CBD oil for oral consumption cannot be legally sold in Spain or in the EU
Hemp extracts with cannabidiol have been considered a novel food since 2019 and, as of September 2026, none has been authorised on the European Union list. Selling CBD oils, capsules, gummies, or infusions intended for ingestion therefore constitutes a sanctionable food-law infringement, including product withdrawal. What you can sell with legal certainty: CBD cosmetics notified in the CPNP, foods derived from hemp seed, and correctly presented flowers. And keep an eye on the timeline, because since February 2026 the EFSA has had a provisional safe intake level and has restarted the assessment of applications: the scenario may start to change product by product.
It’s the most common question in any business in the sector: if CBD is legal, why can’t I sell CBD oil to take? The answer is not in drug law, but in European food law. In Spain you can buy CBD flowers, cannabidiol cosmetics, and all kinds of oils; shop windows suggest everything is normal. And yet the flagship product that almost every customer asks for cannot be sold as a food or as a food supplement in any EU country. In this guide we explain exactly what the Novel Food Regulation says, which products you can sell with legal certainty, and what is changing in Europe in 2026—because it is changing, a lot.
What the Novel Food Regulation is and why it captures CBD
Regulation (EU) 2015/2283 on novel foods, applicable since January 1, 2018, is based on a simple idea: any food or ingredient with no history of consumption in Europe must demonstrate its safety before reaching the market. This article is part of our series on the legal framework for CBD in Spain and goes into detail on this food-law issue, which today is the real barrier between what a CBD shop can invoice and what can cost it a six-figure fine.
A “novel food” is any food that was not used to a significant degree for human consumption in the Union before May 15, 1997. A novel food cannot be marketed until it has passed a safety assessment and is included in the Union list of authorised novel foods (Commission Implementing Regulation (EU) 2017/2470).
The cut-off date is not arbitrary: on May 15, 1997, the first European novel foods regulation entered into force. Anything that was already commonly eaten then was left outside the system; anything that came later must go through the approval process. Edible insects or certain plant proteins have followed this path. CBD as well.
January 2019: the moment that changed everything
The European Commission updated the Novel Food Catalogue with a specific entry for cannabinoids: there is no demonstrated history of significant human consumption of Cannabis sativa L. extracts or isolated cannabinoids before 1997.
Consequence: hemp extracts with CBD, isolated CBD, and synthetic CBD are novel food, and so is any food to which they are added. The same catalogue recognises, however, that hemp seeds and their traditional derivatives (seed oil, flour, protein) do have a history of consumption and are not novel food.
“CBD comes from hemp, and hemp has been consumed in Europe for centuries, so CBD oil is a traditional food and I can sell it.”
The history of consumption covers the seed and its derivatives, not the extract or the cannabinoids. That is why hemp seed oil is sold in supermarkets and CBD oil for ingestion cannot be sold: same plant, opposite legal regime.
Why you cannot sell CBD oil for consumption (as of today)
The operational rule is this: being novel food does not mean being banned forever; it means needing prior authorisation. The problem is that no CBD application has completed the process, so any CBD oil, capsule, gummy, or infusion intended for ingestion is an unauthorised novel food. The Spanish Agency for Food Safety and Nutrition (AESAN) applies this criterion without exceptions, and detection leads to product withdrawals and sanctioning proceedings handled by the consumer and health authorities of each autonomous community.
So why hasn’t it been authorised already? Because the scientific assessment was stuck for years and has only just restarted. This is the timeline any operator in the sector should have in mind:
January 2019 · Cannabinoids enter the catalogue
The European Commission classifies cannabis extracts and cannabinoids as novel food. CBD products intended for ingestion are excluded from the food market without prior authorisation.
November 2020 · KanaVape judgment
The Court of Justice of the EU (case C-663/18) rules that CBD is not a narcotic under EU law. The path for free movement is cleared, but not the food route: the Novel Food barrier remains intact.
June 2022 · EFSA pauses assessments
The European Food Safety Authority states it cannot establish the safety of CBD as a food due to lack of data: effects on the liver, interactions with medicines, drowsiness, and possible effects on the reproductive system remain insufficiently answered. More than 150 applications are frozen.
September 2025 · Requirements are tightened
EFSA updates its position: data gaps persist and dossiers will need to provide dose–response profiles, impurity analyses, and stability studies. It also reiterates that no safe use has been established for under-25s, pregnancy, and breastfeeding.
