Re-evaluation of tara gum (E 417) as a food additive

SCIENTIFIC OPINION ADOPTED: 17 May 2017 doi: 10.2903/j.efsa.2017.4863 Re-evaluation of tara gum (E 417) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Alicja Mortensen, Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambre, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Maged Younes, Leon Brimer, Anna Christodoulidou, Federica Lodi, Alexandra Tard and Birgit Dusemund Abstract The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of tara gum (E 417) as a food additive. Tara gum (E 417) has been evaluated by the EU Scientific Committee for Food (SCF, 1992) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1987), who both allocated an acceptable daily intake (ADI) not specified for this gum. Following the conceptual framework for the risk assessment of certain food additives, re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available for tara gum (E 417). Tara gum (E 417) is unlikely to be absorbed intact and is expected to be fermented by intestinal microbiota. No adverse effects were reported at the highest doses tested in subchronic, chronic and carcinogenicity studies and there is no concern with respect to the genotoxicity. The Panel concluded that there is no need for a numerical ADI for tara gum (E 417) and that there is no safety concern for the general population at the refined exposure assessment of tara gum (E 417) as a food additive at the reported uses and use levels. 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: tara gum (E 417), CAS Registry Number 39300-88-4, food additive Requestor: European Commission Question number: EFSA-Q-2011-00516 Correspondence: fip@efsa.europa.eu www.efsa.europa.eu/efsajournal EFSA Journal 2017;15(6):4863

Panel members: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambre, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. Acknowledgements: The Panel wishes to thank the following for the support provided to this scientific opinion: Jacqueline Wiesner, Dario Battacchi and Lemmetyinen Juho. The ANS Panel wishes to acknowledge all the European competent institutions, the Member State bodies and other organisations that provided data for this scientific opinion. Suggested citation: EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), Mortensen A, Aguilar F, Crebelli R, Di Domenico A, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Lambre C, Leblanc J-C, Lindtner O, Moldeus P, Mosesso P, Oskarsson A, Parent-Massin D, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Younes M, Brimer L, Christodoulidou A, Lodi F, Tard A and Dusemund B, 2017. Scientific Opinion on the re-evaluation of tara gum (E 417) as a food additive. EFSA Journal 2017;15(6):4863, 37 pp. https://doi.org/10.2903/j.efsa.2017.4863 ISSN: 1831-4732 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2017;15(6):4863

Summary Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to re-evaluate the safety of tara gum (E 417) when used as a food additive. Tara gum (E 417) is authorised as a food additive in the European Union (EU) according to Annex II and III to Regulation (EC) No 1333/2008 on food additives and it was previously evaluated by the EU Scientific Committee for Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA), who both allocated an acceptable daily intake (ADI) not specified for this gum. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and reviews, additional literature that became available since then and the data provided following public calls for data. Not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. Tara gum is a galactomannan isolated from the endosperm of the seeds of the tara tree, Caesalpinia spinosa L. Tara gum is commonly defined as a high-viscosity polysaccharide composed mainly of a linear chain of (1-4)-b-D-mannopyranose units with a-d-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. Specifications for tara gum have been defined in Commission Regulation (EU) 231/2012 and by JECFA (2006). Because of both the botanical origin and the polysaccharidic nature of gums, they can be a substrate of microbiological contamination and of field and storage fungal development. The latter has been recently demonstrated by the mycotoxin contaminations of gums (Zhang et al., 2014). The Panel noted that the microbiological specifications for polysaccharidic thickening agents, such as gums, should be harmonised and that for tara gum criteria for total aerobic microbial count (TAMC) and total combined yeasts and moulds count (TYMC) should be included into the EU specifications. Data on in vitro degradation by human gastrointestinal fluids and on in vivo digestibility of tara gum in animals demonstrated that this compound would not be absorbed intact or hydrolysed by digestive enzymes. Based on the fermentation of other galactomannans, the Panel considered that tara gum would be fermented with production of short-chain fatty acids (SCFAs) such as acetic, propionic and butyric acids, during its passage through the large intestine by strains of bacteria found in the human colon. Based on the available knowledge on the role of SCFA as end products of the fermentation of dietary fibres by the anaerobic intestinal microbiota (den Besten et al., 2014; Topping and Clifton, 2001), the Panel considered that their potential formation as fermentation products from tara gum does not raise any concern. Despite the absence of convincing in vivo study in humans, the Panel considered that tara gum would most probably not be absorbed intact but could be fermented by intestinal microbiota in humans. Acute oral toxicity studies with tara gum on rats and mice showed no toxic effects up to a dose of 630 mg/kg body weight (bw) tara gum. Short-term and subchronic animal toxicity studies on tara gum have not shown biologically significant adverse effects associated to the treatment under the conditions of the tests. From studies in rats fed high doses of tara gum, 5% dietary level, decrease of mean body weight and other findings, e.g. increased blood urea nitrogen have been reported. The Panel noted that these findings could be attributed to a nutritional imbalance induced by the high percentage of the compound added in the diet. No-observed-adverse effect levels (NOAELs) identified in short-term and subchronic studies corresponded to the highest dose tested of 12,000, 4,500 and 2,250 mg/kg bw per day for rats (Til et al., 1974; NTP, 1982), of approximately 20,000 and 10,000 mg/kg bw per day for mice (NTP, 1982) and of approximately 1,250 mg/kg bw per day in dogs (Oshita et al., 1975; as reported in JECFA, 1987; Borzelleca et al., 1993). Based on the data available, the Panel concluded that there is no concern with respect to the genotoxicity of tara gum (E 417). Tara gum was tested in chronic toxicity and carcinogenicity assays in rats (two strains) and mice (one strain) receiving diets containing 25,000 and 50,000 ppm tara gum for 103 weeks (equivalent to 3,750 and 7,500 mg/kg bw per day in mice and, 1,250 and 2,500 mg/kg bw per day in rats). No major differences (2 9%) were observed in body weight gain either in males or females, contrary to the sub-chronic studies. In rats, 2,500 mg/kg bw per day and in mice, 7,500 mg/kg bw per day (both the highest dose tested) was identified as the NOAEL by the Panel from chronic toxicity assays. Further, the Panel considered tara gum as not carcinogenic in mice and rats. www.efsa.europa.eu/efsajournal 3 EFSA Journal 2017;15(6):4863

