NMPA for Advanced Training in late July to hold a cosmetics filing training course on the topic, ZOOP' s teachers in the training course, for the training of hot issues to do a summary of the issue, here to send you for reference.

The final opinion is subject to laws and regulations and the opinion of the auditing teacher, and you are welcome to communicate with our team if you have any questions.

Products

1.     Is liquid soap a cosmetic?

Liquid soap is in fact the essence of cleaning products such as shower gel is similar, just the name called soap but does not meet the definition of soap, so if the efficacy of liquid soap claims and methods of use in line with the definition of cosmetics are cosmetics, rather than according to the management of soap to go. (Soap industry standard "Soap" (QB / T 2485-2008) in the definition of soap: milling process, cooling moulding process production of fatty acid sodium soap, and fatty acid sodium-based, add other surfactants, functional additives, additives made of block soap, soap, crystal soap, etc.).

2.     Are blotting papers classified as cosmetics?

not belong to.

3.     Is false eyelash adhesive a cosmetic? Is false eyelash remover a cosmetic?

False eyelash adhesive is not a cosmetic, false eyelash remover is a cosmetic.

4.     Do I have to apply for a special licence for whitening toothpaste?

The Regulations have made it clear that toothpaste is regulated under the provisions for ordinary cosmetics.

5.     Is soap a cosmetic if it claims efficacy?

No, only soaps that claim special effects are considered cosmetics, e.g., whitening soaps are considered cosmetics.

6.     Can I make changes to shorten or extend the shelf life?

Enterprises based on their own long-term stability data found that the shelf life can be achieved than the shelf life filled in the record, you can change the extended shelf life and provide relevant evidence. Shelf life is based on the long-term stability of the product test data, the shorter means that the product does not meet the shelf life of the record, if so, has been on the market for sale need to be recalled and cancellation of the product.

Status of filed information?

Ordinary cosmetics on the packaging of the record number and product implementation of the standard number must be marked on both?

"Cosmetic labelling management measures" in the provisions of the content must be marked, the record number is not required to mark the content, the product implementation of the standard number for the content must be marked.

7.     A raw material would like to use the enterprise's historical use concentration of the enterprise has been on the market for 3 years of the product as the basis for assessment, ready to record the product use parts range is greater than the filed product, can we use the historical use amount? (e.g., the product to be filed is suitable for the whole body, and the filed product is suitable for the face).

Not to be adopted.

8.     The directions for use of the product say to leave it on for 5-6 minutes and then wash it off, is that by the drenching category or the residual category?

Products whose method of use reflects how long they stay are managed according to the requirements of the residency category.

9.     Multiple imported products are listed on the same certificate of manufacture and sale, do I need to submit the original certificate of sale for each product? If a copy is submitted, does it still need to be notarised?

According to "Cosmetics Registration and Filing Information Management Regulations" Article 27, imported products have been marketed and sold documents, commission relationship documents or documents belonging to a group of companies, such as proof of information can be listed on a number of products at the same time. When these products apply for registration or for the record, one of the products can use the original, and the other products can use a copy of the product name where the original is located and the relevant acceptance number, registration certificate number or record number and other information.

10.  Can the Chinese labels of imported products be made into multi-layer labels?

If the consumer before the purchase, can be opened to view and view can be restored without affecting the sale of the case can be made into a multi-layer labels; if it is torn in the form of the consumer to open the view can not be restored to belong to the destruction of the packaging must be purchased in the case can not be.

11.  Can the production process be changed if the feeding sequence is changed, and if so, is it necessary to re-test the microbiological and physical and chemical indicators?

The production process can be changed and needs to be re-tested.

Recorded claims

Is anything beyond the 26 major categories of efficacy a new efficacy?

Not beyond the 26 categories of efficacy of the new efficacy, first of all, the scope of efficacy claims to comply with the definition of cosmetics (Cosmetics Definition: "Cosmetics Supervision and Administration Regulations," Article 3 of the regulations referred to in this regulation, cosmetics, refers to the rubbing, spraying, or other similar methods, applied to the skin, hair, nails, lips and other surfaces of the human body, in order to clean, protect, beautify, and modify for the purpose of the daily use of chemical industry products.) If it does not belong to the scope of cosmetics, such as: anti-mosquito bites, improve inflammation, eczema, eyewash, etc., has exceeded the definition of the scope of cosmetic efficacy claims can not be declared according to the new efficacy to register.

