Registration and Testing of Special Cosmetics

China is a big country in the production and consumption of skin care products. With the continuous development of economy, the consumption level of Chinese residents has also been continuously raised. The market scale of skin care products has significantly expanded，cosmetics has also become indispensable daily necessities from luxury goods, and the competition in cosmetics industry has become more fierce. With the continuous emergence of new brands, new functions and new ingredients, consumers pay more attention on the safety of product ingredient and the facticity of product efficacy. In order to regulate the cosmetics industry, China is setting more strict requirements on cosmetics testing, registration, filing and import etc.

Implemented on January 1, 2021, divides cosmetics into special cosmetics and ordinary cosmetics. China implements registration management for special cosmetics and filing management for ordinary cosmetics. The information of registered and filled product，published on the government website of the National Medical Products Administration is accessible to the public for enquiry. The regulation regulates the registration and filing of cosmetics, also protects the health rights and interests of consumers, has far-reaching impacts on the cosmetics industry.

Aiming at a series of policies such as various management measures, work specifications and technical guidelines issued in 2021, do you have any questions on test items for product filing process, or the process of product filing or other filling problems?

NOA has built a first-class testing platform around cosmetics industry, providing customers with product test for filling, formula review, safety evaluation, efficacy evaluation test, guidance for the system operation, regulation knowledge solution etc., can help customers with professional testing capabilities. NOA’s one-stop solution can help enterprises produce satisfactory, safe and effective cosmetics, provide customers with professional analysis, detection, testing, research and development, regulatory consultation and other technical services at any stage during production development and product.

Filing Process

1. Filing process

1. Submit for test
1. Registration for Inspection Information Management System of Cosmetics Registration and Filing （http://jyxt.nmpa.gov.cn:8080/jyxt/）
2. Production pre-review: product formula, product process, design manuscript review
3. Online application for test(general 9 test items+ necessary risk substances+ toxicology items)
4. Additional test for risk substances（Diethylene glycol, phenol, pesticide residues, etc）and Product testing.
5. Test result tracking
6. Test report delivery

2. Online filling

1. Registration for domestic non special cosmetics in Inspection Information Management System of Cosmetics Registration and Filing （https://zwfw.nmpa.gov.cn/web/index）
2. Obtain registration authority
3. Fill in the information (application form, basis of product name, product formula, product label, product test report, product safety evaluation data, support data and research literature for efficacy declaration)
4. Process tracking for online filling
5. Review of filling result
6. Filing data sorting and archiving

3. Notice of registration

1. Data query from NMPA online（https://www.nmpa.gov.cn/datasearch/home-index.html#category=hzp）

Test Items

1.Microbiological test item

Test Item	Special Cosmetics
Test Item	Anti alopecia^①	Hair dyeing^②	Perm	Freckle removing and whitening	Sunscreen
Total bacterial count	○			○	○
Total number of molds and yeasts	○			○	○
Thermotolerant coliforms	○			○	○
Staphylococcus aureus	○			○	○
Pseudomonas aeruginosa	○			○	○

Notes：

①Products with ethanol content ≥ 75% (w/w) do not need to detect microbial items;

②Physical hair removal products, non oxidative hair dyeing products need to detect microbial items;

③○ means to need to detect microbial items.

2.Physical and chemical test items

Test Item	Special Cosmetics
Test Item	Anti alopecia	Hair dyeing③	Perm	Freckle removing and whitening	Sunscreen
Mercury	○	○	○	○	○
Lead	○	○	○	○	○
Arsenic	○	○	○	○	○
Cadmium	○	○	○	○	○
Methanol①
Dioxane②
Asbestos③
Formaldehyde④
Mercaptoacetic acid			○
Sunscreen^⑤					○
Hair dye		○
pH^⑥			○	○
α-Hydroxy acid^⑥
Anti-dandruff Agents^⑦
UVA resistance parameter - critical wavelength⑧

