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branded ingredient Methylfoca™
Methylfoca™ is a Branded product from Nutri Avenue Ltd. Fresh stocks with third party test reports, guaranteed quality that exceeds your requirement. Click the button below to get a free quote today!
The Benefits for Methylfoca™
Repair DNA
Methylfoca™ (Methyl folate) helps repair DNA
Support heart health
Methylfoca™ (Methyl folate) is also known to generally improve human health.
Antenatal care
Methylfoca™ (Methyl folate) helps with prenatal care
Prevention of cardiovascular disease
Methylfoca™ (Methyl folate) helps improve cardiovascular function.
Prevention of Alzheimer's Disease
Methylfoca™ (Methyl folate) helps prevent Alzheimer's disease
Prevention of Depression
Methylfoca™ may help in the treatment of mood disorders.
Merkingrediënt
What is Methylfoca™ ?
Methylfoca™ is our manufactured calcium salt of L-5-methyltetrahydrofolic or L-methylfolate Ca. Methylfoca™ is also known as L-methylfolate; L-5-MTHF-Ca; L-methylfolate calcium; L-5-Methyltetrahydrofolic acid, calcium salt; [6S]-5-Methyltetrahydrofolic acid, calcium salt. As an alternative to folic acid, it offers good stability, solubility and bioavailability.
5-Methyltetrahydrofolate (5-MTHF) is the most active form of folic acid, the B group vitamin, also known generically as folate. Folate deficiencies have been linked with such health conditions as cancer, cardiovascular diseases and neurological abnormalities.
L-5-Methyltetrahydrofolate Calcium (L-5-MTHFCa) Methylfoca™
Ons voordeel
branded ingredient Methylfoca™ from Nutri Avenue Ltd
Verse voorraad VS
We have prepared sufficient inventory in our CA warehouse in the US, which can provide you with stable supply demand.
Testrapport van derde partij
We will do HPLC test report on each batch of Methylfoca™ to ensure that the purity of each batch can exceed 99%.
10% below market price
Through our mass production, we are able to reduce methylFoca ™ production costs, reducing procurement costs for our customers by at least 10%.
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WETENSCHAP
Methylfoca™ is our manufactured calcium salt of L-5-methyltetrahydrofolic or L-methylfolate Ca. Methylfoca™ is also known as L-methylfolate; L-5-MTHF-Ca; L-methylfolate calcium; L-5-Methyltetrahydrofolic acid, calcium salt; [6S]-5-Methyltetrahydrofolic acid, calcium salt. As an alternative to folic acid, it offers good stability, solubility and bioavailability.
Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver an opinion on the safety of (6S)- 5-methyltetrahydrofolic acid, glucosamine salt (5MTHF-glucosamine), when added for nutritional purposes to food supplements as a source of folate, and on the bioavailability of folate from this source. 5- Methyltetrahydrofolic acid, calcium salt (5MTHF-Ca), has previously been authorised as a source of folate. 5MTHF-glucosamine is proposed as an alternative source of folate to be used in the manufacture of food supplements and it is proposed to be used at up to 1.8 mg/day, which equates to 1 mg 5MTHF and 0.8 mg glucosamine. A crossover comparative bioavailability study was performed in human volunteers and the Panel concluded that folate from 5MTHF-glucosamine exhibited a similar bioavailability to folate from 5MTHF-Ca. The Panel considered that 5MTHF-glucosamine will readily dissociate to 5MTHF and glucosamine in the aqueous environment of the digestive tract. The 5MTHF component will therefore be expected to be absorbed across the small intestine in a similar manner as 5MTHF originating from dietary sources and 5MTHF-Ca. In vitro genotoxicity studies with 5MTHF-glucosamine have been performed and the Panel concluded that the 5MTHF-glucosamine source did not raise concerns with respect to genotoxicity. The Panel therefore concluded that the proposed use and use levels of 5MTHF-glucosamine as an alternative source of folate to be used for the manufacture of food supplements is not of safety concern. The Panel does not conclude on the safety of 5MTHF- glucosamine in terms of the amount of folate that may be consumed, since this is outside the remit of the ANS Panel; however, the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) will advise on population reference intakes for folate by 2015 (EFSA-Q-2011-01212).
