GB 31662-2025 English PDFUS$119.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 31662-2025: National food safety standard - Full nutrition formula foods for tumor patient Status: Valid
Basic dataStandard ID: GB 31662-2025 (GB31662-2025)Description (Translated English): National food safety standard - Full nutrition formula foods for tumor patient Sector / Industry: National Standard Classification of Chinese Standard: C53 Word Count Estimation: 6,670 Date of Issue: 2025-09-02 Issuing agency(ies): National Health Commission; State Administration for Market Regulation GB 31662-2025: National food safety standard - Full nutrition formula foods for tumor patient---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB31662-2025National Standards of the People's Republic of China National Food Safety Standards Complete Nutritional Formula for Tumors Published on 2025-09-02 Implemented on 2026-09-02 National Health Commission of the People's Republic of China State Administration for Market Regulation issued National Food Safety Standards Complete Nutritional Formula for Tumors 1.Scope This standard applies to special medical purpose formula foods for cancer patients aged 10 years and older. 2.Terms and Definitions Complete Nutritional Formula for Tumors Special medical purpose formula foods that can serve as a single source of nutrition to meet the nutritional needs of cancer patients and are suitable for the metabolic characteristics of cancer patients. 3 Technical Requirements3.1 Basic Requirements The formulation of complete nutritional formula foods for tumors should be based on the results of medical and/or nutritional research, and its safety and clinical application (efficacy) should be verified. All results need to be scientifically verified. The production conditions of complete nutritional formula foods for tumors should comply with relevant national regulations. 3.2 Raw material requirements The ingredients used in complete nutritional formula foods for tumors should comply with relevant standards and/or regulations, and the use of ingredients that are harmful to the health of consumers is prohibited. Kang's substances. 3.3 Sensory Requirements The color, taste, odor, texture, and reconstitution properties of complete nutritional formula foods for tumors should conform to the characteristics of the corresponding products and should not have any abnormalities. Visible foreign objects. 3.4 Nutritional Components 3.4.1 Per 100mL (liquid products or products that can be dissolved into liquid in ready-to-eat form) or per 100g (non-liquid products for direct consumption) The energy content of the product should not be less than 502 kJ (120 kcal). Energy is calculated based on the protein and fat content per 100 mL or 100 g of product. Multiply the fat and carbohydrate content by their respective energy coefficients of 17kJ/g, 37kJ/g, and 17kJ/g (the energy coefficient of dietary fiber is...). (8kJ/g), the sum of the results is kJ/100mL or kJ/100g, then divided by 4.184 to get kcal/100mL or kcal/100g. 3.4.2 The protein content should not be less than 0.96g/100kJ (4.0g/100kcal), and all protein should be derived from high-quality protein sources, suitable for whole eggs. Proteins include white proteins, hydrolyzed proteins, and peptides. Protein detection methods should refer to GB 5009.5. 3.4.3 The energy contribution from fat should be 25%–50%, and the energy contribution from n-3 fatty acids (calculated as EPA and DHA) should be 1%–6%, of which EPA should be the most abundant. The content should not be less than 50%. The energy contribution ratio of linoleic acid should not be less than 1.0%, and the energy contribution ratio of α-linolenic acid should not be less than 0.15%. The testing methods for fat content are as follows. According to GB 5009.6, the test method for fatty acids is based on GB 5009.168. 3.4.4 The energy ratio of carbohydrates should be 30% to 50%. 3.4.5 The content of vitamins and minerals contained in complete nutritional formula foods for tumors shall comply with the provisions of Table 1. Table 1 Vitamin and Mineral Indicators Nutrients per 100kJ per 100kcal Minimum value Maximum value Minimum value Maximum value Test methods Vitamin Aa/μgRE 9.3 53.8 39.0 225.0 GB 5009.82 Vitamin Db/μg 0.19 0.75 0.80 3.14 GB 5009.296 Vitamin Ec/mg α-TE 0.19 9.3 0.80 38.9 GB 5009.82 Vitamin K1/μg 1.05 NSe 4.40 NSe GB 5009.158 Vitamin B1/mg 0.02 NSe 0.07 NSe GB 5009.84 Vitamin B2/mg 0.02 NSe 0.07 NSe GB 5009.85 Vitamin B6/mg 0.02 NSe 0.07 NSe GB 5009.154 Vitamin B12/μg 0.03 NSe 0.13 NSe GB 5009.285 Nicotinic acid (nicotinamide) d/mg 0.05 NSe 0.20 NSe GB 5009.89 Folic acid/μg 5.3 15.2 22.2 63.5 GB 5009.211 Pantothenic acid/mg 0.07 NSe 0.29 NSe GB 5009.210 Vitamin C/mg 1.3 26.6 5.6 111.1 GB 5009.86 Biotin/μg 0.5 NSe 2.2 NSe GB 5009.259 Sodium/mg 20 NSe 83 NSe GB 5009.91 or GB 5009.268 Potassium/mg 27 NSe 111 NSe GB 5009.91 or GB 5009.268 Copper/μg 11 120 44 500 GB 5009.13 or GB 5009.268 Magnesium/mg 4.4 NSe 18.3 NSe GB 5009.241 or GB 5009.268 Iron/mg 0.20 0.55 0.83 2.30 GB 5009.90 or GB 5009.268 Zinc/mg 0.1 0.5 0.4 2.2 GB 5009.14 or GB 5009.268 Manganese/μg 6.0 146.0 25.0 611.0 GB 5009.242 or GB 5009.268 Calcium/mg 13 33 56 139 GB 5009.92 or GB 5009.268 Phosphorus/mg 9.6 46.5 40.0 194.4 GB 5009.87 or GB 5009.268 Iodine/μg 1.6 14.6 6.7 60.8 GB 5009.267 Chlorine/mg NSe 52 NSe 218 GB 5009.44 Selenium/μg 0.8 5.3 3.3 22.2 GB 5009.93 or GB 5009.268 aRE stands for retinol equivalent. 