Standard_2_9_1_Infant_Formula_Products_v109
CODEX STAN 295R-2009 Regional Standard for Ginseng Products(人参制品区域标准)英文版
REGIONAL STANDARD FOR GINSENG PRODUCTS(Asia1)CODEX STAN 295R-20091. SCOPE1.1This standard applies to the ginseng products as defined in Section 2 below and offered for directconsumption, including for catering purposes or for repacking if required. It does not apply to the product when indicated as being intended for further processing. This standard applies to ginseng products2used as a food or food ingredient and does not apply to products used for medicinal purposes.1.2 This Standard applies only in those jurisdictions where products defined in2.1 are regulated as foods.2. DESCRIPTION2.1 P RODUCT D EFINITIONThe compulsory ingredient of ginseng product is fresh ginseng roots suitable to eating, derived from Panax ginseng C.A. Meyer and P. quinquefolius L., cultivated for commercial purposes and used for foods. Ginseng products should be packaged in such a manner as to safeguard the hygienic, nutritional, technological and organoleptic quality of the products.2.2 T YPES OF G INSENG P RODUCTS2.2.1 Dried Ginseng2.2.1.1 Dried Raw GinsengDried Raw Ginseng is manufactured when fresh ginseng roots are sun dried or hot air dried or dried using other recognized methods. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced.2.2.1.2 Dried Steamed GinsengDried Steamed Ginseng is manufactured when fresh ginseng roots are prepared using the steaming method or other recognized methods, and dried. The product may be classified into one of such product types that have the main root and/or lateral roots or that are powdered or sliced.2.2.2 Ginseng Extract2.2.2.1 Raw Ginseng ExtractRaw Ginseng Extract is manufactured when soluble components of fresh ginseng roots or Dried Raw Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. This product has a dark brown colour and a high viscosity when much of the water is removed from it. The product may be also presented as a powdered type through spray- or freeze-drying.2.2.2.2 Steamed Ginseng ExtractSteamed Ginseng Extract is manufactured when soluble components of Dried Steamed Ginseng are extracted, using water, ethanol or their mixture and then, they are filtered and concentrated. This product has a dark brown colour and a high viscosity when much of the water is removed from it. The product may be also presented as a powdered type through spray- or freeze-drying.3. ESSENTIAL COMPOSITION AND QUALITY FACTORS3.1 I NGREDIENTSFresh ginseng roots as defined in Section 2.1.1Members of the Codex Alimentarius Commission in the Region of Asia are indicated on the Codex website at /web/members_area.jsp?lang=EN.2Any health claims should comply with the Codex Guideleines for Use of Nutrition and Health Claims (CAC/GL 23-1997)3.2 Q UALITY F ACTORSGinseng products shall have normal flavour, colour, taste and a ginsenoside pattern3unique to ginseng as well as be free from foreign matters.3.2.1 Dried Ginseng(a)Moisture: no more than 14.0% (Powdered type: no more than 9.0%)(b)Ash: no more than 6.0%(c)Water-saturated 1-butanol extracts: no less than 20 mg/g(d)Ginsenoside Rb1: to be identifiedIn addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified.3.2.2 Ginseng Extracts3.2.2.1 Ginseng Extracts (liquid form)(a)Solids: no less than 60.0%(b)Water-insoluble solids: no more than 3.0%(c)Water-saturated 1-butanol extracts: no less than 70 mg/g(d)Ginsenoside Rb1: to be identifiedIn addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified.3.2.2.2 Ginseng Extracts (powdered form)(a)Moisture: no more than 8.0%(b)Water-insoluble solids: no more than 3.0%(c)Water-saturated 1-butanol extracts: no less than 70 mg/g(d)Ginsenoside Rb1: to be identifiedIn addition, in case of the product manufactured from P. ginseng C.A. Meyer, ginsenoside Rf should be also identified.3.3 D EFINITION OF D EFECTSThe following defects shall be applied to the dried ginseng.(a)Insect-damaged ginseng: Ginseng that is visibly damaged by insects or contains dead insects(b)Mouldy ginseng: Ginseng that is visibly affected by mould3.4 C LASSIFICATION OF "D EFECTIVES"A container that fails to meet one or more of the applicable quality requirements, set out in Sections 3.2 and3.3, shall be considered a "defective".3.5 L OT A CCEPTANCEA lot can be considered as meeting the applicable quality requirements referred to in Sections 3.2 and 3.3, when the number of "defectives", defined in Section 3.4, does not exceed the acceptance number (c) of the appropriate sampling plan.3The unique constituents of ginseng are found to be a complex mixture of saponins often referred to as ginsenosides, and more than 30 ginsenosides are known. Ginsenoside Rb1 or ginsenoside Rf is one of the major ginsenosides. Ginsenoside Rb1 is identified in all ginseng species in quantities, while ginsenoside Rf is identified mainly in Panax ginseng C.A. Meyer.4. CONTAMINANTSThe products covered by this Standard shall comply with the maximum levels of the Codex General Standard for Contaminants and Toxins in Foods (CODEX/STAN 193-1995).The products covered by this Standard shall comply with the maximum residue limits for pesticides established by the Codex Alimentarius Commission.5. HYGIENE5.1 It is recommended that the products covered by the provisions of this Standard be prepared andhandled in accordance with the appropriate sections of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969), and other relevant Codex texts, such as Codes of Hygienic Practice and Codes of Practice.5.2 The products should comply with any microbiological criteria established in accordance with thePrinciples for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997).6. LABELLINGThe products covered by this Standard shall be labelled in accordance with the Codex General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985). In addition, the following specific provisions apply:6.1 N AME OF THE P RODUCTThe name of the products defined in subsections 2.2.1.1, 2.2.1.2, 2.2.2.1 and 2.2.2.2 shall be “Dried Raw Ginseng”, “Dried Steamed Ginseng”, “Raw Ginseng Extract”, and “Steamed Ginseng Extract”, respectively. In this case, the products manufactured with P. ginseng C.A. Meyer can be named “White Ginseng”, “Red Ginseng”, “W hite Ginseng Extract”, and “Red Ginseng Extract”.6.2 N AME OF THE G INSENG S PECIESAll ginseng products shall be labelled the scientific or common name of the ginseng that is used as raw material. The common names of the ginseng shall be declared in accordance with the law and custom of the country where the product is consumed, in a manner not to mislead the consumer.6.3 C OUNTRY OF ORIGINThe country of origin of the product and/or raw material shall be declared if its omission is likely to mislead or deceive the consumer.6.4 L ABELLING OF N ON-R ETAIL C ONTAINERSInformation about non-retail containers shall be given on the container or in accompanying documents, except that the name of the product, lot identification and the name and address of the manufacturer, packer or distributor, as well as storage instructions, shall appear on the container. However, lot identification, and the name and address of the manufacturer, packer or distributor may be replaced by an identification mark, provided that such a mark is clearly shown in the accompanying documents.6.5 O THER L ABELLING