Tara gum did not show reproductive or developmental toxicity effects and a NOAEL of 2,500 mg/kg bw per day, the highest dose tested, could be identified by the Panel. To assess the dietary exposure to tara gum (E 417) from its use as a food additive, the exposure was calculated based on (1) maximum levels of data provided to EFSA (defined as the maximum level exposure assessment scenario) and (2) reported use levels (defined as the refined exposure assessment scenario, brand-loyal and non-brand-loyal consumer scenario). Tara gum (E 417) is authorised as a Group I food additive in a wide range of foods. The Panel did not identify a brand-loyalty to specific food categories, and therefore, the Panel considered that the non-brand-loyal scenario was the more appropriate and realistic scenario for risk characterisation; thus, it was assumed that the population would probably be exposed long term to the food additive present at the mean reported use levels in processed food. The refined estimates were based on 11 out of 67 food categories in which tara gum (E 417) is authorised. Overall, the Panel considered that the uncertainties identified would, in general, result in an overestimation of the real exposure to tara gum (E 417) as a food additive in European countries for the refined scenarios when considering only food additive uses for which data have been provided. However, the Panel noted that given the information from the Mintel s GNPD, it may be assumed that tara gum (E 417) is not used in food categories in which it is authorised. A specific exposure assessment scenario taking into account the consumption of food supplements for consumers only was also performed to estimate exposure for children, adolescents, adults and the elderly as exposure via food supplements may deviate largely from that via food, and the number of food supplement consumers may be low depending on populations and surveys. The Panel noted that the exposure to tara gum (E 417) from its use according the Annex III (Parts 2, 3, 4 and 5A) was not considered in the exposure assessment. The Panel also noted that the refined exposure estimates are based on information provided on the reported level of use of tara gum (E 417). If actual practice changes, this refined estimates may no longer be representative and should be updated. Due to the discrepancies observed between the data reported from industry and the Mintel database, where tara gum are labelled in more products than in food categories for which data were reported from industry, the Panel noted that the collection of data on usage and use levels of tara gum (E 417) would allow for a more realistic exposure assessment. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010 (EFSA ANS Panel, 2014), and given that the data received for the 11 food categories were adequate for a refined exposure assessment for these categories; based on the reported use levels a refined exposure of up to 70 mg/kg bw per day in children (3 9 years) in these categories (non-brand-loyal scenario) was estimated; highest refined exposure assessments on consumers only of food supplements was also calculated and ranged from 10 mg/kg bw per day for adolescents to 51 mg/kg bw per day for children; tara gum is unlikely to be absorbed intact and is expected to be fermented by intestinal microbiota; adequate toxicity data were available; no adverse effects were reported in subchronic studies at the highest doses tested in rats (4,500 mg tara gum/kg bw per day), mice (10,000 mg tara gum/kg bw per day) and dogs (1,250 mg tara gum/kg bw per day); no adverse effects were reported in chronic toxicity studies at the highest doses tested in rats (2,500 mg tara gum/kg bw per day) and mice (7,500 mg tara gum/kg bw per day); no adverse effects were reported in reproductive and developmental toxicity studies at the highest doses tested in rats (2,500 mg tara gum/kg bw pe day); there is no concern with respect to the genotoxicity of tara gum; there is no concern with respect to carcinogenicity of tara gum; the Panel concluded that there is no need for a numerical ADI for tara gum (E 417), and that there is no safety concern for the general population at the refined exposure assessment for the reported uses of tara gum (E 417) as a food additive. www.efsa.europa.eu/efsajournal 4 EFSA Journal 2017;15(6):4863

The Panel recommended that the European Commission considers revising the current limits for the toxic elements (lead, cadmium, mercury and arsenic) in the EU specification for tara gum (E 417) in order to ensure that tara gum (E 417) as a food additive will not be a significant source of exposure to those toxic elements in food. harmonising the microbiological specifications for polysaccharidic thickening agents, such as gums, and to include criteria for the absence of Salmonella spp. and Escherichia coli, for TAMC and for TYMC into the EU specifications of tara gum (E 417). investigating whether polycyclic aromatic hydrocarbons are generated during the roasting process and if so establishing maximum levels. www.efsa.europa.eu/efsajournal 5 EFSA Journal 2017;15(6):4863

