For U.S. manufacturers and brands Proposed service
A qualified ingredient would arrive with the evidence your quality unit needs, while the checks the law assigns to you stay with you
Why a U.S. supplement, food or cosmetic manufacturer might buy a scientifically qualified international ingredient through EUTECNIQ, what would come with it, and what is not promised.
Status. EUTECNIQ Sciences is a company in formation. It sells no ingredients today and has no laboratory, accreditation or customer agreements. Testing would be done by qualified external laboratories until EUTECNIQ has its own.
188FDA Form 483 citations of § 111.70(e) specifications in fiscal 2025, the most since at least FY2014
78citations of the conditions for relying on a supplier's certificate, § 111.75(a)(2)(ii)
66citations for missing identity tests of dietary ingredients, § 111.75(a)(1), up from 15 in fiscal 2023
36CFR rule sets mapped for a U.S. supplement maker that imports its ingredients and tests them
The buyer's problem
Every ingredient a U.S. manufacturer buys carries legal duties, and meeting them supplier by supplier is slow and costly
These duties fall on the manufacturer or importer whatever the supplier's certificates say.
Choose your business to follow the path from your legal duties to the documents that would arrive with the ingredientProposed service flow
Text version: buyers, duties, work and documents
Your business
- Supplement manufacturers Must set specifications and test identity under Part 111.
- Food and beverage manufacturers Need a lawful basis for the food use and a supply-chain program.
- Cosmetic brands Carry safety substantiation as the responsible person.
Duties the law assigns to you
- 21 CFR 111.70 Specifications for identity, purity, strength, composition and contaminants.
- 21 CFR 111.75 Identity test of each dietary ingredient; certificates relied on only after qualification.
- 21 CFR 1, Subpart L Foreign supplier verification when you import.
- 21 CFR 117 Supply-chain program for food manufacturers.
- 21 CFR 190.6 New dietary ingredient status.
- 21 CFR 170.30 GRAS for the food use.
- 21 U.S.C. 364d Cosmetic safety substantiation.
EUTECNIQ work (proposed)
- Specification justified limit by limit
- Independent tests on several lots
- Status analysis for your intended use
- Application support in your matrix
- Change control before a changed lot ships
What would come with the ingredient
- Lot documents with each shipment
- Standing technical file Shared under NDA, kept current.
- Specification and test methods
- Status analysis memo A reasoned view, not an FDA determination.
- Application support report
- Change notice with comparability data
Five duties stay with you; each would arrive with the evidence that makes it faster to meetRegulation Proposed evidence
Text version: each duty and what the rule requires
| Your duty | What the rule requires | Source |
|---|---|---|
| Component specifications | A supplement manufacturer sets, for each component, an identity specification, the specifications needed for the finished product's purity, strength and composition, and limits on contamination. | 21 CFR 111.70(b) |
| Identity of dietary ingredients | Before use, at least one appropriate test or examination to verify the identity of each dietary ingredient, unless FDA grants an exemption petition. | 21 CFR 111.75(a)(1) |
| Reliance on certificates | For other specifications, a supplier's certificate of analysis may be relied on only after qualifying the supplier by confirming its results; the certificate must state methods, limits and actual results; reliance is re-confirmed periodically and approved by quality control. | 21 CFR 111.75(a)(2) |
| Imports | The U.S. owner or consignee at entry is the FSVP importer. Modified duties apply to dietary supplement components when the importer, or its customer, is the Part 111 firm that sets and verifies specifications. | 21 CFR 1.500, 1.511 |
| Ingredient status | A supplement with a new dietary ingredient needs a notification at least 75 days before marketing unless the food-supply exception applies; a food ingredient must be GRAS for its use or an approved additive; a cosmetic's responsible person must hold safety substantiation. | 21 CFR 190.6; 21 CFR 170.30; 21 U.S.C. 364d |
Documentation package
Each ingredient would come with lot documents and a standing technical file, so your qualification starts from evidence
The technical file would be built once, kept current under change control and shared under NDA.
