Regulatory Compliance Map
Where each ingredient stands
Cross-market regulatory status for every ASXAN single ingredient across the US, EU, CN, and BR — the precise framework reference per market, quoted verbatim. Search, filter by market, and open any row for the full per-market context.
Last reviewed 2026-07-11 · earliest ingredient review 2026-05-23
How to read this map
- US FDA · DSHEA · GRAS · NDI ✓ 107 ○ 2
- EU Novel Food · EFSA · 2002/46/EC ✓ 62 ○ 8
- CN NHC · SAMR · Common Food ✓ 72 ○ 29
- BR ANVISA · RDC 243/2018 · IN 28/2018 ✓ 61 ○ 25
- Permitted Market-legal under the cited framework (conditions may apply) — no specific approved claim.
- Pending Not yet marketable — under review, not authorized, or prohibited.
“Authorized” means a regulator approved a claim — not an ASXAN efficacy endorsement.
What the framework tokens mean — GRAS · NDI · NHC · Novel Food · Common Food · EFSA · ANVISA
US · FDA
- DSHEA
- Dietary Supplement Health and Education Act (1994) — the baseline law under which an ingredient is lawfully sold as a supplement; allows structure/function statements, not disease claims.
- GRAS
- Generally Recognized As Safe — an FDA safety status that lets an ingredient be used in food without pre-market approval.
- NDI
- New Dietary Ingredient notification — the pre-market notification pathway for ingredients not marketed before 1994.
- Qualified / authorized health claim
- An FDA-permitted substance–disease claim (qualified = allowed with caveats; authorized = significant scientific agreement). Shown as “FDA” in the matrix when such a claim exists.
- Food Additive
- A substance approved for a specific food-additive use (21 CFR) — distinct from the dietary-supplement (DSHEA) pathway.
EU · EFSA
- Novel Food (Reg 2015/2283)
- Market-authorization regime for foods not eaten significantly before 1997 — must be authorized before it can be sold.
- EFSA authorized claim (Reg 432/2012)
- A health claim in the official EU Register. Reg 432/2012 lists the general-function (Article 13) claims evaluated by EFSA and authorized by the European Commission; disease-risk and children claims fall under separate articles.
- 2002/46/EC
- The EU Food Supplements Directive — sets the baseline for supplement format and labelling plus the vitamin/mineral positive lists. Non-vitamin/mineral botanicals and bioactives may still require national rules or a Novel Food check.
- Food Additive
- An additive authorized under EU food-additive law (Reg 1333/2008, E-number) — e.g. a colorant or antioxidant — distinct from the supplement / Novel Food pathway.
CN · NHC / SAMR
- Novel Food (NHC)
- A new food raw material approved by the China National Health Commission (NHC) — lawful for food use once listed on the approved catalogue. (Distinct from the drug regulator NMPA.)
- Health food (SAMR)
- A registered or filed functional health-food product, overseen by the State Administration for Market Regulation (SAMR).
- Common Food
- Conventional-food status — lawful to sell without special registration.
- Food Additive
- A food additive authorized under China GB 2760 (e.g. a colorant or fortifier) — distinct from the health-food / new-food pathway.
BR · ANVISA
- RDC 243/2018
- The Brazilian dietary supplement framework — the primary statute for marketing supplements.
- IN 28/2018
- The positive list of authorized functional claims (Anexo V) plus permitted constituents and limits.
Ingredient and market regulatory matrix
114 ingredients · 4 markets
No ingredient matches — try a different name, market, tier, or body system.
5-HTP
Reviewed 2026-06-13
US · Permitted DSHEA
Legal dietary-supplement ingredient under DSHEA 1994 (sourced from Griffonia simplicifolia seed); structure/function claims only with the mandatory FDA disclaimer; no FDA-approved disease/health claim; FDA has historically issued an eosinophilia-myalgia syndrome (EMS) association warning, so it is never accurate to call it FDA-approved
EU · Permitted 2002/46/EC
No EU-wide position and no authorized Reg 432/2012 health claim; member-state fragmentation — permitted as a food supplement in some states (e.g. historically Germany/UK), restricted or treated as medicinal in others; functional copy is not supported at EU level
CN · Pending Pending
Not a permitted food ingredient in China — not listed as novel/health-food raw material nor on CBEC positive list; no compliant supplement pathway.
BR · Pending Pending
Regulatory classification unclear in Brazil; not an established listed food-supplement constituent — a functional ingredient would require case-by-case ANVISA assessment; no authorized functional claim. (BR access path uncertain.)
Acetyl-L-Carnitine
Reviewed 2026-06-04
US · Permitted DSHEA
GRAS · DSHEA dietary supplement · structure/function claims permitted; not an FDA-approved drug for any condition in the US
EU · Permitted 2002/46/EC
No standalone EFSA Reg 432/2012 authorized health claim adopted for acetyl-L-carnitine
CN · Pending Pending
China: acetyl-L-carnitine is mainly a pharmaceutical-grade ingredient, not a separately authorized health-food/GB 14880 fortifier; no confirmed supplement pathway for the ALCAR ester (parent L-carnitine is listed).
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · no IN 28/2018 Anexo V alegação funcional for acetil-L-carnitina
Akkermansia
Reviewed 2026-06-22
US · Permitted DSHEA
Lawful US dietary ingredient: pasteurized A. muciniphila strains have completed FDA NDI notification (HealthBiome HB05P low-dose acknowledged Dec 2024; AKK PROBIO NDI 2026) and a strain holds self-affirmed GRAS (2024) for live and pasteurized forms. Structure/function claims only; NO FDA-authorized health claim.
EU · Permitted Novel Food
Pasteurized A. muciniphila is an authorized EU novel food (Commission Implementing Regulation (EU) 2022/168; EFSA 2021 positive safety opinion, A-mansia Biotech) for food supplements (Dir 2002/46/EC) and FSMP at <=3.4x10^10 cells/day in adults (excl. pregnant/lactating). NO authorized Reg 432/2012 health claim.
CN · Pending Pending
Not approved as a China novel food ingredient; only an Akkermansia muciniphila fermented-lysate cosmetic notification is pending (June 2025), with no food/supplement approval — not lawfully marketable as a food/supplement ingredient in China.
BR · Pending Pending
No ANVISA record of A. muciniphila on the permitted probiotic-strain or dietary-supplement (RDC 243/2018) list; as a next-generation strain it is not an established listed ingredient and has no confirmed Brazilian market-access path. No Anexo V functional claim.
ALA
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · ALA is not subject to a separately authorized qualified health claim (the FDA omega-3 QHC framework targets EPA + DHA specifically)
CN · Permitted Common Food
Flaxseed / linseed oil is a conventional edible oil (ordinary food) in China; ALA is not separately registered as a novel food or SAMR health-food function
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V framework available for plant omega-3 only at the generic level
Authorized claims (verbatim)
EU · EFSA · Reg (EU) 432/2012 Annex “ALA contributes to the maintenance of normal blood cholesterol levels”
Algae Oil
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · ω-3 qualified health claims under the omega-3 framework (CHD risk reduction · 2003Q-0401; blood pressure · 2014Q-0337) when EPA+DHA dose meets the food-labelling threshold
CN · Permitted Novel Food (NHC)
Novel Food ingredient (microalgae DHA · MOH 2010 Notice No.3 · Schizochytrium / Crypthecodinium / Ulkenia) · mandatory in infant formula GB 10765-2021 (0.2-0.5% DHA) · health-food + general food fortification (GB 14880) pathways · cross-border supplements via e-commerce
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “EPA and DHA contribute to the normal function of the heart.”
EU · EFSA · Reg 432/2012 “DHA contributes to the maintenance of normal brain function.”
EU · EFSA · Reg 432/2012 “DHA contributes to the maintenance of normal vision.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
Alpha-Lipoic Acid
Reviewed 2026-06-04
US · Permitted DSHEA
GRAS · DSHEA dietary supplement (oral form) · structure/function claims permitted; not an FDA-approved drug for any condition in the US
EU · Permitted 2002/46/EC
No standalone EFSA Reg 432/2012 authorized health claim adopted for alpha-lipoic acid
CN · Pending Pending
China: alpha-lipoic acid not in health-food raw-material catalogue nor a novel/general-food additive; domestic identity is OTC drug (diabetic neuropathy); no compliant domestic supplement route, only cross-border e-commerce.
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · no IN 28/2018 Anexo V alegação funcional for ácido alfa-lipoico
Ashwagandha
Reviewed 2026-06-13
US · Permitted DSHEA
DSHEA dietary supplement; KSM-66 holds self-affirmed GRAS (sponsor panel, NOT an FDA no-questions GRN letter, so FDA approved is never accurate); structure/function claims only with mandatory disclaimer; FDA warning letters issued against disease claims
EU · Permitted 2002/46/EC
Marketable as a food supplement in several member states (recognized traditional food-use history, not Novel Food) but NO authorized Art.13/14 health claim; 2024 EU Heads of Food Safety Agencies recommended an Article 8 Novel Food assessment over hepatotoxicity / reproductive / thyroid concerns; member-state policies differ
CN · Pending Pending
Not approved in China: absent from SAMR health-food positive list, novel-food approvals, and medicine-food homology list; not permitted in common food. Only gray cross-border e-commerce; no functional claims.
BR · Pending Pending
Prohibited as food / food supplement (ANVISA RE no 3.669/2022 bans commercialization, import, advertising and use of Withania somnifera); exception: individualized pharmacy compounding under RDC 67/2007 with a qualified prescription
Astaxanthin
Reviewed 2026-05-23
US · Permitted GRAS
GRAS NDI (Haematococcus pluvialis source)
EU · Permitted Novel Food
Novel Food market access authorized (Reg 2015/2283 · Haematococcus pluvialis source · ≤ 8 mg/day food supplement limit per EFSA opinion) · NO authorized health claim under Reg 432/2012 (no EFSA-approved structure/function or health claim for astaxanthin)
CN · Permitted Novel Food (NHC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo I authorized constituent (Haematococcus pluvialis source) · Anexo IV upper limit 6 mg/dia · Anexo VI complementary-labelling warning (not for pregnant/lactating women or children) · NO authorized functional claim in Anexo V — astaxanthin is permitted as a constituent only, not a claim-bearing ingredient
Bacopa monnieri
Reviewed 2026-06-13
US · Permitted DSHEA
DSHEA dietary supplement (marketed under NDI / self-determined dietary-ingredient status; no independent FDA GRAS no-questions letter — GRN 0); standardized branded extracts (Synapsa/PS-BM, BacoMind, CDRI 08/KeenMind, Bacumen) sold legally. Structure/function claims only with mandatory FDA disclaimer; disease claims (Alzheimer/dementia/ADHD/epilepsy treatment) prohibited.
EU · Permitted 2002/46/EC
No authorized EFSA health claim for Bacopa monnieri — its botanical Art.13 cognitive/memory claims remain on the EFSA on-hold list (pending, never finalised), not formally absent. Sold via the Traditional Herbal Medicine / Traditional Herbal Registration (THR) route in member states under traditional-use claims only; member-state rules differ.
CN · Pending Pending
Not approved in China: absent from medicine-food homology, novel-food, and SAMR health-food raw-material catalogues; no clear ingredient pathway; domestic market is cross-border e-commerce only with no functional claims.
BR · Pending Pending
Registrable under RDC 243/2018 as fitoterapico (herbal medicine) or food supplement, requiring submitted safety and efficacy data; approval pathway is comparatively complex, especially for standardized-extract quality control. No Anexo V alegacao funcional for Bacopa.
BCAA
Reviewed 2026-06-21
US · Permitted DSHEA
Permitted dietary-supplement ingredient under DSHEA (structure/function claims with mandatory disclaimer); L-leucine/L-isoleucine/L-valine hold industry self-affirmed GRAS status (no individual FDA GRN), are usable for food fortification under the 21 CFR 172.320 amino-acid framework, and are permitted in infant formula (21 CFR 107.100). No FDA-authorized health claim.
EU · Permitted 2002/46/EC
Permitted for sale as a food-supplement ingredient under Directive 2002/46/EC; existing amino acids (not Novel Food). EFSA has issued NO authorized health claim for BCAA — exercise-performance, muscle and immune Article 13 claims were rejected (EFSA opinions 2010;1817 and 2011;2225).
CN · Permitted Health Food
Permitted nutrient-fortification ingredient under SAMR: branched-chain amino acids (L-leucine/isoleucine/valine) listed in GB 14880-2012 food-fortifier standard and allowed in sports-nutrition foods (GB 24154); no health-function claim without registration.
BR · Permitted ANVISA
Permitted dietary-supplement ingredient in Brazil: L-leucine/L-isoleucine/L-valine listed in IN 28/2018 Anexo I (authorized amino-acid ingredients) and used within the sports-nutrition supplement framework (RDC 243/2018).
Berberine
Reviewed 2026-05-29
US · Permitted DSHEA
DSHEA dietary supplement; not GRAS; FDA warning letters on diabetes/cholesterol disease claims
EU · Permitted 2002/46/EC
Not authorized as food supplement claim; Novel Food considerations
CN · Pending Pending
China SAMR: berberine HCl is an OTC drug for intestinal infection, not a supplement. No dietary-supplement/common-food pathway (absent from GB 2760, GB 14880, health-food raw-material catalogue); only cross-border e-commerce import.
BR · Pending Pending
Berberine is NOT on the ANVISA IN 28/2018 authorized-constituent positive list (a nao-autorizado constituent for food supplements); the RDC 243/2018 framework exists but berberine itself has no compliant dietary-supplement pathway.