Table of contents Abstract... 1 Summary... 3 1. Introduction... 8 1.1. Background and Terms of Reference as provided by the European Commission... 8 1.1.1. Background as provided by the European Commission... 8 1.1.2. Terms of Reference as provided by the European Commission... 8 1.1.2.1. Re-evaluation of tara gum (E 417) as a food additive... 8 1.2. Information on existing evaluations and authorisations... 8 2. Data and methodologies... 9 2.1. Data... 9 2.2. Methodologies... 9 3. Assessment... 10 3.1. Technical data... 10 3.1.1. Identity of the substance... 10 3.1.2. Specifications... 11 3.1.3. Manufacturing process... 13 3.1.4. Methods of analysis in food... 13 3.1.5. Stability of the substance, and reaction and fate in food... 14 3.2. Authorised uses and use levels... 14 3.3. Exposure data... 17 3.3.1. Reported use levels or data on analytical levels of tara gum (E 417)... 17 3.3.1.1. Summarised data on reported use levels in foods provided by industry... 18 3.3.2. Summarised data extracted from the Mintel GNPD database... 18 3.3.3. Food consumption data used for exposure assessment... 18 3.3.3.1. EFSA Comprehensive European Food Consumption Database... 18 3.3.3.2. Food categories selected for the exposure assessment of tara gum (E 417)... 19 3.4. Exposure estimate... 20 3.4.1. Exposure to tara gum (E 417) from its use as a food additive... 20 3.4.1.1. Maximum level exposure assessment scenario... 21 3.4.1.2. Refined exposure assessment scenario... 21 3.4.1.3. Specific scenario: Consumers of food supplements... 21 3.4.1.4. Dietary exposure to tara gum (E 417)... 21 3.4.1.5. Main food categories contributing to exposure to tara gum (E 417) using the maximum level exposure assessment scenario... 22 3.4.1.6. Main food categories contributing to exposure to tara gum (E 417) using the refined exposure assessment scenario... 22 3.4.1.7. Uncertainty analysis... 22 3.5. Biological and Toxicological data... 24 3.5.1. Absorption, distribution, metabolism and excretion... 24 3.5.1.1. In vitro studies... 24 3.5.1.2. In vivo studies... 24 3.5.2. Acute toxicity... 25 3.5.3. Short-term and subchronic toxicity... 25 3.5.4. Genotoxicity... 27 3.5.4.1. In vitro... 27 3.5.4.2. In vivo... 27 3.5.5. Chronic toxicity and carcinogenicity... 27 3.5.6. Reproductive and developmental toxicity... 29 3.5.6.1. Reproductive toxicity studies... 29 3.5.6.2. Developmental toxicity studies... 30 3.5.7. Hypersensitivity, allergenicity and food intolerance... 30 3.6. Discussion... 30 4. Conclusions... 32 Recommendations... 32 Documentation provided to EFSA... 32 References... 33 Abbreviations... 35 Appendix A Summary of the reported use levels (mg/kg or mg/l as appropriate) of tara gum (E 417) provided by industry... 37 www.efsa.europa.eu/efsajournal 6 EFSA Journal 2017;15(6):4863

Appendix B Number and percentage of food products labelled with tara gum (E 417) out of the total number of food products present in Mintel GNPD per food sub-category between 2012 and 2017... 37 Appendix C Concentration levels of tara gum (E 417) used in the maximum level and refined exposure assessment scenarios (mg/kg or ml/kg as appropriate)... 37 Appendix D Main food categories contributing to exposure to tara gum (E 417) using the maximum level and refined exposure assessment scenarios... 37 Appendix E Summary of total estimated exposure of tara gum (E 417) from their use as food additives for the maximum level exposure assessment scenario and the refined exposure assessment scenarios per population group and survey: mean and high level (mg/kg bw per day)... 37 www.efsa.europa.eu/efsajournal 7 EFSA Journal 2017;15(6):4863

