Periploca Sepium Bunge Leaves: Why They Haven't Been Approved as a New Food Ingredient in China

Introduction of Periploca Sepium Bunge

Distribution area

The Periploca sepium Bunge is found in mainland China except the provinces of Guangdong, Guangxi, Hainan. It is also found in Far Eastern Asian Russia. The habitat is plains, slopes and forest edges.

Usage

The loop of Periploca sepium Bunge is used in traditional Chinese medicine for the treatment of rheumatoid arthritis. Laboratory tests have demonstrated an inhibitory effect of the plant extract on the growth and interleukin-6 release of fibroblasts from rheumatic tissue.

There is relatively little literature on the leaves of Periploca sepium Bunge. A study has shown that the leaves contain phenolic components, organic acids, saponins, flavonoids and their glycosides, phytosterols and terpenoids.

History of the application for new food ingredients

According to the National Health Commission (NHC), on August 11, 2022, its application as a new food ingredient was accepted (NHC Application For New Food Ingredients (2022) No. 0009).

 

 Subsequently, on October 18, 2022, the notice of review was issued.

 

 On February 7, 2023, NHC published a decision, that did not approve the application for the leaves of Periploca sepium Bunge as new food ingredient.

 

Possible reasons for a disapprove

The following circumstances will cause the expert review committee to make the conclusion of disapproval:

* Does not have the characteristics of food ingredients

* That do not meet the nutritional requirements that should be present

* That the safety cannot be guaranteed

* Declared materials or samples that have authenticity problems

* Other does not meet the relevant laws and regulations of China

The following points are specific reasons:

* Special promotion of therapeutic effects, description of the pharmacological and medicinal effects of the substance, and inadequate elaboration of the nutritional properties of the food ingredients.

* The declared raw material itself has a clear pharmacology and is regulated as a drug in several other countries.

* Safety is in question. For example, toxicology test results show that the declared raw materials have toxicity, such as 90-day feeding test on the amount of food or other indicators have an impact. Or other international organizations or countries after a safety assessment that the declared raw materials have a safety risk.

Before applying for new food ingredients, ZMUni recommends that a feasibility analysis be conducted first. On this basis, the applicant can better understand the risk points of the matter for the application, so as to make a relatively correct judgment on the matter under application. This helps to plan the corresponding tests and preparation of documents more efficiently. In the preparation of application materials, applicants should focus on the key points of the new food ingredient application requirements.

 

Source

* National Health Commission (NHC)

https://zwfw.nhc.gov.cn/kzx/sdxx/xspylsp_213/202302/t20230208_2452.html 

https://zwfw.nhc.gov.cn/kzx/sdxx/xspylsp_213/202211/t20221112_2386.html

https://zwfw.nhc.gov.cn/kzx/slgs/xspylsp/202208/t20220812_2352.html 

* Tokiwa Takayoshi ; Harada Kuniaki ; Matsumura Toshiharu ; Tukiyama Takashi:  Oriental medicinal herb, Periploca sepium, extract inhibits growth and IL-6 production of human synovial fibroblast-like cells. In: Biological and Pharmaceutical Bulletin. Nr. 27 (10), 2004, S. 1691–1693.

* Chen Ling: Study on the chemical composition of the leaves of Periploca sepium

* Bunge [D]. Master's thesis, Northwest Agriculture and Forestry University, 2007.

*《Pharmacopoeia of The People's Republic of China》

*《Flora Reipublicae Popularis Sinicae (FRPS)》