00:15 --> 00:53
Speaker 1
Welcome to the third and last 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 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.
00:53 --> 00:54
Speaker 2
Hello everyone.
00:55 --> 01:24
Speaker 1
In our first podcast on cosmetic ingredients in China, we detailed the requirements to use new cosmetic ingredients and existing cosmetic ingredients in cosmetic products in China.
In our second podcast, we helped you understand the different steps to put your cosmetic products on the Chinese market.
And today, in this third and last podcast, we will continue discussing the commercialization of finished cosmetic products on the Chinese market with a focus on claims, labeling, safety assessments, and more.
01:25 -->01:34
Speaker 1
To begin, maybe we can talk about product labeling. Can you tell us what the new labeling requirements are? For example, what must appear on the labels?
01:35 --> 02:40
Speaker 2
Sure. The new cosmetic labeling requirements can be found in a text called “Administrative Measures on Cosmetic Labeling” which was published on June 3, 2020. It will be effective starting from May 1st, 2022, so in about a month.
According to this regulatory document, a cosmetic product label should include the product’s name, net weight, expiry date, directions for use and any safety warnings, as well as the list of all ingredients in the product and the product’s notification or registration number. The name and address of the notifier or registrant, of the Chinese Responsible Person, if there is one, and of the manufacturer should also be included. Further, the label should include the production license number of the manufacturer if it is a locally manufactured product.
02:42 --> 02:56
Speaker 1
OK, that seems like a lot of mandatory information to place on the label. How about if the product has a primary and a secondary packaging, like a bottle in a carton box? Should everything be listed on both the carton box and the bottle?
02:57 --> 03:15
Speaker 2
If there is a secondary packaging, the primary packaging that is in direct contact with the product content doesn’t need to list all the aforementioned information, but it should at least contain the product’s Chinese name and expiry date.
03:16 --> 03:20
Speaker 1
What about small-sized products? Do they have different requirements?
03:21 --> 03:49
Speaker 2
For products with a net weight not exceeding 15 g or 15 mL, only the product’s Chinese name, net weight, expiry date, and the name of the registrant or notifier are required. If it is a special cosmetic product, its registration number is also required. The other mandatory information can be stated in a built-in user manual.
03:50 --> 03:56
Speaker 1
And are these labeling requirements applicable if the product is just a free sample?
03:57 --> 04:09
Speaker 2
Yes, 100%. The cosmetic labeling requirements apply to all products provided to consumers even if they are not-for-sale samples or free gifts.
04:10 --> 04:25
Speaker 1
Well-noted. And since overlabeling is authorized in China, can we have all this required information in a Chinese label affixed to the original packaging, so that we don’t have to design Chinese artworks specifically?
00:04:26 --> 04:54
Speaker 2
Yes, that is indeed a practice currently adopted by a lot of foreign cosmetic companies. I would also like to remind companies that any Chinese claims related to the product efficacy and safety must be the same as those on the original packaging. That means we cannot simply hide a prohibited claim on the original packaging with the Chinese label.
04:55 --> 05:03
Speaker 1
Thank you for the reminder. Speaking of prohibited claims, can we find an official list of authorized and prohibited claims in China?
05:04 --> 05:31
Speaker 2
For the time being, such a list is not available. However, we have clear directions regarding the claims we cannot make for cosmetic products; for example, any medical terminology, absolute terms like “the best”, “the top”, “the number 1”, or any assertive statement or guarantee when it comes to product efficacy or safety.
05:32 --> 05:47
Speaker 1
That’s clear. I just have one last question about labeling before we move to the next topic. It is a question I often get from European cosmetic companies: currently, is there any obligation to label nanomaterials and allergens in China?
05:48 --> 05:49
Speaker 2
No, there is none.
05:50 --> 06:05
Speaker 1
Ok. Got it. Now since you mentioned product efficacy, please tell us more about the relevant regulatory requirements; for example, how do we justify the efficacy claims? What are the requirements in terms of clinical studies, or testing laboratories, etc.?
