May 27, 2026 — China's National Health Commission has approved 6S-5-methyltetrahydrofolate calcium for use in infant complementary food nutritional supplements. The applicant, Lianyungang Jinkang Hexin Pharmaceutical Co., Ltd., markets the ingredient under the brand Magnafolate (Crystal Form C).

This is the second new approval Magnafolate has secured in six months, following its clearance for wheat flour fortification in November 2025. Active folate has now entered the infant food category in China for the first time.

Three Years of Preparation, Nine Months of Review

Jinkang Hexin spent more than three years preparing for this submission — toxicological evaluations, formulation validation, and infant-population risk assessments — before filing the application in August 2025.

The review bar for infant food categories sits well above that for general food additives. Beyond standard chemistry and process reviews, applicants must submit toxicological data and a dedicated risk assessment for the infant population. In the materials Jinkang Hexin submitted, an authoritative testing agency concluded the product was practically non-toxic; JK12A impurity levels were controlled to one-tenth of the USP limit; and product purity exceeded 99.8%. The application cleared multiple rounds of technical review before receiving final approval.

What the C-Crystal Form Brings

Magnafolate is built on Jinkang Hexin's proprietary Crystal Form C technology^[1].

The first thing it brings is on the metabolic side. Ordinary folic acid must be converted by the MTHFR enzyme before the body can use it. Approximately 78.4% of the Chinese population carries a gene mutation that reduces this enzyme's activity, meaning conversion efficiency varies from person to person. Active folate bypasses this step entirely — it is already in its active form, absorbed directly without conversion. For infants, this matters even more: their liver metabolic function is not yet fully developed, and their ability to utilize enzyme-dependent folate forms lags behind that of adults.

The second is on the safety side. The practically non-toxic classification, combined with JK12A impurity controls set at one-tenth of the USP standard, addresses the core safety concern in infant food reviews.

The third is on the stability side. The patented C-crystal structure remains stable across a range of climatic conditions and application scenarios, keeping folate content in finished products consistent through processing and throughout shelf life.

[1] Granted patents include: CN201410280541.4, US9150982, EP2805952, KR10-1694710, JP6166736, CA2861891, IN342588

Three Filings, One Map

Magnafolate's footprint in maternal and infant nutrition is taking shape — approved for nutritional supplements for pregnant and lactating women in 2021, for wheat flour in November 2025, and now for infant complementary food nutritional supplements. Prenatal and postnatal nutrition, staple food fortification, and complementary feeding — three pieces that together form a complete map of maternal and infant nutrition coverage. From preconception through breastfeeding to a baby's first solid foods, active folate now spans the full maternal-infant nutrition cycle.

About Jinkang Hexin

Lianyungang Jinkang Hexin Pharmaceutical Co., Ltd. has focused exclusively on active folate R&D and industrialization for 19 years. The company holds 43 active folate patents worldwide, including seven PCT international patents, and maintains one of the world's largest active folate patent portfolios. Since 2017, when Magnafolate was first recognized as a new folate source in China, the company has driven active folate into five application categories: foods for special medical purposes, nutritional formulas for pregnant women and children, foods for special dietary uses, wheat flour, and infant complementary food nutritional supplements.

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References

[1] Lian Z, Liu K, Gu J, Cheng Y, et al. Biological Characteristics and Applications of Folic Acid and 5-Methyltetrahydrofolate. China Food Additives, 2022(2).

[2] Ma W, Xue J, Tu H, Liu K, Cheng Y, Lian Z, et al. Food Safety Evaluation of 6S-5-Methyltetrahydrofolate Calcium Salt. Medical Frontier, 2022, 12(15).

[3] Xu T, Wang K, Zhang J, et al. Study on the Characterization of 6S-5-Methyltetrahydrofolate Calcium Salt Crystal Form C and its Stability Improvement by Ascorbic Acid and Cysteine. LWT - Food Science and Technology, 2024, 198: 115984.

[4] Wang Y, Lian Z, Gu R, et al. Oxidation Product of 5-Methyltetrahydrofolate: Structure Elucidation, Synthesis, and Biological Safety Evaluation. Journal of Molecular Structure, 2024, 1316: 138909.

[5] Lian Z, Chen H, Liu K, et al. Improved Stability of a Stable Crystal Form C of 6S-5-Methyltetrahydrofolate Calcium Salt, Method Development and Validation of an LC–MS/MS Method for Rat Pharmacokinetic Comparison. Molecules, 2021, 26, 6011.