Belgium 2025: CBD at a Crossroads—FAMHP Signals Tighter Oversight While EU Novel Food Bar Remains High

Belgium’s market for CBD products is entering a more formal—and less forgiving—phase. Public communications from the Federal Agency for Medicines and Health Products (FAMHP) and parallel positioning from the Federal Agency for the Safety of the Food Chain (FASFC/AFSCA) show a clear direction of travel: tighter classification controls, stronger inter‑agency coordination, and less tolerance for “grey area” ingestibles.

For retailers, importers, and brand owners, the practical risk in 2025 isn’t only whether a product is “allowed.” It’s whether your product is correctly classified, your claims and presentation avoid a medicinal framing, and your technical file can survive scrutiny at customs, during inspections, or in a complaint-driven enforcement event.

This article is informational only and not legal advice. Regulations can change quickly; always confirm requirements with counsel and the relevant competent authorities.

Belgium’s regulatory map: who controls what in 2025?

Belgium’s CBD oversight is split across different authorities depending on product type, intended use, and presentation.

FAMHP: medicinal products and anything drifting into “medicine” territory

FAMHP is Belgium’s medicines regulator. It publishes a dedicated page explaining how it views “medicines and other products based on … cannabidiol,” including the high‑risk boundary where a consumer product may be treated as a medicinal product due to composition, route of administration, or claims.

FAMHP also clarifies a key handoff point: products containing CBD or plant parts with Δ9‑THC and THCA not exceeding 0.3% fall under the competence of the FPS Public Health, Food Chain Safety and Environment—not FAMHP—unless they are medicines or otherwise regulated as such. In other words, staying under a THC/THCA threshold doesn’t automatically make a product “free to sell”; it often just determines which regulator will scrutinize it. Source: https://www.famhp.be/en/medicines_and_other_products_based_on_cannabis_or_cannabidiol

FASFC/AFSCA: food safety, including Novel Food rules

FASFC explains that Novel Food status is governed at EU level, with no special Belgian deviation, and points businesses to EU authorization channels. Source: https://www.fasfc.be/food/themes/european-legislation-regarding-novel-food

For ingestible CBD (oils, capsules, gummies, beverages), the practical implication is simple: if it’s considered a Novel Food and not authorized at EU level, Belgium is unlikely to treat it as “implicitly acceptable.”

Why 2025 feels different: coordination and contact channels signal enforcement maturity

Your research notes point to mid‑2025 parliamentary briefings and more visible inter‑agency coordination. Even without a single headline “ban,” this operational posture matters. When regulators tighten coordination, businesses typically see:

• more consistent classification decisions across regions and inspection teams
• faster information exchange between market surveillance and border control
• less tolerance for “we sell it as a cosmetic but everyone uses it orally” ambiguity

The EU Novel Food bar remains high—and Belgium is aligning with it

Belgium doesn’t decide Novel Food authorizations; the EU does. But Belgium does decide what is allowed on shelves in Belgian territory, and it enforces food law locally.

EFSA’s updated CBD safety position: a low provisional intake and persistent gaps

The European Food Safety Authority (EFSA) published an updated statement setting a provisional safe intake level for CBD as a novel food of 0.0275 mg/kg body weight/day (about 2 mg/day for a 70 kg adult) and reiterated that data gaps remain, particularly around toxicology and human data. Source: https://www.efsa.europa.eu/en/news/provisional-safe-level-cannabidiol-novel-food

This matters for Belgium because it affects:

• the likelihood of near‑term EU authorizations for typical high‑dose ingestibles
• the types of dossiers regulators will view as credible
• the risk that high‑strength products attract enforcement even without explicit Belgian “dose limits” in consumer law

Business takeaway

If your ingestible product delivers doses far above EFSA’s provisional level, you should expect heightened scrutiny in 2025–2026—especially if the product is not clearly linked to an EU Novel Food authorization pathway.

Classification risk: the central compliance issue for Belgian operators

Belgian enforcement pressure typically concentrates on product classification and presentation. That’s where many CBD businesses fail—not on the ingredient itself.

Food vs. cosmetic vs. medicinal product: what inspectors look at

Authorities tend to assess a combination of:

• route of administration (oral ingestion is higher risk)
• label statements (explicit or implied health outcomes)
• marketing claims on websites, social channels, and reseller listings
• format (dropper bottles, capsule blister packs, and “dose” language often look medicinal)
• consumer instructions (“take X drops daily”)

If a product is presented as preventing, treating, or curing disease—or if it strongly implies pharmacological effects—it may be regulated as a medicine by function or presentation, triggering FAMHP jurisdiction.

Medicinal advertising rules are strict—and the “natural” trap is real

FAMHP publishes materials on advertising rules for medicinal products that emphasize advertising must be accurate, not misleading, and cannot exaggerate properties. One recurring enforcement theme in health-adjacent products is implying that “natural” equals “safe” or “effective.” Source (general advertising rules PDF): https://www.fagg.be/sites/default/files/downloads/Advertising%20general%20rules%20EN.pdf

Even if your product is not a medicine, marketing that reads like a medicine can be used as evidence that it is being placed on the market as one.

