EUTECNIQ Sciences

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Cosmetics and personal care Proposed service Law checked October 22, 2026

A cosmetic may change how skin and hair look; a claim to change how they work makes the product a drug

For skin, hair and oral care brands and the suppliers of their botanical actives: formats, skin delivery, the cosmetic–drug boundary, MoCRA duties and registrations as of October 2026, and what EUTECNIQ proposes.

Status. EUTECNIQ is in formation. It has no cosmetic products, customers or test data, and is not registered with FDA as a cosmetic facility. The services below are proposals; legal statements summarize U.S. federal law as of October 22, 2026 and are not legal advice.

16,398cosmetic facilities registered with FDA under MoCRA (data as of June 30, 2026)
82%of them outside the United States; 8,138 in China alone
1,298,361active cosmetic product listings with FDA
2MoCRA rules past their statutory deadline with none proposed: GMP and fragrance allergens (October 22, 2026)
The journey

Brands and suppliers who need a botanical active that is stable, safe on skin and described lawfully

Choose a customer to follow its path from the rules to the documents it would receiveProposed service flow
Rules link to the U.S. Code or 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

  • Skin and hair care brands Serums, creams, lotions, oils, gels, shampoos and leave-in products built around a botanical active.
  • Oral care developers Toothpastes and rinses with botanical flavors or actives, where one claim can change the category.
  • Botanical active suppliers Need characterization, stability and safety data a brand's responsible person can rely on.

Rules that apply

Platform stages and tests (proposed)

What the customer would receive

The problem

Botanical actives are often large, unstable or colored, and the claims that sell them can cross into drug territory

Ten CFR rule sets touch a cosmetic maker that uses endorsements and environmental claims; MoCRA's duties sit in the statuteeCFR counts

MoCRA's registration, listing, safety substantiation and adverse-event duties are in the statute (21 U.S.C. 364a–364e), not yet in the CFR, so they do not appear here; see the MoCRA section below. Area is the number of sections in eCFR; "*" marks rules that apply only in the circumstances they name.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 cosmetic maker: A cosmetic maker that uses endorsements and environmental claims (eCFR section counts)
Rule setWhat it coversAgency groupeCFR sectionsLevel
21 CFR Part 700General. General cosmetic rules, including ingredients prohibited in cosmetics such as methylene chloride (§ 700.19).FDA · 21 CFR12Applies
21 CFR Part 7, Subpart CEnforcement Policy. FDA's recall policy: recalls are voluntary actions, classified by health hazard, with a recall strategy.FDA · 21 CFR10Check
21 CFR Part 701Cosmetic Labeling. Cosmetic labeling, including the designation of ingredients (§ 701.3).FDA · 21 CFR10Applies
21 CFR Part 740Cosmetic Product Warning Statements. Warning statements required on certain cosmetic products.FDA · 21 CFR8Check
16 CFR Part 260Guides for the Use of Environmental Marketing Claims. The Green Guides: the FTC's views on environmental marketing claims.FTC and CPSC · 16 CFR17Applies
16 CFR Part 465Rule on the Use of Consumer Reviews and Testimonials. Bans fake reviews and testimonials, buying sentiment-conditioned reviews, insider reviews and review suppression.FTC and CPSC · 16 CFR8Applies
16 CFR Part 255Guides Concerning Use of Endorsements and Testimonials in Advertising. How the FTC applies Section 5 of the FTC Act to endorsements and testimonials in advertising.FTC and CPSC · 16 CFR7Applies
29 CFR 1910.1200Hazard communication.. Hazard communication: hazard classification, labels, safety data sheets and worker training.OSHA · 29 CFR1Applies
29 CFR 1910.132General requirements.. Workplace hazard assessment and personal protective equipment.OSHA · 29 CFR1Applies
29 CFR 1910.147The control of hazardous energy (lockout/tagout).. Lockout/tagout of hazardous energy during servicing and maintenance of machines.OSHA · 29 CFR1Check
Total10 rule sets; 7 apply, the rest apply only in the circumstances they name7556 in rules that apply
Explanation, details and sources

The science Published evidence

The outer layer of skin keeps most large molecules out. Many plant constituents oxidize, discolor or carry odor, and they can upset emulsions and preservative systems.

