Pharmaquinone^® 0.45% Olive Oil Vitamin K2 as MK-7

Compliance with Regulations
Pharmaquinone® Products are identical to already authorised under Regulation 258/1997/EC novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation EU 20015/2283. Therefore Pharmaquinone® Products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® Products are in line with the authorised specifications and conditions of use as set out in the Union list of authorised novel foods and/or the implementing Regulations authorizing these substances in accordance to COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.

To whom it may concern,

Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU.The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

To whom it may concern,

VitaSynth does not test for nutritional data. ProductsPharmaquinone®, Vitamin K2 as MK-7 typically donot contribute to the nutritional value of food and dietary supplements due to their extremely low usage levels andtherefore fall under the nutritional labeling exemption defined in Section 101.9(a) and (j) ofTitle 21 of the Code of Federal Regulations, and Annex V of Regulation (EU) No 1169/2011.
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Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

Free from allergens in compliance with EU Directive 1169/2011 Annex II

To whom it may concern,

In compliance with EU Directive 1169/2011 Annex II
1. Cereals containing gluten
2. Crustaceans and products thereof
3. Eggs and products thereof
4. Fish and products thereof
5. Peanuts and products thereof
6. Soybeans and products thereof
7. Milk and products thereof (including lactose)
8. Nuts and products thereof
9. Celery and products thereof
10. Mustard and products thereof
11. Sesame seeds and products thereof
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2
13. Lupin and products thereof
14. Molluscs and products thereof

Your faithfully,
Name: Elżbieta Filutowska
Designation: Quality Department

* <A novel method for the determination of chemical purity and assay of menaquinone-7. Comparison with the methods from the official USP monograph> by Jedynak et al.
** BILE TOLERANT GRAM NEGATIVE BACTERIA INCLIDE ENTEROBACTERIACEAE, PSEUDOMONAS AND AEROMONAS
*** EVERY THIRD BATCH IS TESTED

The only „Single peak” vitamin K2

* <A novel method for the determination of chemical purity and assay of menaquinone-7. Comparison with the methods from theofficial USP monograph> by Jedynak et al.
** BILE TOLERANT GRAM NEGATIVE BACTERIA INCLIDE ENTEROBACTERIACEAE, PSEUDOMONAS AND AEROMONAS

No components need to be disclosed according to the applicable regulations.

The most important known symptoms and effects are described in the labelling (see section 2) and/or in section 11

Treat symptoms. Product has low, dermal, inhalation toxicity and is non-irritating to eye and skin.

Carbon dioxide (CO2). Foam. Dry extinguishing powder. Do not use water.

During fire, gases hazardous to health may be formed.

Self-contained breathing apparatus and full protective clothing must be worn in case of fire.

Use standard firefighting procedures and consider the hazards of other involved materials.No unusual fire or explosion hazards noted.

Keep unnecessary personnel away. For personal protection see section 8.

Avoid discharge into drains, water courses or onto the ground.

Sweep up using spill control material, collect and dispose appropriately.

For disposal see section 13.

Observe good industrial hygiene practices.

Keep container tightly closed, may be stored in temperatures between 15 °C and 25 °C (RH: 30-50%). After opening the container, use as soon as possible or tightly close the container and store in refrigerator.Store in dark. Store away from incompatible materials such as oxidizing agents and materials with high alkaline levels.

Apart from the uses mentioned in section 1 no other specific uses are stipulated.

Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.

The product is stable and non-reactive under normal conditions of use, storage and transport.

This product is stable under normal conditions.

No dangerous reaction known under conditions of normal use.

Protect from light. Keep away from sources of heat.

Strong oxidizing agents. This product may react with strong alkalies.

At high temperatures acrolein may be formed. Other decomposition products - No data available
In the event of fire: see section 5

Not expected to have significant environmental effects

Readily biodegradable

No data available

No data available

No data available

Negative ecological effects are not expected.

Product
Offer surplus and non-recyclable solutions to a licensed disposal company.

Contaminated packaging
Contaminated packaging convey the established processors of waste.

No data available

Generic authorizations of Novel Foods:
Authorizations are no longer individual. Instead, authorized novel foods are added to the EU list, which serves as a so-called ‘positive list’. Every food business operator that complies with the conditions ofthe authorization can place the respective novel food on the market. Also the applicant-specific novel food authorizations under the old Regulation have been included in the European Union list. This led to an initial list containing 125 entries (numbers as mentioned on the website of the European Commission).
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Regulatory Statement:
To the best of our knowledge, this product was not adulterated or misbranded as defined by the Federal Food, Drug, and Cosmetic Act, state, or municipal ordinances in which the definition of adulteration and misbranding is substantially the same as defined by the Act. This product is allowed under the provision of Section 404 or 505 of the Act, to be introduced into interstate commerce.

The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide.
The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions.
It does not represent any guarantee of the properties of other product. VitaSynth shall not be held liable for any damage resulting from handling or from contact with the above product.

To whom it may concern,

We hereby confirm our various Menaquinone-7 products has been shipped to USA market under FDA supervision for several years. As a result, our Menaquinone-7 dilutions preparation site (sistercompany):

Europharma Alliance sp. z o. o. AL. LED 1, 55-020 Rzeplin, Poland

has been audited by FDA on 9th and 10th of October, 2019. It was a comprehensive surveillance inspection of foreign dietary supplement raw material manufacturer conducted in accordance with PAC0314, CGMP/Limited Scope PCHF Inspections, with Operation ID 126761. This inspection covered manufacturing of Vitamin K2 bulk premix as dietary ingredient requiring further processing. Inspectionof raw ingredient/material receiving, quarantine, batch production, master manufacturing records, sanitation, quality and complaints produced 0 FDA 483 Inspectional Observations. No complaints regarding the firm were found in FACTS. FDA “closed” inspection under21 CFR 20.64(d)(3).

Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

To whom it may concern,

VitaSynth sp. z o. o. takes every precaution to manufacture and provide safe and functional productrange under the trademark: Pharmaquinone®, Vitamin K2 as MK-7 used in the food and chemicalindustry.
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To  the  best  of  our  knowledge,  the  above VitaSynth material  has not been  derived  from  or  produced using  bio engineering,  genetically  modified  organisms,  or  their derivatives.  This product does  not contain RNA, DNA and/or protein from genetic modification. Based  on  this  information,  the  product  stated  above,  will  not  on their  own,  require  labeling  of the food stuffs and food ingredients as indicated in 7 CFR Part 66, Regulation (EC) No1829/2003, and (EC) No 1830/2003.
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Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

To whom it may concern,

VitaSynth sp. z o. o. takes every precaution to manufacture and provide safe and functional product range under the trademark: Pharmaquinone®, Vitamin K2 as MK-7 used in the food and chemical industry.
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The manufacturing process does not use any ingredient of animal origin nor do our products come incontact with animal products during storage and transportation. To the best of our knowledge, the product listed above is free from Transmissible Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE) in compliance with good manufacturing practice and EU Regulation (EC) No 999/2001.
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Yours faithfully,

Name: Elżbieta Filutowska
Designation: Quality Department

• Product Identity and Form
• Responsible for Product Development, Research and Regulatory Affairs
• Manufacturing and Quality Assurance/Quality Control Information
• Lot Number System, Product Storage, Packaging and Labelling Information
• Certifications and Compliance
• Regulatory Status and IPR
• Food Safety System
• Origin and Composition
• Nutritional Profile*
• Allergens on Production Line
• Free from Allergen Statement
• Product Specification
• Certificate of Analysis
• Flowchart
• Safety Data Sheet
• Attachments