The European Food Safety Authority (EFSA) has placed its botanicals framework back on the drawing board. A draft mandate from the Scientific Committee, open for public consultation from 8 June to 3 August 2026, proposes to merge and modernise three existing documents into a single, cross-sectoral guidance on the safety assessment of botanicals and botanical preparations across the whole food and feed chain (EFSA Scientific Committee, 2026, draft).
The ambition is considerable, and overdue. Yet the proposal also reopens an old tension that the European Union has never resolved: how to protect consumers without burying centuries of safe traditional use under a pharmaceutical-grade evidentiary apparatus. The key to that balance — the ‘qualified presumption of safety‘ — is present in the mandate but, as this analysis argues, in need of strengthening rather than dilution. And one decisive question is conspicuously absent from the scope entirely.
From 2009 to today: what the mandate seeks to revise
The current architecture rests on the 2009 Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements (EFSA Scientific Committee, 2009), which introduced a two-tier logic:
- Level A allowed a ‘presumption of safety’ for botanicals with an adequate body of knowledge and a history of safe use, without further testing;
- Level B required additional data generation, including toxicological testing, where that presumption could not be established.
Two further texts complete the picture:
- the 2014 Scientific Opinion explored whether a Qualified Presumption of Safety (QPS) approach could apply to botanicals, developing a four-step structured scheme (identity, data evaluation, safety conclusion and iteration) tested against six case studies. It concluded that QPS was feasible in principle but limited at high taxonomic levels, given the chemical variability of botanical preparations (EFSA Scientific Committee, 2014);
- the 2023 Technical Report on mixtures of natural origin then imported tools from the broader chemical-mixtures toolkit — component-based assessment (CBA) and whole-mixture approach (WMA), the substances-of-concern strategy, and the Threshold of Toxicological Concern (TTC) and Margin of Exposure (MOE) methods (EFSA, 2023).
EFSA’s rationale for revision is essentially fourfold. No internationally accepted, cross-sectoral guidance currently exists; in its absence, EFSA Panels and Units have developed divergent sectoral approaches; analytical science and New Approach Methodologies (NAMs) have advanced substantially; and a series of cross-cutting EFSA guidance documents published since 2009 have never been formally integrated. Feedback from EFSA’s own units describes the existing guidance as too narrow, lacking practical tools, and insufficiently specific on questions such as matrix effects and presumption-of-safety criteria (EFSA Scientific Committee, 2026, draft).
Terms of reference: the proposed areas of revision
The mandate sets out six areas, which can be read as a logical progression from scope to practical tools.
General aspects. The headline change is the broadening of scope. The revised guidance would cover not only food supplements but novel foods, food enzymes, food additives, feed additives, food contact materials, botanical pesticide active substances, and substances added to foods under Article 8 of Regulation (EC) No 1925/2006. EFSA also commits to reviewing the state of the art from sister agencies (EMA, ECHA), national authorities (RIVM, BfR, ANSES) and international bodies (OECD, WHO, FDA), and to collaborating with the Botanical Safety Consortium.
Framework for complex mixtures. This is the scientific core. The proposal strengthens characterisation requirements — identity (taxonomy and chemotype), plant part, manufacturing process, composition and markers, contaminants, specifications and batch variability — with reference to standardised nomenclature, and flags particular attention to novel extraction and enzymatic technologies that can alter composition or bioavailability. It envisages a tiered assessment strategy to identify the key risk drivers in a preparation, and floats a potentially significant innovation: a list of ‘substances of no concern’ to complement the existing substances-of-concern logic. It addresses how to proceed when chemical characterisation is incomplete, when to apply CBA versus WMA, definitions distinguishing naturally occurring harmful constituents from impurities, a systematic strategy for substances of concern (pyrrolizidine and tropane alkaloids, furanocoumarins, cyanogenic glycosides), the role of matrix effects, and allergenicity.
New approach methodologies. NAMs — in vitro assays, in silico tools such as QSAR and PBK modelling, read-across and high-throughput screening — would be integrated within a transparent weight-of-evidence framework, with alignment to EFSA’s cross-cutting guidance on uncertainty (2018), TTC (2019a), combined exposure (2019b), benchmark dose (2022) and read-across (2025). Genotoxicity assessment would align with EFSA’s testing strategy currently under revision.