The law Regulatory requirement

FDA judges a product by its intended use, shown by its claims. A claim that the product affects the structure or function of the body makes it a drug, whatever the ingredient.

Formats

The format decides where the active sits and what can break

Six cosmetic formats and the challenge each poses to a botanical activeEUTECNIQ planning view
Six cosmetic and personal care formats with their structure and the typical challenge for a botanical activeSerumsAqueous or hydroalcoholic solutions, sometimesthickened.•Challenge: Solubility and oxidation at the uselevel; colorCreams and lotionsOil-in-water or water-in-oil emulsions, often withlamellar phases.•Challenge: Which phase holds the active;emulsion stability; preservative performanceOils and balmsAnhydrous blends of oils, butters and waxes.•Challenge: Oxidation and rancidity; waxcrystallizationGelsWater swollen by a gelling polymer.•Challenge: Actives, salts and pH can collapse thegelHair careSurfactant systems and conditioning emulsions.•Challenge: Most of the active rinses away;surfactants can bind itOral careAbrasive pastes and aqueous rinses.•Challenge: Taste and stability in water; fluoride ora therapeutic claim makes it also a drugSix cosmetic and personal care formats with their structure and the typical challenge for a botanical activeSerumsAqueous or hydroalcoholic solutions, sometimesthickened.•Challenge: Solubility and oxidation at the use level; colorCreams and lotionsOil-in-water or water-in-oil emulsions, often with lamellarphases.•Challenge: Which phase holds the active; emulsionstability; preservative performanceOils and balmsAnhydrous blends of oils, butters and waxes.•Challenge: Oxidation and rancidity; wax crystallizationGelsWater swollen by a gelling polymer.•Challenge: Actives, salts and pH can collapse the gelHair careSurfactant systems and conditioning emulsions.•Challenge: Most of the active rinses away; surfactantscan bind itOral careAbrasive pastes and aqueous rinses.•Challenge: Taste and stability in water; fluoride or atherapeutic claim makes it also a drug
General formulation engineering. Oral care: fluoride or a therapeutic claim makes the product also a drug (FDA, "Is It a Cosmetic, a Drug, or Both?", September 11, 2024).
Show the table (6 rows): Cosmetic and personal care formats with their structure, the typical botanical challenge a
Cosmetic and personal care formats with their structure, the typical botanical challenge and the work EUTECNIQ proposes.
FormatStructureTypical botanical challengeProposed EUTECNIQ work
SerumsAqueous or hydroalcoholic solutions, sometimes thickened or lightly emulsified.Solubility and oxidation at the use level; color.Solubilization, antioxidant system, packaging compatibility.
Creams and lotionsOil-in-water or water-in-oil emulsions, often with structured lamellar phases.Where the active partitions between phases; emulsion stability; preservative performance.Phase location of the active, droplet size and rheology, preservative efficacy with partners.
Oils and balmsAnhydrous blends of oils, butters and waxes.Oxidation and rancidity; wax crystallization.Antioxidant selection and oxidative stability testing.
GelsWater swollen by a gelling polymer.Actives, salts and pH can collapse the gel.Polymer choice and pH-viscosity mapping.
Hair careSurfactant systems and conditioning emulsions.Most of the active rinses away; surfactants can bind it.Deposition and retention measurements.
Oral careAbrasive pastes and aqueous rinses.Taste and stability in water-rich systems. Fluoride, or a therapeutic claim, makes the product also a drug.Taste masking, compatibility testing, claim screening.

Format descriptions are general formulation science, offered as EUTECNIQ's planning view. Oral care classification: FDA, "Is It a Cosmetic, a Drug, or Both?" (September 11, 2024).