Business takeaway

In Belgium, “classification compliance” is a full-stack requirement: label + website + resellers + influencer scripts. Your compliant label won’t save you if your product page makes disease claims.

Customs and import scrutiny: why documentation matters more in 2025

Importers should prepare for closer review at the border and in post‑market controls. Your research notes highlight the expectation that customs and agencies will scrutinize:

• product category declared at import (food/cosmetic/consumer good)
• ingredient identity and extraction method
• THC/THCA and contaminant test reports
• traceability (supplier chain and origin)

Belgian customs and enforcement statistics routinely show large volumes of drug seizures overall, which tends to support a stricter enforcement environment broadly at ports and airports (even though this is not specific to low‑THC CBD consumer goods). Businesses should assume misclassification or thin paperwork increases seizure and delay risks.

Building a Belgian-specific compliance pack (what to prepare now)

If you sell in Belgium in 2025—or ship into Belgium from another EU country—you should assemble a “ready-to-show” file that matches how Belgian authorities actually evaluate risk.

1) Product classification memo (short, factual, consistent)

Create a concise memo that states:

• product type and intended use
• why it is not a medicinal product (no therapeutic intent, no disease claims)
• how you control presentation risk (approved claims list, training for customer service)
• which authority is competent based on FAMHP’s framework

Link your internal reasoning to FAMHP’s public explanation of competence boundaries and product categories. Source: https://www.famhp.be/en/medicines_and_other_products_based_on_cannabis_or_cannabidiol

2) Origin and extraction proofs

Keep:

• supplier declarations (plant variety, cultivation country)
• extraction method description (e.g., CO₂, ethanol) and refinement steps
• evidence of GMP/ISO controls where applicable

3) Batch testing package (THC/THCA plus contaminants)

A credible pack typically includes:

• THC and THCA results (and method details)
• heavy metals, pesticides, microbiology, residual solvents (as applicable)
• clear batch linkage between COA and finished product lots

Remember: FAMHP’s public note references Δ9‑THC and THCA—not just “total THC.” Ensure labs report what regulators reference.

4) Label and claims governance

Prepare:

• final artwork approvals
• translation control (French/Dutch/German where required)
• a claims register for every channel (label, web, ads)
• reseller compliance policy (what distributors may/may not claim)

5) Novel Food risk plan for ingestibles

If you sell or plan to sell ingestibles:

• document whether the product is linked to an EU Novel Food authorization path
• consider a contingency plan (reformulation, dosage reduction, market restriction)
• track EFSA updates and applicant progress

Belgium’s food authority points businesses to the EU framework for Novel Food authorizations; there is no Belgian “shortcut.” Source: https://www.fasfc.be/food/themes/european-legislation-regarding-novel-food

What to expect from Belgian CBD enforcement in 2025–2026

Based on public regulator posture and EU safety dynamics, businesses should anticipate three practical trends.

1) More action against medicinal-style presentation

Expect more attention to:

• “pain,” “anxiety,” “sleep disorder,” “anti-inflammatory,” “ADHD,” “cancer,” “epilepsy” style claims
• dosage language that looks like a medicine (“titrate,” “therapeutic dose,” “clinically proven to treat”)
• before/after testimonials implying treatment outcomes

2) Less tolerance for ingestibles without a credible Novel Food position

With EFSA maintaining that significant data gaps remain and setting a low provisional intake, Belgian authorities have strong grounds to challenge high‑dose ingestibles on safety and authorization status. Source: https://www.efsa.europa.eu/en/news/provisional-safe-level-cannabidiol-novel-food

3) Documentation-driven enforcement at import and in retail

In practice, enforcement often starts with paperwork:

• missing COAs
• unclear origin
• inconsistent ingredient naming
• mismatch between label and technical file

Clear takeaways for Belgium-focused operators

• Don’t treat “low THC” as a sales permit. It often only determines which authority leads oversight.
• Win the classification battle first. Your product must be coherently food/cosmetic/consumer good—and marketed accordingly.
• Assume ingestibles are Novel Food until proven otherwise. Belgium is aligned with EU Novel Food requirements, and EFSA’s 2025 safety update raises the evidence bar.
• Build a Belgian compliance pack. Origin/extraction proof, batch testing, label/claims controls, and a Novel Food risk strategy are now baseline expectations.

For consumers: what this means on Belgian shelves

Consumers are likely to see:

• fewer ingestible products openly sold, or products reformulated to lower doses
• more cautious labels (fewer health claims, more cosmetic positioning)
• increased product removals where claims are medicinal in tone

Next steps: operationalize compliance (without slowing your business)

If you operate in Belgium, the fastest path to reducing enforcement risk is to treat compliance as an operational system—not a one-time label review.

Use https://www.cannabisregulations.ai/ to monitor Belgium and EU updates, generate jurisdiction-specific compliance checklists, and keep your cannabis compliance documentation and claims controls audit-ready across product lines and import channels.