Following the Notice No.5 issued by three government bodies including the Chinese Ministry of Commerce, on April 25, the Chinese Ministry of Commerce, Chinese General Administration of Customs and the Chinese State Administration for Market Regulation jointly released the Notice on Ensuring Quality of Exported Anti-epidemic Supplies (No.12), to enhance quality supervision of exported medical supplies including face masks (non-medical use), ensure export order, and allow export of products meeting overseas quality standards and registration requirements, thus further injecting vigor into the market. The Notice attracted wide attention at home and abroad. Recently, Vice President Meng Dongping of CCCMHPIE received the joint interview by CCTV NEWS, CGTN and Phoenix TV, and offered insights on related policies (including the Notice No.12) and implementation issues.
I. What is the overview of China’s mask exports?
As COVID-19 spreads and proliferates across the world, an increasing number of countries are asking China for help. So far, we have exported anti-epidemic supplies to 191 countries and regions through commercial procurement. According to Customs statistics, from March 1 to April 25, China inspected and released related exports worth RMB 55 billion, including 21.1 billion masks. Currently, the daily mask exports are close to 1.4 billion, way higher than the 224 million before the introduction of Notice No.5 and are still growing.
Many countries have expresses their appreciation for China in various ways, recognizing the enormous efforts of the Chinese society from the government to the business in support of the fight against the virus all over the world, not least the key role of China-made masks in the global response despite domestic needs in prevention and control.
II. Regarding product quality requirements and compliance, are there quality issues (what is the main cause of disputes)?
The Chinese government takes very seriously the quality and compliance of export products. Upon requests for help from across the world after the outbreak, large quantities of anti-epidemic supplies were exported worldwide. In concert with several departments, MOFCOM successively issued Notice No.5 and No.12, laying down express export quality requirements for medical supplies such as face masks, gowns and testing kits and non-medical face masks, among other key products. In particular, improving on and optimizing No.5, No.12 allows export in multiple trade modes.
Both notices have made clear the attitude and stand of the China government that we will secure export quality and hold trade conduct to strict regulation to ensure the safety and efficacy of anti-epidemic exports. China is a major producer and exporter of medical and health products, especially anti-epidemic supplies. Our economy was hit hard by the epidemic. Nonetheless, at this special time of epidemic combat, rather than going after export quantities and numbers, we are emphasizing time and again export quality safety and compliance. While organizing for orderly exports, we are stressing respect for local laws and regulations, the market law and trade competition rules.
According to common practices in international trade, the importing country is wholly responsible for regulating the quality of imported products. However, the two Notices still clearly require that the exported medical and epidemic prevention supplies should comply with the quality standards and requirements of the importing country and region. The aim is to deliver epidemic prevention materials that meet the quality standards of the countries to the places where they are most needed as soon as possible and to help countries around the world in their fight against the epidemic. It shows that an objective, pragmatic and responsible attitude by the government of China and its respect and commitment for life and health.
III. The relations between Notice No. 12 and No. 5
Notice No. 5 issued on March 31 mainly specified export quality regulatory measures for five categories of medical and epidemic prevention supplies such as surgical face masks. Compared with Notice No. 5, Notice No. 12 is further improved and more inclusive. Notice No. 12 again stresses the quality standards and safety compliance of epidemic prevention exports. While continuing to regulate the export of five key medical and epidemic prevention supplies, including masks, the Notice has strengthened the export regulation of non-surgical masks in particular to ensure that the products are consistent with Chinese or foreign quality standards and requirements. The Notice also added that a joint statement is required for both the importer and exporter. The importer should commit to accept the quality standard of the products they purchase and ensure that such products will not be used for medical purposes. This shows that the government of China respects market principles and fully accommodates the independent regulatory systems and quality standard requirements of other countries. As for medical supplies that are only produced and not sold and used in China, flexible policies may be adopted, especially for companies that have been adopting such operating models for a long time. The epidemic prevention and control supplies that have already achieved the certification under relevant foreign standards, such as CE or FDA certification, even though without medical device registration certificate in China, are allowed for export. By asking the sellers and buyers to sign a joint statement, we hope that companies would shoulder their due responsibilities and obligations as market players. The two notices are connected and are implemented at the same time.
IV. The quality of Chinese products under foreign media hype
We have noticed that, from time to time, there is some foreign media coverage stating the quality problem with Chinese epidemic prevention supplies and we attach great importance to such issues. Not long ago, during my interview on Notice No. 5, I have mentioned that we tracked several cases being reported with the so-called quality problems. After investigations, we found that in most of such cases, it was because that during import, distribution and usage, the sellers and buyers or people involved do not fully understand the specifications, standards and requirements of relevant products, or fail to strictly follow the instructions of the contract, causing unnecessary consequences and impacts. As a matter of fact, these are not real quality issues.
