China Regulatory News

On 2nd Sep. 2022, National Institutes for Food and Drug Control of China (NIFDC) published a notification calling for public and indutry opinions on draft new China Cosmetic Safety and Techinical Sta...

On 2^nd Sep. 2022, National Institutes for Food and Drug Control of China (NIFDC) published a notification calling for public and indutry opinions on draft new China Cosmetic Safety and Techinical Standards (CSTS) which was made in 2022. 

The current CSTS was in force since 2015. In 2021, the new Cosmetic Supervision and Administration Regulation (CASR) was published. To keep cosmetic standards in line with the latest regulation requirements and the overarching aim of cosmetic regulation, CSTS (2015 version) was modified. The main modifications are the followings: 

• List of limited cosmetic raw ingredients 

Based on the list of forbidden cosmetic raw ingredient, the definition of certain terms in list of limited ingredient and scope of list of limited ingredients have been modified in accordance with CSAR (2021). 

• List of allowed raw ingredients 

Adding Lauroyl arginine ethyl ester hydrochloride as allowed ingredients and deleting Mercury-containing preservatives from this list. 

• Test 

12 new test methods have been added, among which eight of them are toxicological tests and four of them are physical chemical tests. In addition, there 15 physical chemical tests have been modified and two toxicological tests have been modified. 

For more information relating to China cosmetic compliance activities, please contact GPC at compliance@gpcregulatory.cn. 

State Administration for Market Regulation of China (SAMR) and National Standardization Administration of China (NSA) issued the final version of national skin disinfection standard – General Requir...

State Administration for Market Regulation of China (SAMR) and National Standardization Administration of China (NSA) issued the final version of national skin disinfection standard – General Requirements for Skin Disinfectant GB 27951-2021. This standard will enter into force from 1^st November 2022. After entering into force, it will replace the previous standard of GB 27951-2011 Hygiene requirements for skin disinfectants and will be under the supervision of National Health Commission of China (NHC). 

The main change in this new standard is that it sets new limits on heavy metals used in the disinfection. 

• 10mg per litre (L) or kilogram (kg) for lead;  
• 1mg/L or kg for mercury; and  
• 2mg/L or kg for arsenic.  

In addition, it also specified several terms definitions, such as skin conditions, revised testing requirements for microbials, toxins and heavy metals in finished products, active ingredients etc. It will be clearer for companies to understand new toxicological testing requirements and limitations for heavy metals. 

For more information relating to China chemical and cosmetic regulation, please contact GPC via compliance@gpcregulatory.cn or follow our WeChat account at 46 0708381983. 

On August 19, 2022, National Medical Products Administration of China (NMPA) published a notification announcing that cosmetic digital certificate will be formally implemented. This notification was m...

On August 19, 2022, National Medical Products Administration of China (NMPA) published a notification announcing that cosmetic digital certificate will be formally implemented. This notification was made based on the rules of ‘Digital Signature Law of China’ and ‘Measures for the Administration of Electronic Certificates of National Integrated Online Government Service Platforms’. 

This notification requires that from October 1, 2022, 

• For special cometic products and cosmetic new ingredients which are registered under Measures for Cosmetic Registration and Notification (part of CSAR, Cosmetic Supervision and Administration Rules) and those certificates which are extended and changed under Measures for Cosmetic Registration and Notification, digital certificates will be granted. Paper-based certificates which were granted before, it will be valid within the validation period. But it won’t be renewed. 
• For special cosmetic products certificate which are allowed to change under Measures for Cosmetic Registration and Notification, the registrants shall return the paper-based certificates to NMPA according to CSAR requirements. 

Additionally, this notification specifies the way and place for picking up the digital certificates. Once the digital certificates are prepared, it will be uploaded to the registrants’ NMPA accounts. Registrants can pick up it by log into NMPA online service center. The digital certificates can be used in many forms, including certificate authorization, scan to check, online verification, online sharing etc. 

If you have any inquires relating to cosmetic products and ingredients registration and submission in China, please contact GPC China via compliance@gpcregulatory.cn or follow our WeChat account 46 0708381983.

To implement ‘New Pollutant Management Action Plan’, on July 20, MEE (Ministry of Environment and Ecology of China) published a notice regarding public comments on chemicals that should be assesse...

To implement ‘New Pollutant Management Action Plan’, on July 20, MEE (Ministry of Environment and Ecology of China) published a notice regarding public comments on chemicals that should be assessed of environmental risks with priority. It seeks to collect suggestion and opinions from public for chemicals to be listed in the first band for prioritize environmental risk assessment of chemicals. 

