Cosmetic safety & MoCRA Proposed service line Statute and FDA status checked October 22, 2026

Cosmetics are not FDA-approved, but since MoCRA the responsible person must hold safety records, register, list and report serious adverse events

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added duties in force and mandated rules FDA has not yet proposed. This page separates the two, explains when a cosmetic becomes a drug and covers labeling. Educational, not legal advice.

Dec 29, 2023safety substantiation and serious adverse-event reporting took effect under MoCRA

15 business daysto report a serious adverse event to FDA, with a copy of the label (FD&C Act § 605)

0proposed rules on cosmetic GMP or fragrance allergens in the Federal Register, as of October 24, 2026; both deadlines have passed

Status. EUTECNIQ Sciences is a company in formation. It has no cosmetic products, facility registrations or safety files of its own. Cosmetic ingredient and safety-substantiation work described here is proposed.

MoCRA status

Four MoCRA duties are in force; the GMP and fragrance-allergen rules are overdue and the talc proposal was withdrawn

Four duties have applied since 2023–2024; the GMP and fragrance-allergen rules are past their deadlines with nothing proposedStatute and FDA status

Sources: 21 U.S.C. 364a–364d (Cornell LII); Pub. L. 117-328, §§ 3503, 3505, 3506; FDA, Modernization of Cosmetics Regulation Act of 2022 (content current as of Aug 10, 2026); 88 FR 77323 (Nov 9, 2023) on the registration and listing compliance policy; Federal Register searches, Oct 22, 2026. Records access and mandatory recall authority are in the text version.

Days past each MoCRA rulemaking deadline on October 22, 2026, with no rule publishedStatutory dates

Statutory dates: 21 U.S.C. 364b and 364e as enacted by Pub. L. 117-328 (December 29, 2022); Federal Register API search for proposed and final rules, October 22, 2026; FDA MoCRA page (content current as of August 10, 2026).

Data table

MoCRA rulemaking deadlines and days elapsed on October 22, 2026
Rulemaking	Statutory date	Days past it
Fragrance allergens, proposed rule	June 29, 2024	845
Cosmetic GMP, proposed rule	December 29, 2024	662
Cosmetic GMP, final rule	December 29, 2025	297

Text version of the timeline

MoCRA provisions and their status as of October 22, 2026
Provision	What it requires	Date	Status
Safety substantiation (§ 608; 21 U.S.C. 364d)	The responsible person must ensure, and keep records supporting, “adequate substantiation of safety.” A product without it is adulterated.	Dec 29, 2023	Statute in effect
Serious adverse-event reporting (§ 605; 21 U.S.C. 364a)	Report serious adverse events to FDA within 15 business days with a copy of the label; report new medical information received within a year; keep records for 6 years (3 for certain small businesses).	Dec 29, 2023	Statute in effect
Facility registration and product listing (§ 607; 21 U.S.C. 364c)	Manufacturing and processing facilities register and renew every two years. The responsible person lists each product, with its ingredients, and updates annually.	Enforced from Jul 1, 2024	Statute in effect
Label contact information (§ 609(a))	Domestic contact information through which the responsible person can receive adverse-event reports.	Dec 29, 2024	Statute in effect
Records access and mandatory recall	FDA may access certain records, including safety records, and may order a recall if the responsible person refuses one, when statutory conditions are met.	MoCRA	Authority in effect
Good manufacturing practice (§ 606; 21 U.S.C. 364b)	FDA must issue GMP regulations for cosmetic facilities. Deadlines: proposed rule by Dec 29, 2024; final rule by Dec 29, 2025.	Deadlines passed	No proposed rule
Fragrance allergen labeling (§ 609(b))	FDA must identify fragrance allergens that require label disclosure. Proposed rule was due by Jun 29, 2024.	Deadline passed	No proposed rule
Asbestos testing for talc-containing cosmetics (§ 3505)	Proposed Dec 27, 2024 (89 FR 105490); withdrawn Nov 28, 2025 (90 FR 54603). FDA cited comments that “warrant further consideration and assessment.”	Nov 28, 2025	Withdrawn
PFAS report (§ 3506)	FDA's report on the use of PFAS in cosmetic products and associated risks.	Dec 29, 2025	Published

Explanation, details and sources

MoCRA was enacted on December 29, 2022 (Pub. L. 117-328). FDA calls it “the most significant expansion of FDA's authority to regulate cosmetics” since the FD&C Act was passed in 1938.

