DSM’s skincare peptide first to be greenlit under new Chinese cosmetics law

26 Jan 2023 --- Royal DSM’s skincare peptide Syn-Up has been approved as a New Cosmetic Ingredient (NCI) in China under the country’s new cosmetic legislation and can now be used freely in skincare formulations in the market. The ingredient is designed to combat skin dryness and redness by interacting with the skin microbiome.

The outcome makes DSM the first company to receive NCI approval in the stringent NCI category 3 and confirms that Syn-Up meets China’s quality and safety for an active peptide.

DSM shares that the positive outcome is the “fruit of a long-term cross functional collaboration” that involved compiling an extensive dossier to give the Chinese authorities the detailed, wide-ranging data they require to grant NCI approval.

The process of planning for this registration took up to six years, according to the company.

“Brand owners, who plan on including new ingredients in their market formulations, should have safety and efficacy data for the finished cosmetic products to provide to the Chinese authorities,” Dr. Volker Rosenberger, DSM’s global marketing manager for skincare, tells PersonalCareInsights. 

“This is where a close collaboration between ingredient manufacturers and end product owners is required,” he highlights. “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.”

“For all China-approved products, we give customers clear and comprehensive information about our products to support them in complying with the market requirements.”

This is the latest global development by DSM, which recently announced its merger with Swiss flavor house Firmenich.

DSM intends to build on this achievement and make more of its innovations accessible to Chinese consumers by obtaining local registration for other products in the future.Key step forward
DSM holds a broad portfolio of products registered in China. However, the supplier has weathered some setbacks due to recent price hikes in its vitamins business, which led to a “major reduction” of vitamin C production at its Jiangshan plant in China. The company says it will evaluate a return to normal production levels in 2023 after the Chinese New Year. 

However, Syn-Up’s registration success is deemed a positive highlight this year, with the DSM team gaining plenty of key knowledge about the new registration process. 

DSM intends to obtain Chinese registration for other products in its range.

“In line with our commitment to make our innovations globally accessible to our customers, we already have other products in the pipeline for registration in China,” says Dr. Rosenberger.

Navigating 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.

“Extensive data on safety, quality and efficacy is required for new product registration in China,” 

Jocelyn Jiao, DSM regulatory affairs manager of Greater China, remarks.

“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.”

There are six categories of NCI approval based on an ingredient’s risk function and whether evidence of three years of safe use in cosmetics can be provided.

The complex and extensive nature of data required to register an ingredient an NCI in China makes it challenging for companies.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.

Globally approved skincare peptide
Syn-Up is an IP-protected, low-molecular-weight dipeptide derivative. Its broad efficacy makes it suitable for use in a number of skincare applications.

External stressors, such as UV irradiation, climate, pollution or chemicals, can disbalance the skin. This activates the production of plasmin, triggering a series of skin damages and signs of aging and negatively impacting all three skin layers (epidermis, dermis and dermal-epidermal junction). 

Syn-Up “fits perfectly” in the active site of plasmin, “like a key into a key-hole,” which rebalances Plasmin in the skin and helps reverse the negative impact, outlines DSM.

As a result, Syn-Up is marketed toward improving the skin barrier function, reducing skin sensitivity and redness, while protecting the dermis and dermal-epidermal junction from degradation. This leaves the skin looking smoother and firmer.

“To identify potential structural features that could be responsible for a molecule’s biological activity our scientists use artificial intelligence capabilities and molecular modeling, a tool new to cosmetics,” details Dr. Rosenberger.

“In essence, molecules were initially modeled virtually to identify the most promising lead compounds. It also enabled us to understand how Syn-Up performed at a molecular level and how it binds in their biological target within the skin.”

Peptide-powered innovation
Peptides continue to exhibit strong commercial viability as research expands their functionalities and applicability. While commonly used in topical skincare formulations, they have been growing in popularity in edible supplement formats, like functional gummies.

There is evidently surging interest in the vegan collagen space. However, there are also notable sustainability gains for animal-based collagen, as companies aim to scale collagen produced from nutrient-rich animal byproducts – like bone fractions and tissues – that would be otherwise discarded or converted into lower-value materials.

Such peptides produced through natural fermentation – like fermented eggshells – have been found to offer greater bioavailability. An example of this is Ancient Nutrition’s collagen peptides, which are sustainably produced using fermented eggshell membranes sourced from chickens raised in the US and grass-fed, pasture-raised cows.

Among other latest developments, Gelita has developed bioactive collagen peptides that have been found to assist women in achieving healthier lifestyles, starting at a younger age and continuing well into menopause, which significantly alters their body’s metabolic processes.

Previously, Gelita’s Verisol collagen peptides received a Foods with Function Claim for skin elasticity in Japan. F&B manufacturers who use bioactive collagen peptides can now claim that their product contains Verisol on their packaging. Gelita also noted that bioactive peptides promote the formation of collagen.

By Benjamin Ferrer