In order to further standardize the supervision and management of cosmetics and guide consumers to make scientific and rational consumption, the cosmetics supervision department of National Medical Products Administration has sorted out the most frequently asked questions during the supervision and management of cosmetics and given answers one by one according to the current provisions of China's cosmetics laws and regulations. The details are as follows:
Q: Why do people often hear about the so-called "cosmeceuticals" in foreign countries, but there is no concept of "cosmeceuticals" in China's cosmetics laws and regulations?
A: It should be clearly pointed out that the concept of "cosmeceuticals" does not exist in China and most countries in the world at regulatory level. It is a common consensus to avoid confusing the concept of cosmetics and drugs in all countries (regions) in the world. In some countries, some medical products have the function of cosmetics, however, such products should meet the regulatory requirements of drugs or pharmaceutical products, and there is no "cosmeceuticals" that are only regulated under cosmetics regulations. According to article 12 and article 14 of Regulations Concerning the Hygiene Supervision over Cosmetics, indications, curative effects, medical terms or medical effects shall not be noted on the labels, small packages or instructions. It is illegal to declare the concept of "cosmeceuticals", "medical skincare products" and other "cosmeceuticals" for registered cosmetics products.
Q: What is the difference between oligopeptide-1 and epidermal growth factor (EGF)? Can EGF be used as cosmetic raw material?
A: Oligopeptide-1 is not the same substance as human oligopeptide-1 (EGF). Oligopeptide-1 is a synthetic peptide composed of three amino acids, which are glycine, histidine and lysine. Human oligopeptide-1, also known as Epidermal Growth Factor (EGF), is a peptide composed of 53 amino acids with a molecular weight of 6,200 Dalton units.
Oligopeptide-1 was included in IECIC 2015 commonly used as skin-conditioning agent. However, human oligopeptide-1 is not included in IECIC 2015 and it is commonly used in the medical field, for instance, topical treatment for burns, trauma and surgical wound healing, and acceleration of epidermal growth after transplantation. It is difficult for EGF to be absorbed under normal skin barrier conditions due to its high molecular weight, and it may cause other potential safety problems once the skin barrier is insufficient. EGF cannot be used as a cosmetic ingredient for efficacy and safety reasons.
In conclusion, human oligopeptide-1 (EGF) is not allowed to be used as cosmetic raw material. It is illegal to add human oligopeptide-1 or EGF to the formula or to claim that the product contains human oligopeptide-1 or EGF.
Q: Can the ingredients used for protection of other ingredients, such as stabilizers, be marked on the product label?
A: According to the national standard "Instruction for use of consumer products - General labeling for cosmetics" (GB5296.3-2008), the name of all cosmetic ingredients should be marked on the visible surface of the cosmetics sales package.
Cosmetic ingredients refer to the ingredients that are purposefully added to the product formulation during the production process and play a certain role in the final product. Trace stabilizers, preservatives, antioxidants and other ingredients used for ensuring the quality of cosmetic raw materials should be filled in the product formula for notification, but they are not cosmetic raw ingredients and may not be marked on the product label.
Q: What is the difference between the domestic responsible person for filing of imported non-special purpose cosmetics and the original responsible entity for the application of administrative license in China?
A: There are two main differences:
First, the scope of authorization and responsibilities are different. The domestic responsible person shall be responsible for the import and operation of the products according to the authorization, and shall bear the corresponding responsibility for product quality and safety according to law; The responsible entity shall be responsible for matters related to the application of cosmetic administrative license and shall be in charge of and bear corresponding legal responsibilities for the application materials of administrative license.
Second, the number of companies foreign cosmetics manufacturers can authorize is different. Foreign manufacturers may authorize multiple domestic responsible persons according to the needs of business activities, but the scope of authorization shall not be repeated, and multiple domestic responsible persons shall not be authorized for the same product. The same imported cosmetics manufacturer can only authorize one responsible entity for application of cosmetic administrative license in China.
Q: How to change the domestic responsible person for the record-keeping of imported non-special use cosmetics?
A: Foreign manufacturer can change the domestic responsible person and the scope of authorization as required. In case of changing the domestic responsible person, the new domestic responsible person shall apply for user name of the online filing system as required; If the scope of authorization needs to be changed only, the domestic responsible person shall re-upload the Power of Attorney through the online filing system.
When it comes to recorded products, both the original and new responsible person shall first reach a negotiated consensus on product liability issues before change, then the application form of change and informed consent form signed by original responsible person shall be submitted at the same time by the new responsible person, followed by original responsible person's confirmation.
Q: Can the imported non-special use cosmetics whose administrative license has not been approved before the full implementation of filing management system be filed later?
A: In terms of non-approved applications of administrative license of imported non-special use cosmetics submitted before November 10, 2018, if there is no safety issue involved, the responsible person can handle the record-keeping afterwards. The decision of disapproval shall be submitted and the reasons for the re-submission shall be explained as well. The testing report, safety assessment data and relevant certification documents in the original administrative license application materials can be submitted as the dossier materials. If the original documents cannot be obtained, the copies need to be provided and stamped with the official seal of the responsible person in China.
Q: Can the imported non-special use cosmetics whose administrative license has been approved before the full implementation of filing management be filed later?
A: In terms of the approved products that need to be kept imported after expiration or be changed before expiration, the application of filing is required to be submitted within 5 working days before the expiration. The original license voids automatically. The informed consent signed by the original responsible entity shall also be submitted at the same time if the domestic responsible person and the original responsible entity are different. The testing report, safety assessment data and relevant certification documents in the original administrative license application materials can be submitted as the dossier materials. If the original documents cannot be obtained, the copies need to be provided and stamped with the official seal of the responsible person in China.
Q: How to carry out in-process and post-market supervision on imported non-special use cosmetics that have been recorded in the pilot free trade zone?
A: The filing management requirements for products recorded before 10th Nov 2018 in Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan, Shaanxi free-trade zone is same with that listed in "Notice on Implementing the Management of Record-keeping of Imported Non-special Use Cosmetics Nationwide (Notice No.88, 2018)"
Q: Can multiple import provinces be included in the filing of imported non-special use cosmetics?
A: The default import province is the province where the domestic responsible person is located. The newly added provinces will be automatically added in the "import province" column of the original record voucher after adding the information of the imported province and consignee in the record system. No manual examination is required for this operation, but the responsible person shall fill it out according to the actual situation. If it is found that the products are not imported from the province recorded, the account will be frozen once confirmed.
Q: How to set the validity period of the electronic certificate for the filing of imported non-special use cosmetics?
A: The validity period is not applicable for the electronic certificate anymore. Each year, the responsible person shall regularly report to the cosmetics supervision and management department through the online filing system about the production or import, marketing and sales, adverse reaction monitoring and acceptance of administrative penalties of the recorded products last year.
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