Four documents with every lot, four once per ingredient, and ten proposed dossiersProposed deliverables
Text version of the package and the ten dossiers
With every lot
- Certificate of analysis stating methods, limits and actual results, the elements a Part 111 buyer needs to rely on a certificate
- Technical and safety data sheets
- Allergen and composition statements
- Lot genealogy back to the raw-material lot
Under NDA, once per ingredient
- Specification with the reason for each limit
- Identity method details and reference-material source
- Independent verification results on several lots
- Supplier audit summary and quality agreement terms
Ten proposed technical dossiers
| Proposed dossier | Contents | How a buyer would use it |
|---|---|---|
| Ingredient Identity Passport | Authentication, plant part, source, fingerprint, specifications, reference materials | Set your identity specification and test |
| Ingredient Safety Dossier | Literature, contaminants, toxicology, exposure, safety conclusion and its limitations | Support your own safety assessment at your dose |
| Regulatory Market-Access File | Category eligibility, notification or authorization strategy, permissible uses | Check the ingredient fits your product category and claims |
| Bioavailability and Delivery Dossier | Formulation characterization, dissolution and digestion data, pharmacokinetic evidence where it exists, stability | Judge delivery-form claims against the evidence behind them |
| Interaction Risk Profile | Enzyme and transporter screening, clinical literature, co-exposure risks | Label and formulation decisions |
| Manufacturing Technology Package | Process description, critical parameters, transfer specifications, analytical methods | Process transfer or second-source qualification |
| Cosmetic Technical File | Ingredient characterization and evidence for the product safety assessment | Your safety substantiation as responsible person |
| Application Development Kit | Prototype formulas, processing guidance, compatibility and sensory information | Faster formulation work |
| Supplier Qualification Dossier | Audit findings, manufacturing controls, quality agreements, traceability | Your supplier approval file |
| IP and Commercial Rights Package | Background IP, new inventions, licensing permissions, territories, royalties | Freedom to use and any exclusivity |
Specifications and testing
Specifications would be justified limit by limit and confirmed by independent tests on several lots
The aim is a specification your quality unit can adopt and a test your laboratory can run.
A marker on target can hide drift that a full fingerprint would catchSchematic, not data
Text version of the four testing areas
Identity
A method that separates the real plant from its likely substitutes
Raw plant material: macroscopic and microscopic examination with a chemical method. Extracts: chemical methods, such as a chromatographic fingerprint against authenticated reference material, because extraction removes the features used to identify whole plants. Method details would be shared so your laboratory can run the identity test the rule requires of you.
Partner laboratoriesContaminants
A panel chosen by risk for the plant, origin and process
Typically toxic elements such as lead, cadmium, arsenic and mercury; pesticide residues; microbiological quality; mycotoxins; residual solvents; and undeclared substitutes or additives. Limits would be set from the intended daily intake, and results reported for several lots, not one.
Partner laboratoriesComposition
Marker assays read together with the full fingerprint
A marker held at its target value can hide drift in the rest of the extract. Fingerprint acceptance criteria would catch it.
Proposed practiceStability
A retest date set from data in the shipping packaging
Stress and real-time studies on representative lots. An ingredient retest date does not validate the shelf life of your finished product.
Proposed practice
Regulatory status analysis
Status would be analyzed for your intended use, because the same plant can be lawful in one product and not in another
Status depends on intended use and claims. An analysis is EUTECNIQ's reasoned view with its sources; it is not an FDA determination.
Show the table (3 rows)
| Your product | What the analysis would cover | Current status of the rule |
|---|---|---|
| Dietary supplement | Whether the ingredient is a new dietary ingredient, whether a notification has been filed or is needed, and the basis; structure/function claim limits (notice to FDA within 30 days of first marketing, required disclaimer; a disease claim makes the product a drug) | Statute Final rules 21 CFR 190.6, 101.93 |
| Conventional food or beverage | Whether a GRAS basis exists for your use and level, or the ingredient needs food-additive approval; dietary supplement ingredients are not automatically lawful in conventional food | Final 21 CFR 170.30; Proposed mandatory GRAS notification, 91 FR 51834 (August 11, 2026) |
| Cosmetic | Ingredient data for your safety substantiation; claim wording that would make the product a drug | Statute MoCRA, 21 U.S.C. 364d; no final cosmetic GMP rule as of October 2026 |
eCFR 21 CFR 190.6, 101.93, 170.30; 91 FR 51834; 21 U.S.C. 321(s), 364d. Status as of October 22, 2026. See regulatory and safety for detail.
