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Herbal infusions and supplements: understanding the new European rules and their practical consequences

The market for herbal teas and supplements remains very dynamic in France and Europe. For consumers, it often seems like a simple and “natural” world. In reality, the legal framework has become much more technical, with European regulations, national controls, and specific requirements depending on the plant, the extract, the dosage, and even the form of the product.

In 2026, several developments confirm a fundamental trend: when it comes to herbal supplements and infusions, compliance is no longer simply a matter of a pretty ingredient list on the label. Between novel food status, substances under surveillance, THC limits for hemp leaves, and documentation requirements, manufacturers, e-tailers, and consumers all have a vested interest in understanding what is changing in practice.

A common European framework, but still very fragmented implementation

At the European Union level, food supplements are regulated by Directive 2002/46/EC. This common framework establishes the regulatory basis, but it does not eliminate all differences between countries. In practice, each Member State can maintain its own control mechanisms, particularly through pre-market notification procedures.

This situation creates a rather fragmented landscape for plant-based products. The same formula may be more readily accepted in one country and subject to more scrutiny in another. This is particularly true when the product contains concentrated botanical extracts, sensitive claims, or ingredients closely related to medicinal plants.

For brands and online retailers, this means that a product that complies in one Member State is not automatically "plug-and-play" everywhere in Europe. Local regulations, national lists, regulatory requirements, and available documentation must be checked. For buyers, this complexity also explains why two seemingly similar products may display different warnings or usage guidelines depending on the country of sale.

Why are plants not treated like simple vitamins?

Botanicals occupy a unique place in European food law. Unlike vitamins and minerals, which benefit from a more harmonized framework, botanical plants and preparations raise far more varied safety concerns. A leaf, a root, or a hydroalcoholic extract does not present the same risk profile depending on the concentration, the part of the plant used, and the quantity consumed.

The EFSA also points out that plants are often sold in concentrated forms: capsules, powders, liquids, or standardized extracts. This concentration changes the situation compared to traditional use as an herbal tea. A plant historically consumed as a light infusion is not automatically equivalent to a highly concentrated extract included in a food supplement.

Another important point: depending on its intended use and national legislation, a botanical substance may fall under either food law or pharmaceutical law. This distinction is crucial. Therefore, an operator cannot simply label a product as “natural” or “plant-based” to market it without worry. Legal classification remains essential from the product's inception.

Article 8 and monitored plant substances

Regulation (EC) No 1925/2006 provides the European Commission with a key tool: Article 8. This mechanism allows it to restrict, monitor, or prohibit substances added to food when the risk to the consumer justifies it. Botanical products are therefore not outside the European radar; quite the contrary.

In practical terms, several plant extracts important to the market are already subject to restrictions. These include ephedra, yohimbe, certain aloe leaf preparations containing hydroxyanthracene derivatives, and green tea extracts rich in EGCG. For the latter, a limit of 800 mg per day applies, along with specific labeling requirements.

The practical consequence is immediate: the label must sometimes include dosage warnings, usage restrictions, and clearly visible safety information. For manufacturers, this requires robust calculations of the daily dose. For consumers, it serves as a reminder that a popular plant-based ingredient is not automatically risk-free, especially when concentrated or consumed daily.

The botanicals dossier continues to evolve at EFSA

The rules concerning plants are not set in stone. EFSA announced in its 2025-2027 work program a revision of its 2009 guidance on the safety assessment of botanicals and botanical preparations used in food supplements. Preparatory work is planned from 2026 onwards, indicating that the scientific framework will continue to be refined.

EFSA also updates its Compendium of Botanicals, which serves as a working reference for safety assessments. It is a very useful tool for identifying substances or preparations that may contain compounds of concern. However, it has a significant limitation: it does not automatically cover synergies or antagonisms between different species, preparations, and substances.

In other words, one cannot too quickly extrapolate the safety of a complex mixture simply because each plant is "known." This is a crucial point for modern formulations that combine several extracts, sometimes with cannabinoids, terpenes, or other functional ingredients. In this context, regulatory and analytical caution becomes a true professional requirement.

Hemp infusions: the major European innovation of 2026

The most concrete change for the sector in 2026 concerns hemp leaves intended for infusion. Regulation (EU) 2026/1828 of 28 July 2026 amends Regulation (EU) 2023/915 and sets maximum THC levels for hemp leaves used as infusions in water, as well as for ready-to-drink infusions made from hemp leaves.

