China Regulatory News

On April 22, 2022, China National Center for Food Safety Risk Assessment (CFSA) announced a consultation notice on approving two new resins used in food contact materials and an expanded use of one fo...

On April 22, 2022, China National Center for Food Safety Risk Assessment (CFSA) announced a consultation notice on approving two new resins used in food contact materials and an expanded use of one food contact material additive.

The concerned substances in this notification are:

• Addition of two new resins
  • hexane, 1, 6-diisocyanato-, polymer with poly (oxy-1,2-ethanediyl), α-methyl-ω-hydroxy- – for use in adhesives with indirect contact with food in moderation according to production needs; and
  • 1,4-benzenedicarboxylic acid, polymer with 1,3-benzenedicarboxylic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol, 1,4-cyclohexanedimethanol, 1,3-propanediol,2-methyl, and adipic acid – for use in paints and coatings at a maximum level of 80% (based on dry weight)
• Expansion of the use of one additive
  • 2-(5-chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol (CAS 3896-11-5) as a food contact additive for use in polystyrene (PS) – This is in addition to its current approved use in polyethylene (PE) and polypropylene (PP) plastics. 

If the above proposal is approved, the substances will be included in the national standard of GB 9685-2016 and adhere to the requirements in GB 4806.1. before they can be used in food contact materials.

The deadline for consultation is 20^th May 2022. 

If you have any opinion or inquiry relating to China regulations, please contact GPC at compliance@gpcregulatory.cn or zhengming@cn.gpcregulation.com for help.

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On April 27, 2022, the General Department of the National Medical Products Administration (NMPA) extends the deadline for submitting certain data under the cosmetic regulation from May 1 until Decemb...

On April 27, 2022, the General Department of the National Medical Products Administration (NMPA) extends the deadline for submitting certain data under the cosmetic regulation from May 1 until December 31. This decision was made due to the rising cases of COVID-19, lock-downs and restrictions in main cities like Shanghai.

This update outlines the new date for cosmetics registrants or filers to supply certain data under the country’s overarching cosmetic regulation – the Cosmetics Supervision and Administration Regulation (CSAR).

This includes: 

• product classification codes for cosmetics that have been approved before May 1, 2021; and 
• product efficacy summaries for cosmetics approved between May 1 and December 31, 2021. 

Since January 1, businesses have been required to substantiate statements made on labels regarding a product's functioning, such as whitening. This is needed when submitting registrations or filings for new products under the CSAR. They also have to submit to the NMPA website, a summary of data in support of all the claims on the labels or marketing materials of finished cosmetic products.  

According to the April 27 notice, companies can submit electronic documents without company stamps and supply stamped documents once COVID-19 is under control. 

The National Institution for Food and Drug Control of China (NIFDC) published the draft revision of “Safety and Technical Standards for Cosmetic” (Safety Standards) on March 31, 2022. This is the ...

The National Institution for Food and Drug Control of China (NIFDC) published the draft revision of “Safety and Technical Standards for Cosmetic” (Safety Standards) on March 31, 2022. This is the first-time revision of the Safety Standards since the first version was published in 2015.

The Technical Standards form part of the overarching framework of NMPA’s Cosmetic Supervision and Administration Regulation (CSAR). All cosmetic ingredients’ manufacturers must make sure that their ingredients comply with the requirements listed in the Technical Standards.

As of now, there are 7 lists in total in the 2015 version. They regulate different areas in using cosmetic ingredients, including banned and restricted ingredients in general, allowed ingredients in sunscreen, preservatives, colorants, and hair dyes in cosmetics.

The revision remains the structure of the 2015 version, while it makes changes in the following parts:

• Adjusted the application scope of restricted or limited cosmetic ingredients. The number of banned ingredients will increases from 1388 to 1393, while the number of restricted ingredients decreases from 47 to 44.
• The number of allowed ingredients is also adjusted in different sectors. There are 48 permitted preservatives in the revision which is down from 51. The number of approved sunscreens and colorants are 26 and 156 respectively, which are all down by one compared to the 2015 version. Currently, the available hair dyes are 73 which is down by two.
• It is also clear from the revision that NIFDC will not permit the use of preservatives containing mercury or mercury compounds.
• 10 physical and chemical inspection methods are excluded from the newly revised version. There will only be 67 approved methods for conducting physical and chemical inspections if the revision is adopted.
• However, eight more toxicological test methods are added. The total toxicological tests amount to 24.
• The number of efficacy evaluation tests also increased from three to five.
• There is an upgrade to the requirement for safety assessment reports in line with cosmetic registration procedures under CSAR.

The consultation period will last until April 30, 2022. If you have any considerations regarding the revision, you can contact GPC via email: compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com or via GPC WeChat: 46 0708381983 (GPC China) for information and help.

On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetic...

