From 1 May, Animal Test of Imported Non-Special Cosmetics Waived
On 4th March 2021, the National Medical Products Administration (NMPA) officially released the Provisions for Management of Cosmetic Registration and Notification Dossiers (Provisions), which take effect from 1st May 2021.
These Provisions finally conditionally waive the requirement for animal testing of non-special cosmetics imported into China, which has been in place since 1989. The European Chamber Cosmetics Working Group has worked continuously over the past 14 years to eliminate such requirements and advocate for advanced alternatives to animal testing.
Efforts of the Cosmetics Working Group
The Cosmetics Working Group Position Paper has included a recommendation to rescind animal testing since 2007.
Over the past 14 years, the Cosmetics Working Group has tracked the progress of relevant regulations, and communicated with various parties on industry updates and the alternative experimental methods used in other countries. The working group’s efforts include but are not limited to:
Collecting and collating
member companies' comments
on regulations relating to
animal testing exemptions and tests.
Providing feedback to the NMPA
and the National Institutes for
Food and Drug Control
on the industry landscape
and technological advances.
Organising meetings
between government and industry
to discuss alternatives
to animal testing and conditions
for animal testing exemptions.
Organising academic exchange training
and overseas study visits
for government and industry experts
involved in safety assessment
and toxicology research.
Many of the cellular models used in alternatives to animal testing are based on human cell designs. In-vitro replacement using human-derived cell models is more relevant to human risk assessment and thus are better predictors of human responses to the effects of products and ingredients.
Advocacy Results
In June 2020, the NMPA released the Cosmetics Supervision and Administration Regulations, in which significant changes and greater acceptance of animal testing replacements can be observed.
On 4th March 2021, the NMPA released the Provisions for Management of Cosmetic Registration and Notification Dossiers, which takes effect on 1st May 2021.
Under the Provisions, if a producer of non-special cosmetics has obtained the production quality management certification issued by the competent government department of the country or region where the production facility is located, and its safety risk assessment result has been substantiated, the producer may be exempted from submitting animal testing reports, except in the following circumstances:
The product will be used on infants or children.
The product uses new cosmetic ingredients that are still under safety monitoring.
The notification applicant, domestic responsible person or production enterprise are listed as key supervision targets according to the NMPA quantitative rating system.
These new requirements in the Provisions reflect a breakthrough in equal treatment by the Chinese cosmetics authorities in terms of registration and notification requirements for domestically produced and imported products. The requirements are also further refined and tend to be more standardised, complete and traceable.
However, apart from the lifting of animal testing, the quality and safety requirements for imported non-special cosmetics have not been reduced.
Janice Ma
Chair of the Cosmetics Working Group
“The European Chamber Cosmetics Working Group has been working with the relevant regulatory authorities in China for many years to actively promote the research, validation and adoption of alternative methods and the improvement of China's cosmetics safety risk assessment system, thereby continuously and further reducing animal testing.
In the context of the implementation of the new regulations, the recently promulgated Guidelines for the Technical Assessment of Cosmetic Safety (2021 Edition), and the forthcoming Provisions for Management of Cosmetic Registration and Notification Dossiers, provide the possibility for imported non-special cosmetics to be exempt from animal testing under certain regulatory conditions.
This reflects the determination of the Chinese regulatory authorities to speed up the construction and implementation of a scientific system for supervision of cosmetics, and is also a recognition of the joint efforts of industries and enterprises over the years.
”Implications
The waiving of animal testing for imported non-special cosmetics that meet the specified conditions will enhance China's image worldwide, and act to level the playing field for domestic and foreign enterprises, as well as to optimise the business environment. The new Provisions will attract more foreign cosmetics brands to the Chinese market, allow those already in China to further expand, and enrich the choice of imported cosmetics available to consumers.
Future Outlook
The Cosmetics Working Group hopes that further advanced alternative testing methods will be adopted, the capacity of domestic laboratories increased and reports from third party laboratories accepted by regulatory authorities. At the same time, domestic cosmetics brands can enhance their alternative testing technology, enabling them to enter markets where animal testing is banned, such as the EU.
What is #BECAUSEOFUS?
As the independent voice of European business in China since 2000, the European Chamber actively participates in China’s legislative process. Our advocacy activities are widely recognised by the Chinese authorities and maintained through the efforts of our working groups (WGs) and desks.
Since 2019, we launched our #becauseofus campaign to show our gratitude for the joint efforts of all stakeholders: governments, think tanks, member companies and our own WG and desk managers. In 2021, we will once again present five examples of our successful advocacy work, one of which will be selected as the winner of the 2020 #becauseofus campaign.
Please click on 'Read more' for details