Curcumin in the EU: Why Food Colour E 100 and Supplement Ingredient Are Two Different Regulatory Paths
Curcumin's novel food status in the EU is the single most common compliance question supplement buyers ask us. "It is the intended use of the product that defines whether curcuminoids are a food additive or a novel food." That sentence, from the UK Committee on Toxicity's 2024 statement on curcumin supplements, captures the regulatory split that catches more EU-bound curcumin buyers than any other.[1] Same molecule. Same supplier. Same batch of powder. If the buyer uses it to colour a beverage, it is an authorised food additive. If the buyer puts it in a capsule and sells it as a dietary supplement, it may be an unauthorised Novel Food — and in several Member States, that product cannot legally be placed on the market.
This guide maps the two regulatory paths, explains what Novel Food authorisation requires, catalogues the Member State differences that determine where enforcement actually happens, and flags the emerging problem that bioavailability-enhanced curcumin formulations pose for the existing safety framework. None of this replaces your own regulatory review. It is a starting point for one.
01 · The split
One Molecule, Two Regulatory Paths
Curcumin's EU regulatory position is not a single status. It is two entirely separate frameworks, divided by the purpose for which the product is sold. The table below sets them side by side.
| Dimension | Food colourant (E 100) | Dietary supplement ingredient |
|---|---|---|
| Legal basis | Regulation (EC) No 1333/2008[2] | Regulation (EU) 2015/2283 (Novel Food)[3] |
| Purity standard | Regulation (EU) No 231/2012 — solvent-extracted from turmeric, purified by crystallisation[4] | No unified standard; depends on the conditions of any Novel Food authorisation granted |
| Authorisation status | Authorised across all Member States | Standard curcumin extract: not authorised. Only tetrahydrocurcuminoids authorised (Sabinsa, 2022) |
| Acceptable daily intake | 0–3 mg/kg bw/day (JECFA 2004, confirmed EFSA 2010)[5] | ADI was set for the food-additive use; the UK COT has questioned whether it applies to supplement-level exposures[1] |
| Maximum use levels | 100–200 mg/L in beverages; up to 500 mg/kg in solid foods (Group III colourant total)[2] | No EU-wide limit; France ANSES recommends < 153 mg/day from supplements[6] |
| Label declaration | "Colour: curcumin (E 100)" | Varies by Member State; Italy requires mandatory hepatobiliary warning since 2019[7] |
| Health claims | Not applicable (colourants are not marketed with health claims) | Botanical claims under Reg 1924/2006 are all on hold; EFSA rejected a curcumin joint-function claim in 2017[8] |
The reason the same molecule sits in two different frameworks is not about chemistry — it is about history. Curcumin has been used as a food colourant in Europe for decades before the Novel Food cutoff date of 15 May 1997. That use is documented and undisputed. The use of concentrated curcumin extract as a stand-alone supplement ingredient — capsules, tablets and powders sold specifically for their purported health benefits — is what several national authorities have concluded was not significantly consumed as food before that date. That is why the curcumin novel food question exists at all: not because the molecule is unsafe, but because this particular use lacks the documented pre-1997 consumption history that the regulation requires.[1][9]
Turmeric powder is not affected
Ground turmeric used as a culinary spice is not a Novel Food. Italy's 2019 labelling decree drew this line explicitly: the mandatory hepatobiliary warning applies to "substances, preparations and extracts from plants of the genus Curcuma," but "turmeric powder" was exempted, "considering its history of consumption as a food."[7] The UK COT distinguished between "raw and powdered turmeric" (traditional food, no special concern at normal dietary levels) and "supplements" (novel, requiring authorisation).[1]
The boundary sits at the processing step. Grinding dried rhizome into a spice preserves the whole-food matrix — starch, fibre, essential oils, curcuminoids at 2–5% of total weight. Solvent extraction followed by purification to 50%, 95% or 98% curcuminoids produces a concentrated ingredient with a composition that has no direct equivalent in the pre-1997 EU food supply. The more concentrated and purified the extract, the harder it is to argue a history of significant food consumption.
How this compares with the United States
In the US, curcumin is permitted as a food colourant under 21 CFR 73.600 and as a dietary supplement ingredient under the DSHEA framework — no Novel Food concept applies to supplements. Several branded curcumin products have received FDA GRAS "no questions" letters. The practical consequence: the same raw material that ships to a US customer for immediate supplement use may require a 2–3 year Novel Food authorisation process and a six-figure investment before it can legally enter the EU supplement market. For companies selling into both markets, this asymmetry is the single most important regulatory difference for curcumin.
