Functional foods and beverages Proposed service Law checked October 22, 2026

In a food or beverage, a botanical ingredient must be lawful as food and survive the process, the package and the shelf

For beverage and food developers, and for ingredient suppliers moving from supplements into foods: the lawful-basis routes and FDA's GRAS record, the processing limits that break botanicals, and the stages and documents EUTECNIQ proposes.

Status. EUTECNIQ is in formation and has no food products, customers or test data. The services below are proposals. Legal statements summarize U.S. federal law as of October 22, 2026 and are not legal advice.

1,071 of 1,317closed GRAS notices answered "no questions" (FDA inventory, updated October 21, 2026)

34%of closed notices for substances named "extract" ended at the notifier's request, against 17% overall

Dec 9, 2026comment deadline on FDA's proposal to make GRAS notification mandatory (91 FR 51834)

pH 4.6 · a_w 0.85thresholds that bring the canning and acidified-food rules (Parts 113, 114) into play

The journey

Three kinds of food business need the same two answers: is it lawful, and will it last

Choose a customer to follow its path from the rules to the documents it would receiveProposed service flow

Rules link to eCFR. Stages and documents are EUTECNIQ proposals; EUTECNIQ has no laboratory yet. Documents are described in the deliverables library.

Text version: customers, rules, stages and documents

Customers

Beverage developers Ready-to-drink products, shots, concentrates and powders that must stay clear or uniform for their whole shelf life.
Food manufacturers Bars, baked goods, dairy and plant-based products where heat, moisture and taste limit what a botanical can do.
Ingredient suppliers Have a supplement ingredient, want a food use, and need its legal basis and processing data.

Rules that apply

21 CFR 170 and 171 Food additives, GRAS and food additive petitions.
21 CFR 117 Food CGMP, hazard analysis and preventive controls.
21 CFR 113, 114 and 120 Low-acid canned foods, acidified foods, juice HACCP.
21 CFR 101 Food labeling, nutrient content and health claims.

Platform stages and tests (proposed)

Lawful-basis assessment Food additive or GRAS for the intended use.
Identity and composition The food-use specification.
Emulsion and dispersion design Droplet size, density matching, pH.
Process-stability tests Heat, pH, light and oxygen at real process conditions.
Shelf-life study In the real product and pack.

What the customer would receive

Food-use specification
Process-stability report Heat, pH, light, oxygen.
Prototype formulation With droplet-size or powder data.
Shelf-life protocol and interim data
Regulatory route memo Food additive or GRAS status.

The problem

An ingredient sold in supplements is not automatically lawful, or stable, in a food

The legal routes differ, and a beverage or a baked product exposes the ingredient to heat, acid, water, oxygen and light that a capsule never sees.

Twenty-three CFR rule sets touch a food or beverage ingredient maker with a laboratoryeCFR 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; 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 food or beverage ingredient maker: A food or beverage ingredient maker with a laboratory (eCFR section counts)
Rule set	What it covers	Agency group	eCFR sections	Level
21 CFR Part 184	Direct Food Substances Affirmed as Generally Recognized as Safe. Ingredients FDA has affirmed as GRAS for the purposes and conditions stated in each section.	FDA · 21 CFR	215	Check
21 CFR Part 182	Substances Generally Recognized as Safe. Substances generally recognized as safe, including spices (§ 182.10) and essential oils and natural extractives (§ 182.20).	FDA · 21 CFR	85	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	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 170	Food Additives. Food additive rules and the GRAS notice procedure (Subpart E); a 2026 proposal would make GRAS notices mandatory.	FDA · 21 CFR	41	Applies
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 S	Additional Traceability Records for Certain Foods. Extra traceability records for foods on FDA's Food Traceability List, which names fresh herbs; dried herbs, extracts and supplements are not named.	FDA · 21 CFR	33	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 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 172, Subpart F	Food Additives Permitted for Direct Addition to Food for Human Consumption. Natural flavoring substances and adjuvants, many of them plants, with their conditions of use (§ 172.510).	FDA · 21 CFR	11	Check
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
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
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	23 rule sets; 10 apply, the rest apply only in the circumstances they name		1549	947 in rules that apply

Explanation, details and sources

A different legal basis Regulatory requirement

A new dietary ingredient notification covers use in dietary supplements. In a conventional food, the ingredient generally has to be an approved food additive or generally recognized as safe (GRAS) for that use.

