Special Edition of FOCUS, GFSF’s Newsletter
GFSF FOCUS SPECIAL EDITION
Interview with Dr. Weng, CFDA POC in the U.S.
- Letter from GFSF Chairman
- Interview with Dr. Weng, CFDA
- About Us
Letter from GFSF Chairman
It just gets better and better! 2016 has been a good year for GFSF. We are grateful to GFSF China staff and Director, Mr. Yuan Yao, for all their creative energies in organizing a series of successful events culminating in the annual June Summit. This year, the Summit was held at the Banji Yanqi Lake International Convention Center outside Beijing, followed by a half day of presentation and discussions at Tootoo Organic Farm, Beijing. On the third day, several registrants joined an official delegation visit to Yantai in the northeastern province of Shandong, China , for a follow-on session with local businesses and visits to local farms, beverage facilities, and agro-software industries.
Our partnership with the World Bank’s Global Food Safety Partnership (GFSP) has been productive in terms of shaping new forms of collaboration. The program now has a new CEO, Ms. Lystra Antoine, and is planning a new program and activity agenda for CY 2017. GFSF publications and social media have gained increasing attention for GFSF and outreach opportunities.
We are continuing our efforts to offer a curriculum of e-courses in collaboration with the University of Maryland, JIFSAN (Joint Institute for Food Safety and Applied Nutrition) and MOOCS in conjunction with GFSP. We now have a few courses available in Chinese and are hopeful that we will secure a formal co-host for these courses in China.
Food safety liability insurance products are another high priority for us. We hosted workshops during the year and will be offering more in CY 2017 to give our members the opportunity to learn of the multiple advantages to these products as suppliers for international buyers. The amended Basic Food Safety Law encourages insurance and we are working with China government counterpart agencies and international buyers to raise participation levels. We hope to educate Chinese companies on the benefits of these products to achieve compliance with national and international standards as well as to satisfy new requirements of international buyers.
As China has advanced in regulatory oversight of food safety in China, we are placing more emphasis on food safety technologies as a complementary effort to help regulators and companies comply with food safety requirements in the global supply chain. We are encouraged by the widening participation of technology providers in GFSF activities. We’re also reviewing options for training in the use of blockchain applications in food safety and are evaluating our own direct participation in offering new blockchain software for food tracing systems technologies.
On the brick and mortar side, we welcome all the support we receive from our strategic partners, including AmCham Vietnam, Food Industry Asia, and the Yale School of Forestry and Environmental Studies. With the help of AmCham, we are preparing to expand our franchise to Vietnam which promises to be a major event for 2017.
We have a robust agenda for new projects and activities in 2017, but the building blocks are much the same as this year. We are grateful for the support we receive from industry and the close collaboration with official China government agencies. GFSF has become a platform to solve problems and create opportunities for collaborative risk mitigation strategies.
As we enter the final quarter of the year, we ask you to join us in our full range of activities and programs that will position your company as a leader in food safety in the China market. For further information on our end-of-the-year special membership rates, please contact us at GIC Group or myself directly at email@example.com
INTERVIEW WITH DR. WENG
As the primary point of contact for China Food and Drug Administration (CFDA) in the U.S., Dr. Weng is committed to strengthening bilateral food and drug regulatory cooperation between China and the U.S. and reaching out to the U.S. food and drug industry. Before being transferred to the Chinese Embassy in Washington DC, Dr. Weng served as a Division Director in the Department of International Cooperation, CFDA, since May 2013. In this capacity, he was responsible for bilateral cooperation with foreign food and drug regulatory authorities and non-governmental organizations, as well as foreign food and drug manufacturers. Dr. Weng was essential in the negotiations of the Implementing Arrangement between CFDA and US FDA regarding the cooperative mechanism of regulatory staff in 2014. Dr. Weng joined State Drug Administration (SDA) in 1998, holding various positions including Division Director in the Department of Drug Safety and Supervision, and Deputy Division Director in the Department of Drug Registration. Dr. Weng got his Ph.D from Shenyang Pharmaceutical University. He completed his MBA degree at the Birmingham University of the United Kingdom.