R EQUIREMENTSExcept when otherwise specified by national legislation, the products should have a clear marking to indicate that they are not intended for medicinal purposes, including other labelling(s) stipulated by any country where ginseng products are distributed.7. METHODS OF ANALYSIS AND SAMPLING7.1 D ETERMINATION OF M OISTUREAccording to AOAC 925.45.7.2 D ETERMINATION OF S OLIDAccording to AOAC 925.45 and calculated by subtracting the content of water from 100%.7.3 D ETERMINATION OF A SHAccording to AOAC 923.03.7.4 D ETERMINATION OF W ATER-INSOLUBLE S OLIDSAccording to the method described in Annex A.7.5 D ETERMINATION OF W ATER-SATURATED 1-BUTANOL EXTRACTS According to the method described in Annex B.7.6 I DENTIFICATION OF G INSENOSIDES Rb1 AND RfAccording to the method described in Annex C.Determination of Water-insoluble Solid ContentPlace ca 1 g sample in 25 ml centrifugal tube with constant weight. Add 15 ml of distilled water and dissolve the sample. Centrifuge for 15 min at 3000 rpm and discard supernatant. Repeat twice this centrifugation. Dry centrifugal tube and residue to constant weight at 105°C. Report results in percent.water-insoluble solid content (%) = (W1-W0)/ S × 100S: weight of sample (g)W1: weight of centrifugal tube and residue after drying (g)W0: weight of centrifugal tube (g)* The method mentioned in Annex A is stipulated in the Korean Food Standards Law and modifies the “AOAC Official Method 950.66.”Determination of water-saturated 1-butanol extracts1. Preparation of water-saturated 1-butanolMix 1-butanol with water in separatory funnel in the ratio of 70:30 and shake it vigorously. Let stand until the upper and lower phases are separated. Discard lower layer (water layer).2. Analysismethod2.1 Dried ginsengWeigh ca 5 g test portion, ground to pass 80 mesh or finer sieve, into 250 ml erlenmeyer flask and reflux with 50 ml water saturated 1-butanol on a water bath at 80°C for 1 hour. Decant 1-butanol into another 250ml erlenmeyer flask. Repeat twice the above extraction. Combine the solvent and filter into a 250 ml separatory funnel. Add 50 ml of distilled water. Shake and stand until the upper and lower layer are separated completely into two layers. Collect 1-butanol layer (upper layer) in an evaporation flask, vacuum-evaporate to dryness. Add 50 ml of diethyl ether, re-flux it on a water bath approximately at 46°C for 30 minutes, and decant the diethyl ether. Dry flask and contents to constant weight at 105°C. Report increase in weight flask as "1-butanol extracts in ginseng". Express the result as mg per gram on dried ginseng.water-saturated 1-butanol extracts (mg/g) = (A-B) / SS: weight of sample (g)A: weight of flask after concentrating and drying extracts (mg)B: weight of flask (mg)2.2 Ginseng extract (including a powered type)Place 1~2 g sample in 250 ml erlenmeyer flask, dissolve in 60ml water and transfer into separating funnel. Add 60ml of diethyl ether. Shake and stand until the upper and lower layer are separated. Collect lower layer and extract with 60 ml water saturated 1-butanol for three times. Combine the solvent into a 250 ml separatory funnel. Add 50 ml of distilled water. Shake and stand until the upper and lower layers are separated completely into two layers. Collect 1-butanol layer (upper layer) in an evaporation flask with constant weight, vacuum-evaporate to dryness. Dry flask and contents to constant weight at 105°C. Report increase in weight flask as "1-butanol extracts in ginseng extract". Express the result as mg per gram on ginseng extract.References1. Planta Medica, Vol. 25, pp 194-202, 19742. Chem. Pharm Bull., Vol. 14, pp 595-600, 19663. Korean J. Ginseng Sci., Vol. 10(2), pp 193-199, 1986Identification of ginsenosides Rb1 and RfGinsenosides in ginseng products can be identified either by thin layer chromatography (TLC) or high performance liquid chromatography (HPLC).1. Preparation of sample solutionDilute the dried 1-butanol extract of Annex B with ten-fold volume of methanol, dissolve completely, and filter through 0.45 µm membrane filter.2. Preparation of standard solutionDissolve standard ginsenosides, such as ginsenoside-Rb1 and -Rf, in methanol to make a 1% solution and filter through 0.45 µm membrane filter.3. Identification3.1 Thin layer chromatographySpot 2-5 µl of the standard and sample solutions, as indicated in the above, on TLC plate (silica gel), previously dried at 110°C for 15 minutes in dry oven. Develop with an upper solution of 1-butanol:ethylacetate:water (5:1:4, v/v/v) or a lower solution of chloroform:methanol:water (65:35:10, v/v/v). Spray 10% sulfuric acid or 30% sulfuric acid-ethanol solution over TLC plate and oven dry it at 110°C for 5-10 minutes to reveal its colour. Identify the ginsenosides of Ginseng products by comparing the Rf values and colours with those of standard ginsenosides.3.2 High performance liquid chromatographyPrepare standard and sample solutions, as indicated in the above. Analyze ginsenoside with HPLC depending upon the operating condition. Identify ginsenosides of sample by comparing retention times of peaks with those of the standard.<Operating condition>Column: NH2 column, µ-Bondapak C18 column, carbohydrate analyzing column or equivalent Detector: UV (203 nm) or ELSDEluent:UV: acetonitrile: water (30:70, v/v)ELSD: acetonitrile: water: isopropanol (94.9:5.0:0.1, v/v/v)Flow rate: 1.0 ml/min ~ 2.0 ml/minReferences1. Journal of Chromatography, Vol. 921, Issue 2, 2001, pp 335-3392. Journal of Chromatography, Vol. 868, Issue 2, 2000, pp 269-2763. Journal of Chromatography, Vol. 356, 1986, pp 212-2194. Journal of Chromatography, Vol. 499, 1990, pp 453-4625. Planta Medica, Vol. 212, Issue 1, 1981, pp 37-496. J. Pharm. Soc. Korea, 23(3,4), 1979, pp181-186。
婴幼儿食品标准
Commission Directive 2006/125/EC
英文名称
中文名称
dietary foods for special medical purposes
特殊医用膳食食品
infant formulae and follow-on formulae and amending Directive 1999/21/EC
17
已发布待实施的婴幼儿食品相关标准
GB 28050-2011 预包装食品营养标签通则 GB 14880-2012 食品营养强化剂使用标准
相关食品安全国家标准
GB 7718-2011 预包装食品营养标签通则 GB 2760-2011 食品添加剂使用标准
18
我国市售婴幼儿食品种类
加工食品中可添加的特殊
营养用物质的安全性评估
提交管理导则
5
美国婴幼儿食品技术标准
CFR Title 21Part106
CFR Title 21Part107
INFANT FORMULA QUALITY CONTROL PROCEDURES
婴儿配方食品质 量控制程序
Infant formula
婴儿配方食品
10
11
பைடு நூலகம்2
我国婴幼儿食品相关标准
序号 标准编号
标准名称
1 GB 13432-2004
预包装特殊膳食用食品标签通则
2 GB/T 23526-2009 食品中必需营养素添加通则
3 GB 23790-2010
粉状婴幼儿配方食品良好生产规范
4 GB 10770-2010
婴幼儿罐装辅助食品
益生菌最新法规标准
中国乳酸菌与益生菌相关标准及法规的发展中国疾病预防控制中心营养与食品安全所罗雪云一、乳酸菌在我国的法规管理及发展一乳酸菌在我国的法规管理及发展二、益生菌在我国的法规管理及发展二益生菌在我国的法规管理及发展三、新资源食品管理办法中有关微生三新资源食品管理办法中有关微生物的法规管理第一部分乳酸菌在我国的法规管理及发展乳酸菌的应用及相关法规乳酸菌在我国相关法规中的定义乳酸菌的应用及相关法规GB 2746-81 《酸牛乳卫生标准》酸牛乳系指以新鲜全脂牛乳，经有效消毒，加入乳酸发酵剂制成。
GB/T 2746-85 《酸牛乳》本标准适用于以牛乳为原料，添加适量的砂糖，经巴氏杀菌和冷却后，加入纯乳酸菌发酵剂，经保温发酵而制成的产品。
GB27461999GB 2746-1999 《酸牛乳》本标准适用于以牛乳或复原乳为主原料，添加或不添加辅料，使用含有保加利亚乳杆菌、嗜热链球菌的菌种发酵剂制成的使含有保加利乳杆菌嗜热链球菌产品。
乳酸菌群: 不得低于1×106 CFU/mL乳酸菌的应用及相关法规GB193022003 《酸乳卫生标准》GB19302-2003牛本标准适用于以牛（羊）乳或复原乳为主原料，经杀菌、发酵、搅拌或不搅拌，添加或不添加其他成分，制成的纯酸乳和风味酸乳。
发酵菌种：保加利亚乳杆菌、嗜热链球菌及发酵菌种保加利亚乳杆菌嗜热链球菌及其他由国务院卫生行政部门批准使用的菌种乳酸菌数：≥ 1×106 CFU/gGB19302-2010 《发酵乳》fermented milk 发酵乳fermented milk以生牛（羊）乳或乳粉为原料，经杀菌、发以生牛（羊）乳或乳粉为原料经杀菌发酵后制成的pH值降低的产品。
酸乳yoghurt以生牛（羊）乳或乳粉为原料，经杀菌、接生牛羊乳或乳粉为料杀菌接种嗜热链球菌和保加利亚乳杆菌（德氏乳杆菌保加利亚亚种）发酵制成的产品。
（续）风味发酵乳flavored fermented milk80%以上以生牛（羊）乳或乳粉为原料，添加其它以以上以生牛（羊）乳或乳粉为原料添加其它原料，经杀菌、发酵后pH值降低，发酵前或后添加或不添加食品添加剂、营养强化剂、果蔬、谷物等制成的产品。
碱水解法测定乳脂肪标准的优化
