Enzyme preparations refer to biological products with special catalytic functions that are directly extracted from edible or non-edible parts of animals or plants, or extracted from traditional or genetically modified microorganisms by fermentation. Enzyme preparations used in the food industry in my country are managed as food additives and processing aids. my country’s enzyme preparation has formed an independent industrial system with a complete range of products and increasingly wide application fields, including brewing, monosodium glutamate, starch sugar, health food, and other fields.
Self-made enzyme preparation is part of the food production process, do I need to obtain a production license separately?
The former State Food and Drug Administration’s “Reply Letter on Issues Concerning Production Licensing of Calcium Oxide Produced by Sugar Enterprises” mentioned: “The Food Safety Law of the People’s Republic of China” stipulates that the state implements a licensing system for the production of food additives. “National Food Safety Standard Food Additive Calcium Oxide” (GB 30614-2014) specifies the technical requirements for food additive calcium oxide. In view of this, enterprises (including self-produced and self-used enterprises) should obtain the production license for food additive calcium oxide according to the law before producing it. Therefore, enterprises need to obtain a food additive production license (the variety details should include enzyme preparations) before they can make their own enzyme preparations.
Is the enzyme preparation allowed to be sub-packaged, and what precautions should be taken?
Food enzyme preparations are food additives, and their packaging should be carried out according to the packaging requirements of food additives. The former General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China’s “Reply Letter on Relevant Issues Concerning Food Additive Subpackaging” mentioned that enterprises (including sub-packaging enterprises) producing food additives shall obtain a food additive production license in accordance with the law before they can produce, sell and use them. However, at present, the supervision of food additive packaging is different in different places. Therefore, whether the enzyme preparation can be packaged or not needs to be consulted with the local regulatory authority.
If it is confirmed by consulting the local regulatory authority that the enzyme preparation can be repackaged, the following items should be paid attention to obtain a food additive production license (subpackage); mark the name and address of the repacker, and indicate the words of the mark after the name); the production date shall be marked according to the date of repacking; the shelf life date shall be marked according to the original shelf life date of the sub packaged enzyme preparation.
Can excipients be added to enzyme preparation products used in the food industry, and what are the requirements for excipients?
“National Food Safety Standards Food Additives Enzyme Preparations for Food Industry” (GB 1886.174-2016) mentioned that commercial enzyme preparation products are allowed to add ingredients that are easy to store and use. The standard requires that the raw materials used for the production of enzyme preparations must comply with good manufacturing practices or relevant requirements, and should not produce residual contamination harmful to health in the final food under normal use conditions. Therefore, excipients can be added to enzyme preparation products, but it should be ensured that the excipients do not produce residual pollution harmful to health in the final food. In the latest draft of the standard released in 2021, it is further proposed that commercialized enzyme preparation products may contain one or more active enzyme components, for product activity preservation, circulation storage, and standardized use, it is allowed to add food raw materials and/or auxiliary ingredients such as secondary additives. It also lists the names and functions of the permitted secondary additives. Therefore, food raw materials, secondary additives, and other auxiliary ingredients can be added to commercial enzyme preparation products.
What are the regulations on excipients in compound enzyme preparations? How are ingredients identified?
“National Food Safety Standards – General Rules for Compound Food Additives” (GB 26687-2011) stipulates that excipients are food raw materials added for the processing, storage, and dissolution of compound food additives. Therefore, the excipients in the compound enzyme preparation should be food raw materials, and their quality specifications should meet the corresponding national food safety standards or related standards.
The labeling of the ingredients in the compound enzyme preparation should comply with the provisions of the “National Food Safety Standard Food Additive Labeling General Rules” (GB 29924-2013): according to the “National Food Safety Standard Food Additive Use Standard” (GB 2760-2014), food additives List the names of every single variety of food additives in the product quality specification standards and the names specified in the food additives approved for use by the competent national authorities. The list of ingredients should be arranged in descending order according to the content of each food additive. If a single variety or compound food additive contains auxiliary materials, the auxiliary materials shall be listed after every single type of food additive and shall be arranged in descending order of auxiliary material content. Therefore, the ingredient list of the compound enzyme preparation should be arranged in descending order according to the content of each enzyme preparation, and the excipients should be listed after the enzyme preparation variety and arranged in descending order.
What is the difference between enzyme preparations and processing aids in use?
Enzyme preparations used in the food industry in my country are managed as food additives and processing aids. Appendix C of “National Food Safety Standards – Standards for the Use of Food Additives” (GB 2760-2014) stipulates the regulations on the use of processing aids in the food industry. Table C.1 specifies the list of processing aids (excluding enzyme preparations) that can be used in various food processing processes and the residue amount does not need to be limited; Table C.2 specifies the processing aids that need to specify functions and scope of use List (excluding enzyme preparations); Table C.3 specifies the enzymes allowed to be used in food processing and the sources and donors of various enzymes. Therefore, except for foods that cannot use food additives in product standards, the enzyme preparations in Table C.3 and the processing aids in Table C.1 can be used in various foods, while the processing aids in Table C.2 Agents must be used according to the specified function and scope of use.
Can enzyme preparations be compounded with other food additives to produce compound food additives?
The “Frequently Asked Questions on National Food Safety Standards” mentions that processing aids can be mixed with other food additives by physical methods to produce compound food additives, but the use of processing aids should be in accordance with their use principles, and the compound food additives produced should be It complies with the provisions of “National Food Safety Standard General Rules for Compound Food Additives” (GB 26687-2011). The general rule applies to all compound food additives except food flavors and gum-based candy bases. Therefore, enzyme preparations can be compounded with food additives other than food flavors and gum-based candy bases to produce compound food additives.
What are the requirements for the naming of compound enzyme preparations?
“National Food Safety Standards General Rules for Labeling of Food Additives” (GB 29924-2013) stipulates that the names of compound food additives should comply with the naming principles in Chapter 3 of “National Food Safety Standards General Rules for Compound Food Additives” (GB 26687-2011). This principle stipulates that food additives compounded with single and identical functions shall be named according to their functions in the final food. That is, “compound” + “name of the functional category of food additives in GB 2760-2014”, such as compound colorant, compound preservative, etc. Food additives with the same function, or food additives with different functions, can be named after all of the main functions they perform in the final food, that is, “compound” + “food in GB 2760-2014 Additive Functional Class Name”. Therefore, if it is compounded with the enzyme preparation in GB 2760-2014, if it is compounded with pectinase and protease, it should be named “food additive compound enzyme preparation”, such as the use of enzyme preparation and other functions The compounded food additives should be named according to their main functions in the final food.
Do enzyme preparations need to be labeled in food?
The labeling of enzyme preparations in the question and answer of “General Rules for the Labeling of Prepackaged Foods”: if the enzyme preparation has lost its enzyme activity in the final product, it does not need to be labeled; if it still maintains the enzyme activity in the final product, it should be labeled according to the food ingredient list The relevant regulations are arranged in the corresponding position of the ingredient list according to the amount of enzyme preparation added in the manufacture or processing of food.
Is it necessary to declare new varieties of food additives for enzyme preparations produced by mutation breeding or genetically modified microorganisms?
Table C.3 of Appendix C of “National Food Safety Standards – Standards for the Use of Food Additives” (GB 2760-2014) specifies the enzymes that are allowed to be used in food processing. The sources and donors of various enzymes should comply with the regulations in the table. Therefore, if the sources and donors of enzyme preparations do not meet the regulations, new varieties of food additives need to be declared, and the genetically modified microorganisms should obtain the Agricultural GMO Safety Certificate from the Ministry of Agriculture.