Beta-Carotene
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · NOT subject to a specific authorized health claim · FDA + IOM tolerable upper intake levels not formally set for β-carotene (vitamin A precursor pathway is regulated)
EU · Permitted Food Additive
E160a food colour (Reg 1333/2008) · vitamin A claims (Reg 432/2012) apply via retinol equivalents (12 µg β-carotene = 1 µg RAE); no separate β-carotene-specific claim · not a novel food (long history of dietary use)
CN · Permitted Novel Food (NHC)
Novel Food ingredient (Dunaliella salina source) · nutrient fortifier (GB 14880) + food colour (GB 2760) · health-food raw material (immune / antioxidant functions require health-food registration) · mandatory smoker-exclusion labelling
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 vitamin A claims applicable when β-carotene contributes to retinol activity equivalents · no β-carotene-specific separate Anexo V claim
Beta-Glucan
Reviewed 2026-05-31
CN · Permitted Novel Food (NHC)
Novel Food ingredient (oat beta-glucan general food use · yeast beta-glucan 2010 notice · adult upper limit 250 mg/day) · mushroom beta-glucan via health-food registration pathway
BR · Permitted ANVISA
RDC 243/2018 dietary supplement framework · IN 28/2018 Anexo I authorized constituent (Beta-glucana de farelo de aveia · Beta-glucana de levedura) · NO Anexo V alegação funcional for beta-glucan (Anexo V fiber claims limited to psyllium ≥ 7 g/dia and quitosana ≥ 3 g/dia)
Authorized claims (verbatim)
US · FDA · 21 CFR 101.81 Authorized Health Claim “Soluble fiber from oats, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the [necessary daily dietary intake of] beta-glucan soluble fiber from oats necessary per day to have this effect.”
EU · EFSA · Reg 432/2012 “Oat beta-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.”
EU · EFSA · Reg 432/2012 “Barley beta-glucan has been shown to lower/reduce blood cholesterol.”
EU · EFSA · Reg 432/2012 “Beta-glucans contribute to the maintenance of normal blood cholesterol levels.”
Biotin
Reviewed 2026-06-13
US · Permitted GRAS
GRAS · lawful dietary-supplement ingredient · structure/function claims (hair/skin/nails/energy metabolism) permissible. FDA 2017/2019 Safety Communications: high-dose biotin interferes with immunoassays (troponin/TSH/BNP) — high-dose products should carry a warning.
CN · Permitted Health Food
Listed as a permitted food nutrition fortifier under GB 14880-2012 and usable in health foods; products may carry the supplement claim 'supplements B-group vitamins', and health-food registrations may apply for related function claims. SAMR recognized.
BR · Permitted ANVISA
Listed in RDC 269/2005 permitted-vitamins list (biotina). ANVISA functional-claim framework (IN 28/2018) available subject to minimum-quantity thresholds.
Authorized claims (verbatim)
EU · EFSA · Reg (EU) 432/2012 Annex (Art. 13(1)) “Biotin contributes to the maintenance of normal hair”
EU · EFSA · Reg 432/2012 “Biotin contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Biotin contributes to normal macronutrient metabolism”
EU · EFSA · Reg 432/2012 “Biotin contributes to the normal functioning of the nervous system”
EU · EFSA · Reg 432/2012 “Biotin contributes to normal psychological function”
EU · EFSA · Reg 432/2012 “Biotin contributes to the maintenance of normal hair”
EU · EFSA · Reg 432/2012 “Biotin contributes to the maintenance of normal skin”
EU · EFSA · Reg 432/2012 “Biotin contributes to the maintenance of normal mucous membranes”
Black Seed Oil
Reviewed 2026-06-13
US · Permitted DSHEA
Dietary supplement under DSHEA; Nigella sativa has a history of food use, no independent GRAS Notice (GRN); structure/function claims only
EU · Permitted 2002/46/EC
0 authorized / 0 non-authorized health claims (no claim dossier submitted); food-use history but no EFSA claim evaluation — no health claim may be made cross-border in the EU
CN · Pending Pending
Not a traditional Chinese food ingredient; requires Novel Food or health-food (SAMR) raw-material application/assessment and has no confirmed domestic approval to date.
BR · Pending Pending
Vegetable-oil category subject to case-by-case ANVISA assessment (RDC 243/2018 framework); no standalone authorized functional (alegacao funcional) claim
Boron
Reviewed 2026-06-13
US · Permitted DSHEA
Lawful as a dietary supplement under DSHEA; no independent GRAS notice (GRN) for elemental boron; structure/function claims permitted (no disease claims).
EU · Permitted Novel Food
0 authorized health claims / 8 non-authorised opinions (bone, joint, cognitive and other directions all returned unfavourable, incl. EFSA J.1261 2009 and J.2209 2011); marketable but no permitted health claim in the EU.
CN · Pending Pending
Not an established positive-list entry: boron is not a GB 14880 nutritional fortification substance and has no clear SAMR health-food raw-material pathway (non-traditional mineral, status to be confirmed); regulatory status pending in China
BR · Pending Pending
Not a default entry on the IN 28/2018 positive list; requires case-by-case (caso-a-caso) assessment for use in supplements in Brazil.
Boswellia
Reviewed 2026-06-13
US · Permitted DSHEA
US dietary supplement ingredient under DSHEA · structure/function claims (joint health, healthy inflammatory response, joint flexibility). Branded extracts Aflapin®/5-Loxin® hold self-affirmed GRAS + NDI notifications; Boswellin® (Sabinsa) + AprèsFlex® (PLT) hold NDI. Boswellia serrata Extract is USP-NF monographed (AKBA assay). All S/F claims require the FDA disclaimer: 'This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.'
EU · Permitted 2002/46/EC
No authorized EFSA health claim — Article 13.1 joint-health / anti-inflammatory / respiratory claims were returned (2009: cause-effect not established, human RCT data deemed insufficient at that time). Not a Novel Food. Traditional Herbal Medicinal Product (THR) registration is available in some member states (Germany BfArM accepts traditional-use registration under Directive 2004/24/EC).
CN · Pending Pending
No confirmed China supplement/food status: Boswellia is a TCM herbal material (Chinese Pharmacopoeia 2020), not a novel food ingredient and not permitted in conventional foods; no health-food registration exists.
BR · Pending Pending
Regulated as a traditional phytomedicine (Fitoterápico / Produto Tradicional Fitoterápico), NOT as a dietary supplement (Suplemento Alimentar) — Boswellia serrata is on the IN 02/2014 Anexo I positive list under RDC 26/2014. Approved traditional use: anti-inflammatory (anti-inflamatório); standardized total boswellic acids typically ≥60%. Requires Fitoterápico Tradicional registration (~6-12 months) + local regulatory agent.
Caffeine
Reviewed 2026-06-27
US · Permitted GRAS
GRAS (21 CFR 182.1180; cola-type beverages limited to 0.02% / 200 ppm) and a lawful dietary-supplement ingredient under DSHEA 1994; structure/function claims permitted with 30-day FDA notification. FDA recommends ≤400 mg/day for healthy adults. 2018 guidance restricts pure/highly-concentrated bulk caffeine sold direct to consumers (overdose risk).
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Permitted in food supplements under the RDC 243/2018 framework (IN 28/2018 authorized-constituent list); energy drinks limited to ≤350 mg/L (RDC 273/2005); mandatory 'CONTÉM CAFEÍNA' label warning plus pregnancy/child cautions. Weight-loss and fatigue-treatment claims are not permitted.
Calcium
Reviewed 2026-06-04
CN · Permitted Health Food
Approved in China as a nutrient-supplement raw material (calcium is an essential mineral listed in the 2023 SAMR Catalogue of Health-Food Raw Materials — Nutrient Supplements) and as a nutrient fortifier under GB 14880-2012. Nutrient-supplement filing supports 'calcium supplementation'; the registered health-food function 'increases bone mineral density' has extensive SAMR registrations as precedent.
Authorized claims (verbatim)
US · FDA · 21 CFR 101.72(e) - Health claims: calcium, vitamin D, and osteoporosis - calcium-only model “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”
US · FDA · 21 CFR 101.72(f) - Health claims: calcium, vitamin D, and osteoporosis - calcium + vitamin D + physical activity model (added by 73 FR 56486, Sept 29, 2008) “Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”
US · FDA · 21 CFR 101.72(f) - calcium + vitamin D + physical activity extended model “Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.”
EU · EFSA · Reg 432/2012 “Calcium contributes to normal blood clotting”
EU · EFSA · Reg 432/2012 “Calcium contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Calcium contributes to normal muscle function”
EU · EFSA · Reg 432/2012 “Calcium contributes to normal neurotransmission”
EU · EFSA · Reg 432/2012 “Calcium contributes to the normal function of digestive enzymes”
EU · EFSA · Reg 432/2012 “Calcium has a role in the process of cell division and specialisation”
EU · EFSA · Reg 432/2012 “Calcium is needed for the maintenance of normal bones”
EU · EFSA · Reg 432/2012 “Calcium is needed for the maintenance of normal teeth”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O cálcio auxilia na formação e manutenção de ossos e dentes.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O cálcio auxilia na coagulação do sangue.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O cálcio auxilia no funcionamento muscular.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O cálcio auxilia no funcionamento neuromuscular.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O cálcio auxilia no processo de divisão celular.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O cálcio auxilia no metabolismo energético.”
Calcium AKG
Reviewed 2026-06-13
US · Permitted DSHEA
GRAS self-affirmation pathway; marketed as a dietary supplement under DSHEA (Rejuvant and other brands legally sold). No specific FDA-authorized health claim.
EU · Permitted 2002/46/EC
Novel Food / EU status: 0 EFSA-authorised and 0 non-authorised health claims (Reg 1924/2006). Some member states permit CaAKG as a food supplement; no EU-level authorized claim.
CN · Pending Pending
Calcium-AKG: AKG not on China's novel-food catalogue; only an unconfirmed calcium-supplement path — no SAMR, common-food, or novel-food approval on record.
BR · Pending Pending
No specific ANVISA approval; would require case-by-case evaluation under the dietary-supplement framework (RDC 243/2018). No IN 28/2018 Anexo V alegação funcional for CaAKG.
Choline
Reviewed 2026-06-22
US · Permitted GRAS
Recognized essential nutrient (IOM 1998); FDA Daily Value 550 mg (2016). Multiple forms (choline bitartrate, choline chloride, alpha-GPC, CDP-choline) are lawful GRAS dietary-supplement / food ingredients; structure/function claims with mandatory DSHEA disclaimer; no FDA-authorized health claim.
CN · Permitted Health Food
Choline (bitartrate/chloride) is a lawful GB 14880 nutritional fortifier; mandatory in infant formula; usable in health foods.
BR · Permitted ANVISA
ANVISA-recognized nutrient usable in food supplements (RDC 269/2005 referencing international references; IN 28/2018 supplement framework). Listed nutrient ingredient; no specific Anexo V functional claim distinct from nutrient declaration.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Choline contributes to normal lipid metabolism”
EU · EFSA · Reg 432/2012 “Choline contributes to the maintenance of normal liver function”
EU · EFSA · Reg 432/2012 “Choline contributes to normal homocysteine metabolism”
Chromium
Reviewed 2026-06-04
US · Permitted DSHEA
United States (FDA): Chromium has NO SSA (Significant Scientific Agreement) authorized health claim under 21 CFR Part 101 Subpart E. Marketed as a dietary supplement under DSHEA (1994); structure/function claims permitted (e.g., "helps maintain healthy blood sugar levels already within normal range") with mandatory DSHEA disclaimer "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." FDA issued a Qualified Health Claim (NOT SSA) via Letter of Enforcement Discretion dated 2005-08-25 (Docket No. 2004Q-0144) for chromium picolinate and reduced risk of insulin resistance / type 2 diabetes: "One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain." Conditions: dietary supplements meeting "high" chromium level (>= 24 mcg per RACC). This is enforcement discretion, not an authorized SSA claim. Trivalent chromium is not affirmed GRAS under 21 CFR 184 — it is a lawful dietary supplement ingredient under DSHEA.
CN · Permitted Health Food
Established nutrient (SAMR): trivalent chromium is a permitted health-food raw material, with a 'assists in lowering blood glucose' health-food function-claim approval precedent for chromium picolinate
Authorized claims (verbatim)
BR · ANVISA · ANVISA IN nº 28/2018, Anexo V (alegações de propriedade funcional autorizadas para suplementos alimentares) “O cromo auxilia no metabolismo de proteínas, carboidratos e gorduras.”
Citicoline
Reviewed 2026-06-13
US · Permitted NDI
Marketed as a DSHEA dietary supplement (Cognizin and others) — NDI / self-determined status varies by manufacturer (no single accepted NDIN confirmed) · 0 GRAS GRN · 0 FDA authorized health claim · note a parallel OTC/Rx drug identity exists internationally (ATC N06BX06) · DSLD ~46 products
EU · Permitted Novel Food
Sold as a food supplement in several EU member states (Italy, Spain, etc.) · 0 EFSA authorized health claim
CN · Pending Pending
Citicoline sodium is a prescription drug in China (injectable, acute neuro indications); oral supplement form not approved as novel/health-food ingredient.
BR · Pending Pending
Regulated principally as a prescription medicine in Brazil · dietary-supplement pathway requires case-by-case evaluation · no IN 28/2018 Anexo V alegação funcional
CLA
Reviewed 2026-06-13
US · Permitted GRAS
Dietary supplement under DSHEA; GRAS — FDA GRAS Notices GRN 521 and GRN 232 both received 'no questions' letters (GRN 153 and GRN 148 ceased). No FDA-authorized health claim; structure/function statements permitted with DSHEA disclaimer.
EU · Permitted 2002/46/EC
Market access permitted as food supplement, but NO authorized EFSA health claim. All Art.13.1 claims (body fat, lean body mass, immune, etc.) were rejected in 2010, and the Clarinol/Tonalin Art.13.5 body-fat application was rejected (EFSA Journal J.3953, 2015 — EFSA concluded CLA-associated fat reduction was accompanied by increased lipid peroxidation and inflammation, not a beneficial physiological effect).
CN · Pending Pending
Not listed in China's health-food (SAMR) raw-material catalog; available only via cross-border e-commerce channels; no domestic conventional-food or health-food approval identified.
BR · Permitted ANVISA
Saleable within the sports-nutrition category (RDC 243/2018 dietary supplement framework / IN 28/2018 pathway). No IN 28/2018 Anexo V alegação funcional specific to CLA.
