SCCS opinion on BHT (Butylated hydroxytoluene) BHT (Butylated hydroxytoluene) (CAS No 128-37-0, EC No 204-881-4) is part of the priority list and the Scientific Council on Consumer Products (SCCS) published its opinion on BHT on December 2nd, 2021. On the basis of a safety assessment, and considering the concerns related to potential endocrine-disrupting properties of […]
Following the Omnibus IV article, we remind you that Commission Regulation (EU) 2021/1902, the so-called Omnibus IV Regulation, enters into force on the 1st of March 2022. Thus, from now on, only compliant products can be placed on the market and made available on the market. A market withdrawal of non-compliant products must be organized […]
This is a brief overview of the most important points regarding Post Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Post Market Survey (PMS) Definition PMS (Post Market Survey) refers to all activities carried out by manufacturers, in collaboration with other Economic Operators*, to establish and keep up to date a systematic proactive data collection […]
The Intention of the European Comission for Nano Ingredients The European Commission notified the World Trade Association (WTO) of its intention to ban the following nano ingredients from the composition of cosmetic products: STYRENE/ACRYLATES COPOLYMER (nano) (CAS: 9010-92-8) SODIUM STYRENE/ACRYLATES COPOLYMER (nano) (CAS: 9010-92-8) COPPER (nano) (CAS: 7440-50-8) COLLOIDAL COPPER (nano) (CAS: 7440-50-8) HYDROXYAPATITE (nano) […]
The Borderline Between a Cosmetic Product and a Medical Device One important change in the Medical Device Regulation (EU) 2017/745 (the MDR) is the integration of 6 groups of products in its scope: the “Cosmetic Products” listed in Annex XVI which reads the following: While some products listed are easy to identify, such as “decorative” […]
Medical Devices Categorization in Europe Medical Devices are categorized in the European Union in 4 classes: Class I, Class IIa, Class IIb and Class III. Class I being the lowest risk ones and Class III the highest risk ones. There are also 3 “subclasses” in the Class I category: All medical device classes require the […]
Colorants in the United States The US FDA colorants list has been amended to ban Lead Acetate and add Silver Nitrate to the list of allowed colorants. Ban of the Lead Acetate The ban of the Lead Acetate has been officially published and will be effective from January 6th, 2022. A transition period of 12 […]
