Preliminary analysis of the pilot management requirements of edible drug Dendrobium ferrugineum

Dendrobium ferrugineum, commonly known as Yunnan ironbark and black knotweed, is a perennial herb
in the family Dendrobium.
It is harvested from November to March of the following year, impurities are removed, part of the root is cut off, and it is twisted into a spiral or spring shape while heating, and dried; Or cut into segments, dry or dry at low temperature
.
The former is called "Dendrobium ironbar" (dendrobium earrings) and the latter is called "Dendrobium ironbark"
.

On November 25, 2019, the National Health Commission and the State Administration for Market Regulation issued the Notice on Carrying out the Pilot Work on the Substance Management of Nine Substances such as Party Ginseng as Both Food and Chinese Materia Medica, and carried out pilot work
on the production and operation of Dendrobium ferrugineum (part: stem) in accordance with the traditional production and operation of substances that are both food and Chinese medicinal materials (hereinafter referred to as "edible and medicinal substances").
The stems of Dendrobium ferrugineum are used as edible medicinal substances and are only produced and operated in the pilot areas, while the leaves and flowers of Dendrobium ferrugineum are managed
as common food raw materials.
In view of the fact that the leaves and flowers of Dendrobium ferrugineum have local traditional eating habits, it is recommended that the review of its declaration as a new food raw material be terminated in accordance with Article 29 of the Food Safety Law
.
When Dendrobium is used as a raw material for health food, it shall be managed in accordance with the relevant provisions of health food; When used as Chinese herbal medicines, it shall be managed
in accordance with the relevant provisions of Chinese medicinal materials.

At present, 12 provinces and municipalities directly under the central government have formulated pilot programs for edible and drug-based Dendrobium, which set management requirements
for the conditions of pilot enterprises such as food production enterprises, catering services and agricultural product producers.

Among them, food production enterprises must meet the requirements of the Measures for the Administration of Food Production Licensing, the General Rules for the Review of Food Production Licenses and the detailed rules of the corresponding category of licensing, and obtain the food production license of that category; A sound food safety traceability system
should be established.
In addition, enterprises need not to be subject to administrative penalties for food safety and other issues in recent years; Has a stable source of substances; Have technical advantages and R&D capabilities; Have the ability to self-detect the iconic components of the pilot substance; It is forbidden to commission the processing of food products using pilot substances as raw materials
.
The specific pilot requirements shall be subject
to the pilot programs of each locality.

Catering services shall obtain a food business license for the production and sale of hot food; Ensure strict implementation of the incoming goods inspection system; Do not declare its medicinal properties, therapeutic functions and other pharmaceutical properties on menus, dining places or verbally; Fresh Dendrobium stems purchased in the market and not prepared for medicinal purposes shall be managed
as edible agricultural products.

Agricultural product producers who sell pilot substances as edible agricultural products to pilot production enterprises shall implement the provisions of the "Law of the People's Republic of China on the Quality and Safety of Agricultural Products", and truthfully record the relevant information about the sale of the pilot food drug Dendrobium as food raw materials, and keep the sales account
.

The application process of the pilot enterprise includes: the local government proposes a pilot plan, including the types of food and drug quality, risk monitoring plan and supporting regulatory measures of the pilot, etc.
, and submits it to the provincial people's government for approval, and then reports to the National Health Commission and the State Administration for Market Regulation for approval
.
Enterprises planning to carry out pilot production and operation shall strictly follow the pilot plan, submit pilot applications to the local municipal market supervision department, submit application materials, and after the municipal market supervision department accepts the enterprise's application, review the relevant materials, put forward review opinions, and if necessary, go to the applicant enterprise and planting base for on-site audit.

If it meets the requirements, it shall be determined as a pilot production enterprise to participate in the pilot work of provincial food and drug quality management, and a notice shall be made
.
The National Health Commission will work with the State Administration for Market Regulation to study the timely inclusion of relevant substances in the food and drug quality catalogue management
according to the pilot situation.
The enterprise standards submitted by the pilot enterprise shall be filed and announced by the municipal health administrative department, and the content of the record shall include the
substances and parts used, production processes, landmark ingredients and contents.

It is understood that Jiangxi Province requires that each production enterprise should not exceed 3 food safety enterprise standards in principle; Zhejiang's "Work Plan for Pilot Inspection and Monitoring of Medicinal and Food Homologous Food (Trial)" stipulates the inspection requirements of Dendrobium ferrugineum, and Zhejiang pilot enterprises can refer to the implementation
.

At present, Yunnan, Guizhou and Guangxi have formulated and issued local food safety standards
related to Dendrobium ferrugineum stems.
The pilot program of Shandong Province requires the inspection of raw materials of Dendrobium ferrugineum to be implemented with reference to the Local Food Safety Standard Dendrobium Stem (DBS52/048-2020) of
Guizhou Province.

After the provincial health commissions and the market supervision bureaus (departments and committees) propose specific pilot plans for edible and drug-based dendrobium according to the actual conditions in their jurisdictions, the production and operation of each pilot need to be strictly supervised in accordance with the pilot plan to prevent risks
.
The pilot plan specifies the pilot food categories, standardizes the pilot scope and sales methods, determines the pilot work cycle, and the supporting risk monitoring plan and supporting regulatory measures
.
Strengthen the supervision of Dendrobium products during and after the event, and promote the high-quality development of
food and drug quality.

(Source: Food Labeling Circle)

China Food News (October 17, 2022, Edition 06).

(Editor: Yang Xiaojing)