This text also provides a much-anticipated clarification: aqueous infusions of hemp leaves, consumed alone or in herbal tea blends, are not considered novel foods under the relevant regulations. This is an important clarification, as it removes some of the legal uncertainty surrounding this product category, while maintaining the objective of protecting public health through THC thresholds.

In practice, this changes a lot for operators. Products such as "hemp infusions" must now be formulated, tested, and labeled with increased attention to THC and THCA. Simply talking about wellness hemp or flavor profile is no longer enough: it must also be demonstrated that the product complies with applicable limits, including whether it is in dry or ready-to-drink form.

Novel food status remains a crucial control point

Novel food status remains a major issue for plant products and their extracts. The European Commission points out that a product can be considered non-novel if its historical use is demonstrated, but this depends on the specific case, the matrix, and the method of consumption. The same plant may therefore be treated differently depending on whether it is consumed as a traditional infusion, as an isolated extract, or in an innovative preparation.

The case of cannabidiol clearly illustrates this caution. In March 2026, the Commission terminated an authorization procedure for cannabidiol oil as a novel food, without updating the EU list at this stage. This does not mean that all CBD are banned outright, but it confirms the need for a very precise analysis of the product's form, its history of use, and its regulatory basis.

For professionals, the lesson is clear: every ingredient, every extract, and every matrix must be thoroughly vetted before being marketed. An infusion, an oil, a capsule, or a ready-to-drink beverage do not necessarily raise the same questions. In the world of hemp, as with other plants, regulatory status should never be assumed; it must be documented.

Labeling, controls and traceability: the concrete impacts for brands

The practical consequences of the new European rules are first visible on labeling. Depending on the plant or extract used, it may be necessary to indicate a maximum daily dose, specific warnings, restrictions for certain categories of people, or more detailed instructions for use. The model applied to EGCG in green tea extracts clearly illustrates the direction taken by the regulator.

Next, documentary traceability becomes crucial. Importers, manufacturers, and e-tailers must be able to justify the origin of raw materials, provide certificates of analysis, contaminant and toxin testing results, the regulatory status of ingredients, and, where applicable, national notifications. The Commission's work on e-commerce imports of food supplements demonstrates that enforcement and market controls remain a priority.

For a reputable online store, this means that a good herbal product is no longer defined solely by its price or packaging. Adult consumers are increasingly seeking products that have been lab-tested, are clearly labeled, and comply with European market regulations. This trend favors transparent businesses that can demonstrate the quality and legality of their products, particularly in sensitive sectors such as hemp and hemp-derived cannabinoids.

What this means for consumers in France and Europe

For the consumer, the first consequence is simple: “natural” does not automatically mean compliant or safe. A herbal infusion, a capsule supplement, or a liquid extract must be evaluated based on its exact composition, dosage, and regulatory status. A clean label for plant-based products is a good start, but it is not a guarantee in itself.

The second consequence is more positive: the new rules are pushing the market towards greater transparency. When an operator works ethically, with lab analyses, traceable raw materials, and careful formulation, the consumer benefits from a better-regulated product. This is particularly useful in rapidly growing categories, such as hemp infusions, oils, or certain concentrated botanical extracts.

Finally, it's important to keep in mind that the framework can still evolve rapidly. The example of fennel in traditional herbal medicines, or the upcoming revisions to the EFSA guidance, shows that regulations closely follow safety data. To make smart purchases in 2026 and beyond, it's best to choose brands that clearly explain their controls, compliance, and the rationale behind their formulations.

Ultimately, the new European rules don't close the door on herbal infusions and supplements. They primarily impose a much more rigorous approach. Between the Food Supplements Directive, Article 8 of Regulation 1925/2006, novel food issues, and the new limits on hemp leaves for infusions, each product must be assessed within its actual context of use.

For both professionals and consumers, the best approach is now the same: systematically check the status of each ingredient, applicable restrictions, safety thresholds, labeling requirements, and any relevant national regulations. In a market where trust is built on evidence, regulatory compliance becomes a true marker of quality and an essential criterion for choosing reliable, legal, and well-controlled plant-based products.

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