Cyclodextrin Safety Overview

Cyclodextrin Safety Overview

We need to have a strict and scientific basis to evaluate whether cyclodextrin and other food additives are harmful to the human body. The use of cyclodextrin in food is based on a set of rigorous and scientific theoretical foundations and experimental data. Generally speaking, the common indicators for evaluating whether food additives are toxic are ADI, LD50 and GRAS. Cyclodextrin is a new type of food additive that has developed rapidly abroad in recent years and is currently widely used in many countries. In fact, Chinese food manufacturers are also using it. With the enhancement of people's health awareness and the admiration of pure natural food, the safety of cyclodextrin as a food additive in food has received more and more attention in recent years. Since cyclodextrin as a food additive is still a new thing in my country, it is necessary to correctly understand the safety of cyclodextrin. First of all, we should admit that the development of the modern food industry today is inseparable from additives. "There is no modern food industry without food additives" is an absolute truth. All additions in accordance with the varieties and contents specified by the state are allowed and safe. To understand the safety of cyclodextrin, we must first understand that toxicity and safety are the lifeblood of food additives. Countries have strict regulations on whether various food additives can be used, their scope of application, and their maximum usage, and they must be subject to regulations and laws to ensure absolute safety. These regulations are based on a set of scientific and rigors toxicity evaluations. At present, the internationally recognised food additive safety indicators are ADI, LD50 and GRAS. The ADI (Acceptable Daily Intakes, ADI) value is the number of milligrammes that the human body is allowed to ingest per kilogramme of body weight per day. The Joint Committee of Food Additives Experts (JECFA) of the United Nations FAO/WHO proposes it every year based on the toxicity reports of food additives used in various countries. The United Nations Committee on Food Additives (CCFA) discusses it at its annual meeting and evaluates, modifies or withdraws the ADI of a certain food additive, which has been accepted by all countries. We can see from the data in the following table that natural cyclodextrin obtained from starch through enzyme conversion is safe and reliable to use as a food additive. We hope that our work will help the country to improve the formulation and approval of cyclodextrin use standards as soon as possible.

1. ADI

As we all know, the ADI value is based on the maximum no-effect dose (MNL) obtained in long-term toxicity tests on small animals (rats, mice, etc.), and 1/100-1/500 of it is taken as the ADI value. Countries formulate the maximum amount allowed in food based on the ADI value, which should be guaranteed in terms of food safety. The maximum use of food additives in food is generally calculated based on the "Danish Budget Method (DBM)" recommended by JECFA. This method has been recognized and adopted by countries around the world, that is: the maximum use of food additives = 40×ADI

2. Median lethal dose (LD50)

LD50 is the second commonly used indicator for judging the safety of food additives, and it is also the first-stage acute toxicity test indicator in the toxicological evaluation that any food additive must undergo. It generally indicates the magnitude of the acute toxicity of food additives. In 1994, the Ministry of Health of China divided the chemical substances used in food into six categories based on LD50 in the "Food Safety Toxicology Evaluation Standards", as shown in the following table:

3. GRAS. GRAS is the safety index of food additives evaluated by the U.S. FDA (U.S. Food and Drug Administration). FDA (U.S. Food and Drug Administration) stipulates: (1) Those existing in a certain natural food (2) Those known to be easily metabolized in the human body (3) Those whose chemical structure is very similar to a known safe substance (4) Those that have been proven to have a long history of safe consumption in a wide range of areas (5) Those that meet the following conditions at the same time: ① Those that have been used in a certain country for more than 10 years recently ② The average maximum dosage in any final food does not exceed 10×106 ③ The annual consumption in the country (referring to the United States) is less than 1,000 pounds ④ Those that have been proven to have no safety issues in terms of chemical structure, composition or actual application Anything that meets one or more of the above categories can be listed as a generally recognized safe food additive (GRAS). Different countries have different regulations on the use of natural cyclodextrin products. For example, the United States and Japan both consider γ-cyclodextrin to be GRAS, while Europe is applying for approval. Because the regulations of each country are different, you need to be careful when using cyclodextrin. For example, the use of β-cyclodextrin as a food additive is unrestricted in Japan, while in the United States and Europe, the safety assessment of the Joint Committee of Experts on Food Additives (JECFA) limits the daily intake (ADI) to 5 mg/kg/day. α and γ-cyclodextrin have no ADI restrictions and are considered safe substances.