February 2026 · First safe intake level (provisional)
The EFSA publishes a provisional safe intake level of 0.0275 mg per kg of body weight per day—about 2 mg daily for a 70 kg adult—applicable only to CBD supplements with a minimum purity of 98%, without nanoforms, and with genotoxicity ruled out. It is not an authorisation, but it unlocks case-by-case assessment: around twenty dossiers are in risk assessment and more than twenty are in the validation phase.
Pending · Opinions and vote on the Union list
After each favourable EFSA opinion, the Commission and Member States must still decide to include the specific product on the Union list. No committed date. The UK, with its own procedure after Brexit, is moving in parallel at a faster pace.
“When a shop consults me, the first thing I review is not the product: it is how it is presented. In the firm I constantly see catalogues where the oil is shown with a dropper, a concentration percentage, a daily drop regimen, and customer reviews saying they take it to sleep. That combination turns the product into a food, or worse, a medicinal product by presentation, in the eyes of any inspector, whatever the label says. The word ‘sublingual’ on a product page is, as things stand today, an invitation to a fine.”
The trap of “external use” and “aromatic use”
The sector’s natural reaction has been to label oils as “external use”, “topical use”, or “not suitable for human consumption”. This is widespread and, if done properly, can be defensible. But it has a clear legal limit: in food and health law, the nature of the product is determined by its overall commercial presentation, not by an isolated phrase on the label. If the format, the website messaging, or staff responses suggest ingestion, the product will be treated as an unauthorised food. And if therapeutic properties are also attributed to it, medicines legislation comes into play and the AEMPS becomes competent, with an even harsher sanctioning regime.
In practice, the difference between a defensible catalogue and a sanctionable one comes down to very specific details:
- A dropper with a drop regimen or “recommended daily dose” on the label, the box, or the product page.
- The word “sublingual” in any medium: label, website, social media, or in-store materials.
- Health claims (better sleep, anxiety, pain), which also open the route to a medicinal product by presentation.
- Featured customer reviews describing oral consumption, selected and published by the retailer itself.
- Staff responses recommending taking the product or setting quantities at the counter.
- CPNP notification and full cosmetic labelling for oils and creams for topical use.
- Clearly topical directions for use, consistent across packaging, product page, and marketing communications.
- Aligned website and social media: zero content suggesting ingestion, including the reviews you highlight.
- THC analyses per batch filed and available for any check.
- A written customer-service protocol so the team knows what it can and cannot say.
That consistency between product, label, website, and sales messaging is exactly what we work on in our compliance programmes for CBD companies and shops: ensuring that what an inspection finds matches what the business claims to be.
What you can legally sell in Spain
The good news is that the lawful product range of a well-advised CBD business is broader than it seems. The key is to fit each product into its correct legal regime and document it. If you are in the process of setting up the business, our guide on how to open a CBD shop in Spain sets out the full structure; here is the product map, organised like a traffic light:
- CBD cosmetics (creams, balms, massage oils) notified in the European CPNP portal, with a product information file and no therapeutic claims
- Food-grade hemp seed oil, with no added CBD and THC within contaminant limits
- Hemp seeds, flour, and protein, with general food labelling
- CBD oil for oral ingestion: unauthorised novel food, with withdrawal and a fine in the event of an inspection
- CBD capsules, gummies, infusions, and drinks: same regime, and the edible format does not even allow the “external use” argument
- CBD food supplements: without an entry on the Union list there is no legal supplement, no matter how many lab analyses are provided
THC limits in hemp foods that are legal
For seed derivatives that can be sold as food, the European Union set maximum limits for delta-9-THC in Regulation (EU) 2023/915 on contaminants in food. These are values your supplier must evidence with analyses for each batch:
| Hemp food | Maximum delta-9-THC limit | Novel Food status |
|---|---|---|
| Hemp seeds | 3.0 mg/kg | Not novel food: legal to sell |
| Ground seeds, flours, and seed derivatives | 3.0 mg/kg | Not novel food: legal to sell |
| Hemp seed oil | 7.5 mg/kg | Not novel food: legal to sell |
| Oil or food with added CBD | Not applicable | Unauthorised novel food: sale not permitted |
“A mistake I often see: buying from a European wholesaler who claims their oil ‘has Novel Food approval’ or comes with a ‘Novel Food certificate’. That certificate does not exist. What exists are applications in progress, and a submitted application does not give you the right to sell. Before signing with a supplier I always ask for three things: THC analyses per batch, the CPNP notification if the product is sold as a cosmetic, and product sheets that do not put you at risk as the marketer. The distributor disappears; the sanctioning file arrives in your shop’s name.”