02 · Novel Food status
Curcumin Novel Food Status: What Has Been Authorised and What Has Not
Novel Food authorisation under Regulation (EU) 2015/2283 is a pre-market approval system — the product cannot be sold until it is authorised and listed in the Union List (Implementing Regulation (EU) 2017/2470). The process runs through EFSA safety assessment to a Commission implementing regulation and typically takes two to three years from submission to authorisation.
Authorised
Tetrahydrocurcuminoids (Sabinsa Europe GmbH) — Implementing Regulation (EU) 2022/961, effective 11 July 2022.[10] These are hydrogenated metabolites of curcuminoids, not standard curcumin extract. Conditions: food supplements for adults only, excluding pregnant and lactating women, maximum 140 mg per day. Sabinsa holds a five-year proprietary data protection period (until July 2027), during which no other company can use the same safety data to support a competing application.
Under review
Solid Lipid Curcumin Particle (SLCP / Longvida) (Verdure Sciences, USA) — submitted to the UK FSA in October 2022, first reviewed by the Advisory Committee on Novel Foods and Processes (ACNFP) in April 2025. The committee requested further information from the applicant. The application is for food supplements for adults at up to 500 mg per day. As of the last published meeting summary, the application remains under review.[11]
Not authorised
Standard curcumin extract — the 50%, 95% and 98% curcuminoid grades that constitute the vast majority of global curcumin trade — has no Novel Food authorisation for supplement use in the EU. In Member States that actively enforce the Novel Food regulation for curcumin, supplements containing these extracts cannot legally be placed on the market.
Recital (9) of Regulation (EU) 2022/961 — the very regulation that authorised tetrahydrocurcuminoids as a Novel Food — states: "Non-hydrogenated curcuminoids and/or curcumin have been used in food supplements on the Union market before 15 May 1997."[10] The European Commission thus acknowledged, in an official regulation, that standard curcumin had pre-1997 supplement use. That acknowledgement did not, however, result in an exemption from the Novel Food requirement for standard curcumin. It was used solely to justify why tetrahydrocurcuminoids — as downstream metabolites of a compound with established use — did not need to demonstrate independent pre-1997 history. The contradiction is on the record but has not been resolved.
Italy's 2023 formal notification referred specifically to "estratto di rizoma di Curcuma longa L con curcumina al 95%."[9] Where does a 50% curcuminoid extract sit? Its composition is closer to a full-spectrum extract than to a purified single-compound powder, and its processing is less intensive than what is needed to reach 95%. Whether this distinction is enough to change its Novel Food status is not settled — no Member State has published a separate determination for lower-purity extracts. If your product uses the 50% grade for the EU supplement market, confirm the position with the competent authority in your target country before launch.
03 · Member-state differences
Where Enforcement Happens — and Where It Does Not
The Novel Food Regulation is EU-wide law, but its application to curcumin supplements has been driven by national authorities responding to safety signals. The result is a patchwork: some countries have taken explicit regulatory action; others have not publicly addressed curcumin's Novel Food status at all. A silent country is not a permissive one — the regulation applies regardless — but the practical risk of enforcement action varies.
Italy
Italy has gone further than any other Member State. In 2019, following approximately 20 reported cases of hepatitis linked to curcumin-containing supplements, the Ministry of Health imposed a mandatory label warning on all supplements containing extracts or preparations of the genus Curcuma: "In case of alterations of liver function, biliary function or gallstones, the use of the product is not recommended. If you take medicines, you should seek the advice of your doctor."[7] Italy's National Institute of Health attributed the hepatitis cases to individual susceptibility and pre-existing hepatobiliary conditions — not to a direct dose-dependent toxicity of curcumin itself — and noted that contamination with synthetic curcumin was raised as a possible contributing factor but not confirmed.[12]
In 2022, Italy prohibited all health claims linked to turmeric on food supplements, including digestive and liver-function claims that had been permitted under Italian national provisions pending EU harmonisation.[12]
In May 2023, the Italian Ministry of Health issued a formal notification confirming that, after consulting other Member States, no evidence had been provided demonstrating significant food consumption of 95% curcumin extract before 15 May 1997. Italy thus became the first Member State to formally confirm the curcumin novel food classification through a published enforcement action, declaring supplements containing the extract not marketable without authorisation.[9]
France
ANSES (the French Agency for Food, Environmental and Occupational Health and Safety) received over 100 reports of adverse effects — including 15 cases of hepatitis — potentially related to curcumin or turmeric supplements.[6] In its June 2022 assessment, ANSES calculated that the daily curcumin intake from supplements should remain below 153 mg for a 60 kg adult, derived as 85% of the EFSA ADI of 180 mg (3 mg/kg × 60 kg), leaving a margin for dietary exposure from turmeric in food (estimated at 27 mg per day for heavy consumers in France).[6]
Critically, ANSES stated that this 153 mg ceiling is valid only for supplements containing the classic form of curcumin. For formulations that enhance bioavailability — piperine, micelles, phytosomes, nanoparticles — ANSES called on manufacturers to provide bioavailability data so that a specific maximum intake can be defined for each product. In the absence of such data, the 153 mg figure cannot be assumed to be safe for enhanced formulations.[6] See Section 04 for the implications.