Exemptions

Small businesses are exempt from registration, listing and the future GMP rule, unless they make higher-risk product types

The exemption does not reach safety substantiation or adverse-event reporting.

Three questions decide the exemptions, and no exemption removes safety substantiation for a cosmetic that is not also a drugStatute

Sources: 21 U.S.C. 364h and 364i (Cornell LII, accessed Oct 22, 2026); FDA MoCRA page, “Exemptions.”

Text version of the decision path

§ 612 · 21 U.S.C. 364h

Small businesses

Responsible persons and facility owners with average U.S. cosmetic sales below $1,000,000 a year over the previous three years, adjusted for inflation, are “not subject to the requirements” of the GMP and registration-and-listing sections. The exemption never applies to anyone making:

products that regularly contact the mucous membrane of the eye;
injected products;
products intended for internal use;
products intended to alter appearance for more than 24 hours where consumer removal is not part of normal use.

Statute

§ 613 · 21 U.S.C. 364i

Products that are also drugs

A cosmetic product or facility that is also subject to the drug and device chapter of the FD&C Act is exempt from MoCRA's adverse-event, GMP, registration and listing, safety-substantiation and several other cosmetic provisions; drug requirements apply to it. A facility that also makes cosmetics that are not drugs stays covered for those products.

Statute

Safety substantiation

No specific test is required, but the evidence must give qualified experts a reasonable certainty that the product is safe as used

Experts must find the evidence sufficient for a reasonable certainty of safety; without it the product is adulteratedStatute and regulation FDA statement

Sources: 21 U.S.C. 364d (Cornell LII); 21 CFR 740.10 (eCFR); FDA, FDA Authority Over Cosmetics (content current as of Nov 18, 2025); FDA MoCRA page (content current as of Aug 10, 2026).

Text version of the figure

“Safe”

The product and its ingredients are “not injurious to users under the conditions of use prescribed in the labeling,” or under customary use. Minor, transient reactions or skin irritation in some users do not by themselves make a product injurious.

21 U.S.C. 364d(c)

No prescribed tests

FDA: “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” Animal testing is not required to market a cosmetic. Existing data on ingredients and similar formulations can be used.

FDA statement

Warning label

An ingredient or product whose safety was not adequately substantiated before marketing is misbranded unless it carries: “Warning—The safety of this product has not been determined.”

21 CFR 740.10

Explanation, details and sources

MoCRA defines “adequate substantiation of safety” as tests, studies, research, analyses or other evidence that qualified experts consider sufficient to support “a reasonable certainty that a cosmetic product is safe.”

Cosmetic or drug

Intended use decides whether a product is a cosmetic, a drug or both, and “cosmeceutical” has no legal meaning

Claims and context set the intended use; a product that is both a cosmetic and a drug must meet the drug requirementsStatute

Sources: 21 U.S.C. 321(g), (i) (Cornell LII); FDA, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) (content current as of Sep 11, 2024); FDA, “Cosmeceutical” (content current as of Feb 25, 2022).

Text version of the figure

Cosmetic · § 201(i)

Articles “intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

Statute

Drug · § 201(g)(1)

Articles intended to diagnose, cure, mitigate, treat or prevent disease, or “(other than food) intended to affect the structure or any function of the body.” The supplement structure/function safe harbor does not extend to cosmetics.

