China Regulatory News

The Ministry of Environment and Ecology of China (MEE) has consulted on the inclusion of four chemical substances to its Inventory of Existing Chemical Substances (IECSC) under MEE Order No.12.  T...

The Ministry of Environment and Ecology of China (MEE) has consulted on the inclusion of four chemical substances to its Inventory of Existing Chemical Substances (IECSC) under MEE Order No.12. 

The concerned substances are: 

• 4-chlorobenzophenone;
• 1,8-naphthalimide;
• (2S,4S)-2-(dimethyl-amino carbonyl)-4-mercapto-1-(p -nitrobenzyloxycarbonyl)- 1-pyrrolidine; and
• cerium (III) acetate hydrate.

These four substances were nominated by the industry on the legal basis that these substances were manufactured in or imported into China before 15^th October 2003 as provided in MEE Order No.12.

The nomination was done on 23^rd October, and it will be opened for consultation for two weeks. From now on, there are no registration or record filling obligations for these four substances under China REACH. For more information regarding China REACH, please contact GPC China via compliance@gpcregulatory.cn. 

On 19th October, China MIIT published a notification which announced 60 standards relating to chemical industry.  Among the 60 standards, there are 20 standards which were made to replace the pre...

On 19^th October, China MIIT published a notification which announced 60 standards relating to chemical industry. 

Among the 60 standards, there are 20 standards which were made to replace the previous standards, covering the area of determination of isocyanate group content in polyurethane prepolymer, the testing for industrial phosphorous acid, industrial strontium carbonate, industrial sodium chlorite, etc. The rest 40 standards are new standards governing the testing for polypropylene series chemical substances and etc. 

The publicity period is from 19^th October 2023 until 19^th November 2023. During this period, if you have any suggestion, you are welcome to contact GPC China via compliance@gpcregulatory.cn. GPC China can help you to report your suggestion to the official. 

On 25 September 2023, the National Medical Products Administration (NMPA) published a notification on the enforcement of toothpaste regulation and simplified the information requirements for toothpas...

On 25 September 2023, the National Medical Products Administration (NMPA) published a notification on the enforcement of toothpaste regulation and simplified the information requirements for toothpaste products which have already done registration and record filing. 

1. The enforcement of toothpaste regulation 

According to this notification, since 1 December 2023, imported toothpaste can only be registered via NMPA, while domestic toothpaste registration can be done via provincial MPA. The product label sample and other relevant information in the toothpaste registration materials should comply with the requirements of the CSAR, Cosmetic Label Management Measures and other regulations. Toothpaste filers should, while filing toothpaste, upload through the filing platform the literature, research data or summary of product efficacy evaluation data on which efficacy claims are based, and accept social supervision. Toothpaste products that only claim to have cleaning effects are exempt from uploading and publishing abstracts.

This notification emphasized again that Children's toothpaste refers to toothpaste claimed to be suitable for children under the age of 12 (including 12 years old). The efficacy categories that children's toothpaste can claim are limited to cleaning and preventing caries. Children's toothpaste should be marked with the children's toothpaste logo on the sales package display surface. Children's toothpaste should also be marked with relevant warnings such as "Use under adult supervision", "Not edible", "Beware of swallowing" and other relevant warnings on the visible side of the sales package.

2. Simplify the information requirements for toothpaste products which have already done registration 

From 1 October 2023 to 30 November 2023, toothpaste filers can submit the following simplified information through the registration platform to register toothpaste products that have been on the market:

1. Basic information of toothpaste filer. Include the name, address, contact information, etc. of the filing person. If production is commissioned, the name, address, contact information, etc. of the actual production enterprise must also be submitted at the same time;
2. Basic product information. Including product name, product formula, product sales packaging label pictures, etc.;
3. Relevant information proving that the product has a history of safe use. This includes, but is not limited to, production and material input records, sales invoices, inspection reports and other relevant information since the product was launched, as well as the filing party’s commitments to product safety and the authenticity of the filing materials.

Toothpaste filers should complete the corresponding product registration materials in accordance with relevant laws and regulations before 1 December 2025. If the first batch of products are put on the market before 1 January 2021, the product registration materials can be kept on file by the filer for future reference; if the first batch of products are put on sale after that, the filer should submit complete filing materials through the filing platform.

