1. Facility Registration and Codes

A facility under MoCRA is any physical building or plant where bulk cosmetic ingredients are transformed into finished products, meaning where products are formulated, mixed, compounded, or filled into primary containers.

· Manufacturing: Combining raw ingredients (e.g., mixing oils, water, and emulsifiers to create a batch of lotion; blending pigments and binders for lipstick).

· Processing: Altering, refining, or treating bulk cosmetic material (e.g., homogenizing, filtering, or bulk blending).

· Filling (Critical Line): Putting bulk product into its primary container (e.g., pouring shampoo into bottles, pressing powder into compacts, filling tubes with lip balm). Under the law, filling is legally defined as manufacturing, not packaging.

a. Statutory Definition of "Facility"

Primary Citation: FD&C Act § 604(3) [Codified at 21 U.S.C. § 364(3)]

General Definition: 21 U.S.C. § 364(3)(A) defines a facility as any establishment (including an establishment of an importer) that manufactures or processes cosmetic

products distributed in the United States.

b. Clarification on Filling:

21 U.S.C. § 364(3)(C) establishes that packaging or repackaging does not include filling a container with a cosmetic product (i.e., container filling is legally classified as

manufacturing/processing).

A. Statutory Exemptions & Exclusions

• Entity Type Exclusions (21 U.S.C. § 364(3)): Establishments solely performing secondary labeling, relabeling, packaging, holding, or distribution are not facilities. Salons, retailers, pharmacies, and direct-to-consumer individual home crafters are also excluded.

• Small Business Exemption (§ 612(b)): Facility owners/operators with average gross annual U.S. sales of cosmetics under $1,000,000 (previous 3-year average) are exempt from facility registration.

• Exemption Voided (High-Risk Products): Small businesses must register if they manufacture:

  • Products contacting the mucus membrane of the eye (e.g., mascara, eyeliner).

• Injected cosmetic products.

  • Internal use products (e.g., mouthwashes).

  • Products intended to alter appearance for more than 24 hours under customary use.

B. Submission Deadlines & Renewal Rules

• New Facilities: Must submit registration within 60 days of beginning manufacturing or processing operations.

• Updates: Must notify FDA within 60 days of any change to previously submitted registration information.

• Biennial Renewal: Registration must be renewed every 2 years from the initial registration date. FDA permits an "abbreviated renewal" if no information has changed.

C. Technical Requirements & Identifiers

• FDA Establishment Identifier (FEI): A valid FEI number is required prior to submitting the registration.

• Submission Mechanism: Submitted electronically via FDA Cosmetics Direct (Structured Product Labeling / SPL format) or via paper Form FDA 5066.

• Required Data Points: Facility legal name, physical address, email, phone number, FEI number, all brand names manufactured at the site, cosmetic product categories produced, and designated U.S. Agent details (for foreign facilities).

D. Enforcement Risk

• Prohibited Act (§ 301(hhh)): Failure to register a facility under § 607 is a prohibited act under federal law.

• Registration Suspension (§ 607(f)): FDA has the authority to suspend a facility's registration if a manufactured product presents a reasonable probability of causing serious adverse health consequences or death, barring the facility from distributing any cosmetics in interstate commerce.

2. Ingredient Review & Safety Substantiation

Under MoCRA, placing a cosmetic on the market requires verifying that every raw ingredient is legally permissible, properly named, toxicologically substantiated for safety, and compliant with mandatory restriction lists.

A. Ingredient Safety Substantiation Mandate

• Primary Citation: FD&C Act § 608 [Codified at 21 U.S.C. § 364d]

• Legal Standard (§ 364d(a)): The Responsible Person (RP) must ensure and hold records proving that there is adequate substantiation of safety for each cosmetic product prior to commercial distribution.

• Definition of Adequate Substantiation (§ 364d(c)): Tests, studies, research, analyses, or other evidence considered by qualified experts to evaluate the safety of the product and its ingredients, establishing that the cosmetic product is safe under customary or intended conditions of use.

• Adulteration Hook (§ 364d(b)): A cosmetic lacking adequate safety substantiation is deemed adulterated under FD&C Act § 601 [21 U.S.C. § 361].

B. Standardized Nomenclature & Disclosure Rules

• Primary Citation: FD&C Act § 607(c)(4)(A)(v) [21 U.S.C. § 364c(c)(4)(A)(v)] & 21 CFR § 701.3

• INCI Standard: All ingredients on product listings and retail labels must be identified by their common chemical or International Nomenclature of Cosmetic Ingredients (INCI) name under 21 CFR § 701.30.

• Descending Order of Predominance: Ingredients present at concentrations greater than 1% must be listed in descending order of predominance. Ingredients at or below 1%, as well as color additives, may be listed in any order at the end (21 CFR § 701.3(a)).

• Fragrance Allergen Disclosure (FD&C Act § 609(b) [21 U.S.C. § 364e(b)]): Responsible Persons must identify mandatory fragrance allergens on retail labels in accordance with FDA final regulations, ending the blanket use of the word "Fragrance" to conceal identified allergenic compounds.

