Dr James Wakefield
The regulatory landscape in China is shifting. With the draft Cosmetic Supervision and Administration Regulation now formally approved, changes to cosmetics regulation that have been in the pipeline for years are due to be enforced.
Here, Dr James Wakefield, Director APAC at safety and regulation solution company Delphic, explains what these changes involve and how cosmetics and personal care brands are affected.
"Changes are imminent in the cosmetic regulatory landscape in China.
Since the publication in December 2018 of the draft Cosmetic Supervision and Administration Regulation (CSAR) there has been anticipation of significant changes to the way cosmetics are regulated in China. The draft regulation was formally approved by the China State Council on 3 January 2020.
The most fundamental change is that non-special use (or general) cosmetics will no longer be subject to mandatory animal testing, whether they are produced domestically in China or imported.
The reliance on animal testing presented an ethical dilemma for cosmetic companies wanting to tap into the China market, with many brands shying away from entering the China market due to wanting to avoid any association with animal testing and consumer perception.
The regulation paves the way for acceptance of cosmetic safety assessments in place of the reliance on animal testing, which along with the ethical concerns are often costly and time consuming. In the fast-paced beauty sector, time to market is also important, and the acceptance of safety assessment for cosmetics in China can expedite the process and reduce the cost while still ensuring that products placed on the market are safe.
There are however some caveats, for example, products which are targeted or aimed for use by children and infants will not be eligible for safety assessment and will still require animal testing, as will products containing new ingredients which have been approved or notified, but are not yet listed in the IECIC. It is therefore, important for cosmetic brands to be aware of these limitations.
One other important consideration is that in order to be eligible for safety assessment in place of safety assessment, a national GMP certification is required.
While many countries, particularly around Asia Pacific may provide GMP certification at the national level, this may pose an issue for manufacturers in Europe or the US, since there is no national GMP certification, and instead GMP certification is provided by 3rd party certification bodies.
In order to navigate this issue, countries which do not issue national GMP certification may look to provide or recognise an equivalent to national GMP to remove the reliance on animal testing.
For products which can be supported by safety assessment there are a number of considerations on the production of cosmetic safety assessments for China, not least that the safety assessments must be provided in Chinese.
Until the formal publication of the CSAR and the guidelines on implementation by the National Medical Products Administration, some questions over the final requirements remain, however, with our extensive team of Chinese speaking toxicologists, who are experienced in cosmetic safety assessment in Asia Pacific, Delphic HSE is well positioned to undertake safety assessments in Chinese to meet the Chinese requirements.
The CSAR also removes the requirement on pre-market authorisation before introduction, in favour of a simplified notification and post-market surveillance in conjunction with a Domestic Responsible Person, similar to the model in the EU.
While there are still some challenges, it is encouraging that the regulatory landscape in China is evolving to provide a formal route to market for imported cosmetics without the need for unnecessary animal testing, and we await the formal publication."
Dr James Wakefield will be addressing the most recent changes to China’s regulations at Cosmetics Business Live. His session "Regulatory shifts in China: Dealing with the red tape" will take place on day one of the conference, click here to find out how you can attend.