Cocoa Extract
Reviewed 2026-06-27
US · Permitted DSHEA supplement
Lawful dietary-supplement ingredient under DSHEA; cocoa flavanols carry an FDA qualified health claim (2023) on the relationship between high-flavanol cocoa powder and reduced cardiovascular-disease risk (qualified — mandatory limiting language). Structure/function claims permitted.
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Permitted dietary-supplement ingredient under RDC 243/2018 (Brazil is a major cocoa-producing country); no specific authorized functional claim — permitted as a constituent only.
Cod Liver Oil
Reviewed 2026-06-04
US · Permitted DSHEA
Traditional food / DSHEA dietary supplement (no FDA no-questions GRAS notice specific to cod liver oil) · qualified (not authorized) health claims under the omega-3 framework (EPA+DHA + CHD risk · 2003Q-0401; EPA+DHA + blood pressure · 2014Q-0337); vitamin A and D structure/function claims permitted within DVs
CN · Permitted Health Food
Permitted in China as an existing food/health-food raw material: fish/cod-liver oil is a traditional food ingredient and has numerous SAMR health-food registrations (e.g. immune support, blood-lipid). Conventional-food use cannot bear health-function claims.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “EPA and DHA contribute to the normal function of the heart.”
EU · EFSA · Reg 432/2012 “Vitamin D contributes to normal absorption and utilisation of calcium and phosphorus.”
EU · EFSA · Reg 432/2012 “Vitamin A contributes to the maintenance of normal vision.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
Collagen Peptides
Reviewed 2026-05-29
US · Permitted GRAS
GRAS · DSHEA dietary supplement; structure/function claims permitted
EU · Permitted 2002/46/EC
No authorized health claim (collagen-specific claims rejected 2011)
CN · Permitted Common Food
Managed as a conventional food in China — gelatin and collagen peptides are ordinary food ingredients, not listed as New Food Raw Materials (novel food); collagen also appears in registered health foods.
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not authorized for collagen
CoQ10
Reviewed 2026-05-29
US · Permitted DSHEA
GRAS · DSHEA dietary supplement; structure/function claims permitted
EU · Permitted 2002/46/EC
No authorized health claim (claims rejected 2010); permitted as food supplement
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not authorized
Cordyceps
Reviewed 2026-06-13
US · Permitted DSHEA
Cordyceps sinensis and C. militaris extracts are legal dietary-supplement ingredients under DSHEA; structure/function claims only with the mandatory disclaimer; no FDA-authorized health/disease claim; FDA GRAS GRN = 0. DSLD lists 48 marketed products.
EU · Permitted 2002/46/EC
Marketable as a food supplement / traditional herbal product in some member states, but 0 EFSA-authorized health claims; both Art.13(1) applications were REJECTED — antioxidant (EFSA Journal 2010;8(10):1752) and exercise/endurance (EFSA Journal 2011;9(6):2247). Functional copy limited to ingredient-fact / mechanism description.
CN · Permitted Novel Food (NHC)
Species-split: C. militaris fruiting body is an approved novel food (MOH 2009 No.3) usable in common and health food; C. sinensis is a TCM material managed under TCM-material rules, not common food.
BR · Pending Pending
No Cordyceps-specific authorization; fungal-extract supplement ingredients require case-by-case ANVISA assessment and Cordyceps is not on the approved functional-claim positive list.
Creatine
Reviewed 2026-05-31
US · Permitted GRAS
Self-affirmed GRAS (AlzChem Creapure · GRN 144 · 2003) · DSHEA dietary supplement framework
CN · Permitted Common Food
Creatine: sports-nutrition food ingredient under GB 24154-2015 (mandatory in speed-strength category) and on the CBEC cross-border positive list; regulated conventional food, no SAMR health-function registration.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Creatine increases physical performance in successive bursts of short-term, high intensity exercise.”
EU · EFSA · Reg 432/2012 “Daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A creatina auxilia no aumento do desempenho físico durante exercícios repetidos de curta duração e alta intensidade.”
Curcumin
Reviewed 2026-05-29
US · Permitted DSHEA
GRAS (turmeric · curcumin) · DSHEA dietary supplement; structure/function claims
EU · Permitted Food Additive
ADI 3 mg/kg bw/day (2010) under re-evaluation 2024; no authorized health claim
CN · Permitted Common Food
China SAMR: turmeric is medicine-food homology; curcumin is approved food-colour additive E100 (GB 2760) and a permitted health-food raw material, but no single-ingredient curcumin authorized health function exists.
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not authorized
DHA
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · qualified health claims under the omega-3 framework when EPA+DHA blend threshold met
CN · Permitted Health Food
DHA and EPA are recognized n-3 PUFA nutrient sources in China; fish oil and DHA algae oil are listed on the SAMR health-food raw-material directory for nutrient supplementation (filing-based).
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “DHA contributes to the maintenance of normal brain function.”
EU · EFSA · Reg 432/2012 “DHA contributes to the maintenance of normal vision.”
EU · EFSA · Reg 432/2012 “Maternal intake of DHA contributes to normal brain development of the foetus and breastfed infants.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
DPA
Reviewed 2026-06-13
US · Permitted DSHEA
Omega-3 fatty acid naturally present in fish oil and seal oil (GRAS only as a fish-oil constituent, no standalone DPA GRAS notice); permitted as a dietary supplement constituent under the DSHEA framework (omega-3 fatty acid category, structure/function claims). No DPA-specific FDA-approved health claim; DPA is not separately listed within the EPA+DHA qualified health claim framework.
EU · Permitted 2002/46/EC
Permitted as a food/food-supplement constituent within fish-oil / marine-oil products. EFSA Reg 432/2012 authorised omega-3 health claims cover EPA and DHA; there is NO standalone EFSA authorised health claim for DPA.
CN · Pending Pending
No independent China regulatory status for isolated DPA; permitted only as a natural minor constituent of approved carrier oils (fish oil / seal oil). No standalone novel-food or health-food approval for DPA alone.
BR · Permitted ANVISA
Permitted as a constituent of food supplements (RDC 243/2018) when present via fish oil or seal oil. IN 28/2018 Anexo V alegação funcional covers EPA and DHA ("Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos."); there is no separate ANVISA functional claim for DPA alone.
EGCG
Reviewed 2026-06-13
US · Permitted DSHEA
Green tea catechins hold an FDA GRAS notice (GRN 259, catechins from green tea extract); EGCG is sold as a DSHEA dietary supplement with structure/function claims permitted (30-day notification + disclaimer). Safety caveat: NIH LiverTox lists green tea extract / EGCG as a known cause of liver injury and USP places it in Class B. 'Liver-protective / hepatoprotective' framing and disease/anti-cancer claims are prohibited.
EU · Permitted 2002/46/EC
Permitted supplement ingredient (Directive 2002/46/EC) but with no authorized health claim (all 2010-2011 applications rejected); safety upper limit <=800 mg EGCG/day (EFSA 2018, EFSA Journal 2018;16(4):5239); several countries (e.g. France's ANSES) recommend labeling hepatotoxicity risk and a high-dose-on-empty-stomach warning. China SAMR: tea polyphenols are a health-food raw material with approved 'antioxidant' and 'assists in lowering blood lipids' claims.
CN · Permitted Health Food
China SAMR: tea polyphenols / green tea extract are common-food + registered health-food raw materials; multiple health foods carry registered antioxidant and assist-lowering-blood-lipids functions. No statutory EGCG dose limit (EFSA 800 mg/day used as internal benchmark).
BR · Permitted ANVISA
Food supplement (RDC 243/2018 + IN 28/2018 positive list); antioxidant-related claims permitted; must carry an adverse-effect warning and a take-with-food instruction.
EPA
Reviewed 2026-06-04
US · Permitted GRAS
Icosapent ethyl (Vascepa) is a prescription drug indicated as an adjunct to statin therapy for CV risk reduction in elevated-triglyceride adults; dietary supplement EPA is GRAS · DSHEA framework · qualified health claims under the omega-3 framework when EPA+DHA blend dose threshold met
CN · Permitted Health Food
DHA and EPA are recognized n-3 PUFA nutrient sources in China; fish oil and DHA algae oil are listed on the SAMR health-food raw-material directory for nutrient supplementation (filing-based).
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “EPA and DHA contribute to the normal function of the heart.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
Ergothioneine
Reviewed 2026-06-13
US · Permitted GRAS
US FDA — GRAS self-affirmed no-objection (synthetic L-EGT): Blue California ErgoActive GRN 734 (no-questions 2019); Tetrahedron MitoPrime (2021). Marketed as DSHEA dietary supplement + food fortification. GRAS self-affirmation is NOT FDA approval/certification.
EU · Permitted Novel Food
EU — Novel Food authorized for synthetic L-ergothioneine (Decision EU 2017/1281 Tetrahedron; Reg EU 2018/462 extension; Union List Reg 2017/2470). EFSA 2016/2017 safety opinions. Adult ceiling 30 mg/day; food-supplement use; NOT recommended for pregnant/lactating women or children <3 yr. NO authorized health claim under Reg 432/2012 (market access only, ≠ functional claim).
CN · Pending Pending
China: purified synthetic L-ergothioneine not in health-food catalogue nor approved as novel food (no approval as of 2026), not a food additive; only edible-mushroom-source natural EGT is legal as general food; purified EGT supplement has no compliant domestic route (cross-border only).
BR · Pending Pending
Brazil ANVISA — NOT listed in IN 28/2018 Anexo I authorized constituents; no dedicated novel-ingredient pathway for purified EGT (case-by-case evaluation). Edible-mushroom extract (whole-food) permissible as traditional food; purified synthetic EGT not authorized as supplement constituent.
Evening Primrose (GLA)
Reviewed 2026-06-13
US · Permitted DSHEA
DSHEA-legal dietary supplement ingredient (women's-health / skin category); marketed with structure/function claims only — no FDA-authorized health claim for EPO
EU · Permitted 2002/46/EC
Permitted food-supplement ingredient in the EU; ZERO EFSA-authorized health claims for evening primrose oil / GLA (only neutral compositional description permitted)
CN · Permitted Common Food
Conventional food in China — evening primrose oil is a national-standard edible oil (GB/T 46116-2025); it is not listed in the SAMR health-food raw-material catalogue.
BR · Permitted ANVISA
Permitted food-supplement ingredient in Brazil under the RDC 243/2018 / IN 28/2018 framework; no standalone authorized functional claim
Fisetin
Reviewed 2026-06-13
US · Permitted DSHEA
Marketed as a dietary supplement (multiple brands) but NO published NDI notification or GRAS determination on record — regulatory grey zone under DSHEA; structure/function language only
EU · Pending Pending
No EFSA authorized health claim. Concentrated/purified fisetin extract may trigger the Novel Food Regulation (EU 2015/2283) absent demonstrated pre-1997 EU food-use history; member-state market status varies
CN · Pending Pending
Not approved as a China novel food ingredient; fisetin (concentrated flavonol) is non-traditional and not on the approved food-ingredient inventory — no lawful food/supplement market path in China.
BR · Pending Pending
NOT on the ANVISA dietary-supplement positive list (IN 28/2018) — market entry would require an innovative-ingredient application (12-24 months); currently not marketable in Brazil
Fish Oil
Reviewed 2026-05-24
US · Permitted GRAS
GRAS · qualified health claim docket 2003Q-0401 (CHD); Vascepa (icosapent ethyl) Rx for hypertriglyceridemia
Authorized claims (verbatim)
EU · EFSA · Commission Regulation (EU) No 432/2012, Annex (EPA/DHA entry) “EPA and DHA contribute to the normal function of the heart”
BR · ANVISA · IN 28/2018 Anexo V “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
Folate
Reviewed 2026-06-04
CN · Permitted Health Food
Folate is listed in the Health-Food Raw-Material Catalogue (Nutrient Supplements) under the filing/notification route; the 5-MTHF calcium salt (calcium 6S-5-methyltetrahydrofolate) holds a New Food Ingredient approval. SAMR recognized.
Authorized claims (verbatim)
US · FDA · 21 CFR 101.79(d)(1)(i) “Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect.”
Fucoxanthin
Reviewed 2026-05-23
US · Permitted NDI
DSHEA dietary supplement · NDI varies by source · no FDA authorized health claim
EU · Pending Pending
Novel Food NOT authorized · 2023 EFSA application for a P. tricornutum ethanolic extract (437 mg/day) declined on process-consistency / compositional / pheophorbide A grounds (not efficacy) · no authorized health claim under Reg 432/2012
CN · Pending Pending
NOT approved · purified fucoxanthin not listed in the China novel food catalog · brown seaweed (kelp / wakame) remains a traditional food but standalone purified fucoxanthin requires additional regulatory review · no health-food approval
BR · Permitted ANVISA
RDC 243/2018 dietary supplement framework · IN 28/2018 alegação funcional not authorized for fucoxanthin specifically
Ginkgo Biloba
Reviewed 2026-06-13
US · Permitted DSHEA
Dietary supplement under DSHEA · no affirmative FDA GRAS determination for standalone Ginkgo biloba (the single GRN mentioning ginkgo — GRN 36 — covered a chromium-picolinate / ginkgo / ginseng combination, and FDA ceased its evaluation at the notifier's request) · structure/function claims permissible (no disease claims) · DSLD ~431 products, median 80 mg
EU · Permitted 2002/46/EC
EMA Ginkgo folium herbal monograph splits two regimes: well-established use for age-related mild cognitive impairment / quality of life in mild dementia, and traditional use for minor circulatory complaints (heaviness in legs, cold hands/feet) — national marketing authorisations rely on this monograph · EFSA: 0 authorized health claims (2012 cognitive/circulation claim applications rejected)
BR · Permitted ANVISA
Listed in Memento Fitoterápico (ANVISA herbal medicine list) · dietary supplement and THR pathways both available
Glucosamine
Reviewed 2026-06-13
US · Permitted DSHEA
Dietary-supplement ingredient under DSHEA (pre-1994 'old' ingredient, no NDI needed); glucosamine HCl is GRAS; USP-NF monographs exist for glucosamine sulfate, glucosamine HCl, and chondroitin sulfate sodium. Structure/function claims only — disease (OA 'treatment') claims prohibited; mandatory FDA disclaimer required. Undeclared crustacean allergen = Class I recall (FALCPA).
