China Regulatory News

According to Notice No.15 of 2022 issued on May 24, 2022, by the General Office of the State Council of the People’s Republic of China, a newly approved Action Plan for New Pollutants Treatment was ...

According to Notice No.15 of 2022 issued on May 24, 2022, by the General Office of the State Council of the People’s Republic of China, a newly approved Action Plan for New Pollutants Treatment was released aiming to improve China’s new pollutants treatment capacity drastically by 2025.

The 14th Five-Year Plan (2021-2025) for National Economic and Social Development and Vision 2035 of the People’s Republic of China has made it clear from its outline that the treatment of the new major types of pollutants - Persistent Organic Pollutants (POPs), endocrine disruptors, antibiotics, and microplastics. This is a straightforward method to strengthen source control and prevent the generation of new pollutants.

For pollutants that pose risks to the environment and human health but have not been effectively treated, the new action plan aims to establish corresponding long-term treatment mechanisms, such as chemical management policies and plans for new regulations, guidelines, restrictions and bans on “priority” chemicals by 2025.

Under the New Pollutants Treatment scheme, responsibilities are in general distributed to the concerned authorities, including the Ministry of Ecology and Environment (MEE), Ministry of Industry and Information Technology, Ministry of Agriculture and Rural Affairs, State Administration for Market Regulation, General Administration of Customs, National Development and Reform Commission, etc.

Among them, the MEE oversees investigations and information gathering of chemical substances, and also formulates relevant technical standards for pollution control, including risk assessments, socio-economic benefit analysis, and hazard testing. MEE will prepare a new overarching chemical framework, the Regulation for the Environmental Risk Management of Toxic and Hazardous Substances (formerly known as ERAC). Once implemented, this regulation will govern both new and existing chemical substances and sit above the country's law on new substances – MEE Order 12, underlining more on toxic and hazardous existing substances. 

Some highlights and target publishing dates set from the Action Plan include:

• To complete the environmental risk screening of high concern and high volume (both production and consumption of chemical substances. 
• To finish the environmental risk assessment of the first batch of high-priority chemical substances.[TO3] 
• To publish a dynamic inventory of new pollutants before the end of 2025.
• To publish the first batch of Priority Assessment Chemicals (PACs) before the end of 2022. 
• To publish the first list of new pollutants subject to priority controls before the end of this year, in which case the production, processing use, import and export of these priority new pollutants shall be prohibited or restricted.
• To complete the first round of a national survey of chemical substances in China before the end of 2023, involving collecting data on chemical names, production and use volumes, and also, more detailed information on the manufacture and use of PACs. 

This plan at the same time focuses on “Green Production”. The MEE proposes to incentivize the substitution of toxic and hazardous chemicals for a "Green Manufacturing System", steering with a drive toward "Green products" and "Green supply chains". The toxic and hazardous chemical limits in national standards for consumer products like toys and school supplies are as well in the revision plan. Pilot projects for new treatments will be conducted in selected enterprises and industrial parks located in the Yangtze River basin, Yellow River basin, key drinking water sources, and key estuaries and bays.

Notably, hazard testing laboratories with adherence to Good Laboratory Practices (GLP) will also be developed, together with the National Chemical Substance Environmental Risk Management Information System and the Chemical Substances Computational Toxicology and Exposure Prediction Platform. It will cover not only industrial chemicals but also antibiotic medicines and pesticides. The persistent Bio-accumulative and Toxic Substances (PBT), Very Persistent, Very Bio-accumulative (vPvB), and adjuvants are gradually phased out and replaced.

Further goals are to crack down on the illegal production and processing of POPs and to strengthen the enforcement of new substance registrations via building computational toxicology and exposure assessment tools. For chemicals listed in the Inventory of Severely Restricted Toxic Chemicals and chemicals listed as obsolete items in the Catalogue for Guiding Industry Restructuring, usage will be strictly restricted to strengthen the environmental management for import and export. Proportion control of the priority new pollutants in products will be strengthened, incorporating control requirements for content of relevant new pollutants into mandatory standards for products like toys, school supplies, etc.

However, the plan only states directives for the MEE and other ministries to cohere in the next three years. Supporting regulations and implementation details shall be published to help the enforcement of the plan, which is expected to come later this year.

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.

Following the “One enterprise, one chemical product, and one QR code” principle, China’s new Hazardous Chemical Registration Comprehensive Service System was launched on February 16, 2022. It su...

Following the “One enterprise, one chemical product, and one QR code” principle, China’s new Hazardous Chemical Registration Comprehensive Service System was launched on February 16, 2022. It supports registry of hazardous chemicals with the automatic generation of QR codes – the Hazardous Chemical Safety Information Codes.

The original chemical management plan turned out to be overly ambitious after its launching, seeing the difficulties in production and supply chain paralysis which resulted from COVID-19 as well as the insufficient supports given from the legislation. The Guangdong pilot project that started on October 1, 2021, has delivered promising results. It mandated Hazchem Codes on labels, packaging, containers, and vehicles before hazardous chemicals leave the factory or warehouse in Guangdong, and the concerned authorities is planning to expand this project to involve more cities at an even larger scale.

For the time being, information supplementation in the new system gains more focus. There are more entries on information about the enterprise and chemicals that have to be filled out in the new system. For example, the identification number (passport number) of the legal person of the enterprise, hazard identification, classification report, dangerous goods classes, storage methods, and storage locations of chemicals, etc.

The local registration offices of different provinces are urging enterprises registered in the old system to supplement such information, where the deadlines are set respectively. The QR code cannot be generated until the registration information is complete, which makes information supplementation in the new system a necessary step for a smooth roll-out of this QR code policy. Currently, no penalty is imposed for failing to supplement the information in time; however, it is highly recommended for the enterprises to respond to the suggestion from their local registration offices.

Despite the high engagement with the national-level promotion of legislation, more time is still needed to finalize the supporting documents. For instance, GB 15258-2009 General Rules for Preparation of Precautionary Label for Chemicals is planned to be revised to incorporate QR code requirements in 2022. As for the draft of the Law of the People’s Republic of China on Safety of Hazardous Chemicals, it aims at establishing a hazardous chemicals information management system and implementing electronic identification as well as the whole life cycle information management of hazardous chemicals. All to be ready for the first reading at the 2022 Legislative Work Plan of the NPC Standing Committee.

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. 

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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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).