In Europe, recent opinions on plant extracts send a very clear signal to the market: the period of uncertainty is receding, and the era of technical documentation is rapidly advancing. For brands, manufacturers, and consumers, this does not necessarily mean less innovation, but clearly more evidence to provide regarding botanical identity, composition, dosage, contaminants, and intended use.
For an audience already closely following topics related to hemp, CBD, and botanical ingredients, this development is particularly important. Because a single plant extract can be subject to several regulatory pathways depending on its classification: food supplement, novel food, cosmetic ingredient, restricted substance, or even traditional herbal medicine. The opinions recently published by EFSA, ECHA, the European Commission, and bodies linked to the EMA show that market access is becoming more regulated, more technical, and above all, more differentiated.
A Europe that strengthens standards on plant extracts
The most visible change lies in the increasing importance of scientific assessment. In January 2026, EFSA published the fourth edition of its Compendium of Botanicals, which now lists 2,701 plant species and 1,538 natural substances of potential concern. This document is not a commercial catalogue of “authorized” plants, but a hazard identification tool for authorities, assessors, and food supplement manufacturers.
This point is crucial: in the European Union, botanicals are widely sold in pharmacies, supermarkets, specialty shops, and online. However, the EFSA (European Food Safety Authority) reiterates that questions remain regarding safety, chemical or microbiological contamination, and the dosage of active substances. In other words, the "natural" nature of a plant extract is no longer sufficient to reassure the regulator.
This evolution reflects a fundamental trend: the increasing scientific rigor of product testing. Files are examined using toxicological databases, scientific reports, and sometimes predictive models such as QSARs. For reputable operators, this presents both a constraint and an opportunity: the stronger the documentation, the greater the product's credibility with distributors, authorities, and consumers.
The EFSA Compendium does not give an automatic green light
It is important to understand the role of the Compendium of Botanicals. EFSA emphasizes that its approach is based on a safety assessment, not a general marketing authorization. In practice, inclusion in EFSA's working tools does not constitute marketing approval or regulatory immunity.
The EFSA toolkit includes a methodological guide, case studies, and the well-known compendium to aid in risk analysis. This means that the assessment focuses first on potential hazards: substances of concern, exposure profiles, toxicological risks, manufacturing quality, and variability in preparations. The message is simple: before selling, you must precisely characterize what you are selling.
For consumers, this helps them to take a more nuanced view of the market. Two products bearing the name of the same plant can be very different depending on the part used, the extraction process, the concentration, the solvent employed, or the standardization of active ingredients. This is precisely why authorities are increasingly demanding more detailed evidence, instead of simply relying on the botanical name on the label.
Dietary supplement, novel food, or substance to monitor: it all depends on the context
The European framework distinguishes between several regimes depending on the use of the botanical extract. When an extract is used in food and does not have a history of safe use before 1997 in the European Union, the EFSA (European Food Safety Authority) can be consulted under the Novel Foods. This is a major issue for many "modernized," enriched, or repositioned plant-based ingredients, often marketed as functional ingredients.
In parallel, certain botanicals may also fall under Article 8 of Regulation (EC) No 1925/2006. This mechanism can lead to a ban, restriction, or monitoring at the European level when security concerns arise. Therefore, we are far from a binary system where an extract is either completely free or completely prohibited: there is a whole spectrum of regulated access.
The practical consequence for operators is very real. The same plant extract can be classified as a food supplement, a novel food, a restricted ingredient, a traditional herbal medicine, or even a cosmetic ingredient, depending on its composition, presentation, and associated claims. This is one of the key regulatory messages for 2026: a product's classification depends on the dossier, not just the ingredient.
The boundary between medicine and food remains a sensitive point
The EFSA clarifies that, like the EMA, it does not define the boundary between “medicine” and “food supplement.” This distinction depends on national legislation and the context of use. This is one of the reasons why regulated access can vary from one Member State to another, even for plant extracts that appear similar on paper.
The European Commission also maintains a specific regime for herbal medicinal products through the EMA's HMPC. Within this framework, certain plant substances and preparations intended for traditional medicines may be included in a European list established based on scientific advice. This clearly demonstrates that the same botanical universe can follow very different regulatory channels depending on its intended use.
For brands, this interface between food and pharmaceuticals demands great caution, particularly in marketing communications. A formulation, concentration, or product claim can be enough to shift regulatory interpretations. For buyers, this underscores the importance of prioritizing clearly formulated products with consistent positioning and easily verifiable compliance information.
