From Sep. 27th to Sep. 28th, the NMPAIED (National Medical Products Administration Institute of Executive Development) held the "Online Training Course on Cosmetic Registration and Filing", which EnterCo was invited to attend. The main questions in the Q&A session were excerpted for your reference.
1. There are both individual packaging and set packaging for product sales. Do we need to select the set packaging option when applying for cosmetic notification?
There is no clear stipulation that the set packaging option must be selected when the product with both individual packaging and set packaging applies for cosmetic notification. Therefore, it is not necessary to select it. However, it is suggested that the packaging description in the product label sample should explain that there are two kinds of packaging for product sales: individual packaging and set packaging.
2. Can a product sold in the form of set packaging only be filed in the form of set packaging?
Two situations are involved: 1) The product has completed filing and been sold. The set packaging label can be added in the label option of product filing, if you want to add set packaging for product sales; 2) The product that is only sold in the form of set packaging without individual packaging should be filed in the form of set packaging product, and the product cannot be sold separately.
For multiple products that have completed filing, if we remove the outer packaging of each product, and combine the naked product into a gift box, whose label contents do not exceed the sum of those of each product, do we need to repeat the filing application?
With reference to the above case 1), a set packaging label can be submitted under the label option of product filing without repeated filing.
3. When a product is filed with a combination of freeze-dried powder and menstruum, can the names of two dosage forms appear in the product name? How to choose the product dosage form of the product classification code? What about the other category options?
Currently, for cosmetic filing in Beijing, the product name can be freeze-dried powder plus menstruum, but it is recommended to use less ➕, because the use of symbols violates the label management method. The product name can be explained together with separately explaining the two dosage forms. Two dosage forms (freeze-dried and liquid) involved in the product classification code must be selected.
For other category options, we need to fill in and submit respectively according to the actual formula.
4. When using body mask product, it will be retained for 20 minutes on the body, which category it belongs to, leave-on or rinse-off, and which toxicology test should be conducted, acute dermal irritation or multiple dermal irritation?
Products that specify how long to retain or stay before rinsing are managed in accordance with the leave-on category, whose toxicology test should be conducted with multiple skin.
5. Hair dye products and hair masks that need to be washed after 20 minutes of application, which category do they belong to, leave-on or rinse-off?
Hair products belong to the rinse-off category.
6. Do we need to issue a statement when applying for re-filing with using the original filing materials after the original filing is cancelled?
It is allowed to submit a re-filing statement, clearly stating the reasons for the cancellation of the original filing and the application of re-filing, and affix the official seal of the filing person.
1. For nail polish that needs to be heated during use, should the safety of heating be considered?
The expert review will provide relevant opinions, such as heating temperature, and safety during heating. Therefore, the safety of heating should be considered.
2. Does methylparaben need to be evaluated for phenol?
It is unnecessary for methylparaben to be evaluated for phenol. Currently, the common raw material to be evaluated for phenol is phenoxyethanol.
3. When raw material safety assessment is not supported by CIR data, can the edible history be used for safety assessment?
Sure, but with the edible history, only the assessment data of systemic toxicity can be exempted, and supporting evidence of local toxicity data still needs to be provided.
4. How to assess the safety of propellants?
The contents shall be assessed for safety by the amount after removing the propellant. The propellant shall be assessed for non-skin contact with considering inhalation toxicity, and the total propellant content shall be 100%.
5. How to assess the safety of nanomaterials that lack photostability data?
If the specifications of nanomaterials we use meet the specifications of the EU assessment, we can directly use the EU assessment data, such as nano-titanium dioxide. Otherwise, the EU data cannot be used, and the safety assessment data shall be provided separately and completely.
6. There are no risk substances in Annex 14 the Provisions for the Registration or Filing Dossier of Cosmetics provided by the raw material manufacturer, do we need to provide COA?
If the quality specification certificate is required for restricted substances and approved substances in the safety technical specifications, COA shall be provided, regardless of whether the risk substances are marked in Annex 14. Annex 14 is the self-requirements of the raw material manufacturer.
If the raw material manufacturer does not fill in Annex 14, how to determine whether there is a risk substance?
It can be identified according to conventional standards of China Cosmetic Regulation.
7. For children's cosmetics, if the raw materials have the data of highest historical usage in IECIC, can they be directly used for safety assessment?
