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GFSF FOCUS SPECIAL EDITION
including

Interview with Dr. Weng, CFDA POC in the U.S.

CONTENTS

  • 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 rickgilmore@gicgroup.com  

Best regards,

Rick Gilmore
Chairman
GFSF
www.globalfoodsafetyforum.org

INTERVIEW WITH DR. WENG

Biographical Information

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.                                                           

QUESTIONS

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 AgricultureMOA,General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), and National Health and Family Planning CommissionNHFPC. Would you briefly introduce the different responsibilities among these government agencies on food safety supervision for our western readers

问题1: 2013年3月中国政府对食品安全监管体系进行了改革,成立了新的国家食品药品监督管理总局。除国家食品药品监督管理总局以外,农业部、质检总局以及卫生计生委在食品安全监管方面也具有一定职责。请你简要介绍上述四个单位在食品安全监管方面的职责分工。

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.

回答:为加强食品安全监管并提高监管效率,2013年中国政府对食品安全监管体系进行了重大改革,改革之后主要有4个部委负责食品安全监管相关工作。国家食品药品监督管理总局主要负责国内食品生产经营监管工作,以及食用农产品从种植养殖环节到进入批发、零售市场或生产加工企业后的质量安全监督管理;农业部主要负责食用农产品从种植养殖环节到进入批发、零售市场或生产加工企业前的质量安全监督管理;国家质量监督检验检疫总局主要负责进出口食品、食品相关产品安全监管工作;国家卫生和计划生育委员会主要负责食品安全风险评估和食品安全标准制定。此外,国家食品药品监督管理总局还加挂国务院食品安全委员会办公室牌子,承担国务院食品安全委员会日常工作,负责食品安全监督管理综合协调,推动健全协调联动机制,督促检查省级人民政府履行食品安全监督管理职责并负责考核评价。

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?

问题2: 2015年10月1日中国新的《食品安全法》正式生效实施。过去1年来国家食品药品监督管理总局在贯彻实施新的《食品安全法》方面开展了许多卓有成效的工作。请扼要介绍国家食品药品监督管理总局所取得的主要成就。

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.

回答:食品安全是中国政府高度重视的一项工作。国家主席习近平曾经指出,要切实加强食品药品安全监管,用最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责(简称“四个最严”),加快建立科学完善的食品药品安全治理体系,坚持产管并重,严把从农田到餐桌、从实验室到医院的每一道防线。最新媒体民意调查显示,新法实施以来,人民群众对食品安全的满意度明显提升。一年来,国家食品药品监督管理总局落实“四个最严”要求,积极推进新法的实施宣贯,基本建立了与新法相配套的新的法规制度体系,陆续出台了食品生产经营许可、保健食品注册与备案、网络食品安全违法行为查处、食用农产品市场销售质量安全监督管理等12部与新《食品安全法》配套的规章制度。按照新法的风险管理原则,对高风险品种实施飞行检查、体系性检查,并探索专业化检查员队伍建设。从2016年12月起,食品药品监管部门将开始对食品生产经营企业按照A、B、C、D四个风险等级进行风险分级监管,进一步提升科学监管水平。

Question: Would you discuss a bit more the implementation of “risk-based” food safety inspection system guidelines?

问题3:你刚才提及A、B、C、D四个风险等级实施监管,能否请你详细介绍一下国家食品药品监督管理总局如何实施这一食品安全检查体系?

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?

问题4:对许多国家的食品安全监管部门来说,网络食品安全监管都是一个巨大的挑战。为保证食品供应链安全,近期国家食品药品监督管理总局出台了《网络食品安全违法行为查处办法》。请简要介绍该办法出台的背景以及主要要求。

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.

回答:随着电子商务经济的迅猛发展,网络食品安全与人民群众日常生活日益密切,越来越成为食品安全监管关注的焦点。一是参与网络食品经营的主体越来越多。同一个主体,同时开展线下和线上交易的现象越来越普遍,趋势越来越明显。二是网络食品经营法律关系相对复杂,涉及信息发布、第三方平台、线上线下结算、第三方配送等,民事法律关系更加复杂。三是网络食品经营监管难度更大。由于网络食品经营的虚拟性和跨地域特点,对行政管辖、案件调查、证据固定、处罚执行、消费者权益保护等带来很大挑战。为加强网络食品安全监管,中国2015年修订的《食品安全法》规定了网络食品交易第三方平台提供者以及入网食品生产经营者的基本法律义务和责任,并在正在修订的《食品安全法实施条例》中对网络抽样检验等进行了明确。2016年7月13日,国家食品药品监督管理总局发布了《网络食品安全违法行为查处办法》(总局令第27号),该办法于2016年10月1日起施行。《网络食品安全违法行为查处办法》是对《食品安全法》相关要求的进一步细化:一是明确了网络食品安全违法行为查处的管辖职责和查处权限;二是明确了入网食品经营者应当依法取得许可并且按照许可项目经营食品,网络食品交易第三方平台应当对入网食品经营者的食品经营许可证、营业执照等材料进行审查,如实记录并更新等规定,同时明确了对违反上述规定行为的处罚;三是进一步强化了对网络食品交易第三方平台备案管理,明确网络食品交易第三方平台提供者应当在通信主管部门批准后30个工作日内,向其住所地省级和县级食品药品监督管理部门备案,取得备案号,并在其网站首页显著位置标注备案信息;四是进一步细化了食品安全法规定的网络食品交易第三方平台责任条款及严重违法行为的具体情形,强化了法律责任。

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?

