Food-Medicine Homology Does Not Travel: The Compliance Dossier a Chinese Botanical Formula Needs Before It Reaches an EU or US Shelf

Food-Medicine Homology Does Not Travel: The Compliance Dossier a Chinese Botanical Formula Needs Before It Reaches an EU or US Shelf

This note is written for the importer or brand owner who has been handed a Chinese botanical formula — a congee powder, a cereal blend, a dried fruit paste — and told that every ingredient is food-medicine homologous, therefore traditional, therefore safe, therefore easy to register. The phrase is real. It names a formal category in Chinese food law, and inside China it carries genuine weight: a substance on the national catalogue may be used both as food and as traditional medicine, which removes a whole layer of product-safety argument at home.

Outside China it carries almost none. The catalogue is a domestic administrative instrument. It has no extraterritorial effect, no mutual recognition, and no standing in a European competent authority's assessment or in a United States premarket review. What a destination market asks is not whether an ingredient is traditional, but whether it was lawfully present in that market, in that form, before a specific date. Those are different questions, and the second one cannot be answered by a supplier's Chinese production licence.

1. One ingredient, three regulatory identities

The same drum of powder can hold three different legal identities depending on where it lands, and the three are not variations on a theme. They are separate regimes with separate evidence standards and separate enforcement bodies.

In China the identity is food raw material, established by catalogue listing. In the European Union the identity is decided by the Novel Food Regulation (EU) 2015/2283, and the operative question is whether the substance was used for human consumption to a significant degree within the Union before 15 May 1997. In the United States the identity is not one thing at all: the same powder may be a conventional food ingredient, a dietary ingredient in a supplement, or, if the presentation crosses a line, a drug.

The practical consequence is that a supplier answering in good faith can still answer the wrong question. A Chinese food production licence, a Chinese standard for the product category, a Chinese safety assessment — all of these establish that the material is lawful to make and sell in China. None of them establishes that it is lawful to place on a shelf in Rotterdam or in New Jersey. That second permission is granted by the destination, and it is granted per ingredient, per preparation, per intended use.

2. The European test is a date, not a tradition

Three details of the European test are consistently underestimated, and each one has sunk a launch.

The novelty test is about European consumption history, not global history. A botanical eaten for centuries in Asia can still be a novel food in the Union if significant consumption within the Union before the cut-off date cannot be demonstrated. The Commission maintains a publicly accessible catalogue recording its view for named substances, and that catalogue is the first place to look — while remembering that it is indicative rather than binding. The binding decision belongs to the competent authority of the Member State where the product is placed on the market, and authorities do not always agree.

Novelty attaches to the species and to the plant part. An entry covering one part of a plant does not cover another. A root with a long European history tells you nothing about the leaf, the flower or the seed of the same species, and it tells you nothing about a preparation that is materially different from the traditional one — a hot-water decoction and a 20:1 ethanol extract are not the same food, and treating them as interchangeable is one of the most common specification errors in this category.

An authorisation belongs to the applicant. Where a substance has been authorised as a novel food, the authorisation names the applicant, the specification and the permitted uses. It does not travel with the commodity. A competitor's clearance does not clear your shipment, and a supplier who says this ingredient is already approved in Europe is usually describing someone else's authorisation for a different specification.

The commercial reading is simple. Establish the novelty position for each binomial and each plant part, for the exact preparation you intend to ship, before the sample is approved rather than after the packaging is printed. Authorisation is applicant-driven and measured in months to years, and it is not a step anyone wants to discover late.

3. The claim layer in Europe is where good products fail

Getting the ingredient lawfully onto the shelf is only half of it. Regulation (EC) No 1924/2006 permits only health claims that appear in the Union register of authorised claims, used under the conditions attached to them. Nutrition claims such as low sugar, source of fibre or high protein are permitted only where the defined thresholds are met, and the thresholds are arithmetic, not rhetorical.

