nutritionally complete food, the minimum energy supply ratio for linoleic acid and α-linolenic acid (essential fatty acids) are determined in GB 29922. Their content ranges in some common edible vegetable oil are listed below:

Table 2. Content range of linoleic acid and α-linolenic acid in edible vegetable oil

Oil	Linoleic acid /%	α-linolenic acid /%
Sunflower oil	48.3~74.0	≤0.3
Soy oil	48.0~59.0	4.2~11.0
Maize oil	34.0~65.6	≤2.0
Rapeseed oil	11.0~23.0	5.0~13.0
Safflower seed oil	67.8~83.2	ND~0.1

Note: the information in the above table is from the corresponding Chinese national standard of the vegetable oil

Therefore, different vegetable oil can be added in different proportions based on different product designs. Besides, medium chain triglycerides (MCT) are permitted to be used as well (qualified by former MOH in the 16th notice at 2012).

3) Carbohydrate:

Carbohydrate sources can be monosaccharide, disaccharide, oligosaccharide/polysaccharide, maltodextrin and glucose polymer, etc., and they can be classified as: digestible carbohydrate (can be digested and provide energy), and dietary fiber (cannot be digested while are good for human health). GB 29922 indicates that, the sources of dietary fiber refer to table C.2 in GB 14880.

Example: fructo-oligosaccharide/polysaccharide (chicory source), raffinose (beet source), etc.

For digestible carbohydrate, GB 29922 has no mandatory requirements, and enterprises can choose different carbohydrate sources based on different characteristics of their products.

Example: glucose syrup (powder), crystalline fructose, maltodextrin, starch sugar, white granulated sugar, etc.

4) Vitamins & minerals:

Different from the macronutrients, in terms of nutritionally complete food, the necessary vitamins and minerals and the requirement on their content are indicated in GB 29922 and their permitted sources are clearly listed in GB 14880.

Example: sources of vitamin B1: thiamine hydrochloride or thiamine nitrate.

5) Optional ingredients:

These kinds of ingredients are listed in GB 29922 for options. Although they are not essential nutrients, they are beneficial to human body growth. The same as vitamins and minerals, their sources are listed in GB 14880.

Example: sources of DHA: Schizochytrium sp, Ulkenia amoeboida, Crypthecodinium cohnii and tuna oil.

6) Amino acids:

To improve protein quality, amino acids are permitted to be used as well. The permitted amino acids (21 varieties) and their sources of compound (35 varieties) are listed in appendix B of GB 29922, and there are also requirements in GB 14880 for several amino acids.

Example: source of tyrosine: L-tyrosine (GB 29922), non-animal source origin (GB 14880)

7) Probi otics:

For products covering people aged 1 to 3 years old, the use of probiotics shall be in accordance with "the List of Probiotics Available for Infant Formula" (former MOH notice no. 25 in 2011 and supplementary notice); probiotics in products which are suitable for people over 3 years old shall be used in accordance with "the List of Probiotics Available for General Food" (former MOH notice no. 65 in 2010 and supplementary notice). Meanwhile, it should be noticed that, probiotics need to be used together with other ingredients, but should not be used alone as FSMP products.

The above information is the analysis and summary regarding the sources of various nutrients in FSMP. It could be realized that GB 29922, GB 14880 and the notice from former MOH have basically covered the use basis of all the raw materials permitted to be used in FSMP in China. Therefore, when designing and developing products, enterprises should strictly abide by the above regulations, standards and notices, and follow the design intention of FSMP (nutrition support and supplement for target population), for the purpose of meeting nutritional requirement of consumers, and fully ensure the safety of the products.

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