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Zeomic is approved by FDA (the U.S. Food and Drug Administration).


Approval No.: FCN000047

Zeomic's safety is also proved by FDA.

FDA has approved a pending application of an inorganic antimicrobial agent "Zeomic" seeking approval as a food contact substance.

This is the first successful inorganic antimicrobial agent applied for FDA approval by a Japanese company, and it is now legal to use Zeomic in synthetic resin for all kinds of food packaging materials used in the U.S. such as wrappings, bottles, films and trays as well as resin materials used for chopping boards and belt conveyers employed in manufacturing processes.

It can be used as an additive to resin for any food application up to 5% in weight for all of the nine food types by FDA classification, which are by far favorable conditions proving its safety when compared with other additives, because it can be used in a much larger quantity and in almost every food packaging form.

We are also the only inorganic antimicrobial agent manufacturer who has chronic toxicity data confirming its product safety at a drug-level of confidence in Japan.

In the U.S. we obtained from EPA (U.S. Environmental Protection Agency) a permit to manufacture and sell Zeomic as an antimicrobial agent in May 1999 and then from NSF (the National Sanitation Foundation) authorization for use in water treatment units. Thus, Zeomic is acknowledged widely in Japan as well as overseas.

The recent FDA approval of Zeomic means that the U.S. government has recognized it as a highly safe antimicrobial agent, or in other words, its safety and antimicrobial effect has been proved by another reliable authority. Zeomic's approval in the U.S., where demand is growing for inorganic microbial agents, which have less impacts on the environment and human bodies by comparison with organic antimicrobial agents, for food-contact use, for which the use of antimicrobials is strictly regulated, has opened the door to business with antimicrobial articles containing Zeomic in the food packaging area not only in the U.S. but also in the world including the Japanese market.

Applicable food packaging forms (all categories)

  1. High temperature heat-sterilized
  2. Boiling water sterilized.
  3. Hot filled or pasteurized (above 150 deg.F.)
  4. Hot filled or pasteurized (below 150 deg.F.)
  5. Room temperature filled and stored (no thermal treatment in the container).
  6. Refrigerated storage (no thermal treatment in the container).
  7. Frozen storage (no thermal treatment in the container).
  8. Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use.

9 food types used by FDA

  1. Nonacid, aqueous products (pH above 5.0)
  2. Acid, aqueous products; including oil-in-water emulsions
  3. Aqueous, acid or nonacid products containing free oil or fat
  4. Dairy products and modifications: Water-in-oil emulsions, Oil-in-water emulsions
  5. Low-moisture fats and oil
  6. Beverages: Containing more than 8 percent alcohol, Containing up to 8 percent of alcohol, Nonalcoholic
  7. Bakery products: Moist bakery products with surface containing free fat or oil, Moist bakery products with surface containing no free fat or oil
  8. Dry solids with the surface containing no free fat or oil
  9. Dry solids with the surface containing free fat or oil

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