FAQs Vol. 5 | Compliance Key Points of General Cosmetics Notification

As stated by Article 29 of Provisions for Management of Cosmetic Registration and Notification Dossiers, the product formula should be production feed formula. It shall list the contents of all ingredients, which are calculated as their mass percentage. All ingredients shall be arranged in descending order of contents’ percentage. For ingredients (except flavors) containing two or more components, the composition and corresponding percentage shall be listed.

Article 29 (4) of Provisions for Management of Cosmetic Registration and Notification Dossiers specifies that, the flavor in product formula can be filled in by two ways, with the following documents to be submitted respectively:

a. If “flavor” instead of any specific flavor is filled in for the ingredient item in the product formula form, there is no need to submit the type and content of specific fragrance components in the flavor. If the specific fragrance components of the flavor are indicated in the product label, or the original packaging label of the imported product contains specific fragrance components, it shall be stated in the remarks column of the formula form；

b. If “flavor” and specific fragrance components in flavor are filled in together for the ingredient item in the product formula form, the documents on the types and contents of all fragrance components contained in the flavor issued by the flavor’s manufacturer shall be submitted.

With reference to Provisions for Management of Cosmetic Registration and Notification Dossiers, when the manufacturer of the ingredients used in or the ingredient quality specifications of notified products have been added or changed, only when the content of ingredients in the formula, the content of main functional components and solvents in the ingredients remain unchanged, an application for change can be made for the change in types and contents of the trace stabilizers, antioxidants, preservatives and other components added to ensure the quality of ingredients. If the formula is incorrectly filled in due to enterprise’s mistakes, the enterprise shall reapply for notification after canceling the original application.  

According to Article 33 of Provisions for Management of Cosmetic Registration and Notification Dossiers, “if multiple production enterprises produce the same product, the applicant shall provide the complete product testing report of the samples from one production enterprise, and the microbiological testing reports as well as the physical and chemical testing reports of the samples from other production enterprises”.

According to Annex 1 “Requirements on Testing Items for Registration and Notification of Cosmetics” to Working Rules for Cosmetic Registration and Notification Testing, “toxicological tests as well as human body safety and efficacy evaluation test can be carried out according to the usage method in the instruction manual. When each part is likely to be used separately, it shall be tested separately”.

Article 33 of Provisions for Management of Cosmetic Registration and Notification Dossiers stipulates that, “general cosmetics with multi-color series sampled for toxicological test according to Working Rules for Cosmetic Registration and Notification Testing can be notified as a group of products. Each product shall be attached with a list of series products, a list of basic formulas and colorants, and a list of sampled products”.

According to Article 11 of Working Rules for Cosmetic Registration and Notification Testing, “the cosmetic enterprise shall provide all samples required for product testing at one time to the first inspection and testing institution that accepts the testing application for registration or notification. The samples submitted for testing shall be commercially available samples with the same batch number that are completely packaged and unopened. The products that have not been sold on the market at the time of submission can be the trial-produced samples”.

No. According to Provisions for Management of Cosmetic Registration and Notification Dossiers, all rinse-off products that claim acne-removing or freckle-removing shall carry out safety evaluation of the cosmetics using tests on human body. Microbiological testing, physical and chemical testing, as well as toxicological testing shall be completed with written reports prior to taking human body safety and efficacy evaluation test. Products that fail the above-mentioned testings shall not proceed to human body safety evaluation test. 

Article 33 of Provisions for Management of Cosmetic Registration and Notification Dossiers clearly states that, “if the production enterprises of the general cosmetics have obtained the relevant qualification certificates of the production quality management system issued by the competent government department of the country (region) where they are located, and the product safety risk assessment result can fully confirm the product safety, it may be exempted from submitting toxicological testing report of the product, except for the following circumstances:

a. The product claims to be used by infants and children;

b. The product uses new cosmetic ingredients that are still under safety monitoring;

c. The notifier, domestic responsible person or production enterprise is listed as key regulatory objects according to the quantitative grading results.

