Analysis of safety management status and Counterme

2022-09-22
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Abstract: in order to understand the international management mode of food packaging materials and provide reference for the safety management of food packaging materials in China, the management modes of food packaging materials in the United States, the European Union, Japan, South Korea and other economically developed countries were compared and analyzed. From the perspective of regulatory settings, management institutions, management procedures, etc., developed countries have established relatively perfect regulatory standard systems and efficient and clear management procedures, and the safety management of packaging materials is relatively mature. China should introduce a highly operable packaging material access system as soon as possible, revise relevant standards, and strengthen the construction of packaging material safety evaluation and testing capacity

key words: food packaging; Product packaging; Food; Safety; Law; With the increasing attention of the whole society to food safety issues, food safety issues caused by food containers and packaging materials have gradually attracted the attention of all sectors of society. According to the definition of China's "food hygiene law", food containers and packaging materials refer to the paper, bamboo, wood, metal, enamel, ceramics, plastics, rubber, natural fiber, chemical fiber, glass and other products used for packaging and containing food, as well as the inner wall coating contacting food. Food containers and packaging materials have dual significance for food safety: first, appropriate packaging methods and materials can protect food from external pollution and maintain the moisture, composition, quality and other characteristics of food itself. Second, the chemical composition of the packaging material itself will migrate to food. If the amount of migration exceeds a certain limit, it will affect the hygiene of food. With the rapid development of food technology and packaging industry, many new packaging materials and packaging forms continue to appear. How to standardize and manage the application of various packaging materials in food has been the concern of governments all over the world

1 United States

according to the federal food, drug and Cosmetic Act (FFDCA), food packaging materials belong to the scope of food additive management. The definition of food additive includes all substances that become food ingredients or affect the properties of food through direct or indirect addition or contact with food. Substances that migrate to food due to packaging, storage or other processing processes are indirect additives. The management of food additives in the United States is carried out on the basis of risk assessment. If it can be proved that a chemical substance causes little harm to human body through food deformation compensation algorithm, there is no need for special approval procedures for such substances. However, the work of proving the degree of harm of chemical substances to human body needs to be completed by the applicant

for a substance whose safety is unknown, according to the American management system for food additive substances, the management procedure used should be selected first. The management of packaging materials in the United States is divided into three situations: exemption from regulatory management, approval of food additives, and notification of food contact substances

1.1 exemption from management if a substance, as a packaging material or as an ingredient, can be proved that the amount of its migration to food is lower than a certain limit, and the substance is not a known carcinogen, will not affect food, and will not affect the environment, an exemption from management method is adopted for this kind of substance. Generally speaking, the requirement of this limit is that the amount of the substance transferred into food does not exceed 0.5 g/kg, or the amount of the substance ingested by the human body through diet every 13 is less than 1% of the allowable intake (ADI) every 13. For the application of substances exempted from management, FDA requires the applicant to provide information including the chemical structure, chemical characteristics, application, migration (including the maximum possible migration amount, the amount used in the processing process or the residue of finished packaging materials), detection and analysis methods, dietary exposure, toxicological evaluation data (especially the carcinogenic test data that China's extruder industry has prospered with the development of plastic processing machinery industry), etc. FDA will evaluate the application data to determine whether the substance is exempted from regulatory management. If the application is approved, FDA will notify the applicant in writing and add the substance to the list of exempted substances. The list is published on the FDA website, including chemical name, application company, purpose, scope of use, etc. under the same conditions, anyone can use the substance in packaging materials according to this list

1.2 for applying for food additive, if there is data proving that it can be transferred to a certain amount of food through the food packaging process, and the substance is not Gras (generally considered safe) substance or substance approved for use before 1958 (or the former University of Michigan researcher reported the approved substance in the British Journal nature · communication), the substance needs to be evaluated and approved according to the evaluation procedure of food additive. The application for food additives requires a series of materials such as chemistry, technology and toxicology to be submitted to FDA. After one or more years of evaluation, it will be listed in the federal regulations through publicity, approval and other steps. For substances listed in federal regulations, anyone can produce and use them according to regulations

