China Cosmetic Regulations



China Cosmetics Market
  • As of 2020, China became the world's second-largest beauty and personal care product market after the U.S in terms of market value

  • More than 70% of cosmetics in china camw from e-commerce sites like Alibaba's Tmall and JD.com

  • In the following decade, the beauty market in china went through an average growth of 15% per year, reaching RMB 300 billion in 2019(i.e, overall 3.5X growth rate). With RMB 340 billion retail sales in 2020.


China's Cosmetic Regulations

Definition

“Cosmetic products refer to daily chemical products intended to be applied on the external part of the human body (such as skin, hair, nails, lips, etc.) by spreading, spraying, or other similar ways for cleansing, protecting, beautifying, or grooming purposes.”


The term "any" external portion and the function "eliminate unpleasant odour" have been eliminated from the prior definition.


Classification


​Special Cosmetics

General Cosmetics

​· Hair Dyes

· Hair Perming Products

· Skin Whitening Products

· Sunscreens

· Anti-Hair Loss

Or Claims A New Efficacy

This includes-skin care, hair care, nailcare products, makeup and perfumes, etc.


There is a five-year grace period for the following categories: Hair growth cosmetics, hair removing products, breast slimming products and deodorants registered as special use cosmetics before july 1, 2021.after the transition period, production, import and sale these products will be prohibited.

Chinese Regulatory Authorities

  • Ministry of health

  • The new china cosmetic regulation, the Cosmetic Supervision and Administration Regulation (CSAR) - - Aims to improve cosmetics quality and safety by increasing cosmetics supervision and management, as well as controlling production and operations to protect consumer health.

  • SAMR is the State Administration for Market Regulation, which is in charge of overseeing the markets for food, cosmetics, medicines, and medical equipment.

  • Cosmetic ingredients will be regulated by the National Medical Products Administration (NMPA) depending on their dangers. New preservatives, sunscreens, colourants, hair dyes, and whitening agents, for example, must register with the NMPA and gain approval, whereas low-risk compounds merely require notification.

  • IECIC is an objective and thorough database of ingredients found in Chinese cosmetics that have been created and sold. It is the only source of information on the regulatory status of cosmetic ingredients.


Regulatory Framework In China

The Ministry of health has approved a new regulation for cosmetics that released from JAN,1 2021 Cosmetics Supervision and Administration Regulations (CSAR), which was previously held by Cosmetics Hygiene Supervision Regulations, released in 1989. The CSAR in China will release administrative rules to establish China’s Cosmetic Regulatory Framework. According to the new rules in China, cosmetics now are defined as Special Cosmetics and General Cosmetics. Special Cosmetics are required to be registered with the NMPA and the registration certificates are only valid for five (5) years, on the other hand ‘General cosmetics’ are required to filing and these certificates do not any expiry dates. For the domestic cosmetic products manufacturing in China- The applicant should provide product test and research data carried out for the Chinese market.


New Cosmetic Ingredients (NCI)

According to Article 11 of the CSAR the cosmetic ingredients are categorized as-

New ingredients- It is a natural or artificial ingredient which possess high risk that is applied in cosmetic products for the first time in China. The NMPA must authorize it before it may be used in cosmetics. After three (3) years of registration or filing, new ingredients must submit annual safety reports, and any subsequent new ingredient must undergo a safety assessment test conducted by professionals with more than five (5) years of expertise. Any cosmetic claim must be backed up by scientific evidence, which may be found on the NMPA website.


Existing ingredients- All the other ingredients which are available in IECIC are the existing ingredients which should just be filed with the NMPA.


SAMR

Main responsibilities include:

  • Market management

  • Market entity registration

  • Quality and safety supervision

  • Standardization work


Market Authorization Process (NMPA)

Filing Person and Registrants Qualifications

  • Has Cosmetic Quality Management System

  • Has Responsible Person In Charge Of Cosmetic Quality And Safety

  • Has An Adverse Reaction Monitoring And Evaluation System

  • Person Should Have Atleast 5 Years Of Experience In Cosmetic Regulation


Chinese Responsible Person

The responsible person for the product's quality, safety, and efficacy is the applicant for cosmetic product registration or filing. (Article 6.) A product safety evaluation must be performed by the Responsible Person or a professional institution prior to the registration or filing of a cosmetic product. Persons with knowledge in cosmetics quality and safety, as well as five years of relevant work experience, must conduct the safety evaluation. (Article 21.) A Responsible Person can either make the goods themselves or entrust it to other manufacturers. (Article 28.)