1. Introduction The present opinion deals with the re-evaluation of the safety of tara gum (E 417) when used as a food additive. 1.1. Background and Terms of Reference as provided by the European Commission 1.1.1. Background as provided by the European Commission Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives requires that food additives are subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union (EU). In addition, it is foreseen that food additives must be kept under continuous observation and must be re-evaluated by EFSA. For this purpose, a programme for the re-evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under the Regulation (EU) No 257/2010 1. This Regulation also foresees that food additives are re-evaluated whenever necessary in light of changing conditions of use and new scientific information. For efficiency and practical purposes, the reevaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the Scientific Committee on Food (SCF) or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU of 2001. The report Food additives in Europe 2000 submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation. As colours were among the first additives to be evaluated, these food additives should be re-evaluated with a highest priority. In 2003, the Commission already requested EFSA to start a systematic re-evaluation of authorised food additives. However, as a result of adoption of Regulation (EU) 257/2010 the 2003 Terms of References are replaced by those below. 1.1.2. Terms of Reference as provided by the European Commission 1.1.2.1. Re-evaluation of tara gum (E 417) as a food additive The Commission asks EFSA to re-evaluate the safety of food additives already permitted in the Union before 2009 and to issue scientific opinions on these additives, taking especially into account the priorities, procedures and deadlines that are enshrined in the Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with the Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. 1.2. Information on existing evaluations and authorisations Tara gum (E 417) is an authorised food additive in the EU according to Annex II and Annex III of Regulation (EC) No 1333/2008 2. In the EU, tara gum was evaluated by the SCF in 1990 (SCF, 1992). The SCF was supplied with new information on digestibility of tara gum and confirmed the acceptable daily intake (ADI) not specified allocated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) based on the use level assumptions presented at that time. Tara gum was evaluated by JECFA in 1986 (JECFA, 1987). Based on the lack of adverse effects in the available toxicity studies, an ADI not specified was allocated. 1 Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. OJ L 80, 26.3.2010, p. 19 27. 2 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, 31.12.2008, p. 16 33. www.efsa.europa.eu/efsajournal 8 EFSA Journal 2017;15(6):4863

The Food Standards Australia New Zealand (FSANZ, 2006) approved tara gum as a new food additive. The Final Assessment Report concludes that approval of tara gum as a food additive does not raise any public health and safety concerns and is technologically justified. No other studies than those in JECFA (1987) and SCF (1992) reports were used for the assessment. Tara gum is one of the food additives that composed jelly mini-cups which were suspended in 2004 by the European Commission to be placed on the market and import (Commission Decision 2004/37/EC), following the measures taken and information provided by different Member States. Jelly mini-cups are defined as jelly confectionery of a firm consistence, contained in semi rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cups or mini-capsule to project the confectionery into the mouth. In 2004, the EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) prepared a scientific opinion on a request from the European Commission related to the use of certain food additives derived from seaweed or non-seaweed origin, including tara gum (E 417) in jelly mini-cups (EFSA AFC Panel, 2004). The AFC Panel concluded that any of these gel-forming additives or of any other type that gave rise to a confectionery product of a similar size, with similar physical and/or physicochemical properties and that could be ingested in the same way as the jelly mini-cups, would give rise to a risk for choking (EFSA AFC Panel, 2004). The use of these additives in jelly mini-cups is not authorised in the EU. The use of these additives in jelly minicups is not authorised in the EU. 3 2. Data and methodologies 2.1. Data The Panel on Food Additives and Nutrient Sources added to Food (ANS) was not provided with a newly submitted dossier. EFSA launched public calls for data 4,5 to collect information from interested parties and, if relevant, contacted risk assessment bodies. The Panel based its assessment on information submitted to EFSA following the public calls for data, information from previous evaluations and additional available literature up to 8 February 2017. Attempts were made at retrieving relevant original study reports on which previous evaluations or reviews were based; however not always these were these available to the Panel. The EFSA Comprehensive European Food Consumption Database (Comprehensive Database 6 ) was used to estimate the dietary exposure. The Mintel s Global New Products Database (GNPD) is an online resource listing food products and compulsory ingredient information that should be included in labelling. This database was used to verify the use of tara gum (E 417) 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. The ANS Panel assessed the safety of tara gum (E 417) as a food additive in line with the principles laid down in Regulation (EU) 257/2010 and in the relevant guidance documents: Guidance on submission for food additive evaluations by the SCF (2001) and taking into consideration the Guidance for submission for food additive evaluations in 2012 (EFSA ANS Panel, 2012). In the context of this re-evaluation, the Panel followed the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EC) No 257/2010 (EFSA ANS Panel, 2014). When the test substance was administered in the feed or in the drinking water, but doses were not explicitly reported by the authors as mg/kg body weight (bw) per day based on actual feed or water consumption, the daily intake was calculated by the Panel using the relevant default values as indicated in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012) for 3 Annex II to Regulation (EC) No 1333/2008. 4 Call for scientific data on food additives permitted in the EU and belonging to the functional classes of emulsifiers, stabilisers and gelling agents. Published: 22 November 2009. Available from: http://www.efsa.europa.eu/en/dataclosed/call/ans091123 5 Call for technical data on certain thickening agents permitted as food additives in the EU Extended Deadline: 31 December 2015. Available online: http://www.efsa.europa.eu/it/data/call/141219 6 Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm www.efsa.europa.eu/efsajournal 9 EFSA Journal 2017;15(6):4863

