For international ingredient manufacturers Proposed service

EUTECNIQ proposes to turn an international ingredient's evidence into a U.S.-ready file, then find and serve its U.S. buyers

For an ingredient manufacturer outside the United States that wants U.S. customers: what you would provide, what EUTECNIQ would do, the documents produced, the decisions along the way, and what is not promised.

Status. EUTECNIQ Sciences is a company in formation. It has no supplier agreements, no laboratory and no accreditation. Testing would be done by qualified external laboratories until EUTECNIQ has its own.

26CFR rule sets mapped for a botanical ingredient shipment entering the United States; most are your importer's or buyer's duties

Oct 1–Dec 31, 2026renewal window for FDA food facility registrations, repeated every even year (21 CFR 1.230(b))

75 daysminimum notice to FDA before a new dietary ingredient is marketed (21 CFR 190.6(a))

90 daysFDA keeps a notification confidential, then publishes it except trade secrets (21 CFR 190.6(e))

In brief

Your evidence, checked and completed for U.S. rules, with a defined commercial route at the end

Choose your situation to follow the path from the U.S. rules to the documents you would receiveProposed service flow

Rules link to eCFR; most are duties of your U.S. importer or buyer that your evidence supports. Testing would be done by qualified external laboratories until EUTECNIQ has its own. Steps and documents are proposals.

Text version: situations, rules, steps and documents

Your situation

Extract manufacturers with an established product Need verified evidence and a U.S. buyer route for an ingredient already sold elsewhere.
Growers and primary processors Need identity, contaminant and quality records that U.S. buyers can verify.
Makers of a new or changed ingredient Need a regulatory route for the intended U.S. use before anything ships.

U.S. rules your evidence serves

21 CFR 1, Subpart H Your own duty: register the facility with FDA.
21 CFR 1, Subpart I Prior notice before each shipment arrives.
21 CFR 1, Subpart L Your importer verifies you as a foreign supplier.
21 CFR 111.75 The supplement maker tests identity itself.
21 CFR 190.6 New dietary ingredient notification, when required.

Steps (proposed)

Gap assessment Your documents against U.S. rules and buyer expectations.
Qualification Audit plan, corrective actions, quality agreement.
Verification testing Independent tests compared with your certificates.
Regulatory strategy Category, NDI status, claims limits, import roles.
Application work Formats and stability, where useful.
U.S. route The chosen commercial model and buyer introductions.

In brief: what you would provide, what EUTECNIQ would do, what you would receive

You would provide

Identity basis, process description, lot data, stability and safety information, regulatory and quality history, samples and commercial terms.

EUTECNIQ would do

Gap assessment, supplier qualification, verification testing through partner laboratories, specification, regulatory strategy, application work and a U.S. commercial route.

Proposed

You would receive

A defined set of documents with agreed ownership, and a decision at each step on whether to continue.

U.S. buyers must verify what they buy, and U.S. rules decide what an ingredient may be used for. EUTECNIQ would close the distance between your current documentation and both.

What you would provide

The work starts from what your company already knows about its ingredient and its process

Only the first row is needed before an NDA. Everything else would be shared under a mutual NDA, in a controlled data room.

Ten kinds of information, one of them before an NDAProposed process

Botanical naming in a notification: 21 CFR 190.6(b) (Latin binomial including the author). Everything after the first card would be shared under a mutual NDA, in a controlled data room.

Text version: the ten kinds of information, what each includes and why it is needed

Information	What it includes	Why it is needed
Non-confidential summary	Ingredient name and form, plant species and part, intended U.S. uses, existing certifications, company contact	Decide whether there is a fit before anything confidential is exchanged
Botanical identity basis	Latin binomial with author, plant part, geographic origin, cultivated or wild-collected, any voucher or reference material	Identity method design; a U.S. new-dietary-ingredient notification names a botanical by its Latin binomial including the author (21 CFR 190.6(b))
Process description	Extraction solvents, ratio of raw material to extract, concentration and drying steps, carriers and excipients	Composition, residual solvents, and whether the process changes regulatory status
Lot data	Current specification and certificates of analysis for several recent lots, with methods, limits and actual results	Baseline for verification testing and for a buyer's reliance on certificates
Stability	Study protocol, results and packaging	Retest date under shipping and storage conditions
Safety information	Toxicology studies, history of use, published literature, adverse-event information	Safety evidence and its gaps for the intended use and intake
Regulatory and import history	FDA food facility registration status, U.S. shipments, refusals or import alerts, authorizations in other markets	Import risk and the regulatory starting point
Quality system	Certifications, recent audit reports, complaint, deviation and recall history	Supplier qualification and audit planning
Commercial terms	Capacity, lead times, minimum order, pricing structure and trade term, preferred U.S. model	Choice of commercial model and landed-cost assessment
Development samples	Representative lots shipped with full documentation	Verification testing; FDA prior notice applies to samples imported for testing (21 CFR 1.277(a))

