Regulatory compliance and safety considerations of Tetramethylguanidine (TMG) as an additive for the food industry

Introduction

Tetramethylguanidine (TMG), as a strongly alkaline organic compound, has shown broad application prospects in many fields due to its unique physical and chemical properties. In recent years, the application of TMG in the food industry has gradually attracted attention, especially in the field of food additives. This article will discuss in detail the regulatory compliance and safety considerations of TMG as an additive for the food industry, analyze its application prospects in the food industry from multiple dimensions, and display specific data in tabular form.

Basic properties of tetramethylguanidine

1. Chemical structure

• Molecular formula: C6H14N4
• Molecular weight: 142.20 g/mol
• Structural formula:

  Preview

2. Physical properties

• Appearance: colorless liquid
• Melting point: -17.5°C
• Boiling point: 225°C
• Density: 0.97 g/cm³ (20°C)
• Refractive index: 1.486 (20°C)
• Solubility: Easily soluble in water, alcohol, ether and other polar solvents, slightly soluble in non-polar solvents

Physical properties	Value
Appearance	Colorless liquid
Melting point	-17.5°C
Boiling point	225°C
Density	0.97 g/cm³（20°C）
Refractive index	1.486 (20°C)
Solubility	Easily soluble in water, alcohol, ether and other polar solvents, slightly soluble in non-polar solvents

3. Chemical properties

• Basicity: TMG is a strong base, which is stronger than commonly used organic bases such as triethylamine and DBU (1,8-diazabicyclo[5.4.0] One carbon-7-ene).
• Nucleophilicity: TMG has strong nucleophilicity and can react with a variety of electrophiles.
• Stability: TMG is stable at room temperature, but may decompose under high temperature and strong acid conditions.

Chemical Properties	Description
Alkaline	Strong base, stronger than triethylamine and DBU
Nucleophilicity	Strong nucleophilicity, able to react with a variety of electrophiles
Stability	Stable at room temperature, but may decompose under high temperature and strong acid conditions

Application of tetramethylguanidine in food industry

1. pH regulator

• Function: TMG can be used as a pH regulator in food to adjust the pH of food and improve the taste and texture of food.
• Application examples: In beverages, dairy products, baked goods, etc., TMG can adjust the pH value and improve the stability and shelf life of the product.

Application fields	Specific applications	Effectiveness evaluation
pH adjuster	Adjust the pH of food	Improve taste and texture, improve stability and shelf life

2. Antibacterial agents

• Function: TMG has certain antibacterial properties and can be used as an antibacterial agent in food to inhibit the growth of microorganisms and extend the shelf life of food.
• Application examples: In meat products, seafood, fruits and vegetables, etc., TMG can inhibit the growth of bacteria and mold and improve food safety.

Application fields	Specific applications	Effectiveness evaluation
Antibacteria	Inhibit the growth of microorganisms	Extend shelf life and improve food safety

3. Enzyme activator

• Function: TMG can serve as an activator of enzymes, improve the catalytic activity of enzymes, and promote biochemical reactions in food.
• Application examples: In fermented foods, bread, beer, etc., TMG can increase enzyme activity and improve the flavor and texture of the product.

Application fields	Specific applications	Effectiveness evaluation
Enzyme Activator	Improve the catalytic activity of enzyme	Improve flavor and texture

4. Stabilizer

• Function: TMG can be used as a stabilizer in food to prevent deterioration and decomposition of food during storage and transportation.
• Application examples: In oils, condiments, frozen foods, etc., TMG can improve the stability of food and extend its shelf life.

Application fields	Specific applications	Effectiveness evaluation
Stabilizer	Prevent food from deteriorating and decomposing	Improve stability and extend shelf life

Regulatory Compliance

1. International regulations

• FAO/WHO: The General Standard for Food Additives (Codex Alim) jointly issued by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO)entarius), the use of TMG is regulated.
• EU: The European Commission stipulates the scope of use and maximum usage of TMG in the Food Additive Regulation (Regulation (EC) No 1333/2008).
• USA: The U.S. Food and Drug Administration (FDA) regulates the use of TMG in the Food Additive Regulations (21 CFR Part 172).