Domestic Notification / Registration of Cosmetics

Special cosmetics must register with the NMPA under China's new cosmetic regulations, but regular cosmetics just require a brief notification.


Classification

Pre-Market Obligation

Competent Authority

Certificate

​Post-Market Obligations

Special Cosmetics

Registration

NMPA

Registration License

Registration Renewal

General Cosmetics

Notification

NMPA or Local Provincial MPA

e-Certificate (Payment)

Annual Report Submission

  1. Application Process

Involved Entities

  • Registrant/Notifier: The first person accountable for cosmetic safety, and he has the option of producing cosmetics himself or entrusting the production of cosmetics to other businesses. The registrant or notifier is responsible for the entire product life cycle, from development to production to distribution.

  • Responsible person (RP): overseas cosmetics registrants and notifiers must designate a domestic responsible person who will handle cosmetic registration and notification, assist them in cosmetic adverse reaction monitoring and product recalls, and cooperate with the medical products administration department's supervision and inspection.

  • Cosmetic registrants/notifiers entrust entrusted production enterprises to create cosmetics for them. The entrusted production firm must meet all applicable production requirements, organize production in accordance with applicable laws, rules, and contractual agreements, be accountable for production operations, and accept supervision by cosmetics registrants and notifiers.


2. Duration and Cost

The duration and cost of the entire registration and notification process are determined by the cosmetic product's category and properties. In general, regular cosmetics take 3-6 months to be notified, whereas special cosmetics can take up to ten months to be registered. Sunscreen, freckle removal and whitening, anti-hair loss, and other products take longer to develop since additional efficacy testing are required.


The testing charge, efficacy evaluation test fee, translation fee, notary fee, and consulting fee are all included in the registration or notification cost (if a regulatory consultant is involved). Registration and notification are both free of charge at the NMPA.


3. Dossiers Necessary for Notification/Registration

Type

Required Dossier

User Permissions and Account Application

(Step 2)

  1. Information form for registrants and notifiers, as well as the resume of the person in charge of quality and safety

  2. Overview of registrants and notifiers in the quality management system.

  3. An overview form of registrants and notifiers for the adverse reaction monitoring and evaluation system.

  4. Information form for the domestic responsible person (applicable to overseas registrants and notifiers )

  5. The domestic responsible person's original authorization letter and its original notarial certificate.

Notification and Registration application

(Step 4)

  1. Registration and notification information form the cosmetics, as well as supporting papers (classification code)

  2. Details on the product name

  3. The formula for the product (ingredient submission code)

  4. Executive product standards

  5. Example of the product label manuscript

  6. Report on product testing

  7. Documents relating to product safety evaluations.

4. Safety Assessment

  • Technical Guidelines for cosmetic safety assessment

  • A subsidiary measure of CSAR + a replacement to guideline for cosmetic safety risk assessment

Qualification of Safety Assessor

CSAR - Article 21

  • Personnel engaged in safety assessment shall possess professional knowledge related to cosmetic quality and safety

  • Shall have 5 years of relevant professional work experience.

Draft guideline- Article 3

  • Shall possess knowledge in areas such as medicine, pharmacy, chemistry, toxicology.

  • Well understand the requirement of manufacturing process and the control of safety and quality of cosmetic product

  • Shall have more than 5 years of relevant work experience


5. Efficacy Claim Evaluation

The efficacy claims of cosmetics must be supported by sufficient scientific basis, which includes literature articles, research data, or efficacy evaluation test findings, according to the Standards for Cosmetic Efficacy Claim Evaluation (“Evaluation Standards”) (including human trial, laboratory test and consumer use test).


Beginning January 1, 2022, cosmetic registrants and notifiers must complete the efficacy evaluation themselves or entrust it to an evaluation institution with the necessary capabilities, and disclose the efficacy evaluation abstract on the NMPA-designated special website for public viewing at the time of registration and notification.

It's worth noting that the evaluation abstracts for the following two sorts of efficacies can be withheld.


  • Efficacy claims that can be recognized directly by vision, smell, and other senses, such as cleansing, makeup removal, beautifying and embellishing, perfuming, body refreshing, hair dying, hair perming, hair colour maintenance, depilating, deodorizing, auxiliary shaving and barbering, and so on.

