Preservative regulations for gelatin hollow capsules

Gelatin is the collagen in animal skins, bones, and tendons. It is a protein product obtained by partial hydrolysis and purification. It is also a good microbial culture medium under a certain water content. Therefore, the microbial control of gelatin products is very important.
China stipulates that there are 29 kinds of preservatives that can be added to food. Among them, hydroxyphenyl esters (paraben esters) have become popular among many domestic hollow capsule manufacturers due to their broad-spectrum antibacterial activity and wide pH adaptability. Preferred. There are four commonly used paraben esters, namely methyl ester, ethyl ester, propyl ester, and butyl ester. Paraben destroys the cell membrane of microorganisms, denatures the proteins in the cells, and inhibits the activities of the respiratory enzymes and electron transfer enzymes of the microbial cells, resulting in antibacterial effects. Usually the combined use of paraben can reduce the dosage and improve the antibacterial effect.
All countries have strict regulations on the amount of paraben esters added to food. Usually, the total content of paraben esters in the finished product is less than 0.05%. my country's GB1760 stipulates that the total amount of paraben esters used alone or in combination should be less than 0.05%; Japan commonly used butyl esters, the maximum limit is 0.028%; the United States allows a small amount of heptyl esters to be used for beer preservation, while the European Union uses DIRECTIVE 95/2 The /EC directive stipulates that it is not allowed to add paraben preservatives in dietary supplements; the United States and the European Union have mentioned in relevant regulations that preservatives cannot be used to reduce GMP or the standards of raw materials. The United States requires that products using chemical preservatives must be clearly and well-known on the label "Add ××× as a preservative" or "Use ××× to inhibit bacterial growth." CP 2010 version of "Gelatin Hollow Capsules" has been added to the content detection of "hydroxyphenyl esters" in the draft for solicitation of opinions, with a limit of 0.05%.
Developed countries no longer add preservatives in the manufacturing process of hollow capsules. In my country, due to the quality of gelatin, production process, or production environment, some hollow capsule manufacturers also need to add preservatives to make the product's microbiological indicators meet the standards during the shelf life. The content of paraben in some hollow capsule samples reaches 0.5%, which is 10 times the usual stipulation. As a medicinal excipient, gelatin hollow capsules are widely used in foods, health foods and medicines, and enter the human body together. Therefore, the content of preservatives must be limited to ensure the health of the people taking them.