问题5:前几年三聚氰胺事件在中国引起广泛关注,消费者对婴幼儿配方奶粉质量心存疑虑。为确保婴幼儿配方奶粉安全和质量,国家食品药品监督管理总局采取了哪些措施?你认为故意造假谋利行为已经得到有效遏制了吗?另外,请你简要介绍新出台的《婴幼儿配方乳粉产品配方注册管理办法》主要要求。

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.

回答:李克强总理指出,要把提升婴幼儿配方乳粉质量安全水平作为抓好中国食品质量安全工作的突破口,从突破口的角度来重视这项工作,全力以赴打好提高婴幼儿配方乳粉质量安全水平的攻坚战,重塑消费者对国产乳粉的信心。婴幼儿配方乳粉质量安全监管一直是国家食品药品监管总局重中之重的一项工作。近年来,中国婴幼儿配方乳粉的质量安全水平总体稳定向好,国民对国产奶粉的消费信心正在逐步恢复。2015年,总局开展婴幼儿配方乳粉国家专项监督抽检,共抽检国产婴幼儿配方乳粉2065批次,检出不符合食品安全国家标准的样品28批次,占样品总数的1.36%;2016年上半年,共抽检国产婴幼儿配方乳粉1274批次,检出不符合食品安全国家标准的样品8批次,占样品总数的0.6%。

国家食品药品监督管理总局采取的主要措施包括:一是严把婴幼儿配方乳粉生产企业的准入关。2013年12月CFDA发布了新版《婴幼儿配方乳粉生产许可审查细则(2013版)》,严格企业生产许可审查,婴幼儿配方乳粉生产企业从原先的133家下降到103家。二是加强婴幼儿配方乳粉的监督抽检。三是加大不合格产品的处置力度。四是推进对婴幼儿配方乳粉生产企业开展食品安全生产规范体系检查。五是进一步明确了婴幼儿配方乳粉生产企业食品安全追溯责任。通过上述监管措施的不断加强,目前我国婴幼儿配方乳粉的产品质量与安全保障水平有了明显的提升。

根据新《食品安全法》有关规定,2016年6月6日,国家食品药品监督管理总局发布了《婴幼儿配方乳粉产品配方注册管理办法》,规定凡在中国境内生产销售和进口的婴幼儿配方乳粉,其产品配方需经国家食品药品监管总局注册批准。申请人应当为具备相应研发能力、生产能力和检验能力的婴幼儿配方乳粉生产企业,包括拟在中国境内生产并销售婴幼儿配方乳粉的生产企业或者拟向中国出口婴幼儿配方乳粉的境外生产企业。申请人还要符合粉状婴幼儿配方食品良好生产规范要求,实施危害分析与关键控制点体系,对出厂产品按照有关法律法规和食品安全国家标准规定项目实施逐批检验。

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.

问题6:在食品安全监管方面,你认为当前国家食品药品监督管理总局面临的最大挑战有哪些?同时,请你谈谈对食品安全国际合作的看法。

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.

回答:中国的食品安全监管工作仍然面临着很多挑战,一些与世界各国面临的挑战一样,如,食品中微生物污染、农兽药残留,以及环境污染带来的等,此外,我们还面临一些困难,如农业种植养殖方式较为粗放、食品生产加工方式差异较大,食品安全标准还需进一步完善,各地监管力量、监管能力还不太平衡等等。随着国际分工越来越细,食品领域的国际贸易规模越来越大。中国每年从国外进口上亿吨的大豆、谷物、肉制品和乳制品;向国际市场出口近千亿美元的食品。加强食品安全领域的国际合作,是食品贸易发展的基本前提。国家食品药品监督管理总局愿意与各国食品安全监管机构进一步加强合作,互相通报食品安全领域的风险隐患,互相通报食品监管的法律、技术法规,有利于相互学习借鉴,节约成本,少走弯路,共同提高食品安全的保障水平。

About GFSF

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.

CONTACT

GFSF/ GIC Group
1434 Duke Street
Alexandria, VA 22314
Phone: 703-684-1366
Fax: 703-684-1369
Email: asansbury@gicgroup.com

 

 

 

 

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