Industry News
Industry News
The medical device technical team of CIRS Group was invited to attend the event, and jointly held a special seminar on FDA & CE MDR Certification and NMPA Clinical Evaluation with the organizer. Empowering Chinese, Korean and global medical device enterprises to comply with regulations and expand overseas with professional regulatory services, CIRS Group has gained high attention and wide recognition from the industry.
On March 27, 2026, South Korea's National Institute of Chemical Safety (NICS) issued Notice No. 2026-5, revising the Designation of Acute Human Hazardous Substances, Chronic Human Hazardous Substances, and Ecological Hazardous Substances under the Act on Registration and Evaluation of Chemicals (K-REACH) and its Enforcement Decree. The previous revision was completed on 7 August 2025.
On March 31, 2026, China’s National Medical Products Administration (NMPA) issued the Announcement on Matters Related to Cosmetic Registration and Filing (Draft for Comments) and is now soliciting public comments.
On March 30, 2026, China's National Medical Products Administration (NMPA) publicly solicited opinions on two mandatory national standards, including “Instructions for use of consumer interest- Part 3: General labelling for cosmetics” and “General requirements of safety and technical for toothpastes”.
On March 19, 2026, the Congressional Record of the U.S. Senate published Bill S.4153 - the Forever Chemical Regulation and Accountability Act of 2026.
Three committees of the European Parliament voted in favor of a proposal to introduce the concept of Small-Medium Companies (SMCs) and extend the current exemptions applicable to Small and Medium Enterprises (SMEs) to SMCs.
On March 26, 2026, the Ministry of Climate and Energy Environment (MCEE) of Korea announced Notice No. 2026-296, partially amending the Existing Chemical Substances. This revision primarily targets substances listed under the Existing Chemical Substances inventory that were notified under generic names due to recognized data protection, where the data protection period has expired. These substances need to be restored to their original chemical names as part of necessary housekeeping.
CIRS Group has compiled and summarized the intended uses and use levels of HMOs approved in the EU for industry reference. Among them, chemically synthesized and microbially produced 2’-FL have identical scope of use and use levels; similarly, chemically synthesized and microbially produced LNnT share the same conditions of use. The remaining HMOs are produced via microbial sources, and their intended uses may vary depending on the production organism.
There are more than 200 types of HMOs, each with specific structures and functions, enabling applications across different fields. As a result, regulatory submissions for HMOs are rapidly increasing worldwide, with commercialization first initiated in Europe and the United States.
In 2015, the U.S. Food and Drug Administration (FDA) recognized the first HMO—chemically synthesized 2’-fucosyllactose (2’-FL) submitted by Glycom A/S—as Generally Recognized as Safe (GRAS).
Since then, multiple HMOs have successively obtained GRAS status in the United States.