V. On standards
1.Are Chinese KN95 masks equivalent to US Surgical N95?
The KN95 masks under the Chinese standard can filter 95% of particles just like US Surgical N95 masks, but it is usually for the general public. It is not fluid resistant. It is usually used for general protection against dust and small particles under a relatively low price. It cannot be used for medical personnel in medical institutions, especially in heavily polluted areas such as ICU, what we call hospital red zones.
US Surgical N95 masks , use a special coating technology to keep them fluid resistant and block droplets. It is relatively expensive. In principle, it is used in the fever clinic, quarantine observation ward, quarantine ward and quarantine ICU of the hospital, as well as during the operations that may generate aerosol. It is relatively small in quantity.
In fact, the Chinese masks equivalent to US N95 medical masks are Chinese medical protective masks, instead of KN95 masks. KN95 is for daily use, while medical protective masks is for medical purposes. Therefore, we would like to remind importers that they should use the masks properly in strict accordance with the requirements set out in contracts.
2.What are the differences between Chinese KN95 masks and European FFP2 masks? What occasions are KN95 masks suitable for?
Chinese KN95 masks are tested for protection against saline particles, not against oily particles, and only KP95 masks are tested for protection against oily particles. Therefore, it is likely that the masks that have passed KN95 tests may fail to pass the FFP2 test for protection against paraffin oil aerosol. Here, N stands for "Non-oil" (non-resistant to oily particulates), and P for "Oil protective" (resistant to oily particulates).
KN95 masks are suitable for protection against solid and non-oily particulates, liquid and microorganisms such as coal dust, cement dust, acid fog, paint fog, etc. However, they provide limited protection against oil smoke, oil mist, asphalt smoke, coke oven smoke, particulates in diesel exhaust, etc.
3.What are the differences between Chinese mask standards and European and US mask standards?
According to regulations, exported non-medical masks must conform to Chinese product standards such as GB2626-2006 and GB/T32610-2016, or meet the quality standard requirements of the importing country or region, such as the EU Regulation 2016/425, which is known as the Personal Protective Equipment Regulation (PPE Regulation).
The product classification and corresponding indicator requirements in China and foreign countries cannot be equated to one another. For example, different non-medical masks have different breathing resistance. GB2626 classifies products into three levels according to the leakage rate and filtering efficiency of the mask, and products at each level are classified as saline particulate-resistant and oily particulate-resistant; GB32610 classifies products into four levels (A, B, C, D); and EN149 only classifies products into three levels of FFP1, FFP2 and FFP3. Therefore, the standards do not correspond to one another.
海内关于夷易近用口罩的标准有GB 2626-2006 《呼吸防护用品—自吸过滤式防颗粒物呼吸器》和GB/T 32610-2016 《日常防护型口罩技巧规范》都是属于夷易近用口罩的范畴，他们和GB 19083-2003《医用防护口罩技巧要求》有着很大年夜的差别。而欧盟的夷易近用口罩检测标准是EN149-2001+A1-2009《呼吸防护装配颗粒防护用过滤半面罩要求、查验和标记》，医用口罩标准是EN 14683。美国是利用的NIOSH相关标准。以是从产品级别分类措施、详细测试指标等多个层面来看，各国的测试标准照样有许多区其余，不能简单的等同。
For the standards of masks for daily use, China has GB 2626-2006 "Respiratory Protective Equipment—Non-Powered Air-Purifying Particulate Respirator" and GB/T 32610-2016 "Technical Specifications of Daily Protective Masks". They are both for masks for daily use, vastly different from GB 19083-2003 "Technical Requirements for Medical Protective Face Masks". The European Union's testing standard for masks for daily use is EN149-2001+A1-2009 "Respiratory Protective Devices - Filtering Half Masks to Protect against Particles - Requirements, Testing, Marking", and its standard for medical face masks is EN 14683. The US applies relavant NIOSH standards. Therefore, there are lots of differences in different countries’ testing standards in terms of the classification of product levels and specific testing indicators. We cannot simply equate one testing standard with another.
The supply of medical protective products is a highly regulated sector and each country has its own standards and inspection requirements. Chinese standards for medical protective products are relatively higher than many other countries. China forms its own regulatory system covering the approval, standard management, inspection and certification of products, which is not completely the same with foreign ones.
4.How effective are the test kits exported from China? How do you explain the relatively low accuracy of these test kits used by European countries?
Huge quantities of test kits are being exported from China to Europe, Asia and Latin America and have been well-received by relevant countries and regions. Nevertheless, we have noted some negative coverage of the effect of the Chinese test kits. There are strict requirements for the storage, transportation and usage of the novel coronovirus antibody test kits. Antibody testing must be carried out by professional staff in accordance with product instructions, otherwise low accruacy or errors might occur.
