On September 20, 2024, the European Commission (EC) updated Regulation (EU) 2024/2462 concerning perfluorohexanoic acid (PFHxA), its salts, and related substances.  Since 2019, Germany has proposed concentration limits for PFHxA. PFHxA is a substance used across various industries and is highly persistent, posing unacceptable risks to health and the environment. As a result, the regulation on th..

On October 30, 2024, a Q&A was published regarding a gradual roll-out of Eudamed, to obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices, in connection with Article 10a inserted in (EU) 2024/1860 (amended on June 30, 2024). This Q&A concerns the obligation to notify the discontinuation or inter..

On November 4, 2024, China’s National Medical Products Administration (NMPA) approved the registration of a new cosmetic ingredient, Isobutylamido Thiazoyl Resorcinol (Thiamidol 630).  This ingredient is the first to be registered since the implementation of the Cosmetics Supervision and Administration Regulation (CSAR) in 2021. It has been verified for its efficacy and safety by the registratio..

The Therapeutic Goods Administration (TGA) of Australia implemented the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.2) 2024 on September 18, 2024.  This amendment modifieds the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018 (“the Principal Determination”..

The Hong Kong Medical Device Division (MDD) has implemented the Medical Device Administrative Control System (MDACS) to regulate medical devices, including operating a device registration system and an adverse event reporting system.  On September 30, 2024, the MDD updated Sections 5.14 and 5.15 in the Guidance (GN-01) on the Overview of the Medical Device Administrative Control System (MDACS), ..

On October 30, 2024, the National Medical Products Administration (NMPA) of China updated the Safety and Technical Standards for Cosmetics (2015). The update includes the addition of five testing methods, one of which is for the “Test Methods for Azelaic Acid and its Salts in cosmetics”These new and revised standards are now incorporated into the 2015 edition of the Safety and Technical Standard..

When a holder of a manufacturing or import license for a medical device wishes to transfer the license to another company, the transfer of the license may be required.  The Thai Food and Drug Administration (TFDA) updated the guidelines for the transfer of medical device licenses for manufacturer and importers on September 19, 2024.  For medical devices that do not require expert review for appr..

On September 24, 2024, the Thai FDA updated its cosmetics advertising guidelines to provide oversight and regulatory direction for cosmetics advertising management, in accordance with the 2015 Cosmetics Act.  The 2024 revised guidelines comprehensively cover topics related to cosmetics advertising, including the definition of cosmetics advertisements, relevant advertising laws, principles for co..

2024年10月14日、英国OPSSで発表された内容によると、化粧品に使用が禁止された「リリアル(Lilial)」成分が含まれたすべての化粧品を廃棄および禁止以後に販売された製品をリコールを考慮することを含みます リリアル(Lilial、Butylohenyl methylpropional)でユリの香りがする香料としてシャンプー、香水、ボディ製品などに使用されてきましたが、生殖毒性、内分泌系の撹乱などで安全性の問題に影響を及ぼすことが知られています。 これに伴い、国内食品医薬品安全処もリリアルの安全性問題を認識し、危害評価結果により原料使用基準を強化しており、該当内容は『化粧品安全基準等に関する規定』改正案(2024年8月2日行政予告)にその使用限度を全含量の0.14%に制限している内容を含んでいます。 食品医薬品安全処は行政予告を通じて意見収斂後、後続手続きを経て告示改正を完了する..

カナダ保健省(HC; Health Canada)は化粧品成分公開に関する一部規定を改正する規定(SOR/2024-63)を2024年4月24日に発表し、10月9日に発効しました。 化粧品業界のすべての利害関係者に影響を与える可能性のある規制要件の調整を含んでおり、当該規定の検討が必要です。 改正された規定は、化粧品に対するラベルの要件を強化し、化粧品ラベルに特定の香料アレルギーを表示するように要求します。 主な改正内容は以下の通りです。  1. 化粧品ラベルに特定香水アレルギー誘発物質を開示（平成26年4月12日発酵） 2. 小型包装販売化粧品の成分公開に対する柔軟性拡大 3. 化粧品監督の改善など 化粧品ラベルに特定の香水アレルギー誘発物質を公開するよう求める規定は、2年後に発効します。 EU転換期間が含まれることにより、新製品は2026年8月1日から化粧品ラベルに香料アレルギー誘..