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REPOR T

ENSuRINg youR SuPPLIERS The DRA who is defined at the start of the filing
CooPERATE IN THE APPRoVAL PRoCESS or registration process has a crucial role to play
From January 1, 2024, a new important regulatory in the Post-Market Surveillance process.
requirement is the submission of safety information They must maintain sales and import records as well as
for all ingredients used in the product formulas samples of each batch of products imported into China.
for new cosmetic registrations and filings. your DRA is equally responsible for the quality and
The ingredient safety information can be submitted safety of the products you put on the market in China.
by completing a document known as “Annex 14” or From January 1, 2022, applicants of general cosmetics must
communicating the Cosmetic Ingredient Code (CIC). submit an annual report on the NMPA filing platform from
From January 2022, the ingredient supplier can apply for January 1 to March 31 of each year covering the activities of
the CIC by submitting all safety information to the NMPA’s the previous calendar year. The annual report should contain:
Cosmetic Ingredient Safety Information Platform. - an overview of the production and import of the products,
The CIC protects the confidential business information of the as well as an update for any suspended production
cosmetics ingredient supplier as only the NMPA can see the - self-inspection information compliance with China
safety information of the cosmetic ingredients submitted. laws and regulations, mandatory national
standards and technical specifications.
DEFINE youR PATHWAy To MARKET: As “special” cosmetics’ registration certificates are only
The Cross Border E-Commerce (CBEC) pathway for cosmetics valid for 5 years, a renewal application must be submitted.
was introduced in 2018 whereby cosmetics can be sold in Hong The renewal can be expected 15 working days after
Kong or on authorized online platforms (such as Tmall Global application and the new validity starts from the previous
or JD Worldwide) directly to end consumers without the need expiration date. The NMPA introduced a new processing
to submit a notification or registration application to the NMPA. timeline for renewal applications of “special” cosmetics.
Please note that “end consumers” means private individuals; sales Submissions can be made between 90 and 30 working days
to distributors, beauty institutes etc are NOT allowed via CBEC. prior to certificate expiration, however, we advise starting the
However, it’s important to note that more than 50% of all renewal process as early as one year prior to the certificate’s
cosmetic consumers still make purchases through physical expiration in case additional testing is required due to
retail channels (according to Daxue Consulting) such as changes in the law, regulations, technical standards or the
wholesale markets, supermarkets, department stores, product itself. And most importantly, timely initiation
dedicated counters, speciality chain stores, drugstores, beauty of renewal applications avoids any disruption in sales
parlours and direct selling. Department stores and speciality or expiry of the certificate. As mentioned previously,
stores make up two of China’s top three sales channels. “general” cosmetics certificates are valid indefinitely.
To sell via such physical channels both general and special During the lifetime of a product, changes in the product
cosmetics must submit either a notification or a registration name, the material supplier or in the packaging may be
application and any eventual animal testing may be required required. In this case an application for a certificate change
if your product does not meet the qualifying requirements is necessary. A change of DRA in China is possible as well. A
mentioned above. Companies should be clear, however, that manufacturer may not be content with their DRA, who may be
CBEC refers only to sales made to Chinese consumers from their distributor, and so they wish to appoint an independent
overseas. If brands want to make sales on mainland China DRA such as a consulting company. Changing a DRA
e-commerce platforms like Tmall or JD, then products will still is not possible when an application for filing or registration
need filings or registrations as previously described. Moreover, has been submitted and is in process. you must wait
cosmetics being sold via CBEC must still comply with the IECIC for the certificate to be issued in order to change the DRA.
and the Safety and Technical Standards for Cosmetics (STSC), Or you may choose to withdraw your application, change
which define the safety standards that cosmetic products must the DRA and start the application process again. In general,
meet in order to be approved for sale and use in China. changing the DRA will mean that a certificate will need to be
cancelled and be re-filed or reregistered as long as all the
uNDERSTAND THE oNgoINg REguLAToRy documents meet current NMPA requirements, and all tests are
REQuIREMENTS AFTER oBTAININg APPRoVAL completed. It will take around 6 weeks to change a DRA who is
Over the last few years, the NMPA has increased scrutiny in the same province, or 10 weeks for a DRA in a new province.
and emphasis on Post-Market Surveillance (PMS)
or Cosmetovigilance. This has led to the introduction To conclude, cosmetics manufacturers must be ready to satisfy
of many PMS requirements including adverse reaction the increasingly strict China regulatory requirements in order
reporting, maintenance of GMP systems, to access this burgeoning market. But the effort is worth it for
NMPA sampling inspections and even overseas the growing market potential, provided the initial set-up and
factory inspections for cosmetic manufacturers. regulatory compliance is appropriately implemented.

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