The cosmetic ingredient session at CRAC-HCF 2020 Virtual Forum hosted by REACH24H was successfully concluded on Dec. 8, 2020. This informative online conference attracted the attendance of international cosmetic companies, chemical companies, NGOs and other experts across a wide array of industries. It was during these sessions, that the following four speakers shared their insights on China's future cosmetic ingredients regulatory management. They are as follows:
Zhao Hua, Beijing Technology and Business University
Zhang Hongwei, Chinese Center for Disease Control and Prevention
Shujun Cheng , Shanghai Jiaotong University School of Medicine
Jiang Ligang, Proya Cosmetics Co.,Ltd.
Below, you will find 7 Q&A that ChemLinked believe will be of great worth to you.
1. Multiple companies responded to the new regulations that it's more time-efficient when it comes to submission of notifications as a successful submission of notification dossiers means completion of the notification. However, requirements for the notification have become stricter. In essence, companies shouldn't let their guard down just because of the simplified notification procedures?
Zhao Hua: You are right. Though the procedures are simplified the safety requirements have become stricter as enterprises will shoulder more responsibilities and as such should act more cautiously in this regard. They must be stricter with their work since in the event of problems found in the follow-up supervision and inspections (e.g. items not tested or disqualified testing results), the punishments will be very serious.
2. The new regulations propose some particular requirements on nano-ingredients and ingredients from biotechnology source for the first time, as well as a special explanation on the documents of these two ingredients. The administration on nano-ingredients aims to fill in the regulatory blanks, with the administration on ingredients from biotechnology source is a global pioneer. What's your opinion on the particular requirements of the aforementioned two ingredients?
Zhao Hua: It's good news for enterprises. Though the new regulations opens some new doors for us, we have to follow the outline of safety. Previously, we were not allowed to claim nano-materials due to safety concerns. With EU recognizing nano-ingredient risk assessment for the past several years, we have started to hold a more open attitude in this regard. Nano-ingredients can be used in cosmetics as long as they are clarified in detail and if they pass the safety risk assessment.
This also applies to the biological ingredients and the fermentative ingredients which are very popular in recent years. As long as you can clarify the substrate, the culture, the animal stem cells and plant stem cells and various factors, and the amino acid sequence and structures, and the ingredients can pass the safety assessment, they can be used in cosmetics. This is a tremendous opportunity for enterprises in fact. Enterprises have the opportunity to use such ingredients as long as they can prove the safety of those ingredients.
3. Many enterprises are concerned about the Inventory of Existing Cosmetic Ingredients in China, namely IECIC. We all know that new cosmetics ingredients that do not have any safety issues within the 3 years will be included in the IECIC. We’d like to know whether the government would revise the IECIC, such as the addition of ingredients permitted for use internationally.
Zhao Hua: Regarding IECIC, new ingredients without safety issues within the 3 years will be included in it. This inventory is dynamic and will be updated annually. And I'd like to mention another list, Chinese INCI-the Catalogue of Standard Chinese Name of International Cosmetic Ingredient. Its 2018 version has been issued for seeking public opinions. As too many regulations were issued recently, the Catalogue has been put on hold. The 2018 draft for comment is the latest translation version, and we may align it with the international INCI every 2 years.
4. As stated in the regulation, animal testing alternatives are conditionally acceptable in China. Only companies adopting internationally accepted methods or integrated strategies should submit evidence of consistent results from the toxicological test methods and the current methods in China. This evidence shall be submitted in the form of a comparative research article that has been published (not a summary), or in compliance with the testing report issued by an internationally accepted GLP laboratory. It shall also include a summary of the method research process, comparative research data of no less than 10 test substances, result in analysis, and conclusion. Many companies think this requirement is set too high. What do you think of this, Ms. Zhang?
Zhang Hongwei: In regards to the evidence required, the first aspect is about the manner of the strategy integration. From my perspective, I think it's targeting at some single tests from which conclusive judgment cannot be made. Take the sensitization test as an example, it's used to judge the allergenicity of a test substance. The in-vitro sensitization test basically can't reach a very complete, or conclusive, judgement. Therefore, generally a combined test is required, which is usually acceptable both domestically and internationally. This is the combined test strategy.