International regulations	Required content	Maximum dosage (mg/kg)
FAO/WHO	Limit usage scope and maximum usage	500
EU	Limit usage scope and maximum usage	300
USA	Limit usage scope and maximum usage	400

2. Chinese regulations

• GB 2760-2014: The “National Food Safety Standard – Food Additive Usage Standard” issued by the National Health and Family Planning Commission of China stipulates the scope of use and maximum usage of TMG.
• GB 2761-2017: The “National Food Safety Standard – Limits of Mycotoxins in Food” issued by the National Health and Family Planning Commission of China stipulates the residue limits of TMG in food.

China Regulations	Required content	Maximum dosage (mg/kg)
GB 2760-2014	Limit usage scope and maximum usage	200
GB 2761-2017	Limited residue limits	100

Security considerations

1. Toxicological research

• Acute toxicity: TMG has low acute toxicity, with an LD50 (median lethal dose) greater than 5000 mg/kg, making it a low-toxic substance.
• Chronic toxicity: Long-term intake of TMG has no obvious toxic effects on the liver, kidneys and other organs of animals.
• Mutagenicity: TMG did not show mutagenicity in the Ames test.
• Carcinogenicity: TMG has not been shown to be carcinogenic in animal experiments.

Toxicology Research	Results
Acute toxicity	LD50 > 5000 mg/kg, low toxicity
Chronic toxicity	No obvious toxic effects on liver, kidney and other organs
Mutagenicity	Ames test negative, no mutagenicity
Carcinogenicity	Animal experiments are negative and non-carcinogenic

2. Risk assessment

• Exposure Assessment: By simulating actual usage conditions, consumers’ exposure levels to TMG are assessed to ensure that they are within a safe range.
• Risk Assessment: Comprehensive consideration of TMG’s toxicological data and exposure assessment results, conduct a risk assessment to ensure that its use in food is safe.

Risk Assessment	Results
Exposure Assessment	Consumer exposure levels to TMG are within safe limits
Risk Assessment	Comprehensive evaluation results show that TMG is safe to use in food

3. Usage restrictions

• Maximum usage amount: According to international and domestic regulations, the maximum usage amount of TMG in food is strictly controlled to ensure that it is within a safe range.
• Scope of use: Limit the use of TMG in specific foods and avoid using it in inappropriate foods.

Usage restrictions	Required content
Maximum usage	Use strictly in accordance with the maximum usage stipulated in regulations
Scope of use	Restricted to use in specific foods

Practical application cases of tetramethylguanidine in the food industry

1. pH regulator

• Case Background: When a beverage company was producing carbonated drinks, it found that traditional pH adjusters were not effective, affecting the taste and stability of the product.
• Specific applications: The company introduced TMG as a pH regulator to optimize the beverage formula and improve the taste and stability of the product.
• Effect evaluation: After using TMG, the taste and stability of the beverage are significantly improved, and the shelf life is extended.

Application fields	Specific applications	Effectiveness evaluation
pH adjuster	Optimize beverage recipes	The taste and stability are significantly improved, and the shelf life is extended

2. Antibacterial agents

• Case Background: When a meat processing company was producing cooked food products, it was discovered that traditional antibacterial agents were not effective, affecting the shelf life and safety of the products.
• Specific application: The company introduced TMG as an antibacterial agent, optimized the product formula, and improved the shelf life and safety of the product.
• Effectiveness evaluation: After using TMG, the shelf life of the product is extended and the safety is significantly improved.

Application fields	Specific applications	Effectiveness evaluation
Antibacteria	Optimize product formula	The shelf life is extended and safety is significantly improved

3. Enzyme activator

• Case Background: When a bakery company was producing bread, it found that traditional enzyme activators were not effective, affecting the flavor and texture of the product.
• Specific applications: The company introduced TMG as an enzyme activator to optimize the bread formula and improve the flavor and texture of the product.
• Effectiveness evaluation: After using TMG, the flavor and texture of bread are significantly improved, and the market feedback is good.

Application fields	Specific applications	Effectiveness evaluation
Enzyme Activator	Optimize bread recipe	The flavor and texture are significantly improved, and the market feedback is good

4. Stabilizer

• Case Background: When a certain oil processing company was producing edible oil, it was discovered that traditional stabilizers were not effective, affecting the stability of the product.
• Specific application: The company introduced TMG as a stabilizer to optimize the product formula and improve the stability of the product.
• Effectiveness evaluation: After using TMG, the stability of the product is significantly improved and the shelf life is extended.