Plant extracts are increasingly being analyzed on a case-by-case basis.
In January 2026, the EFSA published a safety opinion on a pectin-rich extract of Coffea arabica used as a food additive. This dossier reveals the direction taken by the authorities: the analysis combines available data with a QSAR approach applied to certain substances of interest. In short, extracts are no longer viewed simply as botanical traditions, but as complex matrices to be scientifically deciphered.
This type of assessment illustrates the increasing number of applications concerning "enhanced" or technologically reworked extracts. A plant with a long history of use can become a new ingredient if the preparation, enrichment, or desired function significantly alters the product's profile. In this context, the plant's prior use does not automatically resolve the regulatory issues surrounding the extract.
The EFSA 2025-2027 scientific work program points in the same direction. It indicated that a mandate on botanical preparations was being prepared, with finalization expected in autumn 2025 and work starting in early 2026. This signals an institutional strengthening of assessment standards and suggests that documentation requirements will continue to be structured in the coming years.
Technical controls: solvents, contaminants and document quality
Among the points sometimes underestimated, the European framework on extraction solvents remains central. EFSA points out that Directive 2009/32/EC harmonizes the solvents authorized in food production. For many plant extracts used in food or supplements, the manufacturing process is therefore not a mere industrial detail: it directly influences product compliance.
Contaminants represent another key area of control. Authorities monitor for the potential presence of chemical residues, microbiological contaminants, and significant variations in the concentration of active substances. In practice, this encourages reputable stakeholders to strengthen laboratory analyses, technical data sheets, batch traceability, and the accuracy of product specifications.
For an e-commerce site specializing in hemp-based products and other botanical ingredients, this logic makes perfect sense: trust is built on accessible analyses, clear ingredient lists, and consistent quality standards. The European market increasingly rewards operators who can prove what they sell, not just present it well.
ECHA and other bodies are adding safety barriers
The tightening of the framework is not solely due to EFSA. In 2026, ECHA will continue its consultations and opinions on substances covered by REACH and CLP, including those related to plant-derived ingredients or plant-isolated substances. The agency maintains a prior control chain based on consultations, testing proposals, harmonization of classification and labeling, and potential restrictions.
The ECHA's 2026 calendar remains very active regarding restrictions, testing proposals, and harmonized classification and labelling. This demonstrates that, beyond the food sector, access to certain botanical or derived substances is becoming increasingly regulated even before the final regulatory decision. Here again, the market is moving towards greater scientific anticipation and more rigorous screening of applications.
The same reasoning applies to the cosmetics sector. The Commission's website dedicated to SCCS opinions reminds us that recent scientific opinions serve as the basis for restrictions on substances used in non-food products. A plant extract incorporated into a cosmetic product therefore does not follow the same regulatory pathway as one used in a food supplement, which reinforces the key idea: regulatory status follows the product's actual use.
What this changes in concrete terms for brands and for consumers
For operators, the European Union's recent message is clear: no open access without precise characterization. The botanical identity, active substances, contaminants, dosage, and context of use must be documented. Without this foundation, it becomes more difficult to overcome the various safety barriers and maintain stable market access.
For the most rigorous brands, this means investing more in analysis, labeling compliance, extraction process validation, and regulatory monitoring. This may seem burdensome, but it's also what distinguishes a reliable player from an opportunistic offering. In sensitive segments like CBD ,next-generation cannabinoids, or certain wellness extracts, this documentation discipline becomes a true competitive advantage.
For adult consumers in France and Europe, the impact is generally positive in the medium term. A better-regulated market means, in principle, greater transparency regarding the actual composition of products, more consistency in dosages, and stronger guarantees of quality. As a buyer, checking a store's transparency, the existence of lab tests, and the accuracy of product information sheets is becoming more crucial than ever.
Ultimately, recent opinions on plant extracts in Europe do not close the door to innovation; they change the rules of the game. Plants, extracts, and natural substances continue to interest manufacturers and consumers, but they must now meet higher standards of evidence, undergo more technical controls, and operate within a more clearly defined regulatory framework.
In this environment, plant extracts will be those that combine genuine quality, controlled manufacturing, and complete documentation. For players in the CBD and compliant botanical product sectors, this is excellent news: when standards are raised, transparency and integrity ultimately make all the difference.
