How Is the Quality of Chinese Medicinal Materials Guaranteed? Modern Logistics to the Rescue
At the start of 2015, the Ministry of Commerce issued the "Notice on Guiding Opinions for Accelerating the Construction of a Modern Logistics System for Chinese Medicinal Materials," proposing to accelerate the construction of a modern logistics system for Chinese medicinal materials from 6 aspects, striving to initially form an integrated modern logistics system for Chinese medicinal materials covering harvesting, origin processing, packaging, warehousing and transportation by 2020.
In addition, on July 30, 2014, the Ministry of Commerce, through "Ministry of Commerce Announcement No. 54 of 2014," published two standards, the "Specification for Warehousing Management of Chinese Medicinal Materials" and the "Technical Specification for Warehouses of Chinese Medicinal Materials," which will also be officially implemented starting March 1 of this year.
Accelerated Pace in Building a Modern Circulation System for Chinese Medicinal Materials
At present, the total annual logistics volume of Chinese medicinal materials in China is about 17 million tons. However, the current state of logistics for Chinese medicinal materials in China lags 20 years behind that of industrial consumer goods; compared with other agricultural products, it lags 10 years. The core problem is that the quality of Chinese medicinal materials cannot be guaranteed during circulation and logistics. "In particular, the backward conditions and prominent problems in origin processing, packaging, warehousing and maintenance of Chinese medicinal materials have already seriously affected the sustained and healthy development of China's traditional Chinese medicine industry," Zhou Xun, Secretary-General of the Chinese Medicinal Materials Market Professional Committee of the China Association of Traditional Chinese Medicine, told reporters.
The Ministry of Commerce, as the competent department for the circulation of Chinese medicinal materials, believes that with China's economic and social development, the contradiction that the logistics system for Chinese medicinal materials does not adapt to the development of traditional Chinese medicine undertakings and the expanding health needs of the people has become increasingly prominent. This is mainly manifested as: origin processing, packaging and warehousing facilities for Chinese medicinal materials are scattered and backward, modern maintenance technologies are lacking, the level of intensification, standardization and modernization of Chinese medicinal materials logistics is relatively low, service functions are incomplete, and certain hidden dangers are brought to the quality and safety of Chinese medicinal materials. Advancing the construction of a modern logistics system for Chinese medicinal materials is of great significance for improving the organized and modernized level of Chinese medicinal materials circulation, enhancing the ability of Chinese medicinal materials circulation to guarantee quality and safety, and promoting the sustained and healthy development of traditional Chinese medicine undertakings.
To this end, the Ministry of Commerce proposed in the "Notice on Guiding Opinions for Accelerating the Construction of a Modern Logistics System for Chinese Medicinal Materials" that by 2020, an integrated modern logistics system for Chinese medicinal materials covering harvesting, origin processing, packaging, warehousing and transportation should be initially formed, basically meeting the logistics needs of professional markets and e-commerce transactions for Chinese medicinal materials, and basically adapting to the requirements of the development of traditional Chinese medicine undertakings and the people's growing health needs. The specific goals are: a standards system for Chinese medicinal materials logistics should be basically established; logistics infrastructure and circulation networks with major production and sales areas of Chinese medicinal materials as circulation nodes should be basically completed, and bulk Chinese medicinal materials as well as precious and fine, toxic, narcotic and restricted Chinese medicinal materials should achieve centralized warehousing; logistics informatization management technology and new maintenance technologies for Chinese medicinal materials should be widely applied; the circulation traceability system should fully play its role; and the comprehensive strength of large and medium-sized Chinese medicinal materials logistics enterprises should be significantly enhanced.
At the same time, six main tasks and four safeguard measures were proposed. The six tasks are: building origin processing bases for the Chinese medicinal materials industry; standardizing the packaging of Chinese medicinal materials; building a centralized warehousing and distribution network; promoting the application of modern logistics management and technology; improving the supporting logistics service functions of professional markets for Chinese medicinal materials; and making Chinese medicinal materials warehousing and logistics enterprises stronger and larger. The four safeguard measures are: strengthening planning guidance and policy support, striving to provide land, funding and financing support for the construction of intensive origin processing bases and socialized warehousing bases for Chinese medicinal materials; forming as soon as possible a standards system covering the entire process of Chinese medicinal materials logistics; implementing a warehousing quality certification system for Chinese medicinal materials to ensure that enterprises engaged in public warehousing services for Chinese medicinal materials have the corresponding storage conditions; and giving full play to the positive role of relevant industry associations in the formulation and publicity of Chinese medicinal materials standards, talent training, and professional consulting.