studies in rodents or, in the case of other animal species, by JECFA (2000). In these cases, the daily intake is expressed as equivalent. 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 tara gum (E 417) from its use as a food additive was estimated combining food consumption data available within the EFSA Comprehensive European Food Consumption Database with the maximum levels according to Annex II to Regulation (EC) No 1333/2008 7 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 Tara gum (E 417) has the CAS Registry No. 39300-88-4, EINECS No. 254-409-6. Tara gum is also known by the synonyms peruvian carob, Tara-Kern-Mehl among others. Tara gum is a galactomannan, which is a plant reserve carbohydrate like starch, isolated from the endosperm of the seeds of the tara tree, Caesalpinia spinosa L (Ullmann, 2007). No molecular weight is reported for tara gum in the EU legislation [Regulation (EU) 231/2012]. The molecular weight of tara gum reported in the literature, determined by capillary viscometry technique, depended on the temperature, pressure and time. It ranged between 10 6 and 2.33 9 10 6 g/mol (Picout et al., 2002). Tara gum is a high-viscosity polysaccharide composed mainly of a linear chain of (1-4)-b-Dmannopyranose units with a-d-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. According to the literature, tara gum consists of 77 78% galactomannan, 14 15% moisture, 2.5% fibres (acid insoluble), 3 4% nitrogen compounds, 1.5% minerals (ash) and 1% fatty compounds (ether soluble) (Benk, 1977);. The composition of tara gum, when the endosperm was separated manually, was reported to be 97.2% galactomannan, 0.5% acid insoluble material and 0.2% ash (Anderson, 1949; cited from Borzelleca et al., 1993). The carbohydrate composition was determined to be 61.3 64.9% mannose and 21.4 22.3% galactose (Daas et al., 2000). The galactomannan composition, is similar to that of other gums, the ratio of mannose to galactose in tara gum (3:1) is intermediate between that of locust bean gum (about 4:1) and guar gum (about 2:1) (Merck index 2006; Benk, 1977; Tapie et al., 2008). The major amino acids of the proteinaceous fraction of tara gum were identified to be aspartic acid (13.4%), glutamic acid (13.3%) and glycine (8.8%) (Anderson et al., 1986). The structural formula of the carbohydrate content of tara gum is presented in Figure 1. 7 Commission Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, 31.12.2008, p. 16 www.efsa.europa.eu/efsajournal 10 EFSA Journal 2017;15(6):4863

D-galactopyranose 1 α 1 β 4 6 1 β 4 1 β 4 1 4 β 1 β 6 -mannopyranose -mannopyranose -mannopyranose -mannopyranose -mannopyranose α 1 D-galactopyranose Figure 1: Structural formula of the carbohydrate content of tara gum. Tara gum is a white to white-yellow odourless powder [Regulation (EU) No 231/2012; Benk, 1977; Borzelleca et al., 1993; JECFA 2006]. Tara gum is reported to form colloidal solutions in water and to be insoluble in ethanol [Regulation (EU) No 231/2012; JECFA, 2006]. A 1% aqueous dispersion of tara gum has a viscosity of 2000 3600 centipoise (cp). Its viscosity does not change at ph values between 3.0 and 7.5 (Benk, 1977). Tara gum has synergistic gel-strength enhancing effects when combined with carrageenan, xanthan or agar (Borzelleca et al., 1993) 3.1.2. Specifications The specifications for tara gum (E 417) as defined in the Commission Regulation (EU) No 231/2012 and by JECFA (2006) are listed in Table 1. Table 1: Specifications for tara gum (E 417) according to Commission Regulation (EU) No 231/2012 and JECFA (2006) Definition Description Functional uses Identification Solubility Commission Regulation (EU) No 231/2012 Tara gum is obtained by grinding the endosperm of the seeds of natural strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-b-D-mannopyranose units with a-d-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum, this ratio is 4:1 and in guar gum 2:1) A white to white-yellow odourless powder Soluble in water, insoluble in ethanol JECFA (2006) Obtained by grinding the endosperm of the seeds of Caesalpinia spinosa (family Leguminosae); consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1,4)-beta-Dmannopyranose units with alpha-d-galactopyranose units attached by (1-6) linkages; the ratio of mannose to galactose in tara gum is 3:1. (In carob bean gum, this ratio is 4:1 and in guar gum 2:1.) The article of commerce may be further specified as to viscosity and loss on drying White to white-yellow, nearly odourless powder Thickening agent, stabiliser Soluble in water; insoluble in ethanol www.efsa.europa.eu/efsajournal 11 EFSA Journal 2017;15(6):4863

