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 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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