Presumption of safety and history of use. Here the mandate proposes to revise and strengthen the Level A criteria, with explicit evidentiary standards for history of use; requirements for equivalence of species and plant part, preparation method, dose and target population; and analytical verification that substances of concern are absent or controlled. Crucially, it also lists situations where the presumption would be expressly excluded — Article 8 cases, substantial increases in exposure beyond historical ranges, novel processing that alters composition, target populations differing from historical users, and animal safety in feed applications. The QPS structured scheme would be adapted into a practical decision framework with decision trees.
The Compendium of Botanicals. Most recently updated in April 2025, the open-access database would be clarified as a reference tool for identifying potential substances of concern.
Cross-sectoral application and practical tools. Finally, the guidance would establish core common principles with sector-specific appendices, supported by decision trees, data-submission templates, standardised reporting frameworks and worked case studies.
Engagement runs through EFSA’s Panels (NDA, FAF, FEEDAP, CONTAM, FCM), sister agencies and bodies (ECHA, EMA, JRC, SCCS), and initiatives such as the BSC and PARC, with a stakeholder workshop and public consultation. A dedicated Working Group on Botanicals is expected to begin drafting in Q3 2026, over roughly 24 months, with a revised guidance tentatively targeted by the end of 2027.
Stakeholders have until 3 August 2026 to make the case for a framework that is comprehensive in safety and proportionate in burden.
Comprehensiveness against proportionality
On the positive side of the ledger, the case for revision is strong. Harmonising methodologies across EFSA domains should reduce the unjustified divergences that today see the same botanical assessed differently depending on whether it arrives as a supplement, a novel food or a feed additive. Integrating NAMs offers a route to characterise complex mixtures more accurately and, in principle, with less reliance on animal testing. Stronger characterisation requirements and a systematic substances-of-concern strategy respond to genuine safety gaps — pyrrolizidine and tropane alkaloids are not theoretical hazards. And practical tools, decision trees and templates would improve predictability for applicants and assessors alike.
The risk lies on the other side. A more exacting framework, applied without calibration, threatens to increase the regulatory burden on business operators even where no risk is realistically in play. EFSA’s assessments already display a structural asymmetry: where data are incomplete, the default tends towards ‘a safe level could not be established’. The recent berberine proceeding is instructive — EFSA’s draft opinion under Article 8, in public consultation from 2 March to 4 May 2026, again turns on data gaps rather than on positive evidence of harm (EFSA, 2026). Critics have warned that, by the same logic, almost any botanical could be caught: apply the guidance, find an absence of modern toxicological data, and conclude against safety. For small and medium enterprises (SMEs) and for heritage preparations with no patent sponsor to fund a toxicological package, the practical effect is exclusion — not because a botanical is unsafe, but because nobody has paid to re-prove what centuries of consumption already suggest.
This is precisely why the qualified presumption of safety is the key. A well-constructed presumption, anchored in documented history of use with genuine equivalence of species, plant part, preparation and exposure, is the mechanism that keeps a comprehensive framework proportionate. The mandate is right to demand rigour in how history of use is evidenced, and right to exclude the presumption where exposure jumps beyond historical ranges or processing transforms composition. But proportionality cuts both ways: the strengthened criteria must not become so demanding that the presumption is available only in theory. A list of ‘substances of no concern’, if developed seriously, could do real work here — shifting the assessment from an open-ended hunt for the unknown to a bounded evaluation of identified risk drivers. The difference between a fit-for-purpose guidance and a barrier to market lies in that calibration.
Comparative perspective: the US, China and Japan
Botanicals are not assessed in a vacuum, and other major markets have often taken a more balanced approach to reconciling safety, tradition, and innovation.
In the United States, the Dietary Supplement Health and Education Act of 1994 (DSHEA) draws a line at 15 October 1994. Ingredients marketed before that date — ‘old’ or grandfathered dietary ingredients — are treated, by virtue of their history of use, as presumptively acceptable and require no pre-market safety submission. A ‘new dietary ingredient’ must instead be notified to the FDA at least 75 days before marketing, with information supporting a reasonable expectation of safety under the labelled conditions of use; GRAS self-determination offers a parallel route (FDA, 2016). The model is notification-based and operator-responsible rather than authorisation-based — lighter-touch, faster to market, and explicitly built around history of use, at the cost of less pre-market scrutiny.