|Question: CFDA is a relatively new organization, born from the Chinese food safety system reform of March, 2013. Other government agencies also have responsibilities for food safety supervision in China besides CFDA, namely Ministry of Agriculture（MOA）,General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and National Health and Family Planning Commission（NHFPC）. Would you briefly introduce the different responsibilities among these government agencies on food safety supervision for our western readers？
In order to improve food safety supervision and improve the efficiency of regulation, the Chinese government underwent major reforms regarding the food safety regulatory system in 2013. There are four ministries responsible for food safety supervision after this reform. The Ministry of Agriculture (MOA) is mainly responsible for the supervision and regulation of the quality and safety of agricultural products for food use before the products enter the wholesale, retail or processing stages. The China Food and Drug Administration (CFDA) is mainly responsible for the supervision and regulation of domestic food production, distribution, restaurant, and catering, as well as agricultural products for food use after the products enter the wholesale, retail or processing channels. The General Administration of Quality Supervision, Inspection and Quarantine(AQSIQ) is mainly responsible for the supervision and regulation of the safety and quality of food imports and exports, as well as as food packaging materials, containers and food processing equipment. The National Health and Family Planning Commission (NHFPC) is mainly responsible for food safety risk assessment and setting food safety standards. CFDA also has the title of the State Council Food Safety Commission Office, and is responsible for conducting routine State Council Food Safety Commission work, coordinating comprehensive food safety supervisiory work, facilitating improvements in private and public sector food safety coordination and management and supervising and inspecting provincial governments’ work on food safety supervision and monitoring and evaluating their performance.
Question: The new and amended Food Safety Law of China came into effect on the 1st of October 2015. CFDA has accomplished a great deal during this brief period of time. What would you highlight as the Agency’s major achievements?
Food safety is a top priority for the Chinese government. President Xi Jinping has underscored the need to implement the “strictest” measures to ensure food and drug safety, featuring rigorous standards, strict supervision, serious punishments, and an authoritative accountability system. The latest opinion polls show that since the implementation of the new law, consumer satisfaction with food safety has improved significantly. Since the new law came into effect, CFDA has established relevant provisions to implement the law, such as Provision for Food Production and Distribution Permit, Provision for Health Food Registration and Notification, and the Administrative Measures for Investigation and Punishment of Illegal Online Sales of Food, etc. In accordance with the new law, CFDA has adopted a risk-based approach in conducting unannounced inspection and systematic inspections for high risk food products, and is now considering the establishment of professional food inspection teams. Starting from December 2016, Chinese food and drug authorities will classify food manufacturers and distributors into four risk categories, namely A, B, C and D, with corresponding regulatory guidelines for each grouping of companies.
Question: Would you discuss a bit more the implementation of “risk-based” food safety inspection system guidelines?
The risk-based approach to food safety surveillance is an internationally accepted practice which we find not only improves our regulatory efficiencies, but also ensures food manufacturer and distributor accountability. The Administrative Measures for Risk Classification of Food Manufacturers and Distributors (Interim) was issued by CFDA, and came into effect on the first of December, 2016. Risk levels for food manufacturers and distributors are classified from A (lowest) to D (highest). The quantitative risk score is based on a scale of 40 for “static risk” factors and 60 for “dynamic risk factors.” The higher the score, the higher the risk level. The sum of the risk scores of 0-30 (inclusive) is A-level risk; the sum of the risk scores of 30-45 (inclusive) is B-level risk; the sum of the risk scores of 45-60 (inclusive) is C-level risk; and the sum of the risk scores above 60 is D-level risk. Provision for Risk Classification of Food Manufacturers and Distributors also clarifies the inspection frequency for food manufacturers and distributors of different risk levels. For A-level risk companies, regulators will inspect at least 1 time per year; for B-level risk companies, regulators will inspect at least 1-2 times per year; for C-level risk companies, regulators will inspect at least 2-3 times per year; for D-level risk companies, regulators will inspect at least 3-4 times per year.
回答：食品生产经营风险分级管理是一种基于风险管理的有效监管模式，是有效提升监管资源利用率，强化监管效能，促进食品生产经营企业落实食品安全主体责任的重要手段，也是国际的通行做法。国家食品药品监管总局研究制定了《食品生产经营风险分级管理办法（试行）》，并将于2016年12月1日实施。食品生产经营者风险等级从低到高分为A级风险、B级风险、C级风险、D级风险四个等级。风险等级的确定采用评分方法进行，以百分制计算，其中静态风险因素量化风险分值为40分，动态风险因素量化风险分值为60分。分值越高，风险等级越高。风险分值之和为0-30（含）分的，为A级风险；风险分值之和为30-45（含）分的，为B级风险；风险分值之和为45-60（含）分的，为C级风险；风险分值之和为60分以上的，为D级风险。《办法》对不同风险等级食品生产经营者的监督检查频次做出了明确规定：对风险等级为A级风险的食品生产经营者，原则上食品药品监督管理部门每年至少监督检查1次；对风险等级为B级风险的食品生产经营者，原则上每年至少监督检查1-2次；对风险等级为 C级风险的食品生产经营者，原则上每年至少监督检查2-3次；对风险等级为 D级风险的食品生产经营者，原则上每年至少监督检查3-4次。
Question; The task of regulating online sales of food is one of the biggest challenges for food safety authorities in many countries. CFDA has published the Administrative Measures for Investigation and Punishment of illegal Online Sales of Food in an effort to maintain the integrity of China’s food supply chain. Would you briefly discuss what led to the introduction of this initiative and the main requirements of these Measures?
