On May 16, 2024, the Compliance Seminar on Cosmetics and Chemicals sponsored by China National Chemical Information Center （CNCIC）and co-organized by Shanghai Daily Chemicals Industry Association was successfully held in Shanghai. The morning session on cosmetics focused on adverse reactions of cosmetics, alternative methods, registration and filing of new raw materials and compliance claims, while the afternoon session on chemicals focused on new pollutants, "one enterprise, one product, one code" and registration of new chemical substances. The seminar invited Yang Yiwen, Director of Shanghai Adverse Reaction Monitoring Center for Drugs and Medical Devices, Cheng Shujun, Deputy Secretary-General of Shanghai Toxicology, Wang Lei, Director of Nanjing Institute of Environmental Sciences, and Zhu Bin, senior expert of Shanghai Chemical Registration Office, to bring wonderful reports to enterprises and share policy dynamics and regulatory requirements. The conference attracted more than 150 experts and representatives from chemical and cosmetic companies such as Evonik, Norion, LANXess, Clariant, PROYA and Pehchaolin. Representatives of the participating companies and experts had in-depth exchanges and discussions on issues such as hot regulations, industry supervision and market trends.
The Regulations on the Supervision and Administration of Cosmetics officially implemented on January 1, 2021 and the subsequent issuance of a series of secondary regulations have put forward new requirements for the registration and filing of cosmetics and new raw materials, production and operation, adverse reaction monitoring, etc. How enterprises respond to the regulatory requirements and flight inspection, and compliance based on the cosmetics market is crucial.
Shanghai Adverse Reaction Monitoring Center for Drugs and medical devices Director Yang Yiwen
Director Yang Yiwen pointed out that the monitoring of adverse reactions of cosmetics is an important measure for post-marketing supervision of cosmetics. She first made a detailed review and interpretation of the requirements related to adverse reactions in cosmetics regulations, shared the regulatory requirements for adverse reaction monitoring of new raw materials for cosmetics and the responsibilities and obligations of all relevant parties, and combined with the "Guide for Collecting and Reporting Adverse Reactions of Cosmetics Registrants and recordholders (Trial)" issued by the National Adverse Drug Reaction Monitoring Center on April 20. It introduced the reporting process, data requirements and precautions of adverse reaction reports step by step for enterprises, and provided clear directions for enterprises to establish an adverse reaction system. Minister Yang also mentioned that the Shanghai Adverse Reaction Monitoring Center for Drugs and medical Devices will continue to deepen the analysis and mining of monitoring data, explore new methods of monitoring and evaluation, and provide strong support for the high-quality development of Shanghai's cosmetics industry.
Cheng Shujun, deputy secretary-general of the Shanghai Society of Toxicology
With the rapid growth of China's cosmetics consumer market and to cope with the new requirements of China's cosmetics and new raw materials registration and filing system, cosmetics and new raw materials entering the Chinese market need to prove their safety through animal experiments, which is undoubtedly a challenge for many overseas cosmetics companies claiming "zero cruelty", so the development and application of animal alternative methods has become an urgent need. Cheng Shujun, deputy Secretary-General of Shanghai Society of Toxicology, first introduced the new method of evaluation of new raw materials of cosmetics professionally and systematically, pointed out that toxicology is the basis of innovation of new raw materials of cosmetics, and shared the mechanism and combination of alternative test methods at various end points in the current cosmetic technical specifications for enterprises. At last, he also introduced the use of computational toxicology methods in risk assessment, such as QSAR, TTC and Read-across, which are of concern to enterprises.
Xu Yaqing, Chemical Compliance Department, CNCIC
Xu Yaqing, deputy project director from CNCIC, elaborated on the regulatory requirements of cosmetics new raw materials through the regulatory background and status quo of cosmetics raw materials, the declaration requirements of cosmetics new raw materials, and the safety information submission of cosmetics raw materials. She also introduced how to determine whether a cosmetic raw material is a new raw material, as well as the operation process of registration and filing, and combined with many years of reporting experience for the enterprise to share the application information in the preparation process precautions and test requirements, after the registration and filing of the safety monitoring period how to deal with the enterprise, after the meeting also the concern of the enterprise was answered.
Guo Qunfeng, Chemical Compliance Department, CNCIC
Guo Qunfeng, deputy project manager from CNCIC, shared the key points of cosmetics advertising compliance for enterprises, and guided enterprises how to avoid non-compliance publicity through real and vivid examples. She pointed out that false efficacy and false ingredients are the two main types of cosmetic advertising non-compliance, to avoid cosmetics advertising non-compliance from the product characteristics, product efficacy two dimensions, in line with the legal, true, evidence support, integrity, open and consumer informed principles of compliance publicity.
The report of the chemical field in the afternoon is also wonderful.