Belgium
The Belgian Federal Agency for the Safety of the Food Chain (AFSCA) issued a recall for a turmeric supplement product identified during the Italian investigation, after Belgium also reported cases of acute cholestatic hepatitis linked to the same product.[12]
United Kingdom (post-Brexit)
The UK FSA has taken the clearest regulatory position of any authority: "turmeric food supplements, comprising turmeric oleoresin extract or pure curcumin powder, [are] novel, because these products were not significantly used as a food or food ingredient before 15th of May 1997."[1] The UK COT's final statement, updated December 2024, confirmed that idiosyncratic hepatotoxicity is a recognised risk at supplement-level exposures, advised individuals with hepatobiliary conditions against use, and noted that novel formulations (micellar, nano, micro) constitute approximately 10% of the UK supplement market and may warrant additional scrutiny as their market share grows.[1]
Verdure Sciences' SLCP application (submitted October 2022) is the first curcumin Novel Food application to be reviewed by the UK's ACNFP. As of April 2025, it remains under review with additional data requested.[11]
Sweden
The Swedish Food Agency independently confirmed that curcumin is novel at least in foods other than supplements, after reviewing a Novel Food status consultation dossier. The agency stated that it was "not aware of any other evidence for significant use of curcumin within the European Union before 15 May 1997."[13]
Other Member States
Many EU countries have not published a position on curcumin's Novel Food status for supplements. This does not mean curcumin supplements are permitted there — the Novel Food Regulation applies across all Member States. It means enforcement has not yet been triggered, typically because the safety signal (hepatotoxicity reports) has not reached the national authority in sufficient volume. A brand operating in a "silent" country should not assume it has regulatory cover.
Some suppliers cite the EU Novel Food Catalogue entry for "Curcuminoids / Curcumins" as evidence that the curcumin novel food question has been settled one way or the other. The Catalogue is a non-binding orientation tool, not a legal determination. Its status descriptions are advisory. The binding determination is made by national competent authorities, and the Italian 2023 notification and UK FSA position are examples of exactly that.[3]
04 · The bioavailability paradox
Why Enhanced Formulations Face Extra Regulatory Scrutiny
The ADI of 3 mg/kg bw/day was established from toxicology studies that used conventional, unformulated curcumin — a compound with an oral bioavailability below 1%.[5] The safety assessment behind that number assumed, in effect, that most of the curcumin a person swallows passes through the gut without being absorbed.
Bioavailability-enhanced formulations change that assumption. Liquid micelles deliver 57–185 times the plasma exposure of unformulated curcumin; phytosomes deliver roughly 6–29 times; even piperine co-administration was historically claimed to increase exposure by 20-fold, although independent studies have not replicated that figure.[14] A supplement that nominally provides 150 mg of curcumin — well within the ADI — could, if formulated with a high-bioavailability delivery system, produce systemic exposure equivalent to a much higher nominal dose of unformulated curcumin.
Both ANSES and the UK COT have flagged this directly. ANSES stated in 2022: "Even though they do not appear to exceed the ADI, these new formulations can pose a risk of adverse effects by increasing the bioavailability of curcumin in the body."[6] The UK COT wrote: "A high-bioavailability curcumin product should not be assumed as safe as ordinary curcumin, because increasing absorption could substantially increase exposure to curcumin and its metabolites."[1]
For brands using enhanced formulations, the regulatory direction is clear even if specific rules have not yet been set: expect to be asked for product-specific bioavailability data, and do not rely on the conventional ADI as a safety benchmark without accounting for your product's actual absorption profile. ANSES has already recommended that manufacturers provide bioavailability data for each enhanced product so that a product-specific maximum intake can be established.[6] For the pharmacokinetic data behind each delivery technology, see our comparison of curcumin bioavailability: piperine vs phytosome vs micellar.
05 · Compliance checklist
Before You Ship Curcumin into the EU
This checklist condenses the regulatory landscape above into the questions a buyer or brand needs to answer before placing a turmeric root extract product on the EU market.
