China Regulatory News

In a move to strengthen the control over chemicals that can be misused in the production of illicit drugs, China has introduced new regulations that add seven substances to its regulated precursor che...

In a move to strengthen the control over chemicals that can be misused in the production of illicit drugs, China has introduced new regulations that add seven substances to its regulated precursor chemicals list. These substances, including n-phenylpiperidin-4-amine, norfentanyl, and cannabidiol, will be subject to strict oversight from 1 September 2024. The new regulations impact the production, transport, storage, and trade of these chemicals, requiring businesses to adopt tighter compliance measures to align with China's evolving chemical management laws.

Key Points

Overview of the New Substances Added

The seven newly regulated substances include key precursors often used in pharmaceutical and chemical production but with potential for illegal diversion into drug manufacturing. Some notable chemicals include:

• N-phenylpiperidin-4-amine (4-AP): Used in pharmaceutical synthesis, now controlled due to its role in fentanyl production.

• Norfentanyl: A metabolite of fentanyl and a precursor for synthetic opioids.

• Cannabidiol (CBD): Regulated to control non-pharmaceutical uses while allowing research and medical applications under strict supervision.

• Other substances include BMK glycidic acid esters and PMK glycidic acid esters, which are crucial precursors for synthetic drugs such as MDMA and methamphetamine​ (2-methyl-3-phenyl glycidylic acid and its esters, 3-oxo-2-phenybutyric acid and its esters, 2-methyl-3-[3,4-(methylenedioxy)phenyl]glycidyl] glycidyl)

• 1-tert-butoxycarbonyl-4-(N-phenylamino)piperidine which is a precursor to N-phenylpiperidin-4-amine 

Regulatory Framework and Requirements

The Ministry of Public Security, in cooperation with several other agencies, has categorized these substances as Category II precursor chemicals. The key compliance elements include:

• Licensing and Permits: Businesses must obtain licenses to produce, handle, and distribute these chemicals.

• Transportation and Storage: Special approvals are required to transport and store these chemicals to prevent unauthorized access.

• Import and Export Controls: Importers and exporters need to follow specific protocols, including declaring the intended use and obtaining prior approval from the relevant authorities​

Impact on Businesses

The addition of these chemicals to the regulated list creates significant compliance obligations for businesses involved in their manufacture, handling, or distribution. Key impacts include:

• Increased Compliance Costs: Businesses will need to invest in proper documentation, security systems, and monitoring technologies to comply with the new regulations.

• Supply Chain Disruption: Companies handling these substances will face stricter controls on the movement and storage of goods, potentially slowing down operations.

• Enhanced Scrutiny: Regulatory authorities are expected to impose stringent audits and inspections, requiring businesses to maintain comprehensive records of their activities related to these substances​

On 24 July 2024, GB 30000.1-2024 "Specification for Classification and Labelling of Chemicals—Part 1: General Rules" was officially published on the National Public Service Platform for Standards In...

On 24 July 2024, GB 30000.1-2024 "Specification for Classification and Labelling of Chemicals—Part 1: General Rules" was officially published on the National Public Service Platform for Standards Information. This updated standard, which aligns with the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8), will come into force on 1 August 2025 and will replace the existing GB 13690-2009 "General Rules for the Classification and Hazard Communication of Chemicals."

Draft Release and Public Consultation

On 12 March 2024, China's Ministry of Industry and Information Technology (MIIT) released a draft of the revised standard GB 30000.1. This update aims to align China's chemical classification and labelling standards with the UN's GHS 8. Public comments on this draft were invited until 12 April 2024.

Key updates to GB 30000.1

The revised GB 30000.1 introduces significant updates and new categories:

• Terminology and Definitions: Consistency with GHS 8 ensures clear, internationally recognized terminology.

• Hazard Classification: Adds a new category for desensitized explosives, bringing the total number of hazard classes in China to 29.

• Labeling Requirements: Special provisions are made for labeling, particularly for metals and alloys in non-dispersible forms. GHS labels must be used in workplaces, with alternative methods like area-specific labels allowed.

• Safety Data Sheets (SDS): Updated SDS requirements include detailed hazard communication guidelines and cut-off values for different hazard categories.

Exemptions

Certain products, such as pharmaceuticals, food additives, cosmetics, and pesticide residues in food intended for ingestion, are exempt from these labeling requirements unless workers are likely to be exposed during transport.

