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Between European opinions and clinical applications: new benchmarks for the plant extracts sector

The plant extracts sector is entering a more demanding phase of maturity. Between European scientific opinions, growing expectations for traceability, and the realities of clinical practice, operators must now contend with a more structured framework. For both consumers and professionals, this shift is generally good news: it clarifies what an extract can promise, how it must be controlled, and according to what criteria it can be marketed.

In this environment, the hemp wellness sector and botanical products in general are directly affected. The guidelines established by the EFSA, the EMA/HMPC, and, in France, by the ANSM, outline a clear course of action: measurable quality, demonstrable safety, and rigorous communication. For reputable brands that focus on laboratory-tested products compliant with European law, these developments represent less of a hindrance than a lasting competitive advantage.

A plant extracts under constructive scrutiny

Plant extracts and preparations derived from plants, algae, fungi, or lichens play a significant role in food supplements in the European Union. In January 2026, the EFSA reiterated that these ingredients remain central to food safety concerns, with persistent issues surrounding contamination, the variability of raw materials, and the standardization of active substances.

In practical terms, this means that the same plant name does not always guarantee the same product profile. The exact botanical origin, the part used, the extraction solvent, the final concentration, and the possible presence of naturally occurring compounds of concern significantly alter the assessment. For market players, simply referring to a plant is no longer sufficient: the preparation being marketed must be precisely documented.

This trend is of particular interest to sectors related to hemp and wellness cannabinoids, where the demand for transparency is already high. Adult consumers in France and Europe are increasingly seeking legal products that are tested and consistent in their composition. The European framework is therefore pushing the entire sector towards greater clarity and reliability.

The EFSA Compendium 2026, a key tool for better understanding risk

Among the significant new developments, EFSA announced in 2026 a major update to the 4th edition of the Compendium of Botanicals. This open database lists plant species containing substances naturally present that may pose a risk to human or animal health. It provides a very useful methodological framework for the assessment of plant extracts.

This Compendium is not simply a theoretical list. It influences how operators, laboratories, and authorities approach controls, extract characterization, and the analysis of sensitive compounds. In practice, it helps anticipate critical points: alkaloids, natural contaminants, bioactive molecules to monitor, and potential interactions depending on the intended use.

For the industry, this type of tool reinforces the idea that a good plant-based product is not just one that is attractive from a marketing perspective. It is also one whose chemical profile is understood, measured, and controlled. Ultimately, this approach favors catalogs built on stable references, batch analyses, and clear specifications, which reassures buyers attentive to value for money as well as those who prefer premium products.

Health claims: a subject that remains highly regulated

From a marketing perspective, the European message is clear: plant extracts cannot be freely promoted with health claims. The EFSA (European Food Safety Authority) reiterates that claims used on packaging, product information sheets, or advertisements must be scientifically substantiated and understandable to the consumer. This necessitates great care in commercial writing.

One figure sums up the situation well: 1,548 botanical-related claims are currently “on hold” for general function claims , pending a final decision from the Commission and Member States. In other words, a large part of the language historically used around plants is evolving in a sensitive regulatory area, which requires a clear distinction between product information, traditional use, and validated health claims.

The scientific opinion published by EFSA on February 20, 2026, regarding polyphenols in olive oil illustrates this dynamic of ongoing evaluation. Even when a substance is of plant origin and well-known to the public, the European authority maintains an evidence-based approach. For reputable brands, it is therefore better to focus on composition, analytical quality, compliance, and education rather than vague promises.

EMA/HMPC: monographs that structure the use of plants

In parallel with the work of EFSA, the European Herbal Medicinal Products Committee (HMPC) of the EMA will continue its work on monographs, guidelines, and meeting reports in 2026. Its work plan confirms that medicinal plants remain an active area of ​​study, with direct implications for the interpretation of traditional uses and the expected levels of evidence.

HMPC monographs play a structuring role, as they help define how a plant or preparation can be understood within a therapeutic or traditional framework. They do not automatically apply to all commercial forms, but they provide solid guidelines on the plant parts involved, accepted preparations, conditions of use, and safety limits.