Commission Regulation (EU) No 231/2012 JECFA (2006) Gel formation To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed Viscosity Transfer 2 g of the sample into a 400-mL beaker and moisten it thoroughly with about 4 ml of isopropanol. Add, with vigorous stirring, 200 ml of water and continue stirring until the gum is completely and uniformly dispersed. An opalescent, moderately viscous solution is formed. (This solution is less viscous than a tara gum solution, but more viscous than a carob bean gum solution when prepared and tested as indicated in the above described test.) Transfer 100 ml of this solution into another 400-mL beaker, heat the mixture in a boiling water-bath for about 10 min and cool to room temperature. The solution shows a marked increase in viscosity Gum constituents Proceed as directed under Gum Constituents Identification, using galactose and mannose as standards. Galactose and mannose should be present Microscopic examination Place some ground sample in an aqueous solution containing 0.5% iodine and 1% potassium iodide on a glass slide and examine under a microscope. Tara gum contains groups of round to pear-shaped cells; their contents are yellow to brown.(tara gum cells are similar in form but markedly larger in size. Carob bean gum shows long, stretched tubiform cells, separate or slightly interspaced and can be easily distinguished from tara gum.) Purity Loss on drying Not more than 15% Not more than 15% Ash Not more than 1.5% Not more than 1.5% Acid insoluble Not more than 2% Not more than 2% matter Protein Not more than 3.5% (factor N 9 5.7) Not more than 3.5%. Proceed as directed under Nitrogen Determination (Kjeldahl method) (see Volume 4). The percentage of nitrogen determined multiplied by 5.7 gives the percentage of protein in the sample Starch Not detectable Not detectable Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Regarding possible allergies by proteins, the Panel noted that according to Borzelleca et al. (1993) and the current literature research no reports on the allergenicity of tara gum were found. According to the information from the interested party (Documentation provided to EFSA n. 3), protein content (N 9 6.25) is below 3.5%. The proteins in the final product originate from the germ which is removed during the processing of tara seeds. INEC proposes using a conversion factor of 6.25 instead of 5.7 for the protein content calculation in the EC specifications. The Panel was not provided with analytical data on the content of nitrogen in tara germ proteins and therefore could not conclude to use a different conversion factor for protein calculation in the EC specifications for tara gum (E 417). The Panel noted that, according to the Annex 1 of the Regulation (EU) 1169/2011, for the purpose of food labelling the content of protein is calculated using the formula: protein = total Kjeldahl nitrogen 9 6.25, where the conversion factor 6.25 corresponds to the average content of around 16% www.efsa.europa.eu/efsajournal 12 EFSA Journal 2017;15(6):4863

of nitrogen in proteins. This use of a single factor 6.25 is confounded by two considerations. First, not all nitrogen in foods is found in proteins, and second, the nitrogen content of specific amino acids varies according to the molecular weight of the amino acid and the number of nitrogen atoms it contains. Based on these facts, and the different amino acid compositions of various proteins, the nitrogen content of proteins actually varies from around 13% to 19% which would equate to nitrogen conversion factors (also known as Jones factors) ranging from 5.26 to 7.69 (FAO, 2003). In response to these considerations, for more accurate calculations for specific food proteins, more specific conversion factors are used. Some residual enzymatic activity (amylase, galactosidase, mannosidase) may be present in tara gum (Documentation provided to EFSA n.3), depending on the manufacturing process. The Panel noted that specifications on the enzymatic activity are not included in the tara gum specifications from the EU and JECFA. Because of both the botanical origin and the polysaccharidic nature of gums, they can be a substrate of microbiological contamination and of field and storage fungal development. The latter has been recently demonstrated by the mycotoxin contaminations of gums (Zhang et al., 2014). The Panel noted that, different from other gums, no microbiological criteria were defined for tara gum by the EU Regulation. The Panel also noted that the microbiological specifications for polysaccharidic thickening agents, such as gums, should be harmonised and that for tara gum criteria for the absence of Salmonella spp. and Escherichia coli, for total aerobic microbial count (TAMC) and for total combined yeasts moulds count (TYMC) should be included into the EU specifications, as it is the case for other polysaccharidic thickening agents [e.g. alginic acids and its salts (E 400 E 404), agar (E 406), carrageenan (E 407), processed eucheuma sea weed (E 407a), xanthan gum (E 415), gellan gum (E 418)]. No information on the particle size distribution of tara gum (E 417) has been provided. In view of the botanical origin of tara gum, limitations of possible contamination with pesticides should be considered. The Panel noted that, according to the EU specifications for tara gum (E 417), impurities of the toxic elements lead, mercury, cadmium and arsenic are accepted up concentrations of 2, 1, 1, and 3 mg/kg, respectively. Contamination at those levels could have a significant impact on the exposure to these metals, for which the intake is already close to the health-based guidance values or benchmark doses (lower confidence limits) established by the EFSA (EFSA CONTAM Panel, 2009a,b, 2010, 2012a c, 2014). No information on the levels of heavy metals on batches of tara gum has been provided. 3.1.3. Manufacturing process Tara gum is extracted from seeds of the tara tree (C. spinosa L.), which grows mainly in Peru. For removal of the hulls, two different processes exist. In the acid process the hulls are carbonised by treating the kernels with moderately dilute sulfuric acid at elevated temperature. Similar to the guar gum process, the remaining hull fragments are then removed by washing and brushing operations. After a drying step the dehulled kernels are cracked and the germs sifted off from the endosperm. Commercial products are obtained by milling and screening. In the vanishing roasting process the kernels are roasted in a rotating furnace, where the hulls pop. The endosperm is then obtained as described above. This process in which the use of sulfuric acid is avoided yields products of somewhat darker colour than those from the acid process (Ullmann, 2007). The Panel noted that this roasting process could generate polycyclic aromatic hydrocarbons. The Panel noted that limits for polycyclic aromatic hydrocarbons are not addressed in the specifications. Separation of the endosperm of tara seeds can also be done manually. The endosperm obtained under these conditions can be up to 27% of the total weight of the seed (Anderson, 1949; cited from Borzelleca et al., 1993). Depending on the manufacturing process, some residual enzymatic activity (amylase, galactosidase, mannosidase) may be present in tara gum. The Panel noted that there are no specifications for the enzymatic activity. The article of commerce may be further specified as to viscosity and loss on drying (Documentation provided to EFSA n.3). 3.1.4. Methods of analysis in food No specific methods of analysis were identified in the literature for the analysis of tara gum in food. General methods for the qualitative test of gums in mayonnaise and French dressing the AOAC Official Method 937.12 are reported by the Association of Official Agricultural Chemists (AOAC, 2002). The gums are precipitated from the food sample, hydrolysed to monosaccharides which are www.efsa.europa.eu/efsajournal 13 EFSA Journal 2017;15(6):4863

