The European framework for plant extracts is evolving rapidly. Between food safety, wellness uses, medicinal preparations, and contaminant control, EU authorities are refining their approach on a case-by-case basis. This dynamic directly affects consumers, manufacturers, and distributors, particularly in sensitive segments such as hemp, food supplements, and concentrated extracts.
What's changing today isn't just the level of requirements, but the methodology. European institutions emphasize that a plant extract is never assessed in the abstract: everything depends on its preparation, its intended use, the target population, and the available evidence. For adults who buy hemp or other botanical products in Europe, understanding this new European regulatory framework is therefore a real advantage.
Why plant extracts are back at the center of the regulatory debate
“Botanicals” occupy a major place in the European food supplement market. EFSA points out that they are at the heart of this category, while highlighting recurring concerns about chemical or microbiological contamination, as well as compliance with safe limits for certain active substances naturally present in plants.
This increased attention is also explained by the widespread availability of these products. EFSA notes that some are sold without a prescription in pharmacies, supermarkets, specialty shops, and online. The larger a market, the more authorities want to ensure that quality, actual composition, and claims remain consistent with the level of protection expected for the public.
In practice, European authorities no longer treat plant extracts as a uniform category. The 2025 and 2026 dossiers, on the contrary, show separate analyses based on the plant, the preparation, the chemical form, and the claimed use. Therefore, an extract of hemp, fennel, raspberry, or any other plant preparation is not assessed according to a single set of criteria.
EFSA's key role in risk identification
On January 6, 2026, EFSA published the 4th edition of the Compendium of Botanicals. This is a significant update to its open database listing plant species reported as potentially containing substances of natural concern for human and animal health. For the plant extracts sector, this publication confirms that scientific vigilance remains active and structured.
A key point: EFSA clarifies that this compendium does not declare a plant to be inherently safe or dangerous. The tool primarily serves to facilitate hazard identification and the assessment of botanicals. In other words, its function is to help ask the right questions about the profile of a plant or extract, not to automatically resolve every case.
This distinction is crucial for market players. A plant extract can present very different challenges depending on its extraction method, concentration, route of use, and dosage. EFSA's work therefore promotes a more precise, technical, and contextualized analysis of plant extracts, rather than an overly simplistic, general approach.
Medicine, supplements, novel foods: a more closely monitored boundary
EFSA clearly reiterates that the distinction between “medicine” and “food supplement” is not determined solely by EFSA or EMA. This distinction is based on the applicable legal framework and the assessment of the competent authorities in the Member States. This is an important point, as many plant extracts fall into this category depending on their presentation, composition, and claims.
In parallel, the EMA maintains European monographs on herbal substances and preparations. These monographs summarize safety and efficacy data for medicinal uses and serve as the basis for product information: indications, target population, precautions for use, and warnings. This means that the same plant may be subject to very strict medical regulations when intended for therapeutic use.
For consumers, this distinction has concrete consequences. A product may be acceptable as food but not as medicine without appropriate documentation, or vice versa depending on the specific preparation. This new European regulatory balance therefore reinforces the idea that each extract must be judged according to its actual status, and not simply based on the "natural" image of the original plant.
The Novel Food Regulation, a mandatory step for certain extracts
When a botanical substance intended for use in food, including a supplement, cannot demonstrate significant use in the European Union before May 1997, the Novel Food Regulation may apply. In this case, EFSA issues a scientific safety opinion under Regulation (EU) 2015/2283. This is a key point for many concentrated extracts or more recent preparations.
In 2026, EFSA indicated that its “Novel food as food supplements” activity explicitly targets plant extracts, as well as synthetic cannabidiol and nanomaterials. This framework demonstrates that botanical extracts remain a priority in the evaluation of supplements, especially when they take on more advanced or novel technical forms on the European food market.
In practical terms, this means that a plant-based product cannot rely solely on its long-standing cultural tradition or its commercial reputation outside the EU. What matters is proof of a relevant history of use within the appropriate legal framework. For reputable brands, this logic encourages greater investment in documentary traceability, composition analysis, and regulatory compliance before placing products on the market.
The case of hemp and CO₂ extracts illustrates the new approach
On March 30, 2026, EFSA published an opinion on a CO₂ extract of Cannabis sativa L. intended for use as a novel food. The dossier concerned an hemp extract being evaluated as a novel food. This example demonstrates that authorities continue to re-examine plant extracts for food use, including those derived from plants already widely known to the public.
The fact that the extract is obtained using CO₂ is not a trivial technical detail. The extraction method can alter the profile of the final preparation, its concentration of active compounds, and its potential impurities. The EMA also points out that its monographs cover plant preparations, not just the raw plant, which confirms the regulatory importance of the product's precise form.
