On March 5, 2021, the U.S. Food and Drug Administration (FDA) announced a plan to reduce the content of toxic heavy metals in foods for infants and young children. As soon as the plan was issued, it triggered heated discussions in the industry in the United States, and the safety of children's food has once again become a hot topic. The bilateral trade volume of food and agricultural products between China and the United States is huge. The resulting heavy metal pollution of children’s food exported to and imported from the United States and the associated impact on trade are worthy of our domestic regulatory authorities, import and export traders, Related product manufacturers are highly concerned.

1.Background introduction

Lead, arsenic (including inorganic arsenic), cadmium, mercury, etc. are all toxic heavy metals. The World Health Organization (WHO) has declared that they are harmful to human health. Especially for infants and young children, even low levels of exposure can cause serious and often irreversible damage to their brain development. For this reason, the US FDA has carried out a research work on reducing the level of passive and active toxic heavy metals in infant foods since 2019, and used this to formulate broader and stricter product standards and regulatory requirements in response to American society’s concern.

On November 6, 2019, due to reports that there are a large number of toxic heavy metal safety risks in infant foods, the US House of Republication Committee on Supervision and Reform Subcommittee on Economic and Consumer The Policy (hereinafter referred to as the Committee) requires the seven largest infant food manufacturers in the country to provide internal documents and test results, including organic food and traditional food manufacturers. Since then, four companies (nurture, Beech-Nut, Hain, and gerber) have responded to the committee’s requirements, including formulating internal testing policies, conducting heavy metal testing of raw materials and/or finished products and testing results, and handling over Its internal testing limits raw materials and/or finished product procedures; three other companies (Walmart, Campbell, and Sprout Organic Foods) rejected the commission’s investigation. The committee pointed out in a follow-up report that the three companies that refused to cooperate with the investigation were most likely to cover up the fact that their products contained higher levels of toxic heavy metals than competitors' products.

On February 4, 2021, the committee issued a report entitled "Dangerous Levels of Infant Food Contaminated with Arsenic, Lead, Cadmium, and Mercury", stating that: (1) Infant and young children’s food is contaminated by inorganic arsenic, lead, and cadmium. (2) Industry self-discipline can no longer protect consumers, because manufacturers’ internal standards for toxic heavy metals have relatively high limit values; (3) Manufacturers often ignore their internal standards. Continue to sell products with high levels of heavy metals that have been tested; (4) Manufacturers generally adopt the practice of testing only raw materials to cover up the high levels of toxic metals in finished infant food products.

2. Official response

On February 16, 2021, the FDA made a public response to the Committee’s report for the first time. It issued a document entitled "FDA’s Response to the Issue of Toxic Elements in Foods for Infants and Young Children after the Congress Report". The document agreed with the Committee’s concerns. At the same time, it puts forward the goal of "reducing the exposure of toxic elements in food for infants and young children as much as possible ". On February 23, 2021, Krishnamoorthi, Chairman of the Economic and Consumer Policy Subcommittee, submitted the text of the Infant Food Safety Law 2021 to the FDA for technical review and a dialogue on progress in solving the problem of heavy metals in infant food.

On March 5, 2021, the FDA announced that it is developing a comprehensive plan to further reduce the content of toxic elements in foods for infants and young children. This is also a response to the subcommittee’s call for action. In the future, the FDA will re-examine the current level of action based on the plan, and then formulate additional action plans. It will focus on special compliance and enforcement activities, including on-site inspections of manufacturers; it will also discuss how to implement current regulations. The obligation to provide guidance to the industry; will continue to carry out supervision and sampling tasks for children’s food. In addition, the FDA will also issue a draft guidance for finalizing the level of arsenic in apple juice, and issue a series of specific measures including a draft guidance on the level of lead in juice.