EU · Permitted 2002/46/EC
EFSA REJECTED all Article 13 joint-health claims for glucosamine (evidence deemed insufficient for causality given heterogeneity of sulfate vs HCl, dose, and population) — NO authorized EU health claim as a food supplement. Separately, crystalline glucosamine sulfate (pCGS, Dona/Viartril-S) is a PRESCRIPTION SYSADOA drug in several EU states (IT/ES/PT/IE/GR) and is ESCEO-recommended as OA Step-1; prescription-drug evidence must NOT be cited to support supplement claims. Crustacean allergen labeling mandatory (Reg 1169/2011).
BR · Permitted ANVISA
Permitted dietary-supplement ingredient (Suplemento Alimentar). RDC 243/2018 framework; IN 28/2018 positive list. Limits: glucosamine <=1500 mg/day, chondroitin sulfate <=1200 mg/day. Portuguese labeling required; crustacean allergen must be labeled 'Contém derivados de crustáceos'. (China SAMR: health-food ingredient, approved function 'enhances bone mineral density'; NOT permitted in conventional foods; also marketed separately as an Rx OA drug.)
Glutathione
Reviewed 2026-06-13
US · Permitted GRAS
Lawful dietary supplement ingredient under DSHEA (1994); L-glutathione holds GRAS status for food use. Structure/function claims (antioxidant, skin health, liver support) permitted with the mandatory DSHEA disclaimer and 30-day FDA notification. 'Whitening/lightening' phrasing carries drug-claim risk and should be expressed as 'supports even skin tone'. No FDA-authorized SSA health claim exists for glutathione.
EU · Permitted 2002/46/EC
EFSA has NOT authorized any glutathione health claim under Reg (EU) 432/2012 (Art. 13/14). GSH is a non-essential nutrient not on the Union authorized-claims list; member-state regulatory status varies. No authorized EU health claim available.
CN · Permitted Health Food
China SAMR: L-glutathione is on the list of substances usable in health food but requires registration (efficacy via clinical trial); no standing authorized claim; general-food only via yeast-extract side-door with no quantitative GSH claim and no whitening/antioxidant claim.
BR · Permitted ANVISA
Glutationa IS an authorized constituent in IN 28/2018 Anexo I (glutathione from E. coli W fermentation), with intake limits in Anexos III/IV — a compliant supplement route already exists (sold in Brazil as a supplement). It carries no IN 28/2018 Anexo V alegação funcional (no authorized functional claim).
Glycine
Reviewed 2026-06-13
US · Permitted Food Additive
GRAS by direct listing under 21 CFR 172.320 (amino acids added to foods); pre-1994 Old Dietary Ingredient under DSHEA; marketed as a dietary supplement with structure/function claims only
EU · Permitted 2002/46/EC
Authorized food-supplement amino acid under Directive 2002/46/EC Annex I; 0 glycine-specific authorized health claims (general structure/function language only)
CN · Permitted Common Food
China: amino-acid nutritional fortifier / food additive under GB 2760, usable in health-food and general-food formulas; no glycine-specific health-food functional claim approved.
BR · Permitted ANVISA
Permitted dietary-supplement amino-acid raw material (RDC 243/2018 / IN 28/2018); no glycine-specific Anexo V functional claim
Grape Seed Extract
Reviewed 2026-06-27
US · Permitted GRAS
Legal dietary-supplement ingredient: pre-DSHEA Old Dietary Ingredient and self-affirmed GRAS (FDA no-objection). DSHEA structure/function claims (e.g. antioxidant support, supports healthy blood pressure already within the normal range) permitted with the mandatory FDA disclaimer; disease claims prohibited. No FDA-authorized health claim.
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Brazil ANVISA: legal botanical food-supplement ingredient under RDC 240/2018; claims must follow ANVISA-recognized wording; no single-ingredient authorized functional claim. [China NMPA: listed health-food raw material; multiple OPC blue-hat health foods approved for the authorized function 'helps with antioxidation' — the only function approved for grape-seed OPC in China; also a conventional-food ingredient per GB/T 22250-2008.]
Green-Lipped Mussel
Reviewed 2026-06-13
US · Permitted NDI
Dietary supplement under DSHEA; structure/function claims only (joint health/mobility, healthy inflammatory response, post-exercise recovery). NDI notification history for Lyprinol®/PCSO-524 (Pharmalink, up to 300 mg/day lipid extract); whole-mussel powder marketed under pre-1994 Old Dietary Ingredient (ODI) basis. Mandatory 'Contains Shellfish' allergen labeling (FALCPA 2004). FDA disclaimer required on all S/F claims. No 'FDA approved' language permitted.
EU · Permitted 2002/46/EC
Food-supplement ingredient (NOT a Novel Food — pre-1997 EU food-use history). ZERO authorized health claims: EFSA did not establish a cause-effect relationship for joint health / mobility (high RCT heterogeneity). Sold lawfully as a food supplement in UK/DE/NL/FR. Mandatory shellfish-allergen labeling (Reg 1169/2011 Annex II).
CN · Permitted Common Food
Whole green-lipped mussel / mussel meat & freeze-dried powder are edible as conventional food, zero functional claims permitted; the lipid extract (Lyprinol) is not on the novel-food list and needs registration.
BR · Pending Pending
Not on the ANVISA dietary-supplement positive list (RDC 243/2018); GLM lipid extract would require the innovative-ingredient pathway (RDC 239/2018, ~12-24 month review). No authorized functional claim. Portuguese 'Contém moluscos' allergen labeling and a local regulatory representative required.
Guaraná
Reviewed 2026-06-27
US · Permitted GRAS
Lawful dietary-supplement ingredient under DSHEA (pre-DSHEA use history — marketed in the US before 1994, so no NDI notification required) and a self-affirmed GRAS natural caffeine source for food/beverage use; never 'FDA approved'. Structure/function claims only, with the mandatory DSHEA disclaimer and 30-day FDA notification. No disease claims. FDA warning-letter precedent against marketing high-caffeine products to children.
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Fully established in Brazil (origin country): a traditional food ingredient and an authorized dietary-supplement constituent under RDC 243/2018 + IN 28/2018 (Paullinia cupana seed), and a Traditional Herbal Product under RDC 240/2018 Annex I. Dietary-supplement caffeine cap is 420 mg per daily serving (all sources). Mandatory caffeine-content labeling plus the warning 'Contém cafeína. Não recomendado para crianças, gestantes, lactantes e pessoas sensíveis à cafeína'. Traditional-use claims only (no disease claims). No Anexo V functional health claim specific to guarana. [China NMPA, for reference: not approved — absent from novel-food, health-food, and medicine-food-homology lists; only compliant C-end channel is cross-border e-commerce with no functional claims and mandatory caffeine declaration on the Chinese label.]
HMB
Reviewed 2026-06-27
US · Permitted GRAS
Lawful dietary-supplement ingredient under DSHEA · HMB-Ca self-affirmed GRAS (Metabolic Technologies / TSI Group) and treated as a pre-1994 Old Dietary Ingredient; HMB-FA (free acid) may require an NDI notification. Structure/function claims only (no FDA-authorized health claim); the FDA disclaimer is mandatory. ('FDA GRAS self-affirmed' — GRAS is a self-determination with no FDA objection, not an FDA approval/certification.)
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Authorized as a food-supplement constituent (Suplemento Alimentar) under RDC 243/2018; β-hidroxi-β-metilbutirato is listed in IN 28/2018 permitted-constituents annex (HMB-Ca as the principal form). Functional claims permitted only within the ANVISA framework; no disease-treatment claims.
Hyaluronic Acid
Reviewed 2026-06-13
US · Permitted GRAS
Dietary supplement ingredient; FDA reviewed GRN 491 (Bioiberica rooster-comb-derived hyaluronic acid extract) with no questions (2014); fermented sodium hyaluronate is additionally marketed under self-affirmed GRAS / NDI notifications (e.g., Injuv, BioCell Collagen) with no FDA objection. Structure/function claims allowed with mandatory disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
EU · Permitted 2002/46/EC
Microbial-fermentation sodium hyaluronate was determined NOT to be a novel food in food supplements (European Commission Article 4 consultation, Ref. Ares(2023)1368064, 24 Feb 2023), so it is not on the EU Union novel-food list. NO authorized Article 13/14 health claim — skin-hydration and joint-maintenance claims received negative EFSA opinions; EU sales rely on ingredient/source statements only.
CN · Permitted Novel Food (NHC)
Approved as Novel Food ingredient — sodium hyaluronate (NHC 2020 Announcement No. 9, issued 2021-01-07) expanded to conventional foods, ≤200 mg/day; also used in registered health foods.
BR · Permitted ANVISA
Oral hyaluronic acid is an authorized bioactive-substance constituent of food supplements under ANVISA IN no 28/2018, as amended by IN no 102/2021, listed with a maximum dose of 157.7 mg/day for adults aged 19+; no efficacy claim required.
Inositol
Reviewed 2026-06-13
US · Permitted GRAS
GRAS; lawful dietary supplement ingredient; mature market. FDA structure/function claims (e.g., metabolic/cellular-signaling support) permitted with mandatory DSHEA disclaimer — disease implications must be avoided. No FDA-authorized health claim.
EU · Permitted 2002/46/EC
Listed permissible food-supplement ingredient under Directive 2002/46/EC. NO EFSA-authorized health claim (a claim application was submitted in the EU but did not obtain EFSA authorization).
CN · Permitted Common Food
myo-Inositol is a lawful food additive (GB 2760) and nutritional fortifier (GB 14880); usable in health foods within GB 14880 dose ranges.
BR · Permitted ANVISA
Usable under the ANVISA dietary-supplement framework (RDC 243/2018); no inositol-specific authorized functional claim.
Iodine
Reviewed 2026-06-04
US · Permitted GRAS
FDA: No SSA (Significant Scientific Agreement) authorized health claim exists for iodine under 21 CFR Part 101 Subpart E (the 12 SSA-eligible nutrients do not include iodine). Iodine is a recognized essential nutrient with an established RDI (150 mcg) per 21 CFR 101.9. Marketed in dietary supplements under DSHEA (1994) — structure/function claims permitted (e.g. "supports thyroid function", "supports normal energy metabolism") provided they carry the mandatory DSHEA disclaimer ("This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.") and the manufacturer notifies FDA within 30 days of first marketing per 21 USC 343(r)(6). GRAS status as a nutrient (potassium iodide, cuprous iodide, calcium iodate) for use in iodized salt and infant formula per 21 CFR 184.1634 / 21 CFR 184.1635.
CN · Permitted Health Food
Established nutrient (SAMR): iodine is a GB 14880 permitted nutritional fortification substance, and potassium iodide / potassium iodate are statutory additives for iodized salt; iodine-related health-food function claims require SAMR health-food registration
Authorized claims (verbatim)
BR · ANVISA · ANVISA IN 28/2018 Anexo V “O iodo auxilia no metabolismo energético.”
Iron
Reviewed 2026-06-04
US · Permitted GRAS
No FDA-authorized Significant Scientific Agreement (SSA) health claim exists for iron under 21 CFR Part 101 Subpart E (the SSA program covers only twelve specified nutrient-disease relationships and iron is not among them). Iron supplements are marketed under DSHEA (Dietary Supplement Health and Education Act of 1994) using structure/function claims (e.g., "supports red blood cell formation", "helps maintain healthy oxygen transport") accompanied by the DSHEA disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" per 21 CFR 101.93. Solid-oral-dosage-form dietary supplements containing iron or iron salts must carry the warning statement required by 21 CFR 101.17(e): "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately." The 1997 unit-dose packaging requirement for iron supplements containing 30 mg or more per dose was vacated by the court in Nutritional Health Alliance v. FDA (3d Cir. 2003) and the corresponding regulation was removed by FDA in 68 FR 59714 (October 17, 2003); only the warning-statement portion of 21 CFR 101.17(e) remains in force. Iron salts including ferrous sulfate are FDA-affirmed GRAS direct food substances for nutrient use (21 CFR 184.1315; elemental iron 21 CFR 184.1375).
CN · Permitted Health Food
Approved in China as an SAMR health-food nutrient raw material and as a nutrient fortifier under GB 14880-2012, with existing health-food registrations for the 'improvement of nutritional anaemia' function as precedent. Nutrient-supplement filing supports 'iron supplementation'; specific SAMR health-function claims require the registration pathway.
Authorized claims (verbatim)
BR · ANVISA · ANVISA Instrução Normativa IN 28/2018 Anexo V “O ferro auxilia na formação das células vermelhas do sangue.”
Krill Oil
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · qualified health claims under the omega-3 framework when EPA+DHA dose meets the food-labelling threshold
CN · Permitted Novel Food (NHC)
Novel Food ingredient (Antarctic krill oil · MOH 2013 Notice No.16 · max 3 g/day · not advised for shellfish-allergic / pregnant / lactating individuals)
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “EPA and DHA contribute to the normal function of the heart.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
L-Carnitine
Reviewed 2026-06-13
US · Permitted GRAS
Self-affirmed GRAS + 21 CFR 107.100 optional infant-formula nutrient; dietary supplement under DSHEA (structure/function claims only). Prescription Levocarnitine (Carnitor) is an FDA-approved drug for primary carnitine deficiency / dialysis — a medical, not supplement, pathway
EU · Permitted 2002/46/EC
Food supplement under Directive 2002/46/EC (pre-1997 use history, no Novel Food authorization required). ZERO authorized health claims: EFSA rejected L-carnitine/ALCAR/PLC claims for lipid/fat metabolism, fatigue recovery, endurance and cognition. Only neutral nutrition-role description permitted
BR · Permitted ANVISA
RDC 243/2018 / IN 28/2018 supplement framework; carnitine listed in Anexo I as an authorized constituent; no standalone authorized efficacy claim
L-Theanine
Reviewed 2026-05-29
US · Permitted GRAS
GRAS (Suntheanine GRN 209) · DSHEA dietary supplement
EU · Permitted 2002/46/EC
Authorized as food supplement; no health claim
CN · Permitted Food Additive
China: food additive (flavor enhancer) under GB 2760-2014 in beverages/foods only; not Novel Food, no approved health-food functional claim for L-theanine.