If there are multiple production enterprises, and all production enterprises have obtained relevant qualification certificates of production quality management system issued by the competent government departments of the countries (regions) where they are located respectively, the toxicological testing reports can be exempted”.

According to Technical Guidelines for Cosmetic Safety Assessment, the safety assessments on children cosmetics shall comply with the following requirements:

a. When carrying out assessment on children cosmetics, the physical characteristics of children shall be considered in hazard identification and exposure dosage calculation;

b. The principles of the formula design shall be clearly specified. The necessity of using ingredients in the formula shall be explained, especially the fragrances, colorants, preservatives and surfactants, etc.

c. In principle, it is not allowed to use ingredients with purposes of freckle-removing, whitening, acne-removing, depilating, deodorizing, anti-dandruff, anti-hair loss, hair dyeing, or hair perming. If the ingredient used for other purposes is possibly with any of the above-mentioned efficacy, the necessity and the safety of their use in children cosmetics shall be evaluated;

d. Cosmetic ingredients with longer period of safe use history are preferred, and the use of ingredients prepared by new technologies such as genetic technology or nanotechnology is not encouraged. If they must be used as there are no alternative ingredients, the reasons shall be explained, and the safety of their use in children cosmetics shall be evaluated.

As stipulated by Article 34 of Provisions for Management of Cosmetic Registration and Notification Dossiers, the registrant or notifier shall carry out the product safety assessments in accordance with requirements of relevant technical guidelines for cosmetic safety assessments and compile the product safety assessment reports.

Cosmetics that must be used in conjunction with instruments or tools (except brushes, air cushions, hair perming tools, etc., which only assist in rubbing) shall be assessed for their safety when used with instruments or tools. In addition, explanatory documents on whether the instrument or tool has cosmetic function, whether it participates in the reproduction process of cosmetics, whether it changes the mechanism of action between the products and skin, etc., shall also be provided.

According to article 9.1 of the Technical Guidelines for Cosmetic Safety Assessment (hereinafter referred to as Guidelines), if the ingredient’s concentration in products with the same application method that have been placed on the market for at least 3 years (i.e., the ingredient’s historical use concentration in the enterprise) shall be cited as the evidence of assessment, the following requirements shall be met:

a. In principle, the concentration of ingredients in the formulas of the products with the same area and application method shall not be higher than the historical use concentration of the ingredients in the enterprise. If it is higher than the historical use concentration, the safety assessment shall be carried out in accordance with the Guidelines to prove the safety;

b. Historical use concentration of ingredients can be subject to cross-reference. Products with high exposure dosage and long contact time can be used for the assessment on products with low exposure dosage and short contact time. However, it is necessary to fully analyze the rationality from the target population, area and application method, etc.

Documents to prove the enterprise’s historical use concentration shall include the following items:

a. Chinese domestic special products and imported products: registered or notified formula (must be consistent with the formula submitted for application), product registration license or notification certificate, and the product’s sale certificate;

b. Chinese domestic general products: the production records, technique sheets, ingredient lists which include the contents of ingredients or from which the contents can be calculated, notification certificates and the product’s sale certificate;

c. Description of adverse reaction monitoring situations;

d. Other certification documents.

As stipulated by Safety and Technical Standards for Cosmetics, if the product formula contains ingredients that have pH restrictions or requirements when using them, such as Potassium Hydroxide, Sodium Hydroxide, and A-hydroxy Acids (and their salts and esters), etc., the pH control indicators should be reflected in the product executive standards to ensure that they comply with the regulations.

Products that contain paster or membrane carrier materials should check “yes” for “whether contains membrane carrier materials” in the registration and notification system. In addition, as specified by Article 29 (5) of Provisions for Management of Cosmetic Registration and Notification Dossiers, if the paster or membrane carrier materials are used, the material composition of the main carrier material shall be indicated in the remarks column, and the documents including its source, preparation process, quality control indicators, etc., shall also be provided.