On May 16, 2016, Japan’s Ministry of Health, Labor and Welfare (MHLW) notified the World Trade Organization (WTO) of food additive proposals for calcium carbonate and magnesium stearate in various foods. It entered into force after the proposal was issued.
Calcium carbonate (CaCO3) is carbonic salt of calcium and abundant in nature. It is the main component of stone, the shell of marine animals, and shell eggs. To produce for commercial production, CaCO3 is obtained from ground limestone or by the precipitation of calcium ions with carbonate ions. There are many applications of CaCO3 as a food additive with different purposes including as a dietary supplement, dough conditioner, pH control agent, modifier, stabilizer, and texturizing agent for chewing gum. Magnesium stearate (MgSt) is a magnesium salt of stearic acid, which is widely used as a lubricant for tablets, capsules and powders in the pharmaceutical industry. Furthermore, it is also used to bind sugar in hard candies, such as mints, and is a common ingredient in baby formulas.
As a result of the low toxicity of CaCO3 and MgSt for humans, according to the report written by the Joint FAO/WHO Expert Committee on Food Additive (JECFA), it is not necessary to specify an acceptable daily intake (ADI). The US Food and Drug Administration (US FDA) has approved both ingredients as generally recognized as safe substances (GRAS). Maximum levels of use for these compounds for food products in the US and Canada are included under Good Manufacturing Practice (GMP), but, their usage for foods in Japan was restricted. Recently, Japanese regulations have been changed and the World Trade Organization notified. Japan’s revised and current regulations for CaCO3 and MgSt ,  are compared and shown in Table 1.
|Compounds||Current regulation||Revised regulation|
|Calcium carbonate (CaCO3)||
Allowed under the circumstance that is indispensable in the production and processing of foods or for nutritive purposes.
Maximum use limit (as calcium) is 10% by weight in chewing gum and 0.1% in other foods.
These limits are not applied to foods labeled as “special dietary use”.
|Does not set a restriction in foods.|
|Magnesium stearate||Permitted use only in capsule and tablet-form foods with health claim.||Expanded for foods, not in conventional forms (capsule, tablet forms, and tablet confectionaries with health claim).|
What do the changes mean?
This update has the potential to affect food manufacturers. The use of calcium carbonate and magnesium stearate in foods destined for Japan must follow Japanese regulations. When complying with food safety regulations food producers should seek professional advice.
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