Topical delivery

The skin's outer layer filters botanical molecules by size and polarity, so the delivery design starts with the molecule

Molecular weight of ten botanical constituents used in skin care, against the 500-dalton rule of thumbPubChem data Heuristic
  • Ferulic acid cereal brans194.2 Da
  • Caffeine coffee, tea194.2 Da
  • Resveratrol grapes, Japanese knotweed228.2 Da
  • Bakuchiol Psoralea corylifolia seed256.4 Da
  • Quercetin onion and many other plants302.2 Da
  • Rosmarinic acid rosemary360.3 Da
  • EGCG green tea458.4 Da
  • Rutin buckwheat; a quercetin glycoside610.5 Da
  • Glycyrrhizic acid licorice root822.9 Da
  • Asiaticoside Centella asiatica959.1 Da
Show data
PubChem computed properties for the ten constituents.
ConstituentPubChem CIDFormulaMolecular weight, g/molXLogP3 (computed)
Ferulic acid445858C10H10O4194.181.5
Caffeine2519C8H10N4O2194.19−0.1
Resveratrol445154C14H12O3228.243.1
Bakuchiol5468522C18H24O256.46.1
Quercetin5280343C15H10O7302.231.5
Rosmarinic acid5281792C18H16O8360.32.4
Epigallocatechin gallate (EGCG)65064C22H18O11458.41.2
Rutin5280805C27H30O16610.5−1.3
Glycyrrhizic acid14982C42H62O16822.93.7
Asiaticoside11954171C48H78O19959.10.1
The three glycosides lie above 500 daltons; quercetin, the aglycone of rutin, lies below. The rule is a heuristic. Lipophilicity, ionization, the vehicle and the state of the skin also govern penetration, and a molecule under 500 daltons may still penetrate poorly. Plant sources are examples, not specifications. PubChem computed properties (PUG REST), accessed October 22, 2026. Bos JD, Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol. 2000;9(3):165–169. Potts RO, Guy RH. Predicting skin permeability. Pharm Res. 1992;9(5):663–669 (permeability related to molecular size and octanol–water partitioning).
Small actives can enter the barrier; large glycosides mostly stay on it; carriers change where actives sitSchematic, not to scale
Schematic skin cross-section: a product layer holding a small active, a large glycoside and a carrier; the stratum corneum as the main barrier; viable epidermis and dermis below. Small molecules can enter; large glycosides mostly stay at the surfaceProduct layer (vehicle)Stratum corneum: themain barrierEpidermis beneath thestratum corneumDermis, with bloodvesselsSmall active, e.g. caffeine 194 DaLarge glycoside, e.g.asiaticoside 959 DaCarrierLarge activesMay still work at thesurface, e.g. as a filmformer or humectant.Penetration claims needdata on the product.CarriersStructured emulsions,liposomes and lipidnanoparticles changewhere an active sits andhow fast it leaves.Nanomaterials · FDA 2014Describe the material fully;test penetration on intactand impaired skin.Schematic, not to scale. Skin layers: Yousef et al., StatPearls (2024). 500 Da is a rule of thumb (Bos and Meinardi 2000); lipophilicity, ionization, vehicle and skin state alsogovern penetration.Topical delivery: barrier, actives and carriersBarrierThe stratum corneum, the outermost layer of theepidermis, keeps most large molecules out. Rule ofthumb: under 500 Da to be absorbed.Small activeCaffeine, 194 Da, lies under the rule-of-thumb limit.Large activeAsiaticoside, 959 Da, lies above it; it may still work atthe surface, as a film former or humectant.CarriersStructured emulsions, liposomes and lipidnanoparticles change where an active sits and howfast it leaves the product.Nanomaterials · FDA 2014Describe the material fully; test penetration on intactand impaired skin.
Bos and Meinardi 2000, Exp Dermatol 9:165; FDA, Safety of Nanomaterials in Cosmetic Products (June 2014, FDA-2011-D-0489). Molecular weights from the PubChem chart above.
Text version of the delivery notes

Large actives

A large glycoside may still be useful at the skin surface, for example as a film former or humectant. Any statement about penetration needs data on the actual product.

Carriers

Structured emulsions, liposomes and lipid nanoparticles change where an active sits and how fast it leaves the product. See the delivery page for each system and the tests that characterize it.

Nanomaterials Final guidance

FDA's 2014 guidance on nanomaterials in cosmetics says safety should be assessed by fully describing the nanomaterial, and that penetration studies should use both intact and impaired skin.