此外，因为核酸检测和抗体检测（胶体金法）都是定性检测新冠病毒的试剂， 今朝国外客户应用时轻易肴杂，此前西班牙方面的检测试剂争议问题便是例子。核酸检测和抗体（胶体金法）都是从来定性检测新冠病毒的。胶体金可以经由过程肉眼检出结果，15分钟即可出结果，适用于大年夜范围普查；核酸检测是要经由过程实验室设备来完成的，必要 2-8小时检出结果，多适用于个体病例切实着实诊。
Besides, both nucleic acid tests and antibody tests are qualitative testing. Foreign end-users could eaily confuse these two different types of testing, as exemplified by the dispute over test kits in Spain. An antibody test could return results in as soon as 15 minutes and could be easily identified by the human eye. It is more adapted to mass testing. The nucleic acid testing is more suitable for individual cases. A nucleic acid test normally takes 2 to 8 hours and must be conducted in labs.
The antibody testing is less accurate partly due to the inapproriate timing for testing. Such tests could only work on the premise that the patient was infected and has developed antibodies against the virus. If the patient is infected but has not generated antibodies yet, the antibody testing would not work. By contrast, as the “gold standard” for confirming SARS-CoV-2 infection, the nucleic acid testing can directly trace the viral genetic material. The PCR method would detect the virus as long as a certain amount of virus is accumulated in the sample collected (detection sensitivity varies among products produced by different companies). Compared with the antibody testing, the nucleic acid testing could detect the virus at an earlier stage without waiting for the patient to develop antibodies. The second reason for the accuracy issue is related to improper sampling. Nucleic acid tests may also give false negative results if the virus collected in the sample is only present in very small amounts and not able to send a strong enough signal to turn the test positive. This is largely due to incorrect sampling or the fact that the point where doctors collect the sample is not deep enough in the patient’s body.
To avoid similar problems, Notice No.12 requires a joint declaration to be signed by the exporter and importer to confirm that relevant product quality standards are accepted by both sides, and the importer commits that the non-medical face masks purchased would not be used for medical purposes. We caution buyers to carry out testing and inspection on the imported products and use these products in strict accordance with the operational instructions, requirements and scope of application specified in the contracts. In case of any problems, we suggest the two sides resolve the disputes through communication and consultation.
VI. About the List
1.The Notice has been positively received by the international community
The Notice has enjoyed warm market reception for it offers a constantly updated list of qualified companies, which effectively helps foreign buyers dispel confusion and concerns due to lack of information and of the ability to identify counterfeit goods. At this unusual and urgent juncture, some Chinese companies have come through, a sign of both opportunities and challenges for made-in-China products. The popularity of these companies derives mainly from their knowledge of relevant industry standards and international market access systems and their capacity to translate that knowledge through preparation into qualified products for export.
That said, we are also aware of the issues arising from the Notice. We encourage and help Chinese companies to register with local medical products administrations. At the same time, we report market feedback and company requests to relevant government departments to work out solutions together.
2.How will CCCMHPIE review the list in accordance with the Notice?
Entrusted by its supervising government department, CCCMHPIE invites industry experts to review and cross-check manufacturers’ self-recommendation forms collected by local commerce departments. The lists of manufacturers with certification or authorization from other countries, after initial review by local commerce departments, will be submitted to the Office of the National Mechanism for Medical Supplies Export (Department of Foreign Trade, Ministry of Commerce) and copied to CCCMHPIE which will invite experts to confirm their qualifications, submit the lists to the Ministry of Commerce (MOFCOM), and provide updates (at random intervals) based on MOFCOM’s feedback.
At CCCMHPIE, we will collect and compile information regarding the Chinese and English names of the companies, their business codes, names, specifications and models of products, status of certification or authorization in other countries, and contact information. The most important link in this process is compliance review of the licenses obtained by the companies.
Ever since its release, the Notice has triggered considerable attention home and abroad, and CCCMHPIE has received numerous phone calls for more information. To help people better understand it, CCCMHPIE posted answers to frequently asked questions on its website and official WeChat account and illustrated relevant procedures and CCCMHPIE’s work in flowcharts, offering a clear and transparent view of the submission and review processes. If you have any further question, you may contact your local commerce departments.
CCCMHPIE has set up two working groups, one for products for medical use, and the other for non-medical use, due to separate standards, independent certification requirements and different applicable laws and regulations in Europe and the US.
As of April 28, we have listed 223 companies with certification or authorization from other countries, of which 62 are manufacturers of face masks for non-medical use, and 161 are producers of medical supplies.