Cosmetic Compliance
Intelligence & Solutions
China Cosmetic Animal Testing Regulation
Jun 18, 2021
Winnie Xu
Tags : ChinaCSAR
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CONTENTS

China’s mandatory animal testing requirements have been a major stumbling block stymying the entry of many overseas cruelty-free cosmetics brands. Encouragingly on May 1, 2021, China officially exempted animal testing for imported general cosmetics. Overseas cruelty-free brands can now tap into the Chinese cosmetic market under appropriate conditions.

Part 1 The History of Phasing out Cosmetic Animal Testing

For a long time in the past, cosmetic companies were obliged to utilize NMPA-approved (National Medical Products Administration) labs to perform animal tests on their cosmetic finished products or ingredients even if they had already been assessed as "safe" and marketed in other countries. Testing results drawn from non-animal testing methods were not likely to be trusted and accepted by NMPA technical review experts.

As an increasing number of China's trading partners introduced national bans on animal testing due to the growing demand by the public for cruelty-free testing methods, it led to the result that the Chinese cosmetics market has some divergences in standards and regulations compared to the international market. As a response to that, China is inclined to re-align its cosmetics regulations and industry capacities with global practices and trends, and has made great efforts to phase out animal testing of cosmetics over the past few years.

1. Removal of mandatory animal testing for domestic non-special use cosmetics

In 2013, the previous competent authority - CFDA (now NMPA) issued Requirements for Filing of Domestic Non-Special Use Cosmetics stipulating that mandatory animal testing could be avoided for domestic non-special use cosmetics which gained reliable safety assessment reports. The announcement came into force on June 30, 2014. It was the first time for Chinese authorities to put forward specific measures to reduce animal testing.

2. Animal testing exemption for CBEC imports

In 2016 China initiated a regulatory reform on its cross-border e-commerce (CBEC) policies, under which the CBEC-traded commodities were subject to mandatory pre-market registration or filing. However, as the reform sparked considerable controversy among the public, a transitional policy that “temporarily” exempted the pre-market approval for first imported cosmetics, infant formula, etc. via CBEC channel was first launched in 15 CBEC pilot cities such as Shanghai and Hangzhou.

On November 21, 2018, the CBEC transitional policy was officially extended. As per the new rules, cosmetics imported via CBEC channel shall be supervised as personal articles, exempt from customs import license, and not subject to cosmetic regulations. Hence the significant time consumption and financial investment for the compliance with Chinese labeling requirements and mandatory toxicology testing requirements could be avoided. Therefore, it offers an excellent market access route for international cosmetic stakeholders to circumvent animal testing.

3. A De Jure End to Animal Testing for General Cosmetics

In May 2019, China consulted on the draft Administration Measures for Filing of Non-Special Use Cosmetics, first proposing to extend the animal testing exemption from domestic non-special use cosmetics to all non-special use cosmetics. After the largescale cosmetic regulatory reform initiated in 2020, the relevant provisions of high-profile animal testing exemption for general cosmetics were reiterated in the subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR). Two more rounds of public consultations were conducted in August and November 2020. On March 4, 2021, China NMPA released the finalized Provisions for Management of Cosmetic Registration and Notification Dossiers, announcing that general cosmetics can exempt from animal testing from May 1, 2021, which is a de jure end to animal testing for general cosmetics.

Part 2 Animal Testing Requirements for General Cosmetics

As per the Provisions for Management of Cosmetic Registration and Notification Dossiers, general cosmetics whether imported or manufactured in China are permitted to exempt from animal testing from May 1, 2021. But it should be noted that there are three preconditions and three exceptions for the animal testing exemption.

2.1 Three preconditions

  • First, the product must be general cosmetics, which refers to all products complying with the definition of cosmetics within CSAR, except for the special cosmetics. The special cosmetics includes hair dyes, hair perming products, freckle-removing, and whitening products, sunscreens, anti-hair loss products, and cosmetics claiming new efficacy.

  • Second, a certificate of compliance to the good manufacturing practices (GMP) issued by the competent authority of the country of origin shall be provided.