FDA, "Safety of Nanomaterials in Cosmetic Products" (June 2014, docket FDA-2011-D-0489).

Explanation, details and sources

The stratum corneum, the outermost layer of the epidermis, is the main barrier. A widely cited rule of thumb holds that a compound must weigh under 500 daltons to be absorbed through skin.

Penetration does not decide the legal category; intended use does. Penetration data matter for safety, because they bound how much of an ingredient can reach the body.

Cosmetic or drug

Intended use, shown by claims, decides whether a product is a cosmetic, a drug or both

The definitions are quoted in the figure; FDA's examples show where common claims fall.

The claim decides the category: FDA's own examples of cosmetic, drug and dual claimsStatute and FDA examples
Intended use, shown by claims, sorts a product into cosmetic, drug or both, with FDA's own example claims and what follows for each; four things not to equateIntended use, shown by labeling and claims"Cleansing, beautifying, promoting attractiveness, oraltering the appearance" · 21 U.S.C. 321(i)Cosmetic•Cleanses, beautifies, improves appearanceWhat followsNo FDA approval; MoCRA obligations; safetysubstantiation"Intended to affect the structure or any function ofthe body", or to treat or prevent disease · 321(g)(1)Drug•Restores hair growth•Reduces cellulite•Increases or decreases melanin production•Regenerates cellsWhat followsA new drug application, or conformity with anOTC monographBoth definitions metCosmetic and drug•Antidandruff shampoo•Fluoride toothpaste that cleans and freshens•Antiperspirant deodorant•Moisturizer or makeup with sun protectionWhat followsBoth sets of rules, including drug cGMP (21 CFR210/211) and an OTC monograph or approvedapplicationDo not equate"Cosmeceutical"≠a legal categoryRegistration and listing≠FDA approvalSupplement structure/function safe harbor≠available to cosmeticsSkin penetration≠drug statusFDA: the term "cosmeceutical" "has no meaning under the law".Cosmetic, drug or both, by intended useIntended use, shown by claims"Cleansing, beautifying, promoting attractiveness, oraltering the appearance" · 21 U.S.C. 321(i)Cosmetic•Cleanses, beautifies, improves appearance•Then: No FDA approval; MoCRA obligations; safetysubstantiation"Intended to affect the structure or any function of thebody", or to treat or prevent disease · 321(g)(1)Drug•Restores hair growth•Reduces cellulite•Increases or decreases melanin production•Regenerates cells•Then: A new drug application, or conformity with anOTC monographBoth definitions metCosmetic and drug•Antidandruff shampoo•Fluoride toothpaste that cleans and freshens•Antiperspirant deodorant•Moisturizer or makeup with sun protection•Then: Both sets of rules, including drug cGMP (21CFR 210/211) and an OTC monograph or approvedapplicationDo not equate•"Cosmeceutical" ≠ a legal category•Registration and listing ≠ FDA approval•Supplement structure/function safe harbor ≠available to cosmetics•Skin penetration ≠ drug status
21 U.S.C. 321(g)(1) and 321(i); FDA, Is It a Cosmetic, a Drug, or Both? (September 11, 2024); FDA, "Cosmeceutical" (February 25, 2022); 21 U.S.C. 343(r)(6).
Text version of the claims and distinctions
Examples of claims and the category they place a product in, from FDA.
Claim or productCategoryWhat follows
Cleanses, beautifies, improves appearanceCosmeticNo FDA approval; MoCRA obligations; safety substantiation.
Restores hair growth; reduces cellulite; increases or decreases melanin production; regenerates cellsDrugFDA's own examples of drug claims. A new drug application or OTC monograph conformity is needed.
Antidandruff shampoo; fluoride toothpaste that cleans and freshens; antiperspirant deodorant; moisturizer or makeup with sun protectionCosmetic and drugMust meet both sets of requirements, including drug cGMP under 21 CFR Parts 210/211, and conform to an OTC monograph or an approved application.
  • "Cosmeceutical"≠A legal category. FDA: the term "has no meaning under the law."
  • Cosmetic registration and listing≠FDA approval
  • Supplement structure/function safe harbor≠Available to cosmetics
  • Skin penetration≠Drug status (intended use decides)
MoCRA

Four MoCRA duties are in force; the GMP and fragrance-allergen rules have not been proposed

The cosmetics and MoCRA page covers each obligation in depth.