qualitatively identified. This method is not applicable in the presence of starch. A similar method (AOAC Official Method 935.61) for qualitative determination of gums in salad dressing based on a precipitation reaction is applicable in presence of starch (AOAC, 2002). Both methods are usable for determination of the sum of different gums used in foodstuff. Methods for quantitative measurements of monosaccharides after hydrolysis of the polymers are described by Scherz and Mergentaler (1980). The monosaccharides are analysed using thin-layer chromatography (TLC) or, after derivatisation, by gas chromatography. An anion-exchange liquid chromatography method coupled to pulse amperometric detection is described to determine quantitatively complex carbohydrates mixtures (neutral saccharides, aminosacharides, glucuronic acids and disaccharides) in nutritional products (Eberendu et al. 2005). A Fourier transform infrared spectroscopy (FTIR) method was developed for quality control of selected gums and gum mixtures used in the food industry (Prado et al., 2005). This method allows differentiation of tara, locust bean, tara and fenugreek gums. Quantification of individual gums in gum mixtures (0.5 15%, w/w) was possible. A method establishing protein profiles of several gums including tara gum, by capillary electrophoresis was applied to predict the content of tara gum in carob (locust) bean-tara gum mixture in samples (Ramis-Ramos et al., 2003). Identification of the gum constituents by thin layer chromatography is described in JECFA (2006). A reverse phase high-performance liquid chromatography (HPLC)/ultraviolet (UV) detection method was described for quantitative measurements of oligosides, mannose and galactose obtained by combined acid hydrolysis and enzymatic degradation of galactomannans (Tapie et al., 2008). 3.1.5. Stability of the substance, and reaction and fate in food No specific information on reaction and fate of tara gum in food was identified. Galactomannans are rapidly degraded in acidic aqueous solutions at elevated temperatures, resulting in a rapid loss of viscosity. They can also be degraded by oxidants and by microbial enzymes (mannanases). Galactomannans are rather stable under alkaline conditions (Ullmann, 2007). When heated to decomposition acrid smoke and irritating fumes are emitted (Sax, 1984). 3.2. Authorised uses and use levels Maximum levels of tara gum (E 417) have been defined in Annex II to Regulation (EC) No 1333/2008 on food additives, as amended. In this document, these levels are named maximum permitted levels (MPLs). Currently, tara gum (E 417) is an authorised food additive in the EU at quantum satis () in all food categories listed in Table 2. Tara gum (E 417) is included in the Group I of food additives authorised at. Table 2 summarises foods that are permitted to contain tara gum (E 417) and the corresponding MPLs as set by Annex II to Regulation (EC) No 1333/2008. Table 2: MPLs of tara gum (E 417) in foods according to the Annex II to Regulation (EC) No 1333/2008 Food category Food category name number 01.3 Unflavoured fermented milk products, heat-treated after fermentation E-number/ Group Group I Restrictions/exception MPL (mg/l or mg/kg as appropriate) 01.4 Flavoured fermented milk products Group I including heat treated products 01.6.3 Other creams Group I 01.7.1 Unripened cheese excluding Group I Except mozzarella products falling in category 16 01.7.5 Processed cheese Group I 01.7.6 Cheese products (excluding products falling in category 16) Group I www.efsa.europa.eu/efsajournal 14 EFSA Journal 2017;15(6):4863

Food category Food category name number 01.8 Dairy analogues, including beverage whiteners 02.2.2 Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/ 2007 and liquid emulsions E-number/ Group Group I Group I Restrictions/exception MPL (mg/l or mg/kg as appropriate) 02.3 Vegetable oil pan spray Group I 03 Edible ices Group I 04.2.1 Dried fruit and vegetables Group I E 417 may not be used to produce dehydrated foods intended to rehydrate on ingestion 04.2.2 Fruit and vegetables in vinegar, oil, Group I or brine 04.2.4.1 Fruit and vegetable preparations Group I excluding compote 04.2.5.4 Nut butters and nut spreads Group I 04.2.6 Processed potato products Group I 05.1 Cocoa and Chocolate products as covered by Directive 2000/36/EC 05.2 Other confectionery including breath refreshening microsweets Group I Group I Only energy-reduced or with no added sugar E 417 may not be used in jelly mini-cups, defined, for the purpose of this Regulation, as jelly confectionery of a firm consistence, contained in semi rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cups or minicapsule to project the confectionery into the mouth; E 417 may not be used to produce dehydrated foods intended to rehydrate on ingestion 05.3 Chewing gum Group I 05.4 Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4 Group I 06.2.2 Starches Group I 06.3 Breakfast cereals Group I 06.4.2 Dry pasta Group I Only gluten free and/or pasta intended for hypoproteic diets in accordance with Directive 2009/39/EC 06.4.4 Potato Gnocchi Group I Except fresh refrigerated potato gnocchi 06.4.5 Fillings of stuffed pasta (ravioli and Group I similar) 06.5 Noodles Group I 06.6 Batters Group I 06.7 Pre-cooked or processed cereals Group I www.efsa.europa.eu/efsajournal 15 EFSA Journal 2017;15(6):4863

