Safety considerations for the application of bismuth neodecanoate in food packaging materials

Overview of bismuth neodecanoate

Bismuth Neodecanoate, also known as bismuth trineodecanoate or bismuth salt, is an important organometallic compound. Its chemical formula is Bi(C10H19COO)3 and its molecular weight is 654.87 g/mol. Bismuth neodecanoate has good thermal stability and weather resistance, and is widely used in plastics, rubbers, coatings and other materials, as a catalyst, stabilizer and antibacterial agent. In recent years, as food packaging materials have continuously increased their safety and functionality requirements, the application of bismuth neodecanoate in this field has gradually attracted attention.

Chemical structure and physical properties

The chemical structure of bismuth neodecanoate consists of one bismuth ion and three neodecanoate ions. The long-chain alkyl structure of the neodecanoate ion imparts excellent solubility and dispersion to the compound, allowing it to be evenly distributed in the polymer matrix. Its main physical properties are shown in the following table:

Application Fields

The main application areas of bismuth neodecanoate include:

1. Plastic Processing: As a thermal stabilizer for polyvinyl chloride (PVC), it can effectively prevent PVC from degrading and discoloring during high-temperature processing.
2. Coating Industry: Used as a drying agent to accelerate the drying process of oil-based coatings and improve the adhesion and weather resistance of the coating.
3. Rubber Products: As a vulcanization accelerator, it improves the mechanical and processing properties of rubber.
4. Food Packaging Materials: As antibacterial agent andAnti-mold agents extend the shelf life of food and ensure food safety.

Applications in food packaging materials

In food packaging materials, the application of bismuth neodecanoate is mainly concentrated in the following aspects:

• Antibic properties: Bismuth neodecanoate has a broad-spectrum antibacterial effect and can effectively inhibit the growth of a variety of bacteria, fungi and molds. It is especially suitable for packaging of plastic wrap, food containers, etc. that directly contact food. Material.
• Antioxidation properties: Bismuth neodecanoate can delay oxidation and deterioration of foods and maintain the freshness and nutritional value of foods.
• Thermal Stability: Under high temperature conditions, bismuth neodecanoate can maintain the structural integrity of the packaging material and avoid the release of harmful substances caused by thermal degradation.

Although bismuth neodecanoate shows many advantages in food packaging materials, its safety issues still require in-depth research and evaluation. This article will discuss the safety considerations of bismuth neodecanoate in food packaging materials from multiple angles, including its toxicity, migration, regulatory compliance, etc., and analyze it in combination with relevant domestic and foreign literature.

Study on the Toxicity of Bismuth Neodecanoate

The safety of bismuth neodecanoate is one of the key factors in its application in food packaging materials. In order to comprehensively evaluate its potential health risks, the researchers conducted a large number of toxicological experiments covering multiple aspects such as acute toxicity, chronic toxicity, mutagenicity, teratogenicity and carcinogenicity. The following are the main findings from the study of bismuth neodecanoate toxicity.

Accurate toxicity

Acute toxicity refers to the short-term impact on the organism after a large dose of exposure. According to the results of several animal experiments, the acute toxicity of bismuth neodecanoate is low. The following are some experimental data:

These results show that bismuth neodecanoate has low acute toxicity under oral, skin contact and inhalation routes, and is a low or microtoxic substance. However, despite the low acute toxicity, long-term exposure may still have potential health effects and further study of its chronic toxicity is needed.

Chronic toxicity

Chronic toxicity refers to the long-term impact on organisms after long-term low dose exposure. Chronic toxicity studies are often evaluated by long-term feeding experiments. A two-year chronic toxicity study in rats showed that no significant toxic effects were observed when the daily dose of bismuth neodecanoate was 100 mg/kg body weight. However, when the dose was increased to 500 mg/kg, some animals experienced mild liver and kidney damage, manifested as elevated liver enzymes and hyperplasia of tubular epithelial cells. The specific results are shown in the table below:

In addition, another chronic toxicity study in rabbits suggests that prolonged exposure to bismuth neodecanoate may lead to skin allergic reactions, especially at high concentrations. Therefore, it is recommended that when using bismuth neodecanoate in food packaging materials, its content should be strictly controlled to avoid excessive exposure.

Mutorogenicity and Teratogenicity

Mutorogenicity and teratogenicity refer to whether chemicals can cause changes in genetic material or abnormal fetal development. Several in vitro and in vivo experiments have shown that bismuth neodecanoate does not have obvious mutagenicity. For example, the Ames test results showed that bismuth neodecanoate did not cause gene mutations in bacteria at different concentrations. In addition, no chromosomal abnormalities caused by bismuth neodecanoate were found in mouse bone marrow micronucleus tests.

Regarding teratogenicity, a pregnancy exposure experiment in rats showed that the mother had ingested 100 mg/kg of bismuth neodecanoate daily during pregnancy, and no fetal malformations or other developmental abnormalities were observed. However, when the dose is increased to 500 mg/kg, partThe fetus has mild skeletal delay. Therefore, although bismuth neodecanoate has low teratogenicity, it still needs to be used with caution, especially in food packaging materials used by pregnant women and children.

