Mandatory GRAS notifications likely coming – here’s what you need to know!
Mandatory US FDA GRAS Notifications – the US FDA has signaled a major shift: moving the GRAS pathway from voluntary notification to mandatory notification. In its Spring 2025 Unified Agenda, FDA previewed a proposed rule that would require companies to submit notices—and safety data—whenever they conclude a substance is GRAS for use in human or […]
DEA and Prop 65: What 1,211 Notices of Violation Say About Cosmetic Compliance Risks
Over the last 16 months, 1,211 Notices of Violation (NOVs) have been issued under California’s Proposition 65 (Prop 65) for cosmetic and personal care products in relation to Diethanolamine (DEA)—a chemical listed by the state as a carcinogen. This volume of enforcement highlights a serious and ongoing compliance issue that many companies in the cosmetics […]
미국 화장품 MOCRA 서비스 (해외 기업을 위한 서비스)
미국에서 판매되는 화장품에 대한 새로운 요구 사항 이전에 논의한 바와 같이, 미국에서 판매되는 모든 화장품에 대한 새로운 요구 사항이 있습니다 화장품 회사는 미국 FDA에 시설을 등록하고 제품 유형과 구성 정보를 포함한 모든 제품 목록을 업로드해야 합니다 이러한 요구 사항은 미국 외부에 위치한 회사에도 적용되지만, 이들 회사는 중개자로서 미국 대리인을 지정해야 합니다 이 규정은 기타 새로운 […]
Servicios de MOCRA de Cosméticos en EE. UU. para Empresas Extranjeras
Nuevos Requisitos para Productos Cosméticos Vendidos en EE. UU. Como discutimos en una actualización anterior, hay nuevos requisitos para todos los cosméticos vendidos en EE. UU. Las empresas cosméticas deben registrar sus instalaciones ante la FDA de EE. UU., así como subir un listado de todos los productos que incluya el tipo de producto y […]
Services MOCRA de cosmétique américaine pour les entreprises étrangères
Nouvelles exigences pour les produits cosmétiques vendus aux États-Unis Comme nous l’avons discuté dans une mise à jour précédente, il y a de nouvelles exigences pour tous les cosmétiques vendus aux États-Unis. Les entreprises cosmétiques doivent enregistrer leurs installations auprès de la FDA américaine, ainsi que télécharger une liste de tous les produits comprenant le […]
US-Kosmetik MOCRA-Dienste für ausländische Unternehmen
Neue Anforderungen für in den USA verkaufte Kosmetikprodukte Wie wir in einem früheren Update besprochen haben, gibt es neue Anforderungen für alle in den USA verkauften Kosmetika. Kosmetikunternehmen müssen ihre Einrichtungen bei der US-amerikanischen FDA registrieren sowie eine Liste aller Produkte hochladen, die den Produkttyp und die Formulierung umfasst. Diese Anforderungen gelten auch für Unternehmen […]
Servizi MOCRA di Cosmetici USA per Aziende Straniere
Nuovi Requisiti per i Prodotti Cosmetici Venduti negli Stati Uniti. Come abbiamo discusso in un aggiornamento precedente, ci sono nuovi requisiti per tutti i cosmetici venduti negli Stati Uniti. Le aziende cosmetiche devono registrare i loro stabilimenti presso la FDA degli Stati Uniti e caricare un elenco di tutti i prodotti che includono il tipo […]
US Cosmetic MOCRA Services for Foreign Companies
New Requirements for Cosmetic Products Sold in the U.S. As we discussed in a previous update, there are new requirements for all cosmetics sold in the U.S. Cosmetic companies must register their facilities with the US FDA, as well as upload a listing of all products consisting of the type of product and formulation. These […]
California Cosmetic Regulations: CPSA and CFFIRKA
Many cosmetics companies are familiar with the need to comply with California Proposition 65 regulations for their products, but are you aware of the the over-arching and new regulations that apply to cosmetics sold in California? The California Safe Cosmetics Act of 2005 (CSCA) requires manufacturers, packers, and/or distributors of cosmetic products to report to […]
New US FDA MOCRA Update for Cosmetics (September 2023)
The US FDA has published new information regarding the MOCRA facility registration and product listing requirements, including: screenshots/overview of the electronic submission portal (“Cosmetics Direct”) [this is not online yet, expected in October] how to obtain a “FDA Establishment Identifier (FEI)” for your business (which will be required prior to registering your facility through “Cosmetics […]