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not specifically authorized
Lactoferrin
Reviewed 2026-06-27
US · Permitted GRAS
GRAS — bovine lactoferrin (Morinaga GRN 000077; multiple GRAS notices incl. GRN 130/423/464/465/669). Lawful as a dietary-supplement ingredient under DSHEA; structure/function claims only (FDA disclaimer required). rhLF: some firms hold FDA No Objection Letter / self-affirmed GRAS (Helaina Effera 2023; TurtleTree LF+ 2024; precision-fermented rhLF GRN 1284 no questions). 'GRAS' is not 'FDA approval'.
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
bLF authorized — IN 28/2018 authorized constituent (bovine lactoferrin); permitted in infant formula (RDC 43/2011) and dietary supplements (RDC 243/2018). Colostrum products permitted (≥19 yrs, ≤4 g/day). No disease-reduction claims. rhLF: assessed as a novel constituent, no approval to date.
Lion's Mane
Reviewed 2026-06-13
US · Permitted DSHEA
DSHEA dietary supplement (extract/powder). GRN 1124 (H. erinaceus beta-glucans) was self-withdrawn by the notifier 2023 (NOT an FDA no-questions GRAS letter and NOT a rejection). Structure/function claims only with mandatory disclaimer
EU · Permitted 2002/46/EC
No EFSA authorized health claim on record. Marketable as a food supplement in some member states under national rules; beta-glucan immune claims generally rejected at EU level
CN · Permitted Common Food
Hericium erinaceus is a traditional edible fungus usable directly in common food; extract usable in registered health food; common-food form carries no functional claim.
BR · Permitted ANVISA
Fungal extracts assessed case-by-case (RDC 243/2018 / IN 28/2018); no specific authorized functional claim — status pending case evaluation
Lutein
Reviewed 2026-05-29
US · Permitted GRAS
GRAS (marigold extract) · DSHEA dietary supplement
EU · Permitted Food Additive
Authorized food additive E161b; no health claim
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not specifically authorized
Lycopene
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · NO authorized cancer-risk-reduction claim (2005 FDA QHC petition denied for lycopene-cancer); structure/function claims permitted
EU · Permitted Novel Food
Novel Food authorized (Commission Decision 2009/365/EC Blakeslea trispora · 2009/348/EC synthetic · 2009/355/EC tomato) · E160d food colour · NO EFSA Reg 432/2012 authorized health claim (claims rejected)
CN · Permitted Novel Food (NHC)
Novel Food ingredient (new food raw material · MOH 2008 Notice No.12) · health-food raw material (Blue-Cap registration required for functional claims)
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · no IN 28/2018 Anexo V alegação funcional for licopeno
Maca
Reviewed 2026-06-13
US · Permitted DSHEA
DSHEA-legal dietary supplement ingredient (FDA no objection); Structure/Function Claims permitted with mandatory FDA disclaimer; no disease claim. Typical market dose 1500-3000 mg/day.
EU · Permitted 2002/46/EC
Traditional food ingredient / available in EU; some standardized extracts may require Novel Food assessment. NO EFSA-authorized health claim for maca under Reg 432/2012.
BR · Permitted ANVISA
Dietary supplement ingredient under RDC 243/2018; listed on the permitted-plants list via IN 28/2018. No specific Anexo V alegação funcional verbatim confirmed for maca - entry intentionally generic pending direct PDF verification.
Magnesium
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · authorized nutrient content claim "high in magnesium" (≥20% DV)
CN · Permitted Health Food
Approved in China as a nutrient-supplement raw material (magnesium is an essential mineral listed in the SAMR Catalogue of Health-Food Raw Materials — Nutrient Supplements) and permitted as a nutrient fortifier under GB 14880-2012, restricted to catalogue-listed magnesium-salt forms. Note: magnesium L-threonate (Magtein) is NOT yet listed and currently lacks a regulatory identity in China; only approved salt forms (e.g. magnesium glycinate / citrate) may be used domestically.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Magnesium contributes to a reduction of tiredness and fatigue”
EU · EFSA · Reg 432/2012 “Magnesium contributes to electrolyte balance”
EU · EFSA · Reg 432/2012 “Magnesium contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Magnesium contributes to normal functioning of the nervous system”
EU · EFSA · Reg 432/2012 “Magnesium contributes to normal muscle function”
EU · EFSA · Reg 432/2012 “Magnesium contributes to normal protein synthesis”
EU · EFSA · Reg 432/2012 “Magnesium contributes to normal psychological function”
EU · EFSA · Reg 432/2012 “Magnesium contributes to the maintenance of normal bones”
EU · EFSA · Reg 432/2012 “Magnesium contributes to the maintenance of normal teeth”
EU · EFSA · Reg 432/2012 “Magnesium has a role in the process of cell division”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia na formação de ossos e dentes.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia no metabolismo energético.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia no metabolismo de proteínas, carboidratos e gorduras.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia no equilíbrio dos eletrólitos.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia no funcionamento muscular.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia no funcionamento neuromuscular.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “O magnésio auxilia no processo de divisão celular.”
MCT
Reviewed 2026-06-13
US · Permitted GRAS
GRAS (GRN 1049 · Medium-chain triacylglycerols · 2022 · no questions); DSHEA dietary supplement / functional food; structure-function claims used in US market; ~305 DSLD products (median 3000 mg softgel · 15 mL liquid serving). No FDA authorized/qualified health claim for MCT.
EU · Permitted 2002/46/EC
0 authorized health claims — EFSA rejected 3 Art.13(1) claims (weight management / energy expenditure / body-fat reduction) in 2011 (EFSA Journal 2011;9(6):2240). Legal food ingredient (no Novel Food barrier) but no permitted health claim.
CN · Permitted Common Food
Permitted as conventional food ingredient in China (listed in GB 2760 food-additive standard; coconut-oil fractionation product used as common food raw material; allowed in FSMP and infant formula).
BR · Permitted ANVISA
Permitted as a fat source in foods and dietary supplements (RDC 243/2018 framework); long history in enteral/medical nutrition (FSMP). Functional claims assessed case-by-case; no standing MCT-specific authorized functional claim.
Melatonin
Reviewed 2026-06-13
US · Permitted DSHEA
Dietary supplement under DSHEA 1994 (freely sold, no prescription); structure/function claims (sleep-onset, sleep quality, jet-lag, rhythm); no statutory daily limit; market norm 0.5-10 mg
BR · Permitted ANVISA
RDC 587/2021: <=0.21 mg/day as a food supplement; above that regulated as a medicine. The very low cap effectively excludes most international melatonin products from the BR supplement channel
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Melatonin contributes to the reduction of time taken to fall asleep”
EU · EFSA · Reg 432/2012 “Melatonin contributes to the alleviation of subjective feelings of jet lag”
Milk Thistle
Reviewed 2026-06-13
US · Permitted DSHEA
Legal, well-established dietary-supplement ingredient. DSHEA structure/function claims (e.g. supports liver health / antioxidant support) permitted with the mandatory FDA disclaimer; disease claims prohibited. No FDA-authorized health claim.
EU · Permitted 2002/46/EC
Marketable in several member states (traditional-herbal registration / HMPC recognition of traditional use); EFSA has authorized 0 health claims (the MILTE ITALIA 2010 Art.13.5 lactation claim was rejected).
CN · Permitted Health Food
China SAMR: legal health-food raw material; silybin also approved as OTC liver drug. Marketable as supplement ingredient; no single-ingredient authorized health function asserted.
BR · Permitted ANVISA
Usable under the ANVISA traditional-herbal-medicine / food-supplement framework; no IN 28/2018 Anexo V authorized functional claim.
MSM
Reviewed 2026-06-13
US · Permitted GRAS
Lawful dietary supplement ingredient under DSHEA; OptiMSM (Bergstrom Nutrition) holds an independent GRAS determination; Structure/Function claims permitted with mandatory FDA disclaimer; no standardized upper limit
EU · Permitted 2002/46/EC
Permitted as a food supplement ingredient (member-state level, some variation); NO EFSA-authorized health claim under Reg 432/2012
CN · Pending Pending
No confirmed China regulatory status identified: MSM is not on the SAMR health-food positive list, not a novel/medicinal-food ingredient, sold domestically only via cross-border e-commerce.
BR · Permitted ANVISA
Permitted as a dietary/food supplement ingredient under the ANVISA framework; no specific authorized functional claim (alegação funcional) identified
NAC
Reviewed 2026-06-13
US · Permitted DSHEA
Dual identity: FDA-approved prescription drug (acetylcysteine as a mucolytic and acetaminophen-overdose antidote, with roots in the 1960s-70s; the branded IV product Acetadote, NDA 021539, was approved in 2004) AND dietary supplement. In July 2020 FDA issued warning letters over illegal NAC hangover/disease claims, citing as the legal basis that NAC had been approved as a drug before DSHEA (1994) — though FDA notes its own pre-2016 NAC approval records are unreliable and conflicting; in 2022-08 FDA announced enforcement discretion, declining to act against dietary supplements solely for containing NAC. Supplement marketed under Structure/Function Claims + mandatory DSHEA disclaimer; permanent status still pending formal rulemaking.
EU · Permitted 2002/46/EC
No EU-wide harmonized supplement framework and NO EFSA-authorized NAC-specific health claim (Reg 432/2012). Approved as OTC mucolytic / Rx antidote in most member states (Fluimucil, ACC). Supplement status varies by country: Italy / Germany / France (often regulated as medicine). Cysteine carries a conditional Article 13.1 hair/nail/skin claim under specific conditions.
CN · Pending Pending
China: NAC has drug identity only (mucolytic/antidote); not in health-food catalogue, not approved novel food, not a food additive, not. Selling as a supplement is non-compliant; use GSH or L-cysteine as alternative routes.
BR · Permitted ANVISA
Listed in ANVISA permitted constituents for dietary supplements (Suplemento Alimentar) under RDC 239/2018 + IN 28/2018; permitted use as antioxidant / sulfur-amino-acid supplement. Also marketed as a medicine (mucolytic / antidote). Functional claims restricted to ANVISA positive-list wording; requires Portuguese labeling and local regulatory representative.
NADH
Reviewed 2026-06-08
US · Permitted NDI
Dietary supplement under DSHEA · lawful dietary ingredient (NDI · marketed since 1996) · no GRAS notification
EU · Permitted Novel Food
Novel Food classification (case-by-case)
CN · Pending Pending
Not approved — no NHC novel-food or health-food registration pathway; no compliant domestic sales channel
BR · Permitted ANVISA
RDC 243/2018 dietary supplement framework
NADPH
Reviewed 2026-06-02
US · Pending Pending
NOT GRAS · not approved as dietary supplement ingredient (no NDIN filed)
EU · Pending Pending
Novel Food likely required · no current authorization
CN · Pending Pending
NADPH: no SAMR pathway — not a listed novel food, common food, or health-food raw material; case-by-case review only, none approved.
BR · Pending Pending
IN 28/2018 GE (general element) case-by-case registration required
Nervonic Acid
Reviewed 2026-06-21
US · Permitted DSHEA
No FDA GRAS determination for isolated nervonic acid; some Acer truncatum (yuanbaofeng) seed oil products marketed as DSHEA dietary supplements with structure/function claims only; no FDA-authorized health claim.
EU · Pending Pending
No EFSA-authorized health claim; Acer truncatum / Malania seed oil as a source may fall under EU Novel Food regulation requiring EFSA assessment, not currently authorized.
CN · Permitted Novel Food (NHC)
Carrier oil Acer truncatum (yuanbaofeng) seed oil approved as Novel Food ingredient in China (2011 announcement); nervonic acid is its signature functional constituent.
BR · Pending Pending
No specific ANVISA registration or authorized functional claim identified for nervonic acid or Acer truncatum seed oil in Brazil.
Niacin
Reviewed 2026-06-02
US · Permitted GRAS
GRAS (vitamin B3 acid form low dose) · Rx Niaspan for hyperlipidemia
CN · Permitted Health Food
Established nutrient — SAMR-permitted vitamin B3 source (nicotinic acid form) under GB 14880 food-fortifier standard (NRV 15 mg/day); usable in general food fortification and health-food registration. High lipid-modifying doses (1-3 g/day) fall outside routine supplement use and trigger health-food or drug controls.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 “Niacin contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 “Niacin contributes to normal functioning of the nervous system”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2010;8(10):1757 “Niacin contributes to normal psychological function”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 “Niacin contributes to the maintenance of normal mucous membranes”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 + 2010;8(10):1757 “Niacin contributes to the maintenance of normal skin”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2010;8(10):1757 “Niacin contributes to the reduction of tiredness and fatigue”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina auxilia no metabolismo energético.”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina auxilia no metabolismo de proteínas, carboidratos e gorduras.”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina contribui para a manutenção da pele.”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina auxilia na manutenção de mucosas.”
Niacinamide
Reviewed 2026-06-08
US · Permitted GRAS
GRAS (vitamin B3 amide form)
CN · Permitted Health Food
Established nutrient — SAMR-permitted vitamin B3 source (amide form) under GB 14880 food-fortifier standard (NRV 15 mg/day); eligible for health-food, sports-nutrition and general food fortification, and the vitamin B3 health-food function is within the registrable function catalog.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 “Niacin contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 “Niacin contributes to normal functioning of the nervous system”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2010;8(10):1757 “Niacin contributes to normal psychological function”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 “Niacin contributes to the maintenance of normal mucous membranes”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 + 2010;8(10):1757 “Niacin contributes to the maintenance of normal skin”
EU · EFSA · Reg 432/2012 Annex · authorized health claim · EFSA Journal 2010;8(10):1757 “Niacin contributes to the reduction of tiredness and fatigue”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina auxilia no metabolismo energético.”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina auxilia no metabolismo de proteínas, carboidratos e gorduras.”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina contribui para a manutenção da pele.”