  • Third, the safety assessment results can fully confirm product safety.

2.2 Three exceptions

Also, there are some exceptions for animal testing exemption. The following three cosmetic categories still require animal testing.

  • Infant and children cosmetics;

  • Cosmetics using new ingredients during their 3-year monitoring period;

  • Cosmetics whose notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA.

2.3 Noteworthy Points

2.3.1 Submission of GMP Certificates

1. Criteria for GMP certificates for Animal Testing Exemption
According to NMPA officials, there is no unified template for the GMP certificate. Companies are eligible to apply for animal testing exemption as long as the certificate meet the following criteria.

◆ GMP InformationIssued by the local governmental competent authority rather than associations or chambers of commerce;

◆ Reflect the government’s actual supervision of the entire manufacturing process and the overall quality control system rather than a partial process and system;

◆ Whether international cosmetic production licenses can be accepted depends on the local manufacturing standards. If the standards are below the requirements prescribed in the international GMP/ISO, the corresponding production license won’t be accepted.

*For product manufactured by multiple manufacturers, only if all the manufacturers have obtained GMP certificates issued by the local governments, can the product be exempted from animal testing.

2. Trading Partners’ Response to China’s Animal Testing Policy

To exempt animal testing, the GMP certificate must be granted by the local government. However, currently there are very few overseas governmental agencies can issue an official GMP or ISO certification. Instead, the GMP certificates are generally issued by associations or third-party organizations. In response to this problem, the governments in some countries are considering introducing solutions to help local manufacturers obtain the qualified certificates.

Countries

Actions

France

In January 2021, France ANSM (National Agency for the Safety of Medicines and Health Products), the French health authority, announced that it would issue GMP certificates for local cosmetic manufacturers and has already launched an online platform for enterprises to obtain the certificates.

The U.K.

According to a spokesperson from U.K. Department of International Trade, U.K. government is working closely with industry to create a certification system that will satisfy new Chinese regulations on cosmetics, following the removal of the requirement of animal testing on imported cosmetics.

Japan

On April 23, 2021, Japan Cosmetic Industry Association (JCIA) issued an announcement in response to China’s new regulation on animal testing exemption for imported general cosmetics. It states that JCIA will be responsible for handling applications and reviewing the application documents for GMP certificates from cosmetic companies which look to circumvent China's animal testing. Ministry of Health, Labour and Welfare (MHLW) will grant official GMP certificates for the compliant applications. For quasi drugs, companies may refer to the requirements of PMDA. 

2.3.2 Safety Assessment

Apart from the GMP certificates, safety assessment is also a mandatory condition for the animal testing exemption. On April 9, 2021, China released the finalized Technical Guidelines for Cosmetic Safety Assessment 2021 (hereafter referred to as the “Technical Guidelines”), which refined the requirements for safety assessment and clarified the content of safety assessment report. The Technical Guidelines has taken effect on May 1, 2021.

According to the Technical Guidelines, cosmetic product safety assessment should be based on the assessment of all the ingredients and possible risk substances. If there are any chemical or biological interactions between certain ingredients, the risk substances or potential safety risks arising from the interactions should also be assessed.

To ensure a smooth transition, NMPA introduced the following transitional measures:

  • Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments on their own or entrust professional institutions per the Technical Guidelines and submit the assessment report during registration and notification.

  • Considering that there is a gap between the safety assessment capacity of China's cosmetic industry and that of the developed countries, cosmetic registrants and notifiers are allowed to submit a simplified version of the product safety assessment report before May 1, 2024.

    The simplified safety assessment report does not require product stability testing, packaging material compatibility, or preservative challenge testing. Besides, four types of evidence can be used in the simplified report to prove the safety of each ingredient in the formula, including 1) the limitation in Cosmetic Safety and Technical Standards for Cosmetics (STSC), 2) safety limits or conclusions published by domestic or foreign authoritative organizations, 3) the highest use concentration in the company, and 4) the highest historical use concentration specified in IECIC 2021. Companies should select at least one type of evidence in sequence to prove safety. The more complete the type of evidence, the better.

