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Your current position:China ChuangLian Edible Gum Website » Legislation » Re-evaluation of xanthan gum (E 415) as a food additive

  • Re-evaluation of xanthan gum (E 415) as a food additive
  • Source:EFSA(European food safety authority)        Jul 17,2017         556
    【Summary】

    The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of xanthan gum (E 415) as food additive. 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. Based on the reported use levels, a refined exposure of up to 64 mg/kg bw per day in children for the general population, 38 mg/kg bw per day for children consumers only of food supplements at the high level exposure and 115 mg/kg bw per day for infants consuming foods for special medical purposes and special formulae (FSMPs), were estimated. Xanthan gum (E 415) 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 chronic and carcinogenicity studies and there is no concern with respect to the genotoxicity

    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 xanthan gum (E 415) when used as a food additive.

    Xanthan gum (E 415) 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.

    Xanthan gum is a high molecular weight polysaccharide produced by a pure-culture fermentation of a carbohydrate with strains of Xanthomonas campestris.

    The xanthan gum polysaccharide consists of a backbone of β-(1→4) linked d-glucose molecules. Every second glucose molecule is substituted at C3 with a trisaccharide side chain consisting of β-d-mannose-(1→4)-β-d-glucuronic acid-(1→2)-α-d-mannose. In the side chains, the terminal mannose moiety is partially substituted with a pyruvate residue linked as an acetal to the 4- and 6-positions; the internal mannose unit is acetylated at C-6.

    The Panel noted that uses of xanthan gum (E 415) as a food additive according to Annex II and III of Regulation (EC) No 1333/2008, include uses in food for infants under the age of 12 weeks. The Panel considered that these uses would require a specific risk assessment. Therefore, the current re-evaluation of xanthan gum (E 415) as a food additive is not considered to be applicable for infants under the age of 12 weeks.

    Specific purity criteria on xanthan gum (E 415) have been defined in Commission Regulation (EU) No 231/2012 and by JECFA (2006).

    According to the industry, during the fermentation process, the bacteria produce enzymes (i.e. amylases, cellulases or protease) which are reduced as much as possible or deactivated throughout the manufacturing process.

    The Panel noted that limits for possible residual bacterial enzymatic activities may be required in the EU specifications.

    An important property of xanthan solutions is the physicochemical interaction with plant galactomannans, such as locust bean gum and guar gum, or konjac glucomannan. The addition of any of these gums to a solution of xanthan gum at room temperature causes a synergistic increase in viscosity (Tako, 1992; Copetti et al., 1997; García-Ochoa et al., 2000).

    The Panel noted that in cases, where xanthan gum (E 415) is added in combination with other gums, such as locust bean gum (E 410), guar gum (E 412) or konjac glucomannan (E 425 (ii)) to food, the synergistic increase in viscosity has to be taken into consideration. This may be relevant in particular for the above mentioned combined uses of xanthan gum and guar gum in infant food for special medical purposes (see Section 1.2).

    An interested party has provided information on the content of lead (ND–2.0 mg/kg), arsenic (ND–2 mg/kg), cadmium (ND–0.1 mg/kg) and mercury (ND–1 mg/kg) in xanthan gum. According to the European Commission specifications, impurities of the toxic element lead are accepted up to concentration of 2 mg/kg.

    The Panel noted that toxicological studies with an alginate-konjac-xanthan polysaccharide complex, called PGX, were available for its evaluation as novel food by the EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel, 2017). The EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS Panel) did not consider results of these studies in its re-evaluation of the individual substance xanthan gum (E 415). It is not possible to conclude to what extent are the reported effects attributable to one of the individual components of the complex. The physicochemical properties of the individual components might also have changed during the manufacturing process of PGX.

    Studies on the in vitro degradation and the in vivo digestibility of xanthan gum performed in animals and humans have demonstrated that xanthan gum would not be absorbed intact and would not be metabolised by enzymes present in the gastrointestinal tract. However, it would be partially fermented during its passage through the large intestine by the action of the intestinal tract microbiota.