BR · ANVISA · IN 28/2018 Anexo V · alegação funcional autorizada “A niacina auxilia na manutenção de mucosas.”
NMN
Reviewed 2026-06-02
US · Permitted NDI
Dietary supplement (NDI) · FDA withdrew its 2022 IND-exclusion determination 2025-09-29 and restored NDI notification status 2025-12-02 · NMN lawful as a dietary-supplement ingredient under DSHEA · structure/function claims only
EU · Pending Pending
Novel Food NOT authorized (Reg 2015/2283) · 6 applications under EFSA evaluation · cannot be lawfully marketed as a food or food supplement in the EU until authorized
CN · Pending Pending
NOT approved · NHC new-food-raw-material filing rejected 2023 · not listed as an approved novel food ingredient, nutrient supplement, or health-food raw material
BR · Pending Pending
PROHIBITED · ANVISA RE 1139/2022 (2022-04-07) full-chain prohibition (commercialisation / distribution / manufacture / import / advertising / use incl. cross-border e-commerce)
Also authorized outside these four markets: TGA · see the full dossier.
Full ingredient dossier →NMNH
Reviewed 2026-06-02
US · Pending Pending
NOT GRAS · no NDIN filed · status pending
EU · Pending Pending
Novel Food required · no authorization
CN · Pending Pending
Not approved — no novel-food or health-food registration; no compliant domestic channel
BR · Pending Pending
IN 28/2018 GE registration required · no specific framework
NR
Reviewed 2026-06-02
US · Permitted GRAS
GRAS 2016 (NIAGEN · ChromaDex GRN 635) · NDIN accepted 2015
EU · Permitted Novel Food
Novel Food authorized 2019 (Reg 2019/1746 · ChromaDex · max 300 mg/day adults)
CN · Pending Pending
Not approved — not listed in the novel-food directory; cross-border e-commerce distribution only; a separate novel-food application is required
BR · Pending Pending
RDC 243/2018 dietary supplement framework · IN 28/2018 no Anexo V claim · NOT on the ANVISA positive list (pending assessment)
Omega-3
Reviewed 2026-05-31
US · Permitted GRAS
GRAS · 1 qualified health claim (EPA+DHA + coronary heart disease · docket 2003Q-0401) · 1 qualified health claim (EPA+DHA + blood pressure · docket 2014Q-0337)
CN · Permitted Novel Food (NHC)
No detailed regulatory note on file for this market — see the full dossier.
Authorized claims (verbatim)
US · FDA · Qualified Health Claim docket 2003Q-0401 “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
US · FDA · Qualified Health Claim docket 2014Q-0337 “Supportive but not conclusive research shows that consuming EPA and DHA combined may reduce blood pressure in the general population and reduce the risk of hypertension.”
EU · EFSA · Reg 432/2012 + 440/2011 “DHA contributes to maintenance of normal brain function (≥ 250 mg/day).”
EU · EFSA · Reg 432/2012 “DHA contributes to maintenance of normal vision (≥ 250 mg/day).”
EU · EFSA · Reg 432/2012 “EPA and DHA contribute to the normal function of the heart (≥ 250 mg/day).”
EU · EFSA · Reg 440/2011 “Maternal DHA intake contributes to normal brain development of the foetus and breastfed infants (200 mg/day during pregnancy + lactation).”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Fonte de ômega 3.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.”
Pantothenic Acid (B5)
Reviewed 2026-06-13
US · Permitted GRAS
United States (FDA): Calcium pantothenate is GRAS by regulation under 21 CFR 184.1212 (since 1984). Lawful dietary ingredient under DSHEA 1994 (~194 products in DSLD, median ~500 mg/day). Structure/function claims are permitted with the mandatory disclaimer 'This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.' US IOM Adequate Intake (AI) for adults is 5 mg/day; no UL established. No 21 CFR Part 101 Subpart E Significant Scientific Agreement health claim exists for pantothenic acid.
CN · Permitted Health Food
Established nutrient — listed in the SAMR Health Food Raw Material Catalog (nutrient supplements, 2020 ed.) as calcium D-pantothenate / sodium pantothenate, and permitted under GB 14880 food-fortifier and GB 2760 standards; filing pathway available (adult RNI 5 mg/day; no UL set).
BR · Permitted ANVISA
Brasil (ANVISA): Acido pantotenico (vitamina B5) e constituinte autorizado de suplementos alimentares sob RDC 243/2018, com limites minimos/maximos de ingestao diaria regulados pela IN 28/2018 (Anexos III/IV). Alegacoes de propriedade funcional, quando aplicaveis, seguem o padrao verbatim oficial do Anexo V e devem ser usadas sem reescrita Sem UL estabelecido.
Authorized claims (verbatim)
EU · EFSA · Reg (EU) 432/2012 Annex “Pantothenic acid contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Pantothenic acid contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Pantothenic acid contributes to the reduction of tiredness and fatigue”
EU · EFSA · Reg 432/2012 “Pantothenic acid contributes to normal mental performance”
EU · EFSA · Reg 432/2012 “Pantothenic acid contributes to normal synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters”
Pea Protein
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · no specific health claim · qualifies for 21 CFR 101.79 "good source of protein" (≥ 10% DV) when serving size meets the threshold
CN · Permitted Common Food
Ordinary food ingredient (not a novel food); eligible for protein-powder health foods (registration) and sports-nutrition foods (GB 24154)
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Protein contributes to a growth in muscle mass.”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of muscle mass.”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of normal bones.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “As proteínas auxiliam na formação dos músculos e ossos.”
Phosphatidylserine
Reviewed 2026-06-13
US · Permitted GRAS
Legal dietary-supplement ingredient under DSHEA (GRAS self-affirmed, soy/sunflower lecithin source). FDA issued a 2003 Qualified Health Claim (QHC) on phosphatidylserine and cognitive dysfunction / dementia risk in the elderly — but it is a QUALIFIED claim carrying mandatory FDA disclaimer language stating the scientific evidence is very limited and preliminary; the regulator-templated wording must be used unaltered and is NOT a strong/unqualified health claim. The verbatim QHC wording is regulator-fixed and not reproduced here.
EU · Permitted Novel Food
Authorized as a Novel Food / permitted food-supplement ingredient in the EU; 0 EFSA-authorized health claim (Reg 432/2012) — Art.13/14 cognitive claims for phosphatidylserine were not approved.
CN · Permitted Novel Food (NHC)
Soybean phosphatidylserine approved as China novel food ingredient (MOH 2010 No.15 + equivalence extension); used in health-food products; no standalone SAMR function.
BR · Permitted ANVISA
Permitted as a food-supplement (suplemento alimentar) constituent under the RDC 243/2018 framework; no authorized IN 28/2018 alegação funcional for phosphatidylserine.
PQQ
Reviewed 2026-06-13
US · Permitted GRAS
FDA GRAS · no-questions notices exist for PQQ disodium salt (e.g. GRN 641, 701, 709), max 20 mg/day. DSHEA dietary supplement; structure/function claims permitted with mandatory FDA disclaimer. No authorized health claim or qualified health claim. each GRAS notice covers a specific manufacturer grade — generic PQQ not auto-covered.
EU · Permitted Novel Food
Authorized Novel Food · Commission Implementing Regulation (EU) 2018/1122 (PQQ disodium salt, generic authorisation), food supplements ≤20 mg/day adults ≥18. EFSA has authorized NO PQQ health claim (Art 13 / 13.5 / 14 all empty). Mandatory label: not for under-18s / pregnant / breastfeeding women.
CN · Permitted Novel Food (NHC)
China: PQQ disodium salt approved as a novel food (NHC Novel Food Announcement 2022 No.6) for general-food use within limits; not a health-food raw material, no blue-hat approval, no authorized functional claim.
BR · Pending Pending
Not on approved supplement-ingredient lists (not in IN 28/2018); no domestic compliant route. Would require RDC 839/2023 new-ingredient evaluation (est. 12-24 months). No ANVISA-authorized functional claim.
Probiotics
Reviewed 2026-06-22
US · Permitted DSHEA
Many probiotic strains hold self-affirmed or notified GRAS status and are lawfully sold as dietary supplements under DSHEA; structure/function claims only with mandatory disclaimer. NO generic FDA-authorized health claim for 'probiotics' (the 2026 yogurt qualified health claim is product/strain-specific). 'FDA approved' is prohibited.
EU · Permitted 2002/46/EC
One EFSA-authorized Reg 432/2012 claim covers live yogurt cultures (L. delbrueckii subsp. bulgaricus + S. thermophilus) improving lactose digestion at >=10^8 CFU/g. The generic term 'probiotic' is treated as an unauthorized health claim in the EU; supplements are otherwise lawful under Directive 2002/46/EC.
CN · Permitted Common Food
Permitted: China maintains an NHC positive list of probiotic strains (~39) usable in common food; listed strains are lawful in food, and probiotic health foods can be registered with SAMR (Blue Hat). Strain must be on the approved inventory.
BR · Permitted ANVISA
Probiotic strains are permitted in dietary supplements (suplementos alimentares) under the ANVISA RDC 243/2018 framework and probiotics technical regulation, subject to the approved strain list and viability requirements; no generic IN 28/2018 Anexo V functional claim for the 'probiotics' category.
Pterostilbene
Reviewed 2026-06-13
US · Permitted DSHEA
Legal dietary supplement ingredient under DSHEA (NDI notification pathway) · no independent GRAS notification on file · multiple marketed supplements contain pterostilbene · structure/function claims only with mandatory DSHEA disclaimer · NO FDA-authorized health/disease claim
EU · Pending Pending
0 authorized / 0 non-authorized health claim — pterostilbene has never been submitted for EFSA Reg 432/2012 evaluation · likely requires Novel Food (Reg 2015/2283) authorization for EU food-supplement market access (EU Commission Novel Food assessment context as of 2026-01-27, authorization path unconfirmed) · no functional copy supported at EU level
CN · Pending Pending
Not approved as a China novel food ingredient; pterostilbene is a non-traditional, non-listed substance with no lawful food/supplement market path in China pending novel-food authorization.
BR · Pending Pending
No clear Brazilian market-access path · non-traditional food constituent · not an established listed supplement ingredient · would require case-by-case ANVISA evaluation · no IN 28/2018 Anexo V alegação funcional
Pumpkin Seed Oil
Reviewed 2026-06-13
US · Permitted DSHEA
Legal dietary-supplement ingredient under DSHEA and an established food oil; structure/function claims only with the mandatory disclaimer; no FDA-authorized disease/health claim for pumpkin seed oil. Disease claims (hair-loss cure, BPH treatment) are prohibited.
EU · Permitted 2002/46/EC
Marketable as a traditional food oil in the EU (Styrian pumpkin seed oil holds PGI geographical-indication protection); EFSA has NOT authorized any specific pumpkin-seed-oil health claim, so functional copy is limited to ingredient-fact / nutrient-composition description.
CN · Permitted Common Food
Permitted in China as a traditional edible oil and common food raw material (conventional food ingredient); no specific authorized health-function claim.
BR · Permitted ANVISA
Permitted as a food / food-supplement ingredient in Brazil (ANVISA); no Anexo-V/specific functional claim authorized for pumpkin seed oil.
Quercetin
Reviewed 2026-06-13
US · Permitted GRAS
DSHEA dietary supplement ingredient — FDA GRAS Notice GRN 341 (Quercegen Pharma; quercetin up to 500 mg/serving) received an FDA no-questions letter in 2010; Quercefit® has an independent safety dossier · Structure/Function Claims only (FDA disclaimer required) · NOT 'FDA approved' · no disease claims (cancer / allergic rhinitis / asthma / hypertension / COVID-19 all prohibited)
EU · Permitted 2002/46/EC
Food supplement ingredient · EFSA NDA Panel REJECTED quercetin health claims (antioxidant / DNA-protection / cardiovascular) under Reg 1924/2006 Art.13.1 (2009-2011, insufficient causal evidence) · no authorized Art.13.1/14 health claim · ≤500 mg/day tolerability assessed (EFSA 2011) · may be sold without efficacy labelling
CN · Pending Pending
Purified quercetin not on SAMR health-food raw-material catalogue; quercetin-bearing plant extracts (onion, ginkgo) usable in health food; cross-border e-commerce sole compliant C-end channel.
BR · Pending Pending
Purified quercetin NOT listed in IN 28/2018 dietary-supplement positive list · possible fitoterápico route requires separate registration · no disease-risk-reduction claim
Reishi
Reviewed 2026-06-13
US · Permitted DSHEA
Lawful dietary supplement ingredient (Ganoderma lucidum / Reishi mushroom) · structure/function statements such as immune-support / antioxidant-support permissible (no disease claims)
EU · Permitted 2002/46/EC
Marketed as a food supplement in most EU member states · NO EFSA-authorized health claim under Reg 432/2012
CN · Permitted Health Food
Reishi (Ganoderma lucidum) is a medicinal-and-edible fungus per MOH; extract and broken-wall spore powder usable in registered health food; spore-powder products require health-food registration.
BR · Permitted ANVISA
Permissible under ANVISA food/dietary-supplement framework (RDC 243/2018) · traditional fungus · no specific Anexo V functional claim authorized
Resveratrol
Reviewed 2026-06-13
US · Permitted GRAS
Legal dietary supplement ingredient (trans-resveratrol) · multiple NDI notifications on file · structure/function claims permissible (antioxidant support / heart health support / healthy aging) with mandatory DSHEA disclaimer · NO disease claims
EU · Permitted Novel Food
trans-Resveratrol is an authorised EU Novel Food (Commission Implementing Decision (EU) 2016/1190) for food supplements (<=150 mg/day, adults); EFSA did not authorise any Reg 432/2012 resveratrol health claim.