Manufaturing Process
5MTHF-glucosamine is chemically synthesised from folic acid (CAS Registry Number 59-30-3) by reduction with sodium tetrahydroborate, condensation of the resulting tetrahydrofolic acid with formaldehyde and reduction of the formed 5,10-methylene-tetrahydrofolic acid to (6R,S)-5- methyltetrahydrofolic acid with sodium tetrahydroborate. Purification of the racemic mixture is performed by crystallisation processes, yielding pure (6S)-5-methyltetrahydrofolic acid. Glucosamine hydrochloride is used to form the glucosamine salt. The final product is obtained either by lyophilisation or by precipitation in ethanol.
According to the applicant, the glucosamine component of 5MTHF-glucosamine originates from glucosamine hydrochloride (CAS Registry Number 66-84-2) derived from chitin sourced from a specific strain of Aspergillus niger and is United States Pharmacopeia (USP)/National Formulary (NF) grade. The applicant claims that this is the strain evaluated by the NDA Panel (EFSA, 2009), which does not produce ochratoxin A.
The content of (6S)-5-methyltetrahydrofolate (5MTHF) and glucosamine in preparations of 5MTHF- glucosamine, and the diastereoisomeric purity of 5MTHF, can be determined by three separate high- performance liquid chromatography (HPLC) methods. Results from three independent production batches were submitted by the applicant.
Methods of Analysis in Food
The contents of 5MTHF and glucosamine in food supplements (tablets) are determined by separate laboratory-validated HPLC/UV methods. The assay for 5MTHF is also suitable for detection of folate degradation products.
Reaction And Fate in Food To Which The Source Is Added
The stability of 5MTHF and glucosamine in 5MTHF-glucosamine preparations alone, or when 5MTHF-glucosamine was incorporated into a multivitamin tablet preparation, was determined by the applicant. At room temperature, both 5MTHF and glucosamine were stable over a period of at least 18 months as 5MTHF-glucosamine alone and at least 12 months when incorporated into a multivitamin tablet.
Case of Need And Proposed Uses
5MTHF-glucosamine is proposed as an alternative source of folate to be used in the manufacture offood supplements (tablets) according to Directive 2002/46/EC. It is proposed to be used at up to 1.8 mg/day, in vitamin, multivitamin, and vitamin and mineral tablets, as a source of folate.
According to the applicant, the 5MTHF content of the 5MTHF-glucosamine is up to 59 % by weight. In order to receive the same molar dose of folate (5MTHF) from folic acid and 5MTHF-glucosamine, 5MTHF-glucosamine will be used at 185 % of the levels used for folic acid on a weight for weight basis. Using the recommended dose level of 400 μg folic acid/day, this is equivalent to 416 μg of 5MTHF or 740 (741) μg of 5MTHF-glucosamine. Based on the different molecular weights of the two sources, 1.8 mg of 5MTHF-glucosamine corresponds to 1 mg folic acid.
In 2009, the NDA Panel published an opinion on the safety of glucosamine hydrochloride from Aspergillus niger as a food ingredient and concluded that glucosamine hydrochloride from Aspergillus niger is safe as a food ingredient for adult consumers at the proposed intake level of 750 mg of glucosamine/person/day, but that consumers with diabetes mellitus or glucose intolerance should be advised to seek medical advice before consumption (EFSA, 2009). In 2011, an NDA Panel opinion drew attention to the fact that patients taking coumarin anticoagulants constitute a further risk group (EFSA NDA Panel, 2011).
The Panel noted that, although the exact dose-response relationship cannot be determined, the case reports as mentioned in the NDA opinion indicate that glucosamine intakes would be several hundreds mgs/day and above (EFSA NDA Panel, 2011).
The Panel noted that under the proposed uses and use levels, maximum exposure to glucosamine from 5MTHF-glucosamine is 0.8 mg/day. The Panel noted that the maximum exposure to glucosamine in this opinion resulting from the proposed uses and use levels is negligible compared to the exposure given in the NDA opinion on glucosamine from Aspergillus niger.
Conclusions
The Panel concluded that the bioavailability of folate from 5MTHF-glucosamine would be comparable to that of folate from 5MTHF-Ca after oral exposure in humans.
The Panel concluded that the folate source 5MTHF-glucosamine did not raise concerns with respect to genotoxicity.
The Panel concluded that the proposed use and use levels of 5MTHF-glucosamine, when added for nutritional purposes to food supplements as a source of folate, is not of safety concern.
Given the manufacturing process, the Panel concluded that specifications for 5MTHF-glucosamine should include an indication for the absence of mycotoxins.
DOCUMENTATION PROVIDED TO EFSA
Application for the placing on the market of (6S)-5-methyltetrahydrofolic acid, glucosamine salt as novel food ingredient according to Regulation (EC) No 258/97. June 2011. Submitted by GNOSIS S.p.A., Desio, Italy.