For the hemp sector, this interpretation is particularly important. It means that simply referring to “hemp” or “CBD” in general terms is no longer sufficient. Authorities are increasingly scrutinizing the variety, processing method, final product matrix, contaminants, safety thresholds, and intended use. For informed consumers, this reinforces the importance of choosing products that have been laboratory-tested and are presented with clear information.
The EMA continuously re-evaluates the medicinal uses of herbal preparations
On the medicinal side, the EMA continues its regular updating work. The HMPC committee continued in 2025 and 2026 to revise monographs and working documents on medicinal plants. The agenda for March 2 and 4, 2026, explicitly mentions the “review of EU herbal monographs and list entries,” reflecting an ongoing reassessment of recognized uses at the European level.
The HMPC report of May 2025 confirms this. It shows that several monographs and guidelines were under review for adoption or revision, including documents concerning children and adolescents. This clearly illustrates that the scope of use for a herbal preparation can evolve according to new data, population profiles, and safety requirements.
The EMA has also published a 2025-2027 work plan focusing on quality themes particularly relevant to herbal products: supercritical CO₂ extracts, new analytical methods, and the quality of marketed medicines. This reveals a more refined requirement for the technical quality of extracts, going beyond the simple botanical name on the label.
Quality, contaminants and monitoring: the decisive battleground
The regulatory reassessment concerns not only a product's status but also its actual quality. The European Commission reiterates that legislation on food additives and contaminants aims for "the right balance between risks and benefits." This principle applies perfectly to plant extracts used as food ingredients or in preparations within related categories.
In the area of pesticides, the Commission outlines a system of scientific evaluation prior to authorization, in conjunction with EFSA and the Member States, and indicates a desire for a more agile mechanism for reassessing active substances in light of new knowledge. While this primarily concerns plant protection products, this culture of continuous review directly influences the monitoring of plant-based food products.
The EU's coordinated pesticide residue monitoring program for 2026-2028, established by the Commission in May 2025, confirms that monitoring remains active. For consumers of hemp products and other extracts, this serves as a reminder of a simple truth: quality isn't visible to the naked eye. Laboratory testing, transparency regarding origin, and compliance with regulatory limits remain essential.
Stronger cooperation between Europe and the Member States
EFSA mentions enhanced cooperation with the competent authorities of Member States on emerging risks related to supplements other than vitamins and minerals, including botanicals. This information is important because it shows that the re-evaluation of plant extracts is not conducted solely from Brussels or Parma: it also draws on national feedback, field checks, and locally observed market practices.
This networked governance explains why certain issues progress in stages and may be subject to differing interpretations between countries, especially in the short term. National authorities play a key role in applying the law, assessing cases, and monitoring products marketed within their territory. The framework is European, but its implementation remains very concrete and often national.
For both professionals and buyers, this means monitoring both major European positions and the decisions of local authorities. In e-commerce, this is particularly important: a product that looks good on paper must also comply with the regulations of both the country of sale and the destination country. Compliance is therefore not just a marketing ploy, but a lasting condition for trust.
What this new balance changes for the market and for consumers
The authorities' underlying message is clear: plant extracts can fall under different legal frameworks depending on their end use. They may be classified as herbal medicines, novel foods, food supplements, additives, or substances falling under another sectoral regime. This regulatory fragmentation necessitates increasingly detailed, case-by-case analysis.
For the market, this favors operators who can document the product's composition, extraction method, stability, contaminants, and intended use. Reputable players therefore have an interest in focusing on tested batches, clear product information, accessible certificates of analysis, and measured communication. In the medium term, this discipline could even become a competitive advantage for transparent brands.
For adult consumers in France and Europe, the benefit is twofold. On the one hand, the regulations may seem more technical. On the other, they push the market towards greater clarity, more control, and better differentiation between improvised products and genuinely established brands. In a world like hemp and CBD, this increased precision is rather good news for making informed purchases.
Ultimately, the new European regulatory framework is not intended to restrict plant extracts on principle. Its primary aim is to better distinguish between uses, to better regulate preparations, and to align safety requirements with the realities of products sold today. The era when a plant could be treated as a homogenous block is clearly over.
For brands, distributors, and consumers, the best response remains the same: prioritize transparency, analytical quality, and a rigorous review of each product's status. In a dynamic market like that of hemp, plant extracts, and next-generation cannabinoids, this requirement is not an obstacle; it is the foundation of a sustainable, legal, and trustworthy offering.