    Xanthan gum (E 415) can be regarded as non-toxic based on the results of acute oral toxicity studies.

    From short-term and subchronic toxicity studies, no toxicological relevant changes were reported apart from a decrease in red blood cell count and haemoglobin concentration in dogs receiving 2,000 mg/kg body weight (bw) per day for 12 weeks. This effect was marginal and it was not reproduced in a dog chronic toxicity study at 1,000 mg/kg bw per day, the highest dose tested. The Panel noted that decreased total serum cholesterol was frequently reported.

    For genotoxicity, insufficient experimental data were available. However, taking into account the information on structure–activity relationships and considering that xanthan gum has a molecular weight far above the threshold for absorption, according to absorption, distribution, metabolism, and excretion (ADME) data, it was not degraded in the intestine and is slightly fermented to non-hazardous short-chain fatty acids by the gut microbiota, the Panel concluded that xanthan gum (E 415) does not give rise to concerns for genotoxicity.

    In chronic and long-term studies, no adverse effects, including biochemical and haematological parameters, were reported in dogs and rats. The Panel noted that decreased red blood cell counts reported in a subchronic toxicity study in dogs receiving 2,000 mg/kg bw per day at 6 and 12 weeks, effect which was marginal and not reproduced in a dog chronic toxicity study at 1,000 mg/kg bw per day for 107 weeks, the highest dose tested.

    Dietary feeding of xanthan gum at levels of 0 (control), 250 and 500 mg/kg bw per day to groups of albino rats of both sexes during a three-generation reproduction study had no adverse effect on reproduction as judged by all the endpoints evaluated. No prenatal developmental toxicity studies were available to the Panel.

    In special studies in neonatal piglets, no test substance-related effects in haematology or clinical chemistry parameters were observed at any dose. In the high-dose group (3,750 mg/kg bw per day) histopathological findings rated from minimal to moderate were observed in the large intestine (caecum, colon, rectum) and small intestine (duodenum). These effects were observed in fewer animals in the lower dose groups (375 and 750 mg/kg bw per day) and the severity was considered minimal. The Panel considered the no-observed-effect-level (NOEL) for xanthan gum in neonatal piglets to be 375 mg/kg bw per day, based on the changes of the faeces (green, soft, watery, increased defaecation) in the mid-dose and high dose group, and the no-observed-adverse-effect-level (NOAEL) was 750 mg/kg bw per day based on histopathological changes in the intestine in the high dose.

    From a human study with repeated intake ranging from 10.4 to 12.9 g of xanthan gum per day (assuming a body weight of 70 kg corresponding to 149–184 mg/kg bw per day), it was reported that xanthan gum acts as a bulk laxative causing no adverse dietary nor physiological effects. The only effects observed were moderate (10%) reduction in serum cholesterol (p < 0.05) and a significant increase in faecal bile acid concentrations (p < 0.05) (Eastwood et al., 1987).

    A study investigating the effect of repeated intake of 15 g xanthan gum/day (assuming a body weight of 70 kg corresponding to 214 mg/kg bw per day) on colonic function showed significant increases in stool output (p < 0.01), frequency of defecation (p < 0.05) and flatulence (p < 0.01) due to the ingestion of the xanthan gum (Daly et al., 1993).

    In clinical studies involving infants, the Panel noted that consumption of xanthan gum in infant formula or formula for special medical purposes in infant was well tolerated, did not influence minerals (Ca, P, Mg), fat and nitrogen balance and did not affect growth characteristics up to concentration of 1,500 mg/L (232 mg/kg bw per day). These results were supported by the outcome of the post-marketing surveillance with formulae containing xanthan gum at a concentration of approximately 750 mg/L of reconstituted formula.

    The present re-evaluation considered the use of xanthan gum (E 415) in foods for infants from 12 weeks of age onwards and for young children.

