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Background: Cosmetics Can be Exempt from Animal Testing in China
As per the Provisions for Management of Cosmetic Registration and Notification Dossiers, starting from May 1, 2021, general cosmetics whether imported or manufactured in China are permitted to be exempt from animal testing if they meet both of the following two conditions:
A certificate of compliance to the good manufacturing practices (GMP) issued by the competent authority of the country of origin is provided;
The safety assessment results can fully confirm product safety.
To exempt animal testing, the GMP certificate must be granted by the local government. Previously some overseas companies were troubled by this requirement as their GMP certificates were generally issued by cosmetic associations or international standardization organizations but not the government. To solve this problem, the governments of some countries have taken action to provide companies with official GMP certificates.
Supported by REACH24H’s rich experience in cosmetic registration/notification in China, ChemLinked has compiled a list of countries/regions where the government can issue a cosmetic GMP certificate.
List of Countries Where the Government Can Issue A GMP Certificate
Country/Region | Certificate Issuing Department | Remarks | References | |
The US | California | CDPH, California Department of Public Health | To apply for the GMP certificate, applicants should submit a hardcopy application CDPH 8582 form through the mail, or apply online through EDA online system. The processing time for application is about ten days. The certificate is valid for one year.
The Manufacturer Certificate (i.e., GMP Certificate in California) is issued only for companies licensed, registered, permitted, or certified by CDPH. No products or special wording are on this certificate. | |
New Jersey | NJDOH, New Jersey Department of Health | To apply for the GMP certificate, applicants should mail the required documents to NJDOH. The processing time for application is about ten days. The fee is 50 USD per certificate. The certificate is valid for three years.
Electronic submission is not accepted. All documents must be mailed. | ||
France | ANSM, the French National Agency for Medicines and Health Products Safety | Each GMP certificate request made via the online website cost 1,400 EUR and could be accepted or refused after the dossiers were reviewed. The certificate is valid for three years.
The certificate template and the list of required information for the application are set by ANSM. | ||
Germany | The District Office for Consumer Protection, Veterinary and Food Monitoring | The GMP certificate is issued by the county government where the factory is located. | / | |
Hungary | OGYÉI, the National Institute of Pharmacy and Nutrition | The Health and Free Sale Certificate (i.e., GMP Certificate in Hungary) is issued by OGYÉI. The certificate is valid for three years. | ||
Italy | Italian Ministry of Health | The responsible person/technical director/legal representative of the company who intends to export cosmetic products to China, or the third party manufacturing company, should submit the required dossiers to Directorate General for Medical Devices and Pharmaceutical Service by mail or email. GMP certificate is issued within 30 days from the date of acceptance of the application. | ||
Poland | The poviat sanitary inspector | Cosmetic manufacturers should apply to the poviat sanitary inspection authority for GMP certificate. The poviat sanitary inspection authority inspects the plant and requests necessary documentations to confirm the GMP compliance situation. | ||
Spain | AEMPS, Spanish Agency of Medicines and Health Products | The GMP certificate includes its validity period and the production situation of the plant. GMP certificate is issued bilingual in Spanish and English and valid for three years. | ||
Switzerland | The competent cantonal implementing authority responsible for food | GMP certificate is to be issued only if the cosmetics have been manufactured or packaged in Switzerland. The cantonal implementing authority in the canton where the exporter's office is registered is responsible for issuing the certificate. The cantonal chemist or the deputy person signs the certificate.
The Swiss Association of Cantonal Chemists provides a uniform certificate in consultation with the Federal Food Safety and Veterinary Office. | ||
The UK | The Import Licensing Branch of the Department for International Trade | To apply for the GMP certificate, companies need to create an account or log into the DIT ILB Import Case Management System (ICMS), and must be able to show their cosmetic products are manufactured according to GMP guidelines and standards. The certificate is valid for three years. | ||
Japan | MHLW, Ministry of Health, Labour and Welfare | JCIA (Japan Cosmetic Industry Association) is responsible for accepting and checking application documents for the GMP certificate. Applicants should mail the required dossiers to the JCIA office. GMP certificate is issued within 20 days from the date of acceptance of the application. | ||
South Korea | MFDS, Ministry of Food and Drug Safety | Applicants may apply for a GMP certificate from MFDS through: http://nedrug.mfds.go.kr. Cosmetics GMP certificate (in English) can be issued electronically with an electronic signature of MFDS. | ||
Thailand | Bureau of Cosmetics and Hazardous Substances Control, Food and Drug Administration, Ministry of Public Health | The GMP certificate application process has slight differences between Bangkok and applications from each province. Submissions from Bangkok are processed online, while other provinces still need paper submission, and in most cases, a physical inspection of the place is required.
The certificate is valid for three years. | ||
Notes: 1) Besides, the governments of Slovenia and Belgium can also issue GMP certificates. 2) This table will be continuously updated. We welcome any related regulatory information sources (mail to [email protected]). | ||||
Criteria for GMP Certificates for Animal Testing Exemption
According to China National Medical Products Administration officials, they won’t issue a unified template for the GMP certificate. Companies are eligible to apply for animal testing exemption as long as the certificate meets all of the following criteria:
Issued 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 foreign cosmetic manufacture certificate can be accepted depends on the local manufacturing standards. If the standards are below the requirements prescribed in the international GMP/ISO 22716, the corresponding manufacture certificate won’t be accepted.
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