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Opinion on the re‐evaluation of acacia gum (E 414) as a food additive in foods for infants below 16 weeks of age and the follow‐up of its re‐evaluation as a food additive for uses in foods for all population groups

2019; Wiley; Volume: 17; Issue: 12 Linguagem: Inglês

10.2903/j.efsa.2019.5922

1831-4732

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl–Heinz Engel, Paul Fowler, María José Frutos Fernández, Peter Fürst, Rainer Gürtler, Trine Husøy, Wim Mennes, Peter Moldéus, Agneta Oskarsson, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle, Birgit Dusemund, Alicja Mortensen, Dominique Turck, Stefania Barmaz, Camilla Smeraldi, Alexandra Tard, Ursula Gundert‐Remy,

Vitamin K Research Studies

EFSA JournalVolume 17, Issue 12 e05922 Scientific OpinionOpen Access Opinion on the re-evaluation of acacia gum (E 414) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF), Corresponding Author EFSA Panel on Food Additives and Flavourings (FAF) fip@efsa.europa.eu Correspondence: fip@efsa.europa.euSearch for more papers by this authorMaged Younes, Maged YounesSearch for more papers by this authorGabriele Aquilina, Gabriele AquilinaSearch for more papers by this authorLaurence Castle, Laurence CastleSearch for more papers by this authorKarl-Heinz Engel, Karl-Heinz EngelSearch for more papers by this authorPaul Fowler, Paul FowlerSearch for more papers by this authorMaria Jose Frutos Fernandez, Maria Jose Frutos FernandezSearch for more papers by this authorPeter Fürst, Peter FürstSearch for more papers by this authorRainer Gürtler, Rainer GürtlerSearch for more papers by this authorTrine Husøy, Trine HusøySearch for more papers by this authorWim Mennes, Wim MennesSearch for more papers by this authorPeter Moldeus, Peter MoldeusSearch for more papers by this authorAgneta Oskarsson, Agneta OskarssonSearch for more papers by this authorRomina Shah, Romina ShahSearch for more papers by this authorIne Waalkens-Berendsen, Ine Waalkens-BerendsenSearch for more papers by this authorDetlef Wölfle, Detlef WölfleSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorAlicja Mortensen, Alicja MortensenSearch for more papers by this authorDominique Turck, Dominique TurckSearch for more papers by this authorStefania Barmaz, Stefania BarmazSearch for more papers by this authorCamilla Smeraldi, Camilla SmeraldiSearch for more papers by this authorAlexandra Tard, Alexandra TardSearch for more papers by this authorUrsula Gundert-Remy, Ursula Gundert-RemySearch for more papers by this author EFSA Panel on Food Additives and Flavourings (FAF), Corresponding Author EFSA Panel on Food Additives and Flavourings (FAF) fip@efsa.europa.eu Correspondence: fip@efsa.europa.euSearch for more papers by this authorMaged Younes, Maged YounesSearch for more papers by this authorGabriele Aquilina, Gabriele AquilinaSearch for more papers by this authorLaurence Castle, Laurence CastleSearch for more papers by this authorKarl-Heinz Engel, Karl-Heinz EngelSearch for more papers by this authorPaul Fowler, Paul FowlerSearch for more papers by this authorMaria Jose Frutos Fernandez, Maria Jose Frutos FernandezSearch for more papers by this authorPeter Fürst, Peter FürstSearch for more papers by this authorRainer Gürtler, Rainer GürtlerSearch for more papers by this authorTrine Husøy, Trine HusøySearch for more papers by this authorWim Mennes, Wim MennesSearch for more papers by this authorPeter Moldeus, Peter MoldeusSearch for more papers by this authorAgneta Oskarsson, Agneta OskarssonSearch for more papers by this authorRomina Shah, Romina ShahSearch for more papers by this authorIne Waalkens-Berendsen, Ine Waalkens-BerendsenSearch for more papers by this authorDetlef Wölfle, Detlef WölfleSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorAlicja Mortensen, Alicja MortensenSearch for more papers by this authorDominique Turck, Dominique TurckSearch for more papers by this authorStefania Barmaz, Stefania BarmazSearch for more papers by this authorCamilla Smeraldi, Camilla SmeraldiSearch for more papers by this authorAlexandra Tard, Alexandra TardSearch for more papers by this authorUrsula Gundert-Remy, Ursula Gundert-RemySearch for more papers by this author First published: 13 December 2019 https://doi.org/10.2903/j.efsa.2019.5922Citations: 1 Requestor: European Commission Question Number: EFSA-Q-2018-00525 Panel members: Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen and Detlef Wölfle. Adopted: 14 November 2019 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract EFSA is re-evaluating the safety of food additives already permitted in the Union before 20 January 2009 and issuing scientific opinions on their safety