Statute

How FDA determines intended use, with FDA's examples of drug claims
How intended use is shown	FDA's examples of claims that make a product a drug
Claims in labeling, advertising, on the internet or in promotional materials Consumer perception and the product's reputation Ingredients with a well-known therapeutic use	Restoring hair growth Reducing cellulite Increasing or decreasing melanin production Regenerating cells

A product that is both a cosmetic and a drug, such as a sunscreen or an anti-dandruff shampoo, must meet the drug requirements, including drug CGMP (21 CFR Parts 210/211). FDA: “The term ‘cosmeceutical’ has no meaning under the law.” EUTECNIQ uses the word only, if at all, as industry vernacular with that caveat.

Cosmetic, drug or both? Sort FDA's own examples, then compare with FDA's answerFDA examples

A skin moisturizer

A cleansing shampoo

A product claimed to restore hair growth

A product claimed to reduce cellulite

A product claimed to increase or decrease melanin in the skin

A product claimed to regenerate cells

An antidandruff shampoo

A deodorant that is also an antiperspirant

A moisturizer marketed with sun-protection claims

FDA, “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” (content current as of September 11, 2024). A product that is both must meet the drug requirements.

EUTECNIQ uses “cosmeceutical” only, if at all, as industry vernacular, with FDA's caveat that it has no meaning under the law.

Labeling basics

A cosmetic label needs an identity statement, net quantity, the responsible firm, an ingredient list in descending order and MoCRA contact information

These are the core federal elements; specific product types carry additional warnings under 21 CFR Part 740.

Identity and net quantity go on the principal display panel; the ingredient list goes on an information panelRegulation

Sources: 21 CFR 701.3, 701.11, 701.12, 701.13, Part 740 (eCFR, current to Oct 21, 2026); FD&C Act § 609(a); 21 U.S.C. 379e; FDA, FDA Authority Over Cosmetics.

Text version of the label elements

Identity statementOn the principal display panel, in bold type (21 CFR 701.11)
Net quantity of contentsWeight, measure or count (21 CFR 701.13)
Name and place of businessManufacturer, packer or distributor (21 CFR 701.12)
Ingredient declarationDescending order of predominance; fragrance or flavor may be named as such (21 CFR 701.3)
Adverse-event contactDomestic contact for reports, since Dec 29, 2024 (FD&C Act § 609(a))
Color additivesOnly colors listed for that use; the one premarket approval cosmetics need (§ 721)

21 CFR 701.11 requires the identity statement in bold type on the principal display panel. 21 CFR 701.13 places the net quantity on the principal display panel, within the bottom 30 percent of its area. Under 21 CFR 701.3(b) the ingredient declaration may appear on any appropriate information panel. 21 CFR 701.12(a) requires the name and place of business to be stated conspicuously.

Proposed offering

EUTECNIQ proposes to support botanical cosmetic ingredients with characterization and safety-substantiation files

The responsible person owns the safety substantiation. EUTECNIQ's proposed role would be the scientific evidence behind it. See cosmetics and personal care.

EUTECNIQ would supply evidence; the responsible person would keep the substantiation and the MoCRA dutiesProposed service

Service design: EUTECNIQ proposal. Duties: 21 U.S.C. 364a, 364c, 364d.

Text version of the figure

EUTECNIQ would

Characterize botanical ingredients: identity, composition, contaminants
Review existing ingredient and formulation safety data and find gaps
Plan stability and compatibility studies
Assemble a safety-substantiation file the responsible person can keep
Flag claims that would make a product a drug

Proposed

Qualified partners would

Run irritation and sensitization testing, using validated non-animal methods where they fit
Run human use and patch studies under ethics oversight
Give legal opinions on product classification and labeling

External partner

EUTECNIQ does not claim

Compliance with a cosmetic GMP rule that does not yet exist
That registration or listing is an approval
Any cosmetic product, client or safety file to date

Limits

Manufacturing that EUTECNIQ might do in the future would be aligned with FDA's draft cosmetic GMP guidance and ISO 22716; the ISO reference is EUTECNIQ's choice, not an FDA requirement. Proposal

Developing a botanical cosmetic ingredient?

EUTECNIQ is in formation and welcomes early conversations with ingredient suppliers and brands about characterization and safety evidence.

Start a conversation Regulatory overview