Wang Lei, research director of Chemical Center, Nanjing Institute of Environmental Science, Ministry of Ecology and Environment
In May 2022, The General Office of the State Council issued the Action Plan for the Control of New Pollutants, which proposed control targets and action measures for new pollutants that have attracted wide attention at home and abroad. Wang Lei, research director of the Chemical Center of Nanjing Institute of Environmental Sciences, Ministry of Ecology and Environment, introduced the overall requirements and priorities of new pollutant control, and shared with you the challenges and opportunities in the treatment of new pollutants. She pointed out that the insufficient reserve of new pollutant treatment technology will seriously restrict the green and sustainable development of enterprises, and the prevention and control of environmental risks of chemical substances is the core ability of enterprises to proactively respond to management and control and grasp the right to speak in the industry. Director Wang Lei's report is simple and profound, and the delegates at the meeting have benefited a lot. After the meeting, Director Wang Lei answered the problems existing in the treatment of new pollutants in enterprises.
Zhu Bin, senior expert of Shanghai Emergency Management Affairs and Chemical Registration Center
In February 2024, Shanghai officially issued the implementation plan of "one enterprise, one product, one code", which requires all hazardous chemical-related business activities in Shanghai to use the traceability code for the tracking and management of hazardous chemicals. Zhu Bin, a senior expert from the Shanghai Municipal Emergency Management Affairs and Chemical Registration Center, focused on the regulatory requirements for registration of hazardous chemicals, the special law enforcement inspection in 2024, and the application of "one enterprise, one product, one code" and the traceability code. He pointed out that those engaged in the production, import, filling and labeling of hazardous chemicals, as well as the enterprises storing and selling hazardous chemicals from other provinces in the city as the source code and scan code enterprises, the dangerous chemicals listed in the 2015 edition of the catalog and the 88 items listed in the 2828 entry should be assigned a traceability code, and pointed out some cases without code. After the meeting, Mr. Zhu Bin had full communication and exchange with the delegates on the problems that enterprises may encounter in the process of coding.
Liu Yu, Project Manager, Chemical Compliance Department, CNCIC
The environmental management registration of new chemical substances is an important part of the implementation of the action plan for the treatment of new pollutants. Liu Yu, Project Manager of Chemical Compliance Department of CNCIC, introduced the key points of simple registration and routine registration of new chemical substances. She combined with years of registration experience, from the registration process, data requirements, data gap analysis, expert review points and post-registration management and other aspects, carried out a detailed interpretation and sharing, and for the enterprise more concerned about the use of intermediates to fill in the notes, testing institutions qualification and testing methods, information protection of the necessity of the preparation of materials. She suggested that applicants involved in the production or import of new chemical substances should, according to the requirements of laws and regulations and the needs of enterprises, make an assessment plan in advance, pay attention to the registration process and review points, submit the dossier and obtain the registration certificate in time, and be sure to do a good job of post-registration management according to the requirements of the guide.
Ren Yu, senior consultant of Chemical Compliance Department, CNCIC
The requirements for polymer filing data under the 12th Order are more complex, especially in the identification of polymer filing exclusion situations and data preparation, there are certain challenges. Ren Yu, a senior consultant from the Chemical Compliance Department of CNCIC, combined with the hot issues concerned by enterprises, focused on sharing the determination of cationic polymers or potential cationic polymers and the key contents of polymer degradation and stability explanation materials, and introduced the test projects involved in the exclusion of polymers. She also shared the problems that may be encountered in the spot check of the polymer record, reminding enterprises to deal with them in advance.
Liang Fengjiao, deputy project Manager of the Chemical Compliance Department, CNCIC
With the strengthening of our country's requirements for the management of new pollutants and the environmental management of new chemical substances, the environmental risk assessment of chemical substances, one of the core contents, is also the content of special attention of the majority of enterprises. Liang Fengjiao, deputy project manager of Chemical Compliance Department of CNCIC, combined with years of practical experience in environmental risk assessment of new chemical substances, from the aspects of chemical hazard assessment, exposure assessment, risk characterization, common problems and solutions, and other practical cases were comprehensively elaborated. She pointed out that the technical difficulty of environmental risk assessment of chemical substances is relatively high, and enterprises should fully consider the characteristics of chemical substances when preparing reports, and reasonably arrange tests to obtain sufficient assessment data; In the exposure assessment stage, the construction of the exposure scene must be in line with the actual situation, the "three wastes" production should focus on the assessment of substances, as detailed and accurate as possible, environmental risk control measures should be targeted and so on. Moreover, it is especially reminded that we should attach great importance to the data quality of the environmental risk assessment report, so as to ensure the smooth implementation of the application and post-registration management of new substances.
We are very honored to join the Shanghai Daily Chemicals Industry Association, and we are very grateful to the association for its strong support to this conference. We hope that through the professional reports of the experts, we also hope to use our rich experience in regulations and technology to provide enterprises with professional compliance guidance and suggestions to help enterprises comply with the law, green and sustainable development. We also welcome enterprises to communicate with us to help the green and healthy development of the chemical and cosmetics industry.
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