AstaREAL® News - AstaREAL Sets USP FCC World-Class Monograph Standards for Natural Astaxanthin

What is Astaxanthin | About AstaREAL astaxanthin
AstaReal Newsletter header

Vol. 1 .06.2012

AstaREAL® Sets USP FCC World-Class Monograph Standards for Natural Astaxanthin

"Setting an example is not the main means of influencing another, it is the only means"

Albert Einstein

A Food Chemicals Codex (FCC) monograph for microalga Haematococcus pluvialis derived Astaxanthin esters has been published in the third supplement of the USP FCC 7th Edition in 2011 and incorporated into the monograph of USP FCC 8th Edition in 2012.

This new set of reference standard has been developed through an open and transparent process by collecting opinion and data from independent experts and companies in food industry via FCC forum since 2009.

The USP FCC monograph contains specifications and test methods of natural Astaxanthin esters, heavy metal, pheophorbide impurities, and label requirements which are helpful to all manufacturers in health food industry. The monograph will also help to:

1. Differentiate between Astaxanthin esters from Haematococcus pluvialis microalga and other sources such as Krill oil, Xanthophyllomyces dendrohous (Phaffia yeast) and synthetic Astaxanthin.

2. Provides international specifications to help ensure identity, purity and consistency of Haematococcus pluvialis derived natural astaxanthin esters.

3. Protects food industry against low quality and potentially adulterated products, thereby helping to ensure the highest safety for consumers.

Currently, AstaReal is also supporting development of USP Astaxanthin esters monograph in the Dietary Supplements Compendium.

"Being a pioneer and leader in Astaxanthin research and production, it was natural for USP FCC scientific committee to choose AstaREAL® as a reference material to develop this important monograph. We are honored to have received this attention and recognition"

Mitsunori Nishida, President and CEO of AstaReal and Fuji Group

The development of Astaxanthin monographs is the response of regulatory authorities to global recognition and increasing demand of natural Astaxanthin worldwide. By supporting the development of Astaxanthin monographs, we again reaffirm our commitment to quality and safety of AstaREAL® branded Astaxanthin to our customers worldwide.

In 2010, AstaREAL® Astaxanthin esters extracted from Haematococcus pluvialis microalgae had been concluded as safe for human (GRAS or Generally Recognized as Safe). This is because the clinical database for AstaREAL® safety studies includes nearly 30 human studies with more than 900 subjects undergoing treatments lasting from 2 weeks to 6 months. The doses used in these trials ranged from 2mg up to 45 mg/person/day. The trials were designed to investigate the safety and tolerance for AstaREAL® astaxanthin using different doses, treatment periods, research design and demographic variables including age, gender and ethnicity. All studies revealed No Observed Adverse Effect Level (NOAEL) based on hematological, serum chemistry, urine analysis, self-report questionnaires and eye intraocular pressure (review on Kajita et al., 2010).

Today, USP standards are used in more than 130 countries around the world. Some international regulatory authorities and governments have incorporated the standards into their laws and regulatory provisions to help protect the quality of products and ingredients produced in or exported to their countries.

http://www.usp.org/about-usp/legal-recognition

Astaxanthin

Astaxanthin is often called the King of Carotenoid because its antioxidant potency against singlet oxygen has been estimated to be 110 times stronger than Vitamin E; 75 times stronger than a-lipoic acid; 560 times stronger than green tea; 800 times stronger than CoQ10 and 6,000 times stronger than Vitamin C (Nishida, 2007). Astaxanthin orginal molecular structure spans the membrane hydrophllic and hydrophobic layers attracting and then quenching free radicals.

AstaREAL® is a trademark or registered trademark of Fuji Chemical Industry Co., Ltd in Japan, United States of America, Europe and/or other countries.

To ensure to receive this newsletter in your inbox, please add international@astareal.co.jp to your address book.

The information found in this publication is presented in good faith with no guarantee or obligation as to accuracy and no assumption of liability. Users should make their own tests to determine the suitability of these products for their own particular purposes. However, because of numerous factors affecting results, Fuji Chemical Industry makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose other than the material conforms to its applicable current standard specifications. Statements concerning the use of the products or formulations described herein are not to be construed as recommending the infringement of any patent and seller assumes no liability for the infringement arising out of such use.