1.3 notification of food contact substances in 1997, the food and Drug Administration Modernization Act of the United States amended the food, drug and Cosmetics Act and made separate provisions on the management procedures of food contact substances. Food contact substances refer to substances or components that will not have technical impact on food in contact with food in the process of food processing, packaging, storage, transportation, etc. For such substances (generally referred to as food packaging materials), FDA has adopted a simplified method - food contact substance notification system since January 2000. The food contact substance notification system requires the manufacturer to provide FDA with all materials that can prove that the substance will not affect food safety under specific use conditions, including chemical characteristics, processing process, quality specifications, use requirements, migration data, dietary exposure, toxicological data, environmental assessment, etc. FDA determines whether to approve the notification of the substance within 120 days after receiving the application data. If FDA does not give a reply of disapproval after 120 days, it means that the notification has taken effect and is published on the FDA station. Different from the list of exempted substances, the substances notified by the food contact substances notification system are only applicable to the applicant of the substance. If other manufacturers want to apply for the same substance, they must apply to FDA for notification of the substance again. Once the notified substance has food safety problems, the applicant for notification shall bear all the responsibilities. The notification system of food contact substances greatly simplifies the approval procedure of food packaging materials and promotes the development of the packaging industry

2 EU

the purpose of establishing a unified regulatory system for food packaging materials in the EU is to protect the health of consumers and eliminate unnecessary technical barriers to trade. The management of EU food packaging materials includes three kinds of framework regulations, special regulations and separate regulations. The framework regulations stipulate the general principles for the management of food packaging materials, and the special regulations stipulate the special requirements for each type of substance listed in the framework regulations. The separate regulations are special regulations for a single substance that has become a new kind of substance that promotes high-performance and lightweight in the chemical industry

2.1 framework regulation in 2004, the European Union issued a new regulation 1935/2004ec to replace the previously implemented 80/590eec and 89/109/EEC directives. The revised directive stipulates the scope, general requirements and evaluation institutions of packaging material management. According to the general requirements, food packaging materials must be safe, and the amount transferred to food must not endanger human health, change food ingredients, cause deterioration of food quality, and affect the taste of food. In this regulation, the concepts of active packaging materials and intelligent packaging materials are particularly proposed. Active packaging materials or active packaging materials refer to packaging materials that can absorb ingredients in food, or release some ingredients into the environment, so as to prolong shelf life or improve storage conditions. Active packaging materials or active packaging materials can cause changes in the sensory characteristics and composition of food, and the changes should comply with the relevant EU regulations. Intelligent packaging materials or intelligent packaging materials can monitor the environmental conditions of packaged food. Regulations require that active and intelligent materials and products in contact with food should be fully identified

17 types of materials and products are listed in the appendix of the regulation; They are active and intelligent materials and products, adhesives, ceramics, cork, rubber, glass, ion exchange resins, metals and alloys, paper and paperboard, plastics, printing inks, regenerated cellulose, silicone, textiles, varnishes, waxes, wood materials, etc. Regulations require that special management requirements should be formulated for 17 types of materials, products and composites, and recycled materials and products used in production. These requirements usually include the list of permitted substances for packaging materials, quality specifications and standards, exposure data, migration data, inspection and analysis methods, etc. If the EU has not formulated unified special management requirements, member states are allowed to formulate their own management regulations

in terms of approval procedures for new materials and substances, those who wish to add new substances to the permitted list should apply to the national competent department according to the regulations, and be approved by the European Commission after being evaluated by the European food safety agency

2.2 among the 17 categories of substances that must have special management requirements stipulated by the European Union, only three categories of substances, namely ceramics (84/500/EEC), regenerated cellulose film (93/10/EEC) and plastics (2002/72/EC), have issued special directives. In the directive on ceramics, the limits of lead and cadmium in ceramic products in different contact forms with various foods are stipulated. The directive on regenerated cellulose film stipulates the scope of regenerated cellulose film, the substances allowed to be used in processing and the use requirements

the directive on contact with plastic substances used in food is the most important regulation in European Union commodity packaging materials. This directive includes six main parts: text, further provisions on migration detection, list of monomers and raw materials used in the production of plastic products, list of additives used in the production of plastic products, and quality specification requirements. It is stipulated in the text of the directive that the amount of components in general plastic materials transferred to food shall not exceed 10 mg/dm3; For containers with a capacity of more than 500 ml, containers with a contact surface area of food that is difficult to estimate, covers, gaskets, plugs and other items, the substances migrated into food shall not exceed 60 mg/kg. The directive stipulates that the production of plastics should not use substances other than the list of monomers and raw materials and the list of additives listed in the annex to the directive. The 2004/19/EC amendment to the directive issued by the European Union in 2004 requires that all countries must submit the evaluation data of permitted additives that have not been evaluated by the European food safety agency to the European food safety agency by December 31, 2006; By December 31, 2007, the EU will establish a positive list of all additives evaluated by the EU food safety agency

2.3 separate regulations the EU has issued only three separate regulations for certain substances: 78/142/EEC vinyl chloride monomer, 93/11/EEC nitrosamines and EC 1895/2005 badge, BFDGE, NOGE

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