For toothpaste products with simplified filing, the content of the label must comply with the requirements of the CSAR and Measures for the Administration of Cosmetic Labels. If only the format of the label needs to be adjusted, the already marketed sales can be used during the simplified filing. Packaging labels, and complete product label updates as required before 1 July 2024. In addition to those that only claim to have cleaning efficacy, toothpaste products subject to simplified registration must also upload and publish a summary of the basis for product efficacy claims through the registration platform before 1 December 2025.

For any China related inquiries, please contact GPC China via compliance@gpcregulatory.cn. 

On 31st August 2023, the National Institute for Food and Drug Control of China (NIFDC) published the Technical Guidance Principles on Children Cosmetic Products. This guidance was enforced since 31st...

On 31^st August 2023, the National Institute for Food and Drug Control of China (NIFDC) published the Technical Guidance Principles on Children Cosmetic Products. This guidance was enforced since 31^st August 2023. 

This guidance gives detailed information on the technical requirements of all materials to be prepared for submission. This includes the followings. 

• Product name. Product name should be composed of brand name, generic name, and attribute name.
• Product formula. Children cosmetic products should meet the requirements set in “rules on cosmetic registration / record filling management” and “cosmetic safety technical guidance”.
• Standards. The manufacturing process should comply with enforced standards. This includes sensory index, micro-biology, and Phys-chemical index, quality control measures, usage methods, safety warnings, and storage conditions. 
• Labels. Label should be in Chinese and include information as required by cosmetic regulation. 
• Test reports. 
• Safety evaluation. 
• Children cosmetics which are specially made for Chinese market. For such product, in addition to the above points, an illustration on the products which are specifically designed on the skin types and consuming requirements on Chinese children is required. 

Additionally, this guidance includes an annex of the possible allergenic fragrance components released by international authoritative organizations. For more information regarding China cosmetic compliance, please contact GPC via compliance@gpcregulatory.cn

The Ministry of Environment and Ecology of China (MEE) has called for public information on long-chain perfluoro carboxylic acids’ (LC-PFCAs) salts and related compounds and medium chain chlorinated...

The Ministry of Environment and Ecology of China (MEE) has called for public information on long-chain perfluoro carboxylic acids’ (LC-PFCAs) salts and related compounds and medium chain chlorinated paraffins (MCCPs). 

According to the notification, Stockholm Convention expressed that long term persistent organic pollutants (POP) has detrimental effects to environment and human health. In the attachments of the Convention, there are thirty-four categories of chemical substances which are classified as POPs. Ahead of the 19^th Convention committee’s assessment which is expected to be opened in October, MEE solicits information on LC-PFCAs and MCCPs. The deadline for the submission of information is 27^th August. 

MEE requests information on the production, use, import, export, substitutes and alternative technology of the above two substances within China. This includes information on: 

• production and usage conditions, such as volume and usage purpose; and 
• the situation of substitutes or substitute technologies such as on their introduction, costs and effects. 

The POPs Review Committee (POPRC) published draft risk management evaluations of LC-PFCAs and MCCPs in June, recommending that both be added to Annex A of the convention. This would ban their production, use, import and export. The committee is due to discuss the draft evaluations at the October meeting. For more information regarding POP management in China, please contact GPC via compliance@gpcregulatory.cn for help.

The National Center for Food Safety Risk Assessment of China (CFSA) published a notification to solicit public opinions on four food related products, including expanding the use scope of two food con...

The National Center for Food Safety Risk Assessment of China (CFSA) published a notification to solicit public opinions on four food related products, including expanding the use scope of two food contact materials (FCM), one new origin of FCM and one new varieties of resins for FCM. 

• Expanding the use of two FCMs

CFSA has expand the usage scope of resin 2-propenoic acid, 2-methyl-,1,1-(1,4-butanediyl) ester polymer, with butyl 2-methyl-2-propenoate, butyl 2-propenoate and methyl 2-methyl-2-propenoate in coatings and coating layers.  

The maximum use level would be 46% based on the coating formula and a specified migration limit (SML) of 6mg/kg for methacrylate and of 0.05 mg/kg for 1,4-butanediol dimethacrylate. Coatings containing this resin would be banned for use in packaging for foods containing fat or for infants and young children. 

