3行サマリー

  1. 米国のModernization of Cosmetics Regulation Act of 2022 (MoCRA)で10件の改定を検知。
  2. 施行日は原典で要確認。
  3. 対象成分を配合する製品の薬事担当は新旧対照表と原典の確認を推奨。

改定内容の詳細(新旧対照)

対象 区分 旧 新 条件
要求事項 改定 — — If FDA determines there is a reasonable probability that a cosmetic is adulterated or misbranded and use will cause serious adverse health consequences or death, FDA can order a mandatory recall if the responsible person refuses to do so voluntarily.
要求事項 改定 15 business days 15 business days A responsible person must report serious adverse events associated with cosmetic products in the US to FDA within 15 business days, including a copy of the retail packaging label. New information received within 1 year of initial report must also be submitted within 15 business days.
要求事項 改定 Renewal every two years renew every 2 years Manufacturers and processors must register their facilities with FDA and renew registration every two years. FDA may suspend a facility's registration under certain conditions.
要求事項 改定 Annual updates annual updates A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide updates annually.
要求事項 改定 — — A responsible person must ensure and maintain records supporting adequate safety substantiation of their cosmetic products. No specific tests required; animal testing not required; data must be derived from scientifically robust methods.
要求事項 改定 — — FDA to establish Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products.
要求事項 改定 — — FDA to establish fragrance allergen labeling requirements.
Talc 新規 — — FDA to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Proposed Rule December 2024; Withdrawal November 2025.
要求事項 改定 — — Certain small businesses are exempt from GMP, registration, and product listing requirements. Exemptions do not apply to products that contact mucus membrane of the eye, are injected, intended for internal use, or intended to alter appearance for more than 24 hours where removal is not part of usual conditions of use.
Talc 削除 — — FDA is required to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Proposed rule published December 2024; withdrawn November 2025.

影響を受ける成分リスト

INCI名 日本表示名称 中国語名称
Talc タルク 滑石粉
Talc タルク 滑石粉

実務上の対応ポイント

  • 施行日は未確定です。原典の続報をウォッチしてください。

原典

  • 米国 FDA MoCRA
  • 機械抽出根拠: スナップショット #71(取得 2026-08-11T21:56:59.698853Z、検知差分 10件)

本記事は一次ソースの機械抽出データから自動生成されています(人間レビュー済み)。法規情報は参考情報であり、実務上の最終確認は必ず原典および専門家にてお願いします。誤りにお気づきの場合は訂正報告フォームからご連絡ください。