21 U.S.C. 321(s), 348, 350b.

A harsher environment Planning view

Pasteurization, acidification, baking and long ambient storage can degrade active constituents, change color and taste, and break emulsions. These losses have to be measured in the real product, at the real process conditions.

Formats

Each format fails in its own way

The design response is chosen after the failure mode is known.

Five food and beverage formats, the physical risk each poses to a botanical and the design responseEUTECNIQ planning view

General formulation engineering; emulsion physics on the emulsions page and in the creaming chart below.

Show the table (5 rows): Food and beverage formats with the botanical's role, the main physical risk and the propos

Food and beverage formats with the botanical's role, the main physical risk and the proposed design response.
Format	Botanical's role	Main physical risk	Design response EUTECNIQ proposes
Ready-to-drink beverages	Water-soluble extracts or emulsified lipophilic actives.	Creaming, sediment, haze and flavor change over the shelf life.	Droplet-size control, density matching, pH and preservative design.
Shots and concentrates	A high active load in a small volume.	Precipitation at the solubility limit; intense bitterness.	Food-grade solubilization, dilution testing, taste masking.
Beverage emulsions	Carriers for oil-soluble actives and flavors.	Creaming and Ostwald ripening (growth of large droplets at the expense of small ones).	Emulsifier selection, homogenization, weighting with lawful agents.
Powdered drink mixes	Dried extracts or encapsulated oils.	Poor wetting, clumping, caking and oxidation.	Spray drying, agglomeration, encapsulation, moisture control.
Functional foods bars, baked goods, dairy and plant-based products	Extracts or powders blended into a solid or semisolid matrix.	Heat during baking or extrusion, browning reactions, moisture migration, bitterness.	Heat-stability screening, encapsulation, assays validated in each food matrix.

Regulatory frame

Every ingredient in a conventional food needs a lawful basis for that use

Two routes cover most new botanical food ingredients; the GRAS page covers both in depth.

Four questions settle whether a botanical has a lawful basis in a foodStatute and regulation Guidance

21 U.S.C. 321(s), 348(a), 350b; 21 CFR 170.3(i), 170.30, 170.205, Part 171; FDA, docket FDA-2011-D-0490 (final guidance, June 2014).

GRAS notification is voluntary today; the August 2026 proposal would make it mandatoryProposed rule, status October 22, 2026

Federal Register, Substances Generally Recognized as Safe, proposed rule, 91 FR 51834 (August 11, 2026; docket FDA-2025-N-3262); HHS press release, March 10, 2025.

FDA answered 1,071 of 1,317 closed GRAS notices with "no questions"; notices for extracts were withdrawn twice as oftenFDA data

25 of 73 closed notices for substances named "extract" (34%) ended when FDA ceased to evaluate at the notifier's request, against 226 of 1,317 (17%) for all notices; 43 notices are pending. "Extract" is a word match on the substance name, not a botanical classification. A "no questions" letter is not an approval.FDA, GRAS Notice Inventory, downloaded file (last updated October 21, 2026; downloaded October 24, 2026). Year = year of FDA's closing letter; 2026 is partial. Counted by EUTECNIQ.

Data table: notices by year and outcome

GRAS notices by year of FDA's closing letter and outcome; 1,360 notices in the inventory, 43 pending (FDA file last updated October 21, 2026)
	1998	1999	2000	2001	2002	2003	2004	2005	2006	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024	2025	2026
FDA has no questions	4	11	18	23	21	22	20	12	26	17	19	38	38	33	41	28	50	53	56	39	69	55	48	57	37	75	47	61	53
FDA ceased to evaluate at the notifier's request	2	3	3	3	5	0	4	6	3	2	9	7	10	8	9	6	7	10	18	15	7	10	11	13	15	10	17	10	3
Notice does not provide a basis for a GRAS determination	0	6	3	2	5	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1
Of which: substance name contains "extract" (all outcomes)	1	4	1	1	1	3	0	2	1	2	0	2	5	1	2	2	8	4	3	4	1	2	9	3	3	2	1	4	1

Text version of the food additive and GRAS routes

Food additive Statute Final rule

A substance whose intended use makes it a component of food is a food additive unless it is GRAS for that use. A food additive is deemed unsafe unless its use conforms to an FDA regulation, which FDA issues on petition.

The safety standard is "a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use."

21 U.S.C. 321(s) and 348(a); 21 CFR Part 171; 21 CFR 170.3(i).

Generally recognized as safe Final rule Proposed rule

GRAS status rests on the views of qualified experts and on common knowledge throughout the scientific community. When based on scientific procedures, it needs the same quantity and quality of evidence as a food additive approval.