Technical dossier (2012). Request for the authorisation of (6S)-5-methyltetrahydrofolic acid, glucosamine salt for inclusion in Directive 2002/46/EC. July 2012. Submitted by GNOSIS S.p.A., Desio, Italy.
Additional data follow-up EFSA letter on 12 April 2013. Data provided on 25 April 2013.E
| Chemical Name: | Methylfolate |
| CAS Number: | 134-35-0 |
| Molecular Formula: | C20H20N7O6 |
| Molecular Weight: | 454.41 g/mol |
| Packaging: | In paper-drums and two layers of poly bags inside. Net weight: 25kg/drum |
| Main Benefits: | Methylfolate or Folic acid is very important for maintenance of bodily functions. |
| Application: | Dietary Supplements |
The use of folic acid in general populations without MTHFR or DHFR mutation is most likely of limited concern; but even for them, it is considered safe only when the dose is 100 – 200 mcg. For those people having fortified flour or cereal, energy drinks, protein bars and supplement, the dose of folic acid is exceeding the limit easily and considerably.
Beside efficacy differences, when comparing folic acid and 5-MTHF, folic acid is a synthetic compound with no biological function until reduced to its subsequence formats, unmetabolised folic acid starts appearing at dose > 200 mcg, and individuals show wide variations in folic acid reduction ability in vivo.24 On the other hand, 5-MTHF is a better alternative especially in those countries without folic acid fortification of foods, because it is a natural form of folate readily available in vivo for transport and metabolism, and it has no upper intake limit.
5-MTHF has its important advantages compared to synthetic folic acid. Firstly, it is well absorbed even when gastrointestinal pH changes, secondly it is bioavailable and is not affected by metabolic defects.25 The use of 5-MTHF to replace folic acid in treating MTHFR reduces potential of masking haematological symptoms of vitamin B12 deficiency, reduces interactions with medications inhibiting dihydrofolate reductase, prevents formation of unmetabolised folic acid in blood circulation, and overcomes metabolic defects caused by MTHFR polymorphism. Current situation of 5-MTHF marketing and approval is that the U.S. FDA and European Food Standard Agency approved products containing 5-MTHF,26 and thus its replacement of folic acid in treating MTHFR and other disorders is expected.
REFERENCES
Abad AR and Gregory JF, 1987. Determination of folate bioavailability with a rat bioassay. Journal of Nutrition, 117, 866–873.
Aghazadeh-Habashi A and Sattari S, 2002. Single dose pharmacokinetics and bioavailability in the rat. Journal of Pharmacy and Pharmaceutical Sciences, 5, 181–184.
Bhandari SD and Gregory JF, 1992. Folic acid, 5-methyl-tetrahydrofolate and 5-formyl- tetrahydrofolate exhibit equivalent intestinal absorption, metabolism and in vivo kinetics in rats. Journal of Nutrition, 122, 1847–1854.
Butterworth CE and Tamura T, 1989. Folic acid safety and toxicity: a brief review. American Journal of Clinical Nutrition, 50, 353–358.
de Bree A, van Dusseldorp M, Brouwer IA, van het Hof KH, Steegers-Theunissen RP, 1997. Folate intake in Europe: recommended, actual and desired intake. European Journal of Clinical Nutrition, 51, 643–660.
Eichholzer M, Tönz O and Zimmermann R, 2006. Folic acid: a public-health challenge. Lancet, 367, 1352–1361.
EFSA (European Food Safety Authority), 2004. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food related to calcium L- methylfolate. The EFSA Journal 2004, 135, 1–20.
EFSA (European Food Safety Authority), 2009. Opinion on the safety of glucosamine hydrochloride from Aspergillus niger as food ingredient. The EFSA Journal 2009, 1099, 1–19.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2011. Statement on the safety of glucosamine for patients receiving coumarin anticoagulants. EFSA Journal 2011;9(12):2473, 8 pp. doi:10.2903/j.efsa.2011.2473
EFSA Panel on Biological Hazards (BIOHAZ), 2012. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2012 update). EFSA Journal 2012;10(12):3020, 84 pp. doi:10.2903/j.efsa.2012.3020
EGVM (Expert Group for Vitamins and Minerals), 2003. Safe Upper Levels for Vitamins and Minerals. Available online: http://cot.food.gov.uk/pdfs/vitmin2003.pdf.