1 μg RE = 3.33 IU. Vitamin A = 1 μg all-trans retinol (vitamin A). Vitamin A only includes pre-formed retinol. The retinol in the formula does not include any carotenoid components when calculating and claiming vitamin A activity. b. Calciferol, 1 μg of vitamin D = 40 IU of vitamin D. c 1mg α-TE (α-tocopherol equivalent) = 1mg d-α-tocopherol; 1mg dl-α-tocopherol = 0.74mg α-TE (α-tocopherol equivalent). d. Nicotinic acid does not include its precursor form. eN.S. means unless otherwise specified. 3.4.6 Optional Ingredients 3.4.6.1 If one or more of the ingredients listed in Table 2 are selected to be added to or labeled in the product, their content shall comply with the requirements of Table 2. 3.4.6.2 If any substances other than those in Table 2 are added to the product, they shall comply with the relevant national regulations. Table 2 Selectable Component Indicators Selectable component a per 100kJ per 100kcal Minimum value Maximum value Minimum value Maximum value Test methods Chromium/μg 0.4 13.3 1.8 55.6 GB 5009.123 or GB 5009.268 Molybdenum/μg 1.3 12.0 5.6 50.0 GB 5009.297 or GB 5009.268 Fluorine/mg NSb 0.05 NSb 0.20 GB 5009.18 Choline/mg 5.3 39.8 22.2 166.7 GB 5413.20 Inositol/mg 1.0 33.5 4.2 140.0 GB 5009.270 Taurine/mg 0.8 39.8 3.2 166.7 GB 5009.169 L-carnitine/mg 0.4 26.6 1.6 111.1 GB 5009.300 Nucleotides/mg 15.5 77.5 65 325 GB 5413.40 Dietary fiber/g 0.1 0.7 0.4 2.9 GB 5009.88c Arginine/g 0.12 NSb 0.5 NSb GB 5009.124 Glutamine/g 0.04 0.53 0.15 2.22 - Leucine/g 0.03 NSb 0.13 NSb GB 5009.124 Calcium β-hydroxy-β-methylbutyrate/(g) 0.02 0.08 0.08 0.33 - The compound sources of fluorine are sodium fluoride and potassium fluoride; the sources of nucleotides and dietary fiber are those permitted in Table C.2 of GB 14880; other sources... The sources of the compounds in the ingredients are referenced in GB 14880. b NS means unless otherwise specified. c. When adding soluble dietary fiber, appropriate testing methods can be selected. 3.5 Limits for contaminants and mycotoxins 3.5.1 The limits for pollutants shall comply with the provisions of GB 2762. 3.5.2 The limits for mycotoxins shall comply with the provisions of GB 2761. 3.6 Microbial Limits 3.6.1 The limit of pathogenic bacteria in solid products shall comply with the provisions of GB 29921, and other microbiological indicators shall comply with the provisions of Table 3. 3.6.2 Liquid and semi-solid products shall meet the requirements for commercial sterility and shall be tested according to the methods specified in GB 4789.26. Table 3 Microbial Limits project Sampling scheme a and limits (unless otherwise specified, expressed in CFU/g or CFU/mL) ncm M Test methods Total bacterial count (b) 5 2 1000 10000 GB 4789.2 Table 3 Microbial Limits (continued) project Sampling scheme a and limits (unless otherwise specified, expressed in CFU/g or CFU/mL) ncm M Test methods Coliform bacteria 5 2 10 100 GB 4789.3 Plate count method a. The analysis and processing of samples shall be performed in accordance with GB 4789.1 and GB 4789.18. b. Not applicable to products containing live bacteria (aerobic and facultative anaerobic bacteria) [The number of live bacteria in the product should be ≥106 CFU/g (mL)]. 3.7 Food additives and nutritional fortifiers 3.7.1 The use of food additives can refer to the types and amounts of additives permitted in the same or similar products in GB 2760. 3.7.2 The use of nutrient fortifiers shall comply with the provisions of GB 14880 or relevant regulations. 3.7.3 Based on the specific nutritional needs of cancer patients, one or more amino acids can be selected and added to the complete nutritional formula for cancer patients. The amino acid sources should comply with the provisions of GB 29922 and/or GB 14880 and relevant announcements.4 Other4.1 Tags 4.1.1 Product labeling shall comply with the provisions of GB 13432.The labeling of nutrient and optional ingredient content shall include "content per 100 kJ". Quantity indication. 4.1.2 The label should describe the product's formulation characteristics or nutritional features, indicating the source and proportion of protein. The label should also indicate the product's... The product category and target audience should be clearly stated, and it should also be indicated that it is not suitable for use by non-target audiences. 4.1.3 The product label should describe the preparation method, the corresponding osmotic pressure, and the shelf life of the product. 4.1.4 The label should prominently state "Please use under the guidance of a doctor or clinical nutritionist". 4.1.5 The label should indicate that "This product is prohibited for parenteral nutrition support and intravenous injection" and "It is recommended to monitor for nutrient deficiencies regularly." Similar description. 4.2 Instructions for Use 4.2.1 Instructions for product use, preparation, and storage conditions should be clearly stated on the label. 4.2.2 The instructions should provide warnings about the health hazards that may be caused by improper preparation and use. 4.3 Packaging Carbon dioxide and/or nitrogen that meet national food safety standards can be used as packaging media. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 31662-2025_English be delivered?Answer: Upon your order, we will start to translate GB 31662-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 31662-2025_English with my colleagues?Answer: Yes. 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