【FSMP】Nutritionally Complete Food for Ages 1-10: Formula Research and Design Recommendations (Part 1)

Based on the varying nutritional needs across different age groups, nutritionally complete foods are categorized into those suitable for individuals aged 1 to 10, and those aged 10 and above. The former type is specifically processed to meet the unique nutritional or dietary needs of children aged 1 to 10, particularly under specific medical conditions or diseases.

As of the end of 2023, China has officially approved 8 nutritionally complete foods for special medical purposes exclusively for children aged 1 to 10, with 5 domestic and 3 imported. These products intend to address the specific nutritional needs of children with feeding difficulties, impaired digestion and absorption functions, and metabolic imbalances. Detailed products are listed in Table 1, including 7 powdered formulas and one liquid.

CIRS Group has analyzed the formula nutritional characteristics of the aforementioned 8 products, including energy density, energy supply ratio, and raw material sources of three macronutrients. This in-depth research aims to provide valuable reference for researchers in the food for special medical purpose (FSMP) industry and offer professional guidance for clinicians when selecting and utilizing related products.

Table 1 Eight approved nutritionally complete foods for people aged 1 to 10

Table 2 Energy density and energy supply ratios of nutrients

1. Energy density

Energy intake is a crucial factor influencing nutritional efficacy and clinical outcomes. Insufficient energy intake may lead to varying degrees of protein depletion, impacting the structure and function of organs, and thus affecting the prognosis of patients. Therefore, energy metabolism stands as a primary consideration in nutriology. For patients, supplementing energy forms the foundation of nutritional support, with appropriate energy levels promoting improvements in health conditions. In addition, considering that children aged 1 to 10 are in a peak period of growth and development, ensuring an adequate energy intake becomes highly essential.

According to the Clinical Pharmaceutical Consensus on Enteral Nutrition (Second Edition), the energy density of commonly used enteral nutrition preparations in clinic practice ranges from 0.9 kcal/mL, 1 kcal/mL, 1.3 kcal/mL to 1.5 kcal/mL. Moreover, the Encyclopedia of Nutrition Science (Second Edition) points out that whole protein-based enteral nutrition preparations provide comprehensive nutrition with energy density ranging from 0.5 to 2 kcal/ml, catering to the individual needs of patients.

According to GB 29922-2013, the energy density of nutritionally complete foods for people aged 1 to 10 shall not be less than 0.6 kcal/mL. In addition, it is given in the official responses by the Center for Food Evaluation that the energy density of ready-to-consume nutritionally complete foods generally doesn’t exceed 1.2 kcal/ml. As shown in Table 2, the energy density of the 8 registered products ranges from a minimum of 0.7 kcal/mL to a maximum of 1 kcal/mL; the span of those for 1 to 10 is relatively small and is generally concentrated around 1 kcal/mL.

Furthermore, on December 1, 2022, the National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention released the National Food Safety Standard- General Principles for Food for Special Medical Purpose (Draft), introducing some adjusted nutritionally complete foods, including high energy density formulas. Globally, a large number of high-energy density nutritionally complete products from Abbott, Nestlé, Fresenius Kabi, and other companies are currently available on the market. Such foods are designed to meet the dietary needs of individuals with increased energy demands due to malnutrition issues, and those facing restricted food intake (with limited tolerance for liquid intake) whose eating time needs to be shortened. In conclusion, it’s estimated that for the registration of nutritionally complete foods in the future, it is likely that the energy density might not necessarily be limited to the official reply of “generally not exceeding 1.2 kcal/ml”. With proper consideration of the rationality of energy density design and the safety of consumption for the target population, there is a possibility that high-energy density formula foods could also receive approval for market launch. The emergence of products with different energy densities can cater to the individualized needs of a broader range of people, facilitating doctors or clinical nutritionists in the selection of FSMP.

2. Protein

People aged 1 to 10 are at the peak period of growth and development, leading to a higher demand for protein. However, generally speaking, the energy supply ratio of protein tends to gradually decrease with the increase of age. As children grow older, their growth slows down, resulting in a relative decrease in the demand for protein. The ninth edition of the Chinese Residents’ Dietary Reference Intakes (DRIs) (2023 Edition) revised and released this year introduces the Acceptable Macronutrient Distribution Ranges (AMDR) for protein. For children aged 4 to 5, the number ranges from 8%E-20%E, while for those aged 6 to 10, it ranges from 10%E~20%E.