The FDA also stated that it expects to cooperate with US federal partners, academia and other stakeholders to provide information on the development of action levels for lead, cadmium, mercury, and arsenic in foods for infants and young children. At the same time, in order to seek more data sources, the detection of these heavy metal elements will be increased, so as to better understand the prevalence of these elements in foods frequently used by infants and young children. The FDA will also pay attention to and understand the changes in the content of heavy metals in different foods, as well as the potential impact of low exposure on the development of children. In addition, in the coming year, the FDA plans to hold a seminar to gather stakeholders to share knowledge about these issues and discuss potential mitigation strategies.

It is understood that the US FDA has sent a letter to the relevant food industry to remind manufacturers that the FDA will make full use of the existing powers under the Food Safety Modernization Act (FSMA) to reduce the content of toxic heavy metals in infant foods. Hard work. It is believed that in the near future, food production companies, including food manufacturers exporting to the United States, will be required to take preventive control measures against heavy metal contaminants and require them to consider chemical hazards including toxic heavy metal elements when conducting hazard analysis. Risks to significantly reduce or prevent any identified chemical hazards that need to be controlled. For example, some manufacturers will be required to carry out verification activities including but not limited to final product testing.

3. The current status of the US FDA's management and control of heavy metal levels in infant foods

Article 402(a)(1) of the US Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)) stipulates that if the food contains or contains any toxic or harmful substance, it may make it harmful to health, It is regarded as adulterated food. FDA regulations and supervision help ensure the safety of infant foods sold or produced in the United States. When the content of toxic elements or other chemical substances in the food does pose a health threat, the FDA will take measures to remove these foods from the market. On and off shelves.

According to FDA statistics: During 2019-2020, about 65 import-related actions prevented products with higher levels of toxic elements from entering the United States. At present, the FDA has issued import alerts for toxic elements in many types of foods, including arsenic in fruit juices, bottled water and dietary supplement products, and lead in candies, dried fruits, spices, dietary supplements and other foods.

The FDA has issued a number of guidance documents to provide reference for the industry. Among them, the "chemical, metal, natural toxins, and pesticide guidance documents and regulations" include the use of arsenic and lead in some infant foods (rice noodles, candy, and apple juice). Action level or maximum recommended level. According to the provisions of the document: the action level of Kun in infant rice noodles is 100 µg/kg (ppb), and the action level of arsenic in apple juice is 10 µg/kg (ppb); the FDA recommends that children often eat confectionery products The maximum content of lead is 0.1 ppm. The level of arsenic in apple juice and the level of lead in juice are the targets of the FDA's recent review, and new guidance should be issued in light of the potential exposure of children to such products.

FDA believes that the process of reducing the level of toxic elements in food is complex and multifaceted. The key point is to ensure that measures to limit toxic elements in food will not have unintended consequences-such as cancelling foods with significant nutritional benefits, or reducing The presence of one toxic element adds another toxic element. In the coming weeks, the FDA will share its plans in this regard and provide the industry with information on the FDA's future work on this important issue.

4. Influence and thinking on our country

China has a special national food safety standard "National Food Safety Standard Limits of Contaminants in Food" (GB 2762-2017) for heavy metal pollutants. On August 31, 2020, the National Health Commission issued the "Letter from the Secretariat of the National Food Safety Standards Review Committee on Soliciting Opinions on 16 National Food Safety Standards (Draft for Solicitation of Comments) including the limits of contaminants in foods", which also includes " National Food Safety Standard Limits of Contaminants in Food (Draft for Solicitation of Comments). It is believed that this standard will also be updated in the near future.

The United States has carried out research on heavy metal elements in infant foods and then adopted measures such as formulating standards and strengthening supervision, which are all positive measures that our country is happy to see in the control of food safety. On the one hand, China should complete research on whether to delineate and formulate food standards for special ages as soon as possible, and strive to integrate with international food product classification and regulatory measures as soon as possible; on the other hand, the issue of heavy metal content in U.S. infant foods presented by the FDA Research Institute is also It should arouse great attention from my country's imported food regulatory authorities and consumers. At the same time, it reminds manufacturers or sellers that are exporting to the United States or intending to export to the United States of the corresponding category of food, should promptly follow up the U.S. regulatory trends, take corresponding preventive control measures, produce and export products that meet the requirements of the U.S. Even our country has a negative impact on US trade.

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