What is at stake: fines and product withdrawal
Selling foods with CBD is not, in general, a criminal issue: it is a serious administrative issue. The sanctioning framework is set out in Law 17/2011 on food safety and nutrition, and it is worth understanding how it escalates:
| Situation | Scope | Typical consequence |
|---|---|---|
| Detection of a CBD ingestion product in-store or online | Food administrative | Seizure and withdrawal of the product, with the opening of an autonomous-community sanctioning proceeding |
| Marketing an unauthorised novel food | Law 17/2011 | Fine depending on severity: from €5,000 for minor infringements up to €600,000 for very serious ones, amount extendable up to five times the value of the affected products |
| Therapeutic claims on the product, website, or social media | Health administrative | Possible treatment as a medicinal product by presentation, with proceedings before the AEMPS and its own sanctioning regime |
| E-commerce with shipments to other EU countries | European cooperation | Alerts between food authorities (RASFF network) circulating throughout the distribution chain |
The risk almost nobody factors in
The administrative file leaves a trace. In a future inspection, a licence, an insurance renewal, or a business sale, that history matters.
That is why documentary prevention (what you sell, how you present it, what paperwork you have for each SKU) is the most profitable investment for a cannabis business: the cost of putting it in order beforehand is always lower than the cost of defending yourself afterwards.
How to adapt your catalogue: Gabriela’s six-step plan
Based on accumulated experience advising shops, distributors, and brands in the sector, these are the six moves Gabriela recommends implementing now, in this order:
Audit your catalogue reference by reference
Separate each product by legal regime: cosmetic, seed food, flower, technical use. Anything involving ingestion of CBD is removed from the catalogue or reformulated. There is no defensible middle ground.
Convert oils into a notified cosmetic
This is the natural legal route for CBD oil: CPNP notification, product information file, and cosmetics labelling. It stops being a grey-area product and becomes a product with proper documentation.
Clean up your website, product pages, and social media
Remove dosages, the word “sublingual”, health claims, and any content suggesting oral consumption. Also review featured reviews: they form part of your commercial presentation.
Demand real documentation from your suppliers
THC analyses per batch, CPNP notification for cosmetics, and consistent technical sheets. Be wary of “Novel Food certificates” and anyone who assures you “it is legal in their country”: food law is European.
Train your shop team
Staff must know what they can and cannot say to a customer and to an inspector. A spontaneous sentence at the counter can undo months of labelling work.
Prepare for the day after authorization
Active regulatory monitoring and documentation ready to register products as soon as the Union list opens to CBD. Our view is that the ingestible CBD market will end up opening, but product by product and with very demanding purity, traceability, and labelling requirements: the first to enter will take the market.
The CBD seller’s dossier
- THC content analyses for each batch, filed and easy to retrieve.
- Proof of CPNP notification for each CBD cosmetic in the range.
- Supplier technical sheets consistent with the real presentation of each product.
- Labelling reviewed: no dosage, no “sublingual”, no health claims.
- Screenshots or copies of marketing communications on the website and social media as published.
- A written customer-service protocol and a record of the training provided to the team.
- Contracts or purchase terms stating the intended use of each SKU.
That dossier does not prevent an inspection, but it determines how it ends: it is the difference between a request that is closed by providing documents and a case that escalates. And it is also the foundation for a serious CBD product registration strategy, both for today’s cosmetics and for the food products that may be authorised tomorrow.
Frequently asked questions about Novel Food and CBD oil
Can I buy CBD oil in another EU country where “it is sold without any issues” and resell it in Spain?
No. The Novel Food Regulation applies across the European Union, so any de facto tolerance in another Member State does not create any right to market it in Spain. The principle of mutual recognition does not cover products that breach EU-harmonized rules, and liability in an inspection lies with the party marketing it here, not with the supplier in the country of origin.
Is synthetic CBD also a novel food, or only CBD extracted from the plant?