Quality Control碱水解法测定乳脂肪标准的优化姜璎娣黑龙江省泽峰环保科技有限公司，黑龙江哈尔滨 150078摘 要：[目的]为了提高乳制品及婴幼儿配方食品中脂肪的检测效率和结果的稳定性，对《GB 5009.6—2016 食品安全国家标准 食品中脂肪的测定》碱水解法进行优化。
[方法]调整淀粉酶用量、淀粉酶水解时间和脂肪抽提提高检测效率；调整氨水用量提高结果的稳定性。
使用质控样品和参与能力验证的方式，验证优化后结果的准确性，[结果]平行测定试验验证优化结果的精密度，结果符合《GB/T 27404—2008 实验室质量控制规范 食品理化检测》附录F.5准确度要求。
关键词：脂肪；碱水解；优化文章编号：1671-4393（2023）08-0090-05 DOI:10.12377/1671-4393.23.08.160 引言脂肪是乳及其制品中的主要能量物质和营养成分，是乳制品质量监测的重要指标之一。
依据《GB 28050—2011 6.4食品安全国家标准 预包装食品营养标签通则》中表2规定，预包装食品的脂肪含量不高于标签示值的120%，依据《GB 13432—2013 4.3 食品安全国家标准 预包装特殊膳食用食品标签》的规定，婴幼儿配方食品和婴幼儿辅助食品等脂肪含量不低于标签示值的80%。
因此检测过程中试验操作的稳定性和准确性对检测数值的影响尤为重要。
碱水解法是乳制品及婴幼儿配方食品脂肪含量测定的仲裁方法，但对婴幼儿配方食品而言，检测时间长，时间成本高；对成分复杂的发酵乳制品，碱水解效果不好，容易乳化，导致脂肪提取不理想，脂肪数据不稳定。
本文对《GB 5009.6—2016 食品安全国家标准 食品中脂肪的测定》[1]第三法碱水解法进行优化。
试验过程中，通过调整氨水使用量、调整淀粉酶用量、减少淀粉酶水解时间、简化脂肪抽提，实现节约时间成本，提高脂肪提取效率和数据的准确性及稳定性。
依据《GB/T 27404—2008 实验室质量控制规范 食品理化检测》[2]要求，验证优化后方法的精密度和准确度，参加实验室外部的能力验证和内部的质控样测评，证明优化后的碱水解提取脂肪方法具有较高精密度和准确度，优化环节有效、可行。
ASTM F1980-2023
ASTM F1980-2023 Specification for Accelerated Aging of SterileMedical Device PackagesIntroductionASTM F1980-2023 is the standard specification for accelerated aging of sterile medical device packages. This specification provides guidelines for conducting accelerated aging tests to determine the shelf life of sterile medical device packages. Accelerated aging tests can help predict the effects of time on the sterile barrier system over the projected shelf life. This standard is applicable to packages made of various materials such as films, foils, and papers.ScopeThis specification covers the minimum requirements for accelerated aging of sterile medical device packages. It provides guidelines on the selection of test parameters, accelerated aging methods, and the interpretation of test results. The objective of this standard is to ensure that the sterile barrier system maintains its integrity and functionality over the intended shelf life.Test MethodsThe accelerated aging test involves subjecting the sterile medical device packages to elevated temperatures and humidity conditions for a specified period. This test simulates the aging process and provides an estimate of the shelf life of the package. The following test methods are recommended:1.Test Specimen Preparation: The test specimensshould be prepared according to the manufacturer’sinstructions. The size and configuration of the specimens should be representative of the package system.2.Aging Conditions: The test specimens should beexposed to elevated temperatures and humidity conditions.The recommended aging conditions are 55 ± 2°C and 95% relative humidity (RH). The exposure time for accelerated aging may vary depending on the intended shelf life of the package.3.Monitoring: During the aging process, the testspecimens should be periodically inspected for any signs of failure or degradation. This may include visual inspection, seal integrity testing, microbial barrier testing, and physical testing.4.Test Period: The accelerated aging period should bebased on the intended shelf life of the package. The testperiod is typically determined by multiplying the intended shelf life by a factor derived from the Arrhenius equation.The selection of the acceleration factor is based on the type of material used in the package system.Test ResultsThe test results should be evaluated based on the acceptance criteria defined by the manufacturer. The performance of the sterile barrier system should be assessed by conducting various tests such as peel strength, burst strength, microbial barrier testing, visual inspection, and integrity testing. Any failure or degradation observed duringthe accelerated aging process should be documented and reported.ReportingThe test report should include the following information:1.Identification of the package system and testspecimens.2.Aging conditions and exposure time.3.Monitoring and inspection procedures.4.Test results including any failures or degradationsobserved.5.Discussion and interpretation of the test results.6.Conclusion and recommendations for the shelf life ofthe package.ConclusionASTM F1980-2023 provides guidelines for conducting accelerated aging tests on sterile medical device packages. These tests can help determine the shelf life of the package by simulating the effects of time on the sterile barrier system. By following the procedures outlined in this specification, manufacturers can ensure that their sterile medical device packages maintain their integrity and functionality over the intended shelf life. It is important to note that this standardshould be used in conjunction with other relevant standards and regulations applicable to sterile packaging.。
酶比色法测定特殊医学用途婴儿配方食品中的胆碱含量
酶比色法测定特殊医学用途婴儿配方食品中的胆碱含量柯燕娜，张玉柱，鲍笑岭，裴 炜（上海市质量监督检验技术研究院，上海 200233）摘 要：通过质控样品测定、加标回收实验、精密度实验和实际样品测定，考察GB 5413.20—2013《食品安全国家标准 婴幼儿食品和乳品中胆碱的测定》中酶比色法测定特殊医学用途婴儿配方食品中胆碱的适用性。
结果表明：质控样的胆碱含量理论值为171.5 mg /100 g ，测定值为168.4 mg /100 g ，测定结果在允许误差范围内，说明实验结果可靠；乳粉样品和质控样的加标回收率为96.1%～98.4%，相对标准偏差为1.43%，说明酶比色法准确度较高，精密度较好；24 批次市售特殊医学用途婴儿配方乳粉的胆碱含量均符合GB 5413.20—2013的要求，表明酶比色法可以用于检测特殊医学用途婴儿配方食品中的胆碱含量。
关键词：酶比色法；特殊医学用途婴儿配方食品；胆碱Determination of Choline in Infant Formula for Special Medical Purposes by Enzyme ColorimetryKE Yanna, ZHANG Yuzhu, BAO Xiaoling, PEI Wei(Shanghai Institute of Quality Inspection and Technical Research, Shanghai200233, China)Abstract: The applicability of enzyme colorimetry as specified in the National Food Safety Standard: Determination of Choline in Infant Food and Milk Products (GB 5413.20－2013) for the determination of choline in infant formula for special medical purposes was evaluated using quality control and actual samples as well as spiked recovery and precision tests. The theoretical value of choline content in quality control samples was 171.5 mg /100 g, and the measured value was 168.4 mg /100 g. The measured result was within the allowable error range indicating its reliability. Spiked recoveries for infant formula and quality control samples were 96.1%–98.4% with relative standard deviation (RSD) of 1.43%, indicating high accuracy and precision of the method. When the method was applied to 24 batches of commercial samples, the measured values of choline content met the requirements of the national standard. Accordingly, enzyme colorimetry can be used to detect choline in infant formula for special medical purposes.Keywords: enzyme colorimetry; infant formula for special medical purposes; choline DOI:10.15922/ki.jdst.2020.01.004中图分类号：TS252.7 文献标志码：A 文章编号：1671-5187（2020）01-0015-04引文格式：柯燕娜, 张玉柱, 鲍笑岭, 等. 酶比色法测定特殊医学用途婴儿配方食品中的胆碱含量[J]. 乳业科学与技术, 2020, 43(1): 15-18. DOI:10.15922/ki.jdst.2020.01.004. KE Yanna, ZHANG Yuzhu, BAO Xiaoling, et al. Determination of choline in infant formula for special medical purposes by enzyme colorimetry[J]. Journal of Dairy Science and Technology, 2020, 43(1): 15-18. DOI:10.15922/ki.jdst.2020.01.004. 收稿日期：2019-08-26第一作者简介：柯燕娜（1987—）（ORCID: 0000-0002-7867-6903），女，工程师，硕士，研究方向为食品安全与检测。
USP40-NF35通用章节目录