Four MoCRA duties are in force; two rulemaking deadlines passed without a proposed ruleStatute, status October 22, 2026
MoCRA obligations from enactment on December 29, 2022 to October 22, 2026: four duties in effect, two statutory rulemaking deadlines passed without a proposed rule, and the talc testing rule proposed and then withdrawn2023202420252026Enacted Dec 29, 2022Oct 22, 2026Registration and listing§ 607Registration and listing: Enforcement discretion ended Jul 1, 2024In effectSafety substantiation§ 608Safety substantiation: In effect since Dec 29, 2023In effectSerious adverse eventreporting§ 605Serious adverse event reporting: In effect since Dec 29, 2023; 15 business daysIn effectLabel contact information§ 609(a)Label contact information: In effect since Dec 29, 2024In effectGood manufacturingpractice§ 606No rule proposedFragrance allergen labeling§ 609(b)No rule proposedAsbestos testing of talc§ 3505Talc testing rule: proposed Dec 27, 2024; withdrawn Nov 28, 2025WithdrawnIn effectStatutory deadline passed without a ruleProposed, then withdrawnGMP deadlines: proposal Dec 29, 2024 and final rule Dec 29, 2025; FDA has a draft GMP guidance. Fragrance allergen proposal due Jun 29, 2024. Unchanged by MoCRA:no premarket approval except color additives; no specific safety tests or animal testing required.MoCRA obligations and their status, October 22, 2026Enacted December 29, 2022; status October 22, 2026§ 607 · In effectRegistration and listingEnforcement discretion ended Jul 1, 2024§ 608 · In effectSafety substantiationIn effect since Dec 29, 2023§ 605 · In effectSerious adverse event reportingIn effect since Dec 29, 2023; 15 business days§ 609(a) · In effectLabel contact informationIn effect since Dec 29, 2024§ 606 · No rule proposedGood manufacturing practiceProposal due Dec 29, 2024; Final due Dec 29, 2025§ 609(b) · No rule proposedFragrance allergen labelingProposal due Jun 29, 2024§ 3505 · WithdrawnAsbestos testing of talcProposed Dec 27, 2024; Withdrawn Nov 28, 2025
FDA, MoCRA page (content current as of August 10, 2026); 21 U.S.C. 364a–364d; Pub. L. 117-328, §§ 3503(b) and 3505; 88 FR 77323 (November 9, 2023); 89 FR 105490 (December 27, 2024); 90 FR 54603 (November 28, 2025).
Text version: each obligation, what MoCRA did not change
MoCRA obligations, what each requires and its status as of October 22, 2026.
ObligationWhat it requiresStatus, October 22, 2026
Facility registration and product listing FD&C Act § 607Facilities register with FDA and renew every two years; responsible persons list their products.In effect FDA's enforcement discretion ended July 1, 2024.
Safety substantiation § 608The responsible person must "ensure, and maintain records supporting, that there is adequate substantiation of safety." A product without it is adulterated.In effect Since December 29, 2023.
Serious adverse event reporting § 605Report to FDA within 15 business days with a copy of the label; keep records for 6 years (3 for certain small businesses).In effect Since December 29, 2023.
Label contact information § 609(a)A domestic address, domestic phone number or electronic contact, such as a website, through which the responsible person can receive adverse event reports.In effect Since December 29, 2024.
Good manufacturing practice § 606FDA was to propose a rule by December 29, 2024 and finalize it by December 29, 2025.No rule proposed Deadlines passed; FDA has a draft GMP guidance.
Fragrance allergen labeling § 609(b)FDA was to propose a rule by June 29, 2024.No rule proposed Deadline passed.
Asbestos testing of talc products MoCRA § 3505Standardized testing methods.Withdrawn Proposed December 27, 2024; withdrawn November 28, 2025.

