We talked with David Chang, General Manager of Oriental Chemical Information Co., Ltd, referred to as OCI, to know his stands upon the regulations of China Cosmetics newly reinforcement in China
EURO COSMETICS: After the release of Regulation on the Supervision and Administration of Cosmetics of China, is there any major changes in the registration of new cosmetic ingredients (NCIs) and finished products?
David Chang: We divide this content into two parts: NCIs and cosmetics.
The first is the registration of NCIs. The recently approved four NCIs have received extraordinary response in the Chinese industry. This is the first time that China has opened the door for NCI registration in the past 10 years, which is not only the approval of 4 raw materials, but also the beginning of major changes in NCIs. The registration system applied to the registration of NCIs in China, but now it has been transformed into a mode that combines the filing and registration system, reducing registration time and process of the company, and providing companies with greater convenience. In the Administrative Practices on Cosmetic Registration, the difference between filing and registration is clearly proposed for the first time.
Filing refers to the activity in which the filing party submits materials indicating product safety and quality controllability to the Drug Supervision and Administration Department for filing and reference in accordance with legal conditions, procedures and requirements.
Registration refers to the activity in which the registration applicant submits a registration application in accordance with legal conditions, procedures and requirements, and then Drug Supervision and Administration Department reviews the safety and quality controllability of the cosmetics or NCIs applied for registration, and decides whether to approve the registration application.
According to the above definitions, I think you can clearly understand that the greatest change in the registration of NCIs is to give more rights and responsibilities to the company without relaxing the strict requirements, so that the company can undertake greater responsibility for its products. Of course, the Regulation has also increased the penalties of violations, and while being allowed to enjoy their rights, they must also bear their due responsibilities. In addition, China has also established an ex post supervision mechanism and clarified a three-year monitoring period. During this newly reinforcement in Chinaperiod, all NCIs must pass the examination of registration company before they are used. This is not only a three-year monitoring period, but also a three-year non-monopoly market exclusivity for registration companies, which gives companies greater benefits although called monitoring.
Regarding the registration of imported cosmetics, the greatest change should be the newly added efficacy experiments. Before that, the import of cosmetics has never been required to be responsible for the efficacy of cosmetics, but now efficacy-related experiments are added and companies shall be responsible for the efficacy they claimed. Although the corresponding supporting management measures have not been fully released, their implementation is already on the agenda. In addition to the efficacy, the ex post supervision has become stricter. Except for clarifying the penalties in the regulations, it has also established an adverse reaction detection mechanism to improve the supervision mechanism of cosmetics from the registration to the market.
EURO COSMETICS: In addition to the corresponding changes with promulgation of new regulations, what shall foreign cosmetics first specify if they want to venture into China market?
David Chang: This is the same for NCIs and finished products. First, a foreign company must identify a company in China as its filing party or registrant, and this Chinese company shall be fully responsible for all domestic product-related issues of the foreign company, including all issues encountered in the early filing or registration and subsequent supervision. Here I would like to remind companies that it is very important to choose the filing party or registrant. We need to choose a company with good credit, good qualifications and able to establish an adverse reaction monitoring mechanism as your filing party or registrant, because this is closely related to whether our products can sell well in the market later. Especially, there is a three-year monitoring period of NCIs after filing or registration. A corresponding complete monitoring system must be established during this monitoring period to safely and steadily pass the three-year safety monitoring period. Therefore, a good filing party or registrant is the first and most important hurdle for enterprise products to enter China. Of course, the corresponding procedure is not complicated. It only needs the enterprise to authorize the Chinese enterprise, and the domestic enterprise accepts this authorization and applies in the corresponding system.
EURO COSMETICS: Can foreign test reports be accepted by regulatory authorities in China, and can certain alternatives to animal experimentation be accepted in China?
David Chang: The test report description will be divided into two aspects. The first is the NCIs, the test report of which can be presented in the form of foreign test report provided that it has met two conditions. First, the test report shall be issued by an inspection and testing organization that meets the internationally accepted good clinical practices (GCP) and good laboratory practice (GLP) qualifications; Second, the toxicology test items of NCIs shall be subject to the test methods specified in the Safety and Technical Standards for Cosmetics; The items without prescribed methods in Safety and Technical Standards for Cosmetics shall be tested in accordance with national standards or common international practice. Physicochemical and microbiological inspection, human safety and efficacy evaluation test items shall be subject to the test methods specified in the Safety and Technical Standards for Cosmetics or the People’s Republic of China Pharmacopoeia; The items without prescribed methods in Safety and Technical Standards for Cosmetics or People’s Republic of China Pharmacopoeia shall be tested in accordance with national standards or common international practice. If a newly developed test method applies, relevant materials on the applicability and reliability of the method shall be submitted at the same time. As long as the above two conditions are met, the relevant inspection report is available.
Foreign inspection reports are not available for finished cosmetic products, which need to be tested in China.
Alternatives to animal experimentations have always been a big topic for China and China has also been studying the feasibility of it. At this stage, six alternatives to animal experimentations have been listed in the Safety and Technical Standards for Cosmetics, and some other methods may also be included. We can look forward to its further development, but at this stage, in addition to the six methods I mentioned before, if you would like to carry out other alternatives to animal experimentations, you shall also provide evidence that the method is consistent with the results of the traditional toxicology test method. In this way, alternatives to animal experimentations may be carried out.
EURO COSMETICS: With regard to the security of the materials required for the filing or registration of NCIs, is there any way to solve the problem of the materials confidentiality?
David Chang: Don’t worry. According to the Article 73, Chapter V of the Administrative Measures on Cosmetic Registration, the drug supervision and administration department, relevant technical institutions and their staff have the obligation to keep the relevant materials submitted by the registration applicant and the filing party confidential. Therefore, the integrity of the materials shall be ensured when the materials are provided, so as to ensure that no problems occur in the ex post supervision.
EURO COSMETICS: Thank you for the conversation.