USP40-NF35通用章节目录USP40-NF35通用章节目录USP40-NF35通用章节指导目录Guide to General Chapters 通用章节指导（标注底色部分为USP40-NF35新增章节）General Requirements for Test and Assays检查与含量分析的一般要求＜1＞INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS 注射和植入药物产品(注射用) —产品质量测试＜1＞INJECTIONS注射剂＜2＞ORAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 口服药物产品质量测试＜3＞TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS局部和透皮药物产品—产品质量测试＜4＞MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 粘膜药物产品质量测试＜5＞INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS 吸入剂产品—产品质量测试＜7＞LABELING 标签＜11＞USP REFERENCE STANDARDS USP标准品Apparatus for Test and Assays用于检查与含量分析的器具＜17＞PRESCRIPTION CONTAINER LABELING处方容器标签＜21＞THERMOMETERS温度计（本版本已删除）＜31＞VOLUMETRIC APPARATUS容量器具＜41＞BALANCES天平Microbiological Tests 微生物检查法＜51＞ANTIMICROBIAL EFFECTIVENESS TESTING抗菌剂有效性检查法＜55＞BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS生物指示剂－耐药性实验＜61＞MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS非无菌产品的微生物限度检查：微生物列举检查法＜62＞MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS 非无菌产品的微生物限度检查：特定微生物检查法＜63＞MYCOPLASMA TESTS 支原体检查法＜71＞STERILITY TESTS无菌检查法Biological tests and assays生物检查法与测定法＜81＞ANTIBIOTICS—MICROBIAL ASSAYS抗生素－微生物测定＜85＞BACTERIAL ENDOTOXINS TEST细菌内毒素检查法＜87＞BIOLOGICAL REACTIVITY TESTS, IN VITRO体外的生物反应性检查法＜88＞BIOLOGICAL REACTIVITY TESTS, IN VIVO 体内的生物反应性检查法＜89＞ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING药品生产中酶作为辅料所使用＜89.1＞COLLAGENASEⅠ胶原酶Ⅰ＜89.2＞COLLAGENASEⅡ胶原酶Ⅱ＜90＞FETAL BOVINE SERUM—QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS牛胎儿血清-质量品质和功能检查法＜91＞CALCIUM PANTOTHENATE ASSAY泛酸钙测定法＜92＞GROWTH FACTORS AND CYTOKINES USED IN CELL THERAPY MANUFACTURING在细胞疗法中使用生长因子和细胞因子＜111＞DESIGN AND ANALYSIS OF BIOLOGICALASSAYS 生物测定法的设计与分析＜115＞DEXPANTHENOL ASSAY右泛醇（拟胆碱药）测定法＜121＞INSULIN ASSAYS胰岛素测定法＜121.1＞PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS胰岛素的物理化学分析程序＜123＞GLUCAGON BIOIDENTITY TESTS 高血糖素的生物鉴别检查法＜124＞ERYTHROPOIETIN BIOASSAYS 红细胞生成素的微生物测定＜126＞SOMATROPIN BIOIDENTITY TESTS 生长激素的生物鉴别检查法＜127＞FLOW CYTOMETRIC ENUMERATION OF CD34+ CELL 流式细胞术计术34阳性细胞＜129＞ANALYTICAL PROCEDURES FOR RECOMBINANT THERAPEUTIC MONOCLONAL ANTIBODIES重组治疗性单克隆抗体的分析方法＜130＞PROTEIN A QUALITY ATTRIBUTES 蛋白质A的质量特征＜151＞PYROGEN TEST热原检查法＜161＞TRANSFUSION AND INFUSIONASSEMBLIES AND SIMILAR MEDICAL DEVICES 输血输液用具以及相类似的医疗器械＜162＞DIPHTHERIA ANTITOXIN POTENCY TESTING FOR HUMAN IMMUNE GLOBULINS 人免疫球蛋白的白喉抗毒素效力检测＜165＞PREKALLIKREIN ACTIV ATOR前激肽释放酶原激活剂＜171＞VITAMIN B12 ACTIVITY ASSAY……2548维生素B12活性测定法Chemical Tests and assays化学实验检查与测定法鉴别检查＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES鉴别－有机氮碱化合物＜191＞IDENTIFICATION TESTS—GENERAL鉴别实验－通用＜193＞IDENTIFICATION—TETRACYCLINES鉴别－四环素类＜197＞SPECTROPHOTOMETRIC IDENTIFICATION TESTS分光光度计鉴别实验＜201＞THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST薄层色谱鉴别实验＜202＞IDENTIFICATION OF FIXED OILS BYTHIN-LAYER CHROMATOGRAPHY 薄层色谱法对非挥发性油的鉴别＜203＞HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY PROCEDURE FOR IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN 高性能薄层色谱法对植物的鉴别Limit Tests 限度检查法＜206＞ALUMINUM铝＜207＞TEST FOR 1,6-ANHYDRO DERIV ATIVE FOR ENOXAPARIN SODIUM依诺肝素钠的酐类衍生物实验＜208＞ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS普通肝素和低分子肝素产品中抗体Xa和抗体IIa测定＜209＞LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS低分子肝素钠分子量测定＜211＞ARSENIC砷＜212＞OLIGOSACCHARIDE ANALYSIS 低聚糖的分析＜221＞CHLORIDE AND SULFATE氯和硫＜223＞DIMETHYLANILINE二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE4－？－四环素＜227＞4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS对乙酰氨酚药物产品中氨基酚＜228＞ETHYLENE OXIDE AND DIOXANE 环氧乙烷和二氧六环＜231＞HEA VY METALS重金属（删除）＜232＞ELEMENTAL IMPURITIES—LIMITS 元素杂质-限度＜233＞ELEMENTAL IMPURITIES—PROCEDURES 元素杂质-规程＜241＞IRON铁＜251＞LEAD铅＜261＞MERCURY汞＜267＞POROSIMETRY BY MERCURY INTRUSION 水银孔隙仪＜268＞POROSITY BY NITROGEN ADSORPTION–DESORPTION 氮吸附-解吸测定孔隙率＜271＞READILY CARBONIZABLE SUBSTANCES TEST易碳化物检查法＜281＞RESIDUE ON IGNITION炽灼残渣＜291＞SELENIUM硒Other Tests and Assays 其它检查法与测定法＜301＞ACID-NEUTRALIZING CAPACITY酸中和容量＜311＞ALGINATES ASSAY藻酸盐测定法＜341＞ANTIMICROBIAL AGENTS—CONTENT 抗菌剂－含量＜345＞Assay for Citric Acid/Citrate and Phosphate 柠檬酸/柠檬酸盐和磷酸盐的测定＜351＞ASSAY FOR STEROIDS类固醇（甾类化合物）测定法＜361> BARBITURATE ASSAY 巴比妥类药物测定法（本版本已删除）＜371＞COBALAMIN RADIOTRACER ASSAY钴铵素放射性跟踪剂测定法＜381＞ELASTOMERIC CLOSURES FOR INJECTIONS 注射剂的弹性密封件＜391＞EPINEPHRINE ASSAY肾上腺素测定法＜401＞FATS AND FIXED OILS脂肪与混合油＜411＞FOLIC ACID ASSAY叶酸测定法＜413＞IMPURITIES TESTING IN MEDICAL GASES 医用气体杂质检查＜415＞MEDICAL GASES ASSAY 医用气体含量检查＜425＞IODOMETRIC ASSAY—ANTIBIOTICS碘量检查法－抗生素＜429＞LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE粒径的光衍射测量法＜431＞METHOXY DETERMINATION甲氧基测定法＜441＞NIACIN OR NIACINAMIDE ASSAY 烟酰或烟酰胺测定法＜451＞NITRITE TITRATION亚硝酸盐滴定＜461＞NITROGEN DETERMINATION氮测定法＜466＞ORDINARY IMPURITIES一般杂质＜467＞RESIDUAL SOLVENTS残留溶剂＜469＞ETHYLENE GLYCOL, DIETHYLENE GLYCOL, AND TRIETHYLENE GLYCOLIN ETHOXYLATED SUBSTANCES乙氧基物质中乙二醇、二甘醇、三甘醇测定＜471＞OXYGEN FLASK COMBUSTION氧瓶燃烧法＜481＞RIBOFLA VIN ASSAY核黄素（维生素B2）测定法＜501＞SALTS OF ORGANIC NITROGENOUS BASES有机氮盐＜503＞ACETIC ACID IN PEPTIDES 多肽类中乙酸测定＜503.1＞TRIFLUOROACETIC ACID（TFA）IN PEPTIDES 肽中三氟乙酸＜507＞PROTEIN DETERMINATION PROCEDURES 蛋白质测定程序＜511＞SINGLE-STEROID ASSAY单一的类固醇测定法＜525＞SULFUR DIOXIDE 二氧化硫＜531＞THIAMINE ASSAY硫胺素测定法＜541＞TITRIMETRY滴定法＜551＞VITAMIN E ASSAY维生素E测定法＜561＞ARTICLES OF BOTANICAL ORIGIN植物起源的药品＜563＞IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN植物药品的鉴别＜565＞BOTANICAL EXTRACTS植物提取＜571＞VITAMIN A ASSAY维生素A测定法＜580＞VITAMIN C ASSAY 维生素C的测定法＜581＞VITAMIN D ASSAY维生素D测定法＜591＞ZINC DETERMINATION锌的测定法Physical Test and Determinations物理检查与测定法＜601＞INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, ANDPOWDERS—PERFORMANCE QUALITYTESTS吸入剂、鼻雾剂：气溶胶，喷雾，干粉-质量通则＜602＞PROPELLANTS 推进剂＜603＞TOPICAL AEROSOLS 局部喷雾剂＜604＞LEAK RATE 渗漏率＜610＞ALTERNATIVE MICROBIOLOGICAL SAMPLING METHODS FOR NONSTERILEINHALED AND NASAL PRODUCTS非无菌吸入和鼻雾剂可供选择的微生物取样方法＜611＞ALCOHOL DETERMINATION乙醇测定法＜616＞BULK DENSITY AND TAPPED DENSITY堆密度与振实密度＜621＞CHROMATOGRAPHY色谱法＜631＞COLOR AND ACHROMICITY呈色与消色＜641＞COMPLETENESS OF SOLUTION溶解度＜643＞TOTAL ORGANIC CARBON总有机碳＜645＞WATER CONDUCTIVITY水电导率＜651＞CONGEALING TEMPERATURE凝点温度＜659＞PACKAGING AND STORAGE REQUIREMENTS 包装和储藏要求＜660＞CONTAINERS—GLASS 容器-玻璃＜661＞CONTAINERS—PLASTICS容器-塑料＜661.1＞PLASTIC MATERIALS OF CONSTRUCTION塑料包装材料＜661.2＞PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE药用塑料包装系统＜670＞AUXILIARY PACKAGING COMPONENTS 辅助包装部件＜671＞CONTAINERS—PERFORMANCE TESTING 容器－性能测试＜691＞COTTON棉花＜695＞CRYSTALLINITY结晶度＜696＞CHARACTERIZATION OF CRYSTALLINE SOLIDS BY MICROCALORIMETRY AND SOLUTION CALORIMETRY 通过溶液量热学测定结晶性＜697＞CONTAINER CONTENT FOR INJECTIONS 注射剂容器容积＜698＞DELIVERABLE VOLUME抽取体积＜699＞DENSITY OF SOLIDS固体密度＜701＞DISINTEGRATION崩解时限＜705＞QUALITY ATTRIBUTES OF TABLETS LABELED AS HA VING A FUNCTIONAL SCORE ？＜711＞DISSOLUTION 溶出度＜721＞DISTILLING RANGE馏程＜724＞DRUG RELEASE药物释放度＜729＞GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS脂类可注射的乳剂的粒径分布＜730＞Plasma Spectrochemistry 血浆光谱化学？＜731＞LOSS ON DRYING4干燥失重＜733＞LOSS ON IGNITION灼烧失重＜735＞X-RAY FLUORESCENCE SPECTROMETRY X射线光谱＜736＞MASS SPECTROMETRY 质谱＜741＞MELTING RANGE OR TEMPERATURE熔距或熔点＜751＞METAL PARTICLES IN OPHTHALMIC OINTMENTS眼用软膏中的金属粒子＜755＞MINIMUM FILL最低装量＜761＞NUCLEAR MAGNETIC RESONANCE核磁共振＜771＞OPHTHALMIC OINTMENTS眼用软膏＜776＞OPTICAL MICROSCOPY光学显微镜＜781＞OPTICAL ROTATION旋光度＜782＞VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY 振动圆二色谱＜785＞OSMOLALITY AND OSMOLARITY渗透压＜786＞PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING筛分法估算粒径分布＜787＞SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS显微计数法在治疗性蛋白注射剂中应用＜788＞PARTICULATE MATTER IN INJECTIONS 注射剂中的不溶性微粒＜789＞PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS眼用溶液中的不溶性微粒＜790＞VISIBLE PARTICULATES IN INJECTIONS 注射剂中可见异物＜791＞pH＜795＞PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS 药物混合－非无菌制剂＜797＞PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS药物混合－无菌制剂＜800＞HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 在医疗环境中危险药品的处理＜801＞POLAROGRAPHY极谱法＜811＞POWDER FINENESS粉剂细度＜821＞RADIOACTIVITY放射性＜823＞POSITRON EMISSION TOMOGRAPHY DRUGS FOR COMPOUNDING,INVESTIGATIONAL, AND RESEARCHUSES用于正电子发射断层造影术的放射性药物＜831＞REFRACTIVE INDEX折光率＜841＞SPECIFIC GRA VITY比重＜846＞SPECIFIC SURFACE AREA 比表面积＜851＞SPECTROPHOTOMETRY AND LIGHT-SCATTERING分光光度计与光散射（本版本已删除）＜852＞ATOMIC ABSORPTION SPECTROSCOPY 原子吸收光谱＜853＞FLUORESCENCE SPECTROSCOPY 荧光光谱＜854＞MID-INFRARED SPECTROSCOPY 中红外光谱＜855＞NEPHELOMETRY, TURBIDIMETRY, AND VISUAL COMPARISO浊度测定、比浊法、视觉比较＜857＞ULTRA VIOLET-VISIBLE SPECTROSCOPY 紫外可见光谱＜861＞SUTURES—DIAMETER缝线－直径？