Calcium Lactate Gluconate

Calcium lactate gluconate is a mixture of calcium gluconate and calcium lactate, it can be used in both pharmaceuticals and food applications, according to the regulations for the individual salts.

In Europe, calcium lactate (E327) and calcium gluconate (E578) are listed as generally permitted food additives and may be added to all foodstuffs, following the "quantum satis" principle as regulated in EU Regulation (EC) No. 1333/2008 (Annex 2), as long as no special regulations restricts the use.These salts are also allowed in food supplements (Directive 2002/46/EC) and in foods for particular nutritional uses (Directive 2001/15/EC). In addition to existing national allowances in some countries, calcium gluconate and calcium lactate are on the positive list of the new Regulation (EC) No. 1925/2006 on food fortification. It is listed as mineral salt in the EU Regulation (EC) No. 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

The US Food and Drug Administration (FDA) affirmed calcium lactate and calcium gluconate as generally recognised as safe GRAS (generally recognized as safe) food substances and permitted the use in food with specific uses and limits (where relevant) under good manufacturing practice. Calcium lactate is listed in 21 CFR §184.1207, calcium gluconate in 21 CFR §184.1199. Moreover, calcium lactate gluconate is self-affirmed GRAS as a flavouring agent in beverage, beverage powders and dairy alternatives at a level up to 0.25 %.