FAQ of Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing

To continuously improve the quality and efficiency of common cosmetics filing in Beijing, Beijing Cosmetics Review Inspection Center has issued a series of analysis on the common problems of the documents submitted by the filers since November 2021. Up to now, a total of 5 problem analysis has been released. For the convenience of reading, Personal and Home Care Division of CIRS Group has collected the Q&A and made a summary as follows:

Formula

Q1: When filling in the product formula, how do I fill in the contents of ingredients?

A: According to the Article 29 of Provisions on the Management of Cosmetic Registration and Filing Data, product formula shall be the formula of feeding. Products formula shall contain the contents of all ingredients (in percentage by mass) in descending order. Materials containing two or more ingredients (except essence) shall record the composition of each ingredient and the corresponding contents.

Q2: If products use essence as one of the raw materials, how to fill in the product formula and what kind of data should be provided?

A: According to the Article 29(4) of Provisions on the Management of Cosmetic Registration and Filing Data, in this situation, product formula can be filled out in two ways:

If you fill in “essence” in the formula table only, there is no need to submit the type and content of specific components of the essence; If the product label identifies the specific components in the essence, or the label of the original package of the imported product identifies the specific component, the components of the essence shall be explained in the remark columns of the formula table.

If "essence" and its components are recorded in the product formula table, information on the types and contents of all components issued by the essence manufacturer shall be submitted.

Inspections

Q1: If more than one manufacturers produce one same common cosmetics, how to submit the inspection report when processing products filing?

A: According to the Article 33 of Provisions on the Management of Cosmetic Registration and Filing Data: If more than one manufacturing enterprises produce one product, one of them shall provide a complete product inspection report on the samples, and others shall submit the microbiological, physical and chemical inspection report on the sample.

Q2: When applying for registration or filing of cosmetics, can I submit the preproduction sample for testing?

A: According to the Article 11 of Inspection Work Standards for the Registration and Filing of Cosmetics: Cosmetics enterprises shall provide all samples required for product testing to the first testing institution that accepts registration or filing application (hereinafter referred to as the first testing institution) at one time. The samples to be submitted for inspection shall be commercially available samples of the same lot number with complete packaging and unopened. Products not yet placed on the market at the time of submission for inspection may be preproduction samples.

Safety assessment

Q 1: The rinsing products claiming efficacy of acne and anti-wrinkle have submitted a safety evaluation report (simplified version). Can they be exempted from the safety evaluation of human trials?

A: No, they can’t. According to the Provisions on the Management of Cosmetic Registration and Filing Data: Rinsing products claiming efficacy of acne and anti-wrinkle should be tested on human safety. Before conducting safety and efficacy evaluation tests on human, these products shall complete microbial, physical and chemical tests as well as toxicological tests and issue written reports. Products that fail to pass the above inspection items shall not be used for human safety evaluation tests.

Q2: How to evaluate the safety of cosmetics that must be used with instruments or tools?

A: According to the Article 34 of Provisions on the Management of Cosmetic Registration and Filing Data: Registrants and filers shall conduct product safety assessment according to the requirements of the relevant technical guidelines for cosmetic safety assessment and form product safety assessment reports.

For cosmetics that must be used with instruments or tools (except brushes, air cushions, perm tools, etc.), the safety of such instruments or tools shall be assessed under the conditions of use; Related enterprises shall also provide explanatory data 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 product and skin, etc.

Q3: What should be paid attention to in the safety assessment data of children's cosmetics?

A: According to the requirements of Technical Guidelines for Cosmetics Safety Assessment, the safety assessment materials of children's cosmetics should reflect the following information:

When evaluating children's cosmetics, children's physiological characteristics should be combined with identification of hazard and calculation of exposure.

The principle of formulation design should be clarified, and the necessity of using raw materials for formulation should be explained, especially raw materials such as spices, colorants, preservatives and surfactants.

In principle, it is not allowed to use the raw materials with the purpose of anti-freckle, whitening, acne removal, hair removal, deodorization, dandruff removal, prevention of hair loss, hair coloring and perm. If the raw materials with the above effects are used for other purposes, the necessity of use and the safety of children's cosmetics should be evaluated.

Raw materials of cosmetics with a long history of safe use should be selected, and raw materials prepared by new technologies such as gene technology and nanotechnology should not be encouraged. If no alternative raw materials must be used, the reasons should be explained, and the safety of children's cosmetics should be evaluated.

Others

Q 1: Do I need to re-record the ordinary cosmetic products in the filing management system before product cancellation?

A: According to the latest announcement of the system, after the confirmation of historical products, you can directly apply for cancellation without re-recording; The historical products that have been re-recorded but not submitted can also apply for cancellation.

Q 2: What should be paid attention to in the declaration of products when using adhesive and membrane carrier materials?

A: Using adhesive and membrane type carrier materials of products should be checked in the system and select "whether membranous carrier material". According to the Article 29(5) of Provisions on the Management of Cosmetic Registration and Filing Data: When using adhesive and membrane carrier materials, enterprises shall indicate the material composition of the main carrier materials in the remarks column and shall provide its origin, preparation technology and index of quality control etc.

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