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The 3rd Summit Meeting on Cosmetic Regulations in Asia Pacific Q&A Summary

from CIRS by

On 28 and 29 June, the 3rd Summit Meeting on Cosmetic Regulations in Asia Pacific sponsored by China Association for Consumer Products Quality and Safety Promotion (CPQS), organized by CIRS came to a successful conclusion. China’s cosmetic regulations have experienced a series of important changes in 2016, including regulations on safety management of new cosmetic ingredients. This year’s summit meeting focused mainly on the supervisions for online and offline cosmetics and requirements on safety management of cosmetic new ingredients in EU and the US. The detailed agenda of summit can be found here

Enterprise representatives were actively involved in the presentations and came up with good questions of their concerns. CIRS selected and summarized 17 important questions below.

Q1. It was mentioned that there were 3 levels of review in the record-keeping system of Pudong New Area. What are the focuses and specific requirements of the 3 levels?

A from Division Chief of Cosmetic Supervision Department, Shanghai FDA: It is generally the review of the dossier: whether the dossier is prepared in the scope of the record-keeping system, whether it is completed or has met the requirements. The procedure includes obtaining username and password, uploading dossier and waiting for approval. After the approval, companies should prepare hard copies for submission to the window to check if the hard copies are complying with the uploaded soft copies. For any companies interested in the record keeping system, CFDA has training class which companies can participate.

Q2. Are there any updates on animal testing for the record-keeping system in Pudong New Area? Are there any regulations on import Organic cosmetic products?

A from Division Chief of Cosmetic Supervision Department, Shanghai FDA: The requirements on product safety are the same. And there are related regulations on import organic products. However, we are currently lack of institutions for organic certification of cosmetics in China. Hence the word ‘Organic’ will be covered and cannot be claimed on Chinese labels. The entire review and dossier required for import non-special use cosmetic product under the record-keeping system in Pudong New Area are the same as that for CFDA registration, which means animal testing is also mandatory for the new system. There are no updates so far. However, there exists a tendency of adopting alternative tests in the future.

Q3. There was a draft version of REGULATION AMENDMENTS submitted for review in 2015. We found that the amendment of non-high risk cosmetic ingredients was not in the 2017 legislation plan by the State Council. Would there be any updates on this? What is your vision about this? China’s cosmetic regulations are experiencing rapid changes due to following up with regulations of EU. How do companies cope with such rapid changes? Do you have any comments and suggestions?

A from Director of Beijing Daily-Use Chemicals Institute: It is true that REGULATION AMENDMENTS for non-high risk cosmetic ingredients were not in the 2017 legislation plan by the State Council. We hope it will be in the 2018 legislation plan. The new Technical Safety Standards for Cosmetics (Please click here for more information on the Technical Safety Standards for Cosmetics) referred not only to the EU regulation, but also the regulations in other countries such as Japan. Before implementing the new regulation (Version 2015), the review opinions did include deadline of official comments in terms of new regulation and degree of complication for next time modifications. The transitional period is short. For example, methylisothiazolinone (MIT) has safety issues when used in rinse-off cosmetics. EU has also stated that MIT has safety risk in leave-on cosmetics. We have to be very cautious with these products containing MIT. However, it is not quite possible to provide safety risk assessment of MIT used in leave-on baby products. It seems that we are more authoritative than EU. The determination and use of regulations require administrative approval. There is no deadline on technical requirements based on keeping the products safe. Companies should be prepared in advance to the upcoming regulation changes.

Q4. CIQ is the first pass of import cosmetics. While inside China, products will go through the second pass by local FDAs for post market random check. The two passes aim to protect the interests of consumers. Unqualified products will be revealed by CIQ, as well as local FDAs during their random check. Do CIQ and local FDAs have internal communication? What are the suggestions about local FDA’s feedbacks to the CIQ system? Will the process be further improved in the future?