in line with Regulation (EC) No 1333/2008. Acacia gum (E 414) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of acacia gum (E 414) as carry-over in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and to address the issues already identified during the re-evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested parties to provide the requested information to complete the risk assessment. Based on the analytical data submitted in response to this call, the Panel recommended to lower the limits in the specifications for toxic elements and identified the need for further specifications for aluminium, microbiological criteria and protein residues. The Panel noted that information was not provided for oxidising enzymes and recommended that oxidases and peroxidases should be inactivated during the manufacturing process. The interested parties did not submit toxicological, clinical and post-marketing surveillance data specific for the assessment of the safety of acacia gum (E 414) in infants below 16 weeks of age. However, taking the highest doses tested without adverse effects from the subchronic studies available from the previous re-evaluation and comparing them with the estimated exposure in infants, the margins of safety were large indicating that there is no reason for health concern. Summary In accordance with Regulation (EU) No 257/2010, the European Food Safety Authority (EFSA) is currently re-evaluating the safety of food additives already permitted in the Union before 20 January 2009 and issuing scientific opinions on their safety when used in food as per Annexes II and III to Regulation (EC) No 1333/2008. The risk assessment approach followed in the re-evaluation has not covered the use of food additives in food for infants below 12 weeks of age. Additionally, while re-evaluating the safety of food additives referred to above, EFSA identified some concerns, namely (1) data gaps that have triggered recommendations in the published scientific opinions; and/or; (2) data gaps that have increased uncertainties linked to the risk assessment and/or which prevented the Panel from concluding on some aspects of it. On 31 May 2017, EFSA published a guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age, thus enabling EFSA to assess the safety of food additive used in food for infants below this age. The age up to 16 weeks was selected in the guidance because infants are exposed to formula feeding until this age as the only source of food since complementary feeding is not supposed to be introduced before. As follow-up, this Opinion addresses the data gaps previously identified during the re-evaluation of acacia gum (E 414) as a food additive in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) and the safety in the special subpopulation of infants below 16 weeks of age. The process followed involved the publication of a dedicated call for data allowing all interested parties to provide the requested information for completing the assessment and to confirm that the additive is present as carry-over in food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). The data submitted in response to the call for data on acacia gum (E 414) comprised technical information and literature studies i.e. clinical studies on gastrointestinal effects in adults. Acacia gum (E 414) is a dried exudate obtained from the stems and branches of natural strains of Acacia senegal (L.) Willdenow or closely related species. Specifications for acacia gum (E 414) have been defined in Commission Regulation (EU) No 231/2012. According to the submitter, the limits defined in the EU specification reflect the lowest technologically achievable levels for lead, mercury, cadmium and arsenic. The Panel, however, noted that the submitted data by the interested parties allow to lower the limits in the specifications for toxic elements and also identified the need for further specifications for aluminium, microbiological criteria and protein residues. The Panel further noted that no information was provided for oxidising enzymes. The Panel recommended that during the manufacturing process the oxidases and peroxidases present in acacia gum should be inactivated by heating to prevent the possible oxidative degradation of components in preparations to which acacia gum is added. Information on particular specification requirements for identity and the purity of acacia gum (E 414) to be used in the food categories FC 13.1.1 and 13.1.5.1 (e.g. content residual proteins and enzymes, toxic elements) have been requested but were not provided. Analytical data on impurities in the final foods for infants below 16 weeks of age, when no legal limit has been established, were requested