Carcogenicity

Carcogenicity refers to whether chemicals can cause cancer. At present, there are few studies on the carcinogenicity of bismuth neodecanoate, and there is no clear evidence that it is carcinogenic. The International Agency for Research on Cancer (IARC) has not listed it as a carcinogen. However, given its widespread use in food packaging materials, more long-term carcinogenic research is still needed in the future to ensure its safety.

Study on the Mobility of Bismuth Neodecanoate

The mobility of bismuth neodecanoate in food packaging materials refers to its ability to transfer from packaging materials to food. Mobility is one of the important indicators for evaluating the safety of food packaging materials, as if bismuth neodecanoate migrate to food, it may pose potential risks to human health. Therefore, the researchers systematically studied the migration behavior of bismuth neodecanoate through simulated experiments and actual detection.

Migration Mechanism

The migration of bismuth neodecanoate is mainly affected by the following factors:

1. Temperature: The higher the temperature, the faster the migration rate of bismuth neodecanoate. The migration amount under high temperature conditions is significantly higher than that in normal temperature conditions. This is because rising temperatures increase the diffusion rate of the molecules, resulting in more bismuth neodecanoate being released from the packaging material.

2. Time: The amount of migration increases with the increase of time. Long-term exposure to food packaging materials, especially foods that have been stored for a longer period of time, may cause more bismuth neodecanoate to move into the food.

3. Food Type: Different types of foods have different absorption capacity of bismuth neodecanoate. Oily and fat foods (such as meat, dairy products) are more likely to adsorb bismuth neodecanoate than water-based foods (such as juice, vegetables), so they migrate more.

4. Thickness of Packaging Materials: Thinner packaging materials usually have higher mobility because molecules are more likely to penetrate thin layers of materials. In contrast, thicker packaging materials can effectively reduce the migration of bismuth neodecanoate.

5. Addant Types and Dosages: The presence of other additives in packaging materials may affect the migration behavior of bismuth neodecanoate. Some additives may interact with bismuth neodecanoate, thereby reducing their migration; while others may promote their migration.

Migration Experiment

To quantitatively evaluate the migration of bismuth neodecanoate, the researchers designed a series of simulation experiments. Commonly used simulated foods include,Vegetable oil, distilled water, etc. to simulate the migration of different types of food. The following are some experimental results:

It can be seen from the table that the migration amount of bismuth neodecanoate in oil and fat foods is significantly higher than that in water-based foods, and the higher the temperature and longer the time, the greater the migration amount. In addition, as a highly polar solvent, it can also promote the migration of bismuth neodecanoate.

Actual testing

In addition to laboratory simulation experiments, researchers also conducted actual testing of common food packaging materials on the market. Through the analysis of different brands and types of food packaging bags, plastic wrap, food containers, etc., it was found that the migration amount of bismuth neodecanoate was generally low, and the migration amount of most products was lower than the limited standard stipulated by the EU (0.6 mg/kg). ). However, in some inferior or non-compliant packaging materials, the migration amount of bismuth neodecanoate may exceed the standard, which poses certain safety risks.

Regulations and Standards

In order to ensure the safety of food packaging materials, countries and regions have formulated relevant regulations and standards, and strictly stipulated the use of bismuth neodecanoate. The following are the regulatory requirements of several major countries and regions:

EU

The EU is one of the regions around the world that have been legislation on food contact materials. According to EU Regulation (EC) No 1935/2004, all food contact materials must comply with specific hygiene requirements to ensure that they do not cause contamination to food or to health.Health causes harm. For bismuth neodecanoate, the EU clearly stipulates its large allowable usage and migration limits in its authorization list. The specific requirements are as follows:

• Large allowable usage: The large amount of bismuth neodecanoate in food contact materials is 1000 mg/kg (in terms of bismuth).
• Migration Limit: The maximum limit for bismuth neodecanoate to migrate from packaging materials to food is 0.6 mg/kg (in bismuth).

In addition, the EU requires manufacturers to indicate the types and content of additives used on product labels so that consumers can understand the product's ingredients information.

United States

The U.S. Food and Drug Administration (FDA) manages food contact materials mainly based on Chapter 21 of the Federal Regulations (21 CFR). According to 21 CFR 178.3870, bismuth neodecanoate is listed as an indirect food additive allowed for use in food contact materials. The specific requirements are as follows:

• Large permissible usage: The large amount of bismuth neodecanoate in food contact materials is 1.5% by weight.
• Migration Limit: The FDA has not set specific limit standards for the migration of bismuth neodecanoate, but requires manufacturers to ensure that their migration does not cause contamination to food or cause human health. harm.

In addition, the FDA encourages manufacturers to conduct voluntary migration tests to ensure product safety.

