An ingredient's U.S. status does not carry over to other markets, and each market sets its own route, evidence and accountable party
An NDIN acknowledgement, a GRAS conclusion or a U.S. cosmetic listing has no legal effect in the EU, Canada, Australia or Japan. This page compares their entry routes and what evidence can be reused. Educational, not legal advice.
Status. EUTECNIQ Sciences is a company in formation with no international filings, licences or local representatives. The multi-market work described here is proposed and would rely on qualified local partners.
The four markets differ on whether a new ingredient needs authorization, whether products need a licence, and who is accountable
A starting map, not a complete statement of each regime; claims rules are not covered.
Text version of the matrix
| Market | Supplement-type products | New ingredient | Premarket review | Accountable party |
|---|---|---|---|---|
| United States (reference) | Dietary supplements (FD&C Act § 201(ff)) | NDI notification 75 days before marketing, unless the food-supply exception applies | None; FDA does not approve supplements or NDINs | Manufacturer or distributor |
| European Union | Food supplements (Directive 2002/46/EC); only vitamins and minerals are harmonized, botanicals follow national rules | Novel food authorization if not consumed to a significant degree in the EU before 15 May 1997; a notification route exists for traditional foods from third countries | Novel foods: authorization and inclusion in the Union list | Food business operator; for cosmetics, a responsible person established in the EU |
| Canada | Natural health products (SOR/2003-196) | Through the product licence application (ingredient route not covered here) | Product licence before sale (NPN or DIN-HM); site licence to manufacture, package, label or import | Product licence holder and site licence holders |
| Australia | Listed complementary medicines (AUST L), under the Therapeutic Goods Act 1989 | Must be on the Permissible Ingredients Determination before use in a listed medicine | Listed medicines are not individually evaluated before listing; the sponsor certifies compliance | Sponsor |
| Japan | Foods with Function Claims (one of Japan's health-claim systems) | Safety and functionality evidence filed with the notification | Notification to the Consumer Affairs Agency before sale; no government review of the claim | The food business that notifies |
In the EU, a novel food is one not consumed to a significant degree within the Union before 15 May 1997
Three instruments matter most for botanical ingredients: the Novel Food Regulation, the Food Supplements Directive and the Cosmetics Regulation.
Text version of both figures
Novel foods
A novel food is food “not used for human consumption to a significant degree within the Union before 15 May 1997” that falls in one of the Regulation's categories. “Only novel foods authorised and included in the Union list may be placed on the market within the Union as such …” The Regulation has applied since January 1, 2018.
EU lawA notification route
Instead of a full application, an applicant may notify a traditional food with a history of safe use: compositional data and “continued use for at least 25 years in the customary diet of a significant number of people” in at least one non-EU country. Member States and EFSA have four months to raise reasoned safety objections.
EU law, Arts. 3, 14–15Food supplements
Food supplements are concentrated sources of nutrients or other substances “marketed in dose form.” The Directive sets a harmonized list of vitamins and minerals. Botanicals and other substances remain under national rules, and Member States may require notification with a model of the label.
EU lawCosmetics
A cosmetic may be placed on the EU market only if a legal or natural person in the EU is designated as the “responsible person.” Before marketing, that person must ensure a safety assessment and a cosmetic product safety report under Annex I, and notify the product electronically to the Commission (through the Commission's notification portal).
EU lawThe 25-year figure appears in both systems with different force. In the EU it is a legal criterion for the traditional-food route. FDA's 2026 final guidance recommends 25 years of widespread use when history of safe use alone is relied on, and notes that this is consistent with the EU approach.
Under the notification route, the Commission forwards a valid notification to Member States and EFSA within one month (Art. 15(1)). If no duly reasoned safety objection is raised within four months, the Commission authorizes the traditional food and updates the Union list (Art. 15(4)). If an objection is raised, it may not authorize the food, and the applicant may submit an application under Art. 16, on which EFSA gives its opinion within six months (Art. 17(1)). Under a full application, EFSA adopts its opinion within nine months of a valid application (Art. 11(1)), and within seven months of its publication the Commission submits a draft implementing act to the committee (Art. 12(1)).
Sources: Regulation (EU) 2015/2283, OJ L 327, 11.12.2015, p. 1 (EUR-Lex); Directive 2002/46/EC, OJ L 183, 12.7.2002, p. 51; European Commission, Food supplements; Commission report COM(2008) 824 as summarized by the European Parliament Legislative Observatory; Regulation (EC) No 1223/2009, OJ L 342, 22.12.2009, p. 59; FDA final guidance (October 2026), Section VI and footnote 18.