Implementation and Compliance

The revised GB 30000.1 will replace the existing GB 13690-2009 standard. Once adopted, it will better align China's chemical safety standards with international practices, improve hazard communication and ensure safer handling and transportation of chemicals within China and in international trade.

The adoption of GB 30000.1 is a significant step in enhancing chemical safety and regulatory compliance in China. By aligning with the UN GHS 8, China is demonstrating its commitment to global safety standards, facilitating smoother international trade and improving overall chemical safety management.

For more GPC information in Chinese, follow us on WeChat:  

On July 8, 2024, China’s National Institute for Food and Drug Control (NIFDC) released the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials". These...

On July 8, 2024, China’s National Institute for Food and Drug Control (NIFDC) released the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials". These guidelines aim to enhance regulatory oversight by ensuring that cosmetic products maintain their safety, effectiveness, and stability, and prevent adverse interactions with packaging materials. By evaluating compatibility, potential risks are identified and mitigated, preserving the quality and functionality of cosmetic products throughout their shelf life. This news highlights the key points, evaluation procedures, and results as outlined in the guidelines.

Key Indicators

• Extractables: These are substances present in packaging materials that can be extracted using solvents, such as additives, residual monomers and degradation products.

• Leachables: These are substances that migrate from packaging materials into cosmetics during migration tests or are generated during testing.

Evaluation Procedure

1. Preliminary Data Collection:

• Identify the packaging materials that come into direct contact with the cosmetics.

• Analyze the composition of these materials and understand the conditions under which they interact with the cosmetics.

• Review theproduction process of the cosmetic.

2. Extraction Test:

• Obtain information on extractables to predict potential leachables.

• Choose extraction solvents with properties similar to those of the cosmetic.

• Conduct extraction under conditions that mimic the cosmetic processing environment to extract as many substances as possible.

3. Interaction Study:

• Assess the migration or reaction of packaging components into cosmetics under accelerated and long-term stability test conditions to obtain information on leachables.

4. Evaluation Conclusion:

• Perform a safety assessment of the leachables.

• Determine if the packaging material is suitable for use with the cosmetic.

Critical Parameters/Indicators

1. Extraction Test:

• Solvent selection should consider compatibility with the cosmetic, focusing on pH, polarity and ionic strength.

• Extraction conditions should mimic the processing conditions of the cosmetic.

2. Migration Test: Determine key indicators based on the type of packaging material:

3. Adsorption Test: Conducted if necessary to further assess interaction.

Results

The results are based on the analysis of extractables and leachables obtained from the tests. The types and quantities of leachables are identified, and their safety is evaluated. If the leachables fall within the limits specified in the Cosmetic Safety Technical Specification, the packaging material is deemed suitable. For substances without specified limits, a safety risk assessment ensures that they do not cause harm to human health under normal conditions of use. Stability tests further support the evaluation of the interaction between the cosmetic and the packaging materials, ensuring that the quality and safety of the cosmetic is maintained.

This structured approach ensures comprehensive assessment and compliance with safety standards, safeguarding consumer health and maintaining product integrity.

For more GPC information in Chinese, follow us on WeChat:

China has updated its Restriction of Hazardous Substances (RoHS) regulation by adding four new phthalates to the list of restricted substances. On June 29, 2024, the "Announcement on the Approval and...

China has updated its Restriction of Hazardous Substances (RoHS) regulation by adding four new phthalates to the list of restricted substances. On June 29, 2024, the "Announcement on the Approval and Release of 109 National Standards and 4 National Standard Amendments" (National Standard Announcement [2024] No. 14) was released. 

The move reflects China's commitment to environmental protection and is in line with global standards. The new restrictions will come into effect on January 1, 2026 

Newly Restricted Phthalates: 

The four new phthalates added to the restricted list are: 

1. DEHP (Bis(2-ethylhexyl) phthalate) 

2. BBP (Butyl benzyl phthalate) 

3. DBP (Dibutyl phthalate) 

4. DIBP (Diisobutyl phthalate) 

Each of these phthalates must not exceed a concentration limit of 0.1% in electronic information products (EIPs). 

Impact on Manufacturers  

Manufacturers and suppliers of Electrical and Electronic Products  must ensure compliance with these new restrictions in order to legally sell their products in China. Non-compliance may result in penalties and restricted market access. 

