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Guangzhou Administration for Market Regulation Issued FAQs Related to Cosmetic Filing Inspection (2)

Cosmetic Filing Inspection

1. What are the microbiological and physicochemical items respectively?

Microbiological items include: Aerobic Plate Count, Molds and Yeasts Count, Thermotolerant Coliform Bacteria, Staphylococcus aureus, Pseudomonas aeruginosa, etc.;


Physicochemical items include: Mercury, Lead, Arsenic, Cadmium, Methanol, Dioxane, Asbestos, Formaldehyde, pH value, α-hydroxy acid, sunscreen agents, anti-dandruff agents, etc.


2. What are physical and chemical sunscreen agents?

The Technical Specification for the Safety of Cosmetics (Edition 2015) lists 27 types of sunscreen agents that are allowed to be used, including 25 chemical sunscreen agents and 2 physical sunscreen agents. Physical sunscreen agents, also known as inorganic sunscreen agents, are mainly Titanium Dioxide, and Zinc Oxide. The mechanism of action is to achieve sunscreen effect by reflecting and scattering ultraviolet rays. Chemical sunscreen agent is a type of UV absorbent, and common chemical sunscreen ingredients include Benzophenone (Benzophenone-3, Benzophenone-4, Benzophenone-5), Ethylhexyl Salicylate, etc.


3. What items need to be tested for non-sun protection products that have added chemical sunscreen agents?

If chemical sunscreen agents are used in the formula for non-sun protection products, the chemical sunscreen agents contained should be tested;


For products with chemical sunscreen content ≥ 0.5% (w/w) (excluding rinse-off, perfume, and nail polish), in addition to the items listed in Table 1-3 of the Work Specifications for Cosmetics Registration and Record-filing Inspection, skin phototoxicity test and skin allergy test shall also be conducted.


For non-sun protection cosmetics with chemical sunscreen content≥ 0.5% (w/w) (excluding rinse-off, perfume, and nail polish), the SPF value shall be tested.


4. For products used in conjunction with other products, how to conduct filing inspection items?

According to the Work Specifications for Cosmetics Registration and Record-filing Inspection, samples with different packaging types, different formulas for each part, and only one product name should be inspected in accordance with the following requirements:


(1). Microbiological items, if each part of a sample package is individually packaged, should be tested separately; if each part of a sample package is not individually packaged, a mixed sampling test should be conducted. If the product is a combination of different categories of color cosmetics, should be tested separately.


(2). Physical and chemical items should be tested separately according to each part; for items that don’t involve the content of the formula ingredient, and samples cannot be taken separately, the test can be conducted in accordance with the instructions; for items involved the content of the formula ingredient, a semi-finished product before the packaging provided by the enterprise can be tested, the sampling method should be explained in the inspection report.


(3). Toxicological tests, human safety tests, and efficacy evaluation tests can be conducted in accordance with the instructions; when there is the possibility of each part being used separately, it should be tested separately.


5. Requirements for the human safety trial test for general cosmetics

(1). Leave-on products with pH ≤ 3.5 in the physical and chemical inspection results, or products with pH ≤ 3.5 in set enterprise standards, should undergo the human safety trial test.


(2). Rinse-off products that claim to have anti-acne, anti-wrinkle, anti-spot, and other efficacy should undergo the human safety trial test.


Products with two or more doses for mixed-use should be tested according to the instructions.

When there are different concentrations, ratios, and other safety-related methods of use, the human safety trial test should be conducted for each case.


If you have any questions related to cosmetic filing inspection, please contact us via info@enter-co.com.

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