China proposes unified framework for managing cosmetics and toothpaste standards

China’s National Medical Products Administration (NMPA) has released draft measures that would establish a unified framework for the development, publication, implementation, review and management of cosmetics standards.

The proposed Regulations on Supervision and Administration of Cosmetics would apply to both cosmetics and toothpaste and would take precedence over any previous NMPA provisions that conflict with them. An implementation date has not yet been announced.

The draft divides cosmetic standards into three categories:

• mandatory national standards, covering general terminology, labelling requirements and basic safety requirements for cosmetics, their ingredients and packaging materials that come into direct contact with products;
• the Safety and Technical Standards for Cosmetics (STSC) and other technical specifications, issued by the NMPA, where no mandatory national standard exists. These would cover technical requirements for product registration and notification, manufacturing and distribution activities, safety requirements requiring periodic updates and general testing and inspection methods; and
• industry standards, which are generally voluntary and would apply to areas such as cosmetic ingredients, direct-contact packaging materials, efficacy evaluation methods and general testing methodologies. 

Grounded in China's Standardization Law and the Cosmetics Supervision and Administration Regulation (CSAR), the measures would provide a system-wide rulebook for cosmetics standardisation. They would also complement the 2024 charter of the NMPA's Cosmetics Standardization Technical Committee by streamlining procedures for developing and maintaining standards.

Compliance implications

Mandatory standards would be legally binding on all entities involved in the production, import, distribution and regulation of cosmetics. Importantly, the draft clarifies that provisions contained in otherwise voluntary standards would become mandatory when referenced by laws, regulations or mandatory standards.

The measures also encourage companies to adopt industry standards and to establish internal enterprise standards that exceed minimum regulatory requirements.

Transition and implementation

Under the proposal, the transition period between publication and implementation of a new standard would generally be limited to no more than two years, with the exact period determined by factors such as public health impact, regulatory implications, industry readiness and technical complexity.

During the transition period, companies would generally be permitted to comply with either the old or the new mandatory standard. Products manufactured or imported before the implementation date could typically remain on the market until the end of their shelf life, unless evidence emerges that products compliant with the previous standard may pose a risk to human health.

More structured standards development process

For industry, the draft introduces a more predictable and time-bound standards development process.

Drafting bodies would be expected to complete the development of technical specifications and industry standards within 18 months from project approval to submission. As a result, regulatory affairs teams may need to monitor standard-setting projects from the planning stage rather than waiting for draft texts to be released.

Public consultation requirements are also clearly defined. The NMPA would generally provide:

• at least 30 days for consultation on project plans; and
• at least 60 days for consultation on draft standards.

If technical requirements in a draft standard change significantly, further consultation would be required. However, under an emergency fast-track procedure, these consultation periods could be shortened to as little as seven days and 30 days, respectively.

Once adopted, standards would be reviewed at least every five years to determine whether they should be maintained, revised or repealed.

International alignment

The draft places significant emphasis on international harmonisation. It encourages the adoption of international standards and "advanced foreign standards", adapted where necessary to Chinese conditions, and calls for their accelerated incorporation into China's regulatory framework.

Standards development would be required to be science-based and take into account international standards, domestic industry conditions and regulatory needs.

The draft measures, comprising 50 articles across seven chapters, were released for public consultation on 30 June. Comments may be submitted to hzpjgs@nmpa.gov.cn using the official feedback form until 30 July.