We are happy to announce that the effectiveness of Megre Elixir has been proved clinically.
In early March, we received an official medical report and a GOST R state certificate confirming the product’s effectiveness in the treatment of several diseases. You will find the full report, translated into English down below.
The elixir has been recognized as a natural anti-parasitic agent, many times more effective than chemical analogs. It is a 100% natural remedy and has no contraindications and side effects.
To the Federal Service for Consumer Rights and Human Welfare Protection
āNatural Pharmacyā LLC
Federal budgetary scientific institution āscientific research institute of nutritionā (FSBIS āSRI of nutritionā)
2/14, Ystienskii drive, Moscow, 109240
Tel. +7 (495) 698-53-60,
fax: +7(495) 698-53-79
All-Russian Classifier of Enterprises and Organisations (ARCEO) 018997222 ŠŠŠ Š 1027739311907
TIN 7705004254 ŠŠŠ 770501001
03.03.16 Š³. No72/Š-182/Š±-16
Incoming No 1332/b of 16.11.2015
EXPERT REPORT
In accordance with the request ofĀ “Natural Pharmacy” LLC, FSBIS “SRI of nutrition” carried out the sanitary-epidemiological expertise, research as well as the expertise of documentation on theĀ biologically active dietary supplement “Siberian Cedar cone oil” manufactured by “Artlife”LLC , 8/2 Nakhimova St., Tomsk, 634034, RF and āMegreā LLC, 22 Lenina St., Kandaurovo, Kolyvansky District, 633185, Novosibirsk RegionĀ by the order of āNatural Pharmacyā LLC, 69, Nevelsky St., fl. 91,Ā Novosibirsk, 630121, RF for its compliance with current legislation and regulatory requirements to the quality and safety as well as the manufacturerās regulatory and technical documentation.
Expertise documents and results.
The following is presented for the expertise:
– the application for the sanitary-epidemiological expertise of BAD;
– Š¢C 9197-173-12424308-15 “Siberian Cedar cone oil” biologically active dietary supplement;
– technological instruction TI -173/1;
– technological instruction TI -173/2;
– the manufacturer’s declaration that BAD does not contain any poisonous, potent, psychotropic, narcotic components, synthetic drugs, hormones, pesticides, doping and other prohibited substances listed in WADA 2016 (WADA 2016) as well as ingredients obtained using nanotechnologies;
– manufacturer’s declaration that there are no sources containing GMOs in BAD;
– the BAD recipe;
– the declaration ofĀ āArtlifeā LLC and āMegreā LLC that BAD complies with the requirements of TR TS 0242011, TR TS 021/2011 , TR TS 022/2011;
– HC (Hygiene Certificate) on producing BAD for āArtlifeā LLC;
– the conformity certificate of āMegreā LLC production with HACCP requirements;
– the agreement No 61.15.1/1.-Š between āNatural pharmacyā LLC and āArtlifeā LLC;
– regulatory documents on raw materials for BAD;
– the state register extract on āNatural pharmacyā LLC;
– the state register extract on āMegreā LLC;
– the state register extract on āArtlifeā LLC;
– the explanatory note;
– sampling reports from āArtlifeā LLC and āMegreā LLC;
– projects of label inscriptions.
The expert assessment of the food BAD āSiberian Cedar cone oilā for the presence of poisonous, potent, psychotropic, narcotic components, synthetic drugs as well as doping and other prohibited substances included in the WADA 2016 list (WADA 2016), hormones, pesticides and ingredients obtained using nanotechnologies.
āArtlifeā LLC, the developer of the food BAD āSiberian Cedar cone oilā, declares that the food BAD does not contain any poisonous, potent, psychotropic, narcotic components, synthetic drugs, doping and other prohibited substances included in the WADA 2016 list (WADA 2016), hormones, pesticides as well as ingredients obtained using nanotechnologies.
The expert assessment of food BAD for sources containing GMOs.
āArtlifeā LLC, the developer of the food BAD āSiberian Cedar cone oilā, declares that no sources containing GMOs are used to produce the food BAD.
The expert assessment of raw materials to produce the food BAD “Siberian Cedar cone Oil” and characteristics of its production.