Notifying FDA of a GRAS conclusion is voluntary under the current rule: "Any person may notify FDA."

21 CFR 170.30 and 170.205.

Proposed rule GRAS reform, status as of October 22, 2026

On August 11, 2026 FDA proposed to require GRAS notices for substances purported to be GRAS (91 FR 51834; docket FDA-2025-N-3262). Comments close December 9, 2026.
As proposed, the rule would take effect 60 days after a final rule is published, with compliance due 18 months after that.
Self-affirmed GRAS conclusions remain legally permissible today. FDA says it is "not proposing" premarket approval; its responses would remain letters such as a "no questions" letter.
The proposal states that ingredients for use in dietary supplements are not eligible for GRAS classification for that use. Supplement ingredients follow the dietary supplement provisions, including new dietary ingredient notification where required.

Federal Register, "Substances Generally Recognized as Safe," proposed rule, 91 FR 51834 (August 11, 2026); HHS press release, March 10, 2025.

A change in how a food substance is made can matter too. FDA's June 2014 guidance recommends consulting FDA about a significant manufacturing change to a food substance already on the market, especially one involving an emerging technology such as nanotechnology. FDA, docket FDA-2011-D-0490 (final guidance).

Food safety rules

Part 117 governs the plant; pH and water activity decide whether the canning and acidification rules apply too

The thresholds below come straight from the regulatory definitions. A qualified person, often called a process authority, decides how they apply to a specific product.

Which thermal-processing rule applies, by pH and water activityRegulatory definitions

a_w > 0.85

Acid or acidified food

An acid food has a natural pH of 4.6 or below. A low-acid food brought here by adding acid is an acidified food, covered by Part 114 with a scheduled process set by a qualified person.

Carbonated beverages and foods kept under refrigeration are outside Part 114.

Low-acid food

Finished equilibrium pH above 4.6 and a_w above 0.85. When thermally processed in a hermetically sealed container, Part 113 applies, with a scheduled process set by qualified persons.

Alcoholic beverages are outside the definition.

a_w ≤ 0.85

Outside both definitions

Neither the low-acid nor the acidified-food definition applies at a water activity of 0.85 or below. Low water activity limits microbial growth, and Part 117 hazard analysis still applies.

pH ≤ 4.6

pH > 4.6

Simplified. Classification also depends on the container, the process, distribution and the product type; tomatoes and tomato products below pH 4.7 are not low-acid foods. Juice sold as such or used as an ingredient in beverages falls under Part 120 (juice HACCP). 21 CFR 113.3 and 113.83; 114.3 and 114.83; 120.1; Part 117 (eCFR, current to October 21, 2026).

Beverage emulsions

In a beverage, droplet size decides whether an emulsion lasts hours or months

Creaming speed rises with the square of the droplet radius and falls with the density gapIllustrative calculation

Stokes' lawv = 2 g r² (ρ_c − ρ_d)9 η_c

Show data: creaming velocity and time to rise 100 mm

Creaming velocity and time to rise 100 mm for droplets of different radius.
Droplet radius, µm	Creaming velocity, mm/day	Time to rise 100 mm
0.10	0.28	about 1 year
0.25	1.7	58 days
0.50	6.9	15 days
1.0	28	3.6 days
2.5	170	14 hours
0.50, density gap cut to 20 kg/m³	0.72	140 days

Assumed inputs, not measurements: oil density ρ_d = 850 kg/m³, aqueous density ρ_c = 1040 kg/m³, viscosity η_c = 1.3 mPa·s, g = 9.81 m/s². Stokes' law treats a single rigid sphere in a dilute liquid; it ignores Brownian motion, which slows separation of the smallest droplets, and droplet interactions, flocculation and Ostwald ripening. Calculation: src/modules/apps/compute/stokes_creaming.py; the plotted lines use the same equation and inputs.

Small droplets slow creaming; ripening and the density gap decide what happens nextPublished physics FDA action

FDA, Brominated Vegetable Oil (BVO), content current as of July 2, 2024; final rule issued July 3, 2024. Schematic, not to scale; densities as in the calculation above.

Text version of the emulsion mechanisms

The table explains why beverage emulsions are made with submicron droplets and why the density gap matters. Halving the radius cuts the creaming speed by four; cutting the density gap from 190 to 20 kg/m³ cuts it about ninefold.