If there are no other supporting materials, they can be used.
8. Do the supporting documents of raw material specification need to be stamped with the official seal of the safety assessment agency?
Although all materials should be stamped with the official seal of the filing person, while whether the supporting documents of raw material specification need to be stamped with the official seal of the safety assessment agency is not required.
1. Can the Chinese name of a product without the brand name?
According to Article 8 of the Measures for the Administration of Cosmetics Labels, the Chinese name of a product shall include a brand name, which may not be a registered brand name.
2. What is the review standard for inner packaging? Are the names to be displayed continuously and completely on the same surface? Do we need to label the guide words?
For the inner packaging, there is no need to label the guide words. The name should be displayed continuously and completely is not stipulated. The basic principle is that the complete name can be identified on the inner packaging.
How to label the shelf life of the packaging in contact with the contents, inkjet code, or guide words?
Currently, guide words shall be labeled on the visible surface of the outer packaging, while guide words on the inner packaging are not stipulated.
3. The products that apply for registration or filing have both English and Chinese trademarks, and both want to be marked on the packaging. Do the English and Chinese trademarks need to be used as brand names in the product names?
If the brand name for filing has a trademark with a foreign language, a trademark certificate shall be provided. If the foreign trademark is only marked on the label, it is necessary to only provide the Chinese explanation corresponding to the foreign trademark on the label.
4. English-registered trademarks are marked on multiple visible surfaces of the packaging, can we explain the trademarks on one of the visible surfaces?
If trademarks with the same foreign language are marked on multiple visible surfaces, explanations can be marked on one of the visible surfaces.
5. If the product formula does not contain other trace ingredients, does the Chinese label need to state that there are no other trace ingredients?
No, it doesn't.
6. Does the registration of imported special cosmetics need to provide a packaging picture with Chinese labels?
Sure, the sales package picture shall be submitted.
Cosmetic efficacy and claims
1. For products that have completed filing before May 1, 2021, can manufacturers change the packaging on their own, remove some efficacy they do not want to claim, and only conduct an efficacy evaluation of the retained claims?
According to the FAQs on Cosmetics Supervision and Management (3) of NMPA, if the efficacy claim evaluation cannot support the efficacy conclusion, a change application can be made before the transition period expires. The content of the classification code, name, and label shall be modified according to the actual situation.
2. If the generic name of a product involves the name of the raw material, which should be consistent with the product efficacy, does it require effective concentration? Can literature without studying dose response be used as supporting evidence?
If product efficacy claims are made based on the efficacy of raw materials, literature research should be carried out and research data should be analyzed, and it is necessary to confirm that the efficacy of raw materials and product efficacy are fully correlated. To demonstrate an association, it is generally considered that dose data is necessary.
3. If the product claims to be suitable for all skin types, what efficacy type should be selected?
All skin types include sensitive skin, which should be considered. It is recommended that the enterprise specify which skin type the product is suitable for. If the product is claimed to be suitable for all skin types, a sensitive skin option needs to be selected.
4. The Chinese name of the product contains the name of the raw material, does it belong to the claim of raw material efficacy?
According to Article 8 of the Measures for the Administration of Cosmetics Labels, the name of the raw material used should be consistent with the product efficacy. It belongs to the claim of raw material efficacy, and the option of raw material efficacy shall be selected.
5. Is it a mandatory requirement for anti-hair loss products to provide the efficacy basis of functional ingredients?
Yes, it is. In the future, a technical guideline for anti-hair loss (draft for comments) will also be issued similar to the technical guideline for anti-freckle and whitening cosmetics.
6. Does the whitening effect accept foreign test reports?
No, the whitening effect of the product must be tested by a qualified laboratory in China.
7. If the product name contains the name of the raw material, while the raw material currently does not have the product efficacy, can it be named as such?
According to the Measures for the Administration of Cosmetics Labels, the raw materials in the product name should be consistent with the product efficacy claims. If they are not consistent, it is recommended to mark the name of raw material after the attribute name or other names instead of being marked as a generic name. Once the raw material appears in the product name, the efficacy of the raw material needs to be selected.
8. Can a lip balm or facial toner claim refreshing efficacy?
It can be claimed to be cool, but it is not the refreshing efficacy. Refreshing is mainly used for talcum powder and Florida water.