CN · Pending Pending
Not approved as a China novel food ingredient or SAMR health-food raw material; cleared only for cosmetic use; sold domestically via cross-border e-commerce gray channel only.
BR · Permitted ANVISA
RDC 243/2018 dietary-supplement framework available · no resveratrol-specific Anexo V alegação funcional
Rhodiola
Reviewed 2026-06-13
US · Permitted DSHEA
Botanical dietary supplement under DSHEA (Rhodiola rosea root extract); structure/function claims only (adaptogen/stress/energy support); no FDA-approved disease/health claim
EU · Permitted 2002/46/EC
No authorized Reg 432/2012 Art.13 health claim; an EMA/HMPC traditional-use herbal monograph exists; marketable in the EU via Traditional Herbal Registration (traditional-use wording only)
CN · Permitted Health Food
Listed on China medicine-food homology list; usable in common and health food. Registered SAMR blue-hat function 'relieves physical fatigue' (R. crenulata predominant CN species).
BR · Pending Pending
Not listed on ANVISA approved-plant / IN 28/2018 constituent lists; no authorized functional claim; would require case-by-case new-ingredient assessment
Riboflavin (B2)
Reviewed 2026-06-13
US · Permitted GRAS
GRAS by regulation (21 CFR 184.1695 Riboflavin · 21 CFR 184.1697 Riboflavin 5'-phosphate) · lawful dietary-supplement ingredient · structure/function claims permitted with FDA disclaimer
CN · Permitted Health Food
Established nutrient — SAMR-permitted vitamin B2 source (riboflavin / riboflavin 5'-phosphate sodium, FMN-Na) under GB 14880 food-fortifier and GB 2760 standards; usable in health foods and general food fortification (NRV 1.4 mg/day; adult RNI 1.2-1.4 mg/day). Migraine-prophylaxis dosing (400 mg/day) is outside routine supplement scope.
BR · Permitted ANVISA
RDC 269/2005 + RDC 243/2018 dietary-supplement framework · IN 28/2018 daily-maximum monitored · riboflavina constituent permitted · no derivative-specific compliance divergence
Authorized claims (verbatim)
EU · EFSA · Reg (EU) 432/2012 Annex “Riboflavin contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the normal functioning of the nervous system”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the maintenance of normal mucous membranes”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the maintenance of normal red blood cells”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the maintenance of normal skin”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the maintenance of normal vision”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to normal metabolism of iron”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the protection of cells from oxidative stress”
EU · EFSA · Reg 432/2012 “Riboflavin contributes to the reduction of tiredness and fatigue”
Saffron
Reviewed 2026-06-13
US · Permitted DSHEA
GRAS as a flavoring/spice (long food-use history); legal dietary-supplement ingredient under DSHEA (structure/function claims only); no FDA-authorized disease claim
EU · Permitted 2002/46/EC
Marketable as a traditional food / flavoring ingredient; EFSA has NOT authorized any specific saffron health claim — functional copy limited to ingredient-fact / mechanism description
CN · Permitted Health Food
Traditional medicinal material (xihonghua); marketable in registered SAMR health food (blue-hat) and via cross-border e-commerce; not authorized for direct common-food use.
BR · Permitted ANVISA
Permitted as a food flavoring; as a supplement ingredient subject to ANVISA approval (RDC 243/2018); no Anexo V functional claim authorized for saffron
Saw Palmetto
Reviewed 2026-06-22
US · Permitted DSHEA
Legal DSHEA dietary-supplement ingredient; prostate-health category bestseller (~320 mg/day). Structure/function claims with FDA disclaimer permitted; disease claims (treats BPH / treats hair loss / replaces finasteride) prohibited. No FDA-authorized health claim.
EU · Permitted 2002/46/EC
Marketable as food supplement (Directive 2002/46/EC) in several member states; EMA has a traditional-herbal monograph (BPH well-established use) and Permixon is registered as a medicine in some member states. EFSA has authorized no health claim.
CN · Pending Pending
China SAMR: not listed in health-food raw-material catalogue or medicine-food homology list; no clear market-access pathway; market entry restricted.
BR · Permitted ANVISA
Legal food supplement under ANVISA RDC 243/2018 + IN 28/2018 (Serenoa repens extract permitted); daily-amount and use-warning labeling required. No IN 28/2018 Anexo V authorized functional claim.
Selenium
Reviewed 2026-06-05
US · Permitted GRAS
United States (FDA): Selenium has NO authorized Significant Scientific Agreement (SSA) health claim under 21 CFR Part 101 Subpart E. The only FDA-permitted disease-risk claims for selenium are Qualified Health Claims (QHCs) under 21 CFR 101.93, allowed through FDA letters of enforcement discretion. The original 2003 FDA decision letters (Feb 21 and Apr 28, 2003, Wellness Lifestyles/Wellness International petition) granted QHC status to the statement: "Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive." A subsequent 2009 FDA decision (FDA-2008-Q-0323) added site-specific QHCs for bladder, prostate, and thyroid cancers; following the May 27, 2010 federal court ruling (Alliance for Natural Health v. Sebelius) some disclaimers were shortened. Selenium is also permitted as a nutrient content claim ingredient under 21 CFR 101.54 ("good source" / "excellent source of selenium") when meeting %DV thresholds. All disease-related claims are restricted to dietary supplement labels and must carry the FDA-mandated qualifier. Structure/function claims under DSHEA (21 USC 343(r)(6)) are separately permitted with the standard disclaimer ("This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.") and FDA notification within 30 days of marketing.
CN · Permitted Health Food
Approved in China as an essential mineral / health-food nutrient raw material, permitted as a nutrient fortifier under GB 14880-2012, with health-food registrations covering immunity and antioxidant functions. Nutrient-supplement filing supports 'selenium supplementation'; specific SAMR health-function claims require the registration pathway.
Authorized claims (verbatim)
BR · ANVISA · ANVISA IN 28/2018 Anexo V “O selênio é um antioxidante que auxilia na proteção dos danos causados pelos radicais livres.”
Soy Isoflavones
Reviewed 2026-06-22
US · Permitted DSHEA
Legal dietary-supplement ingredient sold freely under DSHEA (structure/function claims with disclaimer). GRN 1 (1998) was a ceased/withdrawn notification — NOT a valid GRAS. The 1999 soy-protein cardiovascular qualified health claim (25 g/day) is for soy protein, not isolated isoflavones, and FDA proposed to revoke it in 2017 (not finalized). No FDA-authorized health claim for soy isoflavones.
EU · Permitted 2002/46/EC
Marketable as food supplement under Directive 2002/46/EC. EFSA has authorized 0 health claims — 6 Art.13(1) applications (incl. hair growth EFSA 2011;9(7):2264, LDL cholesterol, joint maintenance EFSA 2010;8(2):1493) were all rejected. EFSA 2015 safety review confirmed postmenopausal use <=100 mg/day aglycone-equivalent has no adverse effect on breast/thyroid/uterus.
BR · Permitted ANVISA
Legal food-supplement ingredient under ANVISA RDC 243/2018 + IN 28/2018; any claim must conform to the ANVISA positive list. No specific IN 28/2018 Anexo V authorized functional claim asserted for soy isoflavones.
Soy Protein
Reviewed 2026-06-04
CN · Permitted Common Food
Conventional food ingredient (soy is a traditional food); soy protein isolate regulated under general food standards; not a novel food
Authorized claims (verbatim)
US · FDA · 21 CFR 101.82 “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides ___ grams of soy protein.”
EU · EFSA · Reg 432/2012 “Protein contributes to a growth in muscle mass.”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of muscle mass.”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of normal bones.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “As proteínas auxiliam na formação dos músculos e ossos.”
Spermidine
Reviewed 2026-06-13
US · Permitted DSHEA
Lawful dietary-supplement ingredient (spermidine / wheat-germ extract standardized to spermidine) under DSHEA; structure/function claims only (e.g. 'cellular renewal support', 'healthy aging support'). NO FDA authorized or qualified health claim for spermidine.
EU · Permitted 2002/46/EC
Spermidine-rich wheat-germ extract is sold as a food supplement in the EU (a primary spermidine research/market region · Austria TLL/Longevity Labs); NO EFSA-authorized health claim under Reg 432/2012. Synthetic spermidine may face a different (Novel Food) regulatory path than the natural wheat-germ source.
CN · Permitted Common Food
Marketable as a food-derived substance: spermidine-rich wheat-germ extract is sourced from wheat germ, a conventional food in China, so it is treated as a common-food ingredient; no SAMR health-food registration. Isolated/synthetic spermidine would need separate novel-food review.
BR · Pending Pending
Spermidine's explicit status as a food-supplement ingredient under RDC 243/2018 / IN 28/2018 is to be confirmed (status to be confirmed); NO Anexo V alegação funcional for spermidine.
Spirulina
Reviewed 2026-06-27
US · Permitted GRAS
GRAS (GRN 127, no-objection letter); legal dietary supplement ingredient under DSHEA; structure/function claims only, no authorized health claims
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Listed dietary-supplement ingredient (RDC 243/2018 + IN 28/2018) for A. platensis / A. maxima; daily limit <=5.7 g/serving; microcystin limit <=1 ug/g
Sulforaphane
Reviewed 2026-06-13
US · Permitted DSHEA
Sold as a dietary supplement (e.g. Avmacol, Prostaphane, BroccoMax, BrocElite); the broccoli-derived precursor glucoraphanin (Truebroc) holds a self-affirmed GRAS no-objection, while sulforaphane products are marketed via the DSHEA structure/function-claim pathway (30-day notification + FDA disclaimer) as a manufacturer self-determination, not an FDA-authorized health claim. All disease claims are red-lined (cancer/autism/diabetes/H. pylori eradication prohibited). 'Detox' is a high-sensitivity term and should be expressed indirectly as supports the body's natural detoxification processes.
EU · Permitted 2002/46/EC
Broccoli-sprout extract is sold as a supplement in member states such as France and Italy (Prostaphane precedent); highly concentrated/purified SFN may trigger Novel Food assessment. As of 2026 EFSA has authorized no sulforaphane health claim, so no authorized claim exists (science-education / brand context only).
CN · Permitted Common Food
Broccoli is unrestricted common food and sprout powder is sold as vegetable powder; concentrated standardized sulforaphane/glucoraphanin extract has no novel-food approval and needs case-by-case assessment.
BR · Permitted ANVISA
Broccoli as food is unrestricted; concentrated extract is not on the IN no 28/2018 positive list, has no specific functional claim, and requires case-by-case technical assessment. Only a food-grade 'contains cruciferous-vegetable active compounds' description is safe.
Tart Cherry
Reviewed 2026-06-27
US · Permitted GRAS
Conventional food / GRAS food ingredient; lawful as a dietary supplement ingredient under DSHEA. Structure/function claims only with mandatory FDA disclaimer. No FDA-authorized health claim.
CN · Permitted Supplement (CBEC)
No detailed regulatory note on file for this market — see the full dossier.
BR · Permitted ANVISA supplement
Food / fruit-juice ingredient under ANVISA; lawfully marketable with no special restriction. No authorized functional claim for tart cherry as such.
Taurine
Reviewed 2026-06-13
US · Permitted GRAS
GRAS (GRN 586, non-carbonated flavored water-based beverages) + Old Dietary Ingredient under DSHEA (pre-1994, no NDI required); structure/function claims only; no authorized health claim
EU · Permitted Food Additive
Legal food ingredient (not Novel Food); energy-drink use legal. EFSA 2009 safety opinion: no safety concern at routine exposure. ALL taurine health claims REJECTED by EFSA 2011 (heart/fatigue/cognition/vision)
BR · Permitted ANVISA
Permitted food-supplement & energy-drink constituent (RDC 243/2018 / RDC 273/2005 limit 400 mg/100 mL); no taurine-specific functional claim authorized
Thiamine (B1)
Reviewed 2026-06-13
US · Permitted GRAS
GRAS by regulation — 21 CFR 184.1875 (Thiamine HCl) and 21 CFR 184.1878 (Thiamine mononitrate); lawful dietary supplement ingredient; structure/function claims permitted with the mandatory FDA disclaimer (statement not evaluated by FDA; not intended to diagnose, treat, cure, or prevent disease). Daily Value 1.2 mg.
CN · Permitted Health Food
Established nutrient — SAMR-permitted vitamin B1 source (thiamine HCl / thiamine mononitrate) under GB 14880 food-fortifier and GB 2760 standards; usable in health foods and general food fortification (NRV 1.4 mg/day; adult RNI 1.2-1.4 mg/day). Benfotiamine (fat-soluble derivative) requires separate filing.
BR · Permitted ANVISA
Permitted vitamin under RDC 269/2005 and the RDC 243/2018 supplement framework; daily maximum amounts regulated by IN 28/2018; functional claims must use ANVISA-approved wording. Benfotiamine is not on the RDC 269 vitamin positive list and requires separate compliance review for high-dose formulas.
Authorized claims (verbatim)
EU · EFSA · Reg (EU) 432/2012 Annex “Thiamine contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Thiamine contributes to normal energy-yielding metabolism”
EU · EFSA · Reg 432/2012 “Thiamine contributes to the normal functioning of the nervous system”
EU · EFSA · Reg 432/2012 “Thiamine contributes to the normal function of the heart”
EU · EFSA · Reg 432/2012 “Thiamine contributes to normal psychological function”
Tocopherols
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · structure/function claims permitted
CN · Permitted Health Food
Recognized within the vitamin E family — established nutrient (SAMR health-food raw-material catalogue, nutrient-supplement category + GB 14880 food fortifier · GB 10765 infant formula); α-tocopherol the regulated form
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Vitamin E contributes to the protection of cells from oxidative stress.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina E é um antioxidante que auxilia na proteção dos danos causados pelos radicais livres.”
