EU Novel Food Regulation for TCM Products: What Are the Basics?

2026-10-27

EU novel food regulation TCM, novel food authorization China, TCM products Europe compliance

# EU Novel Food Regulation for TCM Products: What Are the Basics?

The EU Novel Food Regulation (Regulation (EU) 2015/2283) requires that any food without a significant history of consumption in the EU before 15 May 1997 must receive novel food authorization before being marketed. For TCM wellness products, this means many herbal ingredients, extracts and new formulations cannot simply be imported and sold — they must first pass a scientific safety assessment, or fit an existing authorized listing.

This article is a practical orientation for importers and brand owners. It is not legal advice: every product decision must be confirmed with a EU-based regulatory consultant and national competent authorities — local regulatory review is mandatory.

What Counts as "Novel" Under the Regulation?

A food is novel if it meets two conditions: it was not consumed to a significant degree in the EU before 15 May 1997, and it falls into at least one of ten defined categories, including:

Plants, and their parts/derivatives, newly introduced to the EU food market (this catches many TCM herbs)
Extracts and concentrates of plants where extraction is new to that food
Foods resulting from new production processes not used before
Vitamins, minerals and other substances in new forms or uses

For a TCM product line, the practical consequence: roots, leaves and mushrooms with a documented EU food history (for example, common tea ingredients) may be fine, while concentrated extracts or lesser-known herbs typically require authorization or must align with the EU "Union list" of authorized novel foods.

How Does the Authorization Process Work?

The standard route is a full dossier submitted to the European Commission via a member state:

Step	Description	Typical Time	Indicative Cost
Pre-submission consultation	Check Union list, similar products, data gaps	1–3 months	€2,000–€8,000 (consultant)
Dossier preparation	Identity, production process, compositional data, toxicology, proposed uses	6–12 months	€20,000–€80,000+ depending on data needs
Formal risk assessment	EFSA evaluates safety	~6–9 months (with clock stops)	Included in fees
Authorization decision	Commission + member states adopt	3–6 months after positive EFSA opinion	—

Total realistic timeline: 12–24 months per ingredient/application, sometimes longer if the safety dataset is thin. Costs scale with how much toxicological data already exists for your ingredient.

What Are the Practical Routes to Market for TCM Brands?

Brands typically choose among four strategies:

Restrict the range to ingredients with established EU food use. Ginseng (Panax ginseng) itself, goji berry, jujube, chrysanthemum, honey and many tea herbs have long consumption histories in some form — but the exact form matters (dried root in tea vs. concentrated extract are treated differently). This is the fastest entry path and the one we recommend for first launches, as covered in our TCM wellness business in Europe guide.
Check the Union list and existing authorizations. Some extracts and preparations are already authorized or under application; using an authorized entry can shortcut years.
Position products as food supplements under national rules. Even supplements face notification requirements in each member state and their own ingredient restrictions — this is still regulation-intensive, not a loophole.
Run a full novel food application for a strategically important ingredient, ideally shared with other applicants to divide cost (data-sharing rules allow cost splitting in defined cases).

What Common Mistakes Should Importers Avoid?

Assuming "it's natural, so it's allowed." Natural origin does not exempt an ingredient from novel food rules.
Copying what competitors sell. Some listings on EU shelves are non-compliant; presence is not proof of authorization.
Ignoring member-state differences. Supplement notification, labeling languages and claims rules vary by country (e.g., Italy, Germany, France each have their own registries).
Confusing food supplements with traditional herbal medicines. A separate EU regime (THMPD directive) covers traditional herbal medicinal products with its own registration — choosing between the two frameworks is a strategic decision requiring professional advice.
Overclaiming. All health claims must comply with the EU claims register; treatment or cure statements are prohibited outright.

Frequently Asked Questions

Q1: Is ginseng itself banned in the EU?

No. Panax ginseng has established use in foods and supplements in the EU. However, specific extracts, concentrations and product types may still require assessment or fall under other rules — verify your exact specification with a regulatory consultant.

Q2: How long does a novel food authorization take?

Realistically 12–24 months per ingredient from dossier start to authorization, depending on data completeness and EFSA workload.

Q3: Can I sell TCM products in the EU while the application is pending?

Only for ingredients that do not require authorization (established food use or already listed). Selling unauthorized novel foods exposes you to border rejections, product withdrawal and fines.

Q4: Do food supplements need novel food approval too?

Yes — the novel food rule applies regardless of category. Supplements additionally need member-state notifications, which is a separate, per-country process.

Q5: What is the cheapest compliant entry strategy?

Start with a narrow range of ingredients with documented EU food history, in conventional forms (teas, simple extracts within existing authorizations), with claims-neutral wellness positioning — then expand via targeted novel food applications once revenue justifies the cost. All final decisions require professional EU regulatory review.