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UL Solutions GMP Certified
BioNatal LLC’s manufacturing and packaging of Black Seed Oil as a dietary supplement has been independently assessed by UL Solutions for conformance with applicable Good Manufacturing Practice and quality-system requirements, including 21 CFR Part 111 and the Natural Products Association GMP Standard for Dietary Supplements.
Phytosanitary Certificate
This Phytosanitary Certificate is posted as a sample to show BioNatal LLC imports its seeds directly from Ethiopia. This certificate is for your reference only
and is not updated.
BioNatal LLC is a direct importer of the best and richest Nigella Sativa seeds from Ethiopia. This Certificate issued by Ethiopian Agricultural Authority for Customs purposes in the United States and FDA. This Certificate is direct confirmation that BioNatal LLC uses Nigella Sativa seeds for the black seed oil production of Ethiopian origin. Also, this certificate is confirming the 99% of seeds purity through the Sortex system and freshness of the crop.
Certificate of Analysis: Thymoquinone and Volatile Oils
BioNatal LLC tests its black seed oil through Eurofins to measure thymoquinone (TQ) and volatile oil content, along with other quality parameters. The attached Certificate of Analysis provides an example of some of the testing we conduct and shows the results for the batch tested. Results vary by batch, and this certificate does not represent the potency of every bottle.
Since August 2018, BioNatal has submitted Nigella sativa seeds from different Ethiopian farms to U.S. laboratories for analysis. This research guides our sourcing decisions and helps us select seeds from farms with a demonstrated history of strong TQ and volatile oil results. We continue working with our farming partners in Ethiopia to maintain consistent seed quality.
Certificate of Analysis: Final Highest Thymoquinone (TQ)
In 2022 BioNatal owners with the help of United States farmers was able to collect information of the geographical and weather conditions that may help Nigella Sativa flowers to create higher Thymoquinone level in the seeds. Based on this information BioNatal got the samples from the specific area in Ethiopia that is neighbor to BioNatals regular farms. This time we got the highest ever TQ of 4.64% and signed contracts with the new discovered farms.
Certificate of Analysis: Benzo(a)pyrene
BioNatal LLC's cold press method is tested once on each machinery used to press oil. This test is done only one time for the new equipment at the beginning.
BioNatal is the only company in the world to prove the cold pressing method through analysis. Most consumers of black seed oil look at the label contents of the oil bottles, but no one has ever seen official proof. Most of the world's black cumin seed oil suppliers are based in the Middle East and Africa, and these regions use old industrial equipment made for soft sunflower seeds and olive pulp, and are not equipped for the Nigella Sativa seeds. As a result, almost all of the black seed oil in the world market gets burned during pressing, and resellers always say that it is impossible to prove that the extraction was cold officially, which is not valid.
It's actually very easy to prove cold press, but most of black seed oil manufacturers are not interested in these tests. BioNatal has the results of oil analyzes produced on our equipment, where the Benzo(a)pyrene component does not exceed 0.95 μg/kg while the global cold-pressed standard does not exceed 2.0 μg/kg.
Certificate of Analysis: Burning Materials
BioNatal LLC's cold press method is tested once on each machinery used to press oil. This test is done only one time for the new equipment at the beginning.
Moreover, there is also an in-depth analysis of cold-pressed natural oils. This analysis identifies the performance of all components that arise in the oil at high temperatures during production. According to the international cold-pressed standard, the sum of all four parts should not exceed 10.0 μg/kg. The sum of these components in BioNatal black seed oil is 6.04 μg/kg, so the BioNatal cold press method has been proven even by detailed analysis.
CERTIFICATE OF ANALYSIS: pH TESTING
BioNatal submitted black seed oil samples made from Ethiopian and Egyptian Nigella sativa seeds for laboratory pH testing. The laboratory reported values of 3.84 for the Ethiopian sample and 5.20 for the Egyptian sample under the test conditions used.
The attached report provides an example of some of the testing we conduct. Results apply to the specific samples tested and should be interpreted alongside the laboratory’s method and sample preparation.
These results alone do not establish product safety, determine thymoquinone (TQ) content, or demonstrate that TQ caused the difference between the reported values.
Certificate of Analysis: Heavy Metals
BioNatal test its Ethiopian black seed oil for laboratory analysis of heavy metals. The attached Certificate of Analysis provides an example of some of the testing we conduct and documents the results for the specific batch tested.
The report lists the metals analyzed, their results, and the laboratory’s reporting limits. Results shown with a “less than” symbol (<) indicate levels below the stated reporting threshold; they do not establish absolute absence. Results apply to the sample tested and may vary between batches.
BioNatal works with farming partners in Ethiopia to maintain consistent seed quality. We share laboratory documentation to help customers make informed decisions about our black seed oil.
Texas Department of State Health Services Licensed Facility
Bionatal LLC is licensed by the Texas Department of State Health Services (TDSHS) for our manufacturing facility in Texas. Our facility operates in accordance with the applicable state requirements associated with this license.
We are committed to maintaining appropriate manufacturing and sanitary standards throughout our production processes.
