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Gluconate is an oxidative metabolite of glucose best known to occur in microorganisms, but also occurring in mammals (Rezzi, et al., 2009). Glucose is oxidized to gluconate by glucose 1-dehydrogenase, which occurs in mammalian tissues (Harrison, 1932). Gluconate enters the pentose phosphate pathway via conversion to 6-phosphogluconate, a metabolic route of glucose catabolism. The formation of 6-phosphogluconate from exogenous gluconate has been demonstrated in mammals, demonstrating mammalian enzymatic capabilities for metabolizing gluconate (Leder, 1957; Hakim & Moss, 1974). Gluconokinase is the enzyme responsible for catalyzing the phosphorylation of gluconate to 6-phosphogluconate and has been identified in mammalian tissues, such as the brain and kidneys (Hakim & Moss, 1974). Thus, gluconate occurs endogenously from the oxidative metabolism of glucose and is utilized in a well-known biochemical pathway (the pentose phosphate pathway) of glucose catabolsim via the action of gluconokinase. Considering that gluconate is an endogenously occurring compound that is utilized by the body in a normal physiological process, studies addressing the mutagenicity/genotoxicity of gluconate are not deemed necessary as it is expected that the compound is not mutagenic/genotoxic.

 

Finally, D-gluconic acid (E 574) / D-glucono-1,5 lactone (E 575) are permitted food additives under European Union law and can be used without restrictions according to the ‘quantum satis’ principle according to Commission Regulation 1129/2011 amending Annex II to Regulation 1333/2008 by establishing a Union list of food additives. Commission Regulation 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation 1333/2008 sets out the purity criteria to be respected.  The substance(s) have in the past been assessed for their safety by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1999http://www.inchem.org/documents/jecfa/jecmono/v042je12.htmand found as safe.  The ADI (Acceptable Daily Intake) was set as ‘not specified’

Reference List:

Hakim, A. & Moss, G., 1974. The effect of ether anesthesia on cerebral glucose metabolism - The pentose phosphate pathway. Anesthesiology, 34(3), pp. 261-267.

Harrison, D., 1932. The product of the oxidation of glucose by glucose dehydrogenase. Biochem J, 26(4), pp. 1295-1299.

Leder, I., 1957. Hog kidney gluconokinase. J Biol chem, Volume 255, pp. 125-136.

Rezzi, S. et al., 2009. Metabolic shifts due to long-term caloric restrion revealed in nonhuman primates. Exp Gerontol, 44(5), pp. 356-372.


Short description of key information:
Considering that gluconate is an endogenously occurring compound that is utilized by the body in a normal physiological process, studies addressing the mutagenicity/genotoxicity of gluconate are not deemed necessary as it is expected that the compound is not mutagenic/genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.