• One new origin of FCM

Coffee grounds has been permitted to use in plastics: polylactic acid (PLA), polybutylene succinate (PBS). The maximum usage is PLA: 20; PBS: 10. The collection, production, processing, storage and transportation of coffee grounds should comply with the relevant provisions of the "National Food Safety Standard General Hygienic Specifications for Food Production" (GB 14881-2013). It shall not be used in the production of special food contact materials and products for infants, and the operating temperature shall not be higher than 100°C. The above restricted use requirements shall be marked in accordance with the provisions of GB 4806.1

• One new varieties of resins for FCM

2-propenoic acid, 2-methyl-,1,1-(1,4-butanediyl) ester, polymer with butyl 2-methyl-2-propenoate, butyl 2-propenoate and methyl 2-methyl-2-propenoate have been permited to use in paint and coating. The maximum usage is 46%, and SML is 6 mg/kg (methacrylic acid) 0.05 mg/kg (1,4-butanediol dimethacrylate). It shall not be used in the production of special food contact materials and products for infants and shall not be used in contact with fat-containing foods. The above restricted use requirements shall be marked in accordance with the provisions of GB 4806.1.

For more information regarding China FCM compliance or China REACH and cosmetic activities, please contact GPC via compliance@gcpregulatory.cn.

The National Health Commission of China (NHC) published notifications for 2023 food safety related national standards legislation plan and 2024 food safety related national standards legislation sugge...

The National Health Commission of China (NHC) published notifications for 2023 food safety related national standards legislation plan and 2024 food safety related national standards legislation suggestion. 

The 2023 national standards legislation plan contains the following 9 sections of different food safety areas. 

• 12 food addictive national standards 

The standards regarding Sodium L-malate, Vanillol and Sanzan Gum will be made for the first time. The standards regarding Tomato Red, Capsicum Red, Pectin, Vitamin B2, Lauric Acid, General Rules for Food Additive Labeling, L-Alanine, Erythritol, L-Cysteine Hydrochloride will be modified based on the current versions.

• 1 food related products standard

The addictive for food contact materials standards (GB 9685-2016) will be modified.

• 3 pollutants standards 

The following 3 pollutants standards will be modified: Limits of Heavy Metals in Dried Meat Products, Limits of Heavy Metals in Dried Aquatic Products, Limits of Contaminants and Mycotoxins in Liquid Special Medical Foods. 

• 11 physical testing methods 

The physical testing methods of Determination of trans fatty acids in food for infants and young children and dairy products (GB 5413.36-2010), Determination of Amino Acids in Food (GB 5009.124-2016), Determination of Indicative PCB Content in Food (GB 5009.190-2014), Determination of perfluoroalkyl compounds in food (GB 5009.253-2016) will be modified based on current standards. The physical testing standards of Food contact materials and articles Determination of 2-methyl-1,3-butadiene and determination of migration, Food contact materials and articles - Determination of migration of citrate and sebacate compounds, Food contact materials and products - Determination of migration of bisphenol A-diglycidyl ether, bisphenol F-diglycidyl ether and their hydroxyl and chlorinated derivatives and etc. 7 standards will be made. 

• 5 micro-biology testing methods 

Food microbiological examination - Examination of diarrhea-causing Escherichia coli (GB 4789.6-2016), Bacteria inspection for food, Bifidobacteria inspection and etc 5 micro-biology testing methods will be made or modified. 

• 1 toxicological testing methods

The toxicological testing methods of Pig-a Gene Mutation Test in Peripheral Blood of Rats in Vivo will be made in 2023. 

• Food product standards

The standards of Vegetable oil (GB 2716-2018) will be modified. 

• 2 special dietary food standards

The standards of Gastrointestinal malabsorption, pancreatitis full nutritional formula food and Foods for special diets for people with gluten intolerance will be made. 

• 3 standards for food nutrition fortifiers 

The standards of Food nutrition enhancer casein phosphopeptide (GB 31617-2014), Food nutrition enhancer carbonyl iron powder (GB 29212-2012), and Food nutrition enhancer inositol (cyclohexyl alcohol) (GB 1903.42-2020) will be modified. 

For more information, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.