Ensuring Food Safety: Japan's Regulatory Approach to Agricultural Residue Control

Pesticides and veterinary drug residues in food is an important aspect of food safety. In particular, the residues standards in processed food is always a focal point for businesses. Following the revision of the Food Sanitation Act, Japan officially implemented the "Positive List System" on May 29, 2006 to regulate pesticides residues in food. Residue regulations in this system can be divided into three main dimensions: "Maximum Residue Limits", "Uniform Limit" and "Exempted Substances".

Additionally, in accordance with the general requirements of the Specification and Standards for Food, Food additives, Etc., Japan prohibits the presence of antibiotics and chemically synthesized antibacterial agents in food. Furthermore, Japan has a list of pesticides and veterinary drugs that should not be detectable in any food.

1. Positive List System

1.1 Maximum Residue Limits

The Maximum Residue Limits (MRLs) is the fundamental requirement for pesticides residue regulation in Japan, setting the maximum allowable residue of pesticides, feed additives, and veterinary drugs in food. If the residue level of a particular agricultural or veterinary drug exceeds the MRL requirement in a specific food, its importation and circulation is prohibited.

The decision principles for establishing MRLs in Japan are roughly as follows:

1. If the MRL of a substance is covered in international Codex standard, it will be adopted;

2. Otherwise, the domestic standards established in Japan (based on the registration and approval standards defined in the Agricultural Chemicals Regulation Act) will be used. However, considering the production, distribution, and actual pesticides use in the exporting country of imported food, foreign standards can be adopted. In addition, for products with low self-sufficiency rates such as yuzu, lemon, pineapple, wheat, soybeans, and corn, foreign standards may be applied if necessary.

3. For substances without both international Codex standards and Japanese standards, foreign standards (such as those from the United States, Canada, European Union, Australia, and New Zealand) will be used.

1.2 Uniform Limit

The uniform limit refers to the established threshold of a substance that does not have negative impacts on human health by the Minister of Health, Labour and Welfare (MHLW), with a defined limit of 0.01ppm (MHLW Notification No. 497, 2005).

It applies in two specific cases:

(1) When residues of pesticides or similar substances are present in food without established residue standards;

(2) When residues of pesticides or similar substances, which have residue standards in some foods, are found in foods without established residue standards.

1.3 Exempted Substances

Exempted substances refer to agricultural chemicals that, at certain residual levels, do not adversely affect human health (MHLW Notification No.498).

It includes chemicals specified in Food Safety Basic Law that do not require risk assessments for their intake (e.g., astaxanthin), agricultural chemicals designated in the Agricultural Chemicals Regulation Act (e.g., sodium bicarbonate), and other substances that do not pose any adverse effects on human health.

Japan MHLW considers various factors when designating exempted substances, such as:

1. Domestic evaluations,

2. Assessments from the Joint FAO/WHO Committee on Food Additives (JECFA),

3. Assessments from the Joint FAO/WHO Meetings on pesticides Residues (JMPR),

4. Evaluations based on the Agricultural Chemicals Regulation Act,

5. Evaluations conducted by other countries and regions (Australia and the United States, etc.) that align with JECFA's scientific assessments.

1.4 General requirements

1.4.1 Antibiotics and chemically synthesized antibacterial agents

In principle, food should not contain any antibiotics or chemically synthesized antibacterial agents. However, there are exceptions as specified in the regulations.

• List of antibiotics or chemically synthesized antibacterial substances published at positive list

For example, for sulfamoildapsone, there are residue limit standards defined for pork muscle, pork fat, pork liver, pork kidney, and other edible parts of pork. In these five types of foods, if sulfamoildapsone is detected, it is permissible as long as the detected value does not exceed the MRLs. For other food items, sulfamoildapsone should not be detected. The below are examples of MRLs of antibiotics/chemically synthesized antibacterial agents in different types of foods.

1.4.2 Substances that shall be "not detected" in foods

There are some substances used as ingredients of agricultural chemicals and other chemical substances that are stipulated shall be "not detected" in foods. The list currently includes 24 substances such as 2,4, 5-T and Captafol.

2. Compliance with Processed Food

Japan currently has MRLs for pesticides and veterinary drugs in only 60 types of processed foods and mineral water, leaving many processed food categories without corresponding limits. For such unregulated processed foods, in principle, a uniform limit (0.01 ppm) should be followed, except for "not detected" and exempted substances.

However, processed foods objectively present complexities in terms of the diversity of ingredients and processing methods. In the actual inspection and quarantine process, the MHLW emphasizes that the residual levels of pesticides and veterinary drugs in the raw materials should be used as the basis for assessment. For more information of this point, please refer to the Positive List System Q & A: Processed Food, which specifically addresses processed food.

MHLW Frequently Asked Questions for reference:

Q82. Frozen spinach and blanched vegetables are considered processed foods. How compliance with food standards is determined in these cases?

Answer: For vegetable processed products that undergo simple processing such as blanching or salt boiling, it is unlikely that there will be a significant change in moisture content (at least concentration is unlikely to occur). Therefore, the conformity with standards is determined based on the standard for the raw vegetables used as ingredients. For example, in the case of dried spinach, the concentration level is calculated based on the moisture content of the product, which will be converted to the equivalent of fresh produce for assessment.

Therefore, even if these unregulated processed foods are found to contain pesticides residues exceeding 0.01 ppm during quarantine inspections, there is no need to be overly concerned.

Specific problems are analyzed individually. Generally, quarantine authorities will consider the food production process and calculate a conversion factor based on fresh produce, which is used to determine whether the pesticides and veterinary drug residues in the final product comply with regulations. For example, if quarantine authorities find that "XX pesticides" in frozen spinach is 0.05 ppm by using the conversion factor, which is higher than the approved limit of 0.03 ppm listed in the positive list, the import inspection authorities will determine the product non-compliant.

3. ChemLinked Suggestions

Enterprises should make sure the residues of pesticide and veterinary drugs in the food comply with Japanese regulatory requirements before export. The specific MRLs in certain processed food product and the Positive List System should be strictly adhered to. For processed food products without established standards, enterprises need to ensure that the pesticide residue limits in the product's raw materials meet the requirements.

Starting from April 1, 2024, a portion of the food hygiene responsibilities of the MHLW have been transferred to the Consumer Affairs Agency (CAA). It is reported that the development of standards for food additives and pesticide residue is now under the CAA's purview. Consequently, there have been changes in the website addresses where certain regulations are published. Additionally, pesticide residue limits in Japan undergo frequent updates. Considering the language barriers, stakeholders are recommended to get timely updates by following ChemLinked.