Asia-Pacific Regulatory Update: Regulations Refined—GMPs, Children's Cosmetics, Animal Testing and More in China

Read the full article in the February 2022 digital edition. . .

Editor's Note: From September to December 2021, China ramped up its supervision of the cosmetic sector and further improved the new regulatory framework by introducing important regulations and notices on products and ingredients relating to animal testing, children's cosmetics, packaging, skin brightening and more. Following are brief updates.

Excessive Packaging

On Sept. 2, 2021, the State Administration of Market Supervision (SAMR) issued GB 23350-2021 Requirements of Restricting Excessive Package—Food and Cosmetics¹ in replacement of GB 23350-2009,² which was created to address the growing excessive packaging problem in China’s cosmetic sector. This new standard will take effect on Sept. 1, 2023, allowing a two-year grace period for stakeholders.

Specific revisions include: improving the definitions of some key terms such as contents, packaging layers, packaging interspace ratio, excessive packaging, etc.; introducing new terms and their definitions, such as “necessary spatial coefficient of commodity;” revising the packaging interspace ratio’s limit and calculation methods; and adding outer packaging volume detection methods, judgment rules and the necessary spatial coefficient for different products.³

Good Manufacturing Practices (GMPs)

On Sept. 8, China’s National Medical Products Administration (NMPA) consulted on the second draft of, “Good Manufacturing Practices for Cosmetics.”⁴ Compared with the first draft, released on Sept. 28, 2020, the main amendments include:⁵

1. Clarifying that the practices only apply to cosmetic registrants, notifiers and entrusted production enterprises in China;

2. Relaxing the qualification requirements for the person in charge of quality and safety, the person in charge of the quality management department, and the person in charge of the production management department;

3. Adding new responsibilities for the person in charge of quality and safety, including label review, adverse reaction monitoring and product recall management;

4. Clarifying that in entrusted production, the entrusting party (brand) should be the registrant or notifier; and

5. Revising the enterprise self-inspection system, testing capability management, production plant's environmental requirements, employee's health file retention period, etc.

. . .Read more in the February 2022 digital edition. . .

References

1. ChemLinked. (2021, Aug 8). GB 23350-2021 requirements of restricting excessive package—food and cosmetics. Available at: https://cosmetic.chemlinked.com/database/view/1298
2. ChemLinked. (2009, Mar 31). GB 23350-2009 requirements of restricting excessive package—food and cosmetics. Available at: https://food.chemlinked.com/database/view/1998
3. SAMR. (2021). China national standard announcement no.9 of 2021. Available at: https://www.samr.gov.cn/bzjss/tzgg/202109/P020210902563275358113.pdf
4. ChemLinked. (2021, Sep 8). Good manufacturing practices for cosmetics (second draft for comments). Available at: https://cosmetic.chemlinked.com/database/view/1308
5. National Medical Product Administration (NMPA). (2021, Sep 8). The comprehensive department of the state food and drug administration once again publicly solicited opinions on the 'cosmetics manufacturing quality management standards (draft for solicitation of comments). Available at: https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjhzhp/20210908164424103.html?type=pc&m=