but were not provided. Analytical data on toxic elements in final infant formulae were not provided by the interested party. Therefore, the Panel considered that the manufacturers have no particular specifications requirements for the additive for the use in infant formulae. According to Regulation (EC) No 1333/2008 (Annex III, part 5, section B), acacia gum (E 414) is authorised for use as a food additive in nutrient preparations intended to be used in foodstuffs for infants and young children, including food for infants below 16 weeks of age. Dietary exposure to acacia gum (E 414) from its use as a food additive was assessed based on maximum permitted level (MPL) set out in the EU legislation. The interested party confirmed that that the level of use of acacia gum (E 414) in infant formulae is compliant with this limit. The exposure scenario is based on the consumption levels recommended in the relevant Scientific Committee Guidance to be used in risk assessment; 200 and 260 mL formula/kg body weight (bw) per day as conservative mean and high level consumption values for 14- to 27-day-old infants. For infants below 16 weeks of age consuming infant formulae (FC 13.1.1) or infant food for special medical purpose (FSMP) (FC 13.1.5.1), mean exposure to acacia gum (E 414) was estimated to be 2 mg/kg bw per day while the high level was estimated at 2.6 mg/kg bw per day. The Panel also noted that the exposure estimates are based on the maximum levels for carry-over of acacia gum (E 414) from nutrient formulations used in infant formulae into the final product. The interested party did not submit toxicological and clinical data which can be used to assess the safety of the acacia gum in infants below the age of 16 weeks. In addition, post-marketing surveillance data were not provided. However, in this special situation, where the exposure is low and only due to the carry over, a margin of safety (MOS) approach can be applied using available data from adult animals. Taking the highest doses tested without adverse effects in subchronic studies of 5,000 mg acacia gum/kg bw per day in rat and 20,000 mg acacia gum/kg bw per day in mice from the former EFSA evaluation in 2017 and comparing them with the exposure in infants of 2.6 mg/kg bw per day (high level estimate), MOS are roughly 2,000 and 8,000. These large MOS indicate that there is no reason for health concern. It is further noted that the data available from the former EFSA evaluation in 2017 did not show genotoxicity. Additionally, cases of allergenicity were not identified in the literature and in the former assessment. 1 Introduction The present opinion deals with: the risk assessment of acacia gum (E 414) in food for infants below 16 weeks of age in the food categories (FC) 13.1.1 (Infant formulae as defined by Directive 2006/141/EC) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) according to uses in nutrient formulations authorised in section B of part 5 of Annex III to the Regulation (EC) No 1333/20081 on food additives. the follow-up on issues that have been expressed in the conclusions and recommendations of the Scientific Opinion on the re-evaluation of acacia gum (E 414) as a food additive (EFSA ANS Panel, 2017). 1.1 Background and Terms of Reference as provided by the requestor 1.1.1 Background The composition of food intended for infants and young children, as defined by Regulation (EU) No 609/20132, is regulated at EU level and such rules include requirements concerning the use of substances as food additives. The use of food additives is regulated by Regulation (EC) No 1333/2008 on food additives. Only food additives that are included in the Union list, in particular in Annex II and III to that Regulation, may be placed on the market and used in food under the conditions of use specified therein. In accordance with Regulation (EU) No 257/20103, EFSA is currently re-evaluating the safety of food additives already permitted in the Union before 20 January 2009 and issuing scientific opinions on their safety when used in food as per Annexes II and III to Regulation (EC) No 1333/2008. However, the risk assessment approach followed until now has not covered the use of food additives in food for infants below 12 weeks of age. In addition, in these opinions EFSA identified some concerns, namely (1) Data gaps that have triggered recommendations in the published scientific opinions; and/or; (2) Data gaps that have increased uncertainties linked to the risk assessment and/or which prevented the Panel from concluding on some aspects of it. On 31 May 2017, EFSA published a guidance document (EFSA Scientific Committee, 2017) on the risk assessment of substances present in food intended