Inulin-oligofructose Enriched Handling/Processing 1 2 Identification of Petitioned Substance 3 18 4 Chemical Names: 19 Fibrulose® (inulin) 5 oligofructose-enriched inulin 20 Orafti® (inulin) 6 oligofructose only: fructose oligosaccharide, 21 Raftilose® (oligofructose) 7 fructooligosaccharides 22 NutraFlora® (oligofructose) 8 23 Osteoboost™ (inulin-oligofructose) 9 Other Names: 24 Inulin FOS (inulin-oligofructose) 10 easily fermentable inulin (EFI) 25 11 hardly fermentable inulin (HFI) 26 CAS Number: 12 27 9005-80-5 13 Trade Names: 28 14 BENEO®™ Synergy 1 Inulin/OFS Powder 29 Other Codes: 15 Raftiline® (inulin) 30 EC number: 232-684-3 16 31 MDL number: MFCD00131407 17 32 33 Summary of Petitioned Use 34 35 Inulin-oligofructose enriched (IOE) is currently included on the National List of Allowed and Prohibited 36 Substances (hereafter referred to as the National List) as a nonorganically-produced agricultural product that can 37 be used as an ingredient in or on processed products labeled as “organic” when the substance is not 38 commercially available in organic form (7 CFR 205.606). In organic processing and handling, IOE is used as an 39 ingredient in foods, specifically yogurt, to improve calcium bioavailability and absorption, to serve as soluble 40 dietary fiber or a prebiotic ingredient, and to enhance the texture and consistency of the food. 41 42 Characterization of Petitioned Substance 43 44 Composition of the Substance: 45 IOE is made up of two carbohydrates—inulin and oligofructose—that are included in a group of dietary fiber 46 compounds called fructans (Kaur and Gupta, 2002). Inulin is a naturally-occurring carbohydrate found in the 47 roots of chicory (Cichorium intybus) and many other food plants, and oligofructose is derived from inulin 48 (Coussement, 1999; Roberfroid, 2007; Singh and Singh, 2010; U.S. FDA, 2003). To extract the oligofructose portion 49 of IOE, inulin must be further refined. 50 51 Inulin is a polymer chain of multiple fructose molecules with a glucose molecule at one end. The length of the 52 fructose chain of inulin can range from 2–60 fructose molecules (Frippiat et al., 2010). “Native inulin” extracted 53 from the fresh roots of the chicory plant has an average chain length of 10 to 20 fructose molecules (Flamm et al., 54 2001). Shorter inulin chains (2–10 fructose molecules) are also called easily fermentable inulin (EFI), and longer 55 inulin chains (10–60 fructose molecules) are also referred to as hardly fermentable inulin (HFI) (Coussement, 56 1999; Frippiat et al., 2010; U.S. FDA, 2003). This report uses interchangeably the terms EFI for oligofructose, HFI 57 for inulin, and IOE for inulin-oligofructose enriched. The ideal percentages of EFI and HFI in food to increase 58 calcium absorption are approximately 45% EFI and 55% HFI (Frippiat et al., 2010). The molecular structure of 59 generic inulin (also referred to as GFn) is pictured in Figure 1. The complex fructan sugars that make up 60 oligofructose are called kestose (one glucose and two fructose molecules), nystose (one glucose and three fructose 61 molecules), and fructosyl nystose (one glucose and four fructose molecules). These oligofructose polymers (also 62 referred to as GF2, GF3, and GF4, respectively) are also shown in Figure 1. 63 64 Oligofructose is also used separately in organic handling and processing as a specific mixture of short-chain EFIs 65 called fructooligosaccharides (Coussement, 1999; Eurofins, 2012; Roberfroid, 2007; Singh and Singh, 2010). The ___________________________________ January 20, 2015 Technical Evaluation Report – Limited Scope Page 1 of 10 Compiled by ICF International for the USDA National Organic Program Technical Evaluation Report Inulin-oligofructose Enriched Handling/Processing 66 short-chain EFI molecules can be obtained by filtering the inulin solution or from the partial hydrolysis (i.e., 67 breakdown by water) of inulin by the inulinase enzyme (Coussement, 1999; Roberfroid, 2007; Singh and Singh, 68 2010). The primary source of the inulinase enzyme for industrial production is the fungus Aspergillus niger 69 (Coussement, 1999; Singh and Singh, 2010). 70 Generic Inulin Kestose GFn: glucose – fructose – n - fructose GF2: glucose – fructose – fructose (n = up to 58 fructose units) Nystose Fructosyl Nystose GF3: glucose – fructose – fructose – GF4: glucose – fructose – fructose – fructose fructose – fructose 71 72 Figure 1: Chemical Structures of Inulin and Selected Oligofructose Sugars 73 (NLM, 2012; Sigma-Aldrich, 2014) 74 75 IOE is considered dietary fiber and is mostly indigestible by human digestive enzymes due to its shape (relative 76 to the shape of the digestive enzymes), but is digestible by microbes in the large intestine (Roberfroid, 2007). EFI 77 is typically fermented in the proximal or ascending part of the large intestine whereas HFI is typically fermented 78 in the transverse or descending part of the large intestine (Frippiat et al., 2010). For this reason, IOE can serve as a 79 prebiotic, a nutrient source for microflora in the human digestive system (Ophardt, 2003; Roberfroid, 2007). 