The food BAD “Siberian Cedar cone Oil” is produced by āArtlifeā LLC, 8/2 Nakhimov St., Tomsk, 634034, RF and āMegreā LLC 22 Lenina St., Kandaurovo, Kolyvansky District, 633185, Novosibirsk Region in accordance with TC 9197-173-12424308-15 developed by āArtlifeā LLC,Ā and it is to be realised through the pharmacy chain and retail specialised departments. The production of the food BAD by āArtlifeā LLC is confirmed by HC NoĀ 70.Š¢Š”.04.000.Š.000218.03.09, and the conformity certificate No Š ŠŠ”Š”.RU.ŠŠŠ¤Š.Š00045 of āMegreā LLC confirms the production compliance with the requirements of ISO 22000:2005(HACCP).
The food BAD “Siberian Cedar cone Oil” is unrefined pine nut oil (Pinus sibirica) obtained by means of cold-pressed technology, with adding 0.1% of antioxidant “Gridox 539” which includes ascorbyl palmitate E304, tocopherols E306 concentrate mixed and lecithin E322. To produce BAD the following raw materials are used: unrefined cedar oil “Siberian cedar cone oil” (Conformity declaration TS ā RU D-RU.AB29.B.17178 of 10.02.2016) and food additive “Grindox (Grindox) 539 (Conformity declaration TS ā RU D-DK.AE09.B.00406).
In terms of safety the raw materials employed comply with the requirements TR TS 021/2011 and TR TS 029/2012. It is allowed to use the analogous raw materials with the same parameters produced by home and foreign companies.
The food BAD “Siberian Cedar cone Oil” is produced as soft gelatine capsules weighing 1000 mg plus-minus 10% (the total capsule weight is 1439 mg plus-minus 10%) and as a liquid in bottles from 25 to 500 g.
In accordance with technical conditions BAD contains at least 54% of omega-6 polyunsaturated fatty acids, including at least 36% of linoleic acid Š” 18:2 and octadecatrienoic acid C 18:3, Š 5,9,12 (the identity index of cedar oil is at least 15%.
BAD is a fatty liquid of yellow-green color with the taste and smell specific of cedar nuts.
According to the data presented in TCĀ 9197-173-12424308-15, “Siberian Cedar cone Oil” as a liquid is packed into 25-500 ml glass bottles with dispensers GOST 52022, polymer containers GOST 51760, sachets made from aluminum foil or packets made from metallised PVC with dispensers GOST 24370, GOST 12302.
BAD capsules are packed into polymer jars containing 30, 45, 60, 90, 120 or 180 pieces GOST 51760. It is possible to put capsules into aluminum foil blister packs GOST 745 or TC 48-21-270, with each blister having 10 or 20 capsules, then they are packed into cardboard boxes.
BAD package is performed in accordance with TR TS requirements 005/2011 āOn safe packingā and it is designated for food products.
Š¢C 9197-173-12424308-15 for the product contain all necessary indices of quality and safety which comply with Technical Regulations of the Customs Union āOn the food production safetyā TR TSĀ Ā 021/2011.
The results of sanitary-chemical studies (master record No. 1332/000226/14-16 of 03.03.2016)
Samples:
25 cm3 glass bottle (Manufacturer is āArtlifeā LLC, sample No 1), 1430 mg capsules (Manufacturer is āMegreā LLC, sample No 2)
| Index | Determined | Manufacturer’s specifications, TR TS requirementsĀ 021/2011. | |
| Peroxide number,
Mmol/mol of active Oxygen/kg Sample No 1 Sample No 2 Acid value, mg. CON/g Sample No 1 Sample No 2 |
2,47 2,60
2,27 2,22 |
Not more than 10,0
Not more than 4,0 |
|
| Toxic elements, mg/kg:
Lead Cadmium Iron Copper Arsenic Mercury |
Sample No 1 | Sample No 2 | Less than
0,1 0,05 5,0 0,4 0,1 0,03 |
| 0,076
Less than 0,001 0,940 0,062 Less than 0,01 – |
0,021
Less than 0,001 0,640 0,172 – Not found |
||
| Microbiological indicators:
Pathogenic germs including salmonella in 10 g |
Sample No 2
Not found |
Not allowed |
|
| Aflatoxin B1, mg/kg | Sample No 1
Not found |
Not more than 0,005 | |
| Pesticides, mg/kg:
ŠŠµŠŗHexachlorocyclohexane (HCCH) Dichlorodiphenyltrichloromethyl-methane (DDT and its metabolites) ŠŠ»Š“ŃŠøŠ½ ŠŠµŠæŃŠ°Ń Š»Š¾Ń |
Sample No 1
Not found Not found
Not found Not found |
Not more than 0,2 Not more than 0,2
Not allowed Not allowed |
|
The analysis of the documentation presented and research resultsĀ (master record No 1332/000226/14-16 of 03.03.2016) of the Testing laboratory center, FSBIS āSRI of nutritionā Accreditation certificate Š ŠŠ”Š” RU.0001.21 SEP14 of 22.08.2014) have confirmed the compliance of the food BAD “Siberian Cedar cone Oil” with the technical requirements of TR TS 021/2011 āOn the safety of food productionā, āUnified Sanitary, Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (control)ā of the Eurasian Economic Community Customs union and manufacturerās technical rules and regulations.