Food category number Food category name E-number/ Group Restrictions/exception MPL (mg/l or mg/kg as appropriate) 07.1 Bread and rolls Group I Except products in 7.1.1 and 7.1.2 07.2 Fine bakery wares Group I 08.3.1 Non-heat-treated meat products Group I 08.3.2 Heat-treated meat products Group I Except foie gras, foie gras entier, blocs de foie gras, Libamaj, libamaj egeszben, libamaj t ombben 08.3.3 Casings and coatings and decorations for meat 09.2 Processed fish and fishery products including molluscs and crustaceans Group I Group I 09.3 Fish roe Group I Only processed fish roe 10.2 Processed eggs and egg products Group I 11.2 Other sugars and syrups Group I 12.1.2 Salt substitutes Group I 12.2.2 Seasonings and condiments Group I 12.3 Vinegars Group I 12.4 Mustard Group I 12.5 Soups and broths Group I 12.6 Sauces Group I 12.7 Salads and savoury-based Group I sandwich spreads 12.8 Yeast and yeast products Group I 12.9 Protein products, excluding Group I products covered in category 1.8 13.2 Dietary foods for special medical Group I purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) 13.3 Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) Group I 13.4 Foods suitable for people Group I Including dry pasta intolerant to gluten as defined by Regulation (EC) No 41/2009 14.1.2 Fruit juices as defined by Directive Group I Only vegetable juices 2001/112/EC and vegetable juices 14.1.3 Fruit nectars as defined by Group I Only vegetable nectars Directive 2001/112/EC and vegetable nectars and similar products 14.1.4 Flavoured drinks Group I 14.1.5.2 Other Group I Excluding unflavoured leaf tea; including flavoured instant coffee 14.2.3 Cider and perry Group I 14.2.4 Fruit wine and made wine Group I 14.2.5 Mead Group I www.efsa.europa.eu/efsajournal 16 EFSA Journal 2017;15(6):4863

Food category number Food category name E-number/ Group Restrictions/exception MPL (mg/l or mg/kg as appropriate) 14.2.6 Spirit drinks as defined in Group I Except whisky or whiskey Regulation (EC) No 110/2008 14.2.7.1 Aromatised wines Group I 14.2.7.2 Aromatised wine-based drinks Group I 14.2.7.3 Aromatised wine-product cocktails Group I 14.2.8 Other alcoholic drinks including Group I mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15% of alcohol 15.1 Potato-, cereal-, flour- or starchbased Group I snacks 15.2 Processed nuts Group I 16 Desserts excluding products covered in category 1, 3 and 4 Group I 17.1 (a) Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms 17.2 (a) Food supplements supplied in a liquid form 17.3 (a) Food supplements supplied in a syrup-type or chewable form 18 Processed foods not covered by categories 1 17, excluding foods for infants and young children According to Annex III, Part 2 of Regulation (EC) No 1333/2008, tara gum (E 417) is authorised as a food additive other than carriers in all food additive preparations at. According to Annex III, Part 3 of Regulation (EC) No 1333/2008, tara gum (E 417) is also authorised as a food additive in food enzymes with a maximum level in the products (beverages or not) at. In addition, according to Annex III, Part 4 of Regulation (EC) No 1333/2008, tara gum (E 417) is authorised as a food additive including carriers in all food flavourings at. Finally, according to Annex III, Part 5, Section A of Regulation (EC) No 1333/2008, tara gum (E 417) is also authorised as a food additive in all nutrients except nutrients intended to be used in foodstuffs for infants and young children listed in point 13.1 of Part E of Annex II. 3.3. Exposure data Group I Group I Group I Group I E 417 may not be used to produce dehydrated foods intended to rehydrate on ingestion MPL: maximum permitted level. (a): FCS 17 refers to food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council excluding food supplements for infants and young children 3.3.1. Reported use levels or data on analytical levels of tara gum (E 417) Most food additives in the EU are authorised at a specific MPL. However, a food additive may be used at a lower level than the MPL. Therefore, information on actual use levels was required for performing a more realistic exposure assessment, especially for those food additives for which no MPL is set and which were authorised according to. In the framework of Regulation (EC) No 1333/2008 on food additives and of Commission Regulation (EU) No 257/2010 regarding the re-evaluation of approved food additives, EFSA issued public calls 8,9 for occurrence data (usage level and/or concentration data) on tara gum (E 417). In response to this public call, updated information on the actual use levels of tara gum (E 417) in foods 8 http://www.efsa.europa.eu/sites/default/files/consultation/ans091123.pdf 9 http://www.efsa.europa.eu/sites/default/files/consultation/140310.pdf www.efsa.europa.eu/efsajournal 17 EFSA Journal 2017;15(6):4863