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ENI’s Myrtillex™ Bilberry extract is made from the fruit of the small European blueberry, Vaccinium myrtillus. Its highly concentrated extracts have been widely used in Europe and the US for decades, for its benefits in addressing ocular, microcirculatory and vascular related disorders.

Benefits of Bilberry

Though studies have shown vascular and circulatory benefits, the main focus of Bilberry use has been for the support of eye health. In the American Botanical Council Clinical Guide to Herbs, Mark Blumenthal et al outline 15 studies, ‘Clinical Studies on Bilberry’. All but one of these demonstrated positive effects for indications including ocular conditions (night/day vision and retinopathy), and vascular conditions including venous insufficiency and micro- and macro peripheral circulation [1-2].

Quality Concerns

Bilberry extracts are generally standardized to their anthocyanins, a group of water-soluble pigments that are responsible for the red, purple, blue and violet colors in many fruits and flowers.

Because of the high concentration required for Bilberry extracts (100:1), the tight supply of fresh bilberry material, and the process involved in manufacturing a consistent grade of material, Bilberry is one of the most expensive extracts in regular use for botanical based supplements.

Blueberries

For many years a UV test method was considered satisfactory to quantify the anthocyanin levels in Bilberry extracts. This method uses Ultra Violet light to detect and quantify the range of color compounds that are present in the bilberry anthocyanins. However it is not specific enough to detect the presence of anthocyanins from other plant sources or synthetic dyes that are added to deceive the UV system.

Thus adulteration has been found in many Bilberry samples approved by the UV method. In these cases, adulterants had been added to either make poor quality bilberry look more potent, or to make fake bilberry look potent and real. The addition of only a small amount of adulterant can make the extract significantly less expensive to manufacture.

The following typical methods of adulteration have been identified:

  • Azo dyes (synthetic) have been used to spike the results given for total anthocyanin content measured in Bilberry extract. The European Union views one of the illegal Azo dyes (Sudan I) as both genotoxic and carcinogenic. Mandatory testing for Azo dyes in spices and processed foods has passed into European law [3].
  • Other adulterants used are from plant compounds that are high in anthocyanin levels include: mulberry (Morus nigra), black bean skins, blueberry, etc.

Because UV does not distinguish between the different forms of anthocyanins (but only determines a total), these spiked materials pass the test for total anthocyanin or total anthocyanidin by UV.

Quality solutions

Because the UV spectrometer has proven unreliable for Bilberry testing, Indena developed a high-performance liquid chromatography (HPLC) method to verify the anthocyanin profile and the concentrations of various Anthocyanins found in bilberry. This test can thus distinguish between genuine and adulterated Bilberry material.

Myrtillex™ and Quality Validation

ENI’s Myrtillex™ Bilberry extract is produced exclusively from European origin bilberry. Customized identity testing, plus USP-HPLC analysis is conducted to verify the botanical identity and quantity of each anthocyanin and anthocyanidin in the extract. This USP-HPLC test is specific to each anthocyanin and rules out potentially adulterated material.

Good Manufacturing Practices (GMP), thorough supply chain management, unique process and standardization of active principals in the product ensure that all batches of Myrtillex™ Bilberry extract meet specifications

For complete information on quality concerns and testing of Bilberry extracts, please go to/click on:
Myrtillex™ Bilberry Extract PhytoReport

 

References::
[1] Muth, E. R. et al. (2000) The effect of bilberry nutritional supplementation on night visual acuity and contrast sensitivity. Altern Med Rev 5(2), 164–73.
[2] Neumann L. (1973). Long-term therapy of vascular permeability disorders using anthocyanosides. Munch Med Wochenschr 115, 952–4.
[3] Gafner, S. (2015). Bilberry Extract Adulteration Laboratory Guidance Document. ABC-AHP-NCNPR Botanical Adulterants Program. Retrieved on 8/31/21 from https://www.herbalgram.org/resources/botanical-adulterants-prevention-program/adulterants-bulletins/bilberry-extract-bulletin-april-2016

 

Ethical Naturals Inc., is certified to comply with NSF GMP Registration Program Requirements of NSF/ANSI 173, Section 8 which includes FSMA and cGMP (21 CFR 111), (21 CFR 117).

 
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