China Regulatory News

The National Health Commission of China published a notification which approved 2 substances to be categorized as new food materials, 6 substances to be categorized as new food contact materials (FCM)...

The National Health Commission of China published a notification which approved 2 substances to be categorized as new food materials, 6 substances to be categorized as new food contact materials (FCM), and 6 substances to be categorized as food related products new materials. There are in total 14 substances which were approved to use under certain conditions by this notification. 

1. 2 substances were approved as new food materials 

The two substances which were approved as new food materials are Blueberry Anthocyanins and Rye Pollen. The use of them is strictly limited according to the annex of the notification report. 

2. 6 substances were approved as new FCM

The six substances which were included for use as FCM are 

• L-Se-methylselenocysteine, 
• D-psicose 3-epimerase, 
• L-ascorbgy Palmitate, 
• Vitamin B1, 
• Vitamin B2 and 
• Taurine. 

The NHC has approved it for use in coatings and coating layers, at a maximum usage of 5%. However, it cannot be used in FCMs for infants and toddlers.

3. 6 substances were approved to use in food related products as new materials 

The six substances which were permitted to use in food related products are 

• Hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 
• 4-tert-butylbenzoic acid, Tricyclodecanedimethanol polymer withterephtalic acid and 1,6-hexandiol, 
• Fatty acids, C18-unsatd., dimmers, hydrogenated polymers with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, block, 
• 1,6-Hexanedioic acid, polymer with (E)-2-butenedioic acid and tricyclodecanedimethanol, 
• Polymer of 1,4-butanediol, 2,2-dimethyl-1,3-propanediol, 1,4-cyclohexanedicarboxylic acid andm-phthalic acid, and 
• Polymer of butanediol-1,4, tricyclodecanedimethanol and dimethyl terephthalate. 

Manufacturers must label packaging containing any of the substances in accordance with the provisions set out in national standard GB 4806. If you need any help regarding China regulatory compliance work, please contact GPC via compliance@gpcregulatory.cn for help.

On 4th May 2023, National Institutes for Food and Drug Control of China published a notification calling for public opinions on the Guidance for Cosmetic ingredient safety information submission. Acc...

On 4^th May 2023, National Institutes for Food and Drug Control of China published a notification calling for public opinions on the Guidance for Cosmetic ingredient safety information submission. According to technical guidance on cosmetic safety evaluation (2021 edition), when conducting the cosmetic risk evaluation, the risk of all ingredients must be evaluated. Thus, this Guidance was made to guide the filling of ingredients information. 

There are eleven sections in the Guidance. The first to third section are set for general principles which gives information about the preface, application scope and general principles. The fourth to tenth sections include the main contents of the basic information, manufacturing process and quality control requirements of ingredients. In addition, the Guidance also considers the requirements on evaluation conclusion from international authorities, use in other industries, risk ingredient’s limitation. The last part clarified the conditions and procedures for cosmetic registers or record fillers to update ingredients information under certain conditions. 

The public consultation period is open until 20^th May 2023. If you have any opinions regarding this guidance, you are welcome to contact GPC via compliance@gpcregulatory.cn. We can help you to submit the opinion. 

The Standardization Administration of China and State Administration for Market Regulation jointly published the revised version of national standard on Lip moisturizer (gel and cream), GB/T 26513-202...

The Standardization Administration of China and State Administration for Market Regulation jointly published the revised version of national standard on Lip moisturizer (gel and cream), GB/T 26513-2023. This revision will replace the previous one of GB/T 26513-2011. 

The new standard covers the following sections. 

• the definition of a lip moisturiser; 
• technical terms; 
• classifications; 
• product technical requirements; 
• test methods and testing rules; 
• labelling and packaging requirements; 
• transport and storage requirements; and 
• shelf-life details

Compared to the previous standard, the scope of lip moisturizer was broadened, the classification criteria and label were modified. The new standard is expected to come into force from first April 2024. If you have any questions regarding this standard, you are welcome to contact GPC via compliance@regulatory.cn.

China’s National Center for Food Safety Risk Assessment (CFSA) has called for industry feedback on draft national safety standard on food contact materials to include more polymers and food ingredie...

China’s National Center for Food Safety Risk Assessment (CFSA) has called for industry feedback on draft national safety standard on food contact materials to include more polymers and food ingredients.  

The current enforcing standard for food contact materials is GB 4806.1-2016: General Safety Requirements on Food Contact Materials and Articles. It specifies the definitions, basic requirements, restrictions, compliances, test methods, traceability, and product information requirements for food contact materials. Specifically, it clarifies the overarching definition of “food contact material” which excludes any outer packaging or material, unless it comes into direct contact with food.

