NMPA Open a Door to the Third-Party Testing Lab Nationwide for the Cosmetics Registration and Filing Inspection Work

Measures for the Administration of Cosmetics Registration and Filing Inspection (Draft for Comments) was released by the National Medical Products Administration (NMPA) on January 4 this year. On September 10, 2019, NMPA Issued the Announcement on Implementing Work Specification for Cosmetics Registration and Filing Inspection (shorted as SPECIFICATION). At the same time, NMPA issued an official interpretation of the specification on September 12, 2019, as follows.

(I) Since the date of publication of this announcement, the inspection institutions that meet the requirements of the specification may submit the relevant information through the cosmetics registration and filing inspection management system and undertake the registration and filing inspection of cosmetics.

Key points: It means that as long as the inspection institutions in line with the requirements of the "specification", they can deal with the registration and filing inspection of cosmetics through the management system,

(II) Since the date of publication of this announcement, if the newly registered or filed cosmetics have not been tested, the inspection shall be carried out in accordance with the requirements of the SPECIFICATION; If an inspection has been carried out or an overseas laboratory has completed the sunscreen inspection and issued the inspection report, the inspection report can still be used for the registration or filing of cosmetics. For the registered or filed products, if the original test items are inconsistent with the SPECIFICATION, the test items shall be supplemented and completed according to the requirements (except the human safety test) within one year after the publication of this announcement. The supplementary inspection report shall be submitted at the time of application for the renewal of product administrative license or be kept for future inspection when the filed product will continue to produce.

Key points: 1) Newly registered or filed cosmetics that have not been tested since September 10, 2019 shall be tested in accordance with the requirements of the SPECIFICATION; 2) The original test report is still valid for registration or filing. Meanwhile supplementing new test items; 3) For registered or filed products, in addition to human safety test, additional tests should be completed within one year. Supplementary lab report is used for license renewal or future inspection.

(III) Since November 1, 2019, the previously NMPA certified testing labs for cosmetics administrative licensing and filing of domestic non-special use cosmetics will be automatically terminated, relevant inspection institution shall not continue to handle the inspection work in the name of original designated qualification.

Key points: From November 1, 2019, the qualification of the previously designated cosmetics administrative licensing or filing inspection institution will automatically terminate.

Background of SPECIFICATION

According to article 3 of the Administrative Measures for Qualification Identification of Cosmetics Administrative Licensing Inspection Institutions issued on February 11, 2010, cosmetics administrative licensing inspection institutions refer to the inspection institutions that are qualified by NMPA, undertake the inspection of cosmetics administrative licensing, and issue the related inspection report. Licensed inspection institutions include hygiene safety inspection institutions and human safety inspection institutions.

Under the original legal system, the procedures of qualification identification are mostly overlapped with the China Metrology Accreditation (CMA) of cosmetics inspection institutions, and the scope of qualification identification is small, resulting in uneven distribution of inspection resources, and serious queuing of cosmetics registration and filing inspection, which takes too long and affects the progress of launching products.

What conditions must be met by the inspection institutions to undertake cosmetic registration and filing inspection?

1) Generally, it shall have independent legal personality;

2) Obtain the CMA qualification of inspection in the field of cosmetics, and the scope of competence obtained for qualification certification can meet the requirements of cosmetics registration and filing inspection;

3) Institutions of human safety and efficacy evaluation inspection have to consist of two full-time staff at least with a physician qualification certificate for dermatology-related majors and having at least five years’ work experience in cosmetics human safety and efficacy evaluation, establishing subjects informed and volunteer management system with the capability of disposal of cosmetics adverse reactions.

Up to now, there are 35 (including 28 hygiene safety inspection institutions and 7 human safety inspection institutions) originally designated testing labs for the inspection of cosmetics administrative licensing. And 222 registered testing labs for the filing inspection of domestic non-special use cosmetics.

New requirements for cosmetics registration and filing inspection

i. Enterprises, inspection institutions and regulatory authorities shall use the online system of cosmetics registration and filing inspection for the application and acceptance of inspections, information management of inspection institutions, and supervision work.

• Interpretation: Through the online system, cosmetics enterprises shall select inspection institutions that are in line with the requirements of SPECIFICATION, fill in product inspection related information and submit inspection application. And the inspection institutions can accept the inspection application online. The government can carry out the supervision work to the product safety and efficiency and inspection institutions.

ii. In addition to human safety tests, efficacy evaluation or asbestos tests, other inspection items of the same product are generally completed independently by the same inspection institution.

• Interpretation: except asbestos, all other hygiene safety tests (microbiology, toxicology, physics and chemistry) should be carried out in the same inspection institution.

iii. Cosmetics enterprises shall provide all required samples one-time to the first inspection institution that accepts the application for registration or filing inspection. The samples for inspection shall be the market products with unsealed and complete package of the same batch. Or can be the trial samples if the products have not been put on the market in the time of inspection.