Tocotrienols
Reviewed 2026-06-04
US · Permitted GRAS
GRAS · DSHEA dietary supplement · structure/function claims permitted; not a separately scheduled FDA Daily Value
EU · Permitted 2002/46/EC
Falls under the Reg 432/2012 vitamin E oxidative-stress claim when calculated within α-tocopherol equivalents; no standalone tocotrienol authorized claim
CN · Permitted Health Food
Recognized within the vitamin E family — established nutrient (SAMR health-food raw material + GB 14880 food fortifier), counted within alpha-tocopherol equivalents
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 vitamin E framework applicable when tocotrienol is counted within α-tocopherol equivalents
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Vitamin E contributes to the protection of cells from oxidative stress.”
Tryptophan
Reviewed 2026-06-08
US · Permitted DSHEA
GRAS (amino acid food ingredient · post-1995 reinstatement)
EU · Permitted 2002/46/EC
Reg 432/2012 rejected mood claims 2010 · no authorized health claim
CN · Permitted Common Food
China: essential amino acid permitted as GB 14880 / GB 2760 nutritional fortifier/food-additive in food and supplement formulas; no tryptophan-specific health-food functional claim approved.
BR · Permitted ANVISA
RDC 243/2018 dietary supplement framework · IN 28/2018 no Anexo V claim
Type II Collagen
Reviewed 2026-06-13
US · Permitted DSHEA
US FDA — DSHEA dietary supplement; structure/function claims permitted with mandatory disclaimer. UC-II (Lonza, formerly InterHealth) holds GRAS status (self-determined GRAS (Bioiberica Collavant n2 and others)) and a New Dietary Ingredient (NDI) notification record. Disease/treatment claims for osteoarthritis or rheumatoid arthritis are prohibited.
EU · Permitted 2002/46/EC
EU — legal to market as a food supplement under Directive 2002/46/EC; chicken-source type II collagen has a use history (not classified as Novel Food, though specific new extraction processes may trigger case-by-case evaluation). EFSA has NOT authorized any Article 13/14 health claim for type II collagen (no company application submitted); only ingredient-fact statements are permissible in the EU.
CN · Permitted Common Food
Approved for conventional-food use in China (2016, National Health Commission) as undenatured type II collagen from chicken sternum cartilage; not classified as a New Food Raw Material (novel food).
BR · Permitted ANVISA
Brazil ANVISA — permitted dietary supplement (Suplemento Alimentar) under RDC 243/2018; the positive list (IN 28/2018 Anexo I, as amended by IN 76) includes the entry 'Colágeno de frango com colágeno tipo II não desnaturado.' Anexo III minimum effective dose 1.2 mg/day (>=19 yr); Anexo IV sets no explicit upper limit. Commercial UC-II dose of 40 mg/day is a market consensus (Lugo 2016), not a regulatory ceiling. Portuguese-language labeling and poultry-allergen consideration required.
Ubiquinol
Reviewed 2026-07-11
US · Permitted GRAS
Self-affirmed GRAS (Kaneka Ubiquinol / KanekaQH) · DSHEA dietary supplement; structure/function claims permitted
EU · Permitted 2002/46/EC
No authorized health claim (same status as CoQ10, claims rejected 2010); permitted as food supplement
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not authorized
Urolithin A
Reviewed 2026-06-13
US · Permitted GRAS
GRAS for food use (GRN 000791 · Amazentis SA · FDA no-questions 2018-12-20 · 500 mg/serving general food, 1000 mg/serving high-protein food). Marketed as a dietary supplement under DSHEA via NDI self-affirmation; NO FDA-authorized health claim — structure/function statements require the mandatory FDA disclaimer. 'FDA approved/certified' is prohibited.
EU · Pending Pending
EU novel-food authorisation is pending/ongoing (Amazentis/Mitopure dossier; EFSA 2021 positive safety opinion, but not yet a granted Union authorisation) in specified food categories (cereal/protein/nutrition products); EFSA 2021 positive safety opinion at ≤500 mg/day for adults. NO authorized health claim under Reg 432/2012. Not for children, pregnant or lactating women (not assessed).
CN · Pending Pending
No record of approval as a China novel food ingredient; synthetic urolithin A (Mitopure) lacks Chinese food-use history and novel-food authorization — not lawfully marketable as a food/supplement ingredient in China at present.
BR · Pending Pending
No public ANVISA approval record for synthetic urolithin A as a food supplement constituent; no Anexo V alegação funcional. Status to be confirmed via official channel — treat as not authorized.
Vitamin A
Reviewed 2026-06-06
US · Permitted GRAS
United States (FDA): NO 21 CFR Part 101 Subpart E Significant Scientific Agreement (SSA) health claim exists for vitamin A. The SSA catalogue is limited to specific nutrient-disease pairs (calcium/osteoporosis, sodium/hypertension, dietary fat/cancer, saturated fat & cholesterol/CHD, fiber-grain products/cancer, fiber-fruits-vegetables/CHD, folate/NTDs, sugar alcohols/dental caries, soluble fiber/CHD, soy protein/CHD, plant sterol-stanol/CHD, fluoride/dental caries) — none of which involve vitamin A. Vitamin A in dietary supplements is governed by: (1) DSHEA §403(r)(6) structure/function claims under 21 CFR 101.93 with the mandatory disclaimer "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."; (2) nutrient-content claims under 21 CFR 101.54 (e.g., "high in", "good source of vitamin A"); (3) labeling per 21 CFR 101.9 with %DV based on the 900 mcg RAE adult reference. No FDA Qualified Health Claim (QHC) for vitamin A as a standalone nutrient has been issued at the standalone-nutrient level. Pre-formed vitamin A teratogenicity warning per FDA UL of 3,000 mcg RAE/day required on supplements; pregnancy supplementation >10,000 IU/day contraindicated.
CN · Permitted Health Food
Listed in China's nutrient-supplement filing catalogue and approved as a food nutrition fortifier under GB 14880-2012; also a permitted health-food raw material. Health-food products may carry the supplement claim 'supplements vitamin A' and the function claim 'helps maintain dark-adaptation vision'; ordinary foods may not bear function claims. SAMR recognized.
Authorized claims (verbatim)
BR · ANVISA · IN 28/2018 Anexo V “A vitamina A auxilia na visão.”
Vitamin B6
Reviewed 2026-06-05
US · Permitted DSHEA
United States (FDA): NO 21 CFR Part 101 Subpart E SSA health claim exists for vitamin B6. Vitamin B6 is not among the 12 SSA-authorized nutrient-disease pairs. No FDA Qualified Health Claim (QHC) under 21 CFR 101.93 has been authorized for vitamin B6 either. Vitamin B6 is regulated as an essential nutrient under 21 CFR 101.9 (Nutrition Facts) with a Daily Value of 1.7 mg, and may bear DSHEA structure/function claims under 21 CFR 101.93 (e.g., "supports nervous system function", "supports energy metabolism") provided the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." is included.
CN · Permitted Health Food
Established nutrient — SAMR-permitted vitamin B6 source (pyridoxine hydrochloride) under GB 14880 food-fortifier and GB 2760 standards; usable in health foods and general food fortification (NRV 1.4 mg/day; adult RNI 1.4 mg/day; UL 60 mg/day). P5P form on the permitted list is unconfirmed.
Authorized claims (verbatim)
BR · ANVISA · IN 28/2018 Anexo V “A vitamina B6 auxilia no metabolismo de proteínas, carboidratos e gorduras.”
Vitamin C
Reviewed 2026-06-04
US · Permitted GRAS
United States: Vitamin C (ascorbic acid) is recognized as an essential nutrient with an established Daily Value (90 mg) under 21 CFR 101.9. There is NO authorized Significant Scientific Agreement (SSA) health claim for vitamin C under 21 CFR Part 101 Subpart E (SSA health claims are limited to twelve specified substances such as calcium, sodium, dietary fat, saturated fat, dietary fiber, fruits and vegetables, folate, sugar alcohols, soluble fiber, soy protein and plant sterols/stanols; vitamin C is not among them). Permitted communications are limited to: (a) nutrient content claims (e.g. "Excellent source of vitamin C" if ≥20% DV per serving, "Good source" if 10-19% DV per serving) under 21 CFR 101.54; and (b) DSHEA structure/function statements (e.g. "supports immune function", "supports antioxidant defenses") under 21 USC 343(r)(6), which must bear the FDA disclaimer ("This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.") and be substantiated, truthful and not misleading. Qualified Health Claims (QHCs) and disease prevention/treatment claims are NOT permitted for vitamin C in the absence of a specific FDA letter of enforcement discretion.
CN · Permitted Health Food
Listed in the Health-Food Raw-Material Catalogue (Nutrient Supplements) 2020 edition under filing/notification route, and a permitted food nutrition fortifier (GB 14880-2012) and food additive (GB 2760). Notified supplements may claim 'supplements vitamin C'; registered health foods may bear approved function claims such as immune enhancement / antioxidant. Ordinary foods bearing vitamin C may not make any health-function claim. SAMR recognized.
Authorized claims (verbatim)
BR · ANVISA · ANVISA IN 28/2018 Anexo V “A vitamina C auxilia no funcionamento do sistema imune.”
Vitamin D3
Reviewed 2026-05-31
Authorized claims (verbatim)
US · FDA · 21 CFR 101.72(f) Authorized Health Claim (SSA standard · docket 2008Q-0317 final rule) “Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”
EU · EFSA · Commission Regulation (EU) 1228/2014 art 14 (disease risk reduction claim) “Calcium and vitamin D help to reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor for osteoporotic bone fractures.”
EU · EFSA · Reg 432/2012 “Vitamin D contributes to the maintenance of normal bones.”
EU · EFSA · Reg 432/2012 “Vitamin D contributes to the maintenance of normal muscle function.”
EU · EFSA · Reg 432/2012 “Vitamin D contributes to the normal function of the immune system.”
EU · EFSA · Reg 432/2012 “Vitamin D contributes to normal absorption/utilisation of calcium and phosphorus.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina D auxilia na formação de ossos e dentes.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina D auxilia na absorção de cálcio e fósforo.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina D auxilia no funcionamento do sistema imune.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina D auxilia no funcionamento muscular.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina D auxilia na manutenção de níveis de cálcio no sangue.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina D auxilia no processo de divisão celular.”
Vitamin K2
Reviewed 2026-06-04
US · Permitted NDI
GRAS · DSHEA dietary supplement · NDI for MK-7 cleared
CN · Permitted Health Food
Permitted as a food nutrition fortifier under GB 14880-2012 and as a health-food raw material (vitamin K is in the Health-Food Raw-Material Catalogue). Health-food approvals exist mainly as combinations (calcium + D3 + K2); standalone K2 registrations are limited. SAMR recognized.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Vitamin K contributes to the maintenance of normal bones.”
EU · EFSA · Reg 432/2012 “Vitamin K contributes to normal blood clotting.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “A vitamina K auxilia na coagulação do sangue.”
Whey Protein
Reviewed 2026-05-31
US · Permitted GRAS
GRAS · food ingredient · DSHEA dietary supplement
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Protein contributes to a growth in muscle mass.”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of muscle mass.”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of normal bones.”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “As proteínas auxiliam na formação dos músculos e ossos.”
Yeast Protein
Reviewed 2026-06-03
US · Permitted GRAS
GRAS for S. cerevisiae as food ingredient (21 CFR 184.1983) · protein isolate forms covered under DSHEA dietary supplement framework
CN · Permitted Novel Food (NHC)
No detailed regulatory note on file for this market — see the full dossier.
Authorized claims (verbatim)
EU · EFSA · Reg 432/2012 “Protein contributes to a growth in muscle mass”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of muscle mass”
EU · EFSA · Reg 432/2012 “Protein contributes to the maintenance of normal bones”
BR · ANVISA · IN 28/2018 Anexo V alegação funcional “As proteínas auxiliam na formação dos músculos e ossos.”
Zeaxanthin
Reviewed 2026-05-29
US · Permitted GRAS
GRAS (marigold + algae source) · DSHEA dietary supplement
EU · Permitted Novel Food
Novel Food authorized (Commission Decision 2013/49/EU synthetic zeaxanthin · food supplement use up to 2 mg/day) · NO EFSA authorized health claim · note: zeaxanthin is NOT on the EU permitted food-colour list (E161h not EU-authorised)
CN · Permitted Health Food
Nutritional fortifier (GB 14880); lutein ester is the registered functional (visual-fatigue) health-food raw material — standalone zeaxanthin appears only as a co-component, not independently listed
BR · Permitted ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 alegação funcional not specifically authorized
Zinc
Reviewed 2026-06-04
US · Permitted GRAS
No FDA-authorized SSA (Significant Scientific Agreement) health claim exists for zinc under 21 CFR Part 101 Subpart E. Zinc is regulated as an essential nutrient with Daily Value 11 mg (21 CFR 101.9) and as a dietary supplement ingredient under DSHEA (21 USC 343(r)(6)). Structure/function claims (e.g., "supports immune health", "supports normal taste and smell", "supports skin health") are permitted under DSHEA provided the manufacturer (a) has substantiation, (b) notifies FDA within 30 days of first marketing the claim, and (c) includes the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Intranasal zinc gluconate products were the subject of an FDA warning (June 2009) due to anosmia reports.
CN · Permitted Health Food
Approved in China as a nutrient-supplement raw material under the SAMR Catalogue of Health-Food Raw Materials — Nutrient Supplements, and as a permitted nutrient fortifier under GB 14880-2012. Supplement-grade claims limited to nutrient-supplement filing ('zinc supplementation'); specific SAMR health-function claims (e.g. immunity) require the registration pathway.
Authorized claims (verbatim)
BR · ANVISA · IN 28/2018 Anexo V “O zinco auxilia no funcionamento do sistema imune.”
Machine-readable regulatory data
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Regulatory framework references are surfaced verbatim for educational reference and reflect each ingredient's last evidence-record review date (shown per row). This is not legal or regulatory advice — verify the current framework text with the relevant authority before any commercial decision.