Steps to Compliance 

• Review Product Composition: Assess current product formulations to ensure that the concentration of the restricted phthalates is within the permissible limit. 

• Update Testing Protocols: Implement updated testing protocols to include the newly restricted substances. 

• Documentation and Reporting: Maintain appropriate documentation and reporting to demonstrate compliance. 

This update aligns China’s RoHS with global regulations (i.e. EU RoHS 2.0)  and improves the safety and environmental sustainability of electronic products. 

On July 8, 2024, China’s National Medical Products Administration (NMPA) announced the comprehensive implementation of electronic submission for cosmetics and new cosmetic ingredients, effective fro...

On July 8, 2024, China’s National Medical Products Administration (NMPA) announced the comprehensive implementation of electronic submission for cosmetics and new cosmetic ingredients, effective from September 1, 2024. This significant regulatory change, outlined in Announcement No. 91 of 2024, aims to enhance efficiency and facilitate the registration process for companies involved in the cosmetics industry.

Background

In accordance with the Cosmetics Supervision and Administration Regulation (CSAR) issued by the NMPA, China applies a registration management system for higher risk new cosmetic ingredients and a filing management system for other new cosmetic ingredients. New cosmetic ingredients are defined as natural or synthetic raw materials used in cosmetics for the first time in China. Registration entities can determine whether an ingredient is a new cosmetic ingredient by consulting the Inventory of Existing Cosmetic Ingredients in China (IECIC).

Key Points of the Announcement

1. Full Implementation of Electronic Submission:

Starting from September 1, 2024, all relevant entities, including registrants, filers, domestic responsible persons and manufacturing enterprises, must submit all documents electronically via the Cosmetics Registration and Filing Information Service Platform. Paper documents will no longer be accepted but must be archived by the relevant domestic entities for future reviews or inspections.

2. Submission of Original Documents:

Original documents, third party certification materials, and other required paper documents must be signed and confirmed for authenticity by the registrant, filer, or domestic responsible person before being submitted electronically through the Information Service Platform.

3. Procedural Adjustments:

The NMPA’s cosmetic technical institutions and provincial drug supervision departments will adjust their submission procedures to optimise the acceptance, technical review and management of registration and filing dossiers.

Recommendations for Enterprises

1. Apply for Certificate Authority Certificates Early:

Companies are advised to apply for Certificate Authority (CA) certificates in advance to facilitate online electronic signing. This preparation will allow efficient handling of multi-page documents with electronic signatures, thereby eliminating the need to print, sign and scan documents and significantly improving workflow efficiency

2. Organize and Archive Documents:

Companies must meticulously organise and archive all electronic documents in accordance with the new regulations. Given that these documents will be critical for future reviews or inspections, it is essential to ensure their completeness and accuracy.

For more GPC information in Chinese, follow us on WeChat:

In May 2024, in accordance with the "Measures for the Environmental Management Registration of New Chemical Substances" (MEE Order No. 12) and the requirements outlined in the "Announcement on the Rel...

In May 2024, in accordance with the "Measures for the Environmental Management Registration of New Chemical Substances" (MEE Order No. 12) and the requirements outlined in the "Announcement on the Release of the Guide for Environmental Management Registration of New Chemical Substances and Related Supporting Forms and Instructions for Completing Forms" (MEE Announcement 2020 No. 51), the Ministry of Ecology and Environment (MEE) of China made significant updates to the "Inventory of Existing Chemical Substances in China". This update includes the addition of 7 new chemical substances and the inclusion of 34 previously registered chemical substances.

Newly Added Chemical Substances

Before producing, importing or using these chemical substances, chemical-related enterprises, filing persons and registrants must submit application materials and go through the review and public announcement processes in accordance with the requirements in MEE Order No.12. For substances already included in the "Inventory of Existing Chemical Substances in China," the application process may be simplified.

Details of Newly Added and Registered Chemical Substances

The detailed list of newly added chemical substances (7) and the list of registered chemical substances (34) are as follows:

Newly added chemical substances

Newly registered chemical substances

For more GPC information in Chinese, follow us on WeChat 

The National Center for Food Safety Risk Assessment (CFSA) in China has held a public consultation on seven food contact materials (FCMs) and additives. The consultation focused on innovations in food...

