China Regulatory News

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.

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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

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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.

Starting from June 1, 2024, medical devices listed in the third batch implementation product catalogue in China must complete registration and obtain a Unique Device Identification (UDI) in accordance...

Starting from June 1, 2024, medical devices listed in the third batch implementation product catalogue in China must complete registration and obtain a Unique Device Identification (UDI) in accordance with the new regulations, according to the National Medical Products Administration (NMPA) Announcement No. 22 of 2023.

Implementation of the UDI System

The Unique Device Identification (UDI) System Rules, which were established by the NMPA on October 1, 2019, aim to standardise the construction of UDIs and strengthen the lifecycle management of medical devices. Each device receives a unique identification code, and registrants must create, maintain, and assign the UDI for devices, upload data, and use the UDI to improve the overall lifecycle management of devices.

First and Second Batch

On January 1, 2021, NMPA decided to implement the UDI system for the first batch of 69 Class III medical devices, and on June 1, 2022, following the implementation for the second batch of other Class III medical devices (including in vitro diagnostic reagents), Order No. 22 of 2023 announced the third batch of products to adopt the UDI system.

Details of the Third Batch

This third batch includes high-demand single-use products, items selected for centralized procurement, and medical aesthetic products, totaling 103 types in 15 categories. The detailed catalogue can be found on the official announcement page here.

Compliance Requirements

The new regulations took effect on June 1, 2024. From that date, new registration applicants are required to submit product identifiers for the smallest sales unit in the registration system. For devices registered before June 1, 2024, registrants must provide these identifiers when renewing or amending their registrations.

On April 30, 2024, the National Institutes of Food and Drug Control (NIFDC) published two essential guidelines for the identification and assessment techniques of risk substances in cosmetics. These t...

On April 30, 2024, the National Institutes of Food and Drug Control (NIFDC) published two essential guidelines for the identification and assessment techniques of risk substances in cosmetics. These two guidelines are summarized below in two scenarios.

Scenario one

First group

• Special cosmetics, baby & child cosmetics, cosmetics containing new ingredients within the safety monitoring period.

Second group

• Products containing nanomaterials.

• Non-sunscreen cosmetics using sunscreens not listed in the "Cosmetic Safety Technical Specifications".

• Products claiming efficacy in acne treatment, anti-wrinkle (excluding physical anti-wrinkle), deodorizing, dandruff removal, hair removal or exfoliation (excluding physical exfoliation).

• Product forms that include patches, films, containing substrates (patches, films, substrates containing active ingredients or dyes, etc.), or aerosols.

• Products that require the use of instruments or tools (excluding brushes, cushions, hair styling tools used only for auxiliary application, etc.

Scenario two

All other ordinary cosmetics from the second group, but not included in scenario one.

These two guidelines are applicable to registrants and filing applicants to identify and evaluate the possible risk substances in cosmetics.

For more information on compliance with China’s cosmetic regulation, please contact GPC Regulator Executive:  jingyan@cn.gpcregulatory.com or annie@cn.gpcregulatory.com

On 19 April 2024, China’s Centre for Drug Re-evaluation (NMPA) and the National Centre for Adverse Drug Reaction Monitoring issued final guidelines on the collection and reporting of adverse reactio...

On 19 April 2024, China’s Centre for Drug Re-evaluation (NMPA) and the National Centre for Adverse Drug Reaction Monitoring issued final guidelines on the collection and reporting of adverse reactions to cosmetics for registrants and filers.  

The guidelines provide guidance on how to go through each step of the procedure, which includes the following:

• Collection of adverse reactions to cosmetics.

• Recording and communication of adverse reactions to cosmetics.

• Confirmation of cosmetic adverse reaction reports.

• Analysis and evaluation of adverse reactions of cosmetics.

• Submission of Cosmetic Adverse Reaction Reports.

• Quality control of Cosmetic Adverse Reaction Reports

• Cosmetic adverse reaction record management.

Categorization and Reporting Procedures

Reactions are categorized into 3 groups according to how severe they are as follows:

• General cosmetic adverse reactions

• Serious cosmetic adverse reactions

• Cosmetic adverse reactions that may cause greater social impact.

Registrants and recorders must report cosmetic adverse reactions within a specified time frame, starting from the first discovery of the reaction, which is recorded as Day 0. General adverse reactions should be reported within 30 days, serious reactions within 15 days, and reactions with social impact within 3 days.

Record-Keeping and Administration

Monitoring records should as a minimum include reporter information, information about adverse reactions, symptoms or signs, the severity of the adverse reaction, date of occurrence of adverse reactions, date of discovery or knowledge of the adverse reaction, date of reporting of the adverse reaction, name of the cosmetics used, etc.

Records, whether paper or electronic, should be kept properly to prevent loss or damage, be clear, legible, and easy to understand and have  a retention period of at least three years.