With the rapid growth of e–commerce, online food safety and people’s daily lives are closely interrelated, requiring close scrutiny for food safety compliance. E-commerce food transactions present a complex of challenges: a/ rapid growth of online food providers; b/ the legal determination of party liability; c/ difficulties in regulating online food transactions. Because of fictitious and cross-regional characteristics in online food transactions, regulatory supervision is confronted with challenges of evidentiary based findings, commensurate punitive action, and consumer rights’ protection, etc.
China’s food safety law revised in 2015 stipulates basic legal obligations and responsibilities of the online food providers and the third-party platform providers engaged in online food trading. On July 13, 2016, the CFDA published the Administrative Measures for Investigation and Punishment of illegal Online Sales of Food, which came into effect on October 1, 2016. The main requirements include: a/online food providers should have food distribution licenses, and the third-party platform should review the licenses; b/ thirty working days after the approval of the telecommunication authorities, the third-party platform should document and submit their relevant information to the local food and drug authorities, and post the recorded information on the website of the third-party platform; and, c/clarify the legal responsibilities of the third-party platform.
Question: The melamine scandal has gotten wide attention in China and noted consumer concern. What measures has CFDA taken to ensure the safety and quality of infant formula milk powder which has been the source of concern? Since the scandal first broke, do you consider this flagrant EMA (economically motivated adulteration) practice now to be resolved? In short, what are the main requirements of the new CFDA Provisions for Formula Registration of Infant Formula Milk Powder?
Premier Li Keqiang has highlighted the importance of improving the quality and safety of infant formula milk powder in China with an aim to building consumer confidence in domestic product. Quality and safety supervision of infant formula milk powder have been the top priorities for the CFDA. In recent years, China’s infant formula milk powder quality and safety levels have improved, gaining national consumer confidence in domestic milk powder. In 2015, the CFDA initiated a special supervision and surveillance program for domestic infant formula milk powder and found that 28 batches out of the total of 2065 batches did not meet the national food safety standards, accounting for 1.36% of the total sample. In the first half of this year, a total of 1274 batches of domestic infant formula milk powder were tested with 8 batches failing to meet the standards, accounting for 0.6% of the total samples.
The main measures taken by the CFDA include: a/ stricter threshold requirements for manufacturers of infant formula milk powder. In December 2013, CFDA issued a new version of Infant Formula Milk Powder Production License Review Rules (2013 version) which includes stricter production license review requirements. These requirements have served to a/ reduce the number of operating manufacturers of infant formula milk powder from 133 to 103; b/ strengthen the surveillance and sampling for infant formula milk powder; c/ initiate severe punishment for substandard products; d/ improve systematic inspection for manufacturers of infant formula milk powder; and e/ clarify the traceability responsibilities of the manufacturers of infant formula milk powder. Through continuous strengthening of regulatory measures, the quality and safety of China’s infant formula milk powder products have been significantly improved.
According to the new Food Safety Law and the relevant provisions, on June 6, 2016, the CFDA issued the Provision for Formula Registration of Infant Formula Milk Power, which lays out formula registration requirements for domestic and imported products of infant formula milk powder. The applicants must have the appropriate R & D capacity, production capacity and testing capacity of infant formula milk powder. Applicants must also comply with the requirements of the Good Manufacturing Practices for powdered infant formula, implement the Hazard Analysis and Critical Control Point system, and carry out batch-by-batch testing of the manufactured products in accordance with the relevant laws and regulations and the national standards for food safety.
Question: My last question—I promise. What would you say are the biggest challenges for CFDA at the moment? And what’s your thought on food safety international cooperation?
Thank you, Dr. Weng.
China’s food safety supervision still faces many challenges. These are the challenges that the rest of the world is also facing, such as microbial contamination of food, pesticide residues and environmental pollution. In addition, we are facing a number of other difficulties. For example, our agricultural cultivation methods are relatively unrefined; food safety standards need to be improved; and the regulatory resources and capacity in different regions are not equal among all the provinces. China imports hundreds of millions of tons of soybeans, grains, meat products, and dairy products from abroad every year, and exports food products worth nearly 100 billion US dollars to the international market. Strengthening international cooperation in the field of food safety is the basic prerequisite for the development of food trade. The CFDA looks forward to improving cooperation with other countries’ food safety regulatory authorities in sharing information on food safety risks and food regulatory laws and regulations. We look forward to learning from one another and collaborating in the overall goal of improving and strengthening global food safety standards.
GFSF is a not-for-profit organization, founded and managed worldwide by GIC Group, with a diverse but interrelated industry membership: producers, processors, merchandisers/shippers/distributors, and retailers. GFSF/China is jointly managed by the GIC Group and its partner, BRIC Global Agricultural Consultants, with offices in Washington, DC, and Beijing.
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