＜871＞SUTURES—NEEDLE ATTACHMENT缝线－穿孔实验＜881＞TENSILE STRENGTH张力＜891＞THERMAL ANALYSIS热分析＜905＞UNIFORMITY OF DOSAGE UNITS制剂单位的含量均匀度＜911＞VISCOSITY—CAPILLARY METHODS黏度-毛细管法＜912＞VISCOSITY—ROTATIONAL METHODS 黏度-旋转法＜913＞VISCOSITY—ROLLING BALL METHOD 黏度-球法＜914＞VISCOSITY—PRESSURE DRIVEN METHODS 黏度-压力驱动方法＜921＞WATER DETERMINATION水分测定＜941＞CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDSBY X-RAY POWDER DIFFRACTION (XRPD)X光衍射General Information通用信息＜1004＞MUCOSAL DRUG PRODUCTS—PERFORMANCE TESTS粘膜药物产品性能测试＜1005＞ACOUSTIC EMISSION 声频发射＜1010＞ANALYTICAL DATA—INTERPRETATIONAND TREATMENT分析数据－解释与处理＜1015＞AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS放射性自动合成装置＜1024＞BOVINE SERUM 牛血清＜1025＞PANCREATIN胰液素＜1027＞FLOW CYTOMETRY 流式细胞仪＜1029＞GOOD DOCUMENTATION GUIDELINES 好的文件指南＜1030＞BIOLOGICAL ASSAY CHAPTERS—OVERVIEW AND GLOSSARY生物测定章节-综述和术语＜1031＞THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUGCONTAINERS, MEDICAL DEVICES, ANDIMPLANTS用于药物容器、医疗设施和植入剂的材料的生物相容性＜1032＞DESIGN AND DEVELOPMENT OF BIOLOGICAL ASSAYS 生物试验的设计和开发＜1033＞BIOLOGICAL ASSAY V ALIDATION 生物试验的验证＜1034＞ANALYSIS OF BIOLOGICAL ASSAYS 生物测定分析＜1035＞BIOLOGICAL INDICATORS FOR STERILIZATION灭菌用生物指示剂（本版本已删除）＜1039＞CHEMOMETRICS 化学＜1041＞BIOLOGICS生物制剂＜1043＞Ancillary Material for Cell, Gene, and Tissue-Engineered Products细胞，基因与组织设计产品的辅助材料＜1044＞CRYOPRESERV ATION OF CELLS 细胞低温保存＜1045＞BIOTECHNOLOGY-DERIVED ARTICLES 生物技术提取产品（本版本已删除）＜1046＞CELLULAR AND TISSUE-BASED PRODUCTS细胞与组织产品＜1047＞GENE THERAPY PRODUCTS 基因治疗产品＜1048＞QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEINPRODUCTS生物技术产品的质量：从蛋白质产品中提取的r-DNA 产品在细胞中表达结构的分析＜1049＞QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OFBIOTECHNOLOGICAL/BIOLOGICALPRODUCTS生物技术产品的质量：生物技术/生物产品的稳定性实验＜1050＞VIRAL SAFETY EV ALUATION OF BIOTECHNOLOGY PRODUCTS DERIVEDFROM CELL LINES OF HUMAN OR ANIMALORIGIN从人或动物细胞中提取的生物技术产品的病毒安全性评估＜1050.1＞DESIGN, EV ALUATION,AND CHARACTERIZATION OF VIRAL CLEARANCE PROCEDURES 病毒清除过程的设计、评估和鉴定。
解读汇报“特殊医学用途配方食品”
解读“特殊医学用途配方食品”在新食品安全法中，特殊医学用途配方食品与保健食品、婴幼儿配方食品一起纳入“特殊食品”。
一直以来按药品实施注册管理的特殊医学用途配方食品，作为“食品”的法律地位终获明确。
业内人士普遍认为，新食品安全法明确特殊医学用途配方食品法律地位，是一个具有里程碑意义的历史性的进步。
受制于不食不药、又食又药的尴尬身份，一直都被看好、但市场迟迟未能启动的特殊医学用途配方食品产业，如今可以憧憬一下未来了。
什么是特殊医学用途配方食品？特殊医学用途配方食品是为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要，专门加工配制而成的配方食品。
该类产品必须在医生或临床营养师指导下，单独食用或与其他食品配合食用。
当目标人群无法进食普通膳食或无法用日常膳食满足其营养需求时，特殊医学用途配方食品可以作为一种营养补充途径，起到营养支持作用。
同时针对不同疾病的特异性代谢状态，对相应的营养素含量提出了特别规定，能更好的适应特定疾病状态或疾病某一阶段的营养需求，为患者提供有针对性的营养支持。
但此类食品不是药品，不能替代药物的治疗作用，产品也不得声称对疾病的预防和治疗功能。
国际法规、标准现状国际食品法典委员会发布了针对婴儿使用的产品标准CODEX STAN 72 –1981《婴儿配方食品及特殊医学用途婴儿配方食品标准》；发布了CODEX STAN 180-1991《特殊医学用途食品标签和声称法典标准》，对FSMP的定义和标签标识进行了详细规定。
2011年第34届CAC大会通过了特殊医学用途食品中允许使用的添加剂名单，并进一步明确FSMP的定义：特殊加工或配方的，用于病人的膳食调节/管理，可能只能在医学监督下使用的特殊用途食品。
用于摄入、消化、吸收或者代谢普通食品或其所含营养成分的能力有限或者能力降低的病人，或者有其他特殊医疗目的的营养素需要的人（其膳食管理仅依靠正常膳食、其他特殊膳食用途食品或者二者组合产品的调节无法达到目的），作为这些人群唯一或者部分营养来源的食品。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
STANDARD 2.9.1INFANT FORMULA PRODUCTSPurposeThis Standard provides for the compositional, and labelling requirements for foods intended or represented for use as a substitute for breast milk, herein referred to as ‘infant formula products’. This Standard applies to all infant formula products whether in powder, liquid concentrate or ‘ready to drink’ forms.This Standard also provides for infant formula products intended for infants with special nutritional requirements.There are Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form part of the legally binding Standard.Standard 1.3.1 contains provisions relating to the food additives permitted in infant formula products. Standard 1.6.1 contains the microbiological limits in relation to infant formula products. Standard 1.3.4 contains specifications for permitted nucleotides and added nutrients. Standard 1.1.1 defines nutritive substances for the purposes of this Code.See Standard 1.5.1 – Novel Foods for requirements for novel food and novel food ingredients.Table of ProvisionsDivision 1 – General ProvisionsSubdivision 1 – Interpretation1 Definitions2 InterpretationSubdivision 2 – Calculationsenergy3 Calculationofproteinof4 Calculationpotential renal solute load5 CalculationofSubdivision 3 – General compositional requirementsandprohibitions6 Restrictionssubstancesnutritive7 Permitted8 Limit on nucleotide 5’-monophosphates9 Lactic acid cultures10 Limit on aluminiumSubdivision 4 – General labelling and packaging requirements11 Representations of food as infant formula product12 Prescribednames13 Requirement for a measuring scoop14 Required warnings, directions and statements15 Print and package size16 Declaration of nutrition information17 Date marking and storage instructions18 Statement of protein source19 Statement on dental fluorosisrepresentations20 ProhibitedDivision 2 – Infant Formula and Follow-on Formula21 Composition22 Protein23 Fat24 Vitamins, minerals and electrolytesDivision 3 – Infant Formula Products for Special Dietary UseSubdivision 1 – Infant formula products formulated for premature or low birthweight infants 25 Composition and labellinglabelling26 AdditionalSubdivision 2 – Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions27 Composition28 Claims29 Composition of lactose free and low lactose formulas30 Claims relating to lactose free and low lactose formulasSubdivision 3 – Infant formula products for specific dietary use based upon protein substitutes31 Composition32 Proteinandminerals33 Vitamins34 Additional permitted triglyceridesSchedule 1 Permitted forms of vitamins and minerals in infant formula products Guidelines for infant formula productsClausesDivision 1Subdivision 1 – Interpretation1 Definitions(1) The definitions in clauses 1 and 2 of Standard 1.2.8 apply to this Standard.(2) In this Code –infant means a person under the age of 12 months.infant formula product means a product based on milk or other edible foodconstituents of animal or plant origin which is nutritionally adequate toserve as the principal liquid source of nourishment for infants.infant formula means an infant formula product represented as a breastmilk substitute for infants and which satisfies the nutritionalrequirements of infants aged up to four to six months.follow-on formula means an infant formula product represented as either abreast-milk substitute or replacement for infant formula and whichconstitutes the principal liquid source of nourishment in aprogressively diversified diet for infants aged from six months.lactose free formula and low lactose formula means infant formulaproducts which satisfy the needs of lactose intolerant infants.pre-term formula means an infant formula product specifically formulatedto satisfy particular needs of infants born prematurely or of lowbirthweight.soy-based formula means an infant formula product in which soy proteinisolate is the sole source of protein.medium chain triglycerides means triacylglycerols which contain predominantly