If the product name contains the name of the ingredient, and the product claims 3 effects, is it necessary to fill in the summary of the 3 effects for the specific claims of the ingredient?

No need, just fill in at least one of them.

12.  Can the efficacy claims on the packaging be more or less than the claims on the filing system?

The efficacy claims on the packaging can be less but not more than the claims on the filing system.

13.  A product in foreign countries has been hundreds of years of history has been exclusively for the use of a foreign country's royal family, and can provide relevant information to support, can the product packaging claim that a certain royal family has been used?

It is not recommended to claim this.

14.  The packaging reflects that it is suitable for all skin types, does the summary of efficacy need to be ticked for sensitive skin, and if it is ticked for sensitive skin, do the subjects in the consumer test report have to be 100% sensitive skin? If so, should the subjects in the consumer test report be 100% sensitive? Or is it sufficient to reflect that some people have sensitive skin?

Tick the box to test according to the requirements of the specific claim, and the test population should be all sensitive skin.

15.  In the efficacy test report, if it is a self-scoring report by the consumer based on a scoring criteria, is the report counted as an efficacy test? Or is it a consumer test report?

Consumer scoring is part of the consumer use test report

16.  Does the label claim that "6 < pH < 7" and "95% of testers preferred to use the moisturising spray in an air-conditioned room" count as quantitative claims? Or does a numerical description related to efficacy, such as "90% of testers found the product to be gentle to use" count as a quantitative claim? For example, if a sunscreen spray claims that it "instantly cools down** degrees after use", is this a quantitative claim?

Whether it is the pH of the skin or the product, claims about the pH of the skin after use are quantitative claims of efficacy, claims about the pH of the product are not. "90 per cent of testers found the product to be gentle to use" is a quantitative indicator; sunscreens are not intended to be used for cooling, which is not an efficacy of cosmetic products, and such claims are not recommended.

If the product claims to be pleasurable and improve one's mood with the use of the product. Is that OK? Can perfumery products make such claims?

According to the cosmetic naming guidelines and naming regulations, perfumery products can be claimed to be refreshing and relaxing, and such claims are permitted for this type of product.

17.  Under what circumstances can claims be made about "anti-ageing" and "collagen boosting"? Or are these claims prohibited altogether?

Exceeding the scope of cosmetic efficacy claims.

18.  Are claims such as anti-glycation, antioxidant and stabilisation compliant and are they new?

Stability claims are beyond the definition of cosmetics. Anti-glycation and antioxidant belong to the mechanism vocabulary, not the final efficacy of the product, and anti-glycation and antioxidant belongs to the scope of cosmetics, whether it should be registered in accordance with the new efficacy, there is no conclusive results.

19.  The flower box is labelled that the product contains *** raw materials, but does not reflect the efficacy of the raw materials, whether it is a specific claim of raw materials.

The current Shenzhen filing will not categorise such cases as specific claims (ingredient efficacy).

20.  If a product does consumer testing and then moisturising efficacy in humans, should the summary of efficacy reflect both?

Just upload at least one.

21.  Some cosmetic packages in Japan are labelled with the words "醫薬部外品" and "薬用", but if they are labelled with these words, do they need to be deleted from the package when applying for registration in China?

Should ensure compliance with our relevant regulations and requirements content; it is best to delete. Or the instruction manual should explain that "this product is a cosmetic and does not have medical effects".

Is it okay to claim on the label or in an advertisement that the product was developed jointly with a university or a professor and that the university or professor has granted a licence to use the product for promotional purposes?

If it is the same responsible entity as the registrant/filer, it can be claimed; if not it is not allowed.

22.  Do you have to look at toxicology tests when those claiming mild, non-irritating or tear-free formulas have already done efficacy tests to prove it?

Claims of mild, non-irritating or tear-free formulations, product claims should be consistent with the actual product, including the results of toxicological testing.

