What US federal law actually prohibits in cosmetics: 21 CFR Part 700 Subpart B and MoCRA

US federal law does not maintain a list of thousands of restricted cosmetic ingredients the way the EU does. Instead, the Food and Drug Administration relies on a general safety and adulteration standard, a short list of explicit ingredient prohibitions, a much larger set of color additive regulations, and a separate drug framework for sunscreens. This article walks through each mechanism using the primary texts, plus what the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added on top of them.

cosingchecker.com/regulations/us/ currently holds 99 published US records. That figure is not a count of "banned ingredients": it is the number of individual 21 CFR sections the site has imported and source-validated against eCFR — 9 of them are the outright prohibitions in Part 700 Subpart B, and the remaining roughly 90 are color additive regulations in Parts 73, 74 and 82. An imported record is identity evidence that a rule exists and what it says, not permission to use a substance, and the absence of a US record for a given ingredient is not proof it is allowed.

The short list: 21 CFR Part 700 Subpart B

Subpart B of Part 700 ("Requirements for Specific Cosmetic Products") is the closest thing US federal law has to an EU-style prohibited list, and it is genuinely short. As reflected in the site's imported and source-validated US records, it currently contains nine operative sections:

That is the entire list of ingredient-level prohibitions written directly into the cosmetics regulations. Everything else in US cosmetic law is either a labeling requirement, a color additive rule, or the general prohibition on marketing an "adulterated" or "misbranded" cosmetic under the Federal Food, Drug, and Cosmetic Act — a standard that FDA and courts apply case by case rather than through a pre-cleared ingredient list.

Color additives are the real pre-market gate

Unlike other cosmetic ingredients, color additives used in the US must be affirmatively listed by FDA before use, under 21 CFR Parts 73 (color additives exempt from certification), 74 (color additives subject to certification) and 82 (straight colors). Parts 74 and 82 additives require batch certification: FDA must certify each production batch before it can be used. Part 73 additives — mineral pigments such as titanium dioxide, iron oxides and mica, plus a set of plant and other exempt colors — are listed with conditions but do not require batch-by-batch certification.

This is why most of the site's US records are not prohibitions at all: entries such as 21 CFR 73.2575 (titanium dioxide), 73.2991 (zinc oxide) or 74.2101 (FD&C Blue No. 1) are positive-list permissions with specific identity, use and labeling conditions attached — for example, titanium dioxide under 73.2575 is permitted for general cosmetic coloring, including eye-area use, subject to identity and specification requirements, while a listing like D&C Red No. 6 (74.2306 / 82.1306) is permitted only in specified product types at specified concentrations. Color additive status has to be checked ingredient by ingredient; there is no single blanket rule.

Sunscreens are not cosmetics under US law

A product that makes a sun protection factor (SPF) claim is regulated in the US as an over-the-counter drug, not a cosmetic, under 21 CFR Part 352 (Sunscreen Drug Products for Over-the-Counter Human Use). This is a structural difference from the EU, where UV filters are cosmetic ingredients listed with conditions in Annex VI of Regulation (EC) 1223/2009 — the site currently holds 33 Annex VI entries, covering filters such as octocrylene, ethylhexyl methoxycinnamate and titanium dioxide used specifically as a UV filter. In the US, the same active ingredients are evaluated and monographed as drug actives, with separate labeling, testing and manufacturing requirements that sit entirely outside the cosmetic rules discussed above. A moisturizer with SPF and a plain moisturizer are regulated under different legal frameworks even if the formulas are similar.

What MoCRA actually changed

MoCRA, enacted December 29, 2022 as part of the Consolidated Appropriations Act, 2023, gave FDA new administrative authority over cosmetics without creating an EU-style pre-market approval list. Its main operative pieces, and their status as of this writing:

• Facility registration: manufacturers and processors of cosmetic products for the US market must register facilities with FDA and renew every two years. FDA delayed enforcement of the initial registration and listing requirements to July 1, 2024.
• Product listing: a "responsible person" must list each marketed cosmetic product with FDA, including its ingredients, and update the listing at least annually. Small businesses under MoCRA's revenue threshold are exempt from both registration and listing, except for products that regularly contact the mucous membrane of the eye, injected products, products for internal use, and products intended to alter appearance for more than 24 hours - those are covered whatever the size of the business.
• Adverse event reporting: responsible persons must report serious adverse events to FDA within 15 business days of receipt, and must forward related new medical information received within one year of the initial report within another 15 business days.
• Safety substantiation: responsible persons must maintain records supporting a reasonable basis for concluding the product is safe; MoCRA does not mandate specific tests or animal testing methods.
• Fragrance allergen labeling: MoCRA directed FDA to propose a rule requiring disclosure of fragrance allergens on cosmetic labels by June 29, 2024. FDA missed that statutory deadline, and no proposed rule had been published as of this writing. The target date has moved more than once; the Unified Agenda entry for this rulemaking (RIN 0910-AI90) carries the current one.
• Talc/asbestos testing methods: FDA published a proposed rule on standardized testing methods for asbestos in talc-containing cosmetics on December 27, 2024, then withdrew that proposal on November 28, 2025, citing the complexity of the comments received, while stating it intends to issue a new proposed rule to meet MoCRA's underlying statutory obligation.

None of this changes the Part 700 Subpart B prohibition list or the color additive framework described above — MoCRA is a registration, reporting and record-keeping regime layered on top of the existing prohibition and color-additive rules, not a replacement for them.

Contrast with the EU's Annex II

The structural difference between the two systems is the point. The EU's Cosmetics Regulation prohibits substances by adding them to Annex II, a single running list that the site currently tracks at 1,739 entries (cosingchecker.com/annex/II/), covering everything from CMR substances carried over from other EU chemical law to individually assessed cosmetic ingredients. US federal law has no equivalent negative list of comparable scope: the nine Part 700 Subpart B prohibitions are it. A substance can be absent from both the US prohibition list and any FDA color additive listing and still not be lawfully usable in a US cosmetic, because the underlying legal test is the FD&C Act's general adulteration and misbranding standard, not membership on a specific list. That is a materially different compliance exercise from checking a substance against Annex II, and the two cannot be read as equivalent coverage. cosingchecker.com/market-divergence/ tracks where jurisdictions diverge on the same substance for exactly this reason.

What this means in practice

For a formulator checking US eligibility, three separate questions have to be answered, not one: does the substance appear in the Part 700 Subpart B prohibition list; if it is a color additive, is it listed in Parts 73/74/82 with matching identity, product-type and concentration conditions, including certification if required; and if the product carries an SPF claim, is the relevant active listed in the Part 352 OTC monograph rather than treated as a cosmetic ingredient at all. A clean answer on one of these does not settle the others, and none of them substitutes for the FD&C Act's general safety standard, which FDA and courts can apply to a substance that appears on no list at all. State law can layer further restrictions on top of the federal framework; verify any specific state requirement against that state's own current text before relying on it, since this article does not attempt to catalogue them.