This article is updated with the latest information – CSAR guidelines updated 1st September.
If you are keeping an eye on animal testing in China for imported cosmetics you may have seen some information released in the last couple of weeks.
There is a lot of discussion which is also causing some confusion. As many of my clients are very interested in this topic I thought I would do a summary of the changes as they stand today.
What was announced on 16th June was The New Cosmetics Supervision and Administration Regulation – CSAR. This has been anticipated for a long time.
Since then there have been several further clarification to the overall regulation and the guidelines out 1st September finally say that in some circumstances animal testing will not be required! This is fantastic to finally have a reference to it. However it doesn’t give us the full picture yet – we don’t know exactly what documentation will be needed and which type of products will be exempt.
But it is certainly a big step in the right direction.
Here are 4 key areas that are outlined in the new regulation with a detailed explanation below:
1. Which cosmetics can go through filing vs. registration
2. What is needed for filing
3. Who is responsible and what are the implications for non compliance
4. Changes to process for new ingredients
1. REGISTRATION VS. FILING
Cosmetics are now split into two main categories – General Cosmetics & Special Cosmetics.
Special use cosmetics will still require registration and general cosmetics will use a filing system.
Special cosmetics are anything associated with hair dye, perm, freckle removal, whitening, sunscreen, hair loss and any products with “new efficacy”.
General cosmetics is everything else.
2. FILING PROCESS & REQUIREMENTS
The details on how the filing system will work has not been fully detailed. What has been indicated is companies will need to provide proof of Formula, GMP, Executive standard, Testing report, Certificate of free sale.
GMP – overseas production complies with cosmetic production quality manufacturing standard.
Certificate of free sale –shows you sell the product in your origin/production market.
The hope is that it means there will be no animal testing required for general cosmetics. But that is not yet fully confirmed.
The September update talks about Efficacy claims needing to be backed up by tests or specific documentation but does not outline exactly what – so this is also awaiting further confirmation.
There is a requirement that any brand importing the cosmetics has a local Chinese representative to apply for registration and/or filing. They will also be responsible for post market safety reports and analysis.
The fines for non-compliance have been increased significantly signaling the government wants the burden of product safety be put on brands and their local representatives.
4. NEW INGREDIENTS
It has been notoriously difficult to get new ingredients registered in China. No new ingredient has been passed since 2014. This new regulation will make this a lot easier. Helping get cutting edge ingredients into the China market.
They have split ingredients into 2 categories: High risk and low risk. High risk are preservatives, UV filters, colourants, hair dyes, whitening will all require registration. Low risk will process to filing. Both types will need testing – unclear if that requires animal testing.
The CSAR is a long overdue change to the existing Chinese cosmetic regulations but it does not state the end of animal testing in China.
We need to wait for the detailed guidelines from the NMPA before understanding if animal testing will still be a requirement.
This new system is due to be implemented by Jan 2021 so we hope to get detailed guidelines in next few months. Then we will hopefully really be able to say animal testing in China has ended (for general cosmetics) but for now we need to continue to await confirmation.
If you are interested in entering China you should start to prepare now. Do get in touch if you want to discuss further about the market and what is needed to enter.