  • Efficacy claims that work by just covering, preserving, or frictioning the skin, and are expressly stated on the label to have solely physical effects, such as freckle removal and whitening by physical covering, physical exfoliating, physical elimination of blackheads, and so on.


Imported Cosmetic Registration, Filing Procedure and Dossier Checklist-NMPA

Filing Procedure For Imported General Cosmetics-






Filing Procedure For Imported Special Cosmetics-



Cosmetic Labelling Requirement-NMPA

  1. Name of the product (in line with Requirements on Naming of Cosmetics)

  2. Manufacturer's name and address, as well as distributor's name and address

  3. Originating country

  4. Approval ID number (such as "J20130000") on administrative license or record-filing certificate

  5. Ingredient list (all substances with concentrations more than 1.0 percent must be mentioned in decreasing order of "quantity" with Chinese INCI names; in the lack of an INCI name, the corresponding name in the Chinese Pharmacopoeia, its chemical or botanical name can also be used)

  6. Content on the internet

  7. The batch number and expiration date, or the production date and shelf life

  8. Warnings (for products containing banned substances, such as Zinc phenolsulfonate, the term "avoid contact with eyes" must be included on the label; and for special-purpose cosmetics, such as hair dye)

  9. Condition of instruction and storage (provided if inadequate storage impacts safety)

  10. Additional information (the local distributor or wholesaler can be indicated as well)


Labeling cosmetic products for import into China now has two options:

  • Companies may create a label tailored to the Chinese market based on the above description.

  • Companies may create a China-recognized over-label to affix to imported products sold within the country.


While the CSAR has been praised by many in the personal care, beauty, and cosmetics industry for opening up many new opportunities for selling these products in what may soon be the world's largest market, these new labelling provisions are bolstered by a framework for levying fairly significant penalties and fines against companies that fail to comply.


Animal Testing-NMPA

Animal Testing Exemption for General Cosmetics

According to the Provisions for Management of Cosmetic Registration and Notification Dossiers, China officially removed the mandatory animal testing on MAY 1, 2021, for general cosmetics, whether it is imported or manufactured in China. Cruelty-free brands from other countries can now enter Chinese cosmetic market without animal testing but it must meet the two preconditions and three exceptions given below-



Two Preconditions

Three Exceptions

  • The cosmetics must be of a generic kind. Animal testing is still required for certain cosmetics, such as sunscreens and hair colours.

  • The competent authority in the country of origin must issue a certificate of compliance with good manufacturing procedures (GMP).

  • The results of the safety assessment can thoroughly validate the product's safety.

Animal testing is not permitted for the following three cosmetic categories:

• Cosmetics for infants and children

• Cosmetics that use novel substances throughout their three-year monitoring term

• Cosmetics whose notifier/RP/manufacturer is identified by the NMPA as a major supervision target


Animal Testing Requirements for New Cosmetics

Data from the Animal testing alternative methods (not included in China’s STSC but validated by an international authoritative alternative method validation agency such as OECD, ICCR, ICCVAM, EURL-ECVAM, JaCVAM, etc.) for NCI registration and notification can be conditionally accepted and are used for toxicological tests for NCI, Evidence demonstrating that the approach can anticipate the toxicological endpoint properly should be submitted. In addition, appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected during the evaluation of NCI safety based on the structural properties of the component and specific toxicological endpoints.


Animal Testing Exemption Conditions (According to ZMUni)

  • General cosmetics only

  • QMS certification issued by local government

  • Not intended for infants or children

  • Does not use new ingredients that are in the safety monitoring period

  • The filing person, Chinese responsible person, or manufacturers do not have bad records in China.


Children Cosmetics-NMPA

The ‘Draft Regulation on Supervision of Children's Cosmetics,' published by the National Medical Goods Administration (NMPA), comprises labelling standards and production rules for cosmetic products for children under the age of 12.

The following are important aspects to remember from the regulation:

  • For the sake of children's safety, raw materials such as fragrances, colorants, harsh preservatives, and surfactants should be used less frequently, and gentle ingredients should be used instead;

  • Raw materials that have been used safely in the past should be chosen, and materials that are still in the monitoring period should not be used;

  • Acne, hair removal, hair strengthening, deodorization, scar removal, anti-dandruff, hair coloring, and perming are all examples of raw components that should not be utilized in children's cosmetics.


Artixio provides cosmetic registration services in China using its local presence. For any queries regarding cosmetic regulations in China, please email us at info@artixio.com