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For the purpose of regulating the supervision and administration of cosmetics, and protecting the legitimate rights and interests of consumers, China National Medical Products Administration (NMPA) has released an announcement to answer the questions of great concern to the cosmetics industry.
Q1. How to correctly submit cosmetic ingredient safety information in the process of registration or notification?
A1. According to Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations) , Administrative Measures for the Registration and Notification of Cosmetics, and the Technical Specification for the Safety of Cosmetics , cosmetic registration or notification persons shall conduct safety risk assessment of cosmetic ingredients, and submit the safety information of ingredients used in product formula during the registration and notification. In order to optimize the administrative efficiency of the ingredients in cosmetic industry, NMPA has established the Cosmetic Ingredient Safety Information Registration Platform (the Registration Platform). On the platform, the ingredient manufactures can effectively submit safety information of the ingredients, and obtain the ingredients submission codes. Cosmetic registration or notification persons just need to fill in the ingredients submission code provided by the ingredient manufacturers, then the platform will automatically associate the code with safety information documents of ingredients. This avoids the repeated submission of safety information documents, so the efficiency of cosmetic registration and notification can be further improved.
In consideration of protecting trade secrets, the Registration Platform is only accessible to cosmetic ingredient manufactures. When providing submission code to registration or notification persons, the ingredient manufactures shall also provide necessary safety information of the ingredients. If the submission code is not provided, cosmetic registration or notification persons can submit relevant safety information of ingredients on the Information Service Platform for Registration and Filing of Cosmetics based on the safety information documents of ingredients issued by the manufacturers.
Q2. How to correctly understand cosmetic efficacy claim evaluation? What should be done for registered and notified products to comply with the regulatory requirements of cosmetic efficacy claim?
A2. According to the Standards for Cosmetic Efficacy Claim Evaluation (the Standards) issued by NMPA,not all cosmetic products are required to provide efficacy claim evaluation. For the major efficacy claims of cosmetics on the market, which can be directly evaluated by sight, smell or other senses (e.g. cleaning, makeup-removing, beautifying and embellishing, perfuming, body refreshing, hair dyeing, hair perming, hair color maintaining, hair-removing, deodorizing, auxiliary shaving or barbering, or function achieved through physical covering, adhesion, friction, etc.), they can be exempted from efficacy evaluation. Only for a few claims, which have strong functions and are strictly managed as drugs or external drug products in most countries and regions (e.g. freckle-removing and whitening, sunscreen, anti-hair loss, acne removing, nourishing, repairing, etc.), the human body efficacy evaluation test is required. Other efficacy claims can be evaluated by means of literature review, research data analysis or cosmetic efficacy claim evaluation test, etc.
For cosmetics that have been registered and notified before May 1, 2021, cosmetic registration or notification persons shall upload the justification abstract of the efficacy claim of relevant products under the transitional policies. As required by the Regulations, registration or notification persons shall evaluate their efficacy claim. If the evaluation result cannot support the efficacy claim presented in the product name or label, an application for amendment shall be filed before the expiry of the transitional period. In the application, the registration or notification persons shall adjust the classification code of the product based on its actual properties, and modify the relevant content in the product name or label, to make it comply with the regulatory requirements.
Q3. How should cosmetic registration or notification persons retain the samples of products? What’s the requirement for the quantity of retained examples?
A3. As stipulated by the Measures for the Supervision and Administration of Production and Distribution of Cosmetics (the Measures), the Rules for Registration and Notification Dossiers of Cosmetics (the Rules) , and Good Manufacturing Practices for Cosmetics (the Practices), cosmetic registration or notification persons shall retain the samples of each batch of products leaving the factory. The purpose of sample retention system is to ensure the traceability of product quality and safety, and to specify the accountability of registration or notification persons. Meanwhile, if there is any quality issues or counterfeiting, the legality and safety of each batch of products can be inspected effectively.
