Botanicals at a Crossroads: Mutual Recognition or Fragmentation?

Why Cross-Border Growth Now Requires a Regulatory Risk Map

Botanical food supplements occupy one of the most commercially attractive and legally unsettled areas of the European food market. A product may achieve a successful launch in one EU Member State and encounter a restriction, a request for additional safety evidence, or a borderline medicinal product assessment in the next.

Directive 2002/46/EC created a common framework for food supplements, including a shared definition, core labelling requirements and harmonised lists of permitted vitamins, minerals and their sources. It did not create an EU positive list for botanicals or for the wider category of substances with a nutritional or physiological effect. Those ingredients remain governed by general EU food law, selected EU-wide restrictions and a substantial body of national rules.1

This division of responsibility has practical consequences. The same species may be accepted in one country, limited to a particular plant part in another, subject to a maximum daily intake or warning elsewhere, or challenged because the extraction process produces a preparation that falls outside traditional use. Mutual recognition provides an important route for cross-border trade, though it does not guarantee access. A receiving Member State may restrict a product where the measure pursues a legitimate public interest, including protection of human health, and is necessary and proportionate.2

The operational question for brands is clear: how can these risks be identified early enough to change the formulation, label and launch sequence?

Where EU Harmonisation Stops

The present fragmentation reflects the scope chosen for Directive 2002/46/EC. Article 4(8) required the European Commission to report on the advisability of establishing specific rules, including positive lists, for nutrients and other substances beyond vitamins and minerals. In 2008, the Commission concluded that laying down specific EU rules for those substances was not justified at that stage. It considered that general food safety law, novel food legislation, medicines law and the procedure for restricting substances under Regulation (EC) No 1925/2006 could address the main concerns.3

The Commission's 2020 evaluation confirmed that the use of plants and plant preparations in foods was still not governed by specific harmonised EU legislation. National systems had developed in parallel, with different lists, conditions of use, notification procedures and approaches to enforcement.

Some cooperation has reduced part of the divergence. The BELFRIT project brought Belgium, France and Italy together to develop a common list of 1,025 plants considered eligible for use in food supplements. The project influenced national frameworks. The list itself did not become binding EU law and did not remove country-specific restrictions, warnings or interpretation.4

France applies the Order of 24 June 2014, which identifies authorised plants and plant parts and establishes conditions for preparations used in food supplements. Italy regulates botanical substances and preparations under the Ministerial Decree of 10 August 2018. Belgium's Royal Decree of 31 August 2021 divides plants into prohibited, edible mushroom and conditionally permitted categories, and requires prior notification for food supplements. Germany publishes federal and Länder substance lists for plants, fungi and algae as assessment aids. The German lists support classification and risk evaluation. They do not constitute authorisations or a statutory positive list.5

These national instruments also operate alongside EU rules. Appearance on a plant list does not establish that every extract from that plant is acceptable. It does not resolve novel food status, demonstrate safety at the proposed dose, authorise a health claim or prevent medicinal product classification.

Botanicals at a Crossroads

Mutual Recognition and Its Boundaries

The principle of mutual recognition supports the free movement of goods in areas that have not been fully harmonised. Regulation (EU) 2019/515 strengthened the procedure for goods lawfully marketed in another Member State and introduced a voluntary mutual recognition declaration.2

Completion of a notification form does not by itself establish lawful marketing. The product must comply with the applicable rules in the Member State of origin, or with the absence of relevant national rules, and must have been made available to end users there. A robust evidence file therefore connects the exact formulation, specification, recommended intake, label and sales history to the market of origin. Notification acknowledgements remain useful. They may confirm administrative filing without showing that the authority completed a substantive assessment.

The receiving authority may assess whether a national technical rule applies and whether a restriction is justified. It must follow the procedural safeguards in Regulation (EU) 2019/515 and respect proportionality. Product Contact Points can provide information on national rules and competent authorities.

Mutual recognition applies only to the non-harmonised aspect of the product. It cannot cure an unauthorised novel food, override an EU-wide restriction under Regulation (EC) No 1925/2006, permit a prohibited health claim, displace the general food safety obligation, or prevent application of medicines law. This boundary is central to launch planning. A company needs to establish which issue is genuinely national before relying on mutual recognition.

Safety Belongs to the Preparation, Dose and Consumer

A botanical species does not have a single toxicological identity. Safety depends on taxonomy, chemotype, plant part, geographical origin, processing, extraction solvent, extraction ratio, concentration, constituent profile, daily exposure and duration of use. Interactions with medicines and risks for vulnerable groups may also change the conclusion.