Raw material and formula
1. The algae extract should note the algae species, which species can be used?
The algae species already listed in the IECIC 2021 can be used. If it is not listed, it may be a new raw material and needs to be further confirmed.
2. Is the purpose of use of the raw material consistent with the content in the reported safety information?
Since raw material manufacturers should be very clear about the purpose of use of raw materials, the purpose of use of the raw material should be consistent with the content in the reported safety information in theory. In addition, special attention should be paid to the purpose of use of some special raw materials, such as new raw materials that have been approved. If the purpose of use is different from the purpose of use declared at the time of approval, it should be re-registered or re-filed according to the new raw materials.
3. Can the control index of sunscreen in the formula be directly written as ±20%?
Sure, but the maximum control index shall not exceed the regulatory limit. Otherwise, it will lead to disapproval.
4. When applying for registration and filing of new raw materials, should the source of raw materials be single?
Yes, different sources have different safety risks. When registering and filing, it is necessary to confirm that the source is single.
5. Is the base and lake of the colorant a component of the raw material?
6. If the fragrance is changed in the formula, but the content remains unchanged, is it a formula change?
Of course, the flavor type is changed when the fragrance is changed in the formula. The product shall apply for registration or filing again because of a formula change.
7. Will China have a whitening list?
Maybe, it is still under discussion.
Special application questions
1. If the product contains a pH adjuster, such as potassium hydroxide, do we need to set the pH index in the control index?
The control range of pH value can be described directly in the production technique, and the implementation standard may not be involved. But it needs to be reflected in the filing materials.
2. There are 32 testing methods in the implementation standard for hair dye products. Do we need to test them all?
Only the hair dye used in the formula needs to be filled in. The test method is determined according to the specific hair dye in the formula, and not all test methods are required.
3. The formula of adult cosmetics contains salicylic acid, and the packaging is marked with a sentence that "this product contains salicylic acid, and it is not suitable for infants under three years old". Does it mean that this product is suitable for children aged 3-12?
No, this sentence is a specific label for the product that contains salicylic acid according to the requirements of technical specifications, and it does not mean that it is available for children aged 3-12.
4. After submitting the application for special cosmetics, it is found that the site of action is wrong, can we apply for supplementary revision?
No, we can only wait for the conclusion of the application review. During this period, there was no concept of supplementing and modifying application materials.
5. For the site of action, does the face include the neck?
No, if the site of action of a product includes the neck, the body option should be selected.
6. If the product formula is changed, can the product produced before the formula change be sold until the expiration date, and can the same product name be retained after the original formula is cancelled?
From the date of cancellation of the product, the enterprise is not allowed to manufacture the product. Before the cancellation, if the enterprise produced it according to the relevant regulations, it can be sold until the end of the product validity period. The same product name can be used, and it is recommended to label it with phrases like new formula or upgraded formula.
7. The product dosage form is an aerosol, can the product name only be called XX aerosol?
It is not a naming requirement, since it depends on dosage forms in the product classification code. If the product contains a propellant, aerosols must be selected.
8. How to set the control range of anti-freckle agents, whitening agents, and sunscreen agents in the implementation standard?
There are no specific regulations that the control range of anti-freckle and whitening agents, and sunscreen agents should not exceed the limits of safety technical specifications. Therefore, we only need to set a reasonable range value, usually about ±20%.
1. When applying for cosmetic registration, how should I submit safety-related information for cosmetic raw materials that have not yet obtained the cosmetic raw material submission code?
The registrant, filing person, or domestic responsible person can choose either of the following two methods according to their own circumstances:
1). Provide raw material quality specification documents stamped with the official seal of the raw material manufacturer or safety-related information for raw materials (Annex 14 of the Provisions for the Registration or Filing Dossier of Cosmetics). (Note: The registrant or domestic responsible person shall also stamp the official seal page by page at the same time.)
2). If the raw material manufacturer authorizes the registrant, the filing person, or the domestic responsible person to fill in the safety-related information for raw materials (Annex 14), it shall be provided with stamping the official seal of the registrant, the filing person, or the domestic responsible person. Meanwhile, the contents that the registrant, the filing person, or the domestic responsible person (specific enterprise name) is authorized by the raw material manufacturer (specific enterprise name) to fill in the relevant content which shall be true, complete, and accurate in Annex 14, shall be noted in the "other issues to be explained" column.