1. Should ingredients such as stabilizers added in cosmetic raw materials aiming to protect the raw materials be marked on the product label?
According to the national standard "Instruction for use of consumer products—General labeling for cosmetics" (GB5296.3-2008), the names of all the cosmetic product ingredients should be truly marked on the visible surface of the sales package of cosmetics.
Cosmetic product ingredients refer to the ingredients that are purposefully added to the product formula during the production process and play a certain role in the final product. In order to ensure the quality of cosmetic raw materials, although tiny amounts of stabilizers, preservatives, antioxidants and other ingredients added to the raw materials should be reported in the product formula, they do not belong to the category of cosmetic product ingredients and may not be marked on the product label.
2. How to change the domestic responsible person for the imported general cosmetic notification?
Overseas cosmetic enterprises can change the domestic responsible person and the scope of authorized products according to their needs. If the domestic responsible person is changed, the new domestic responsible person shall register the user name of the online filing system as required; if only the scope of authorized products is changed, the domestic responsible person shall re-upload the new authorization letter through the online filing platform.
If the change of the domestic responsible person involves the products that have completed the filing, the domestic responsible person before and after the change shall reach an agreement on the responsibility of the products that have been imported and sold in the previous period. Then the new domestic responsible person shall apply for the change through the online filing platform, and submit an informed consent signed by the original domestic responsible person. The change operation will be completed after it is confirmed by the original domestic responsible person through the online filing platform.
3. Can I choose multiple import provinces when submitting the filing of imported general cosmetics?
The default province of the filing system where the domestic responsible person is located is the import province. When the domestic responsible person needs to import general cosmetics from other provinces, the information related to the import province and consignees can be added to the filing system, and then the names of newly added provinces will be automatically generated in the "Import Province" module of the filing system. The operation does not require manual review, but the domestic responsible person should truthfully fill in it in accordance with reality. In the follow-up supervision and inspection conducted by the regulatory department, if the reality that the domestic responsible person has not imported general cosmetics from the province filled in the system is confirmed, it will be investigated and handled as the case of submitting false filing materials. Once verified, the domestic responsible person will be frozen as an abnormal user.
4. How to set the validity period of the electronic NMPA certificate for the filing of the general cosmetics?
Since the filing management is adopted in general cosmetics, the validity period of the electronic NMPA certificate will no longer be set. The domestic responsible person shall regularly report relevant information on products that have completed the filing such as the production or import, marketing, adverse reaction monitoring, and acceptance of administrative punishments in the previous year.
5. If the original package of imported products is marked with the contents prohibited by Chinese laws and regulations, such as the product claims with the description of "抗炎症成分(anti-inflammatory ingredients)", how to conduct the declaration of registration or filing?
If the label content in the original package of imported products is inconsistent with Chinese laws and regulations, it should be first confirmed whether they conform to the definition of cosmetics stipulated by Chinese laws and regulations in combination with the application method, site of action, and purpose of use related to the products. Those that do not conform to the cosmetic definition shall not conduct registration or filing in accordance with the imported cosmetics. Those that conform to the definition of cosmetics shall revise and improve the relevant content of the original package label in accordance with the relevant regulations on the management of cosmetic labels.
6. For the whitening cosmetic that claims to have only a physical covering effect, if its formula also adds other whitening ingredients with a non-physical covering effect, whether it can be registered in accordance with the cosmetics category of "anti-spot (only achieved through physical covering) "?
According to the notice on matters related to the adjustment of the registration and filing management of cosmetics (No. 10, 2013) issued by the former CFDA (named as NMPA now), the whitening cosmetics with only physical covering effect refer to the products whose whitening effect is only achieved through the physical covering. For the whitening cosmetic that claims to have only a physical covering effect, if its formula also adds other whitening ingredients with a non-physical covering effect, it shall be able to provide sufficient scientific evidence to prove that the use purpose of the ingredient is not for whitening. Otherwise, it shall be not registered in accordance with the cosmetics category of "anti-spot (only achieved through physical covering) ".
7. How to regulate the shampoo, hair mask, and other products in the market that can change the color of hair with the claim of "neutralizing hair color"?
The products with the purpose of changing the color of hair, which cannot restore the original color after use when being washed immediately, shall be strictly regulated in accordance with the hair-dyeing products. Shampoos, hair masks, and other products that can change the color of hair with the claim of "neutralizing hair color", shall be the hair-dyeing products, whose labels shall mark the required warning words and other relevant information. Meanwhile, in terms of the safety evaluation of products, in addition to meeting the requirements of conventional hair-dyeing products, the corresponding toxicology tests, safety risk assessment, and other safety evaluation requirements should be determined in accordance with the exposure frequency, application methods of shampoos, hair masks, and other products.
8. How to manage when the name of raw materials is used in the Chinese name of cosmetics? What are the specific requirements when the name of raw materials is the common name or the name of the whole plant?
According to the Rules for Naming of Cosmetics, the name of specific raw materials or words indicating the category of raw materials used in the product name should be consistent with the ingredients of the product formula. If the name of a specific raw material is used in the product name, the product formula should contain the raw material; if the words indicating the category of raw materials are used in the product name, the product formula should contain specific raw materials that can be included in the category. If the name of the raw material used in the product name is common, the common name should be consistent with the standard Chinese name of the raw material in the product formula. If the name of the raw materials used in the product name is the name of the whole plant, the ingredients in the product formula can be the raw materials of the specific parts of the plant.
9. If the product with the new formula still uses the name of the product with an old formula that has been cancelled after the change of the product formula, can words such as "升级版(upgraded version)" be added to distinguish the product with two formulas?
Considering that the new product still uses the name of the product with an old formula which has been cancelled after the change of the product formula, and the new product and the old one may exist in the market at the same time, the new product label can be marked with "新配方(new formula)", "配方调整(formula adjustment)" and other objective words so as to protect the consumer's right to know and distinguish the product with two formulas. Words such as "升级版(upgraded version)" have no clear basis for judgment, and are suspected of misleading consumers.
10. The range of pH value of facial cleanser, skin care lotion, hair perm, and other related products set in the recommended national standards or industrial standards is relatively wide. Can the enterprise directly use the range of pH value set in the recommended national standards or industrial standards when setting the control range of pH value of specific products?
In order to make the standards universally applicable, the range of pH value of facial cleanser, skin care lotion, hair perm, and other related products set by the recommended national standards or industrial standards is relatively wide. Some include both acidic and alkaline areas, and even reach the level of strong acid or strong alkali. Therefore, the enterprise shall set the range of pH value of specific products which can characterize the safety control index of the product in accordance with the product formula, the production technique, the application methods, etc., and the range of pH value set in the recommended national standards or industrial standards shall not be copied blindly.