Second, the alternative method acceptable to OECD also requires a validation process, and at least test substances should be used in the process. For an alternative method included by OECD, it also substantially uses some substances for validation in the development and research of alternatives. In some references or the validation of methods, not just validation data of 10 substances are involved, but a large amount of validation data is provided. This document may virtually express the intention to obtain some of your validation data, the data of at least 10 substances and some current methods. Namely, we usually use such test methods for comparison, but companies should look up into the reference materials and documents, and obtain such data as supporting evidence.
Another aspect is about the independently developed alternative methods done by companies. That is to say, validation is also conducted when developing and studying the methods. So, if companies have carried out validation, they will obtain some experimental validation data for tested substances, which is to be collected and provided by companies. And such data can be absolutely used as evidence for the known methods. So, in actual practice, perhaps having such understanding will make the regulations more operational.
5. As required by the regulation, if methods that are not included in the Safety and Technical Standards for Cosmetics are used, the internationally accepted methods or national standards, etc. shall be adopted. If the methods adopted are inconsistent with those specified in the Safety and Technical Standards for Cosmetics, evidence of consistent results obtained by both methods shall be provided. As you know, some methods included in China are actually based on the OECD methods. For in previous acute oral toxicity or dermal toxicity tests, if OECD401 or OECD402 methods are adopted, it is also acceptable. If these methods are adopted in accordance with the new standard, are companies also required to submit evidence of consistency?
Zhang Hongwei: No validation is required if the methods used are included in the Safety and Technical Standards for Cosmetics. You may be speaking of the methods included in the Safety and Technical Standards for Cosmetics. You mentioned 401, 402. Actually, the acute oral toxicity or dermal toxicity test among the methods we have included takes a reference to OECD401 and OECD402. Maybe 401 and 402 are updated on some contents, which are not completely consistent with the methods in our current regulation. But requirements are set for some principled contents in our current regulation. We are not taking a reference without any changes.
If there is no big discrepancy between the animal test methods used in 401 and 402 and those in our regulation, the methods specified in 401 and 402 are also acceptable. But in general, the methods should have been included in our regulation.
6. What factors are considered by national authorities in formulating the policy or what conditions should be met to accept an alternative method at the policy level in China? For the cosmetics or new ingredients, how can the enterprises meet the compliance requirements by using alternative methods? Do you have any advice?
Cheng Shujun: We have to admit the fact that the alternative methods have been accepted in the legislation in China though in a moderate manner, which accords with Chinese actual situation.
For an alternative method, the new regulation requires such methods better adopted in the international community or developed by the international authoritative organization. What we need to do is to demonstrate the capability of the alternative method. Capability demonstration of an alternative method is totally different from verification of its scientific basis and reliability.
What we need to do is to reproduce these methods in China. The first thing we need to do is to reproduce such a laboratory. Second, we should collect data based on application scenarios in China. The application of the alternative methods cannot be improved without any data or use as the problems of alternative methods only appear in use. Also, the regulators should establish the registration, notification, and adoption procedures of in vitro data. As these methods will eventually replace the animal experiments, a reasonable plan should be established to facilitate the acceptance of data and the status of alternative methods.
7. The new version of the Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments) sets out the Guidance on Submitting Information Related to the Quality and Safety of Cosmetic Ingredients, encouraging ingredient suppliers to submit quality and safety information of ingredients. If the ingredient suppliers have submitted the information and obtained the ingredient submission code, the registrant and notifier of cosmetics can directly fill in the ingredient submission code. So, in your opinion, can this practice motivate cosmetic ingredient companies to submit relevant information to the competent authority despite the pressure from finished product companies?
Jiang Ligang: That's for sure. Actually, I have just mentioned this question. I think that cosmetic companies should encourage ingredient companies to obtain the code, only after which can they use the ingredient. Only when everyone acts in this way will we embrace a sound market for cosmetic ingredients.
There's another problem. We need to consider both big and small companies in China. As small companies may buy a small number of ingredients from ingredient suppliers, ingredient suppliers may ignore them. Right? So small companies may be provided with incomplete information and receive poor service. Though small companies really buy products from ingredient suppliers, the suppliers may not necessarily provide various services so proactively due to the small purchase quantity.
Well, now things are getting better, as ingredient suppliers are required to register relevant information online. If you buy their ingredients, the code can be associated. In this way, things will be easier for you, as it will save ingredient suppliers from the trouble of offering it to every client. In turn, it will also be easier for small companies, as this can save them from the trouble of asking for it every time. This is good for all parties. For ingredient suppliers, the relevant requirements are standardized. I think this is good.
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