Botanical health claims sit in an uncomfortable middle. A large number of claims submitted for plant substances remain in a pending list without a Commission authorisation, because the scientific assessment has not been completed. Member State enforcement of that pending status differs in practice, which produces a specific commercial risk: the same pack copy that a retailer's buyer accepts in one country can be challenged by an authority in another. A brand that treats a single approved artwork as valid across the Union is exposed in every market except the one where it was cleared.

Then there is the border between food and medicinal product. Under Directive 2001/83/EC a product presented for treating or preventing disease is a medicinal product, whatever its ingredients are and however it is packaged. The traditional herbal medicinal product route in Article 16a requires thirty years of medicinal use, at least fifteen of them within the Union. Chinese use history does not satisfy that fifteen-year requirement, and a food cannot borrow the route at all. So a formula can be entirely lawful as a food, and lose that status the moment the copy says it nourishes the spleen, supports immunity or balances blood sugar. The ingredient did not change. The presentation did.

4. The American version is three doors, not one

United States law does not have a single answer for a botanical, and the door a product goes through determines the evidence it needs.

Conventional food. An ingredient added to a conventional food must be generally recognised as safe, or an approved food additive. General recognition can rest on scientific procedures or on common use in food prior to 1958 — a United States date again. Long use as a food in another country does not by itself create that recognition, and a supplier's assertion that a material is traditionally consumed is not the same submission as a safety basis a reviewer can evaluate.

Dietary supplement. Under DSHEA a botanical may be used as a dietary ingredient, but an ingredient not marketed in the United States before 15 October 1994 is a new dietary ingredient, and its use requires a notification filed at least 75 days before introduction, setting out the history of use or other evidence supporting a reasonable expectation of safety.

Drug. A disease claim moves the product into a different regime entirely, with a different evidentiary burden and a different timescale.

The trap sits between the first two doors. Lawful as a supplement ingredient does not make an ingredient lawful in a conventional food. The same powder moved from a capsule line into a snack bar changes its legal basis, not just its packaging, and a brand that reformats a supplement into a food without re-examining the ingredient basis has made an unforced error. Structure and function statements are available for supplements, with the required disclaimer, and are not a substitute for the food-ingredient analysis.

5. Three other markets, briefly

Canada assesses natural health products under its own regulations and issues a Natural Product Number, with the food-or-NHP question turning on presentation, dose form and claims. Australia places complementary medicines on the listed medicines register, where the sponsor holds the evidence and certifies it at listing. Japan allows foods with function claims on notification, with the scientific basis held by the notifier rather than approved in advance.

The common thread matters more than the differences. Every one of these regimes places the evidential burden on the party putting the product on the market, and none of them accepts a classification granted by another country as proof of anything.

6. Four fields that decide the market

Most disputes in this category start with a specification that says ginseng, or mushroom extract, and nothing else. Four fields close that gap.

The binomial and the plant part. Genus and species in Latin, plus root, rhizome, fruit, leaf, flower or seed. A specification written at genus level cannot be assessed by anyone, and cannot be defended if the question is asked later.

The preparation. Extraction solvent, extraction ratio, carrier or excipient, and whether the material is a powder of the whole plant or a concentrate of it. These are not processing trivia. They determine which regulatory entry, if any, applies.

The marker compound and the assay. Which compound is measured, by which method, and against which reference standard. Without this the specification describes a colour and a smell.

The novelty and conservation status. Novel food position for the destination market, and CITES listing where relevant. Both are checkable in advance and both are routinely checked late.

7. The layers buyers forget

The identity question is the headline. Four technical layers sit underneath it, and any one of them can stop a container.

Pesticide residues. European maximum residue levels are set under Regulation (EC) No 396/2005. Where no level is set for a substance on a commodity, a low default limit of determination applies, and this is where botanical materials from smallholder supply chains most often fail. An organic certificate does not resolve it: organic status addresses how the crop was grown, not which residues are detectable in the lot.