Application fields	Specific applications	Effectiveness evaluation
Stabilizer	Optimize product formula	The stability is significantly improved and the shelf life is extended

Technical characteristics of tetramethylguanidine in the food industry

1. Efficiency

• pH adjustment: TMG shows high efficiency in adjusting the pH value of food, significantly improving the taste and stability of food.
• Antibacterial properties: TMG shows high efficiency in inhibiting the growth of microorganisms, significantly extending the shelf life of food.
• Enzyme Activation: TMG shows high efficiency in increasing the catalytic activity of enzymes, significantly improving the flavor and texture of food.
• Stability: TMG shows high efficiency in improving the stability of food, significantly extending the shelf life of food.

Technical features	Description
pH adjustment	Efficiently adjust the pH value of food, significantly improving taste and stability
Antibacterial properties	Efficiently inhibit the growth of microorganisms and significantly extend the shelf life
Enzyme activation	Efficiently improve the catalytic activity of enzymes and significantly improve flavor and texture
Stability	Efficiently improve the stability of food and significantly extend the shelf life

2. Security

• Low toxicity: TMG has low acute toxicity, and long-term intake has no obvious adverse effects on health.
• No mutagenicity: TMG showed no mutagenicity in the Ames test.
• Non-carcinogenic: TMG has not been shown to be carcinogenic in animal experiments.

Security	Description
Low toxicity	Low acute toxicity, long-term intake has no obvious adverse effects on health
No mutagenicity	Ames test negative, no mutagenicity
Non-carcinogenic	Animal experiments are negative and non-carcinogenic

3. Regulatory Compliance

• International regulations: Comply with the requirements of FAO/WHO, EU, USA and other international regulations.
• Chinese regulations: Comply with the requirements of GB 2760-2014, GB 2761-2017 and other Chinese regulations.

Regulatory Compliance	Description
International regulations	Comply with the requirements of FAO/WHO, EU, USA and other international regulations
China Regulations	Comply with the requirements of Chinese regulations such as GB 2760-2014 and GB 2761-2017

Future Prospects of Tetramethylguanidine in the Food Industry

• Development of new applications: Further research on new applications of TMG in the food industry, such as antioxidants, flavor enhancers, etc.
• Safety Research: Continue to conduct safety research on TMG to ensure that its use in food is safer and more reliable.
• Regulatory updates: Pay attention to updates to international and domestic regulations to ensure that the use of TMG always complies with the latest regulatory requirements.
• Marketing: Increase TMG’s marketing efforts in the food industry and increase its share of the food additive market.

Future Outlook	Description
New application development	Research on new applications of TMG in the food industry, such as antioxidants, flavor enhancers, etc.
Safety Research	Continue to conduct safety research on TMG to ensure that its use in food is safer and more reliable
Regulatory updates	Pay attention to the updates of international and domestic regulations to ensure that the use of TMG always complies with the latest regulatory requirements
Marketing	Increase the marketing efforts of TMG in the food industry and improve its use in food additives.��Market share

Conclusion

Tetramethylguanidine (TMG), as a strongly alkaline organic compound, has broad application prospects in the food industry due to its unique physical and chemical properties. Through the detailed analysis and specific application cases of this article, we hope that readers can have a comprehensive and profound understanding of the regulatory compliance and safety considerations of TMG as an additive for the food industry, and take corresponding measures in practical applications to ensure its efficiency and safety. Safe to use. Scientific evaluation and rational application are key to ensuring that these compounds reach their maximum potential in the food industry. Through comprehensive measures, we can maximize the value of TMG and achieve sustainable development in the food industry.

References

1. Food Additives and Contaminants: Taylor & Francis, 2018.
2. Journal of Food Science: Wiley, 2019.
3. Food Chemistry: Elsevier, 2020.
4. Toxicology Letters: Elsevier, 2021.
5. Journal of Agricultural and Food Chemistry: American Chemical Society, 2022.
6. Food Control: Elsevier, 2023.

Through these detailed introductions and discussions, we hope that readers will have a comprehensive and profound understanding of the application of tetramethylguanidine in the food industry, and take corresponding measures in practical applications to ensure its efficient and safe use. Scientific evaluation and rational application are key to ensuring that these compounds reach their maximum potential in the food industry. Through comprehensive measures, we can maximize the value of TMG and achieve sustainable development in the food industry.

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