Intensive Work on Formulating Warehousing and Logistics Standards for Chinese Medicinal Materials
In recent years, the Ministry of Commerce has done a great deal of work to promote the construction of a modern logistics system for Chinese medicinal materials, mainly in the following three aspects: first, it secured support from the Ministry of Finance to use central government funds to promote the construction of a circulation traceability system for Chinese medicinal materials. Second, it commissioned the China Warehousing Association and the China Association of Traditional Chinese Medicine to organize relevant units to carry out the research project "Research on the Construction of a Modern Logistics System for Chinese Medicinal Materials." Third, based on the research results of the project, it issued the "Guiding Opinions on Accelerating the Construction of a Modern Logistics System for Chinese Medicinal Materials," made arrangements and requirements for related work, and launched the construction of a logistics standards system for Chinese medicinal materials, proposing a "5+1" standardization system for Chinese medicinal materials logistics, including the "Quality Management Specification for Chinese Medicinal Materials Logistics," "Technical Specification for Warehouses of Chinese Medicinal Materials," "Specification for Warehousing Management of Chinese Medicinal Materials," "Technical Specification for Controlled Atmosphere Maintenance of Chinese Medicinal Materials," "Technical Specification for Origin Processing of Chinese Medicinal Materials," and "Technical Specification for Packaging of Chinese Medicinal Materials."
At present, the two standards "Technical Specification for Warehouses of Chinese Medicinal Materials" and "Specification for Warehousing Management of Chinese Medicinal Materials" have been officially promulgated and will be officially implemented in March 2015; the "Technical Specification for Controlled Atmosphere Maintenance of Chinese Medicinal Materials" was reviewed and formed into a draft for approval by an expert review meeting on November 24, 2014, and submitted to the Ministry of Commerce for approval and release; the national standard "Quality Management Specification for Chinese Medicinal Materials Logistics" and the two industry standards "Technical Specification for Origin Processing of Chinese Medicinal Materials" and "Technical Specification for Packaging of Chinese Medicinal Materials" are applying for the 2015 standards plan.
Guan Feng, Secretary-General of the China Warehousing Association, said that there are three focal problems in Chinese medicinal materials logistics: first, the degree of intensification and scale is very low; second, facilities and technology are very backward; third, there is a lack of unified standards and whole-process supervision. The purpose of formulating relevant standards is to solve the current problems of Chinese medicinal materials warehousing being "small, scattered and poor," and to guide Chinese medicinal materials warehousing toward the direction of "scaled, intensive and specialized" development.
The two industry standards about to be implemented, the "Technical Specification for Warehouses of Chinese Medicinal Materials" and the "Specification for Warehousing Management of Chinese Medicinal Materials," were organized, applied for and submitted by the China Association of Traditional Chinese Medicine and the China Warehousing Association, and were included in the Ministry of Commerce's 2013 circulation industry standards plan. Zhou Xun said that the "5+1" standards system for Chinese medicinal materials we proposed is a complete system. Standardized warehouses are the foundation and basis for providing standardized warehousing management and standardized maintenance, and are the follow-up facilities for standardized origin processing and packaging. Standardized warehouses are the condition for the implementation of other standards; standardized origin processing provides a guarantee for standardized maintenance, and is also a prerequisite for the implementation of standardized packaging and standardized warehousing management; standardized packaging is the carrier for the traceability of Chinese medicinal materials circulation and a necessary condition for standardized warehousing management of Chinese medicinal materials. In short, standardization is the means by which the construction of a modern logistics system for Chinese medicinal materials is realized, and is the top priority in industry development.