Cosmetics registration filing information service platform

1. What should I do if the recipe cannot be imported and some of the ingredients are recognised as new?

"Recipe sheet import prompts recipe information processing failure, ** raw material format error!" Please download the latest template formulas, in the "whether the new raw materials" column, according to the requirements of the form, fill in 0 or 1 before uploading; product filing information is submitted, the information collated in the process of some of the raw materials are identified as new raw materials were returned, according to the "catalogue of raw materials have been used", carefully verify the formula of the raw material format is correct, such as the standard Chinese name contains spaces, special symbols, etc..

2. No new ingredients are used, but the recipe page says "There are new ingredients for which no authorisation request information has been sent".

If the product does not use new raw materials, do not need to "use the registered new raw materials", "use the filed new raw materials" option to fill in the content, such as spaces, "no", "/" and so on. "/" and so on, otherwise the system will prompt "there is a new material has not been sent to the authorisation application information".

3. After submitting an application for a change in the responsible person in the territory and contacting the relevant supervisory authority, the reviewer is unable to view and review the application, and the application information cannot be accessed.

When submitting, select the original enterprise to confirm. If the original in-country responsible person does not perform the confirmation operation, the application will not enter the audit stage, and the original in-country responsible person will be able to perform the audit operation only after confirming the application.

4. After the first filing to create an application, the pre-filing number enough to be able to modify the pre-filing number information?

After the first filing application is created, the pre-filing number will show the status of "Used", and if there is no record of submission and review, delete the first filing application, and the pre-filing number will be restored to the status of "To Be Used", and you can modify the information in this status.

5. The submission of enterprise information has been reviewed and approved, but there is no "enterprise information maintenance" function in the system page.

Ans: In the process of submitting and reviewing enterprise information, the authorisation of the operator without reviewing and passing the audit results in the function of "enterprise information maintenance" not being able to be issued normally, and the application can be submitted for re-issuance through the function of "feedback on system problems".

6. The business name cannot be changed to be entered manually in the general audit update.

Ans: If you want to change the name of the enterprise, you need to change the information of the legal person in the online office first, after the change is completed, enter the enterprise information maintenance menu of the enterprise information management module, and apply for the "General Audit and Update", and the system will automatically synchronise with the latest information in the online office, and then complete the change of the name of the enterprise after the supervisory staff confirms the adoption of the change. After confirmation and approval by the supervisors, the change of enterprise name will be completed.

7. Location to fill in, district and county location information shows blank, can not choose to fill in.

Ans: If the enterprise belongs to a municipality directly under the central government such as Beijing, Shanghai, etc., it is necessary to select the option of "Municipal districts" in the second level of the region, otherwise the third level of the region information will not be able to be selected.

8. There is a lack of information in the content of "residential address" in the product filing information reporting.

Ans: When submitting the application in the enterprise information management module, the "address" in the "basic information" should be filled in with complete information including provinces, cities and other regional information to avoid incomplete information on the enterprise address when declaring the products.

9. When submitting business information data, information such as business name and legal person documents cannot be manually modified and entered.

Ans: The information of enterprise name and legal person documents in the basic data is synchronised from the legal person information in the online office hall and cannot be modified manually. If there is any error in the content, please correct it in the online office hall and then edit and submit it.

10. "Existing user login authorisation" binding prompt: original account authentication error!

Answer：When using the old system account to bind, the original account authentication error is prompted. After eliminating the case of wrong password input, if the old system password has been changed after 1 April 2021, the password before the change can be used to bind.

11. The legal person and other operators jointly bind the existing user login authorisation, prompt: XXXX user has been bound!

Ans: The old system account can only be bound once and cannot be bound repeatedly. If a legal person or one of the operator accounts has been bound to the old system account, all other accounts should choose to create a new account to be associated through the unified social credit code.

12. The corporate account shows "Unbinding" in red but cannot be unbound successfully.

Ans: You cannot unbind the legal person account after it is bound, if you need to unbind the legal person account, you should send the application for unbinding through the function of "Feedback on System Problems".

13. Notes on unbundling the manager's account and being authorised by a new legal entity account.

Ans: Before the operator account is de-authorised by the new legal person account, the operator account should be de-authorised by the new legal person account before de-authorising the binding relationship with the cosmetic registration and filing information service platform, and then de-authorised by the legal person account for the operator, and without unbundling operation with the system, the operator account cannot be de-authorised by the new legal person account to be bound to the cosmetic business system.