for infants below 16 weeks of age (SCF, 1998), thus enabling EFSA to assess the safety of food additive used in food for infants below 12 weeks of age. EFSA has launched dedicated calls for data to be able to perform such risk assessments. The EC considers it is more effective that EFSA, in the context of these dedicated calls for data, also addresses all the issues and data gaps already identified in the relevant published scientific opinions on the re-evaluation of the safety of food additives permitted in food category 13.1. In accordance with the current EC approach (European Commission, online) for the follow-up of EFSA's scientific opinions on the re-evaluation of the safety of permitted food additives for which some concerns have been identified, a specific call for data would be published by the EC on DG SANTE's website4 on food additives and additional (missing) information would then be provided by interested parties to the EC. However, for those scientific opinions on the re-evaluation of the safety of permitted food additives in food category 13.1 for which the risk assessment does not address their uses in food for infants below 12 weeks of age and for which some concerns have been identified by EFSA, the EC considers that for the sake of efficiency it would be appropriate to streamline the approach as described above. Therefore, the EC requests EFSA to address all the issues and data gaps already identified in the relevant published scientific opinions of those food additives (or groups of additives that can be addressed simultaneously) as part of the upcoming work on the safety assessment of food additives uses in food for infants below 12 weeks of age. This follow-up aims at completing the re-evaluation of the food additives in question for all food categories, and includes calls for data covering the actual use and usage levels of food additives in food for both infants below 165 weeks of age as well as for older infants, young children and other groups of the population for which EFSA has already finalised its assessment. The future evaluations of EFSA should systematically address the safety of use of food additives for all age groups, including the infants below 16 weeks of age. 1.1.2 Terms of Reference In accordance with Article 29(1)(a) of Regulation (EC) No 178/20026, and as part of EFSA's work in completing its risk assessments concerning the use of food additives in food for infants below 12 weeks of age,5 covered by the re-evaluation programme and its terms of reference, the European Commission requests the European Food Safety Authority to address all the data gaps specified in the recommendations made in this scientific opinions on the re-evaluation of the safety of food additives permitted in food category 13.1 (food for infants and young children) of annex II to Regulation (EC) No 1333/2008. 1.1.3 Interpretation of Terms of Reference The assessment will address the safety of acacia gum (E 414) in food intended for infants up to 16 weeks of age which are exposed to formula feeding until this age as the only source of food since complementary feeding is not supposed to be introduced before this age (see EFSA Scientific Committee, 2017). 1.2 Previous evaluations of acacia gum (E 414) for use in foods for infants Acacia gum (E 414) was never formally evaluated by the EU Scientific Committee for Food (SCF). Nevertheless, acacia gum (E 414) was accepted for use in weaning food (SCF, 1991). In 1999, the SCF considered 'that the use of acacia gum/gum arabic in coatings for nutrient preparations containing trace elements is acceptable provided carry-over levels in infant formulae, follow-on formulae or FSMP7 do not exceed 10 mg/kg' (SCF, 1999). In 1982 and 1990, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated acacia gum; based on the lack of adverse effects in the available toxicity studies, an acceptable daily intake (ADI) 'not specified' was allocated (JECFA, 1982, 1990). Acacia gum has also been reviewed by the Nordic Council of Ministers (TemaNord, 2002), who concluded that even though the existing data do not raise any toxicological concern, allergy/intolerance and the problem of marketing gums originating from acacia species not included in their evaluation should be considered in future evaluations. 