Enzyme preparations are so strict in international safety and health management

The enzyme preparation industry is a knowledge-intensive high-tech industry and an economic entity for bioengineering. The enzyme preparations used in the industry are basically divided into two categories: one is a hydrolase, including amylase, cellulase, protease, lipase, pectinase, lactase, etc., which accounts for more than 75% of market sales. At present, about 60% of the enzyme preparations have been produced with genetically modified strains, and 80% of the strains used by NOVO are genetically modified strains. The second type is non-hydrolase, which accounts for about 10% of market sales, and tends to increase year by year, mainly for enzymes for analytical reagents and enzymes for pharmaceutical industry. In the food industry, the proportion of enzymes used for starch processing is still the largest, at 15%; followed by the dairy industry, accounting for 14%. Although the traditional applications of enzymes in the food, textile, and tanning industries are quite extensive and technically mature, they are still evolving. Below we will talk about the safety and health issues of enzyme preparations.

Safety and health management of enzyme preparation

China's accession to the WTO is imminent, and we must pay attention to the safety and health management of enzyme production. The enzyme preparation for food is used as a food additive abroad, and its safety and hygiene regulations are very strict. Although the enzyme itself is a biological product, it is safer than chemical products, but the enzyme preparation is not a simple product, and often contains a medium residue, an inorganic salt, a preservative, a diluent, etc. It may also be contaminated by Salmonella, Staphylococcus aureus and Escherichia coli during the production process. In addition, it may contain biotoxins, especially aflatoxins. Even Aspergillus niger, some strains may produce aflatoxins. Aflatoxin is either produced by the strain itself or by the raw material (moldy food material). In addition, inorganic salts are used in the medium, and it is inevitable to mix toxic heavy metals such as mercury, copper, lead, and arsenic. In order to ensure the absolute safety of the products, the raw materials, strains, post-treatment and other processes must be strictly controlled. The production site must meet the requirements of GMP (Good Manufacturing Practice).

For the safety requirements of enzyme preparation products, the FAO (FAO) and World Health Organization (WHO) Expert Committee on Food Additives (JECFA) proposed the safety of the source of enzyme preparations as early as 1978 at the 21st WHO Conference. The evaluation criteria: (1) enzymes produced from automatic plant edible parts and traditionally used as food ingredients, or traditionally used in food, can be considered as food if they meet appropriate chemical and microbiological requirements. It is not necessary to carry out a toxicity test.

(2) Enzymes produced by non-pathogenic general food-contaminated microorganisms are required for short-term toxicity tests.

(3) Enzymes produced by unusual microorganisms are subject to extensive toxicity tests, including long-term feeding trials in mice. This standard provides a basis for safety assessment of the production of enzymes in various countries. The production strain must be non-pathogenic, and does not produce physiologically active substances such as toxins, antibiotics and hormones. The strains need to be tested for harmlessness before being used in production. For the determination of toxins, in addition to chemical analysis, biological analysis is also required. The safety of additives in the UK is assessed by the Chemical Toxicity Committee (COT) and recommendations are made to the Governmental Expert Advisory Committee FACE (Food Additives and Pollution Committee). COT is most concerned with the toxicity of the strain. It is recommended that the microbial enzyme be tested for at least 90 days in a mouse feeding test and bioassay with high standards. COT believes that strain improvement is necessary, but biotest should be performed after each improvement.

Enzyme preparation management system

There are two kinds of management systems for enzyme preparations in the United States: one is GRAS (Generalrecognizedassafe) substances; the other is in line with food additive requirements. An enzyme considered to be a GRAS substance can be produced as long as it conforms to GMP. Enzymes that are considered food additives are subject to approval prior to marketing and are registered with the Federal Code of Management (CFR, The Code of Federal Regulation). The application for GRAS is subject to two major assessments, namely the acceptance of technical safety and product safety test results. GRAS Approvals In addition to the FDA's authority to conduct, any expert who has assessed the safety of food ingredients can also be independently assessed. In the United States, animal raw materials used to produce food enzymes must meet the requirements of meat testing and carry out GMP production. However, the residues of plant raw materials or microbial culture media under normal use conditions must not hinder health. The equipment, diluents, additives, etc. used should be substances suitable for food. The production methods and culture conditions must be strictly controlled so that the production bacteria do not become toxins and a source of health problems. The Microbial Food Enzyme Production Association (AMFEP) developed the minimum and microbiological indicators for enzyme preparations in 1994 according to the opinion of the Chemical Codex (FCC): As<3ppm; pb<10ppm; heavy metal≤40ppm; mycotoxins: Negative; antibiotics: negative; coliforms ≤ 30/g; E. coli: negative/25g; Salmonella negative/25g; total live count ≤ 50000/g. The indicators formulated by the China Food Inspection and Inspection Institute are basically based on the above standards.

Edited by Suzhou Yacoo Science Co., Ltd.