- Identify the intended use. The curcumin novel food requirement is triggered by use as a dietary supplement ingredient, not by use as a food colourant (E 100). The answer determines whether you are operating under Regulation 1333/2008 or Regulation 2015/2283. There is no third option.
- If colourant: confirm your curcumin meets the purity specifications in Regulation 231/2012, use the product within the maximum permitted levels for the relevant food category (100–200 mg/L for beverages, up to 500 mg/kg for most solid foods as part of the Group III colourant total), and declare it as "Colour: curcumin (E 100)" in the ingredients list.
- If supplement: check whether your target Member State actively enforces the Novel Food classification for curcumin extract. In Italy, France, the UK and Sweden, enforcement is documented. In other Member States, the regulation still applies even without published enforcement action.
- If your product uses a bioavailability-enhanced formulation (piperine, micelles, phytosome, nanoparticles): prepare for additional scrutiny. Have product-specific bioavailability data available, and do not assume the conventional ADI covers your product's actual systemic exposure.
- Label requirements vary by country. Italy requires the hepatobiliary warning text on all curcuma-extract supplements. France recommends keeping curcumin intake from supplements below 153 mg per day. Check the requirements for every country in which you intend to sell.
- Do not use unauthorised health claims. No curcumin health claim has been authorised under Regulation 1924/2006. Botanical claims remain on hold. EFSA rejected a curcumin joint-function claim in 2017. Italy has specifically prohibited digestive and liver-function claims for turmeric.
- If you need Novel Food authorisation: budget for a 2–3 year process and a six-figure investment. The safety dossier must include toxicological data, human pharmacokinetics, stability, specification and proposed use conditions. Consider whether proprietary data protection (five years) justifies the investment.
- Curcumin stability under processing and storage affects the final curcuminoid content in your product, which in turn affects compliance with any dose limits. Our curcumin stability guide covers this in detail.
06 · Evidence base
References
[1] UK Committee on Toxicity (COT). Statement on the potential risk to human health of turmeric and curcumin supplements. COT/2024/07. Updated December 2024. COT
[2] European Parliament and Council. Regulation (EC) No 1333/2008 on food additives. Official Journal of the European Union, L 354, 31.12.2008. EUR-Lex
[3] European Parliament and Council. Regulation (EU) 2015/2283 on novel foods. Official Journal of the European Union, L 327, 11.12.2015. Novel Food Catalogue available at: EC Catalogue
[4] European Commission. Regulation (EU) No 231/2012 laying down specifications for food additives — E 100 Curcumin. Official Journal of the European Union, L 83, 22.3.2012. EUR-Lex
[5] EFSA ANS Panel. Scientific Opinion on the re-evaluation of curcumin (E 100) as a food additive. EFSA Journal. 2010;8(9):1679. DOI
[6] ANSES (Agence nationale de sécurité sanitaire). Adverse effects associated with the consumption of food supplements containing turmeric. 27 June 2022. ANSES
[7] Italian Ministry of Health. Decree of 26 July 2019 modifying the Decree of 10 August 2018 — mandatory warning for food supplements containing substances, preparations and extracts from plants of the genus Curcuma. Effective 31 December 2019. Summary
[8] EFSA NDA Panel. Curcumin and normal functioning of joints: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal. 2017;15(5):4774. DOI
[9] Italian Ministry of Health. Conclusione attività relativa alla ricezione dei dati sull'uso significativo di estratti di Curcuma longa e spp ad elevato titolo di curcumina. May 2023. Confirmed that 95% curcumin extract is a Novel Food; supplements containing it are not marketable without authorisation.
[10] European Commission. Implementing Regulation (EU) 2022/961 authorising the placing on the market of tetrahydrocurcuminoids as a novel food. Official Journal of the European Union, L 165, 21.6.2022. EUR-Lex
[11] UK ACNFP. 171st ACNFP Meeting — Solid Lipid Curcumin Particle (SLCP) Discussion Paper. April 2025. Application RP1776 from Verdure Sciences. ACNFP
[12] NutraIngredients. Italy prohibits all health claims linked to turmeric, issues warning for labels. August 2022; and Italy rejects contamination as hepatitis cause citing 'individual susceptibility.' July 2019. NutraIngredients
[13] Swedish Food Agency. Statement on novel food status — Curcumin. Consultation response via EC Novel Food status process. Concluded that no evidence demonstrated significant EU consumption before 15 May 1997. EC Document
[14] Kocher A, Schiborr C, Behnam D, Frank J. Increasing post-digestive solubility of curcumin is the most successful strategy to improve its oral bioavailability. Molecular Nutrition & Food Research. 2021;65(24):2100613. DOI
Reviewed by
Prof. Bingji MaScientific Adviser, PhytoVale · Professor & Medicinal Plant Science Expert. Research focus: Chinese medicinal materials, phytochemistry, natural products and medicinal plant quality.