06:07 --> 08:02
Speaker 2
All efficacy claims must be substantiated in accordance with a regulatory text called “Standards for Cosmetic Efficacy Claim Evaluation”. The type of substantiation may include clinical studies, consumer use surveys, laboratory tests, scientific research, and/or regulatory data, depending on the type of efficacy claims. There are 26 types of efficacy claims specified in the text “Cosmetic Classification Rules and Catalogue”. Among these 26 efficacies, some do not need to be substantiated since they can be visually or olfactorily identified; for example, cleaning, makeup, perfume, hair colouring, hair perm, hair removal, etc. All the other efficacies need some form of substantiation. Other than that, cosmetic claims such as “suitable for sensitive skin”, “tear-free formula”, “gentle formula”, etc., also need to be substantiated.
Sometimes, scientific literature can be regarded as a sufficient form of substantiation; for example, for moisturizing. In other cases, clinical study is a must; like for anti-acne, nourishing, or repairing. It is also important to bear in mind that spot removing / whitening, sunscreen, and anti-hair loss require clinicals conducted in an accredited lab in China using the official study protocols.
08:02 --> 08:14
Speaker 1
Does that mean if I have an existing clinical study report for sunscreen or whitening efficacies which was issued outside of China, I cannot use it in China for product registration?
08:15 --> 08:26
Speaker 2
Indeed, you have understood correctly. If you want to register a sunscreen or whitening product in China, you must conduct clinical studies in China.
08:27--> 08:43
Speaker 1
Noted. I also heard that, starting from May 1st 2022, efficacy abstracts will have to be completed and published online on the NMPA website. Can you please tell us more about these efficacy abstracts? What do they consist of exactly?
08:43 --> 09:46
Speaker 2
Of course. Due to the fact that regular consumers do not have access to the cosmetic product’s claim substantiation documents, the authority asks cosmetic companies to publish an abstract, or we can say a summary, that outlines the basic information in relation to claim substantiation. This abstract should list all the efficacy claims that the product has, and should tell the consumers how the claims are evaluated and substantiated. For instance, when it’s a clinical study, a consumer use survey, or a test done in a laboratory, we should state the protocol used and the identity of the institution that performed it. When it’s scientific research data or a regulatory document, we should state the name of the document, its source, and explain this data’s relevance to the efficacy claim in question.
09:47 --> 10:05
Speaker 1
Thanks for the explanation. And now let’s move to our last subject: the Cosmetic Product Safety Report, which is a new requirement introduced by the CSAR. Sometimes, European companies ask me if we can use the European CPSR for China notification or registration. Can we?.
10:06 --> 11:37
Speaker 2
Unfortunately, no. Even if an EU CPSR is translated into Chinese completely, it cannot be submitted for notification or registration purposes in place of a Chinese Cosmetic Safety Assessment Report. The Chinese report is done based on Chinese requirements, such as the “Technical Guidance for Cosmetic Safety Assessment”, the “Safety and Technical Standards for Cosmetics 2015 edition”, the “Inventory of Existing Cosmetic Ingredient in China 2021 edition”, etc. This report has its own templates and its own logic. Currently, there are 2 versions accepted by the authority: a simplified version, which is required between May 2021 and April 2024, and a full version, which will be required starting from May 2024. In terms of content, I would say the full version is more similar to the EU CPSR than the simplified version, so if a company plans on drafting a full version of the Chinese safety assessment report, I guess the EU CPSR can always be a good reference.
11:37 --> 11:38
Speaker 1
Thank you very much Celeste for your precise answers.
00:12:05.430 --> 00:12:06.720
Speaker 2
It was my pleasure, Laure.
00:12:08.410 --> 00:12:32.820
Speaker 1
That concludes this podcast series. If you haven’t listened to the previous episodes, you can find them on the same platform to learn more about other aspects of the new Chinese cosmetic regulation and its impacts.
A reminder to our listeners that Intertek can support you with all these China-related topics: We can help you submit your raw materials on the NMPA portal, notify or register your new cosmetic ingredients, build your notification or registration files for your finished products, and more.
Thank you for listening, and see you soon!
00:12:54.850 --> 00:12:55.640
Speaker 2
See you.
