Japans Nutraceuticals Today - CoQ10, GMP and FOSHU Update

薬食同源 Japan’s Nutraceuticals Today

By Paul Yamaguchi

CoQ10, GMP and FOSHU Update

Japanese Manufacturers Are Rushing To Meet the World Demand for CoQ10

Worldwide consumption for CoQ10 in 2004 was estimated to be about 140-150 metric tons annually, with almost 90 percent of the supply coming from Japan. United States is the largest market for CoQ10, and in 2004 it consumed about 110 metric tons. Since CoQ10 has been deregulated from a drug to food in 2001, the Japanese market has rapidly expanded and created a worldwide shortage. In 2004, Japanese consumed almost 30 metric tons. Since other Japanese manufacturers increased their production of CoQ10, the shortage has been somewhat eased now, but worldwide demand for CoQ10 continues to increase at a rate of 20-25 percent per year, as other Asian countries are soon going to deregulate the ingredient.

Kaneka (www.kaneka.co.jp) has been the largest supplier of CoQ10 since 1977. Currently Kaneka produces 150 tons a year and is going to increase its capacity to 180 tons a year by October 2006. In addition, Kaneka announced plans to build a new plant in Texas to produce an additional 100 metric tons per year to meet the demand for US and European consumers.

Other Japanese CoQ10 manufacturers have also announced production increases. Japan’s number two CoQ10 supplier, Nihhin Pharma (www.nisshin.com) has started to supply highly concentrated, water-soluble CoQ10 powder, mostly for the Japanese market. Mitsubishi Gas Chemical, another CoQ10 producer, has announced plans to build a new plant capable of producing 40 metric tons per year. They expect to begin production in 2006. Other suppliers Kyowa (www.kyowa.co.jp) and Asahi Kaesi Pharma are concentrating on developing their own line of value-added CoQ10 products for Japanese market.

It will take a little while for the capacity to meet the increasing worldwide demand for CoQ10. Kaneka and Nisshin Pharma continue to concentrate on overseas markets and the other three manufacturers are focusing more on domestic markets while keeping an eye on other Asian markets. If current demand growth continues, by 2010, the world consumption of CoQ10 will reach approximately 400 metric tons per year and the Japanese are going to supply about 300 metric tons. China, Taiwan and other countries will have to fill in the balance.

Japan Coenzyme Q Association Approved 10 Products

The Japan Coenzyme Q Association (www.coenzymeq-jp.com) (JCQA) has approved 10 products from 7 companies which meet the organization’s standard for safety, quality and other specifications. JCQA has been a sister organization of the International Coenzyme Q 10 Association (Wayne, PA) since November 2002. In June 2005, JCQA started a program of CoQ10 certification and this is their first group of products to comply with their standards. Products must be produced from GMP- or ISO-approved factories and must contain a minimum of 30mg of CoQ10 in a capsule or a tablet. Approved products are not limited to dietary supplements but can also be for food and beverages applications. One of the approved products this particular time was a beverage from Coca Cola Japan, (www.cocacola.co.jp) called Coca Cola Coenzyme Q10. It contains 60mg of CoQ10, L-Carnitine and vitamin C.

JCQA issues its logo for use on approved products to organizations who comply with their standards.

(JCQA’s Approved Logo)

Two Organizations Agreed; 300 mg per day is the Maximum

Two Japanese organizations; Japan Health & Nutrition Food Association (JHNFA) (www.jhnfa.org) and Japan Coenzyme Q Association (JCQA) have agreed on the maximum daily safe consumption of CoQ10.

Since November of 2003, the MHLW [Ministry of Health, Labor and Welfare] has been asking JHNFA for a study on the maximum amount of daily intake for CoQ10. In August this year, the organization came to the conclusion that 300 mg is a reasonably safe maximum amount, and reported its findings to the MHLW. In September, JCQA announced that it supports JHNFA’s findings. Questions still remain regarding whether 300 mg is truly the safe amount. For drug use, 30 mg of CoQ10 is considered the maximum and typically, supplements should not exceed the amount set for drug usage by MHLW. Sources suggest that the MHLW may announce the official maximum safety amount of daily CoQ10 consumption by the end of the year.

Two Organizations Spearhead a GMP Certification Program

JHNFA (Japan Health Food & Nutrition Food Association) and a newly formed Japanese Institute for Health Food Standards (JIHFS) (www.jihfs.com) have founded a GMP (Good Manufacturing Practices) certification program. The GMP for health foods and dietary supplements were adapted from drug manufacturing safety standards to meet MHLW’s FOSHU (Foods for Specified Health Uses) manufacturing standards. They are not a requirement for non-FOSHU products manufacturers yet, but increasing creditability and developing a competitive manufacturing environment (especially among contract manufacturers) will eventually lead to implementation of GMP into non-FOSHU manufacturers’ plants.

Both programs are based upon third party inspections and the organization’s own audits and evaluation of their respective GMP programs. So far, JHNFA has approved 3 plants and JIHFA has approved one. JIHFS allows its JIHFS GMP logo to be used on products made by approved manufacturers.

(JIHFS’s GMP Approved Logo)

Standardized FOSHU Begins

In February 2005, a new FOSHU (Foods for Specified Health Uses) regulation was implemented. The new FOSHU was designed to increase the number of approved functional foods with health claims and supplements. MHLW has adopted three new categories into FOSHU. One of the new categories is Standardized FOSHU, meaning, if the product meets FOSHU standards set by the MHLW (Ministry of Health, Labor and Welfare) and includes a MHLW-approved ingredient, it can go through a faster approval process.

In July 2005, MHLW published a list of ingredients that have been approved for the new Standardized FOSHU. They are 3 dietary fiber and 6 oligosaccharides products. The list includes: Dietary fibers: Indigestible dextrin, Polydextrose and Guar gum disintegrate. Oligosaccharides: Soy, Fructo, Galacto, Lactosucrose, Xylo, and Isomalulose oligosacchrides.

If the product contains one of the above ingredients and meets the FOSHU product standard, it takes only 3 months, instead of one or two years to get approval and the cost is far less than the normal $1 million or more.

So far this year 63 products have been approved and the total of FOSHU approved products is now 537, with retail volume of about $6.3 billion (estimate).

Paul Yamaguchi is president of Paul Yamaguchi & Associates, Inc., Tarrytown, NY.
His company publishes a number of Japanese nutrition market reports. His latest report is Nutritional Supplement Japan 2005, Inside of $11.1 billion Japanese dietary supplement market. Other report is Functional Foods and FOSHU Japan 2004, Market & Product Report.

For details and information on the reports, visit: http://www.functionalfoodsjapan.com/ or contact Paul at [email protected]
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