Interpretation of Two Standards for the Construction of Chinese Medicinal Materials Warehousing
What key points in the two industry standards "Technical Specification for Warehouses of Chinese Medicinal Materials" and "Specification for Warehousing Management of Chinese Medicinal Materials" should the industry pay close attention to? Relevant experts from the China Association of Traditional Chinese Medicine and the China Warehousing Association provided an interpretation.
The experts pointed out that regarding the scope of application of the standards, the applicable objects stipulated by the standards are Chinese medicinal materials business enterprises, traditional Chinese medicine decoction piece enterprises, and logistics enterprises engaged in Chinese medicinal materials warehousing operations. Whether the two standards apply to the broad masses of medicinal herb farmers, specialized cooperatives and self-employed households is not clearly stipulated in the standards. This reflects a basic guideline of the standards drafting group, the standards review meeting and the national competent authorities: advocating the enterprise-based construction and operation of Chinese medicinal materials warehouses.
The experts believe that only through enterprise-based, market-oriented and socialized operation can the "scaled, intensive and specialized" construction of warehouses be guaranteed, and can the current poor state of Chinese medicinal materials storage be fundamentally changed. Of course, the standards also do not stipulate that they do not apply to "farmers and self-employed households," and we do not oppose farmers and self-employed households building scaled warehouses according to these standards. We only advocate that "farmers and self-employed households" build "scaled, intensive and specialized" warehouses in the form of registered enterprises and manage them through enterprise behavior.
The industry standard "Technical Specification for Warehouses of Chinese Medicinal Materials" includes the definition of 7 terms and requirements in 7 aspects for the planning and construction of Chinese medicinal materials warehouses. The basic requirements in 7 aspects include how to carry out warehouse site selection, how to choose the professional type of warehouse according to the region and the characteristics of Chinese medicinal materials, how to choose the building type of warehouse according to the characteristics of Chinese medicinal materials logistics, and it stipulates the minimum scale of Chinese medicinal materials warehouses, as well as the basic requirements for other warehouse supporting facilities.
The experts pointed out that the professional type warehouses for Chinese medicinal materials are proposed for the first time in this standard. From the perspective of the storage needs of Chinese medicinal materials, it defines the temperature and humidity ranges of 3 professional types of warehouses. Its parameters are based on the "Pharmacopoeia of the People's Republic of China," as well as the actual conditions learned from Chinese medicinal materials warehousing enterprises in different regions during the research project on the construction of a modern logistics system for Chinese medicinal materials, and were formed into unified conclusions after full discussion at the expert review meeting.
Regarding the basic principles of warehouse planning and construction, there are mainly three considerations: first, nationwide layout should be based on the overall plan for the construction of the Chinese medicinal materials logistics system and follow the principle of giving priority to centralized warehousing at production areas, supplemented by transfer warehousing at markets; second, the scale of the warehouse should be determined according to the local warehousing needs of Chinese medicinal materials cultivation and trade, combined with the actual situation of existing compliant warehouses; third, the specific site selection of the warehouse should consider convenient transportation, rational planning and concentrated construction.
The standard proposes the applicable regions for professional types of Chinese medicinal materials warehouses and the types of medicinal materials suitable for storage. Northeast China, North China, Northwest China and Central China are suitable for building normal-temperature warehouses; the Yangtze River Basin is suitable for building cool warehouses; the southeast coastal areas are suitable for building low-temperature warehouses. Normal-temperature warehouses are suitable for storing medicinal materials that are not prone to insect damage, mildew or oil exudation; cool warehouses are suitable for storing Chinese medicinal materials that are prone to volatilization, sublimation or oil exudation; low-temperature warehouses are suitable for storing precious and fine (rare) medicinal materials, animal-derived medicinal materials, and seed-kernel medicinal materials.
The standard also proposes the building types and applicable conditions of Chinese medicinal materials warehouses, mainly based on the situation obtained from investigation and research, based on the basic laws and different needs of Chinese medicinal materials logistics, ensuring the safety of Chinese medicinal materials warehousing (length of storage time, convenience for adopting controlled atmosphere maintenance), while also considering the input and output of the warehouse and the efficiency of logistics operations. Based on these factors combined, the applicable objects are proposed. For example, single-story warehouses are suitable for storing Chinese medicinal materials of a single variety, small batches and shorter storage time; multi-story buildings are suitable for storing Chinese medicinal materials of many varieties, large batches and longer storage time; stereoscopic warehouses are suitable for storing Chinese medicinal materials with standardized packaging, many varieties, small batches and fast turnover. Chinese medicinal materials warehouses should mainly promote multi-story buildings.
