化妆品 MoCRACosmetics · MoCRA

MoCRA 带来了什么What MoCRA Changed

2022 年《化妆品法规现代化法案》（MoCRA）是美国化妆品监管几十年来最大的一次改革：FDA 从 2024 年 7 月起正式执法，要求化妆品企业完成设施注册与产品列名。对中国出口企业来说，“只管发货” 的时代结束了。The 2022 Modernization of Cosmetics Regulation Act (MoCRA) is the biggest overhaul of US cosmetics regulation in decades: since July 2024, FDA enforces mandatory facility registration and product listing. For Chinese exporters, the “just ship it” era is over.

• ✓设施注册：Facility registration: 在美国生产、加工化妆品的境内外企业须向 FDA 注册设施。Domestic and foreign facilities manufacturing or processing cosmetics for the US must register with FDA.
• ✓产品列名：Product listing: 每个化妆品须向 FDA 列名，提交成分、品牌等信息。Each cosmetic product must be listed with FDA, with ingredients, brand, and related information.
• ✓美国代理人：US Agent: 境外企业注册时必须指定位于美国的代理人。Foreign companies must designate a US-based agent when registering.
• ✓持续义务：Ongoing duties: 注册与列名须及时更新；责任人须在 15 个工作日内向 FDA 报告严重不良事件。Registrations and listings must be kept current; responsible persons must report serious adverse events to FDA within 15 business days.

标签与成分合规Labeling & Ingredient Compliance

注册只是入场券，标签与成分才是日常检查的重点：Registration is just the ticket in — labels and ingredients are what day-to-day checks focus on:

• 按 21 CFR Part 701：成分表（INCI 名称、降序排列）、净含量、警示语、制造商信息缺一不可。Per 21 CFR Part 701: ingredient declaration (INCI names, descending order), net quantity, warning statements, and manufacturer information are all required.
• 禁用 / 限用成分核查，避免用到 FDA 禁止或限量的物质。Screening for prohibited / restricted ingredients to avoid substances FDA bans or limits.
• 安全佐证（safety substantiation）：企业须能证明产品在常规使用下安全。Safety substantiation: companies must be able to support that the product is safe under customary use.

化妆品 vs 药品：一条线要分清Cosmetics vs. Drugs: Know the Line

在美国，产品按“宣称与用途”归类，不按你的叫法。宣称祛痘、美白、防晒（SPF）、止汗除臭等功效的产品，可能被归为药品（OTC），走完全不同的监管路径。In the US, products are classified by claims and intended use — not by what you call them. Products claiming acne treatment, whitening, sun protection (SPF), or antiperspirant effects may be regulated as drugs (OTC), under a completely different pathway.

• 防晒、祛痘、止汗类产品：多为 OTC 药品，须做药品企业注册与药品列名。Sunscreen, acne, antiperspirant products are often OTC drugs requiring drug establishment registration & listing.
• 普通护肤、彩妆、护发：按化妆品走 MoCRA。General skincare, color cosmetics, hair care: MoCRA cosmetics pathway.
• 拿不准？先做品类判定——这是我们咨询的第一步，也是免费的。Not sure? Start with a category determination — the first step of our consultation, and it's free.

这项服务包含什么What's Included in This Service