It is as well. The Novel Food Catalogue includes both hemp extracts with cannabinoids and CBD obtained by chemical synthesis. In fact, among the dossiers EFSA is currently assessing there are applications of both types. For food purposes, there is no shortcut via the synthetic route.
What is the difference between CBD oil and hemp seed oil?
Hemp seed oil is obtained by pressing the seed and does not contain cannabinoids in relevant amounts: it has a history of traditional consumption, is not novel food, and is legally sold as a food provided THC limits are respected. CBD oil is a plant extract rich in cannabidiol, usually diluted in a carrier oil: it is an unauthorised novel food and cannot be sold for ingestion. They are different products, even if marketing tends to blur the distinction.
Can I sell hemp seed oil “enriched with CBD”?
No. Hemp seed oil is legal precisely because it contains no added cannabinoids. The moment it is enriched with CBD, it stops being a traditional food and becomes a food with an unauthorized novel ingredient, under the same regime as any oral CBD oil. Also beware of labelling that implies CBD content in a seed oil: it is a classic trigger for cases involving misleading labelling.
Does the 2 mg/day safe level set by EFSA mean I can now sell CBD oil?
No. The provisional level published in February 2026 is a scientific reference, not a marketing authorisation. It allows EFSA to assess pending dossiers case by case, and it applies only to CBD supplements with a minimum purity of 98%, without nanoforms, and with genotoxicity ruled out. Until a specific product appears on the Union list, sale for ingestion is still not permitted.
What should my staff answer if a customer asks in the shop whether they can take the oil?
The only safe answer is that the product is not intended for consumption and that they cannot recommend ingesting it or advise on dosage. It seems obvious, but in practice it is one of the most frequent weak points: an inspection may treat what is said at the counter as part of the product’s commercial presentation. A written internal protocol and brief team training resolve a disproportionately high risk.
Do gummies, infusions, or drinks with CBD have any different legal fit than oil?
None. Any food or drink to which CBD or a cannabinoid-rich hemp extract is added is an unauthorized novel food, regardless of format. Edible formats are even harder to defend than oil, because they do not allow the external-use argument: a gummy can only be eaten.
When will it be possible to legally sell CBD oil for consumption in Spain?
There is no committed date, but for the first time there is a pathway: since February 2026, EFSA has a provisional safe intake level and is assessing dossiers case by case. After each favourable opinion, a decision by the Commission and the Member States will still be needed to include the specific product in the Union list. The first authorizations, when they come, will be for specific products with strict purity and labelling requirements, not a general opening of the market.
Novel Food is not a bureaucratic whim: it is the line that today separates a sustainable CBD business from one built on a product that can disappear from the catalogue at the first inspection. The sector’s paradox is that the framework, while restrictive, is also predictable: it is known what is allowed, what is under review, and where the market will start to open. With that information on the table, the competitive advantage is not in pushing the grey area, but in putting the catalogue in order today and having the paperwork ready for the moment the food route authorises the first products.
Sources and rules consulted
- Regulation (EU) 2015/2283 on novel foods, and Commission Implementing Regulation (EU) 2017/2470 establishing the Union list.
- European Commission Novel Food Catalogue, entry on cannabinoids (January 2019 update).
- EFSA, provisional safe intake level for cannabidiol as a novel food (February 2026) and previous statements from June 2022 and September 2025.
- Regulation (EU) 2023/915 on maximum levels for certain contaminants in food, regarding delta-9-THC limits in hemp seeds and derivatives.
- Law 17/2011, of July 5, on food safety and nutrition, regarding the sanctioning regime.
- Judgment of the Court of Justice of the European Union of November 19, 2020, case C-663/18 (KanaVape).
Would your catalogue withstand an inspection tomorrow?
Gabriela Sierra, a lawyer specialising in CBD businesses, supports shops, brands, and distributors in fitting each product into its legal framework: cosmetics, hemp foods, flowers, and strategy for the new Novel Food scenario. Review your catalogue, your labelling, and your suppliers before an inspection does—and prepare the registration of your products for when the food route opens.
Consult on your caseNotice: this article is for informational and educational purposes only, reflects the regulatory framework in force on the date of publication (September 2026), and does not constitute legal advice. The rules on novel foods and CBD products are evolving rapidly and their application depends on the circumstances of each case. For an analysis of your specific situation, contact Lawyer Sierra.