In general, there are five main changes in this new regulation:
The first is the labeling of ingredients. The Measures requires that cosmetic labels should indicate the full ingredients of cosmetics, and ingredients in the formula with content less than 0.1% (w/w) should be labeled separately under the term "other trace ingredients".
The second is the affixed Chinese label. Generally, the original packaging of imported products is mostly in foreign languages, and Chinese labels will be affixed when entering China. The previous regulations primarily concentrated on the compliance review of the contents claimed in Chinese, but now a new item is subject to review. That is, if a Chinese label is affixed, the contents related to product safety and efficacy claims thereon shall be consistent with the relevant contents on the original label.
In this way, on the one hand, the Chinese label affixed cannot claim the efficacy that is not on the original packaging and cannot delete or add any content related to product safety on the original packaging. On the other hand, the relevant content on the original packaging itself must comply with Chinese laws and regulations.
The third is the requirements for claiming certain ingredients or the efficacy of ingredients on the label. In recent years, it has become a trend in the industry to name cosmetics with ingredients, such as "Retinol Eye Cream" and "Carnosine Base Primer." The Measures puts forward strict requirements in response to this phenomenon, stipulating that where the generic name of a product uses the name of a specific ingredient or indicates the category of the ingredient, the ingredient shall be consistent with that in the product formula, and the efficacy of such ingredient in the product shall be in line with the product’s efficacy claim. At the same time, it is not allowed to claim the function of the ingredient used to imply the product having the efficacy that it does not actually possess or that is forbidden in claims. For example, a cosmetic is only a moisturizing product but claims on the packaging that it "contains XX ingredients with whitening effect." This is clearly a violation of the Measures.
The fourth is the product’s executive standard number. The Measures requires the Chinese label to indicate the product’s executive standard number. The notion may seem quite foreign to overseas companies. For general cosmetics, this number is actually the preparatory notification number received by the applicant at the time of notification. It is automatically generated by the system and will replace the "notification number" that must be marked on the label before.
The fifth is the expansion of words that are not allowed to use on cosmetic labels or in claims.
The reason why NMPA adds such requirement is mainly in response to the previous market chaos that some cosmetics companies widely advertise that the product contains a certain ingredient, but the actual amount of the ingredient is negligible and far from achieving the corresponding effect. This behavior belongs to "conceptual addition," which severely disrupted the market order, harmed other companies' legitimate interests, and grossly misled consumers. Therefore, in the process of developing the Measures, China proposed to make a distinction on the labeling between "ingredients" and "other trace ingredients" with content less than 0.1% (w/w).
For companies, this new rule puts forward higher requirements on cosmetics labeling. They need to mark trace ingredients truthfully to ensure that consumers are informed of the actual addition of cosmetic ingredients. Therefore, the labels and packaging of all existing cosmetics are subject to adjustments of the ingredient listing. Another impact of the change is that products adding tiny amounts of a certain ingredient but greatly promoting its function or efficacy may be no longer attractive to consumers as the ingredient will be clearly listed as a trace ingredient.
Given the Measures have relevant requirements on the original packaging, I suggest the companies first conduct self-inspection or entrust a professional organization to check whether the contents of the product’s safety and efficacy claims on the original packaging meet the requirements of Chinese regulations.
If the product packaging meets the requirements of Chinese regulations, companies can choose to keep the original packaging and enter China with an affixed Chinese label. It shall be noted that the contents of the product’s safety and efficacy claims on the affixed Chinese label shall correspond to the original label.
If the original product packaging does not meet the requirements of Chinese regulations after inspection, companies can choose to export to China with a packaging designed specifically for the Chinese market. At the time of registration or notification, the original packaging and the packaging specially designed for the Chinese market shall be submitted with reasons.
However, companies need to be aware that products with claims on the packaging exceeding the definition of Chinese cosmetics, especially medical claims, are not allowed to enter China even they have a specifically-designed packaging targeting the Chinese market, for these products are not cosmetics according to China’s definition.
To give the industry enough time to cope with the new Measures, NMPA have introduced some transitional measures. Companies should make full use of the transitional period to consume packaging materials inventory, learn and understand the requirements of the Measures, and check and update product labels as soon as possible to achieve a smooth transition between the old and new regulations.
Apart from this, special attention should also be paid to the following points:
The new Measures also apply to cosmetics free samples, giveaways, gifts, product “not for sale," etc.
For all products with packaging boxes, their primary packaging shall bear the Chinese product name and durability.
For products with a net content of no more than 15g or 15mL, only part of the Chinese label information is required to be labeled on the sales packaging. Other required labeling information can be indicated in the leaflet. Notably, if such small-size products have a packaging box, the products’ Chinese name and durability shall still be labeled on their primary packaging.
Under the previous regulations, China did not mandate the labeling of the manufacturer's information, but the new Measures clarifies that the name and address of the manufacturer must be marked on the Chinese label. For imported cosmetics that involve entrusted production, they can merely indicate the "country or region of origin" before. But after new Measures takes effect, the name and address of the actual manufacturer must be indicated on the Chinese label.
About the Expert:
Alice ZhangCosmetic Regulatory Technical Engineer from REACH24H
Alice Zhang focuses on Regulation Interpretation, Cosmetics Registration, and Compliance of mainland China. With her specialty, she devotes to grab opportunities from the updating of laws and regulations and provides professional solutions for our clients.