The new revision to this regulation was published on 19^th April 2023. It proposed that materials such as plastics, rubber, silica gel, paints, adhesives, and oil paints which are already permitted in China can be blended for use in food contact materials on condition that there are no chemical reactions. In addition to this, any substance which already has been approved for use as food ingredients in China, if it meets concerned standards, it can be used in the manufacture of FCMs. 

The consultation period is until 15^th May 2023. If you have any opinions, you are welcome to contact GPC via compliance@regulatory.cn. We will help you to submit your opinions to the authority. 

On 1 March 2023, to align national standards and requirements with the UN Model Regulations, the Standardization Administration of China (SAC) published draft revisions of two transport regulations fo...

On 1 March 2023, to align national standards and requirements with the UN Model Regulations, the Standardization Administration of China (SAC) published draft revisions of two transport regulations for public consultation.

The two concerned national mandatory standards are GB 6944 Classification code of dangerous goods and GB 12268 List of dangerous goods. These two standards were first released in 2005 and revised in 2012. 

The classification Code introduces the definition, categories, and numbering and naming rules of dangerous goods. Compared to the previous version, the new standard had made several changes to classification methods and determing packing groups in the UN model regulations. The List of Dangerous Goods proposed to add 59 items to the list. Both the two standars help to standardize the system for dangerous goods transportation, storage, distribution, and other related activities in China. 

There will be a 12 months transition period after finish publishment. The public consultation period is until 8 May 2023. If you have any opinion or want to know more about chemical compliance in China, please contact GPC via compliance@gpcregulatory.cn.

On 4th April 2023, NMPA published a notice announcing the new regulation on cosmetic online service operators -- "Measures for the Supervision and Administration of Cosmetics Online Operations". This...

On 4^th April 2023, NMPA published a notice announcing the new regulation on cosmetic online service operators -- "Measures for the Supervision and Administration of Cosmetics Online Operations". This measure is expected to come into force from 1^st September 2023. 

Prior to the announcement of this new measure, there is no special rules governing cosmetic online operationists. And the online service providers are exempted from the application of CSAR regulation. This new measure includes five chapters governing all cosmetic e-commerce operators, including cosmetics e-commerce platform operators, cosmetics operators on the platform, and e-commerce operators who operate cosmetics through self-built websites and other network services. However, those who engaged in cross-border e-commerce retailing of imported cosmetics are exempted from the application of this new measure. 

NMPA and local MPA will be responsible for the administration and supervision of this new measure. E-commerce operators shall require platform cosmetic operators to provide address, ID and contact information. Such information shall be updated every 6 months. And operators’ information shall be kept for at least three years after they exit the platform. Regular checking recording shall be kept for at least 2 years since the recoding is made. 

E-commerce platform operators shall ensure that the products sold by them are in line with those which are registered under NMPA and keep relevant information. If any cosmetic products are identified as not complied, then the operators shall stop selling concerned products. For the other batches of the same variety, if the operator wants to continue selling it online, then it shall publish the result for a year. 

For more information, regarding China cosmetic regulation compliance, please contact GPC via compliance@gpcregulatory.cn. 

On 27 March, NMPA published a notification on optimizing cosmetic ingredients registration procedures and some adjustment to the transitional measures. The following points were addressed in the notif...

On 27 March, NMPA published a notification on optimizing cosmetic ingredients registration procedures and some adjustment to the transitional measures. The following points were addressed in the notification. 

1. Content of existing cosmetic ingredients submission 

Cosmetic ingredients safety information mainly includes ingredient quality, safety risk evaluation and related safety information. Under IECIC published by NMPA, it specified all the existed cosmetic ingredients. Cosmetic products producers shall ask ingredients provides to provide all the safety information. If ingredient submission code is available, the cosmetic product producers should connect the code, without repeating the safety information by filling it in the system. 

2. Ways of ingredient submission 

Since the publishment of this notification, registrants can submit by the following ways: 

• If ingredient submission codes are available, then ingredient submission codes are preferred. But cosmetic product registrants shall still ask ingredient providers to share ingredient’s safety information for the purpose of backing up. 
• If ingredient submission codes are not available, then cosmetic product registrants shall fill and upload the ingredients safety related information by themselves.
• For the same cosmetic products, if only some of the ingredients obtain ingredient submission codes, then the above two ways can be adopted at the same time. 

3. Adjustment to transitional measures

• The deadline for submitting ingredients safety information was delayed from 1 May 2023 to 1 January 2024. 
• If the registration was done before 1 May 2021, then ingredient’s safety information shall be submitted before 1 January 2024. 
• For cosmetic products which used special cosmetic ingredients and the registration was done between 1 May 2021 and 31 Dec 2023, then the ingredients safety information shall be filled before 1 January 2024. 

If you are interested in China NMPA CSAR regulation, please contact GPC via zhengmin@cn.gpcregulatory.cn for more information.