China Regulatory News

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.

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.

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.

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.