What MoCRA did not change

  • FDA does not approve cosmetics or cosmetic ingredients before sale; color additives are the exception.
  • "Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients." Animal testing is not required.
  • A short list of ingredients is prohibited or restricted by regulation, including mercury compounds, chloroform, vinyl chloride and methylene chloride (21 CFR Part 700, Subpart B).
  • False advertising of cosmetics is unlawful under the FTC Act (15 U.S.C. 52).

How EUTECNIQ would describe its own practice Proposal

No cosmetic GMP rule exists to comply with. EUTECNIQ would describe cosmetic work as aligned with FDA's draft cosmetic GMP guidance and with ISO 22716:2007, "Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices." Products that are also drugs would be made only by manufacturers operating under drug cGMP.

FDA, "Modernization of Cosmetics Regulation Act of 2022 (MoCRA)," content current as of August 10, 2026; 21 U.S.C. 364a to 364d; Pub. L. 117-328, §§ 3503(b) and 3505; 88 FR 77323 (November 9, 2023); 89 FR 105490 (December 27, 2024); 90 FR 54603 (November 28, 2025); FDA cosmeceutical page; 21 CFR 700.11 to 700.35; 15 U.S.C. 52; ISO 22716:2007 (confirmed 2022).

FDA lists 16,398 active registered cosmetic facilities; 13,468 of them, 82 percent, are outside the United StatesFDA data
Bubble area is proportional to the number of facilities. FDA also counts 1,298,361 active product listings. A registration number is not FDA approval of the facility or its products. Ten small countries and territories (12 facilities) have no point on this map.FDA, Registration & Listing of Cosmetic Product Facilities and Products (content current as of September 9, 2026) and its facility metrics by state and country, data as of June 30, 2026; read October 24, 2026.
Data table: facilities by country
Active registered cosmetic product facilities, data as of June 30, 2026 (FDA MoCRA metrics): 16,398 in all, 2,930 in the United States and 13,468 in 109 other countries and territories; the twenty largest shown
Country or territoryFacilitiesShare of all
United States (all states and territories)2,93017.9%
China8,13849.6%
Korea, South9475.8%
India5683.5%
Italy3282.0%
Japan3011.8%
France2871.8%
Canada2361.4%
Mexico1921.2%
Brazil1891.2%
Turkey1791.1%
Taiwan1761.1%
United Kingdom1611.0%
Vietnam1571.0%
Hong Kong1470.9%
Spain1440.9%
Colombia1240.8%
Australia1100.7%
Germany1070.7%
Israel790.5%
Poland640.4%
All other countries (89)8345.1%
What EUTECNIQ proposes

Active characterization, prototypes and stability in house; skin safety, consumer studies and manufacturing with partners

Characterization and prototypes in house; skin safety, consumer studies and manufacturing with partnersProposed External partners
Proposed division of cosmetic work: active characterization, prototypes, stability and exposure studies in house; skin safety, microbiology, consumer studies, counsel and manufacturing with partnersCharacterizePrototype andstabilityExposure and safetyClaimsManufactureEUTECNIQ in-houseOnce its laboratoryexists; proposedIdentity, composition,color and odor profileof botanical activesPrototype serums,emulsions and gelswith physical stabilitydataChemical stability ofthe active in productand packageIn vitro release andskin-penetrationstudies to boundexposureScientific support forthe safetysubstantiation fileNoneNoneQualified partnersExternal; contractedNonePreservative efficacyand microbiologytestingIrritation andsensitization testing,including human patchtests under IRBoversightInstrumental andconsumer-perceptionstudies forappearance claimsRegulatory counsel forclaims and labelsContractmanufacturers; drugcGMP manufacturersfor drug-cosmeticproductsProposed division of cosmetic work: active characterization, prototypes, stability and exposure studies in house; skin safety, microbiology, consumer studies, counsel and manufacturing with partnersEUTECNIQ in-house (proposed)Qualified partners1. CharacterizeEUTECNIQ in-houseIdentity, composition, color and odor profile ofbotanical actives2. Prototype and stabilityEUTECNIQ in-housePrototype serums, emulsions and gels withphysical stability dataChemical stability of the active in product andpackageQualified partnersPreservative efficacy and microbiology testing3. Exposure and safetyEUTECNIQ in-houseIn vitro release and skin-penetration studies tobound exposureScientific support for the safety substantiation fileQualified partnersIrritation and sensitization testing, includinghuman patch tests under IRB oversight4. ClaimsQualified partnersInstrumental and consumer-perception studies forappearance claimsRegulatory counsel for claims and labels5. ManufactureQualified partnersContract manufacturers; drug cGMPmanufacturers for drug-cosmetic products
EUTECNIQ proposal. EUTECNIQ is not registered with FDA as a cosmetic facility.
Text version of the division of work