Notes：

① For products with a total content of ethanol and isopropanol ≥ 10% (w/w), methanol testing is required.
② Products containing ethoxy structural raw materials in the formula need to be tested for dioxane items.
③ Products containing talc powder in the formula need to be tested for asbestos items.
④ Products containing formaldehyde and formaldehyde sustained-release materials in the formula need to be tested for free formaldehyde.
⑤ Non sunscreen products that contain chemical sunscreen agents in their formulations need to be tested for their chemical sunscreen content.
⑥ Declare to contain α- Hydroxy acids or, although not claimed to contain α- Products with hydroxy acids, but their total amount ≥ 3% (w/w), need to be tested α- Hydroxy acid project, while detecting the pH value. Pure oil based (wax based) products do not require pH testing; If the pH value of a product used in combination with multiple agents needs to be tested, in addition to testing in a single agent, the pH value of the mixed sample should also be tested according to the instructions for use.
⑦ Products that contain ingredients intended for use as anti dandruff agents in the declared formula need to be tested for the anti dandruff agent they contain.
⑧ Products that claim UVA protection or broad-spectrum sunscreen require testing of the cosmetics' UVA resistance parameter - critical wavelength or PFA value.
⑨ If the final product cannot be sampled due to packaging reasons or the inspection results may be affected (such as spray products, air cushion products, etc.), the enterprise can cooperate in providing semi-finished products of the last process before packaging while submitting complete test samples, and the inspection and testing agency shall explain in the inspection report.

3. Toxicological test items

Test Item	Anti alopecia	Hair dyeing^⑦	Perm	Freckle removing and whitening	Sunscreen
Acute eye irritation test^②	○	○	○
Acute skin irritation test			○
Multiple skin irritation tests^③	○			○	○
Skin allergy test	○	○	○	○	○
Skin allergy test^④	○			○	○
Bacterial reverse mutation test^⑤	○	○^⑥
In vitro Mammalian Chromosome Aberration Test	○	○^⑥

Note：

① For products not covered in the table, the selection of test items should be determined based on the actual situation, and inspection items can be added or reduced according to specific product uses and categories.
② Acute eye irritation tests should be conducted on freckle removing and sunscreen products that are easily accessible to the eyes.
③ Only acute skin irritation tests are required for rinsing products, and multiple skin irritation tests are not required.
④ In addition to hair care products, sunscreen products and freckle removal products, products with chemical sunscreen content ≥ 0.5% (w/w) (except perfume and nail polish) should also be subject to skin phototoxicity test.
⑤ Bacterial reverse mutation test or in vitro mammalian cell gene mutation test can be selected.
⑥ Non oxidative hair dye products are not subjected to bacterial reverse mutation testing and in vitro mammalian cell chromosome aberration testing.
⑦ Products mixed with two or more doses should be tested according to the instructions. When there are different use methods related to safety such as different concentrations and proportions, it is necessary to conduct relevant toxicological tests for each case.

4、Human safety test project

Test Item	Special cosmetics
Test Item	Anti alopecia	Freckle removing and whitening	Sunscreen
Human skin patch test^①		○	○
Safety evaluation of human trial test^②③	○
Test method for sun protection index (SPF value) of sunscreen cosmetics			○
Test method for waterproof performance of sunscreen cosmetics			○
Test method for long wave ultraviolet protection index (PFA value) of sunscreen cosmetics			○
Test method for freckle removing and whitening efficacy of cosmetics		○
Test method for anti hair loss efficacy of cosmetics	○

Note：

① When the human skin patch test is conducted for freckle removing and sunscreen cosmetics, and there are irritating results or the results are difficult to determine, a repeated open skin application test should be added.
② For products with a physical and chemical test result of resident products with a pH ≤ 3.5 or a pH ≤ 3.5 set in the enterprise standard, a human trial safety evaluation should be conducted.
③ Launching products that claim efficacy in acne, wrinkle, and freckle removal should be subject to human trial safety evaluation.
④ Products mixed with two or more doses should be tested according to the instructions. When there are different use methods related to safety such as different concentrations and proportions, it is necessary to conduct relevant human safety tests for each situation.

