FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.

Recently, the National Medical Products Administration (NMPA) discovered that Japan HOYU Limited had violated the requirements of the Cosmetics Supervision and Administration Regulations (CSAR) and the Measures for the Supervision and Administration of Cosmetics Production and Operation in an unannounced inspection. The enterprise has changed the production process of its products without obtaining the authorisation, and is suspected of not producing cosmetics in accordance with the technical requirements stated in the cosmetics registration documents.

To implement the Cosmetics Supervision and Administration Regulations (CSAR) and the Measures for the Supervision and Administration of Cosmetics Production and Operation, the National Medical Products Administration (NMPA) has organized to draft the Measures for the Administration of Cosmetics Inspection and released it for public consultation. Any comments are welcomed between October 19 and November 10, 2023.

The US Food and Drug Administration has published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetic product facility registrations and product listings are now included within the SPL framework. The Implementation Guide can be used to develop SPL authoring tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software including Xforms, for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

On September 22, 2023, the Scientific Committee on Consumer Safety (SCCS) issued a final opinion on methyl salicylate to assess its safety and use in cosmetics. In the SCCS/1633/21 Opinion, the Committee concluded that Methyl Salicylate (CAS No.119-36-8) in toothpaste is safe for children under six years of age when used up to the maximum concentration of 2.52%.

On August 2, 2023, the Indonesian Food and Drug Administration (Badan Pengawas Obat dan Makanan, BPOM) published Regulation No. 17 of 2023 on the Product Information File (PIF) guidelines for cosmetics, which came into effect from the date of publication. Parties that obtain product notification codes before August 2, must update PIF within six months. The PIF should be prepared by cosmetic manufacturers and importers and should be submitted to the BPOM before products obtain market authorization.

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

On July 20, 2023, the United Kingdom issued the Cosmetic Products (Restriction of Chemical Substances) Regulations 2023 (No. 836 of 2023), to revise the requirements for the use of Methyl-N-methylanthranilate (CAS No. 85-91-6), HAA, and HAA (nano) (CAS No. 919803-06-8). This regulation applies to England, Wales, and Scotland.