Why Cosmetics FBA Compliance Is Non-Negotiable (And Costly to Ignore)

• FBA Shipment Rejection: Amazon’s warehouse teams inspect cosmetics for compliance markers (e.g., FDA labels, CE marking). Missing or incorrect documentation will result in instant rejection, forcing you to reroute inventory at high cost.
• Customs Holds & Fines: US CBP and EU Customs target cosmetics shipments for ingredient and labeling checks. Non-compliant products may be seized, with fines ranging from $1,000 (EU) to $100,000 (US) for serious violations.
• Seller Account Suspension: Amazon’s A-to-z Guarantee prioritizes consumer safety—repeat compliance issues can lead to permanent account suspension, wiping out your FBA revenue stream.
• Legal Liability: If non-compliant cosmetics cause skin irritation or harm, you may face lawsuits from consumers or regulatory action from authorities like the FDA.

US Cosmetics FBA Compliance Requirements (FDA Regulations)

1. Ingredient Compliance & Prohibited Substances

• FDA-Approved Ingredients: All ingredients must be on the FDA’s “Generally Recognized as Safe and Effective” (GRASE) list. Prohibited substances (e.g., mercury, chloroform, certain color additives) are strictly banned.
• Fragrance Disclosure: If your product contains fragrance, you must list it as “fragrance” or “parfum” on the ingredient label (the FDA does not require disclosure of individual fragrance components).
• SPF Claims (If Applicable): Cosmetics with sunscreen claims (e.g., “SPF 30 moisturizer”) are classified as “drug-cosmetics” and require additional FDA approval. You must submit a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) before selling.

2. Labeling Requirements for US FBA Cosmetics

• Principal Display Panel (PDP): A clear, visible panel with the product name, net quantity (e.g., “100mL”), and intended use (e.g., “facial moisturizer”).
• Information Panel: Includes ingredient list (in descending order of weight), manufacturer/distributor name and address, and warning statements (e.g., “For external use only,” “Avoid contact with eyes”).
• Batch/Lot Code: A unique code to track production batches—critical for recalls and Amazon’s quality control checks.
• FBA Shipment Labels: Standard FBA labels (shipment ID, SKU, carton label) must be affixed to every package, without covering FDA-required information.

3. Documentation for US FBA Shipments

• Certificate of Analysis (CoA): A lab report confirming ingredient safety and compliance with FDA standards. Amazon may request this at any time.
• Commercial Invoice: Clearly lists product details (name, quantity, value), ingredient summary, and FDA compliance statement (e.g., “All ingredients comply with FDA 21 CFR 700-740”).
• CPSIA Compliance (If Applicable): Cosmetics intended for children under 12 must meet CPSIA lead and phthalate limits, with a Children’s Product Certificate (CPC) on file.

EU Cosmetics FBA Compliance Requirements (Regulation (EC) No 1223/2009)

1. Ingredient Compliance & CPNP Notification

• EU Ingredient Restrictions: The EU prohibits over 1,300 substances in cosmetics (more than the US) and restricts hundreds more (e.g., parabens, certain UV filters). All ingredients must be listed in the EU’s CosIng database.
• CPNP Notification: Before placing any cosmetic product on the EU market (including FBA), you must notify the European Commission’s Cosmetic Products Notification Portal (CPNP). This includes details on ingredients, packaging, and manufacturer information. Notification is free but mandatory—non-compliance leads to shipment seizure.
• Nano Ingredients: If your product contains nano ingredients (e.g., nano zinc oxide in sunscreen), you must declare them in the CPNP and on the product label.

2. Labeling Requirements for EU FBA Cosmetics

• CE Marking: Indicates compliance with EU Cosmetics Regulation (not required for US imports, but mandatory for EU-manufactured products).
• Ingredient List: In descending order of weight, using INCI (International Nomenclature of Cosmetic Ingredients) names. Fragrance components that are potential allergens (e.g., limonene, linalool) must be listed if they exceed 0.001% (leave-on products) or 0.01% (rinse-off products).
• Batch/Lot Code & Expiry Date: Batch code for tracking, plus expiry date (e.g., “EXP 12/2026”) or period-after-opening (PAO) symbol (a jar icon with a number, e.g., “6M” for 6 months after opening).
• Responsible Person Information: Name and address of the EU-based responsible person (mandatory for non-EU sellers shipping to EU FBA). This person is liable for compliance and must be reachable by authorities.

3. Documentation for EU FBA Shipments

• Certificate of Compliance (CoC): Confirms the product meets EU Cosmetics Regulation requirements. Must be issued by the manufacturer or EU responsible person.
• CPNP Notification Confirmation: A copy of the CPNP notification receipt—customs and Amazon may request this during inspection.
• REACH Compliance: Ensure ingredients comply with REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations, which restricts hazardous substances in consumer products.

Common Cosmetics FBA Compliance Pitfalls to Avoid

• Ignoring Regional Ingredient Differences: An ingredient approved in the US (e.g., certain parabens) may be banned in the EU. Never assume compliance transfers between markets.
• Missing Expiry/PAO Labels: EU authorities and Amazon strictly enforce expiry date requirements—missing or incorrect PAO symbols are a top cause of shipment rejection.