China Regulatory News

The Ministry of Industry and Information Technology of China (MIIT) published a notification calling for public opinions on twelve national mandatory standards which includes four chemical related sta...

The Ministry of Industry and Information Technology of China (MIIT) published a notification calling for public opinions on twelve national mandatory standards which includes four chemical related standards. 

• Safety and Technical Guidance on Transportation Package of Hazardous Chemicals and Packaging which Contains Several Hazardous Chemicals 

This Guidance gives information about the classification of dangerous goods and packaging, packaging coding and marking, shipping marks and shipping labels, packaging requirements, special requirements for limited quantity packaging and excepted quantity packaging. 

• Transport packaging for dangerous goods - Safety technical specifications for salvage packaging

This Guidance specifies the classification of dangerous goods and packaging, packaging coding and marking, transport marks and transport labels, and general requirements.

• Rules for Classification and Labeling of Chemicals Part 1: General Rules

This document specifies the terms and definitions related to chemical classification and labeling, as well as chemical hazard classification, labeling and chemical safety data sheets.

This document is applicable to the classification and labeling of chemicals according to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (hereinafter referred to as GHS). Drugs, food additives, cosmetics, and pesticide residues in food, etc., are excluded from the label coverage of this document when ingested intentionally. However, if there is a possibility of worker exposure, or potential exposure during transportation, the provisions of this document still need to be followed.

• Rules for Classification and Labeling of Chemicals Part X: Desensitized Explosives

This part of GB 30000 specifies the terms and definitions, classification criteria, decision logic and guidance, and labeling of desensitized explosives.

This part applies to the classification and labeling of desensitized explosives according to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (hereinafter referred to as GHS).

The consultation period is until 16^th August. All the above standards will be enforced a year after it is being officially published. If you need any help regarding China REACH, please conduct GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com  

On 5th June, China National Institutes for Food and Drug Control (NIFDC) published a notification including nine guidelines on cosmetic products and cosmetic new ingredients registration process.  ...

On 5^th June, China National Institutes for Food and Drug Control (NIFDC) published a notification including nine guidelines on cosmetic products and cosmetic new ingredients registration process. 

Cosmetic products and cosmetic new ingredients are under the overarching framework of Cosmetic Supervision and Administration Regulation (CSAR) based on the risks. The nine guidelines cover the following areas: 

• Registration and approval of new cosmetic raw materials with higher risks;
• Approval of amended registration for domestic special cosmetic products;
• Approval of first registration of domestic special cosmetic products; 
• Renewal of registration and approval of domestic special cosmetic products; 
• Approval of deregistration of domestic special cosmetic products; 
• Approval of amended registration of imported special cosmetic products; 
• Examination and approval of first registration of imported special cosmetic products; 
• Approval of renewed registration of imported special cosmetic products; and
• Approval of deregistration of imported special cosmetic products.

If you have any questions regarding China cosmetic compliance, or you would like to have to the full text of these guidelines, please contact GPC via compliance@cn.gpcregulatory.com.

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.