On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetics. It is expected to come into force on October 1, 2022. This measure will apply to all companies who register/notify their cosmetic or cosmetic ingredients under Cosmetics Supervision and Administration Regulation (CSAR).

This measure consists of seven chapters that extensively lay down rules relating to the responsibilities and obligations for notifiers, cosmetics’ adverse reaction report requirements, adverse reaction analysis and evaluation, investigation on adverse reaction, and administration supervision methods.

According to the measure, adverse reaction means a normal and proper use of cosmetics resulting in pathology change in skin and other related health issues. For better monitoring of the adverse reaction, companies are required to establish post-registration adverse reaction monitoring systems. Such systems will be used to collect information on adverse reactions to cosmetics sold via various channels including distributors, shops, and hospitals. Domestic companies are required to report all this collected information to NMPA, while overseas companies comply with this via their Chinese responsible person such as their Only Representative  (OR) and importer. Though the information will be submitted to NMPA, all the collected information must be kept for at least three years.

Further, this regulation categorizes the reactions into three types according to their severity level:

1.  Normal adverse reactions, which means minor ailments such as itchiness and rashes.
2. Severe adverse reactions. It refers to large-scale or deep damage to the skin and organs, including mucous membranes and systemic damage to other organs.
3. Extremely severe adverse reactions. It means those that might impact a lot of people or have a large social impact.

Based on different categories, the notification timeline is different. Normal adverse reactions must be reported to NMPA within 30 days when the adverse reaction is found, while reporting time for severe and extremely severe situations are shortened to 14 days and 3 days respectively.

For more inquiries regarding Chinese cosmetic regulation and compliance issues, please contact us via compliance@gpcregulatory.cn or send a message to our WeChat account of 46 0708381983 (GPC China). 

The Ministry of Environment and Ecology of China (MEE) published a Draft Plan for Digital Transformation in Hazardous Waste Management on the 18th of January 2022. This draft mainly focuses on the...

The Ministry of Environment and Ecology of China (MEE) published a Draft Plan for Digital Transformation in Hazardous Waste Management on the 18^th of January 2022.

This draft mainly focuses on the following aspects:

1.     Digital transformation in hazardous waste environment management

It mainly includes the implementation of the electronic management ledger of hazardous waste, the unified management of the transfer of hazardous waste, the implementation of a paperless operation of the inter-provincial transfer of hazardous waste, the regulation of hazardous waste management reports, and the regulation of hazardous waste export approval.

2.     Improving the intelligent level of environmental supervision of hazardous waste

This aim requires adapting to a new supervision mode on hazardous waste via the Internet of Things (IoT). This includes the construction of an online trading platform for hazardous waste and the pilot of third-party payment, and the deepening of the pilot work of collecting and transferring waste lead-acid batteries.

3.     Strengthen the docking and application of a national information system

This notification focuses on further strengthening the docking and application of a national information system that can clarify the relevant requirements for data docking, reporting, and application.

For further information, please email compliance@gpcregulatory.cn or message the WeChat account of 0708381983 (GPC China).

On the 16th of January 2022, China’s Ministry of Emergency Management (MEM) launched a new online platform for the registration of hazardous chemicals. The previous system launched in 2020 was clo...

On the 16^th of January 2022, China’s Ministry of Emergency Management (MEM) launched a new online platform for the registration of hazardous chemicals. The previous system launched in 2020 was closed on January 28, after which the new Hazardous Chemicals Registration Comprehensive Service Platform became operational.

This new platform solves the fear foreign companies once had about over-sharing their confidential business information, as this site helps secure such information. The new platform is referred to as National Registration Centre for Chemicals (NRCC).

With the new system, foreign companies can decide to either appoint a domestic agent or entrust the process to a third party so that confidentiality can be achieved. Before now, the only available option was the appointment of an agent which companies were wary of disclosing sensitive information to them.

Furthermore, Bryan Zhou says the foreign companies can meet registration obligations by working with the local importers of their substance. They can also appoint these local importers as their agents in China.

Therefore, there are lots of options that come with the new online platform. However, all options still require disclosure of information, some less than others. 

Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice &lsq...

Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification was published on 7th January 2022, and it is expected to come into force in July 2022.

With nine chapters and two attachments, the notification document details the requirements for the whole process of cosmetics production and usage, from the purchasing of raw materials to producing, experimenting, storing, selling and recalling cosmetics. It aims to ensure that high quality cosmetics are placed in the China market.

According to these specification requirements, it will apply to all companies that register or manufacture cosmetics in China. For those who secure manufacturing licenses or certificates before 1st July 2022, they are required to update their facilities, equipment, and management rules to meet the new specifications before 1st July 2023.

You can download the full specification requirements here. For more information or inquiry regarding China cosmetic regulations, you can email compliance@gpcregulatory.cn (for general business inquiry) or zhengmin@cn.gpcregulatory.com (for personal inquiry).

Last Update: 2022-01-21