On 14 September 2024, China’s Ministry of Industry and Information Technology (MIIT) announced a consultation to revise the national standard on "Regulations on the Preparation of Chemical Safety Labels" to align with the ninth revised edition of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS 9). The Ministry released this announcement on the portal of the National Standards Administration and invited stakeholders to comment on it by 14 October 2024. 

After the official publication of the National Standard on the Provisions on the Preparation of Chemical Safety Labels, the National Technical Committee for Standardization of Hazardous Chemicals Management will work on its implementation. 

Insights of New Labelling Standard 

This new labelling standard will have the following revised information: 

• Alignment with the technical content of the ninth edition of the United Nations GHS, including hazard classification and precautionary statements. 

• Implementation of the "one enterprise, one product, one code" regulation to meet the needs of national safety supervision of hazardous chemicals. Additionally, the means of transmitting hazardous chemical hazard information needed to be strengthened, and the last mile of hazardous chemical hazard information transmission needed to be opened. 

Previous Update  

Previously China’s National Standards Administration revised the Provisions on the Preparation of Chemical Safety Labels in 2009. However, this 2009 version followed GHS 2 while the Ministry has now proposed to align with the provisions of GHS 9. 

Comment Period and Enforcement Date 

Stakeholders are invited to comment on this draft announcement till 14 October 2024. The Ministry has not yet officially announced the enforcement date of the same. 

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​