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® Productsare 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

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 theofficial 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

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

No data available

Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Carbon oxides

Wear self-contained breathing apparatus for firefighting if necessary

No data available

Avoid dust formation. Avoid breathing vapors, mist or gas. For personal protection see section 8

Do not let product enter into soil or sewer.

Sweep up and shovel. Keep in suitable, closed containers for disposal.

For disposal see section 13.

Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide adequate ventilation and local exhaust ventilation at places where dust is formed.

Keep container tightly closed, may be stored in temperatures between 5 °C and 25 °C (RH: 20-70%). 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.

Ingredients with workplace control parameters.

Not expected to have significant environmental effects

No data available

No indication of bio-accumulation potential

No data available

This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher

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 of the 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).

ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by Road; AIIC- Australian Inventory of Industrial Chemicals; ASTM -American Society for the Testing of Materials; bw- Body weight; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardization; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rateresponse; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Codefor the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organization for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - LethalConcentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. -Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed(Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bio accumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of theCouncil concerning the Registration, Evaluation, Authorization and Restriction of Chemicals; RID -Regulations concerning the International Carriage of Dangerous Goods by Rail; SADT -Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN- United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative.

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 (sister company):

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. Inspection of 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 under 21 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 product range under the trademark: Pharmaquinone®, Vitamin K2 as MK-7 used in the food and chemical industry.
‍
To the best of our knowledge, the product listed above is not derived from genetically modified starting raw materials, or additives that are derived from genetically modified organisms, and do not contain detectable levels of genetically modified materials (known as PCR negative) in compliance with EU Regulation No 1829/2003, including amended EU Directive 2001/18/EC.
‍
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.
‍
The manufacturing process does not use any ingredient of animal origin nor do our products come in contact 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.
‍
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
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• Nutritional Profile*
• Allergens on Production Line
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