Regulatory Status
Metafolin® is the body's preferred form of the folate vitamin and the bioactive metabolite of the provitamin folic acid. Metafolin® is approved in first key regions and for first product categories.
Metafolin® 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.
| 1999® |
USA: GRAS (generally recognized as safe) self affirmation for Metafolin® |
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An independent expert committee confirms that L-methylfolate is "generally recognized as safe" ("GRAS") for use as a source of folate in conventional and medical foods as well as dietary supplements.
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| 2001® |
U.S. FDA: New Dietary Ingredient Notification for Metafolin® |
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U.S. FDA accepts L-methylfolate as a source of the naturally-occurring form of folate.
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| 2004® |
EFSA (EU) considers Metafolin® as safe |
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The "European Food Safety Authority" (EFSA) Panel concluded that the use of L-methylfolate as a source of folate in foods for specific nutritional uses, food supplements and normal foods, with a tolerable upper level of 1 mg/adult person/day is not of concern from the point of view of safety.
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| 2005® |
JECFA considers Metafolin® as safe |
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The "Joint FAO/WHO Expert Committee on Food Additives" (JECFA) has no safety concern for the proposed use of L-methylfolate in dry crystalline or microencapsulated form as an alternative to folic acid used in dietary supplements, foods for special dietary uses and other foods.
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| 2006® |
EU Commission published 2006/34/EC and 2006/37/EC with Metafolin® |
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The "EU Standing Committee on The Food Chain and Animal Health" (SCFCAH) amended the positive lists for foods for particular nutritional uses (2001/15/EC) and food supplements (2002/46/EC) with L-methylfolate and changed the heading of the substance group from "folic acid" to "folate".
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| 2007® |
Metafolin® approved in Switzerland and Norway |
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The Swiss and Norwegian authorities follow the EU regulation and therefore approved the use of L-methylfolate. |
Further regulatory approvals are expected shortly. For more information regarding the regulatory status of Metafolin® please contact us. 
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