SAFEGUARDS | Food NO.089/17
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.
SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, improve food safety and quality. For more information, please visit our website: www.foodsafety.sgs.com
For enquiries, please contact:
Global Competence Support Centre Food Specialist
t: +66 2683 0541 ext 2423
Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!
© SGS Group Management SA - 2017 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.