In-house, once the laboratory exists Proposal

  • Identity, composition, color and odor profile of botanical actives.
  • Prototype serums, emulsions and gels with physical stability data.
  • Chemical stability of the active in the product and its package.
  • In vitro release and skin-penetration studies to bound exposure.
  • Scientific support for the responsible person's safety substantiation file.

With qualified partners External partner

  • Skin irritation and sensitization testing, including human patch testing under IRB oversight.
  • Preservative efficacy and microbiology testing.
  • Instrumental and consumer-perception studies for appearance claims.
  • Contract manufacturers; drug cGMP manufacturers for drug-cosmetic products.
  • Regulatory counsel for claims and labels.
Evidence levels

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

Safety substantiation is required; cell-level activity claims risk drug statusRoles per statute
Five levels of evidence and what each can support for a cosmeticLevel, and what it showsWhat it cannot showRole for cosmetics5Human outcomeA visible or measurable change in people undercontrolled conditionsEffects outside the studied productand populationSubstantiates appearance claims in labeling andadvertising4ExposureHow much of the active enters or crosses the skinBenefitFeeds the safety assessment by bounding systemicexposure3Biological activityAn effect on skin cells or tissue modelsAn effect in people; a claim built on itmay describe a drug effectRationale only. Claims of cell-level action risk drugstatus2SafetyThe product is safe under its conditions of useBenefitRequired: adequate substantiation of safety, heldby the responsible person1Identity and compositionThe material is what the label says, at a definedstrengthSafety or benefitThe starting point of any safety assessment and ofthe ingredient declarationEach level answers its own question; none substitutes for the one above it.Five levels of evidence and what each can support for a cosmeticLevel 5 at the top; role for cosmetics in the boxes5Human outcomeA visible or measurable change in people undercontrolled conditionsCannot show: Effects outside the studied productand populationSubstantiates appearance claims in labelingand advertising4ExposureHow much of the active enters or crosses the skinCannot show: BenefitFeeds the safety assessment by boundingsystemic exposure3Biological activityAn effect on skin cells or tissue modelsCannot show: An effect in people; a claim built onit may describe a drug effectRationale only. Claims of cell-level action riskdrug status2SafetyThe product is safe under its conditions of useCannot show: BenefitRequired: adequate substantiation of safety,held by the responsible person1Identity and compositionThe material is what the label says, at a definedstrengthCannot show: Safety or benefitThe starting point of any safety assessmentand of the ingredient declarationEach level answers its own question; none substitutes forthe one above it.
21 U.S.C. 364d; FDA cosmetic-versus-drug page (2024); 15 U.S.C. 52.
Text version of the evidence levels
Evidence levels with what each shows, what it cannot show, and its role for cosmetics.
LevelWhat it showsWhat it cannot showRole for cosmetics
1 Identity and compositionThe material is what the label says, at a defined strength.Safety or benefit.The starting point of any safety assessment and of the ingredient declaration.
2 SafetyThe product is safe under its conditions of use.Benefit.Required: adequate substantiation of safety, held by the responsible person.
3 Biological activityAn effect on skin cells or tissue models.An effect in people; and a claim built on it may describe a drug effect.Rationale only. Claims of cell-level action risk drug status.
4 ExposureHow much of the active enters or crosses the skin.Benefit.Feeds the safety assessment by bounding systemic exposure.
5 Human outcomeA visible or measurable change in people under controlled conditions.Effects outside the studied product and population.Substantiates appearance claims in labeling and advertising.

Developing a botanical cosmetic or personal care product?

Describe the active, the format and the claims you plan to make. The first reply would flag any claim that risks drug status and the data the safety file will need.

Discuss a cosmetic projectMoCRA overview