Thirty-six CFR rule sets touch a U.S. supplement maker that imports its ingredients and tests themeCFR counts
Data table: every rule set in the treemap
| 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 | Applies |
| 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 | Check |
| 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 | Applies |
| 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 58 | Good Laboratory Practice for Nonclinical Laboratory Studies. Good laboratory practice for nonclinical studies supporting the FDA submissions listed in § 58.3; NDINs are not listed. | FDA · 21 CFR | 36 | 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 |
| 40 CFR Part 261 | Identification and Listing of Hazardous Waste. Which wastes are hazardous: ignitable wastes (§ 261.21) and listed wastes such as spent solvents (§ 261.31). | EPA · 40 CFR | 83 | Check |
| 40 CFR Part 262 | Standards Applicable to Generators of Hazardous Waste. Duties of hazardous-waste generators, scaled by generator category. | EPA · 40 CFR | 66 | Check |
| 16 CFR Part 1700 | Poison Prevention Packaging. Child-resistant packaging, including supplements with 250 mg or more elemental iron per package (§ 1700.14(a)(13)). | FTC and CPSC · 16 CFR | 8 | Check |
| 29 CFR 1910.1200 | Hazard communication.. Hazard communication: hazard classification, labels, safety data sheets and worker training. | OSHA · 29 CFR | 1 | Applies |
| 29 CFR 1910.132 | General requirements.. Workplace hazard assessment and personal protective equipment. | OSHA · 29 CFR | 1 | Applies |
| 29 CFR 1910.134 | Respiratory protection.. Respiratory protection programs where respirators are needed. | OSHA · 29 CFR | 1 | Check |
| 29 CFR 1910.147 | The control of hazardous energy (lockout/tagout).. Lockout/tagout of hazardous energy during servicing and maintenance of machines. | OSHA · 29 CFR | 1 | Check |
| 29 CFR 1910.1000 | Air contaminants.. Permissible exposure limits for air contaminants, such as solvent vapors. | OSHA · 29 CFR | 1 | Check |
| 29 CFR 1910.1450 | Occupational exposure to hazardous chemicals in laboratories.. Chemical hygiene plan and exposure controls for laboratory use of hazardous chemicals. | OSHA · 29 CFR | 1 | Applies |
| Total | 36 rule sets; 18 apply, the rest apply only in the circumstances they name | 1722 | 1198 in rules that apply |
Supply continuity and change control
You would hear about a change before a changed lot ships, with the data to judge it
No changed lot would ship before you have the notice and the dataProposed practice
Text version of change control, continuity and traceability
Change control
- Advance written notice of changes in source region, harvest practice, solvent, process, site or carrier
- Comparability data on changed lots: fingerprint, markers and contaminants against reference lots
- Regulatory impact checked before acceptance
Continuity
- Forecast-linked purchasing and safety stock
- A second qualified source where one exists, with its own comparability data
- Retest-date management for stock on hand
Traceability and recall
- Lot genealogy from raw material to delivered lot
- Mock trace exercises
- Written complaint and recall procedure shared with you
For imported dietary supplement components where EUTECNIQ is the importer and you are the Part 111 manufacturer, EUTECNIQ would use the modified FSVP route in 21 CFR 1.511(b) and ask you each year for written assurance that you meet the Part 111 specification and testing requirements.
Technical support
Application support would be part of the supply, scoped to what each product needs
Four kinds of application support, and four pairs a buyer should not treat as equalProposed
Text version of the support and the four pairs
- Dispersibility, solubility and stability of the ingredient in your matrix
- Processing guidance for capsules, powders, beverages or emulsions
- Support during your audits of the supply chain
- Investigation support for complaints and out-of-specification results
- Supplier certificate≠Your identity test
- Ingredient retest date≠Finished-product shelf life
- Status analysis≠FDA determination
- Better dispersibility≠Demonstrated bioavailability
Duties you keep
Citations of the duties a buyer keeps hit a 12-year high in fiscal 2025; buying through EUTECNIQ would shorten that work, not transfer it
FDA investigators cited the specification requirement 188 times and the identity test 66 times in fiscal year 2025FDA data
Data table: citations by requirement and fiscal year
| FY2014 | FY2015 | FY2016 | FY2017 | FY2018 | FY2019 | FY2020 | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specifications for identity, purity, strength, composition and contaminants, § 111.70(e) | 63 | 58 | 74 | 104 | 89 | 92 | 57 | 62 | 117 | 104 | 144 | 188 |
| Conditions for relying on a supplier's certificate, § 111.75(a)(2)(ii) | 48 | 23 | 45 | 63 | 46 | 57 | 27 | 17 | 32 | 30 | 44 | 78 |
| Identity testing of each dietary ingredient, § 111.75(a)(1) | 56 | 46 | 50 | 45 | 54 | 36 | 24 | 15 | 22 | 15 | 39 | 66 |
| All of Part 111 | 1,549 | 1,294 | 1,625 | 1,842 | 1,640 | 1,444 | 871 | 704 | 1,218 | 1,173 | 1,583 | 1,938 |
What is not promised: the five limits (also at the foot of the duties figure above)
- Your Part 111 duties stay with you. You still test the identity of each dietary ingredient and approve suppliers through your quality unit.
- No FDA determination. EUTECNIQ's regulatory analysis does not bind FDA and does not guarantee FDA will not object.
- No FDA approval. FDA does not approve dietary ingredients or ingredient facilities.
- No claim substantiation for your product. Ingredient documentation does not substantiate your label claims unless that work is separately contracted.
- No accreditation today. EUTECNIQ holds none; results would come from qualified external laboratories.
Tell us what you need to qualify
Describe the ingredient, intended use and dose, product format and the documents your quality unit requires. Confidential details can wait for an NDA.