1.3 Summary of the previous EFSA re-evaluation of acacia gum (E 414) for uses in food for all population groups except for infants below 12 weeks of age8 Under the frame of Regulation (EC) No 257/2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) has re-evaluated the safety of acacia gum (E 414) when used as a food additive (EFSA ANS Panel, 2017). In its scientific opinion, the ANS Panel reviewed available technical, biological and toxicological data on acacia gum (E 414) used as a food additive. Having considered the data available, the ANS Panel concluded that acacia gum is unlikely to be absorbed intact and is slightly fermented by the intestinal microbiota. The fermentation of acacia gum would lead to products considered of no safety concern by the ANS Panel such as short-chain fatty acids (SCFA). Acacia gum is considered to have low acute oral toxicity. Adverse effects were not reported in subchronic and carcinogenicity studies at the highest dose tested with the highest doses tested being 5,000 mg acacia gum/kg body weight (bw) per day in rat and 20,000 mg acacia gum/kg bw per day in mice and there was no concern with respect to genotoxicity. In the available studies addressing developmental and reproductive toxicity, effects were not reported up to the highest tested doses. Case reports on allergic reactions after oral exposure to acacia gum were not identified by the ANS Panel. The oral intake for up to 18 days of large amounts of acacia gum (up to 30,000 mg acacia gum/person per day approximately equivalent to 430 mg acacia gum/kg bw per day) was well tolerated in adults. Some individuals experienced flatulence which was considered by the ANS Panel as undesirable but not adverse effect. No cases of allergenicity after oral exposure to acacia gum were identified. Overall, the ANS Panel concluded that a numerical ADI was not needed for acacia gum (E 414) and that there was no safety concern for the general population at the refined exposure assessment (EFSA ANS Panel, 2017). The ANS Panel, however, considered that the conclusions reached on the re-evaluation of the food additive were not applicable to the use of acacia gum (E 414) in food for infants under the age of 12 weeks.5 The ANS Panel considered that these uses would require a specific risk assessment. In addition, recommendations for revisions of the specifications were included in the ANS opinion. In particular, the ANS Panel noted that the detected levels of the toxic elements (lead, cadmium, mercury and arsenic) were far below those defined in the European Commission specifications for acacia gum, and therefore, recommended that the current limits should be lowered in order to ensure that acacia gum (E 414) as a food additive will not be a significant source of exposure to those toxic elements, in particular for infants and children. The ANS Panel also recommended the inclusion of limits for aluminium in the specifications. Furthermore, the inclusion of criteria for total aerobic microbial count (TAMC) and total combined yeast and mould count (TYMC) as well as limits for residual enzymatic activities and for protein content was recommended. Finally, the ANS Panel recommended that the oxidases and peroxidases in acacia gum should be inactivated during the manufacturing process to avoid any oxidative degradation of components in preparations to which acacia gum is added. 2 Data and methodologies 2.1 Data EFSA launched a public call for data9 and, if relevant, contacted other risk assessment bodies to collect relevant information from interested parties. The Panel based its assessment on information submitted to EFSA following the public call for data, information from previous evaluations and additional available literature up to 2 October 2019. The Mintel's Global New Products Database (GNPD) is an online database which monitors new introductions of packaged goods in the market worldwide. It contains information of over 3 million food and beverage products of which more than 1,100,000 are or have been available on the European food market. Mintel started covering EU's food markets in 1996, currently having 20 out of its 28 member countries and Norway presented in the Mintel's GNPD. This database was used to verify the use of the food additive acacia gum (E 414) in food products. 2.2 Methodologies This opinion was formulated following the principles described in the EFSA Guidance on transparency with regard to scientific aspects of risk assessment (EFSA Scientific Committee, 2009) and following the relevant existing guidance documents from the EFSA Scientific Committee and in particular the EFSA Guidance of the Scientific Committee on the risk assessment of substances present in food intended for infants below 16 weeks of age (EFSA Scientific Committee, 2017). In order to conclude on the safety of acacia gum (E 414), the FAF Panel assessed the information provided: for the follow-up on issues that have been raised in the conclusions and recommendations of the Scientific Opinion on the re-evaluation of acacia gum (E 414) as a food additive (EFSA ANS Panel, 2017); and for the risk