It is stipulated in GB 29922-2013 that the protein content in nutritionally complete foods for people aged 1 to 10 should not be less than 0.5g/100kJ (2g/100kcal, protein-energy ratio of ≥8.5%). Additionally, high-quality protein should account for no less than 50%. It can be observed from Table 2 that among the 8 registered products, the energy supply ratio of protein ranges from 12% to 16%, predominantly featuring standard protein content formulas. However, GB 29922 does not impose a uniform requirement on the specific type of protein to be added to the products. It only specifies the protein content and the content of high-quality protein. In fact, different product categories may involve varied choices of protein sources.

Nutritionally complete foods can be categorized into three types based on the degree of protein aggregation, namely intact protein formula, protein hydrolyzed formula, and amino acid formula. Intact protein formulas are suitable for patients with intact gastrointestinal function, a structurally sound digestive system, and normal secretion of digestive enzymes. On the other hand, protein hydrolyzed formulas undergo a simpler process of digestion and absorption, making them particularly fitting for individuals with lower digestive capabilities, and compromised or limited gastrointestinal function.

As shown in Table 3, among the currently registered products, except for 麦孚乐贝, which adopts a protein hydrolyzed formula, all other products employ intact protein formulas. Additionally, there are currently no amino acid formula products in the market. The protein of麦孚乐贝is entirely derived from hydrolyzed whey protein powder with no intact protein added, facilitating the digestion and absorption of children while reducing the risk of milk protein allergies. Among the seven intact protein formulas, the main sources of protein include whey protein, milk protein, soy protein, casein, and caseinate - all of which are high-quality proteins. Whey protein, renowned for its rich content of branched-chain amino acids, especially leucine, and lower aromatic amino acids, not only provides excellent nutritional components but is also favored for its taste and easy digestibility. In the current domestic and international enteral nutrition preparations market, whey protein finds extensive application and has become one of the preferred protein sources. Only two products, Pediasure and 小拜妥优 include soybean protein, adopting a model of animal protein + plant protein, while other products utilize solely animal protein (milk protein).

Soy protein isolate stands out as a widely used plant protein. As for animal proteins, proteins from dairy products, such as whey protein, casein, and caseinate, are commonly employed. When formulating nutritionally complete foods, companies need to strike a balance between cost and nutrition. Soy protein is cost-effective, while casein and whey protein offer superior nutritional value but come at a higher price. Striking a balance between these factors is crucial for companies seeking to optimize both cost-effectiveness and nutritional quality in their formulations.

Table 3 Protein raw material sources

3. Fat

The Chinese Residents’ Dietary Reference Intakes (DRIs) (2023 Edition) specifies the Acceptable Macronutrient Distribution Ranges (AMDR) for total fat as follows: 35%E for 1-3 years old, and 20%E-30%E for 4-10 years old; the Adequate Intake (AI) for essential fatty acids is set at 4.0%E for linoleic acid and 0.60%E for α-linolenic acid. GB 29922-2013 explicitly stipulates that the energy supply ratio of linoleic acid in nutritionally complete foods for the 1-10 age group should be no less than 2.5%, and that of α-linolenic acid should be no less than 0.4%.

From Table 2, it can be observed that the energy supply ratio of fat of all 8 products falls within the recommended range of DRIs. The range spans from a minimum of 33% to a maximum of 35%, exhibiting a relatively narrow variation, and all are concentrated within the 30%-35% range, aligning with international standards for enteral nutrition preparations. That of linoleic acid falls between 3% to 8%, while that of α-linolenic acid varies from 0.5% to 1.4%, meeting the minimum requirements outlined in the national standards. When selecting fat sources, it is crucial not only to ensure fat content compliance with relevant standards but also to pay special attention to the energy supply ratios of linoleic acid and α-linolenic acid, so as to ensure the nutritional balance and health benefits of the product.

Plant oil is considered more beneficial to human health due to its higher content of unsaturated fatty acids than animal fats. As the levels of linoleic acid and α-linolenic acid vary among various plant oils, rarely can a single type of oil meet the specific requirements outlined in GB 29922 regarding the energy supply ratio of these two essential fatty acids. Therefore, to achieve the minimum energy ratio limits as specified, it is typically necessary to prepare various plant oils to ensure a scientifically and rationally balanced nutritional profile.

As seen in Table 4, the fat in all 8 approved products are derived from two or more plant oils. Except for 小拜妥优, the remaining 7 products specifically include medium-chain triglyceride (MCT), which is known for its efficient absorption characteristics. It can swiftly pass through the intestinal wall and be taken up by cells, a process independent of pancreatic enzymes or bile salt actions. Additionally, MCT doesn’t require the formation of chylomicrons or the transportation through the lymphatic system, providing a rapid energy pathway. Due to these biological features, MCT is frequently incorporated into formulas for FSMP to enhance quick energy delivery. Moreover, when companies apply for nutritionally complete foods using MCT as a fat source, they should provide relevant materials detailing the necessity, dosage, safety considerations, and clinical usage basis corresponding to the applicable population.