2.3.3 Post-Market Animal Testing

It is also worth noting that the animal testing exemption discussed above is all about pre-market testing. Regarding the post-market phase, animal testing has not been explicitly excluded from post-market testing methods by the regulatory authorities.

However, as far as we know, the chance of encountering post-market animal testing is quite low and it is mostly for those with serious safety risks. In fact, animal testing is not used in post-market surveillance for years. As long as the products’ manufacture and operation comply with China’s regulations, no need to worry too much about post-market animal testing. Even if it does happen, companies are allowed to pull products from shelves rather than enable officials to test products on animals.

Part 3 Workarounds for Special Cosmetics and General Cosmetics without Recognized GMP Certificates

Under CSAR, the special cosmetics and general cosmetics without recognized GMP certificate are still required to be animal tested. For international stakeholders, the following workarounds are possible.

The most convenient method is through CBEC. Cosmetics imported through CBEC are regulated as personal articles and exempt from registration and notification. Thus, no matter special or general cosmetics, animal testing is not required.

For general cosmetics without a recognized GMP certificate, in addition to CBEC, there are two other options.

  • First one, going local. Overseas companies that intend to avoid animal testing can set up a factory in China, entrust a Chinese OEM for production, or fill and pack the products in a Chinese factory.

  • In view of Chinese consumers may prefer imported products, if overseas companies would like to keep their products as imported, they can outsource the production to a country whose GMP certificate is recognized by NMPA.

Part 4 Animal Testing Requirements for New Cosmetic Ingredient (NCI)

Regarding the animal testing requirements for the application of NCI in China, the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers released on March 4, 2021 regulates that data from animal testing alternative method for NCI registration and notification can be conditionally accepted.

If 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.) are used for toxicological tests for NCI, the evidence proving that the method can accurately predict the toxicological endpoint should be submitted.

In addition, during the evaluation of NCI safety, appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected according to the ingredient's structural characteristics and specific toxicological endpoints.

Part 5 Alternatives to Animal Testing

The animal testing alternative methods serve as viable surrogate markers in the assessment of potential toxicities, adverse effects, and hazards associated with the use of cosmetics and can reduce the authority and the industry’s reliance on the use of animal testing.

5.1  Approved Alternatives in China

At present, six alternative methods have been approved and incorporated into STSC for the relevant cosmetic registration/notification and post-market surveillance testing. Significantly, these six methods are all designed for cosmetic ingredients.

Effective Date

Testing Method

Testing Item

Range of Application

December 1, 2016

In-vitro 3T3 Neutral Red Uptake Phototoxicity Test Method for Chemicals used in Cosmetics

Skin Phototoxicity

Cosmetic Ingredient

August 21, 2017

In Vitro Skin Corrosion Transcutaneous Electrical Resistance Test (TER) for Chemicals Used in Cosmetics

Skin Corrosion

Cosmetic Ingredient

January 1, 2020

Short Time Exposure In Vitro Test Method (STE)

Eye Irritation

Cosmetic Ingredient

In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)

Skin Sensitization

Cosmetic Ingredient

Skin Sensitization: Local Lymph Node Assay: DA(LLNA: DA)

Skin Sensitization

Cosmetic Ingredient

Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA(LLNA: BrdU-ELISA)

Skin Sensitization

Cosmetic Ingredient

5.2  Alternatives under Validation

In recent years, a larger number of domestic organizations such as the National Institutes for Food and Drug Control and Zhejiang Institute for Food and Drug Control have developed a partnership with international non-profit organization Institute for In Vitro Sciences. The goal of these collaborations is to open more in vitro toxicity testing laboratories and to establish more alternatives to animal testing methods. By now, there are five methods under validation.

Alternatives under Validation

  1. Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA)

  2. Skin Sensitisation: ARE-Nrf2 Luciferase LuSens Test Method

  3. Skin Sensitisation: U937 Cell Line Activation Test (U-SENS™)

  4. Eye Irritation/Corrosion: Fluorescein Leakage (FL) Test

  5. Skin Sensitisation: human Cell Line Activation Test (h-CLAT)

Tags : ChinaCSAR