Under Regulation (EC) No 178/2002, unsafe food must not be placed on the market, and food business operators carry primary responsibility for compliance. A national positive list can inform the assessment. A product-specific safety evaluation remains necessary.6

EFSA's Compendium of Botanicals supports hazard identification by listing plant species reported to contain naturally occurring substances of potential concern. The transformed Compendium published in April 2025 includes plant, substance, adverse-effect and genotoxicity information. EFSA expressly states that inclusion does not establish that a plant is unsafe, absence does not establish safety, and the Compendium has no legal or regulatory force.7

Green tea extracts show why preparation and dose matter. EFSA found no general indication of liver damage from traditional green tea infusions. Supplemental intake of 800 mg or more of epigallocatechin-3-gallate per day was associated with concern. Commission Regulation (EU) 2022/2340 now requires the daily portion of a food containing green tea extracts to provide less than 800 mg of EGCG and imposes specific warnings.8

EU controls also prohibit Ephedra herb and its preparations and require a daily portion containing monacolins from red yeast rice to provide less than 3 mg, together with mandatory warnings.9 These examples show how Article 8 of Regulation (EC) No 1925/2006 can create EU-wide restrictions for selected substances. The broader botanical landscape remains nationally fragmented.

The legal status of restrictions can also change through litigation. In November 2024, the General Court annulled key entries introduced by Regulation (EU) 2021/468 for hydroxyanthracene derivatives and certain botanical preparations. The Commission appealed in January 2025. Static prohibited-ingredient summaries can become inaccurate when court proceedings alter the underlying measure.10

Novel Food Status Creates a Separate Gate

A plant may be accepted under national botanical rules and still fall within Regulation (EU) 2015/2283. Novel food status turns on whether the relevant food was consumed to a significant degree in the Union before 15 May 1997 and whether it falls within a category covered by the Regulation.11

The assessment must address the material that will actually be marketed. Evidence for a tea, culinary herb or crude powder may provide limited support for a selective extract, purified fraction, newly concentrated constituent or preparation manufactured through a process that changes composition or structure. Traditional medicinal use may support context. It does not automatically prove significant consumption as a food.

The Commission's Novel Food Status Catalogue is a valuable screening tool. It is non-binding, non-exhaustive and based on information provided by Member States. The food business operator remains responsible for proving pre-1997 food use. An entry stating that an ingredient is not novel in food supplements is also use-specific, and expansion into conventional foods may still require authorisation.12

A defensible history-of-use file should identify the species, plant part, preparation, manufacturing process, food category, geography, dates and scale of consumption. Dated labels, invoices, catalogues, import records, official documents and contemporary publications generally provide stronger support than broad supplier declarations.

Claims and Borderline Classification Have Become More Exposed

Regulation (EC) No 1924/2006 establishes a prohibition in principle on health claims unless they are authorised or benefit from an applicable transitional measure. Member States originally submitted approximately 44,000 claims, which were consolidated into about 4,600 claims for assessment. The evaluation of many claims referring to botanical substances was suspended, leaving a large on-hold group.13

The legal significance of that on-hold status became clearer in Novel Nutriology, Case C-386/23. On 30 April 2025, the Court of Justice held that specific botanical health claims describing or referring to psychological or behavioural functions could not be used during the Commission's incomplete examination unless the conditions of Article 28(6) were satisfied. General, non-specific references to health or well-being also required an accompanying specific claim that could lawfully be used.14

The judgment makes reliance on the phrase 'on hold' alone unsafe. Operators should verify the precise claim wording, the category of function involved, the relevant pre-2008 national position, the existence and timing of any application, and current national enforcement. Claims used on websites, social media, retailer pages and influencer content belong within the same assessment as the product label.

Medicinal product classification creates an additional country-sensitive risk. Directive 2001/83/EC covers products presented as treating or preventing disease and products that restore, correct or modify physiological functions through pharmacological, immunological or metabolic action. Where a product falls within the medicinal product definition and another regulated category, the medicinal product regime applies in cases of doubt.15

Authorities consider the complete presentation, including the product name, dosage form, recommended intake, claims, imagery, consumer instructions and surrounding marketing. Botanicals associated with sleep, mood, hormonal effects, pain, glucose control or other clinically framed outcomes deserve particular attention.

