Composé actifIngrédients alimentairesPhase 2 · 2a

Soy Isoflavones & Equol

大豆イソフラボン・エクオール (Daizu Isoflavone / Equol)

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Pourquoi sourcer au Japon

Sourced from Nationwide (Otsuka Pharmaceutical Tokushima facility) with year-round Japanese supply, consistent quality, and traceability to the prefecture of origin.

Spec clé

Glycine max (soybean); Lactococcus 20-92 (for Equol fermentation) source; FFC notification(s) on file; MOQ from 1 kg (concentrate) – 100 kg (lower-concentration grades).

Produit fini typique

Femcare / yuragi-ki menopause-transition supplement (tablet, soft-gel, or jelly) — Midlife women's wellness; for S-equol products, positioning around 'directly delivers the bioactive metabolite regardless of gut microbiota' (per the EQUELLE® precedent).

En un coup d'œil

Fournisseurs répertoriés
5 fournisseurs
MOQ typique
1 kg (concentré) – 100 kg (grades à plus faible concentration)
Régions d'origine
Nationwide (Otsuka Pharmaceutical Tokushima facility)
Catégorie
Ingrédients alimentaires
Statut réglementaire au Japon
Accepté par le FFC pour le « maintien osseux » ; approbations Tokuho pour les produits historiques
Nom japonais
大豆イソフラボン・エクオール
Romaji
Daizu Isoflavone / Equol

À propos de cet ingrédient

Isoflavones de soja (formes aglycone et glycosylée) et S-Équol produit par fermentation au Lactococcus 20-92. « Equelle » (2014), d'Otsuka Pharmaceutical, est le premier complément commercial d'équol issu de soja fermenté au monde. Seules 50 % environ des femmes japonaises (~30 % des femmes occidentales) produisent naturellement de l'équol à partir du soja alimentaire.

Statut réglementaire

JaponAccepté par le FFC pour le « maintien osseux » ; approbations Tokuho pour les produits historiques
Union européenneLe cadre Novel Food s'applique aux isoflavones isolées
États-UnisComplément alimentaire DSHEA ; allégations notifiées à la FDA disponibles

FAQ pour les acheteurs OEM

Q. What MOQs and lead times are typical for Japanese soy isoflavone and S-equol ingredients?

Sourcing reality varies sharply by ingredient form. Standardised aglycone-form soy isoflavone powders (e.g., koji-fermented preparations) are typically available in 1–10 kg trial lots and 50–500 kg commercial lots with 4–10 week lead times. Fermented S-equol concentrate is a much narrower market: Otsuka's EQUELLE® is the dominant commercial source in Japan and is sold as a finished consumer product, not as a bulk ingredient. Brands seeking S-equol as a bulk ingredient must work with the limited set of S-equol producers globally and should expect long lead times and IP-related restrictions on positioning.

Sources · Dernière vérification: 2026-04-26

Connaissance sectorielle — non encore rattachée à une source primaire unique

Q. What documentation should we expect from a soy isoflavone ingredient supplier?

Standard documentation includes: (1) per-lot CoA reporting individual isoflavone composition (daidzein, genistein, glycitein and their glycoside forms) by HPLC, total isoflavone content as aglycone-equivalent, residual solvents, heavy metals, microbiology, and allergen status (soy is a Codex-recognised major allergen and must be declared); (2) GMO status declaration — Identity-Preserved (IP) non-GMO soy is the norm for premium positioning, with supporting traceability paperwork; (3) for fermented preparations, the fermentation organism declaration and a process flow sufficient to confirm the absence of live bacteria in the finished material; (4) for S-equol products, a chiral purity statement (S- vs R-/racemic) since only S-equol is the biologically active form produced by gut bacteria.

Sources · Dernière vérification: 2026-04-26

Q. Are non-GMO, kosher, halal, and organic options available for Japanese soy isoflavones?

Identity-Preserved (IP) non-GMO soy is the standard input for export-oriented Japanese soy isoflavone production; many Japanese suppliers source IP non-GMO soybeans from certified North American or domestic supply chains. Kosher and halal certifications are commonly available because the production process is plant-based with no animal-derived inputs, but should be confirmed per supplier and per ingredient grade. Organic-certified soy isoflavone powders exist but are rarer and command a premium — verify the certifying body (JAS / EU / USDA NOP) and confirm whether the certification covers the soy alone or the full extraction process.