The food BAD is stored in a dry, cool place protected from light and children before and after unpacking.
According to the technical conditions the expiration date of liquid BAD is 1 year, capsules – 2 years from the production date.
BAD labeling is carried out in accordance with the requirements of TR TS 022/2011 “Food product labeling” with placing the data on the food and energy value of the product and Customs Union conformity mark.
The expert assessment of the biological efficiency of the food BAD “Siberian Cedar cone Oil”.
The biological active food additive “Siberian cedar cone oil” is cedar oil obtained from Siberian cedar seeds (Pinus sibirica).
BAD “Siberian Cedar cone Oil” is a natural source of omega 6 polyunsaturated fatty acids. The research performed have shown that BADs produced by two manufacturers contain 66.3 – 66. 8% of omega 6 PUFAs. the share of linoleic acid (18:2 omega 6) is 46.31-47%.Ā Cedar oil contains 20.4-20.9% of oleic acid (18:1). The amount of octadecatrienoic acid with double bonds 5,9,12 (C18:3 omega 6) is 19.87-20.0%. The presence of this linolenoic acid isomer is a specific feature of cedar oil and confirms its authenticity.
Linoleic acid C18:2 6 contained in BAD canāt be synthesized inside the human body, its deficiency results in the predisposition to different diseases.Ā Linoleic acid normalizes the condition of blood vessel walls, increases their plasticity and reduces their permeability, also it makes some antisclerotic effect. Octadecatrienoic acid C 18:3 6 with double bonds 5,9,12 is a biologically active energy component which produces some immunostimulating and generally strengthening effect.
Biologically active components of the BAD.
(master record No 1332/000226/14-16 of 03.03.2016)
| Index | Determined | Manufacturer’s specifications | |
| Level of basic fatty acids, %
Š” 14:0 16:0 18:0 18:1 Ń 9 18:1 Ń 11 18:2 Ļ6 18:3 Ī»5, 9, 12 18:3 Ļ3 20:1 20:2 20:5 Ļ3 20:3 Sum of PUFAs Ļ6 |
Sample No 1 | Sample No 2 |
Complies with the declared:
Not less than 36% or 360 mg/caps. Not less than 15% or 150 mg/caps.
Not less than 54% or 540 mg/caps. |
| 0,54
4,91 2,16 20,43 1,84 46,31 or 460 mg/caps. 20,00 or 200 mg/caps. 1,67 0,71 0,88 1,22 0,23 66,31 or 663 mg/caps. |
0,50
4,60 2,11 20,93 1,52 47,00 or 470 mg/caps. 19,87 or 198 mg/caps. 1,83 0,65 0,93 1,05 0,16 66,87 or 668 mg/caps. |
||
In accordance with the āNorms of physiological requirements in energy and food for different groups of population RFā (MP 2.3.1.2432-08), āUnified Sanitary, Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (control)ā of the Eurasian Economic Community Customs union, the requirements of TR TS 022/2011 the recommended intake of BAD for adults is: 2 capsules with food twice a day or 2 g of oil (12 dispenser puffs) with food twice a day, it provides the appropriate intake of PUFA omega 6 by 22% and linoleic acid by 144% (which does not exceed the upper acceptable level of the intake).
The period of administration is 1-2 months. Before starting to take the BAD, it is recommended to consult with the doctor.
Contraindications: individual intolerance to BAD components, pregnancy, breast-feeding.
Based on the above and in accordance with Sanitary Regulations and Norms 2.3.2.1290-03 “Hygienic requirements to the organization of production and distribution of biologically active food additives (BAD), the food BAD āSiberian cedar cone oilā can be recommended as an additional source of PUFA omega 6, including linoleic acid.
Conclusion.