assessment of acacia gum (E 414) in food for infants below 16 weeks of age in the FC 13.1.1 (Infant formulae as defined by Directive 2006/141/EC) and 13.1.5.1 (Dietary foods for special medical purposes and special formulae for infants) according to uses in nutrient formulations authorised in section B of part 5 of Annex III to the Regulation (EC) No 1333/20081 on food additives. When in animal studies, the test substance was administered in the feed or in drinking water, but doses were not explicitly reported by the authors as mg/kg bw per day based on actual feed or water consumption, the daily intake is calculated by the Panel using the relevant default values. In case of rodents, the values as indicated in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012) are applied. In the case of other animal species, the default values by JECFA (2000) are used. In these cases, the dose was expressed as 'equivalent to mg/kg bw per day.' When in human studies in adults (aged above 18 years) the dose of the test substance administered was reported in mg/person per day, the dose in mg/kg bw per day was calculated by the Panel using a body weight of 70 kg as default for the adult population as described in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012). Dietary exposure to acacia gum (E 414) from its use as a food additive in nutrient formulations for use in foods for infants below 16 weeks of age was estimated combining the mean and highest consumption figures reported for the period of 14–27 days of life which corresponds to values of 200 and 260 mL/kg bw per day, respectively, with the maximum levels according to Annex III to Regulation (EC) No 1333/2008 and/or reported use levels and analytical data submitted to EFSA following a call for data. Different scenarios were used to calculate exposure (see Section 3.3.1). Uncertainties on the exposure assessment were identified and discussed. 3 Assessment 3.1 Technical data 3.1.1 Identity of the substance According to Commission Regulation (EU) No 231/201210, the food additive 'E 414' is named as 'acacia gum'. A synonym for 'acacia gum' is 'gum arabic' (Commission Regulation (EU) No 231/20128; JECFA, 2006). Acacia gum is a dried exudate obtained from the stems and branches of natural strains of Acacia senegal (L.) Willdenow or closely related species (Commission Regulation (EU) No 231/2012; JECFA, 2006). 3.1.2 Specifications The specifications for acacia gum (E 414) as defined in the Commission Regulation (EU) No 231/2012 and as proposed by JECFA (2006) are listed in Table 1. Table 1. Specifications for acacia gum (E 414) according to Commission Regulation (EU) No 231/2012 and proposed by JECFA (2006) Commission Regulation (EU) No 231/2012 JECFA (2006) Definition Acacia gum is a dried exudation obtained from the stems and branches of strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid Gum arabic is a dried exudate obtained from the stems and branches of Acacia senegal (L.) Willdenow or Acacia seyal (fam. Leguminosae) Gum arabic consists mainly of high-molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid. Items of commerce may contain extraneous materials such as sand and pieces of bark, which must be removed before use in food Synonym Gum arabic Gum arabic (Acacia senegal), gum arabic (Acacia seyal), Acacia gum, arabic gum, INS No. 414 CAS Numbers 9000-01-5 EINECS 232-519-5 Molecular weight Approximately 350,000 Description Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material Gum arabic (A. senegal) is a pale white to orange-brown solid, which breaks with a glassy fracture. The best grades are in the form of whole, spheroidal tears of varying size with a matt surface texture. When ground, the pieces are paler and have a glassy appearanceGum arabic (A. seyal) is more brittle than the hard tears of gum arabic (A. senegal) Gum arabic is also available commercially in the form of white to yellowish white flakes, granules, powder, roller dried or spray-dried material An aqueous solution of 1 g in 2 mL flows readily and is acid to litmus Identification Solubility 1 g dissolves in 2 mL of cold water forming a solution which flows readily and is acid to litmus; insoluble in ethanol 1 g dissolves in 2 mL of water; insoluble in ethanol Gum constituents Proceed as directed under Gum Constituents Identification (FNP 5) using the following as reference standards: arabinose, galactose, mannose, rhamnose, galacturonic acid, glucuronic acid and xylose. Arabinose, galactose, rhamnose and glucuronic acid should be present. Additional spots corresponding to mannose, xylose and galacturonic acid should be absent Optical rotation Gum from A. senegal: aqueous solutions are levorotatory Gum from