The Technical Specifications for Plant Extract Production Process (hereinafter referred to as the Technical Specifications), which was initiated in 2017 and jointly drafted by the Chinese Academy of Standardization, the Ministry of Agriculture and Rural Affairs and other units, has been studied for five years and asked for comments from the society. The deadline for feedback is December 18, 2022. Experts in the industry believe that for a long time, there has been no uniform production specification for plant extracts in China. Simple water extraction or ethanol extraction will produce many different control processes and process parameters. Therefore, standardizing the production process of extracts will have far-reaching significance from resource utilization to improving the market competitiveness of products.
Promote gradual standardization of the industry
Plant extracts are very complex, not only contain a variety of chemical components, but also different components in different parts. Generally, plants contain the following chemical components: alkaloids, glycosides, organic acids, resins (including resin acids, resin alcohols and hydrocarbon resins), volatile oils, sugars (including starch, inulin, gum and mucus, etc.), amino acids, proteins and enzymes, tannins, plant pigments (including chlorophyll, carotenoids, flavonoids, betaine and quinones, etc.), oils and waxes, and inorganic components (trace elements).
Plant extract is a product formed by taking plants as raw materials, according to the use needs of the extracted final product, through the physical and chemical extraction and separation process, to obtain and concentrate one or more effective ingredients in plants directionally without changing the structure of their effective ingredients.
According to the different components of extracted plants, glycosides, acids, polyphenols, polysaccharides, terpenoids, flavonoids, alkaloids, etc. are formed; According to different properties, it can be divided into vegetable oil, extract, powder, lens, etc. Plant extracts can be used in food, medicine, beauty and other industries. There are many kinds of plant extracts. At present, there are more than 2000 kinds of plant extracts produced in China and more than 5000 manufacturers.
The Technical Specifications pointed out that the plant extract industry developed rapidly, with many production and operation enterprises, fierce market competition, uneven product quality, coexistence of natural extraction and artificial synthesis, coexistence of high-tech enterprises and small workshops, and serious product homogeneity. The quality of plant extracts is greatly affected by factors such as place of origin and process, among which the production process has the greatest impact on its quality. Extraction solvent, extraction temperature, extraction method, concentration method, drying method, etc. will have a great impact on the quality of the extract product, which is also the reason for the uneven and unstable quality of plant extract products.
In order to promote the healthy development of plant extract industry, it is necessary to standardize the production process of plant extract, keep the quality of corresponding products consistent and stable, and enhance China's international voice in the field of plant extract. At the same time, since many plant extracts are directly used in health food, the application review process of health food is basically evaluated with reference to the standards of pharmaceutical extracts. However, the existing raw materials and testing results show that there are many process sources for such raw materials. In addition, due to the fact that its quality standards are still in accordance with pharmacopoeia, foreign standards or even user-defined standards, the specification of raw materials is not uniform.
At present, there are no relevant standards in the International Organization for Standardization concerning the technical specifications for the production process of plant extracts. There is no corresponding national or industrial standard for the production process of plant extracts in China, and only some social organizations have formulated some corresponding quality standards for plant extracts. There is a lack of instructive description of some important technical steps, which is not conducive to the corresponding standards guiding practice. Therefore, insiders said that the formulation of this standard plays an important role in guiding the development of relevant industries.
Promote enterprises to improve quality
Chinese herbal medicine and food medicine substances are often used in food, health care products, cosmetics, etc. In most cases, they need to be extracted and processed to obtain water-soluble, oil soluble or alcohol soluble effective substances, so as to facilitate the development and application of terminal products in the later stage. The release of the Technical Specifications is directly related to the standardized production, processing and standardized quality control of drug food homologous extracts.
First, the extraction process is clearer. The extraction process is the most important process of plant extracts, but in the past, there was no description of the process and specific parameters, so there was no substantive guidance. The Technical Specifications require manufacturers to refine the extraction process, improve the technical parameters of each step, and really have the role of guiding and standardizing production.
Secondly, the agreed content of the extract standard is more perfect. The previous standards for plant extracts focused on the quality standards of products. After the promulgation of the Technical Specifications, relevant enterprises must take the extraction process as the key content for standard agreement.
Since the current group standards and industry standards for plant extracts mainly focus on product quality requirements, common extraction process descriptions are relatively simple, such as raw materials being extracted, concentrated, extracted, spray dried, crushed, mixed and packaged to form products, which has no guiding effect on important technical steps in the production process, is not conducive to standardized production, has no traceability, and causes great trouble to daily supervision.
After the release of the Technical Specifications, the quality standards for extracts will be more specific in terms of process description, more binding and practical. When necessary, the enterprise needs to provide the process flow chart and extract the technical parameters such as the processing process description.
Third, the extraction process is more standardized. According to the provisions of the Technical Specifications, the extraction process needs to have a clear process flow, parameters of process critical control points, and technical indicators, which can be more standardized and traceable, which is conducive to the production management of the enterprise itself and the inspection of the market supervision and management department.
Fourth, the same kind of extract is easier to standardize. At present, most plant extracts are produced according to enterprise standards, industry standards, or the standards for medicinal extracts when declaring health food. The same raw materials will have multiple processes, different production conditions, and product specifications cannot be unified. After the release of the Technical Specifications, the process of the same extract will be transformed into a better extraction method, and finally a situation of unified market and basically consistent product specifications will be formed.
Fifth, low-end extraction technologies will be eliminated. From the perspective of raw material extraction and utilization, only those enterprises that have long-term research on the extraction process and found out better experimental conditions will have better process control and obtain more stable and high-quality extracts, while low-end enterprises will eventually be eliminated.
Industry insiders believe that the release of the Technical Specifications can promote the healthy development of the plant extract industry, encourage enterprises to explore and develop more new ingredients through process transformation and optimization, improve product quality standards and improve market competitiveness.
See China Food News (November 14, 2022, edition 6) for details