Sources · Dernière vérification: 2026-04-26

Connaissance sectorielle — non encore rattachée à une source primaire unique

Q. What contract considerations are unique to soy isoflavones and S-equol?

Three areas warrant explicit contract treatment: (1) IP and trademark scope — EQUELLE®, Equelle®, ゆらぎ期®, Fuji-Flavone, AglyMax and similar marks are registered to specific companies and cannot be used by buyers without licensing; spell out in the supply agreement whether the supplier permits any reference to the upstream brand; (2) regulatory positioning — fix in writing which market(s) the buyer intends to sell into and confirm the supplier's documentation is sufficient for that market (EU Novel Food considerations, US DSHEA structure-function claim limits, China NMPA health-food filing, Korea MFDS health-functional-food review); (3) for FFC-eligible positioning in Japan, clarify whether the supplier provides systematic-review-ready clinical data or whether the buyer must build its own dossier.

Sources · Dernière vérification: 2026-04-26

Q. What price-sensitivity factors drive soy isoflavone and S-equol pricing?

Per-kilo pricing is driven primarily by (1) form — direct fermented S-equol carries a multiple-order-of-magnitude premium over standardised soy isoflavone aglycone powder, which in turn carries a premium over crude soy extract; (2) standardisation — guaranteed minimum aglycone-equivalent content (e.g., 40% vs 10%) significantly affects unit price; (3) IP status — patented or branded ingredients (e.g., AglyMax®) may carry licensing components in the price; (4) raw-soy commodity pricing and IP non-GMO supply availability. Fluctuations in the global non-GMO soy market and any disruption in Japanese fermentation capacity can both move prices.

Sources · Dernière vérification: 2026-04-26

Connaissance sectorielle — non encore rattachée à une source primaire unique

Cas d'usage

  • Femcare / yuragi-ki menopause-transition supplement (tablet, soft-gel, or jelly)

    Positionnement
    Midlife women's wellness; for S-equol products, positioning around 'directly delivers the bioactive metabolite regardless of gut microbiota' (per the EQUELLE® precedent)
    Niveau d'usage typique
    Aglycone-form soy isoflavones: per-serving dose designed to keep supplement contribution within Japan's 30 mg/day aglycone-equivalent guidance. S-equol: typical reference per EQUELLE® product literature (10 mg S-equol per daily serving as a precedent dose).
    Notes de formulation
    For Japanese-market positioning, aligning per-serving dose to the Food Safety Commission supplement-intake guidance is critical. For FFC notification, the dose, isoflavone form, and study population must mirror the underlying clinical evidence cited in the dossier. S-equol should be specified as the S-enantiomer; R- or racemic equol is not the biologically active form.

    Sources

  • Bone-maintenance functional supplement (FFC-positioned in Japan; structure-function claims in US)

    Positionnement
    Postmenopausal bone metabolism support, leveraging the legacy Tokuho precedent and current FFC notifications for soy isoflavone bone endpoints
    Niveau d'usage typique
    Per-serving aglycone-equivalent dose set per the FFC dossier; formulators commonly co-formulate with calcium and vitamin D
    Notes de formulation
    Bone-related claims in Japan must align with either an existing Tokuho approval or a self-filed FFC notification. In the US, claims must remain in DSHEA structure-function territory; specific disease (osteoporosis prevention) claims are not permitted without an FDA-authorised health claim. Co-formulation with calcium and vitamin D is conventional.

    Sources

  • Beauty drink / collagen-isoflavone jelly (Japan domestic)

    Positionnement
    'Inner beauty' / skin-quality positioning, often paired with collagen peptide, placenta extract, or hyaluronic acid
    Niveau d'usage typique
    Aglycone-equivalent dose constrained by Japanese supplement-intake guidance; isoflavone serves as the headline functional ingredient with co-actives delivering complementary positioning
    Notes de formulation
    Soy isoflavone is moderately heat-stable but should be added after the high-temperature dissolving step where possible. Match the chosen isoflavone form (aglycone vs glycoside) to the target absorption kinetics and to any FFC evidence the SKU intends to lean on.

    Sources

  • S-equol-direct supplement for non-equol-producing markets (e.g., Western women)

    Positionnement
    Bypasses the gut-microbiota requirement that limits equol exposure to roughly 20–35% of Western adults
    Niveau d'usage typique
    Reference precedent: 10 mg S-equol per daily serving (per EQUELLE® product literature)
    Notes de formulation
    Critical to specify the S-enantiomer rather than racemic equol. Brands launching outside Japan must clear country-specific regulatory paths: in the US, DSHEA structure-function claims; in the EU, isolated S-equol may engage Novel Food considerations and should be cleared with regulatory counsel before launch. Avoid implied therapeutic claims for menopausal symptoms; keep claim language to wellness / quality-of-life territory unless supported by an authorised claim.

    Sources

Fournisseurs japonais

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