Toxicological tests have always been required for imported cosmetics registration and notification in China which include skin irritation, eye irritation, etc. Animals are generally used as test subjects, so they are also called cosmetics animal tests. Cosmetics brands that refuse to use animals for toxicology tests, such as The Ordinary acquired by Estee Lauder, are called cruelty-free cosmetic brands and have been attracting widespread attention overseas. Many well-known overseas brands such as The Body Shop, Aesop, Huda Beauty, Ren, and Tatcha have also been looking forward to the change of domestic cosmetics policies in order to enter the Chinese domestic market.
According to the Rules for Registration and Notification Dossiers of Cosmetics implemented on May 1, 2021, and other regulatory documents, registration persons and filing persons shall submit product test reports including toxicological test reports when applying for cosmetic registration or filing. General cosmetics that meet the following conditions can be exempted from submitting the toxicological test report:
1. Cosmetic manufacturers have already obtained the relevant qualification certification of the production quality management system issued by the administrative department of the country (region) where they are located.
(GMP is a very typical certificate related to the quality management system of manufacturers, while in many countries and regions, it is issued by associations and third-party certification agencies, and few are issued by local administrative departments. Since the implementation of this new policy in China, the governments of overseas countries have successively inspected and issued corresponding certificates to local manufacturers. For example, the French manufacturers can apply for certificate from Agence nationale de sécurité du médicament et des produits de santé (ANSM). However, there are still regions where enterprises cannot obtain such certificates because there are no relevant local policy requirements. If you want to know which other national government agencies can issue certificates that meet the requirements of Chinese regulations, please contact email@example.com)
2. The product safety risk assessment results can fully confirm the product safety.
(Cosmetics manufacturers can conduct cosmetic product safety assessments by themselves or by entrusting professional institutions, but the personnel engaged in safety assessments shall have professional knowledge related to the quality and safety of cosmetics and have more than 5 years of relevant professional experience. EnterCo has professional laboratories and qualified technicians, which can carry out cosmetic safety assessments and issue safety reports of cosmetics.)
3. The product is claimed not to be used by infants and children.
4. The product can not use new cosmetic ingredients within the safety monitoring period.
5. Filling persons, domestic responsible persons, and cosmetic manufacturers are not listed as the key supervision objects.
(In other words, it means that all related companies have no serious violations in China in the past. EnterCo, as a professional and efficient cosmetic regulatory compliance consulting firm specializing in the cosmetic industry, undoubtedly meets the exemption condition for domestic responsible persons. We are willing to serve as the domestic responsible person for companies that are interested in long-term cooperation and attach importance to product compliance.)
Trend and influence
Since March 2013, the EU has taken the lead in completely banning cosmetic animal tests, and more and more countries have joined the ranks. Although China has not completely banned cosmetics animal tests, the new regulations also exempt qualified general cosmetics from animal testing. Due to the change in China's cosmetics policy, more and more overseas cosmetics brands will choose to meet the above five conditions if they want to enter the domestic market, thus exempting toxicology tests (animal tests). With the implementation of relevant regulations, domestic cosmetic brands will be affected to a certain extent.
If you would like to check if your products can meet the five conditions to enter the China market without animal testing, just contact EnterCo for more information: firstname.lastname@example.org.