The industry standard "Specification for Warehousing Management of Chinese Medicinal Materials" includes the definition of 5 terms and 6 basic requirements for the warehousing management of Chinese medicinal materials.
"Controlled atmosphere storage and maintenance" is an important term in this standard and is also the advanced method for the maintenance of Chinese medicinal materials that this standard preferentially recommends.
The standard proposes 6 basic requirements for the warehousing management of Chinese medicinal materials. Among them, Article 2 states that the warehousing management of Chinese medicinal materials should have service functions such as acceptance and warehousing, in-warehouse management, in-warehouse maintenance, and outbound delivery; Article 3 states that the warehousing management of Chinese medicinal materials should use a warehouse management system (WMS) to manage the entire process of Chinese medicinal materials warehousing; Article 4 states that the warehousing management of Chinese medicinal materials should be equipped with trained and qualified professional and technical personnel engaged in the warehousing management of Chinese medicinal materials; Article 5 states that the warehousing management of Chinese medicinal materials should, for the purpose of ensuring the quality of Chinese medicinal materials, establish a warehousing quality management system and improve warehousing operation processes and operating specifications. These four articles are requirements proposed for Chinese medicinal materials warehousing by reference to modern logistics methods. Article 1 states that according to the characteristics of Chinese medicinal materials, normal-temperature warehouses, cool warehouses and low-temperature warehouses should be selected respectively for storage. Chinese medicinal materials must not be stored in the open air; Article 6 states that during storage, Chinese medicinal materials must not be fumigated with aluminum phosphide, and sulfur fumigation must not be abused. Chinese medicinal materials stored for more than 30 days should adopt maintenance methods such as controlled atmosphere storage. These two articles are relevant provisions formulated according to the basic characteristics of Chinese medicinal materials.
Why must "aluminum phosphide fumigation not be used"? Experts say that on the one hand, in 2011, five ministries and commissions including the Ministry of Agriculture, the Ministry of Industry and Information Technology and the General Administration of Quality Supervision, Inspection and Quarantine issued Announcement No. 1586, banning or restricting the use of the highly toxic agent aluminum phosphide; on the other hand, there are hazards in the use of aluminum phosphide such as poisoning of operators, fire, corrosion of equipment (especially serious for copper and copper alloys), and environmental pollution.
Why must "sulfur fumigation not be abused"? In view of the announcement issued in 2011 by the State Food and Drug Administration and the Chinese Pharmacopoeia Commission, which stipulated that the sulfur content of 11 medicinal materials including Chinese yam, twotooth achyranthes root, Gastrodia elata, largehead atractylodes rhizome and Codonopsis pilosula should be less than 400 PPM, and the sulfur content of other Chinese medicinal materials should be less than 150 PPM; and the Chinese Pharmacopoeia stipulates that sulfur must not be used to process or whiten medicinal materials, therefore, this standard does not prohibit the use of sulfur fumigation, but sulfur dioxide residues must comply with national regulations; "sulfur fumigation must not be abused" means that sulfur must not be used to process and whiten medicinal materials.
Why choose the time node of "30 days"? Because the physiological cycle from insect eggs to larvae and then to adults is about 36 days. If Chinese medicinal materials are stored for more than 30 days and are not maintained scientifically and effectively, there is a very high possibility of pest infestation, which not only affects the quality of the medicinal materials but also damages the economic benefits of enterprises.
Experts said that at present, the production of traditional Chinese medicine in China has strict GMP and quality traceability systems, but Chinese medicinal materials and traditional Chinese medicine decoction pieces, which are the source of traditional Chinese medicine, cannot achieve traceability, and their quality problems have become a major difficulty and hidden danger for traditional Chinese medicine. Therefore, the construction of a modern logistics system for Chinese medicinal materials will surely become an important link in enabling traditional Chinese medicine to further trace back to the source.