SubmittedĀ for the expert assessment so as to ensure the State registration, the food BAD “Siberian Cedar cone oil” manufactured by “Artlife”LLC , 8/2 Nakhimov St., Tomsk, 634034, RF and āMegreā LLC, 22 Lenina St., Kandaurovo, Kolyvansky District, 633185, Novosibirsk RegionĀ by the order of āNatural Pharmacyā LLC, 69, Nevelsky St., fl. 91,Ā Novosibirsk, 630121, RF, complies with current legislation and regulatory requirements to the quality and safety established for this kind of food production, including the requirements of TR TS 021/2011 āOn the safety of food productionā, āUnified Sanitary, Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (control) of the Eurasian Economic Community Customs union, the requirements of TR TS 022/2011 “Food product labellingā and manufacturerās technical rules and regulations.
BAD is produced in accordance with TC 9197-173-12424308-15 and is to be realised through the pharmacy chain and retail specialised departments.
Capsules weighing 1.0 g and bottles with liquid from 25 to 500g.
BAD is recommended as an additional source of PUFA omega 6, including linoleic acid.
It contains food additives Š304, Š306, Š 322, with capsules including additionally Š 422.
Biologically active components of BAD:
| PUFA omega 6 , %, not less, | 54 |
| including Š” 18:3 5,9, 12 %, not less | 15 |
| Linoleic acid 18:2, omega 6%, not less | 36 |
Ā
Safety indices:
| Peroxide number Ā½ O mmol/kg, not more | 10,0 |
| Acid value, mg. CON/g, not more: | 4,0 |
| Toxic elements, mg/kg, not more: | |
| Lead | 0,1 |
| Arsenic | 0,1 |
| Cadmium | 0,05 |
| Mercury | 0,03 |
| Iron | 5,0 |
| Copper | 0,4 |
| Aflatoxin B1, not more | 0,005 |
| Pesticides, mg/kg, not more: | |
| HCCH (isomer sum) | 0,2 |
| DDT and metabolites | 0,2 |
| Aldrin, heptoclorine, mg/kg | not allowed |
| Dioxins, mg/kg, not more | 0,000002 |
| Microbiological indices: | |
| Pathogenic germs including salmonella in 10 g. | not allowed |
| Radionuclides, Bq/kg, not more: | |
| Cesium -137 | 60 |
| Strontium -90 | 80 |
Ā
The recommended intake of BAD for adults is: 2 capsules with food twice a day or 2 g of oil (12 dispenser puffs) with food twice a day, it provides the appropriate intake of PUFA omega 6 by 22% and linoleic acid by 144% (which does not exceed the upper acceptable level of the intake).
The period of administration is 1-2 months. Before starting to take the BAD, it is recommended to consult with the doctor.
Contraindications are: individual intolerance to BAD components, pregnancy, breast-feeding.
BAD is to be kept in a dry cool place protected from light and children before and after unpacking.
The expiration date of BAD in liquid is 1 year, in capsules – 2 years from the production date.
Food BAD āSiberian cedar oilā.
The consumer label is marked with: product name, ingredient composition, manufacturerās name and address, date of issue, expiration date, storage conditions, indications, contraindications, number of the state registration certificate, the inscription “is not a medication”, data on the food and energy value and presence of Customs Union (EAC) conformity mark.
The label text is agreed.
The authentication in terms of PUFA omega 6 content and composition as well as octadecatrienoic acid content Š” 18:3 5,9,12
Food BAD is not a medication and canāt substitute it. It is not allowed to present any information on its therapeutic benefits on its label, in its instructions, advertising or anywhere else.
The documents of the expert report produced by FSBIS “SRI of nutritionā canāt be considered as the basis for presenting the inscription of āRecommended or approved by FSBIS “SRI of nutritionā onto the product label.
Reprinting and using the given report text in full or partly in advertising and elsewhere without the written permission of FSBIS “SRI of nutritionā are prohibited!
Appendix: 4-page master research record No 1332/000226/14-16 of 03.03.2016 of the Testing laboratory center in FSBIS “SRI of nutritionā (Accreditation certificate ROSS RF.0001.21.SEP14 of 22.08.2014)
| Deputy chairman of the Expert Council
Professor, PhD in medicine |
[signed]
(signature) |
A.K. Baturin |
Experts:
S.N. Kulakova, V.I. Chiburaev
Certified to be a true copy
Director of āArtlifeā LLC
A.N. Avstrievskaya