Data table
| Route and step | Article | Months |
|---|---|---|
| Traditional food: Commission forwards a valid notification | 15(1) | 1 |
| Traditional food: Member States and EFSA may raise reasoned safety objections | 15(4) | 4 |
| Traditional food after an objection: EFSA opinion | 17(1) | 6 |
| Novel food application: EFSA opinion | 11(1) | 9 |
| Novel food application: Commission draft implementing act after the opinion is published | 12(1) | 7 |
Without an objection the traditional-food route runs about five months before the Commission authorizes; a full application allows up to 16 months before the draft implementing act.
In Canada, a natural health product needs a product licence before sale, and its makers, packagers, labelers and importers need site licences
Canada licenses products before sale, which the United States does not do for supplements.
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“No person shall sell a natural health product unless a product licence is issued in respect of the natural health product.”
Canadian regulationLicensed products carry an eight-digit Natural Product Number (NPN), or DIN-HM for homeopathic medicines.
Canadian regulationManufacturing, packaging, labelling or importing a natural health product for sale requires a site licence.
Canadian regulationIn Australia, a listed medicine may contain only permitted ingredients, so a new botanical ingredient must be added to that list first
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Not individually evaluated before listing. The applicant must certify that the medicine contains only ingredients specified in a determination under s. 26BB and meets its requirements. Indications come from a list of pre-approved, low-level indications.
Australian lawAlso low risk and limited to permitted ingredients, but efficacy for specific claims is evaluated before listing.
Australian lawFull evaluation of safety, quality and efficacy before marketing. Used for high-level indications and for certain scheduled ingredients that listed medicines cannot contain. All three tiers must be made under GMP.
TGA factsheet (2018)The permitted-ingredient list is a legislative instrument revised several times a year. The Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2026 replaced No. 4 of 2025 in February 2026, No. 2 followed in June 2026, and No. 3 (F2026L01382, registered October 13, 2026) was the version in force on October 24, 2026. An amending instrument titled "Removal of Andrographis Paniculata" was registered on September 14, 2026. Check the version in force before relying on any ingredient's status. The TGA's own web pages on the tiers could not be retrieved automatically; the tier descriptions for AUST R rely on a TGA factsheet dated March 2018.
Explanation, details and sources
Listed medicines are considered low risk. Their safety and quality are not evaluated by the TGA before listing, which is why the ingredient list and the sponsor's certification carry the weight.
Check the Determination in force before relying on any ingredient's status.
In Japan, a business notifies the Consumer Affairs Agency before using a function claim and remains responsible for it
Foods with Function Claims differ from FOSHU (Foods for Specified Health Uses), where the government reviews the claim.
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The Consumer Affairs Agency describes the system as one in which a business that notifies the Commissioner, before sale, of required information, including the scientific basis for safety and functionality, may display a function claim. The government does not review the claim; the business is responsible for it. The English summary here is EUTECNIQ's rendering of the Japanese source.
The system was revised after 2024, and the Consumer Affairs Agency lists amended standards and notification guidance dated October 1, 2025. EUTECNIQ has not verified the details of the new obligations and would check current guidance with a qualified Japanese partner. A notification is not an approval.
Legal status stays within its own market; well-designed evidence can often be reused
A multi-market plan separates the scientific core, which can serve every submission, from the market-specific legal modules.
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- An FDA acknowledgement of an NDIN, or FDA's silence
- A U.S. GRAS conclusion or an FDA “no questions” letter
- U.S. cosmetic registration and listing
- U.S. structure/function claim notifications
- Identity, specification and contaminant data on the same material
- Studies run to OECD Test Guidelines under OECD GLP: under the OECD Mutual Acceptance of Data decision, adherent countries accept such data for assessment, while each interprets the results itself
- Documented history-of-use evidence, judged against each market's own test
EUTECNIQ proposes to build one scientific core per ingredient and work with local partners on each market's filing
Designing studies once, to the standard the strictest target market expects, can avoid repeating them later.
- Map target markets and their entry routes early
- Build a shared identity, specification and safety core
- Design pivotal studies to OECD guidelines and GLP where several markets are planned
- Coordinate market-specific modules with local partners
- Act as the EU responsible person or food business operator where needed
- Hold Canadian product and site licences, or Australian sponsorship
- File notifications in Japan
- Give local legal and regulatory opinions
- Any foreign authorization, licence, listing or notification
- That U.S. status supports any foreign filing
- Any local partner agreements to date
Planning an ingredient for more than one market?
The earlier the target markets are named, the more evidence can be designed once. EUTECNIQ is in formation and welcomes early conversations.