What EUTECNIQ would do

EUTECNIQ would close the gap between your documentation and what U.S. buyers and rules require

Each step would be scoped and priced before it starts.

At each of six steps: what you would provide, what EUTECNIQ would do, where partners would actProposed External partners

EUTECNIQ proposal. Inputs as listed in the table above; the steps follow the global ingredient pathway.

Text version of the steps and roles

Gap assessmentYour documents against U.S. rules and buyer expectations
QualificationAudit, corrective actions, draft quality agreement
VerificationIndependent testing, fingerprint, specification
Regulatory strategyCategory, NDI status, claims limits, import roles
Application workFormats and stability, where useful
U.S. routeDistribution, representation, co-development or private label

EUTECNIQ, proposed

Plans the work and owns the gap assessment and specification
Reviews all laboratory data and audit findings
Prepares the regulatory market-access file and U.S. technical data package
Presents the ingredient to U.S. buyers under the chosen model

Proposed

Qualified partners

External laboratories for identity, fingerprint, contaminant and stability testing
Third-party auditors where an on-site audit is needed and EUTECNIQ cannot attend
Regulatory and commercial counsel for legal conclusions and agreements
Customs brokers and warehouses once goods move

External partner

Documents produced

Each step ends in a named document whose ownership is agreed before the work starts

Default ownership is a starting proposal for negotiation.

Eight documents, grouped by who would own each by defaultProposed defaults

Names are proposed EUTECNIQ deliverables, not certifications or regulatory approvals.

Text version: contents and default ownership of each document

Document	Contents	Proposed default ownership
Gap assessment report	What U.S. buyers and rules need, what exists, what is missing, and the cost and time to close each gap	Supplier, when the supplier pays for it
Supplier qualification dossier	Audit findings and corrective actions, manufacturing controls, draft quality agreement, traceability description	Shared; buyers see it only with the supplier's consent
Ingredient identity passport	Authentication basis, plant part and source, fingerprint, specification, reference materials	Set by the agreement
Specification with justification	Each limit for identity, purity, strength, composition and contaminants, with its method and reason	Set by the agreement; under private label, EUTECNIQ
Verification test summary	Independent results on several lots compared with your certificates of analysis	Party that paid for the testing
Regulatory market-access file	Intended-use category, NDI status memo, claims boundaries, FSVP role plan, draft notification where needed	Set by the agreement, including rights to reference it
U.S. technical data package	Technical and safety data sheets, allergen and composition statements, certificate template	Supplier
Commercial term sheet	Model, territory, exclusivity scope, minimums, pricing mechanism, term	Both parties

Who may file a new dietary ingredient notification: the manufacturer or distributor of the ingredient or of the supplement (21 CFR 190.6(a)). EUTECNIQ's methods, templates and know-how would remain its background IP; see commercialization and licensing.

Decision points

Six decisions would let either side stop early, before cost accumulates

Each decision would be taken on written evidence; stopping is a normal outcome.

Either side could stop at any of six decisions, before cost accumulatesProposed decisions

EUTECNIQ proposal. Documents produced up to a stop remain usable under the agreed ownership.

Text version of the six decisions

Decision	Question	If the answer is no
1. Initial fit	Does the ingredient have a plausible U.S. use and buyer group?	Decline politely, before any NDA
2. Scope and fee	After document review, is the gap closable at a cost both sides accept?	Stop; the summary of gaps is shared
3. Qualification	Do the audit and verification tests support approval?	Corrective actions and retest, or stop
4. Regulatory pathway	Is there a lawful U.S. pathway for the intended use with evidence that can be produced?	Change the intended use, plan the evidence, or stop
5. Commercial model	Which model fits, with what exclusivity, minimums and term?	Keep the documents; no distribution agreement
6. First commercial lots	Do lots clear entry, meet specification on receipt and pass customer qualification?	Investigation and corrective action before further shipments

Rules that apply

Twenty-six CFR rule sets touch an imported botanical ingredient; most are duties of your U.S. importer or buyer

CFR rule sets for a botanical ingredient shipment, by agency and sized by length in eCFR; select a part to open iteCFR counts

Area is the number of sections in eCFR, a measure of length, not of importance; "*" marks rules that apply only in the circumstances they name. Select a part to open it in eCFR.Applicability as mapped on the CFR atlas for a bulk dietary ingredient that is imported; section counts from the eCFR API, up to date as of October 21, 2026. Orientation, not legal advice.