The most frequently used oils are sunflower seed oil and (low erucic acid) rapeseed oil, followed by soybean oil, maize oil, and coconut oil. Table 5 provides the detailed linoleic acid and α-linolenic acid content in common vegetable oils. Among them, sunflower seed oil, soybean oil, and maize oil exhibit notably high levels of linoleic acid, while (low erucic acid) rapeseed oil and soybean oil excel in α-linolenic acid content. Notably, low erucic acid rapeseed oil stands out for its ideal balance of oleic acid, linoleic acid, and α-linolenic acid, making it the preferred fat for FSMP. In contrast, coconut oil has lower levels of these three acids, but its high content of MCT secures its place in FSMP, primarily serving as a source of medium-chain fatty acids..

Table 4 Fat raw material sources

Table 5 Plant oil composition analysis

4. Carbohydrate

Carbohydrates play a crucial role in human metabolism, serving as the primary source of energy that provides essential fuel for daily activities. Additionally, their inherent sweetness is widely utilized to enhance the taste and flavor of food, thereby enhancing consumers’ eating experience. It’s given in the Chinese Residents’ Dietary Reference Intakes (DRIs) (2023 Edition) that the Acceptable Macronutrient Distribution Range (AMDR) for total carbohydrates is set between 50%E-65%E, while GB 29922-2013 does not provide specific regulations for carbohydrates. As shown in Table 2, the energy supply ratio of total carbohydrates in the 8 products generally falls within the recommended range of the DRIs, ranging from a minimum of 49% to a maximum of 55%.

Carbohydrates can be sourced from monosaccharides, disaccharides, oligo/polysaccharides, maltodextrin, glucose polymers, or other raw materials approved. Based on their role in the human body, carbohydrates can be categorized into two types: those that are utilizable, meaning they can be digested, absorbed, and utilized by the body to provide energy; and dietary fiber, a type of carbohydrate that, although indigestible in the small intestine, holds significant importance in maintaining human health.

According to the provisions of GB 29922-2013, there are no specific restrictions on the use of utilizable carbohydrates. Therefore, production enterprises can choose appropriate sources of carbohydrates based on the unique requirements of their product formulas. Among the 8 approved products, except for Pediasure, the other 7 products primarily use maltodextrin as the main source of carbohydrates. Maltodextrin is widely employed in FSMP due to its excellent flowability, solubility, and relatively lower osmotic pressure (compared to free glucose), which helps reduce the risk of gastrointestinal discomfort. In addition to maltodextrin, some sweetening agents with a certain level of sweetness, such as white granulated sugar, glucose syrup, and starch sugar, are typically added.

According to the provisions of GB 29922-2013, the sources of dietary fiber are referenced from the allowed sources listed in Table C.2 of GB 14880-2012, which currently includes several nutrition enhancers that can be used as monomers of dietary fiber, namely, galacto-oligosaccharides (from lactose), fructo-oligosaccharides (from chicory), polyfructose (from chicory), raffinose (from beet), and polydextrose. These substances can be used as sources of monomeric dietary fiber in FSMP for people aged 1 to 10. According to Announcement No. 6 of 2012 and No. 8 of 2013 issued by the former National Health and Family Planning Commission (NHFPC), fructo-oligosaccharide derived from sucrose and white granulated sugar were added. Therefore, fructo-oligosaccharide used in FSMP can be derived from chicory, sucrose, or granulated white sugar. As per the National Health Commission (HNC) Announcement No. 8 of 2017, galacto-oligosaccharide derived from whey filtrate was added. Hence, those selected for FSMP can be derived from lactose or whey filtrate. According to NHC Announcement No. 2 of 2019, the applicable scope of galactomannan, a nutrition enhancer, was expanded, allowing its use in FSMP (except those related to 13.01), with a use level of ≤120 g/kg. Moreover, raw materials that are high in dietary fiber, such as wheat bran, oats, and resistant dextrin, if used in FSMP, can also increase the total dietary fiber content of such products. Therefore, whether using various raw materials or dietary fiber monomers, the overall dietary fiber content should comply with the requirements of GB 29922. As shown in Table 6, 6 of the 8 registered products have added soluble dietary fibers, with fructo-oligosaccharides being the most widely used raw material.

Table 6 Carbohydrate raw material sources

The above is our discussion about the formula research and design analysis of nutritionally complete foods for people aged 1 to 10, from the perspectives of energy density, macronutrient energy supply ratios, and sources of raw materials. For more information about the registration of FSMP in China, please click here to learn about our FSMP registration service.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

A Comprehensive Review of the Registration and Approval Status of Foods for Special Medical Purpose (FSMP) in 2023