Written by
FloraContent Editor, PhytoVale · Product Content & Editorial Specialist. Focuses on botanical ingredient specifications, sourcing information and B2B technical content.
07 · Questions
Frequently Asked Questions
Is curcumin approved as a dietary supplement ingredient in the EU?
The curcumin novel food position is clear: standard curcumin extract (50%, 95%, 98% curcuminoids) has not received Novel Food authorisation for use as a dietary supplement ingredient in the EU. The only curcumin-derived product that has been authorised as a Novel Food is tetrahydrocurcuminoids, manufactured by Sabinsa Europe, authorised in July 2022 at up to 140 mg per day for adults (excluding pregnant and lactating women). Tetrahydrocurcuminoids are hydrogenated metabolites of curcumin — a chemically different product — and Sabinsa's authorisation does not extend to other companies or to standard curcumin extract.
Is curcumin E 100 the same thing as a curcumin supplement?
Chemically, both can come from the same batch of turmeric root extract. Regulatorily, they are in different frameworks. When used to add or restore colour in food, curcumin falls under food-additive legislation (Regulation 1333/2008) as E 100, an authorised colourant. When sold as a stand-alone ingredient in a dietary supplement, the same extract falls under the Novel Food Regulation (Regulation 2015/2283) and, in the view of the UK FSA, the Italian Ministry of Health and other authorities, requires pre-market authorisation that it does not currently have.
Can I sell curcumin supplements in Italy?
Italy's position is the most restrictive in the EU. The Ministry of Health confirmed in May 2023 that 95% curcumin extract is a Novel Food and supplements containing it are not marketable without authorisation. All turmeric-extract supplements sold in Italy must carry a mandatory hepatobiliary warning. All health claims related to turmeric have been prohibited since 2022, including digestive and liver-function claims. The spice turmeric powder is not affected by these restrictions.
What is the maximum daily dose of curcumin in EU supplements?
There is no EU-wide harmonised maximum daily dose for curcumin in supplements. The EFSA ADI for curcumin as a food additive is 0–3 mg per kg body weight per day (180 mg per day for a 60 kg adult). The French agency ANSES recommends that supplement intake remain below 153 mg per day for a 60 kg adult, calculated as 85% of the ADI to allow for dietary exposure. Critically, ANSES stated that this ceiling applies only to conventional curcumin formulations — enhanced-bioavailability products require product-specific assessment.
Is turmeric powder (the spice) a Novel Food?
No. Ground turmeric used as a culinary spice has a well-documented history of consumption as food in the EU before 15 May 1997 and is not considered a Novel Food. Italy's 2019 labelling decree explicitly exempted turmeric powder from the mandatory warning. The Novel Food question arises when turmeric undergoes solvent extraction and purification to concentrate the curcuminoid fraction — a process that produces a product compositionally different from the whole spice.
Can I make health claims about curcumin supplements in the EU?
Currently, no. All botanical health claims under Regulation (EC) 1924/2006 remain on hold — EFSA's evaluation of these claims has been suspended for over a decade with no published timeline for resolution. The only curcumin-specific health claim to receive a full EFSA assessment — "curcumin and normal functioning of joints" — was rejected in 2017, with EFSA concluding that a cause-and-effect relationship had not been established. Italy has additionally prohibited all turmeric-related health claims, including digestive and liver-function claims, at the national level.
How long does a Novel Food application take, and what does it cost?
Sabinsa's tetrahydrocurcuminoids application took approximately two and a half years from submission (January 2020) to authorisation (July 2022). Verdure Sciences' SLCP application, submitted in October 2022, was still under review with additional data requested as of April 2025. The safety dossier must include toxicological data, human pharmacokinetics, stability, full specification and proposed use conditions. The cost of preparing and supporting an application through EFSA assessment typically runs to six figures in euros. Proprietary data protection (five years) may justify the investment for a differentiated product, but it is not a feasible path for generic curcumin extract.
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Request a quotation →See turmeric extract grades →Disclaimer: this article is intended for regulatory orientation and B2B purchasing decisions. It is not legal advice and does not replace a compliance review by qualified regulatory counsel in the buyer's target market. PhytoVale supplies turmeric root extract as a raw material and makes no health claims for it. Regulatory positions vary by jurisdiction and change over time; the information presented here reflects the published positions of the cited authorities as of the date of writing. © 2026 PhytoVale.