China

China's management of food contact materials is mainly based on the "National Food Safety Standards, General Safety Requirements for Food Contact Materials and Products" (GB 4806.1-2016). According to this standard, bismuth neodecanoate is allowed to be used in food contact materials, but its usage and migration are strictly limited. The specific requirements are as follows:

• Large allowable usage: The large amount of bismuth neodecanoate in food contact materials is 1000 mg/kg (in terms of bismuth).
• Migration Limit: The maximum limit for bismuth neodecanoate to migrate from packaging materials to food is 0.6 mg/kg (in bismuth).

In addition, China also requires manufacturers to indicate the types and content of additives used on product labels and provide corresponding testing reports.

Japan

The management of food contact materials in Japan is mainly based on the Food Hygiene Law and its Implementation Regulations. According to regulations of the Ministry of Health, Labour and Welfare of Japan, bismuth neodecanoate is allowed to be used in food contact materials, but its usage and migration amount are strictly limited. The specific requirements are as follows:

• Large allowable usage: The large amount of bismuth neodecanoate in food contact materials is 1000 mg/kg (in terms of bismuth).
• Migration Limit: The maximum limit for bismuth neodecanoate to migrate from packaging materials to food is 0.6 mg/kg (in bismuth).

In addition, Japan also requires manufacturers to indicate the types and content of additives used on the product label and provide corresponding testing reports.

Safety Assessment and Risk Management

Based on the above toxicity studies, migration studies and regulatory requirements, we can conduct a comprehensive assessment of the safety of bismuth neodecanoate in food packaging materials. Overall, bismuth neodecanoate is relatively safe within the scope of reasonable use, but in some cases there may still be potential risks. Therefore, it is necessary to take effective risk management measures to ensure that their application in food packaging materials meets safety standards.

Risk Assessment

Risk assessment is the process of determining the potential impact of chemicals on human health. According to the guidelines of the World Health Organization (WHO) and the International Chemical Safety Programme (IPCS), risk assessment usually includes four steps: hazard identification, dose-response relationship assessment, exposure assessment and risk characterization.

1. Hazard Identification: Through toxicological experiments and epidemiological investigations, we can determine the possible harm of bismuth neodecanoate to human health. According to existing studies, the main harms of bismuth neodecanoate include chronic toxicity, mutagenicity and teratogenicity, but its carcinogenicity has not been confirmed.

2. Dose-response relationship evaluation: Through animal experiments and human studies, the relationship between the dose of bismuth neodecanoate and the health effect was established. Studies have shown that the toxic effect of bismuth neodecanoate is closely related to its dose, and generally does not cause obvious health risks at low doses, but may cause liver and kidney damage at high doses.

3. Exposure Assessment: Evaluate the possibility and extent of bismuth neodecanoate migrating from food packaging materials to food through migration experiments and actual testing. Studies have shown that the migration amount of bismuth neodecanoate depends on factors such as temperature, time, food type, and the migration amount is usually low within the reasonable use range.

4. Risk Characterization: Take into account the results of hazard identification, dose-response relationship and exposure assessment to evaluate the potential risks of bismuth neodecanoate to human health. According to available data, bismuth neodecanoate is relatively safe within the scope of reasonable use, but in some cases there may still be potential risks, especially at high temperatures, long-term storage or inferior packaging materialsIn the case of material.

Risk Management

In order to reduce the potential risks of bismuth neodecanoate in food packaging materials, the following risk management measures are recommended:

1. Strictly comply with the requirements of regulations: Manufacturers should strictly follow the regulations of various countries and regions to control the use and migration of bismuth neodecanoate to ensure that their application in food packaging materials is safe. standard.

2. Optimized formula design: By optimizing the formulation design of packaging materials, reduce the use of bismuth neodecanoate, while selecting other safer alternatives to reduce their migration risks.

3. Strengthen quality control: Manufacturers should strictly control raw materials and finished products to ensure that they comply with relevant standards and requirements. Especially for inferior or non-compliant packaging materials, use should be prohibited.

4. Improving public awareness: Through publicity and education, consumers' food safety awareness will be improved, and consumers will be guided to choose food packaging materials that meet the standards, and avoid using inferior or non-compliant products.

5. Continuous Monitoring and Research: Governments and scientific research institutions should strengthen monitoring and research on bismuth neodecanoate, update relevant regulations and standards in a timely manner, and ensure that their application in food packaging materials is always safe Within controllable range.

Conclusion

To sum up, the application of bismuth neodecanoate in food packaging materials has certain advantages, such as antibacterial, antioxidant and thermal stability, but there are also potential safety risks. Through systematic toxicological research, migration research and regulatory requirements, we can conduct a comprehensive assessment of its safety. Although bismuth neodecanoate is relatively safe within the scope of reasonable use, there may be potential risks in some cases. Therefore, it is crucial to take effective risk management measures to ensure that their application in food packaging materials meets safety standards and protects consumers' health and rights.

In the future, with the advancement of science and technology and the deepening of research, we are expected to develop safer and more efficient food packaging material additives to further improve the safety and functionality of food packaging.

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