Data table: every rule set in the treemap

CFR parts for a botanical ingredient shipment entering the United States: A shipment of botanical ingredient entering the United States (eCFR section counts)
Rule set	What it covers	Agency group	eCFR sections	Level
21 CFR Part 111	Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. CGMP for anyone who makes, packages, labels or holds a dietary supplement, including identity tests of dietary ingredients.	FDA · 21 CFR	84	Check
21 CFR Part 117	Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. CGMP, hazard analysis and preventive controls for human food, including dietary ingredients.	FDA · 21 CFR	61	Applies
21 CFR Part 101	Food Labeling. Food labels: Supplement Facts (§ 101.36), health claims (§ 101.14) and structure/function statements (§ 101.93).	FDA · 21 CFR	50	Check
21 CFR Part 1, Subpart R	Laboratory Accreditation for Analyses of Foods. Certain food tests, such as tests to support admission of an import, must be run by a LAAF-accredited laboratory.	FDA · 21 CFR	42	Check
21 CFR Part 1, Subpart O	Sanitary Transportation of Human and Animal Food. Shippers, loaders, carriers and receivers keep food safe during transport; § 1.900(b) lists exempt operations.	FDA · 21 CFR	18	Check
21 CFR Part 1, Subpart L	Foreign Supplier Verification Programs for Food Importers. Importers verify that foreign suppliers produce food safely; § 1.511 modifies the program for dietary supplements.	FDA · 21 CFR	15	Applies
21 CFR Part 1, Subpart H	Registration of Food Facilities. Facilities that make, process, pack or hold food for U.S. consumption register with FDA and renew every two years.	FDA · 21 CFR	14	Applies
21 CFR Part 1, Subpart J	Establishment, Maintenance, and Availability of Records. Keep records of the immediate previous source and the immediate subsequent recipient of food.	FDA · 21 CFR	13	Applies
21 CFR Part 1, Subpart D	Electronic Import Entries. Lists the data FDA needs in each electronic customs entry of an FDA-regulated article.	FDA · 21 CFR	12	Applies
21 CFR Part 1, Subpart I	Prior Notice of Imported Food. Imported food needs prior notice to FDA: at least 2 hours before arrival by road, 4 by rail or air, 8 by water.	FDA · 21 CFR	10	Applies
21 CFR Part 7, Subpart C	Enforcement Policy. FDA's recall policy: recalls are voluntary actions, classified by health hazard, with a recall strategy.	FDA · 21 CFR	10	Check
21 CFR Part 11	Electronic Records; Electronic Signatures. Electronic records and signatures that meet FDA record rules must be trustworthy, reliable and equivalent to paper.	FDA · 21 CFR	10	Applies
21 CFR Part 1, Subpart E	Imports and Exports. FDA import sampling, hearings and relabeling of refused goods, and the records kept for certain exports.	FDA · 21 CFR	9	Check
21 CFR Part 190	Dietary Supplements. A new dietary ingredient needs notification to FDA at least 75 days before marketing, unless the food-supply exception applies.	FDA · 21 CFR	1	Check
19 CFR Part 141	Entry of Merchandise. Entry of merchandise: liability for duties, who may enter, invoices, duty deposits and release.	Trade: CBP, OFAC, FWS	69	Applies
19 CFR Part 113	CBP Bonds. Customs bonds that secure payment of duties and compliance with import rules.	Trade: CBP, OFAC, FWS	53	Applies
19 CFR Part 142	Entry Process. The entry process: entry documents, entry summary, immediate delivery and line release.	Trade: CBP, OFAC, FWS	40	Applies
19 CFR Part 134	Country of Origin Marking. Country-of-origin marking of imported articles or their containers (§ 134.11).	Trade: CBP, OFAC, FWS	33	Applies
19 CFR Part 177	Administrative Rulings. Binding advance rulings from CBP, for example on tariff classification.	Trade: CBP, OFAC, FWS	25	Check
19 CFR Part 152	Classification and Appraisement of Merchandise. Tariff classification and customs valuation of imported goods.	Trade: CBP, OFAC, FWS	21	Applies
19 CFR Part 12 (selected subject groups)	Special Classes of Merchandise. CBP rules for FDA-regulated goods (§ 12.1), plants, goods made with forced labor, and goods under sanctions.	Trade: CBP, OFAC, FWS	16	Applies
19 CFR Part 149	Importer Security Filing. Importer Security Filing for ocean cargo; core data due 24 hours before loading at the foreign port.	Trade: CBP, OFAC, FWS	6	Check
7 CFR Part 319	Foreign Quarantine Notices. Conditions for importing plants and plant products that can carry pests; they depend on the commodity and origin.	USDA · 7 CFR	128	Check
7 CFR Part 330	Federal Plant Pest Regulations; General; Plant Pests, Biological Control Organisms, and Associated Articles; Garbage. Restrictions on moving plant pests, biological control organisms and associated articles, and on garbage.	USDA · 7 CFR	24	Check
7 CFR Part 357	Control of Illegally Taken Plants. Lacey Act plant declaration (§ 357.3): required for tariff codes on APHIS's phase-in schedule; "plant" excludes common cultivars and common food crops (§ 357.2). CFR atlas	USDA · 7 CFR	4	Check
40 CFR Part 180	Tolerances and Exemptions for Pesticide Chemical Residues in Food. Tolerances and exemptions for pesticide residues in food; inert-ingredient exemptions are in §§ 180.910–180.960.	EPA · 40 CFR	755	Applies
Total	26 rule sets; 14 apply, the rest apply only in the circumstances they name		1523	1122 in rules that apply

