Kaiseraugst (CH), 25 January 2023
Royal DSM, a global purpose-led science-based company, today announces that its skin care peptide SYN-UP® has been approved as a New Cosmetic Ingredient (NCI) in China under the country’s new cosmetic legislation and can be used freely in formulations all over the world. The outcome makes DSM the first company to receive NCI approval in the stringent NCI category 3 and confirms that SYN-UP® meets the highest levels of quality and safety for an active peptide
This successful result is the fruit of a long-term, cross functional collaboration which involved compiling an extensive dossier to give the Chinese authorities the detailed, wide-ranging data they require to grant NCI approval. It also reflects DSM’s commitment to providing customers with impeccable service in the regulatory and quality sphere. The company intends to build on this success and make more of its innovations globally accessible to customers, by obtaining registration in China for other products in the future.
Impeccable customer service within a complex regulatory landscape
In China, responsibility for cosmetic premarket approval lies with the National Medical Products Administration (NMPA). Under previous legislation, implemented in 1990, new cosmetic ingredients (NCI) not listed by the China Inventory had to be registered before they could be used in finished cosmetic products. However, due to the complex and extensive nature of data the NMPA required, very few NCI were granted approval. Between 2008 and 2020, just eight NCIs were approved and four of these only received approval in December 2020.
Under new legislation, which came into force in May 2021, NCI registration is now based on risk level. This means that while new cosmetic ingredients with a function of high risk must undergo a full registration procedure, other ingredients can undergo a quicker, notification procedure. However, in both cases, the dossier requirements are the same and NCI notification is still subject to strict post approval inspection, making the need for a good quality dossier essential. There are six categories of NCI approval based on an ingredient’s risk function and whether evidence of three years’ safe use in cosmetics can be provided. With SYN-UP®, DSM has become the first international company to achieve NCI approval in the most stringent of these categories, namely Category 3.
To achieve Category 3 approval, DSM had to demonstrate that SYN-UP® met five specific criteria over three years of use. To this end, a dedicated project team began working on NCI registration for the peptide in 2016. Jocelyn Jiao, DSM Regulatory Affairs Manager Greater China said: “Extensive data on safety, quality and efficacy is required for new product registration in China. Our project team has worked tirelessly for several years to achieve NCI registration for SYN-UP® and their hard work has paid off as it is the high-quality dossier they prepared and submitted that has convinced the authorities here. We are now well placed to meet the requirements of any future post-notification inspection, from any authority, and to support our customers with any safety and efficacy justifications they need for finished cosmetic products containing our peptide”.
Globally approved skin care peptide
SYN-UP® is a sophisticated, IP protected, synthetic dipeptide derivative. Its broad efficacy makes it suitable for use in a number of skin care applications. With the Chinese authorities having confirmed that SYN-UP® meets very high level of quality and safety for an active peptide, the ingredient now has global approval. This is good news for DSM’s customers, who will be able use SYN-UP® in their formulations anywhere in the word, and for the market, where demand for high-efficacy solutions continues to grow.
Dr. Volker Rosenberger, DSM Global Marketing Skin Care said: “I am delighted that SYN-UP® has achieved the approval as NCI in China – this really is testament to its safety and efficacy. At DSM we plan to build on this success and in line with our promise to make our innovations globally accessible to our customers, we already have other products in the pipeline for registration in China”.