    Concerning uses of xanthan gum in food for infants and young children the Panel concurs with the SCF (1999) ‘…that it is prudent to keep the number of additives used in foods for infants and young children to the minimum necessary. The Committee has stressed in the past that there should be strong evidence of need as well as safety before additives can be regarded as acceptable for use in infant formulae and foods for infants and young children’.Xanthan gum (E 415) is authorised in a wide range of foods. The Panel did not identify brand loyalty to a specific food category and therefore the Panel considered that the non-brand-loyal scenario covering the general population was the more appropriate and realistic scenario for risk characterisation because it is assumed that the population would probably be exposed long-term to the food additive present at the mean reported use in processed food.

    A refined estimated exposure assessment scenario taking into account the food for special medical purpose for infants and young children, for consumers only, was also performed to estimate exposure for infants and toddlers who may be on a specific diet. Considering that this diet is required due to specific needs, it is assumed that consumers are loyal to the food brand, therefore only the refined brand-loyal estimated exposure scenario was performed.

    A refined estimated 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.

    For the general population 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:

    • from all the data received, data were adequate for a refined exposure assessment for 25 out of 79 food categories;
    • based on the reported use levels, a refined exposure (non-brand-loyal scenario) of up to 64 mg/kg bw per day in children (3–9 years) was estimated;
    • refined exposure assessments for consumers only of food supplements was also calculated and was up to 38 mg/kg bw per day for children (3–9 years) considering high level exposure (95th percentile);
    • xanthan gum is unlikely to be absorbed intact and is expected to be partially fermented by intestinal microbiota;
    • adequate toxicity data were available;
    • there was no concern with respect to genotoxicity;
    • no adverse effects were reported in chronic studies in rats and dogs up to 1,000 mg/kg bw per day, the highest dose tested. In rats, the compound was not carcinogenic;
    • repeated oral intake by adults of large amounts of xanthan gum up to 15,000 mg/person per day, corresponding to 214 mg/kg bw per day for at least ten days was well tolerated, but some individuals experienced abdominal discomfort, which was considered by the Panel as undesirable but not adverse;
    • the Panel concluded that there is no need for a numerical ADI for xanthan gum (E 415), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of xanthan gum (E 415) as a food additive.

    For infants and young children consuming foods for special medical purposes and special formulae, concerning the use of xanthan gum (E 415) in ‘dietary foods for special medical purposes and special formulae for infants’ (Food category 13.1.5.1) and in ‘dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC’ (Food category 13.1.5.2), and given that:

    • for populations consuming foods for special medical purposes and special formulae, the highest refined exposure estimates (p95) on the maximum reported data from food industry (750 mg/L for categories 13.1.5.1 and 250 mg/L for 13.1.5.2) were up to 115 mg/kg bw per day for infants (12 weeks–11 months, brand loyal scenario);

    • in a number of clinical studies, consumption of xanthan gum in infant formula or formula for special medical purposes in infant was well tolerated up to concentration of 1,500 mg/L (232 mg/kg bw per day);
    • no cases of adverse effects were reported from post-marketing surveillance with formulae containing xanthan gum at a concentration of approximately of 750 mg/L of reconstituted formula which supported the results of the clinical studies;

    the Panel concluded, that there is no safety concern from the use of xanthan gum (E 415) in foods for special medical purposes consumed by infants and young children at concentrations reported by the food industry.

    The Panel recommended:

    • the European Commission to considers revising the current limit for toxic element lead in the European Commission specification for xanthan gum (E 415) and adding limits for the impurities of the other toxic elements mercury, cadmium and arsenic in order to ensure that xanthan gum (E 415) as a food additive will not be a significant source of exposure to these toxic elements in food;

    • due to the discrepancies observed between the data reported from industry and the Mintel database, where xanthan gum is labelled in more products than in food categories for which data were reported from industry, the Panel recommended collection of data on usage and use levels of xanthan gum (E 415) in order to perform a more realistic exposure assessment.

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