China offers a strikingly different but equally pragmatic logic rooted in the concept of ‘medicine–food homology‘ (yao shi tong yuan):
- a positive list, governed by the National Health Commission, identifies roughly a hundred substances that may be used both as food and as traditional medicine within specified sources, uses and dosages; the list has grown incrementally from its 2002 base, with additions in 2019 and 2023, and a 2021 management regulation introduced safety-evaluation procedures and dynamic risk monitoring (He et al., 2024);
- botanicals that do not have a history of traditional consumption in China and are not included in the relevant catalogue are generally regulated as ‘new food raw material’ (the category that replaced ‘novel foods’ under the 2009 Food Safety Law). That route is authorisation-based: the applicant submits a safety dossier to the National Health Commission, the China National Center for Food Safety Risk Assessment conducts the technical evaluation, and approval — once granted — is published with defined conditions of use (National Health Commission, 2017);
- supplement-type products making health-function claims — China’s health food (保健食品) category, colloquially the ‘blue hat’ regime — are administered separately by the State Administration for Market Regulation (SAMR), under measures originally issued by the China Food and Drug Administration (CFDA, 2016, as amended).
Japan is perhaps the most useful case for comparison because it operates a carefully designed tiered system:
- Foods for Specified Health Uses (FOSHU), in place since 1991, undergo government pre-evaluation of both safety and efficacy;
- the Foods with Function Claims (FFC) regime introduced in April 2015 is a notification system: the food business operator self-substantiates functionality through a systematic review or a randomised controlled trial, and the full dossier is disclosed publicly on the Consumer Affairs Agency website, without government pre-approval (Consumer Affairs Agency, 2015);
- the evidentiary burden therefore varies in proportion to the novelty and strength of the claim, rather than being governed by a single standard applicable to everything.
The common thread is that each of these jurisdictions treats history of use as a legitimate, load-bearing element of the assessment, and each provides a proportionate, predictable pathway for established preparations. The EU’s challenge — and the test of this mandate — is to deliver comparable legal certainty and an innovation-friendly environment without lowering its safety guard, for the benefit of competitiveness and consumers alike.
The missing point: evaluation criteria for health claims
For all its breadth, the mandate is strictly about safety. It does not, and by its remit cannot, touch the question that arguably does the most damage to the European botanicals sector: the evaluation criteria for health claims on botanicals as foods and food ingredients.
That gap matters because the two issues are inseparable in practice. Roughly two thousand botanical health claims have languished ‘on hold’ since 2010, in a transitional limbo under the Nutrition and Health Claims Regulation (EC) No 1924/2006 that the European Court of Auditors has criticised as an exceptional and unjustifiable delay (ECA, 2024). The Court of Justice, in Novel Nutriology (Case C-386/23, 30 April 2025), narrowed the conditions under which such claims may be used, interpreting the transitional regime more restrictively than its earlier ruling in Case C-363/19 (Court of Justice of the European Union, 2025). The upshot is an incoherent framework in which an identical botanical faces radically different evidentiary demands depending solely on whether it is sold as a food or as a traditional herbal medicinal product — the latter benefiting from a simplified registration that accepts long-standing use as evidence (Dongo, 2025).
A reform of the health claims framework should mirror the proportionality this safety mandate aspires to. The tiered model proposed by the European Federation of Associations of Health Product Manufacturers (EHPM, 2021) — distinguishing traditional-use, well-established-use and scientifically substantiated claims, with appropriately qualified wording for each — points the way, as does Italy’s national approach treating validated physiological-effect information as mandatory, on food supplements labels, rather than voluntary (Ministry of Health, Italy, 2023). The US structure/function model and Japan’s FFC and FOSHU tiers show that information provision and consumer protection can coexist.
The logical conclusion is this: a modernised, proportionate safety guidance that strengthens the qualified presumption of safety will deliver only half its potential value if the claims regime remains frozen. The Commission cannot reasonably ask operators to invest in fuller characterisation and assessment while denying them any lawful, proportionate means of communicating substantiated benefits to consumers. The botanicals dossier requires that both issues be addressed in a reasonable manner and without further delay.