In the actually practice of the sample retention, the Cosmetic Supervision Department of NMPA has sorted out the quantity of the retained samples for common products sold on the market (Table 1). Drawn under the regulations mentioned above, from actual supervision work, and industry research results, this table takes the factors such as different product categories, packaging specifications, finished products status,etc., into consideration. It, therefore, reduces the operation cost for enterprises. For product categories not listed in Table 1, cosmetic registration or notification persons are allowed to determine the quantity of retained samples according to the regulatory requirements.
Table 1: Recommended Quantify for Retained Samples
|No.||Product Category||Recommended Quantity for Retained Samples|
|1||Hair dyes||≥ 3 packages; total quantity ≥ 90g/ml|
|2||Freckle removing / whitening products||≥ 3 packages; total quantity ≥ 50g/ml|
|3||Makeup products||≥ 3 packages; total quantity ≥ 60g/ml|
|4||Skincare products||≥ 3 packages; total quantity ≥ 80g/ml|
|5||Sunscreens||≥ 3 packages; total quantity ≥ 50g/ml|
|6||Anti-acne products||≥ 3 packages; total quantity ≥ 200g/ml|
|7 (1)||Facial masks (sheet masks)||Individually packed product: ≥ 7 patches; total quantity ≥ 140g/ml|
|Boxed product: ≥ 3 boxes ( ≥ 7 patches); total quantity ≥ 140g/ml|
|7 (2)||Facial masks (smear-on masks)||≥ 3 packages; total quantity ≥ 80g/ml|
|8||Shampoo and hair care products||≥ 3 packages; total quantity ≥ 50g/ml|
|9||Nail polish products||≥ 6 packages; total quantity ≥ 30g/ml|
|10||Toothpaste||≥ 3 packages; total quantity ≥ 80g/ml|
Notes: If the net content of makeup product is less than 1g, when retaining the samples of finished products, samples from semi-finished products can also be used. The retained samples shall meet the requirement of product quality testing.
Q4. Where should the samples of imported cosmetics be retained by registration or notification persons ?
A4. In November 2011, NMPA issued a notice of the enforcement rules of the Measures. It clarified that, since January 1, 2022, overseas cosmetic registration or notification persons shall retain samples from each batch of products imported into China, and their responsible persons in charge within the territory of China shall keep the samples and records. If the same production batch of products are imported in multiple batches, samples shall be retained at least once at the time of the first import.
With reference to the Practices, the entrusted cosmetic registration or notification persons shall retain samples in their domicile or main business premise; they may also retain samples in other business premises where their domicile or main business premise is located. The understanding of “location” of the domicile or main business premise is generally deemed as not exceeding the administrative region of the same prefecture-level city or the same municipality directly under the Central Government. If the responsible person in China keeps the retained samples, the selection of the place for keeping the samples shall refer to the above provisions. Meanwhile, It shall meet the requirements of laws and regulations, and the requirements of product storage indicated on labels.
Q1: Where imported general cosmetics are notified as set form and marketed, do the single products and set packaging of the set need to be submitted when in notification？
A1: According to Article 32 of the Rules for Registration and Notification Dossiers of Cosmetics, during notification of general cosmetics and prior to special cosmetics going on the market, cosmetic registrant and notifier or Chinese responsible person shall upload the label picture of product sales packaging. Therefore, the picture submitted and uploaded shall be the product notified as set form.
A2: According to Article 48 of the Rules for Registration and Notification Dossiers of Cosmetics, product list of Chinese RP which is intended to be changed , Informed Consent of the original Chinese RP or the effective judgement documents which can prove that Chinese RP has changed(rulings, judgments, mediation, etc.), and letter of commitment of Chinese RP which is intended to be changed are required to be submitted when applying for changing Chinese RP.
A3: According to Article 32 of the Rules for Registration and Notification Dossiers of Cosmetics, For registered or notified products sold in combination form of set or gift box, the combination process does not touch the contents of the product, apart from adding the name of the product packaged in combination, other labeled content does not exceed the label content of each product and the label information of the combined packaging covers the label content of each product inside, there is no need to repeatedly upload the label picture when notifying products packaged in combination.
