Our latest episode of the Assurance in Action podcast is dedicated to the Chinese cosmetics market and focuses on finished cosmetic products. Join Intertek experts Laure Moutier and Celeste Teng as they discuss the requirements introduced by China's new Cosmetics Regulation (CSAR) that came into force more than a year ago.
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Welcome to the second episode of our Assurance in Action podcast series dedicated to the Chinese Cosmetics Market.
A new Chinese cosmetics regulation called “Cosmetic Supervision and Administration Regulation” came into force on January 1st 2021, replacing the previous “Cosmetic Hygiene Supervision Regulations”. In this podcast series, we’ll discuss the requirements introduced by this new regulation, and key changes and updates to cosmetics regulations in China.
I am Laure MOUTIER from Intertek France and I am with my colleague Celeste TENG from Intertek China who will answer some questions about the new Chinese regulations. 00:35:32.670 -->
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Our first podcast was about cosmetic ingredients in China. Today, we will talk about finished cosmetic products and help you understand the different steps to put your cosmetic products on the Chinese market.
To begin, could you please explain to us how cosmetics are classified in China?
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No problem. In China, cosmetics are divided into 2 categories. The first one is called special cosmetics, which includes hair coloring, hair perming, dark spot removal and whitening, sunscreen, anti-hair loss, plus any cosmetic product that claims a new type of efficacy that is represented by a letter instead of a number in the regulatory document called “Cosmetic Classification Rules and Catalogue”. Special cosmetic products can be a cosmetic product that claims an efficacy other than any of the 26 efficacies listed in the previously mentioned Cosmetic Classification Rules and Catalogue, a product used on an application area not mentioned in the list, or a product intended to be used by pregnant and breastfeeding women.
The second category is called general cosmetics. Basically, if it is not a special cosmetic product, then it is a general cosmetic product.
By the way, in the past we called the cosmetic products “special use” and “non-special use”. The new terms no longer contain the word “use” and we no longer say “non-special”. Instead, we say special and general. Some people might translate the term as “ordinary cosmetics”.
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Good to know. We often come across companies who wonder whether their products belong to cosmetics in China and should comply with CSAR or not. Could you give us some examples of personal care products that may be related to cosmetics in other parts of the world but are not considered cosmetics in China?
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Of course. To give an example, toothpastes do not belong to cosmetics in China but they will be managed in a way similar to general cosmetics in the near future. There will be regulations and guidelines specific to toothpastes. Similar examples may include mouthwashes, make-up products such as temporary tattoos or false nails, inks used for tattoos, toiletry products for animals, and Sodium Hyaluronate used as injection solution—these products do not belong to cosmetics in China.
Soaps for general use (for example cleansing) do not belong to cosmetics either. However, if a soap has a whitening claim, for example, which is one of the efficacies of special cosmetics, then this soap will be regulated as a special cosmetic.
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Interesting. And now, in concrete terms, what do the categories of special cosmetics and general cosmetics imply?
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In short, the process to put a product on the market will be different: special cosmetics will have to go through a registration process whereas general cosmetics will go through a notification process.
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And what are the similarities and differences between registration and notification?
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Well both registration and notification should be performed prior to importation. Both need to be cancelled if the product is no longer imported or sold in China.
On the other hand, registration of a special cosmetic product means you need to get an approval from the authority before you can import and sell the product in China. On the other hand, for notification of a general cosmetic product, the product can be imported as soon as the notification is completed, without having to wait for any approval from the authority.
Another key distinction is that registration certificates have a validity period—they are valid for 5 years—whereas notification has no time limit.
The last important difference is that, for notified general cosmetics, an annual report must be submitted to the authority each year as long as the product is sold on the market. The same annual report does not apply to registered special cosmetics.
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Thanks for the clarification. My next question is regarding the qualifications to sell cosmetic products in China: what are the minimum qualifications?
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According to the new CSAR, this company should be legally established, should possess a competent quality management system, and have the capacity to monitor and evaluate any adverse reactions.
Moreover, a non-Chinese company must appoint a Chinese company to be its Responsible Person (or RP) in China. Typically, this Chinese RP can be an importer or a distributor of the product, or a local subsidiary of the overseas company.
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Ok, I see that China also has a role called Responsible Person like in Europe. In terms of dossier, what information or document is needed to register or notify a cosmetic product?
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The product dossier includes quite a lot of information. For example, it includes information about the Notifier or Registrant company, about the Chinese RP, and about the Manufacturer, as well as a description of the quality management system and the cosmetic adverse reaction monitoring system in place. From a technical point of view, the dossier requires the product formula, the labels and packaging, a description of the production process, test reports, safety assessment reports, substantiation of efficacy and claims, etc. Then there is also a big administrative aspect; for example, a GMP certificate, free sale certificate, etc.
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Regarding the tests, can they be performed outside of China or do they have to be performed in Chinese-accredited laboratories?
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In fact only some non-mandatory tests can be performed outside of China (example: some efficacy tests). Most of the tests have to be performed in China in a lab with CMA accreditation. CMA stands for “China Meteorological Administration”.
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I have a last question regarding animal testing, we hear that the new Chinese regulation allows animal testing exemptions. What are the conditions?
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Exemption of animal testing is now possible if all the following conditions are met:
First, the product has to be a general cosmetic product and must not be intended for babies and children; second, the manufacturer of the product has to possess a GMP certificate issued by the local government; third, the safety assessment performed on this product has to fully confirm its safety; fourth, the product must not contain a new ingredient that is still within its 3-year safety monitoring period; and, last but not least, the involved companies must not be “blacklisted” by the authority in any way.
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Thank you very much, Celeste, for your detailed answers.
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It was my pleasure Laure.
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As a reminder to our listeners that Intertek can support you with the notification or registration of your cosmetic products in China. We can help you build your notification or registration files, identifying what the requirements are, which tests are necessary, and which information is needed.
Stay tuned for our next podcast, where we will continue discussing the commercialization of finished cosmetic products on the Chinese market with a focus on claims, labeling, safety assessments, and more.
Thank you for listening, and see you soon!
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