Cosmetic definition

Amendments

It refers to chemical products for the daily use intended to be applied on any external part of the human body (such as skin, hair, nails, lips, etc.) by spreading, spraying or other similar ways to keep the body clean, eliminate unpleasant odor, protect the skin, and improve appearance and beauty.

It refers to daily chemical products intended to be applied to the external part of the human body, such as skin, hair, nails, lips, etc. by spreading, spraying, or other similar ways for the purpose of cleansing, protecting, beautifying and modifying.

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• Under the CSAR, toothpaste shall be managed in line with general cosmetics. Efficacy claims (such as "anti-caries," "inhibit plaque," and etc.) of toothpaste products are permitted to be used after conducting efficacy evaluation following the national or industrial standards by toothpaste filer.

• Soaps are outside the scope of this regulation, except for those with the efficacy of special cosmetics.

Ingredient management

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Cosmetic ingredients are classified into new ingredients and used ingredients. New ingredients with high risk shall conduct registration while other cosmetic new ingredients are subject to filing management.

New ingredient application

Amendments  

The manufacture of cosmetics using new ingredients must be approved by the health administrative department under the State Council.

Ingredients with high risk such as new preservatives, sunscreens, colorants, hair dyes, whitening agents shall register with NMPA and obtain approval, while other new ingredients shall file with NMPA before use.

The following dossiers shall be submitted for new ingredients filing/registration:

• Name, address and contact information of registration applicant or filer;

• R&D report;

• Research materials on manufacturing process, stability, and quality control standards;

• Safety assessment dossiers.

Usage report of new ingredients

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The registration applicant or the filer shall report the usage and safety information of the new cosmetic ingredients to the NMPA every year for three years. Only the new ingredient without safety problems before the expiry of a 3-year observation period will be included in IECIC.

Cosmetic classification

Amendments  

• Special use cosmetics: hair growth, hair dye, hair perming, depilating, breast beauty, slimming, deodorant, whitening (anti-spot) products, and sunscreen products;

• Non-special use cosmetics: skincare, hair care, nail (toe) care, make-up, fragrance products.

• Special cosmetics refer to hair dye, hair perm, whitening, sunscreen, anti-hair loss products, and products with new efficacy and are subject to registration.

• The general cosmetics are defined as all other cosmetics excluded from special use cosmetics and shall conduct filing.

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Both the registration applicant and filer of new ingredients and cosmetics should carry out safety assessment by itself or by entrusting a professional institution prior to registration and filing. The personnel engaged in safety assessment should have professional knowledge related to cosmetics quality and safety and have more than five years of relevant work experience.

Efficacy claim

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Cosmetic efficacy claims shall have sufficient scientific evidence that can be relevant literature, research data, or efficacy evaluation documents and shall be exposed to the public on NMPA's website for social supervision.

GMP and COFS

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Imported cosmetics also require submission of certifications relating to manufacturing quality control of the overseas manufacturers abroad and supporting documents that prove those products have been put into market in the country (region) where those products are manufactured or originally made shall also be submitted. For those products specially produced for China market without the supporting documents, the applicant shall submit related research and test data for China consumers.

Required registration dossiers of special cosmetics/ Required filing dossiers of general cosmetics

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1. Name, address and contact information of registration applicant or filer;

2. Name, address and contact information of manufacturer;

3. Product name;

4. Product formula or a full list of ingredients;

5. The standards adopted;

6. Sample manuscript of the label;

7. Testing report;

8. Safety assessment dossiers.