The ‘New Pollutant Management Action Plan’ was released in May 2022. The aim of it is to assess the environmental and health hazard of chemicals, with a primary focus on substances produced or used in large quantities, detected frequently in the environment, or used for various purposes, while developing an assessment database. Within this Action Plan, it outlined a plan to assess important chemicals which will be formulated and prioritized for environmental risk assessment. As a result of the plan, the notice was published to circulate public opinions. The estimate deadline for compiling these substances is the end of 2022. 

According to the requirements mentioned in this notice, proposed chemicals must meet the requirements of the guidelines for screening of priority assessment chemical substances (HJ 1229-2021). Meanwhile, this notice also enclosed an attached form which is Chemical Substance basic information list. Proposed chemicals need to include the following information: 

• Chemical name in Chinese and English
• CAS 
• Eco-toxic features and health toxic features 
• PBT characters 
• Hazardous classification 
• Use history in China and overseas 
• Risk and risk control measures 
• Others 

If you have any inquiry relating to China REACH, please contact us via compliance@gpcregulatory.cn. 

On the 30th of June, the China Solid Waste and Chemicals Management Center under the Ministry of Environment and Ecology (MEE-SCC) published a FAQ document which specified several hot debated question...

On the 30^th of June, the China Solid Waste and Chemicals Management Center under the Ministry of Environment and Ecology (MEE-SCC) published a FAQ document which specified several hot debated questions for new chemical substances registration under MEE Order No.12. Below are some key questions excerpt from the FAQ document.

1. Testing institutions’ qualifications for polymer registration.

The "Guidelines for Environmental Management Registration of New Chemical Substances" has corresponding requirements for domestic and foreign testing institutions for physical and chemical properties. The testing institutions for GPC and other spectra have the same requirements as those for physical and chemical properties.

2. Identification information requirements when applying for inclusion to IECSC.

The identification information of chemical substances that the applicant should provide includes Chinese name, English name, CAS number, molecular formula, structural formula, etc. The identification information should be accurate and normative, obtained from authoritative institutions, or from published literature reports, authoritative databases, etc. Common names, common industry names, etc. are provided as aliases. The identification information of chemical substances should be consistent with the information related to chemical substances in the certification materials.

3. Annual activity report requirements

For a registered substance that needs to submit an annual activity report, an annual activity report should be submitted every year until the chemical substance is included in the Inventory of Existing Chemical Substances in China.

4. For a new chemical substance that has obtained a registration certificate MEP Order No. 7 and is re-registered under Order No. 12, should the previous certificate be cancelled?

The registration certificate for regular registration or simplified registration obtained under MEP Order No. 7 should be returned for a new registration certificate, and there is no need to cancel the registration certificate.

For more inquiries, please contact GPC via email compliance@gpcregulatory.cn

The Shanghai Port recently issued a notice to further strengthen the management of hazardous chemicals containers at the port. The notice indicates that for containers of hazardous chemicals that have...

The Shanghai Port recently issued a notice to further strengthen the management of hazardous chemicals containers at the port. The notice indicates that for containers of hazardous chemicals that have been unloaded, the shipping company and agent/customer must put into writing, explaining relevant information about the goods. They should attach an appraisal report of the hazardous chemicals classification and the report should be issued by a qualified third-party organization.

Starting from July 1, 2022, shipping companies and agents have to provide the operation terminal with the dangerous characteristics of the hazardous chemicals container, as issued by a qualified third party. The documents, classification appraisal report and declaration form for dangerous goods operation at the port should be submitted 24 hours before the ship arrives at the port.

If this information is readily available, it will then be more possible for the port terminal to take necessary safety precautions.

The Ministry of Industry and Information Technology (MIIT) in China made an announcement explaining China’s plan to make stronger its restriction of hazardous substances in electrical and electronic...

The Ministry of Industry and Information Technology (MIIT) in China made an announcement explaining China’s plan to make stronger its restriction of hazardous substances in electrical and electronic products under its RoHS-like regulation (RoHS2) within the next three years.

China plans to add four phthalates to the scope RoHS2 covers. These four phthalates are DEHP, BBP, DBP, and DIBP. China proposes adding four phthalates to RoHS2 and to this effect, the ministry will start revising the requirements of GBT 26572-2011 on restricted substances and their concentration limits in electrical and electronic products. The revision will start in July 2022 all through to November set as the deadline to complete the revision.

Compliance with regulations for these substances means that companies must label the products that contain the phthalates, and the substances must not exceed the concentration limits. Products also have to be labelled according to the marking standard SJ/T11364-2014 which specifically explains the marking requirements for hazardous substances in electrical and electronic products, recyclability and the environmental protection use period. Seeing as a consultation opened on March 15 and closed on March 25, 2022, a significant change is expected regarding the addition of the four phthalates. A revised version of this standard is expected to be published in November 2022. While waiting for this new revision to be published in November 2022, the MIIT has started to draft a policy document to widen RoHS2 substances control to include the new addition, and there will most likely be a 180-day transition period after its publication.