the saturated fatty acids designated by 8:0 and 10:0.protein substitute means L-amino acids and/or the hydrolysate of one or more of the proteins on which infant formula product is normally based.Editorial note:Subclause 1(2) is structured to indicate that the definitions of specific infant formula products are within the more general ‘infant formula product’ definition. Therefore the usual practice of listing definitions in alphabetical order has not been applied in this subclause.2 InterpretationA reference to any infant formula product in the compositional provisions of this Standard is a reference to –(a) a powdered or concentrated form of infant formula product which has beenreconstituted with water according to directions; or(b) an infant formula product in ‘ready to drink’ form.Subdivision 2 – Calculations3 Calculation of energyThe energy content of infant formula product, expressed in kilojoules (kJ), must be calculated using –(a) only the energy value contributions of the fat, protein and carbohydrateingredients of the infant formula product; and(b) the relevant energy factors set out in Standard 1.2.8.4 Calculation of proteinThe prescribed formula for the calculation of the protein content of infant formula product for the purposes of this Standard is –FormulaFor milk proteins and their partial protein hydrolysates -Protein content = nitrogen content x 6.38; orIn any other case –Protein content = nitrogen content x 6.25.5 Calculation of potential renal solute loadThe prescribed formula for the calculation of the potential renal solute load for the purposes of this Standard is –FormulaPotential renal solute load in mOsm/100 kJ = [Na (mg/100 kJ) /23] + [Cl (mg/100 kJ) /35]+ [K (mg/100 kJ) /39] + [P avail (mg/100 kJ)/ 31] + [N (mg/100 kJ) /28)].In this formulaP avail = P of milk-based formula + 2/3 of P of soy-based formulas.Subdivision 3 – General compositional requirements6 Restrictions and prohibitions(1) A vitamin, mineral, food additive or nutritive substance must not be added to infant formula product unless –(a) expressly permitted by this Code; or(b) it is naturally present in an ingredient of the infant formula product.(2) Infant formula product must contain no detectable gluten.7 Permitted nutritive substances(1) Any nutritive substance listed in column 1 of the Table to this clause may be added to infant formula product provided that –(a) the nutritive substance is in one or more of the forms specified in column 2of the Table in relation to that substance; and(b) the total amount of the nutritive substance in the infant formula product isno more than the added and any naturally occurring amount specified incolumn 4 of the Table.(2) The label on a package of infant formula product must not include any words indicating, or any other indication, that the product contains a nutritive substance specified in column 1 or in column 2 of the Table to this clause unless the total amount of the added and any naturally occurring nutritive substance in the food is no less than the amount specified in column 3 of the Table.Table to clause 7Column 1 Column 2 Column 3 Column 4Nutritive substance Permitted forms Minimumamount per100 kJ Maximum amount per 100 kJAdenosine 5’-monophosphate Adenosine 5’-monophosphateAdenosine 5’-monophosphatesodium salt0.14 mg 0.38 mgL-carnitine L-carnitine 0.21mg0.8mg Choline CholinechlorideCholine bitartrate1.7 mg 7.1 mgCytidine 5’-monophosphate Cytidine 5’-monophosphateCytidine 5’-monophosphate sodiumsalt0.22 mg 0.6 mgGuanosine 5’-monophosphate Guanosine 5’-monophosphateGuanosine 5’-monophosphatesodium salt0.04 mg 0.12 mgInosine 5’-monophosphate Inosine 5’-monophosphateInosine 5’-monophosphatesodium salt0.08 mg 0.24 mgLutein Lutein from Tagetes erecta L. 1.5 µg 5 µgInositol Inositol 1.0mg9.5mg Taurine Taurine 0.8mg3mg Uridine 5’-monophosphate Uridine 5’-monophosphateUridine 5’-monophosphate sodiumsalt0.13 mg 0.42 mg8 Limit on nucleotide 5’-monophosphatesInfant formula product must contain no more than 3.8 mg/100 kJ of nucleotide 5’-monophosphates.Editorial note:Standard 1.3.4 contains specifications for nucleotides.9 Lactic acid culturesL(+) producing lactic acid cultures may be added to infant formula product.9A Permitted inulin-derived substances and galacto-oligosaccharides(1) Infant formula product may contain no more than –(a) 110 mg per 100 kJ of inulin-derived substances; or(b) 290 mg per 100 kJ of galacto-oligosaccharides; or(c) 290 mg per 100 kJ of combined inulin-derived substances and galacto-oligosaccharides, where the inulin-derived substances is no more than110 mg per 100 kJ.(2) For subclause (1) the maximum permitted amount only applies when the substances are added. In that case the maximum permitted amount then applies to the sum of the naturally occurring and the added substances.10 Limit on aluminium(1) Infant formula product, other than a pre-term formula or soy-based formula product, must contain no more than 0.05 mg of aluminium per 100 mL.(2) Pre-term formula must contain no more than 0.02 mg of aluminium per 100 mL.(3) Soy-based formula must contain no more than 0.1 mg of aluminium per 100 mL.Editorial note:Standard 1.4.1 contains the maximum level (ML) of lead contaminant in infant formula products.Subdivision 4 – General labelling and packaging requirementsas infant formula productfood11 RepresentationsofA food must not be represented as an infant formula product unless it complies with this Standard.12 Prescribednames‘Infant Formula’ and ‘Follow-on Formula’ are prescribed names.13 Requirement for a measuring scoop(1) A package of infant formula product in a powdered form must contain a scoop to enable the use of the infant formula product in accordance with the directions contained in the label on the package.(2) Subclause (1) does not apply to single serve sachets, or packages containing single serve sachets of an infant formula product in a powdered form.14 Required warnings, directions and statements(1) The label on a package of infant formula product must include the following warning statement –(a) in the case of infant formula product in powdered form –‘Warning – follow instructions exactly. Prepare bottles and teats asdirected. Do not change proportions of powder except on medical advice.Incorrect preparation can make your baby very ill’; and(b) in the case of concentrated infant formula product –‘Warning – follow instructions exactly. Prepare bottles and teats asdirected. Do not change proportions of concentrate except on medicaladvice. Incorrect preparation can make your baby very ill’; and(c) in the case of ‘ready to drink’ infant formula product –‘Warning – follow instructions exactly. Prepare bottles and teats asdirected. Do not dilute or add anything to this ‘ready to drink’ formulaexcept on medical advice. Incorrect preparation can make your baby veryill’.(2) The label on a package of infant formula product must include directions for the preparation and use of the infant formula product which include words and pictures instructing –(a) that each bottle should be prepared individually; and(b) that if a bottle of made up formula is to be stored prior to use, it must berefrigerated and used within 24 hours; and(c) that potable, previously boiled water should be used; and(d) where a package contains a measuring scoop, that only the enclosed scoopshould be used; and(e) that formula left in the bottle after a feed must be discarded.