The National Center for Food Safety Risk Assessment (CFSA) in China has held a public consultation on seven food contact materials (FCMs) and additives. The consultation focused on innovations in food contact materials and additives and included a comprehensive review of new materials, expanded uses of existing additives, and the introduction of new resin types.

New Materials for Food Contact Coatings

Chromium Nitride Coatings

A significant development is the introduction of chromium nitride coatings, which are made from nitrogen and chromium. These coatings, identified by CAS numbers 12053-27-9 and 24094-93-7, are designed for use in food contact applications. The coatings, which are applied using physical vapor deposition (PVD) technology, improve the hardness and non-stick properties of metal substrates. The nitrogen content in these coatings ranges from 18% to 40%, while the chromium content ranges from 60% to 82%.

Chromium Nitride Coatings are already approved by the US FDA and the Dutch Ministry of Health, these coatings offer superior surface hardness and non-stick properties for metal substrates.

Expanded Use of Food Contact Additives

C.I. Pigment Black 7; Carbon Black

The use of C.I. Pigment Black 7 (Carbon Black) has been extended to food contact applications with polycyclohexylene dimethylene terephthalate (PCT) plastics. This additive, recognized by CAS number 1333-86-4, is known for its excellent light resistance, chemical and heat stability. It is essential for maintaining color intensity and durability at low addition levels. However, it must meet specific purity requirements and is restricted from use in foods containing more than 50% ethanol or at temperatures above 100°C.

C.I. Pigment Black 7 is widely used in a variety of materials, this pigment's approval for PCT plastics by several international bodies highlights its stability and effectiveness in maintaining color and durability.

Sodium Hydroxide

Sodium hydroxide, identified by CAS number 1310-73-2, is now approved for use in the production of polyvinylidene fluoride (PVDF) plastic materials. This substance, which is soluble in water, ethanol and glycerol, plays an important role as a processing aid. PVDF materials containing sodium hydroxide are restricted to use at temperatures of up to 70°C and for up to 24 hours. They must not come into contact with foods with high ethanol content or fatty foods.

Sodium hydroxide is already approved for a variety of uses, the extension of this substance to PVDF production underscores its role as an important processing aid that improves the production efficiency of PVDF materials.

Dibutyl Sebacate

Another additive, dibutyl sebacate (CAS number 109-43-3), has had its use extended to PVDF plastic materials. This clear, colorless liquid improves the flow and plasticity of PVDF materials during processing. Conditions of use are similar to sodium hydroxide, with restrictions on temperature and food contact.

Dibutyl Sebacate’s role as a plasticizer improves the processing properties and plasticity of PVDF materials, making it an essential additive for food contact applications.

2,4,8,10-Tetraoxa-3,9-Diphosphaspiro[5.5]Undecane

This compound, identified by CAS number 154862-43-8, is now approved for use in adhesives that come into direct contact with food. At a maximum use level of 0.04%, this additive provides excellent thermal and hydrolytic stability in adhesives. It is suitable for room temperature applications and certain hot filling conditions but must not come into contact with fatty foods.

The approval of 2,4,8,10-Tetraoxa-3,9-Diphosphaspiro[5.5]Undecane for food contact adhesives highlights its stability and protective qualities against degradation and yellowing.

New Resin Varieties for Food Contact

Copolymer of Trimethoxyphenylsilane, Methyltrimethoxysilane, and Silica

A new copolymer resin, composed of trimethoxyphenylsilane, methyltrimethoxysilane, and silica is now approved for use in coatings. This resin, which is only suitable for metal surfaces, offers excellent adhesion, scratch resistance, non-stick properties, wear resistance and corrosion resistance.

This innovative resin, approved for coatings on metal surfaces, brings significant improvements in adhesion, scratch resistance, and overall durability.

Expanded Use of Food Contact Resin

Hydrogenated Benzene, Ethenyl-, Polymer with 1,3-Butadiene

The use of a hydrogenated polymer resin, known by CAS number 66070-58-4, has been extended for food contact coatings. This resin, previously approved for a range of plastic materials, is now suitable for single use in food packaging coatings. It is particularly noted for its excellent anti-fouling and heat-sealing properties.

Hydrogenated polymer resin’s expanded use in food contact coatings emphasizes its effectiveness in providing protective and functional coatings for food packaging materials.

The consultation on these new varieties of food contact products aims to enhance food safety and innovation in food packaging materials, reflecting ongoing advances in materials science and regulatory standards.