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Food Additives

Food additives are used in the process of manufacturing foods or for the purpose of processing or preserving foods. They include preservatives, sweeteners, coloring agents and flavoring agents.

While food additives largely contribute to today's distribution of a variety of foods, much caution is needed to ensure the safety of additives, which do not have a long history of human consumption unlike foods.

The Consumer Affairs Agency (CAA)* consults the Food Safety Commission of Japan (FSCJ) and authorizes the use of them only when they are unlikely to harm human health.

The CAA continuously takes adequate measures to review the safety of authorized food additives, for example, by surveying daily intake levels per person.

Note: On April 1, 2024, responsibilities on setting and evaluation of food safety standards were transferred to the CAA from the Ministry of Health, Labour and Welfare (MHLW).

Historical background

In 1947, Ministry of Health and Welfare (the present MHLW) enacted the Food Sanitation Act (the Act) as the first comprehensive act for food safety and hygiene, and introduced a positive list system for food additives. Under the system, only additives designated as safe may be used in foods. Since 1947, all food additives have been regulated by this act.

Definition

The Act defines ''food additive'' in Article 4 as:

  • -substances used in or on food in the process of manufacturing food, or
  • -substances used for the purpose of processing or preserving food.

Consequently, ''food additive'' includes both substances remaining in the final products, such as food colors and preservatives, and substances not remaining in the final products, such as microorganism control agents and filtration aids.

The scope of food additives referred to by the Act is not necessarily the same as that defined by the Codex Alimentarius Commission (CAC). The substances given below, which are not defined by the CAC as food additives, are all categorized as food additives in Japan.

  • Processing aids,* like infiltration-supporting agents
  • Vitamins, minerals, and amino acids
  • Flavoring agents

* Processing aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. (An excerpt from Procedural Manual of CAC, "Section I : Definitions for the purpose of the Codex Alimentarius")

Regulation

Food additives permitted for use in Japan

Basically, only food additives designated based on the Act are permitted for use in Japan. They are called "designated additives." Besides the designated additives, those classified in either of the three categories are also usable. These categories are "existing food additives," "natural flavoring agent," and "ordinary foods used as food additives."

Designated Additives

Designated additives are those designated by the Prime Minister (by the Minister of Health, Labour and Welfare until March 2024) as substances that are unlikely to harm human health based on Article 12 of the Act. Targets of the designation system are not only chemically synthesized substances but also natural substances.

Existing food additives.

Existing food additives are substances derived from natural origins. These substances are permitted for use and distribution in Japan as an exception, without through the designation system provided by the Act. This is because they have been widely used in Japan and have a long history of consumption by humans. They are placed on the List of Existing Food Additives. This additive status was set in 1995, when the Act was amended and all additives (not only chemically synthesized substances but also natural-origin substances) came to be subject to the designation system.

Natural flavoring agents

These substances are natural products that are obtained from animals and plants and used to flavor foods. These substances include vanilla flavoring and crab flavoring. The each amount used is generally very little.

Ordinary foods used as food additives

They are substance that are generally provided for eating or drinking as food and also used as food additives(e.g., strawberry juice and agar).

Standards for Use of Food Additives

Even food additives classified in the above four categories must comply with the standards, if use standards for these additives (e. g., target foods and maximum use levels) are established under the Act.

Japan's Specifications and Standards for Food Additives

The Act requires the CAA to prepare an official compilation of specifications and standards for food additives. The compilation contains compositional specifications for individual additives as well as standards for manufacturing and use of these additives. The compilation is updated every several years to introduce new and improved test methods commensurate with the progress in science and technology, and to achieve international harmonization of standards. Japan's Specifications and Standards for Food Additives is the English translation of the official compilation of food additives.

For inquiries about the possible use of food additives in foods, please contact quarantine station in Japan.

Application for designation of food additives or revision of standards

Prossess of the Designation of Food Additives

Those wishing to apply for designation of food additives or revision of standards for food additives must submit documents required for the application together with the application form to the CAA.

For details for application procedure, please refer to the following two guidelines and prepare documents according to "The Procedure for Preparing Application Documents for Designation of Food Additives and Revision of Use Standards for Food Additives" (食品添加物の指定及び使用基準改正要請資料作成に関する手引).

* For prior consultation of application for designation of food additives or revision of standards, please contact Food Additive Designation Consultation Center (FADCC) of National Institute of Health Sciences.

When receiving an application form accompanied with required documents, the CAA requests the FSCJ for risk assessment on the food additive concerned. The CAA reviews the assessment results from FSGJ. For the revision of standards, basically the same procedure is taken.

Guidelines for FSCJ's risk assessment (provisional translation):

Reference: risk assessment by the FSCJ

The standard period required to the designation or the revision:

Data of average intake of individual food―additional data to the survey report on food intake and frequency (食品摂取頻度・摂取量調査の特別集計業務 報告書追加資料)

Documents required for application of the designation of food additives and the revision of standards*

* "Materials required for assessments of food additives (Appendix 1 of FSCJ's Guideline for Assessment of the Effect of Food on Human Health Regarding Food additives)"

Items Designation Revision of standard
Information on the additive subject to assessment
1. Name and usage Required Required
2. Origin or process of discovery Required *
3. Usage in other countries Required Required
4. Assessments by international organizations and other organizations Required *
5. Physiochemical properties Required *
6. Suggestions for usage standards Required Required
7. Others (Information useful for assessments of the effect of food on health) * *
Findings regarding safety
1. Tests for disposition in organisms Required *
2. Toxicity
(1) Subchronic toxicity studies and chronic toxicity studies Required *
(2) Carcinogenicity studies Required *
(3) Toxicity/carcinogenicity combination studies with one-year repeated-dose administration Required *
(4) Reproductive toxicity studies Required *
(5) Prenatal developmental toxicity studies Required *
(6) Genotoxicity studies Required *
(7) Allergenic potential studies Required *
(8) General pharmacological studies Required *
(9) Other studies * *
3. Findings in humans Required *
4. Estimation of daily intake, etc. Required Required
    • Note 1. When requesting a division of usage standards for a food additive for which assessment of the effect of the food on health has already been carried out by FSCJ, the materials required for "Revision of standard" should be submitted. When requesting a division of usage standards for a food additive for which assessment of the effect of the food on health has not been carried out by FSCJ, documents required for designation should be submitted, in principle.
    • Note 2. Materials marked "Required" should be submitted whenever applicable. Materials marked with an asterisk (*) should be submitted as necessary (when there is a new finding, for example).
    • Note 3. When a combination test for chronic toxicity and carcinogenicity is carried out using one rodent species, a chronic toxicity test and carcinogenicity test on another rodent species can be omitted.
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