(3) Subject to subclause (4), the label on a package of infant formula product must contain the following warning statement –‘Breast milk is best for babies. Before you decide to use this product, consult yourdoctor or health worker for advice.’;under a heading that states –‘Important Notice’ or any word or words having the same or similar effect.(4) Subclause (3) does not apply to infant formula products for metabolic, immunological, renal, hepatic or malabsorptive conditions.(5) The label on a package of an infant formula product must contain statements indicating that –(a) the infant formula product may be used from birth, in the case of infantformula; and(b) the infant formula product should not be used for infants aged under 6months in the case of follow-on formula; and(c) except in the case of packages of pre-term formula, it is recommended thatinfants over the age of 6 months should be offered foods in addition to theinfant formula product.15 Print and package size(1) Where an infant formula product is in a package having a net weight of more than500 g, the statements required by subclauses 14(1), (3) and 26(1) must be in size of type of no less than 3 mm.(2) Where an infant formula product is in a package having a net weight of 500 g or less the statements required by subclauses 14(1), (3) and 26(1) must be in size of type of no less than 1.5 mm.16 Declaration of nutrition information(1) The label on a ‘ready to drink’ infant formula product must include a statement,which may be in the form of a table, that contains the following information –(a) the average energy content expressed in kJ per 100 mL; and(b) the average amount of protein, fat and carbohydrate expressed in g per 100 mL;and(c) the average amount of each vitamin, mineral and any other nutritivesubstance permitted by this Standard expressed in weight per 100 mL; and(d) when added, the average amount of –(i) a combination of inulin-derived substances and galacto-oligosaccharides; or(ii) inulin-derived substances; or(iii) galacto-oligosaccharidesexpressed in weight per 100 mL.(2) The label on a powdered or concentrated form of infant formula product mustinclude a statement, which may be in the form of a table that contains the following information –(a) the average energy content expressed in kJ per 100 mL of infant formulaproduct that has been reconstituted according to directions; and(b) the average amount of protein, fat and carbohydrate expressed in g per 100 mLof infant formula product that has been reconstituted according to directions;and(c) the average amount of each vitamin, mineral and any other nutritivesubstance permitted by this Standard expressed in weight per 100 mL ofinfant formula product that has been reconstituted according to directions;and(d) a declaration –(i) of the weight of one scoop in the case of powdered infant formula;and(ii) of the proportion of powder or concentrate required to reconstitutethe formula according to directions; and(e) when added, the average amount of –(i) a combination of inulin-derived substances and galacto-oligosaccharides; or(ii) inulin-derived substances; or(iii) galacto-oligosaccharidesexpressed in weight per 100 mL.Editorial note:As a guide to how nutrition information may be presented, see the Guidelines for Infant Formula Products at the end of this Standard. These Guidelines do not form part of thelegally binding Standard.17 Date marking and storage instructions(1) Paragraphs 2(1)(c) and (d) of Standard 1.2.5 do not apply to this Standard.(2) A label on a package of infant formula product must contain storage instructions covering the period after it is opened.Editorial note:The full range of climatic conditions that exist in Australia and New Zealand may need to be considered when determining valid and appropriate storage instructions.18 Statement of protein sourceThe label on a package of infant formula product must contain a statement of the specific source, or sources, of protein in the infant formula product immediately adjacent to the nameof the infant formula product.Editorial note:Standard 1.2.2 requires that all food be labelled with its name. The requirement in clause 18 of this Standard applies only to the name on the label on the product in accordance with the requirement in Standard 1.2.2.19 Statement on dental fluorosis(1) An infant formula product must comply with subclause (2) where it contains –(a) more than 17 μg of fluoride per 100 kJ prior to reconstitution, in the case ofpowdered or concentrated infant formula product; or(b) more than 0.15 mg of fluoride per 100 mL, in the case of ‘ready to drink’formula.(2) The label on a package of infant formula product referred to in subclause (1) must contain statements –(a) indicating that consumption of the formula has the potential to cause dentalfluorosis; and(b) recommending that the risk of dental fluorosis should be discussed with amedical practitioner or other health professional.representations20 Prohibited(1) The label on a package of infant formula product must not contain –(a) a picture of an infant; or(b) a picture that idealises the use of infant formula product; or(c) the word ‘humanised’ or ‘maternalised’ or any word or words having thesame or similar effect; or(d) words claiming that the formula is suitable for all infants; or(e) information relating to the nutritional content of human milk; or(f) subject to clause 28, a reference to the presence of any nutrient or nutritivesubstance, except for a reference to a nutrient or nutritive substance in –(i) clause 30 – claims relating to lactose free formula or low lactoseformula; or(ii) Standard 1.2.4 – Labelling of Ingredients; or(iii) clause 16 – declaration of nutrition information; or(g) subject to Division 3, a representation that the food is suitable for aparticular condition, disease or disorder.(2) Subject to clause 28, the label on a package of infant formula product must not contain a reference to inulin-derived substances or galacto-oligosaccharides except for a reference to either substances in –(a) a statement of ingredients; or(b) the nutrition information statement.Editorial Note:Division 3 relates to Infant Formula Products for Special Dietary Use. Clause 28 permitslabelling which varies from this clause.Division 2 – Infant Formula and Follow-on Formula21 Composition(1) Infant formula and follow-on formula must –(a) have an energy content of no less than 2500 kJ/L and no more than 3150 kJ/Lin the case of infant formula, and no less than 2500 kJ/L and no more than3550 kJ/L in the case of follow-on formula; and(b) contain an amount of each nutrient specified in column 1 of the Table tothis clause which is no less than the amount specified in column 2 of theTable and no more than the amount specified in column 3 of the Table.Table to clause 21Column 1 Column 2 Column 3Nutrient Minimum amount per 100 kJ Maximum amount per 100 kJProtein 0.45 g 0.7 g for infant formula1.3 g for follow-on formulag1.5Fat 1.05g(2) Follow-on formula must have a potential renal solute load value of no more than8 mOsm/100 kJ.22 Protein(1) The L-amino acids listed in column 1 of the Table to this clause must be present ininfant formula and follow-on formula at the minimum level specified in column 2 of theTable, subject to subclause 2 and 3.Table to clause 22Column 1 Column 2L-Amino Acid Minimum amount per 100 kJmg Histidine 12mg Isoleucine 21mg Leucine 42mg Lysine 30 Cysteine, cystine and methionine 19 mgPhenylalanine & Tyrosine 32 mgmg Threonine 19 Tryptophan 7mgmg Valine 25 (2) Infant formula or follow-on formula must provide no less than –(a) 6 mg of cysteine, cystine or combined cysteine and cystine per 100 kJ; and(b) 17 mg phenylalanine per 100 kJ.