A4: According to Article 7 of Specifications for Cosmetics Efficacy Claim Evaluation, “Efficacy claims which can be directly identified by sight, smell and other senses (such as cleaning, makeup removing, beauty modifying, aroma, toning, hair dye, perm, hair color care, depilating, deodorant and auxiliary shaving/hair shaving, etc.), or come into effect by simple physical cover, attachment, friction and other means (such as spot whitening by physical cover , physical way to exfoliate and physical way to remove blackheads, etc.) and are clearly identified on the label with only physical effects, can be exempted from publicizing the abstract of the product efficacy claim basis.”
Other efficacy claims shall be evaluated in accordance with NMPA announcement on issuing Specifications for Cosmetics Efficacy Claim Evaluation(NO.50 of 2021). Besides, uploading the abstract of the product efficacy claim basis at the time of applying for cosmetic registration or notification.
A1: According to (2) of Article 33 of the Rules for Registration and Notification Dossiers of Cosmetics, the toxicological test report of general cosmetics can be exempted from submission where the manufacturer of general cosmetics has obtained the production quality management system related qualifications issued by government authorities in the country/region where it is located, and the safety risk evaluation result of the product can fully confirm the safety of the product. The exceptions are as follows:
1.The product claims it is for infant/child use
2.The product uses new cosmetic ingredient that is in safety monitoring
3.According to the results of the quantitative grading score, the notifier, the Chinese responsible person, the manufacturer are listed as a key regulatory objects.
It can be exempted from submission of toxicological test report where the general cosmetics are produced by several manufacturers and all the manufacturers have obtained the production quality management system related qualifications issued by government authorities in the country/region where it is located.
A2: There are two fill-in methods: method including propellant or method excluding propellant, however behind the control range of sunscreen indicators it must be noted whether the propellant is contained.
For example,sunscreen spray products propellant filling volume is “Total mass of propellant : Total mass of ingredient for formulation = 60 : 40”, the formulation declaration volume of the sunscreen “ethylhexyl salicylate” is 4.5%(excluding propellant), and its control range can be set at 3.6%-5.0%(excluding propellant), or at 1.44%-2.0%(including propellant).
A3: shall be filled in according to the formulation declaration volume of hair dyes. For two or more doses of mixed hair dye products there are two ways to fill in: Firstly, fill in the control range of hair dye indicators according to the concentration of doseⅠor each hair dye in the dye. Secondly, fill in that in accordance with the concentration of each hair dye when they are mixed in use and specifying the mixing ratio.
A4: According to 3 of (5) of Article 30 of the Rules for Registration and Notification Dossiers of Cosmetics, where inspection method is adopted as quality control measure, the specific name of the inspection method shall be filled in correctly and reasonable inspection frequency shall be noted. Where inspection method outside Safety and Technical Standards for Cosmetics(STSC) is adopted as quality control measure, this method and specific inspection methods contained in STSC shall be validated. The validation result shall comply with requirements and complete inspection method and method validation materials shall be kept the file for reference.
It applies to the registration, notification, management and supervision activities of cosmetics and new raw materials for cosmetics in China.
If the registrant or notifier is a foreign enterprise, it shall designate an enterprise corporation in China as the domestic responsible person, and the domestic responsible person shall carry out the obligations of registration and notification.
Before the “general cosmetics” be launched or imported, the notifier shall submit the notification data through the information service platform in accordance with the requirements of National Medical Products Administration. The notification will be completed after the submission of date.
Before producing or importing “special cosmetics”, the applicant for registration shall submit application materials in accordance with the requirements of National Medical Products Administration.
According to NMPA, “if the same production batch of products is imported in multiple batches, samples shall be retained at least once at the time of the first import”. With this clarification, the retained samples can represent the overall situation of this production batch of products, and thus it is not required for enterprises to retain samples every time they import the same production batch of products.