A from Section Chief of Food Safety Department, Shanghai CIQ: Shanghai CIQ and Shanghai FDA have issued a joint announcement regarding the record-keeping process of import non-special use cosmetic products in Shanghai Pudong New Area, which indicates our corporation and communication have already begin. The announcement includes clarifications on how companies proceed with the process, how to import and how to undertake the responsibilities for companies when product safety issue happens during the post-market.

Q5. Are the foreign manufacturing companies needed to be audited for manufacturing qualifications after the products have been approved by CFDA? Is it possible to adopt certifications from foreign labs by advancing the process of The Belt and Road?

A from Section Chief of Food Safety Department, Shanghai CIQ: Foreign manufacturing companies will not be further audited. Because some qualifications like CFS and manufacturing agreement have been reviewed during administrative approval. Retrospective review of some manufacturing companies is possible, like we’ve done for some Korean and German companies. But it is not necessary and depending on specific circumstances, e.g. products are found to have safety issues after marketing. Certifications from foreign labs are currently not recognized by CFDA, but may be further advanced in the future.

Q6. Regarding the safety evaluation for inhalable particles of cosmetic ingredients, whether there is a unified standard of inhalation exposure evaluation between the US and EU?

A from Senior Toxicology of Cosmetic Ingredient Review: There is not much difference on this in the US and EU. Data on accidental inhalation of products is lacked. If the particles are too small, it will cause accidental inhalation. But particle size is not the only factor to be considered, irritation and sensitization are also important factors. There will be relevant models for such evaluation.

Q7. Can product safety evaluation for facial cleansing products also be applied to mouth wash product?

A from Senior Toxicology of Cosmetic Ingredient Review: The major concern of mouth wash products is whether the products will cause short-term harm. But it might be different for different cases. Generally, we should look at the maximum level of the ingredients in the products and conduct safety evaluation afterwards.

Q8. When companies using new ingredients in EU or the US, will the CIR conduct the safety evaluation of the new ingredient immediately?

A from Senior Toxicology of Cosmetic Ingredient Review: We will surely carry out the evaluation for new ingredients in cosmetics. And we will evaluate ingredients in prior base on frequency of use, registration information and information published by manufacturing companies. If the ingredient is at low frequency of use, we will not conduct the safety evaluation immediately.

Q9. What is your opinion on animal testing and alternative tests in the US and EU?

A from Senior Toxicology of Cosmetic Ingredient Review: The US has not banned animal testing at the moment. And we are not willing to ban animal testing if this will slow down the research progress of cosmetic ingredients and affecting the development of the industry. For alternative tests, we use accurate predicting models or big data technology on computers for analysis and judgments. And in fact, animals are essentially different from human. Hence testing results on animals will not represents that in human bodies.

Q10. Many foreign products claim ‘full spectrum protection’ or ‘infrared protection’ on their packaging. What are the specific requirements for the safety evaluation of ‘full spectrum protection’ and ‘infrared protection’?

A from Director of Technical Regulatory Affairs, Cosmetics Europe: In EU, if the product has passed the safety evaluation of UVA and UVB, it can claim ‘full spectrum protection’. There is no completed safety evaluation system for infrared protection at the moment, but we will conduct such safety evaluation in the near future.

Q11. For the new policy of cross-border e-commerce in 2018, will there be any new simplified measures? And what are the specific measures?

A from Section Chief of Food Safety Department, Zhejiang FDA: We currently have quite easing supervision for non-special use cosmetics on cross-border e-commerce. The competent authority might not take sudden steps and let the companies panic. The process will be step by step.

Q12. We know the competent authority will take some measures for unqualified products by cross-border e-commerce such as retrospect, removal and recall. What are the guidelines for companies? How to reveal unqualified products sold on cross-border e-commerce?