(3) L-amino acids listed in the Table to this clause must be added to infant formula or follow-on formula only in an amount necessary to improve protein quality.23 FatThe fats in infant formula and follow-on formula must –(a) not contain medium chain triglycerides except where a medium chaintriglyceride is present in a particular infant formula or follow-on formula asthe result of being –(i) a natural constituent of a milk-based ingredient of that particularinfant formula or follow-on formula or;(ii) a processing aid used in preparations of permitted fat solublevitamins of that particular infant formula or follow-on formulawhere the fat soluble vitamins have been specified in Schedule 1 tothis Standard; and(b) have a ratio of linoleic acid to α-linolenic acid of no less than 5 to 1 and nomore than 15 to 1; and(c) if specified in column 1 of the Table to this clause, comply with the limits,if any, specified in columns 2 and 3 of the Table; and(d) have a ratio of total long chain omega 6 series fatty acids (C>= 20) to totallong chain omega 3 series fatty acids (C>= 20) that is not less than 1 in aninfant formula or follow-on formula which contains those fatty acids; and(e) where long chain polyunsaturated fatty acids are present in an infantformula or follow-on formula, an eicosapentaenoic acid (20:5 n-3) contentof no more than the docosahexaenoic acid (22:6 n-3) content.Table to clause 23Column 1 Column 2 Column 3Fatty acids Minimum % totalfatty acids Maximum % total fatty acidsEssential fatty acidsLinoleic acid (18:2) 9 26α-Linolenic acid (18:3) 1.1 4 Long chain polyunsaturated fatty acidsLong chain omega 6 series fatty acids (C>= 20) 2Arachidonic acid (20:4) 1Long chain omega 3 series fatty acids (C>= 20) 1Total trans fatty acids 4 Erucic acid (22:1) 1Editorial note:Standard 1.3.4 contains specifications for Docosahexaenoic acid (DHA) rich oil derived fromthe algae Crypthecodinium cohnii and Arachidonic acid (ARA) rich oil derived from thefungus Mortierella alpina.24 Vitamins, minerals and electrolytes(1) Infant formula and follow-on formula must contain the vitamins, minerals andelectrolytes specified in column 1 of the Table to this subclause provided that, in relation toeach vitamin, mineral or electrolyte –(a) the added vitamin, mineral or electrolyte is in a permitted form as listed inSchedule 1; and(b) the infant formula or follow-on formula contains no less than the amountspecified in column 2 of the Table; and(c) the infant formula or follow-on formula contains no more than the amountspecified in column 3 of the Table, if any.Table to subclause 24(1)Column 1 Column 2 Column 3Nutrient Minimum amount per 100 kJ Maximum amount per 100 kJVitaminsVitamin A 14 μg 43μgVitamin D 0.25 μg 0.63μgVitamin C 1.7 mgThiamin 10 μgRiboflavin 14 μgPreformed Niacin 130 μgVitamin B69 μg 36μgFolate 2 μgPantothenic acid 70 μgVitamin B120.025 μgBiotin 0.36 μgVitamin E 0.11 mg 1.1 mgVitamin K 1 μgMineralsChloride 12 mg 35 mgCalcium 12mgPhosphorus 6 mg 25 mgMagnesium 1.2 mg 4.0 mgIron 0.2 mg 0.5 mgIodine 1.2 μg 10μgCopper 14 μg 43μgZinc 0.12 mg 0.43 mgManganese 0.24 μg 24.0μgSelenium 0.25 μg 1.19μgElectrolytesSodium 5 mg 15 mgPotassium 20 mg 50 mg(2) Infant formula and follow-on formula must contain no less than 0.5 mg of Vitamin E per g of polyunsaturated fatty acids.(3) The ratio of calcium to phosphorus in infant formula and follow-on formula must be no less than 1.2 to 1 and no more than 2 to 1.(4) The ratio of zinc to copper –(a) in infant formula must be no more than 15 to 1; and(b) in follow-on formula must be no more than 20 to 1.Editorial note:This Standard contains guidelines setting out the recommended levels of vitamins, minerals and electrolytes that as a matter of good practice should not be exceeded.Division 3 – Infant Formula Products for Special Dietary Use Subdivision 1 – Infant formula products formulated for premature or lowbirthweight infants25 Composition and labellingInfant formula products may be specifically formulated for premature or low birthweight infants provided that in all other respects they comply with this Standard.26 Additionallabelling(1) The label on a package of pre-term formula must include the warning statement –‘Suitable only for pre-term infants under specialist medical supervision’.(2) The words ‘pre-term’ must appear as part of the name of a food standardised in this subdivision.Subdivision 2 – Infant formula products for metabolic, immunological, renal, hepatic and malabsorptive conditions27 CompositionInfant formula products may be specifically formulated to satisfy particular metabolic, immunological, renal, hepatic or malabsorptive conditions provided that in all other respects the products comply with this Division.28 ClaimsWhere a label contains a claim that the infant formula product is suitable for infants with metabolic, immunological, renal, hepatic or malabsorptive conditions, then the label on the package of infant formula product must include a statement indicating –(a) that the product is not suitable for general use and should be used undermedical supervision; and(b) the condition, disease or disorder for which the food has been speciallyformulated; and(c) the nutritional modifications, if any, which have been made to the infantformula product.29 Composition of lactose free and low lactose formulas(1) A lactose free formula or low lactose formula must, except for the lactose content, comply with the compositional and labelling requirements which apply to the infant formula product of which they are a variety.(2) Lactose free formula must contain no detectable lactose.mustcontain no more than 0.3 g lactose per 100 mL of infantformulalactose(3) Lowformula product.30 Claims relating to lactose free and low lactose formulasWhere a label contains a claim that the infant formula product is lactose free, low lactose or words of similar import, the label on a package of lactose free or a low lactose formula product must include –(a) the words ‘lactose free’ as part of the name of lactose free formula; and(b) the words ‘low lactose’ as part of the name of low lactose formula; and(c) the following statements –(i) the amount of lactose expressed in g per 100 mL; and(ii) the amount of galactose expressed in g per 100 mL.Subdivision 3 – Infant formula products for specific dietary use based uponprotein substitutes31 CompositionAn infant formula product for specific dietary use based upon protein substitutes must –(a) have an energy content of no less than 2500 kJ/L and no more than 3150 kJ/Lin the case of infant formula, and no less than 2500 kJ/L and no more than3550 kJ/L in the case of follow-on formula; and(b) have a potential renal solute load of no more than 8 mOsm per 100 kJ; and(c) contain an amount of each nutrient specified in column 1 of the Table tothis clause which is no less than the amount specified in column 2 of theTable and no more than the amount specified in column 3 of the Table.。