What is not promised

No regulatory outcome, sale or exclusivity would be promised before evidence and a signed agreement exist

Eight things a supplier should not read into the proposed serviceStatute and regulation Proposed terms

FDA's acknowledgment of a notification≠FDA approval of the ingredient
FDA's silence on a notification≠A finding that the ingredient is safe (21 CFR 190.6(f))
A GRAS conclusion≠A conclusion that cannot be challenged
Work toward U.S. buyers≠A promised volume, price, customer or exclusivity
A report from EUTECNIQ≠A certification
EUTECNIQ's support≠A transfer of your duties: facility registration, manufacturing practice, data accuracy
A foreign GMP certificate or U.S. status≠U.S. marketability, or status in any other market
Your certificate of analysis≠A buyer's own identity test (21 CFR 111.75(a)(1))

21 CFR 190.6(f): failure of FDA to respond to a notification "does not constitute a finding" that the ingredient is safe; 21 CFR 111.75(a)(1): a supplement manufacturer tests the identity of each dietary ingredient itself. Terms are EUTECNIQ proposals.

Text version: the five limits

No regulatory outcome. FDA approves neither dietary ingredients nor notifications; its silence is not a finding of safety. A GRAS conclusion can be challenged.
No volume, price, customer or exclusivity before a signed agreement.
No certification: reports would be evidence for buyers.
Your duties stay yours: facility registration, manufacturing practice, data accuracy.
One market at a time: U.S. work does not establish status elsewhere.

Confidentiality

Nothing confidential would be requested before a mutual NDA is signed

Confidential information would move in five stages, each with a purpose and an access listProposed 21 CFR 190.6(e)

21 CFR 190.6(e): an NDI notification is kept confidential for 90 days, then made public except trade secrets and confidential commercial information.

Text version of the five stages

First contact. A non-confidential summary only.
Mutual NDA. Defines confidential information, use for evaluation only, no analysis of samples beyond the agreed tests, term, and return or destruction.
Data room. Dossiers, process details and audit reports shared in a controlled folder with access logging.
Development agreement. Ownership of new data and reports, rights to reference them in regulatory files, and publication only with consent.
Before any filing. FDA keeps a new dietary ingredient notification confidential for 90 days, then makes it public except trade secrets and confidential commercial information (21 CFR 190.6(e)). What is marked confidential is planned before filing.

EUTECNIQ would not use one supplier's confidential data for another supplier's product.

Start with a non-confidential summary

Send the ingredient, plant species and part, form, intended U.S. uses and existing certifications. A reply would say whether there is a fit and propose an NDA.

Supplier inquiry See the full pathway