Botanicals at a Crossroads

Mapping Regulatory Risk Before Market Entry

Regulatory risk mapping should begin with a preparation identity file. The file records the accepted botanical name and author, relevant synonyms, chemotype where applicable, plant part, manufacturing steps, extraction solvent, drug-extract ratio, native extract ratio, marker compounds, constituents of concern, contaminant controls, specifications, daily dose and intended consumer group. This prevents a general plant name from masking material differences between preparations.

The next review screens the EU-wide gates. The team should confirm novel food status, food safety evidence, Article 8 restrictions, contaminant and pesticide requirements, claims compliance and potential medicinal product classification. Any unresolved issue at this level affects the entire EU strategy and cannot be solved through mutual recognition.

The preparation is then mapped against each target country's national framework. The assessment should identify list status, permitted plant parts, restrictions on extracts or essential oils, maximum levels, mandatory warnings, age or population limitations, notification requirements, supporting documents, language rules and relevant authority guidance. Countries can be grouped as clear, conditional, unresolved or restricted. These categories describe the strength of the available evidence and the likely regulatory pathway, without implying a numerical certainty that the law cannot provide.

A separate mutual recognition record should identify the Member State of origin, the exact product marketed there, evidence of availability to end users, the national rule encountered in the destination market and the public-health rationale that an authority may raise. The voluntary declaration under Regulation (EU) 2019/515 can organise this information, supported by specifications, labels, notifications, invoices and sales records.

The completed map guides market sequencing. A country with direct national acceptance and a defined notification route may provide a sound first launch. A country with an unresolved novel food issue, a restrictive plant list or a high medicinal classification risk may require reformulation, additional evidence or early dialogue with the competent authority. A single EU formulation may remain feasible for part of the portfolio. Selected markets may require different doses, warnings, claims or product versions.

The same structure should continue after launch. A botanical master dossier can hold the common identity, quality, safety and history-of-use evidence, with country annexes covering national conditions and notifications. Change control should trigger reassessment when the supplier, plant origin, solvent, extraction ratio, standardisation, daily dose, specification, target population or claims change. National lists, authority positions and EU case law also require periodic monitoring.

The Direction of Travel

The European Parliament's 2024 resolution on implementation of the food supplement framework highlighted the absence of EU positive and negative botanical lists and called for progress on botanical health claims. The resolution is politically significant. It does not create binding rules.16

EFSA released a substantially developed Compendium in 2025 and is revising its scientific guidance for botanical safety assessment. No harmonised EU positive list for botanicals had been adopted by July 2026, and national rules continued to determine many market-entry outcomes.7

For brands, the practical response is earlier regulatory intelligence. A preparation-specific, country-specific map makes uncertainty visible before manufacturing, translation, distributor appointment and launch. It shows where evidence can resolve a question, where a national adaptation is realistic and where the proposed product faces a fundamental barrier.

Botanicals remain at a regulatory crossroads. Mutual recognition can support market access when the product is lawfully marketed and the disputed requirement is genuinely non-harmonised. Fragmentation continues where Member States reach different safety, classification and policy conclusions. Companies that understand that boundary can build stronger dossiers, choose markets more deliberately and manage botanical portfolios with fewer avoidable surprises.

Selected Regulatory Sources

  1. Directive 2002/46/EC on food supplements
  2. Regulation (EU) 2019/515 on mutual recognition
    Commission Notice, Guide on Articles 34 to 36 TFEU
  3. European Commission, COM(2008) 824 final
  4. Italian Ministry of Health, The BELFRIT Project
    ANSES opinion referring to the harmonised list of 1,025 plants
  5. France, Order of 24 June 2014
    Italian Ministry of Health, Botanical substances and preparations
    Belgian FPS Public Health, Plants in food supplements
    German BVL, Federal and Länder substance lists
  6. Regulation (EC) No 178/2002, General Food Law
  7. EFSA, Compendium of Botanicals, April 2025
  8. EFSA, Safety assessment of green tea catechins
    Commission Regulation (EU) 2022/2340
  9. Commission Regulation (EU) 2015/403 on Ephedra
    Commission Regulation (EU) 2022/860 on monacolins
  10. General Court, Aloe Vera of Europe v Commission, T-189/21
    Court of Justice case record, Commission v Ortis, C-54/25 P
  11. Regulation (EU) 2015/2283 on novel foods
  12. European Commission, Novel Food Status Catalogue
  13. European Commission, Health claims
  14. Court of Justice, Novel Nutriology, C-386/23
  15. Directive 2001/83/EC on medicinal products for human use
  16. European Parliament resolution of 18 January 2024 on implementation of Directive 2002/46/EC