Filing Test for Ordinary Cosmetics-NOA Testing & Certification Group

Filing Test for Ordinary 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.

Regulations on the Supervision and Administration of Cosmetics 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, are there any testing items that are not clear during the product filing process? Not sure about the filing process? Filing review problems occur frequently?

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. 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 inspection.

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. Public notice for record

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

Test Item

1.Microbiological test item

TestItem	Ordinary Cosmetics ①②
Total bacterial count	○
Total number of molds and yeasts	○
Thermotolerant coliforms	○
Staphylococcus aureus	○
Pseudomonas aeruginosa	○

Notes：

①Nail polish remover does not need to detect microbial items;

②Products with ethanol content ≥ 75% (w/w) do not need to detect microbial items

③○ means to need to detect microbial items

2.Physical and chemical test items

Test Item	Ordinary cosmetics
Mercury	○
Lead	○
砷	○
Arsenic	○
Methanol①
Dioxane②
Asbestos③
Formaldehyde④
Mercaptoacetic acid
Sunscreen⑤
pH ⑥
αα-Hydroxy acid⑥
Anti-dandruff Agents ⑦

Notes：

①Methanol items shall be tested for products which the content of ethanol and isopropanol≥ 10% (w/w) Dioxane shall be tested for products containing ethoxyl structural raw materials

②Asbestos shall be tested for products containing talc powder；

③ Free formaldehyde shall be tested for products containing formaldehyde and formaldehyde slow-release materials .

④ Sunscreen shall be tested for non-sun block products containing sunscreen

⑤Product claimed to contain α- Hydroxy acid or product not claimed to contain α- Hydroxy acid, but containing total amount ≥ 3% (w/w) of α- Hydroxy acid, shall to test α- Hydroxy acid and pH. Pure oil (containing wax base) products do not need to test pH. If products with multiple agents need to test pH, single agent and the mixed products according to instruction all shall test pH.

⑥ If the product formula contains raw material used as a dandruff remover, it is necessary to detect the dandruff remover

⑦ For products that claim UVA protection effect or broad-spectrum sunscreen, it is necessary to detect the anti UVA ability parameters - critical wavelength or PFA value

⑧ If the final products cannot be sampled due to packaging reason or factors affecting the test results (such as spray products, air cushion products, etc.), the enterprise can provide the semi-finished products from the last processing before packaging, while submitting the full samples, and the inspection and testing organization shall explain it in the report.

Toxicology test item

Test item	Hair Care Product	Skin Care Product		Makeup Product			Fingernail (toenail) Product	Fragrance
Test item	Product easy to reach eye	General skin care product	Productseasy to reach eye	General makeup product	Eye makeup	Lip care and lip makeup	Fingernail (toenail) Product	Fragrance
Acute skin irritation test ④	○						○	○
Acute eye irritation test⑤⑥	○		○		○
Multiple skin irritation test		○	○	○	○	○

Notes：

①Products not listed in the table, the selection of test items should be determined according to the actual situation, and the test items can be added or reduced according to the application and category of product.

②No toxicological test is required for repair and painted fingernail (toe) product.

③Product with chemical sunscreen content ≥ 0.5% (w/w) (except for rinsing, perfume and nail polish), skin phototoxicity test and skin allergy test should also be carried out in addition to the items listed in the table.

④Rinsing skin care product only need to carry out acute skin irritation test, multiple skin irritation test is not required.

⑤Acute eye irritation test is not required for wash free hair care product and eyebrow painting cosmetics.

⑥Bath product should test acute eye irritation.

Service Process

Q&A

How to fill in the safety information of cosmetic raw materials correctly during the cosmetics registration process ?

According to the regulations and technical specifications such as , , < Safe and Technical Specifications for Cosmetics >, applicant for registration and filing of cosmetics should conduct a safety risk assessment on cosmetics raw materials and fill in the safety information of raw materials used in product formulas during the registration and filing process. In order to promote the level of safety management of raw material in China's cosmetics industry, National Medical Products Administration uses information means to organize and establish a platform for reporting the safety information of cosmetics raw materials, so as to facilitate raw material enterprises to fill in the safety information of raw materials and generate raw material submission codes. Cosmetic registrants and filers can only fill in the raw material submission code provided by the raw material manufacturer, which is related by the platform, without filling in detailed raw material safety information, so as to improve the efficiency of cosmetic registration and filing.
Considering the protection of trade secrets, the raw material safety information platform is only for cosmetic raw material enterprises to fill in and use. Raw material enterprises should provide necessary safety information of cosmetics raw materials while providing raw material submission codes to the cosmetics registrants and filers . If there is no raw material submission code, it will not affect the registration and filing of cosmetics. The cosmetic registrant and filer can fill in the raw material safety related information on the cosmetics registration and filing platform according to the raw material safety information document issued by the raw material manufacturers.

At what time should the products in old system finish the supplementary? What does the supplementary information include?

According to the requirements of NMPA announcement of the implementation of (No. 35, 2021) and NMPA announcement of (No. 49), domestic ordinary cosmetics registrants and filers should make a supplementary record before May 1, 2022 through the new registration and filing platform, including the product classification code, implement standards, draft of product label, and product formula.

For cosmetics that can be recognized directly by the senses or effects only produced by physical means, how to operate on the filing system in order not to publish the abstract of efficacy claim?

According to Article 4 of , when applying for registration or filing, the registrant and filer of cosmetics should upload the summary of the basis of efficacy claims of products on the special website designated by the State Drug Administration in accordance with the requirements of this specification. For products that are exempted from publishing the abstract of the basis for product efficacy claims, the product efficacy claims need to be filled in the "efficacy claims" module in the general cosmetics filing management system. According to the classification code of the products, 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 the description that "according to the" evaluation specification for efficacy claims of cosmetics ", the summary of the basis for efficacy claims of products that can be directly recognized by vision, smell and other senses can be exempted from publication", and then submit the efficacy claim.

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