Beverage makers have closed the density gap with weighting agents. Each one has to be a lawful food ingredient in its own right. FDA revoked the regulation authorizing brominated vegetable oil, used "to keep the citrus flavoring from floating to the top," effective August 2, 2024.

Small droplets are not the end of the problem. Over months, Ostwald ripening can grow large droplets at the expense of small ones, so the size distribution has to be measured over the shelf life. The emulsions page covers the full set of breakdown mechanisms.

FDA, "Brominated Vegetable Oil (BVO)," content current as of July 2, 2024; final rule issued July 3, 2024.

Explanation, details and sources

An oil droplet lighter than the surrounding liquid rises. Stokes' law gives its speed: four times faster for every doubling of radius, and in direct proportion to the density gap.

Labeling and claims

A food label may describe nutrition and, within limits, health; it may not promise treatment

From nutrient content to health claims, a food label stays on the food side of the drug lineStatute and regulation

21 CFR 101.4, 101.9, 101.13, 101.14; FDA, Label Claims for Conventional Foods and Dietary Supplements and Structure/Function Claims (March 28, 2024); FDA, Food Allergies (March 11, 2026); 21 U.S.C. 321(g)(1).

Text version of the labeling rules

Nutrition and ingredients Final rule: Nutrition Facts labeling and an ingredient statement using common or usual names. 21 CFR 101.9; 101.4.
Major food allergens Statute: Nine: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added by the FASTER Act, effective January 1, 2023. FDA, "Food Allergies" (March 11, 2026).
Nutrient content claims Final rule: Describe the level of a nutrient, with terms such as "free," "high" and "low." 21 CFR 101.13.
Health claims Final rule: Describe a relationship between a food substance and reduced risk of a disease or health-related condition. Authorized by FDA regulation under the "significant scientific agreement" standard, or used as qualified health claims under FDA enforcement discretion. 21 CFR 101.14; FDA, "Label Claims for Conventional Foods and Dietary Supplements" (March 28, 2024).
Structure/function claims: On conventional foods they "focus on effects derived from nutritive value." FDA does not require notification or a disclaimer for them. FDA, "Structure/Function Claims" (March 28, 2024).
Disease treatment: A claim to diagnose, cure, mitigate, treat or prevent disease, outside an authorized health claim, makes the product a drug. 21 U.S.C. 321(g)(1).

What EUTECNIQ proposes

Characterization and prototyping in house; expert panels, process authorities and co-packers as partners

Laboratory work in house; expert, process and production roles with partnersProposed External partners

EUTECNIQ proposal. EUTECNIQ has no laboratory yet.

Text version of the division of work

In-house, once the laboratory exists Proposal

Ingredient characterization and specifications for food use.
Heat, pH, light and oxygen stability screening of the active.
Emulsion, powder and concentrate prototypes with droplet-size and stability data.
Assays validated in each food matrix.
Assembly of the scientific evidence for a GRAS conclusion or a food additive petition.

With qualified partners External partner

Independent experts qualified to evaluate safety for a GRAS conclusion.
Process authorities for acidified and low-acid products.
Co-packers operating under Part 117.
Sensory and consumer testing.
Regulatory counsel for labels, claims and submissions.

Evidence levels

Five levels of evidence, and what each can support for a food

Each level of evidence answers one question; only human outcome data support a health claimRoles per regulation

21 CFR 170.3(i), 170.30, 101.14; FDA label claims page (2024).

Text version of the evidence levels

Evidence levels with what each shows, what it cannot show, and its role for conventional foods.
Level	What it shows	What it cannot show	Role for foods and beverages
1 Identity and composition	The material is what the label says, at a defined strength.	Safety or benefit.	Needed for any GRAS conclusion or petition, which addresses a defined substance.
2 Safety	The ingredient is safe at the intended use and exposure.	Benefit.	Required: reasonable certainty of no harm at the estimated dietary exposure.
3 Biological activity	A plausible mechanism, in cells or animals.	An effect in people.	Rationale only; supports no label claim.
4 Exposure	How much reaches the gut lumen or the blood.	Benefit, or safety at the higher exposure.	Informs formulation and the safety assessment.
5 Human outcome	The claimed effect in people, under controlled conditions.	Effects outside the studied product, dose and population.	Needed for a health claim, which FDA authorizes by regulation or allows as a qualified claim.

Putting a botanical into a food or beverage?

Describe the product, the process and the target shelf life. The first reply would identify the legal basis to confirm and the stability risks to test first.

Discuss a food project GRAS pathway