Service Process

Q&A

What is whitening cosmetics?
Whitening cosmetics generally refer to cosmetics that help alleviate or slow down skin pigmentation and achieve skin whitening and whitening effects. Due to the relatively high risk level of such products, the "Regulations on the Supervision and Administration of Cosmetics" clearly defines them as special cosmetics and implements registration management.
At present, the judgment of whitening cosmetics in China is mainly based on the product's label claims and inherent attributes. In addition, relevant departments are preparing to draft a cosmetic whitening agent list, which is expected to have a further impact on the definition of whitening cosmetics in China after its release.
It is important to remind consumers that products that achieve skin whitening and whitening effects through physical covering in China are also under the management of freckle whitening cosmetics. However, the number of such products is relatively small, and the product category on the approval document is printed with the words "freckle whitening (only with physical covering effect)", and the label of such products also needs to be clearly marked with "only with physical covering effect" to distinguish them. This type of product only serves as a temporary covering whitening effect and does not truly whiten the original skin color. Therefore, when purchasing freckle removing and whitening cosmetics, it is important to pay special attention to the differences between these two types of products.

How do you think of "377" in ordinary products?
During a spot check on the quality of domestic ordinary products, the State Food and Drug Administration found that some enterprises added phenylethyl resorcinol (trade name SymWhite? 377, commonly known as 377), a raw material that only has whitening effects, to ordinary products. This raw material is a new cosmetic material approved by the former State Food and Drug Administration in 2012. The only approved use purpose is to "whiten the skin and inhibit the formation of melanin by inhibiting the activity of tyrosinase.".
From the perspective of raw material use, the efficacy of using this raw material in ordinary cosmetics other than whitening exceeds the approved use purpose of this raw material, and it should be registered or filed in accordance with the new raw material registration and filing regulations before use. From the perspective of product formulation, adding the only raw material for use as a whitening agent to a common product formulation and having no other functions means that the product to which the raw material is added should have whitening functions, or that the company's practice implies that the product has whitening functions. The product should be managed as a freckle whitening cosmetic, and the product can be marketed only after registration.
How to correctly fill in and report the safety information of cosmetic raw materials during the registration and filing process of cosmetics?
According to regulations and technical specifications such as the Regulations on the Supervision and Administration of Cosmetics, the Administrative Measures for the Registration and Filing of Cosmetics, and the Safety Technical Specifications for Cosmetics, cosmetic registrants and recorders should conduct safety risk assessments on cosmetic raw materials, and fill in and submit safety information on the raw materials used in product formulations during the registration and filing process. In order to promote the level of raw material safety management in the cosmetics industry in China, the State Drug Administration has made full use of information technology to organize the establishment of a cosmetics raw material safety information submission platform, facilitating raw material enterprises to uniformly fill in and submit raw material safety information and generate raw material submission codes. Cosmetics registrants and recorders can only fill in the raw material submission code provided by the raw material manufacturer and associate it with the platform. There is no need to repeatedly fill in detailed raw material safety information, improving the efficiency of cosmetics registration and filing.
Based on the consideration of protecting trade secrets, the raw material safety information platform is only used by cosmetic raw material enterprises to fill in and report. The raw material enterprise shall provide necessary cosmetic raw material safety information while providing the raw material submission code to the cosmetics registrant and registrant. The absence of a raw material submission code does not affect the registration and filing of cosmetics. The cosmetics registrant and registrant can fill in and submit raw material safety related information on the cosmetics registration and filing platform based on the raw material safety information document issued by the raw material manufacturer.
For cosmetics that can be directly identified by the senses or that have effects only through physical means, how should the summary of the basis for product efficacy claims that are exempt from publication be operated on the filing system?
According to Article 4 of the "Standards for the Evaluation of Cosmetic Efficacy Claims", when applying for registration or filing, cosmetic registrants and recorders shall, in accordance with the requirements of this standard, upload a summary of the basis for product efficacy claims on a special website designated by the National Drug Administration. For products that are exempt from publishing the summary of product efficacy claims, it is necessary to fill in the product efficacy claims in the "Efficacy Claims" module of the general cosmetics filing management system. According to the product classification code, fill in the efficacy name in the "Product Efficacy Claims" item, and check "Yes" in the "Yes No Exemption" column, The "Remarks" column will automatically display a description of "According to the" Evaluation Specification for Cosmetic Efficacy Claims, those that can be directly identified by visual, olfactory, and other senses can be exempted from publishing a summary of the basis for product efficacy claims ", and then submit the efficacy claim.

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Registration and Testing of Special Cosmetics Professional technical team services to accelerate the registration

Registration and Testing of Special Cosmetics

Registration and Testing of Special Cosmetics
Professional technical team services to accelerate the registration