For the plant extracts, this creates a kind of regulatory and scientific framework. The further an operator deviates from a well-documented preparation, the more they must be able to explain how their extract remains consistent, safe, and properly characterized. This logic also applies to botanical innovations, where market enthusiasm must always be tempered by the robustness of the technical documentation.

Traditional use or clinical application: the decisive distinction

One of the most important methodological reminders of the HMPC in 2026 concerns the distinction between traditional use and clinical evidence. European authorities emphasize that a history of use for a single active substance is not necessarily sufficient to establish traditional use for a fixed combination of substances. The evidence must be tailored to the specific preparation being evaluated.

This precision is essential to avoid oversimplification. Two plant-based products can share the same starting plant but differ significantly in their extraction method, standardization, or combination with other compounds. Therefore, one cannot automatically extrapolate usage data or published results without verifying their precise relevance to the specific formula in question.

From a clinical application perspective, this necessitates a better integration of the levels of evidence: traditional knowledge, preclinical data, pharmacology, pharmaceutical quality, safety, and clinical trials when required. For the most rigorous professionals, this requirement serves as a useful benchmark: it prevents overinterpretation of data and allows for the development of a more credible offering in the long term.

“Borderline products”: a real challenge for brands

The minutes of the HMPC meeting of January 2026 remind us that the issue of borderline products remains particularly sensitive. In many cases, it remains difficult to classify a product that straddles the line between medicine, food supplement, or another category, due to a lack of complete harmonization within the European Union. This issue directly affects the most innovative plant extracts

For operators, the risk is not merely theoretical. The chosen regulatory category influences the applicable requirements for formulation, dosage, communication, distribution, and monitoring. A product presented in a certain way can shift from one status to another depending on its claims, composition, or the perception of its primary use.

In practice, this requires editorial and technical discipline. Labeling, product descriptions, analyses, certificates, and marketing materials must all be aligned. For a shop specializing in legal and tested botanical products, this consistency is crucial: it protects both regulatory compliance and the trust of the end customer.

France: ANSM confirms the topic is still relevant

At the national level, France is also closely monitoring developments in this matter. A 2025 ANSM report mentions pharmacoclinical studies on an aqueous extract, as well as discussions concerning the quality of various extracts and phytoconstituents. This indicates that the issue is not confined to Brussels or Amsterdam; it is also influencing French discussions.

This type of institutional exchange reveals a clear expectation regarding product characterization. Authorities do not only consider the trade name or the associated promise, but also the precision of the process, the nature of the constituents, the reproducibility of the manufacturing process, and the consistency between the data provided and the intended use.

For consumers, this is reassuring. Behind the sometimes technical terms, the objective remains simple: to better identify what is actually in an extract, how it is made, and within what limits it can be presented. For responsible sellers, this environment encourages higher standards and a more transparent selection of products.

Towards a sustainable three-pronged approach: proof, quality, safety

The underlying trend for 2026 can be summarized in three words: evidence, quality, safety. EFSA, in its 2024-2026 programming, emphasizes the desire to better understand the molecular mechanisms linked to toxicity or claimed positive effects, while reducing the use of animal studies. This approach more closely integrates biology, risk assessment, and consumer communication.

For the plant extracts, this framework represents a cultural as well as a regulatory shift. It is no longer simply a matter of opposing tradition and science, but of properly integrating them. A tradition of use can influence interest in a plant, but the quality of the final product, its safety, and the relevance of the evidence remain crucial for any serious commercialization.

In the medium term, the brands that will stand out will likely be those capable of providing clear analyses, controlled origin, consistent batches, and a straightforward approach. In the world of botanical products, CBD , and next-generation cannabinoids, this requirement can become a real differentiator, even for customers who value fair prices but refuse to compromise on reliability.

Ultimately, the new European guidelines do not close the door to plant extracts ; they primarily require the industry to become more precise. Between the opinions of the EFSA, the work of the HMPC, and the signals from national authorities, a common thread is emerging: a plant is no longer judged solely by its reputation, but a preparation by the quality of its evidence, its manufacturing process, and its safety.

For the most reputable players, this is a real opportunity. By focusing on compliant products that are tested and presented in an informative way, the industry can meet a key expectation of the European adult public: access to plant extracts . In a rapidly evolving market, trust will increasingly be built on solid data, not vague promises.

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