Dario Dongo
Credit cover Nataliya Vaitkevich
References
China Food and Drug Administration. (2016). Administrative measures for the registration and filing of health food (CFDA Order No. 22). http://www.gov.cn/gongbao/content/2016/content_5139668.htm
China National Center for Food Safety Risk Assessment. (2025). New food raw materials: Approvals and applications under review. https://www.cfsa.net.cn/
Consumer Affairs Agency of Japan. (2015). Foods with function claims (FFC): Notification system for foods with health functions. Government of Japan. Government of Japan. https://www.caa.go.jp/policies/policy/food_labeling/foods_with_function_claims/notice/
Court of Justice of the European Union. (2020, September 10). Judgment of the Court (Second Chamber) in Case C-363/19, Konsumentombudsmannen v Mezina AB (ECLI:EU:C:2020:693). https://curia.europa.eu/juris/liste.jsf?num=C-363/19
Court of Justice of the European Union. (2025, April 30). Judgment of the Court (Fifth Chamber) in Case C-386/23, Novel Nutriology GmbH v Verband Sozialer Wettbewerb eV (ECLI:EU:C:2025:304). https://curia.europa.eu/juris/document/document.jsf?docid=298696&doclang=EN
Dongo, D. (2025, May 1). EU Court ruling on botanicals highlights urgent need for NHCR reform. Food Times. https://www.foodtimes.eu/consumers-and-health/eu-botanicals-health-claims-nhcr-reform-cjeu/
European Food Safety Authority. (2023). Principles that could be applicable to the safety assessment of the use of mixtures of natural origin to manufacture food contact materials. EFSA Supporting Publications, 20(11), EN-8409. https://doi.org/10.2903/sp.efsa.2023.EN-8409
European Food Safety Authority. (2026). Draft scientific opinion on the safety of plant preparations containing berberine pursuant to Article 8(2) of Regulation (EC) No 1925/2006 [Public consultation, 2 March – 4 May 2026]. https://www.efsa.europa.eu/en/events/targeted-stakeholder-meeting-food-business-representatives-efsas-draft-opinion-plant
EFSA Scientific Committee. (2009). Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. EFSA Journal, 7(9), 1249. https://doi.org/10.2903/j.efsa.2009.1249
EFSA Scientific Committee. (2014). Scientific opinion on a qualified presumption of safety (QPS) approach for the safety assessment of botanicals and botanical preparations. EFSA Journal, 12(3), 3593. https://doi.org/10.2903/j.efsa.2014.3593
EFSA Scientific Committee. (2026). Mandate – Guidance on the safety assessment of botanicals and botanical preparations [Draft for public consultation, 8 June – 3 August 2026]. European Food Safety Authority. https://connect.efsa.europa.eu/RM/sfc/servlet.shepherd/document/download/069Tk00000N9LxfIAF
European Court of Auditors. (2024). Food labeling in the EU. Consumers can get lost in the maze of labels. Special Report 23/2024. Publications Office of the European Union. https://www.eca.europa.eu/ECAPublications/SR-2024-23/SR-2024-23_EN.pdf
European Federation of Associations of Health Product Manufacturers. (2021). Botanical health claims on foods and food supplements in the EU: EHPM proposal. EHPM. https://ehpm.org/wp-content/uploads/2021/01/EHPM_Paper_Botanical_Health_Claims.pdf
Food and Drug Administration. (2016). Dietary supplements: New dietary ingredient notifications and related issues – Draft guidance for industry. U.S. Department of Health and Human Services. https://www.fda.gov/media/99538/download
He, R.-R., Wang, T., Wang, R.-F., Liu, M.-M., Yang, Z.-Y., & Su, W.-W. (2024). The evolution and significance of medicine and food homology. Acupuncture and Herbal Medicine, 4(1), 14–32. https://journals.lww.com/ahm/fulltext/2024/03000/the_evolution_and_significance_of_medicine_and.3.aspx
Ministry of Health, Italy. (2023). Guidelines on the physiological effects of plant substances in food supplements (Circular No. 4234-P). Department of Food Safety, Nutrition and Public Veterinary Health. https://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_2_file.pdf
National Health Commission of the People’s Republic of China. (2017). Administrative measures for the safety review of new food raw materials (新食品原料安全性审查管理办法). http://www.nhc.gov.cn/wjw/c100221/202201/0bbea384f540430485b886edba385559.shtml
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Consolidated text: 13/12/2024. http://data.europa.eu/eli/reg/2006/1924/2014-12-13
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, Consolidated text: 26/11/2025. http://data.europa.eu/eli/reg/2006/1925/2025-11-26
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods. Consolidated text: 27/03/2021. http://data.europa.eu/eli/reg/2015/2283/2021-03-27
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
