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Regulatory Updates

BASF's MCE Becomes China's First UV Filter to Complete NCI Registration Since CSAR Took Effect
Published on:2026-10-30

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On October 29, 2026, the National Medical Products Administration (NMPA) issued its Delivery Information for Cosmetic Approval Documents, confirming the registration of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate, a new cosmetic ingredient submitted by BASF SE. The ingredient was granted Registration Certificate No. 国妆原注字20260001, making it the first UV filter to complete NCI registration since the implementation of China's Cosmetics Supervision and Administration Regulation (CSAR).

 

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On October 30, the NMPA published the ingredient's registration information on its official website.

 

 

1. MCE: Basic Information and Regulatory Requirements in China

 

BASIC INFORMATION

INCI Name

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate

Chemical Name

2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate

Common Name

Mexoryl 400

Abbreviation

MCE

CAS Number

1419401-88-9

Molecular Formula

C₁₇H₂₆N₂O₄

Molecular Weight

322.41

 

TECHNICAL REQUIREMENTS

Intended Function

UV Filter

Applicable Product Scope

All types of cosmetic products, except products that may lead to exposure of the end user's lungs by inhalation

Maximum Concentration

1%

Restrictions and Conditions of Use

1. Not to be used in products that may lead to exposure of the end user's lungs by inhalation.

2. Not to be used in combination with nitrosating agents; the maximum nitrosamine content must not exceed 50 μg/kg.

3. To be stored in nitrite-free containers.

 

Innovation Guidance List

On October 20, 2025, China's National Institutes for Food and Drug Control (NIFDC) announced the first group of 16 new cosmetic ingredients selected for innovation guidance. MCE was listed as No. 7, with its intended function identified as a sunscreen agent and BASF SE named as the registrant. Approximately one year after its inclusion in the list, MCE has completed registration in China. For more information about the other 15 ingredients, see our previous article: China to Speed Up Review of 16 High-Risk New Cosmetic Ingredients.

 

 

2. MCE: An Established UV Filter in International Markets

 

MCE has already been authorized for use as a UV filter in the European Union. It was added to Annex VI of Regulation (EC) No. 1223/2009 through Commission Regulation (EU) 2020/1684.

 

In the EU, MCE is permitted at concentrations of up to 3% in ready-for-use cosmetic products, subject to specific conditions:

Requirement

EU Conditions

Maximum Concentration

3%

Restrictions and Conditions of Use

1. Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.

2. Not to be used in combination with nitrosating agents.

3. Maximum nitrosamine content: 50 μg/kg.

4. Keep in nitrite-free containers.

 

The EU Scientific Committee on Consumer Safety (SCCS), in its final opinion SCCS/1605/19 adopted on December 13, 2019, concluded that MCE is safe for use as a UV filter in cosmetic products at concentrations of up to 3%. The assessment did not cover inhalation toxicity.

 

In addition, MCE is also permitted for use as a UV filter in markets such as South Korea, Australia and Indonesia.

 

3. Three Related Sunscreen Products Registered on the Same Day

 

MCE was developed through approximately ten years of research collaboration between L'Oréal and BASF. It is the UV filter powering L'Oréal's UVMune 400 technology, which is designed to provide protection against ultra-long UVA rays (380–400 nm). The technology was first introduced in La Roche-Posay's Anthelios sunscreen range, making La Roche-Posay the first brand within the L'Oréal Group to adopt it.

 

On October 29, three La Roche-Posay sunscreen products also received special cosmetics registration certificates:

 

  • 理肤泉特护轻盈倍护防晒乳

  • 理肤泉特护轻盈控油防晒乳

  • 理肤泉特护轻盈防晒乳

 

The three products were registered on the same day as MCE, suggesting a possible connection between their applications. However, it is not clear whether they contain MCE.

 

This may be linked to China's simultaneous application mechanism for new cosmetic ingredients and related products. Under theNIFDC's noticepublished on May 9, 2025, registrants or filers of new cosmetic ingredients may simultaneously submit registration applications for special cosmetics containing the relevant ingredients.

 

 

From its commercial use in overseas markets to its inclusion in China's NCI innovation guidance list and eventual registration, MCE's journey offers a valuable reference for international ingredient companies looking to enter the Chinese market. It also provides a practical example of how ingredients selected for China's innovation guidance program can progress toward registration and commercial application.

 

 

 

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