C. Prohibited & Restricted Ingredients in Cosmetics Cosmetics cannot contain ingredients banned or restricted under 21 CFR Part 700, Subpart B:

• 21 CFR § 700.11: Bithionol

• 21 CFR § 700.13: Mercury compounds (restricted except specific eye-area preservative exceptions at <65 ppm)

• 21 CFR § 700.14: Vinyl chloride (propellant)

• 21 CFR § 700.15: Halogenated salicylanilides

• 21 CFR § 700.16: Chloroform

• 21 CFR § 700.18: Methylene chloride

• 21 CFR § 700.19: Hexachlorophene

• 21 CFR § 700.23: Chlorofluorocarbon (CFC) propellants

• 21 CFR § 700.27: Prohibited cattle materials (BSE/TSE risk materials)

• MoCRA § 3506: Mandates FDA assessment of the safety and use of Per- and Polyfluoroalkyl Substances (PFAS) in cosmetics.

D. Color Additive Compliance & Certification

• Primary Citation: FD&C Act § 721 [Codified at 21 U.S.C. § 379e] & 21 CFR Parts 70–82

• Strict Pre-Market Approval: Unlike standard cosmetic ingredients, no color additive may be used in a cosmetic unless it is explicitly approved by the FDA for that specific area of application (e.g., eye area, lips, general body).

• Batch-Certified Colors (21 CFR Part 74 & Part 82): Synthetically derived colors (e.g., FD&C Red No. 40, D&C Yellow No. 10) require physical FDA batch certification and must carry an assigned FDA lot certification number.

• Exempt from Certification (21 CFR Part 73): Naturally derived colorants (e.g., titanium dioxide, iron oxides, mica, caramel) do not require individual lot testing by the FDA but must still strictly meet statutory purity, heavy metal, and identity specifications.

E. Technical Safety Dossier Components To satisfy § 608 requirements during an FDA audit or retail onboarding review, an ingredient safety file must contain:

• Raw Material Documentation: Certificate of Analysis (CoA), Safety Data Sheet (SDS), and technical specifications for each incoming raw ingredient.

• Toxicological Risk Assessment (TRA): Margin of Safety (MoS) calculations, systemic exposure dosage (SED) modeling, and no-observed-adverse-effect levels (NOAEL) based on established toxicological literature (e.g., Cosmetic Ingredient Review / CIR monographs).

• Preservative Efficacy Testing: Verification of microbiological stability via USP <51> Antimicrobial Effectiveness Testing (for aqueous formulas).

• Finished Product Stability & Compatibility: Accelerated and real-time physical/chemical stability testing ensuring formula-packaging compatibility and absence of phase separation, degradation, or leaching.

3. Cosmetic Product Listing

Under MoCRA, the Responsible Person (RP)—the entity whose name appears on the product label—must register every cosmetic SKU distributed in the U.S. with the FDA.

• Primary Citation: FD&C Act § 607(c) [21 U.S.C. § 364c(c)]

• Mandatory Data Points:

  • Facility FEI: The active FDA Establishment Identifier of every physical manufacturing and filling site.

  • Product Identification: Commercial product name, cosmetic category code, and full ingredient deck (INCI nomenclature).

  • RP Details: Legal name and contact information matching the retail label.

• Flexible Grouping (§ 364c(c)(4)(B)): Products with identical base formulations that differ only by shade/color, fragrance, flavor, or net contents may be submitted under a single grouped listing.

• Deadlines & Maintenance:

  • New Products: File within 120 days of entering interstate commerce.

  • Annual Updates: Review and update listings annually; abbreviated renewals are permitted if formulas and sites remain unchanged.

• Small Business Exemption: Entities under $1,000,000 in gross annual 3-year average U.S. sales are exempt (unless manufacturing high-risk products: eye-area, injectables, internal use, or 24+ hour appearance-altering formulas).

4. Serious Adverse Event Reporting & Recordkeeping

MoCRA establishes mandatory electronic reporting and documented recordkeeping protocols for significant health-related incidents.

• Primary Citation: FD&C Act § 605 [21 U.S.C. § 364a]

• Definition of "Serious Adverse Event" (§ 364a(a)): An event resulting in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, infection, or significant disfigurement (including serious burns, severe rashes, or extensive hair loss).

• Mandatory Submission Window: The RP must submit a report to the FDA via MedWatch Form FDA 3500A (with a copy of the product label) within 15 business days of receipt.

• Follow-Up Period: Any new medical information received regarding a previously reported event within 1 year must be submitted to the FDA within 15 business days.

• Record Retention (§ 364a(e)):

  • Standard: Retain all adverse event records (serious and non-serious) for 6 years.

  • Small Businesses: Retain for 3 years.

  • FDA Audit Access: Records must be made available to FDA personnel during routine inspections.

5. Labeling & Disclosure Requirements

MoCRA updates packaging mandates to improve adverse-event intake transparency, require fragrance allergen declarations, and govern salon-grade items.

• Primary Citation: FD&C Act § 609 [21 U.S.C. § 364e]

• Domestic Contact Point (§ 364e(a)): Every retail container must bear a domestic street address, domestic phone number, or direct electronic contact info (website URL/email) for consumers to report adverse reactions.

• Fragrance Allergen Disclosures (§ 364e(b)): Labels must disclose specific designated fragrance allergens once FDA finalizes the federal allergen list and concentration thresholds (ending the blanket term "Fragrance" for listed substances).

• Professional-Use Only Products (§ 364e(c)):

  • Products formulated solely for licensed professionals (cosmetologists, estheticians, barbers) must state clearly on the packaging: "For Professional Use Only" or "To be administered only by licensed professionals."

  • Professional products must still provide a complete ingredient declaration under 21 CFR § 701.3.

• Misbranding Hook (FD&C Act § 602(j) [21 U.S.C. § 362(j)]): Any cosmetic failing to meet § 609 labeling rules is legally misbranded, subjecting the inventory to commercial detention, seizure, or import refusal.