• Interpretation:
• On-site sample sealing by the supervision department was canceled and replaced with the sample sealing by the first inspection institution. Cosmetics enterprises shall provide all samples one-time to the first inspection institution. The quantity of samples shall be determined by the institution according to the needs of inspection and retention of samples.
• Trial sample shall be fully packaged with Chinese sticker which includes the product name, manufacturer, production date and shelf life, or production batch number and expiry date and other info related to the cosmetics registration and filing inspection.
• If trial samples were submitted for registration inspection of imported special use cosmetics, one trial sample sealed by the inspection institution and one unsealed sale product shall be submitted at the same time during product registration.
• If the trial samples are inconsistent with the products sold on the market, the inspection report of the products become invalid, and the investigation shall be conducted as a consideration of submitting false declaration materials.

iv. Chemical sunscreen agents are required to be tested for the formula of non-sunscreen products containing chemical sunscreen agents.

v. For non-special cosmetics with the content of chemical sunscreen agent ≥0.5% (w/w) (except rinse-off, perfume and nail polish products), in addition to test items listed in the table, skin phototoxicity test and skin sensitization test should be conducted.

vi. For special use cosmetics, in addition to hair growth, sunscreen and anti-freckle products, skin phototoxicity test is required for products with the content of chemical sunscreen agent ≥0.5% (w/w) (except perfume and nail polish products).

vii. SPF test is needed for non-sunscreen products with the total amount of chemical sunscreen agents ≥0.5% (w/w) (except washing, perfume and nail polish).

• Interpretation:

viii. Other new test items:

• For finished products that cannot be sampled or may affect the inspection results (such as spray products, air cushion products, etc.), for physical and chemical test, the enterprise may provide both finished and semi-finished products, which shall be explained by the inspection institution in the test report.
• The rinse-off products for anti-acne treatment, anti-wrinkle and anti-freckle should be evaluated through human trial safety test.
• Products for whitening, anti-freckle, hair loss prevention and other new efficacy claiming should be conducted corresponding efficacy tests according to the testing requirements of Guidelines of Cosmetics Efficacy Evaluation.
• Antibiotics and metronidazole tests are canceled for anti-acne and anti-mite products

The new regulatory approaches to inspection institutions

The provincial MPAs shall organize routine supervision and inspection, dependent inspection, flight inspection and capability evaluation to the inspection institutions. On August 30, 2019, NMPA issued the Guiding Principles for the Capacity Building of Cosmetics Inspection and Testing Institutions, which serves as a general guideline for the capacity building of inspection and testing institutions, and also serves as a reference document for regulatory authorities and enterprises to conduct system building and capacity evaluation of inspection institutions.

The daily supervision and special site inspection work mainly focus on the authenticity of information submitted by inspection institutions to the online system, standardization of inspection, authenticity of test data, retention and archiving of inspection data and materials, as well as sample collection, sealing, inspection and retention.

If problems are found in the supervision and inspection of cosmetics registration and filing, NMPA will suspend the inspection system permission of the inspection and testing institution when existing one of the following situations:

(1) Misstatement or omission of relevant information of the inspection institution, or failure to timely update the inspection information into the online system as required once the information is changed;

(2) Inspection acceptance procedures are not standardized;

(3) The test report does not meet the specified requirements;

(4) The inspection records, samples retention and archival data storage do not meet the requirements;

(5) An error occurred during the inspection;

(6) The test report issued beyond the scope of inspection capability;

(7) Failing to participate in the ability assessment as required or the result of the ability assessment fails to meet the requirements without special reasons;

(8) Deliberately failing to cooperate with the supervision and inspection of provincial MPAs

Inspection institutions shall carry out rectification as required. If it fails to rectify after the deadline or still fails to meet the requirements after rectification, NMPA will remove the information of the inspection institution, or if the circumstances are serious, it shall no longer accept and publish the information of the inspection institution within three years when existing one of the following situations:

(1) Falsely report or conceal relevant information of inspection institutions;

(2) Fraud of the inspection process and results;

(3) Issue or falsify false inspection reports or records;

(4) The inspection institution that issues the test report is different from the one that undertakes the inspection of cosmetics;

(5) The inspection information filled in the inspection system is inconsistent with the actual situation

Abolition of the file

Notice on Issuance of Administrative Measures for Cosmetics Licensing Inspection (CFDA [2010] no. 82)

Notice on Issuance of Administrative Measures for Qualification Identification of Cosmetics Administrative Licensing Inspection Institutions (CFDA [2010] no. 83)

Notice on the Issuance of Administrative Measures on Filing of Domestic Non-special Use Cosmetics (CFDA [2011] no. 181).

CIRS Comments

1) The release and implementation of the SPECIFICATION allows more third-party inspection institutions to participate in the inspection work of cosmetics registration and filing, which greatly avoids the phenomenon of queuing and helps enterprises to speed up the progress of product launching.

2) No matter domestic or imported products, if the products have not been put on the market at the time of inspection, trial production samples can be provided. However, if the trial production samples are inconsistent with the products sold on the market, it will be considered as submission of false declaration materials.

3) The test items of the products for sunscreen, anti-wrinkle, anti-freckle, anti-acne, or spraying, air cushion products will be adjusted greatly. This will increase the cost and time of testing. As the Guidelines of Cosmetics Efficacy Evaluation is not effective, the test of efficacy evaluation cannot be carried out for the time being.

4) The competent authority manages the use rights and inspection qualification of inspection institutions through the online inspection information system.

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Resource:

http://www.nmpa.gov.cn/WS04/CL2138/358128.html

http://www.nmpa.gov.cn/WS04/CL2103/334296.html

http://www.nmpa.gov.cn/WS04/CL2078/357838.html

http://www.nmpa.gov.cn/WS04/CL2202/358303.html