80 81 Source or Origin of the Substance: 82 IOE contains inulin and oligofructose, two carbohydrates found in many plant foods that function as 83 dietary fiber (Coussement, 1999; Roberfroid, 2007). Chicory (Cichorium intybus) is a natural source of inulin 84 and oligofructose and it is the most commonly used vegetable source for the industrial production of inulin 85 (Coussement, 1999; Roberfroid, 2007). Oligofructose can also be produced from the enzyme synthesis of 86 sucrose as is most common with the production of fructooligosaccharides, a group of short-chain 87 oligofructose compounds (Sangeetha et al., 2005). Inulin was first discovered by isolation from the roots of 88 the elecampane plant (Inula helenium). In addition to chicory, inulin is found in food plants such as garlic, 89 onion, bananas, Jerusalem artichoke, asparagus, wheat, and rye (Coussement, 1999; Kowalchik and Hylton, 90 1998; Morris and Morris, 2012). January 20, 2015 Page 2 of 10 Technical Evaluation Report Inulin-oligofructose Enriched Handling/Processing 91 92 Production of IOE begins with washed and shredded chicory roots, which are treated with hot water, 93 juiced, and filtered to remove the raw inulin (Frippiat et al., 2010; Gibson et al., 1994). The raw inulin is 94 purified by treatment with lime (calcium hydroxide), carbonated, and filtered to remove the short-chain 95 inulin and simple sugars (Gibson et al., 1994). A portion of the inulin is then spray-dried while the 96 remaining portion is treated with enzymes to convert the inulin to oligofructose (Gibson et al., 1994). 97 98 EFI is produced from inulin by filtration and use of the enzyme inulinase (Singh and Singh, 2010). 99 Filtration removes any short-chain oligofructose molecules from the raw inulin extract before treatment 100 with the inulinase enzyme (Frippiat et al., 2010; Singh and Singh, 2010). The inulinase enzyme is naturally 101 occurring in several species of fungi, including Aspergillus niger, Aspergillus japonicus, Fusarium oxysporum, 102 and Aureobasidium pullulans (Coussement, 1999; Santos and Maugeri, 2006; Singh and Singh, 2010). 103 Inulinase breaks down inulin through the process of enzymatic hydrolysis—a process by which enzymes 104 facilitate the breakdown using water (Roberfroid, 2007). 105 106 Properties of the Substance: 107 IOE is an odorless, white to cream-colored solid, with a neutral to slightly sweet taste and a molecular 108 weight ranging from 504.43–9908.84 g/mol, depending on the specific numbers of fructose chain units in 109 the sample (NLM, 2012; Spectrum Chemical, 2009). The water solubility of oligosaccharides with 10 or 110 fewer fructose units is 120 g/L at 25 °C, while the solubility of inulin with fructose chains between 10 and 111 60 units is 25 g/L at 25 °C (Spectrum Chemical, 2009). 112 113 IOE is included in a larger class of chemicals called fructans, which includes inulin from chicory, 114 oligosaccharides from chicory-derived inulin, and synthetically-produced oligosaccharides derived from 115 sucrose (Roberfroid, 2007). IOE is a mixture of inulin with oligosaccharides, the properties of which are 116 listed in Table 1 for selected IOE compounds and fructooligosaccharides (NLM, 2012; Silva et al., 2013). 117 Molecular weight, molecular formula, CAS number, and water solubility for these compounds are also 118 provided in Table 1. The sugars all have the same molecular base (sucrose) with the addition of 1–59 119 fructose molecules attached to the terminal sucrose, resulting in sugar chains of 2–60 fructose molecules. 120 Figure 2 shows a schematic diagram of fructans and some of its carbohydrate subgroups that are discussed 121 in this report. 122 Fructans Inulin/ HFI Oligofructose/ Oligosaccharides/ Fructooligosaccharides EFI Inulin-oligofructose enriched 123 124 125 Figure 2: Schematic Diagram of Fructans and Selected Carbohydrate Subgroups 126 January 20, 2015 Page 3 of 10 Technical Evaluation Report Inulin-oligofructose Enriched Handling/Processing 127 Table 1: Properties of Selected Oligofructose Compounds and Inulin (NLM, 2012; Ranawana, 2008) Molecular Water Fructose Chain Molecular Compound CAS Number Weight Solubility Units Formula (g/mol) (g/L, 25 °C) Kestose 470-69-9 2 504.43 C18H32O16 Nystose 13133-07-8 3 666.58 C24H42O21 120 Fructosyl 59432-60-9 4 828.72 C30H52O26 nystose GF10 not available 10 1801.59 C66H112O56 25 GF60 not available 60 9908.84 C366H612O306 128 129 Specific Uses of the Substance: 130 IOE is added to yogurt (primarily) and other foods to: (1) improve calcium bioavailability and absorption, 131 (2) serve as a nondigestible soluble dietary fiber, and (3) enhance the food’s texture and consistency. As a 132 dietary fiber, IOE is moved to the lower digestive tract undigested and serves as a nutrient source for 133 beneficial bacteria in the gut (Roberfroid, 2007; Sangeetha et al., 2005; Sheu et al., 2013; Tymczyszyn et al., 134 2014). When mixed in yogurt, IOE improves its texture and consistency and acts as a food source for 135 Lactobacillus bacteria in the yogurt (Pimentel et al., 2012).