A from Section Chief of Food Safety Department, Zhejiang FDA: We are gradually groping and improving our supervision standards. Import product quality is generally quite good and can meet the requirements. But we will indeed remove and recall unqualified products. Product recall is very rare for import cosmetics, but happens more on import food products at the moment. And there is no imported cosmetic product banned yet. Normally, the products can be no longer picked up from the CIQ warehouse if there are any safety issues. We conduct the evaluation simultaneously with implementing regulations. Our CIQ is a very basic unit. We report unqualified cosmetics level by level to superior departments. They will reveal the unqualified products. However, the reveal system is not completed yet for cross-border e-commerce. So we normally inform companies for internal rectifications.

Q13. How does the plant extract hair dye get approved?

A from Division Chief of the Department of Drug and Cosmetic Registration, CFDA: The plant extract hair dye is reviewed according to the STANDARD PROCEDURE, not as a new ingredient. We are working at regulations on hair dyes to clarify which ingredients are regarded as new ingredients and which are not.

Q14. What will be the surveillance measure on personal items on cross-border e-commerce in 2018?

A from Division Chief of the Department of Drug and Cosmetic Registration, CFDA: Cross-border e-commerce is a new born business. We have to encourage and support it. If supervision is too tight and strict, it will hinder the development of the cross-border e-commerce. The regulation concerning the supervision of personal items on cross-border e-commerce is signed by Ministry of Commerce. It is very difficult to supervise personal items according to the current regulations. Hence we are taking transitional policy at the moment. It is quite urgent to draw up specialized regulations and policies for the supervision of cosmetics by cross-border e-commerce.

Q15. The draft regulation for non-high risk cosmetic ingredients was not in the list of 2017 legislation plan by the State Council. Why is this? Will there be any related pilot to implement? Is it possible to have more pilots similar to the record-keeping system in Pudong New Area?

A from Division Chief of the Department of Drug and Cosmetic Registration, CFDA: Amending regulations is a very difficult work. The State Council Legislative Committee has heavy workloads with limited staffs. They tend to put more important things in prior, e.g. regulations for food products. Therefore they didn’t put the draft regulation for non-high risk cosmetic ingredients in the plan of 2017. It is not the problem with the regulation itself. Opening a pilot system has to be authorized by the State Council when it is related to the confirmation of REGULATIONS. It does not make sense to open a pilot system in case the regulation will come into force immediately.

Q16. What is your opinion on alternative tests?

A from Division Chief of the Department of Drug and Cosmetic Registration, CFDA: China is an open country, and alternative testing has become a trend nowadays. From the regulatory point of view, we will follow and study the trend. However, China has its own sovereignty system; we have to make decisions based on our actual situation. Alternative tests are still immature at the moment with many unsolved problems. On the other hand, EU is always at the forefront of the research on alternative tests, we should admit it is a future trend.

Q17. Is there any web tool that can be used by online shopkeepers to check the authenticity of customers’ comments? If a customer receives a damaged product, how can we know at which stage the product was damaged?

A from QA Expert, Alibaba: In fact, we have such tool called ‘Customer’s Voice’. Online shopkeepers can see their customers’ behavior and feedback through this tool, and they can adjust their marketing strategy according to the feedback information. We also have our own logistics system – Alibaba’s Cainiao Guoguo to track the products and to know whether the product is damaged in the logistical process. For specific products, especially electrical appliances, Alibaba requires the products to be gathered in the warehouse with unified packaging for better supervision.

From the Q&A’s above, the concerns of companies focus mainly on the following aspects: consistency of technical review of record-keeping process in Pudong with CFDA; whether animal testing can be exempt from the record-keeping process in Pudong; implementation time of the Regulation Concerning the Supervision and Administration of Cosmetics; requirements on safety evaluation of high-risk ingredients in EU and the US; supervision on cross-border e-commerce; evaluating customers’ comments on e-commerce platforms, etc. The 3rd Summit Meeting on Cosmetic Regulations in Asia Pacific’ provides a platform for worldwide cosmetic companies to learn regulations in different countries and exchange ideas in order to promote a healthy development of the cosmetic industry.

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