Contaminants. Regulation (EU) 2023/915 sets maximum levels for lead, cadmium, arsenic, mercury and other contaminants. For plant materials there is an additional and easily missed category: maximum levels for pyrrolizidine alkaloids in certain foods, including herbal infusions. A product positioned as a tea-style or infusion-style preparation is caught by those limits, and a supplier who has only tested the raw herb has not tested the product as consumed.

Sulphur dioxide. Dried fruit and fruit-based pastes can carry sulphites above declaration thresholds, and the declaration obligation interacts with any preservative-free positioning on the pack.

Conservation status. Some botanicals used in Chinese formulations are listed on CITES Appendix II — American ginseng and the Dendrobium orchids among them. Trade requires an export permit from the country of origin and an import permit at destination. A supplier statement that the material has been shipped many times before usually means nobody checked, and an unpermitted shipment is seized rather than regularised.

8. Six questions worth asking before the sample is approved

1. For each botanical, what is the binomial and which plant part is used?

2. What is the preparation — solvent, ratio, carrier — and is that exact preparation the one covered by any regulatory assessment you hold?

3. Has this preparation been assessed for our destination market specifically, and can you give the reference rather than a conclusion?

4. What is the marker compound, the assay method and the specification range?

5. Which certificates attach to this product line, as distinct from the company or the site?

6. What changes if the source region changes, and who notifies whom before the next lot ships?

9. What we can put on the table

The range includes congee powders built on botanicals that appear in the Chinese food-medicine catalogue — Pueraria root, lion's mane mushroom and Chinese yam among them — alongside red date, snow fungus and freeze-dried hawthorn products. We describe them that way deliberately: product line, binomial where it matters, and no formula ratio, because a ratio is not a compliance document and publishing one would help nobody.

The measurement side is where the file is strongest. Glycaemic index is determined by human clinical trial to WS/T 652-2019, the Chinese national standard for GI determination, and to ISO 26642:2010 where the destination market expects the international reference. Testing runs in a laboratory holding both CMA and CNAS recognition, so method and laboratory are two separate questions with two separate answers. The claim system is operated with certification bodies authorised within the Chinese national framework by CNCA. The oat bran and the wholewheat buckwheat biscuit both carry a human-measured index of about 50.

Manufacturing runs in a clean workshop rated to ten thousand particles per cubic metre, development work is carried out with medical specialists through a joint low-GI research centre with Dr. Liu Rui advising, and the company was founded by Tang Yishen after a career in senior retail leadership rather than in manufacturing. The apple crisp is specified against the BRC FOOD certification held by the Shanxi Zhongkang facility. The range covers more than forty product lines and one hundred specifications across staples, bakery, snacks and drinks, and reaches over ten thousand retail terminals in China.

For a botanical formula the useful part is the paperwork discipline: per-lot certificates of analysis, a certificate index organised by line rather than by company, a botanical list with binomial and plant part, a written change-control commitment covering source region and preparation, and product training in the language of the market you are entering.

10. The honest version

We will not tell you that a botanical is cleared in a market where it is not. We do not hold novel food authorisations on your behalf, and we cannot lend you one. We will not draft European claim copy for you, because the acceptable wording is a Member State question as much as a Union one and it belongs with your own regulatory counsel. And nothing in this note changes the rule that applies everywhere: food must not carry disease treatment or prevention claims.

What we can do is make the ingredient side unambiguous. Send the destination markets and the intended product format, and we will come back with the binomial and plant-part list, the preparation details, the measured values with the methods that produced them, the certificates with their numbers and the lines they cover, and a straight statement of what we do not hold. If a formula needs to be reformulated to sit inside a market's food law, that is a decision for the brand owner — but it is a far cheaper decision when it is taken before the artwork than after.

The catalogue in Beijing is a real thing and it is worth knowing. It is simply not a passport.

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