Food additives are substances used during the manufacturing and processing of foods to achieve various purposes such as preservation, sweetening, coloring, and flavor enhancement. While food additives greatly contribute to the availability of a wide range of food options, ensuring their safety is of utmost importance.
In 1947, Japan introduced the Food Sanitation Act (FSA) as its first comprehensive legislation addressing food safety and hygiene. As part of this act, a positive list system was implemented for Japanese food additives, meaning that only additives designated as safe by the Minister of Health, Labour and Welfare (MHLW) are permitted for use in foods.
Initially, the designation system solely applied to chemically synthesized additives. However, in 1995, the FSA was amended to encompass all types of additives, whether synthetic or naturally derived, within the designation system, with a few exceptions.
1. Definition
According to Article 4-2 of the FSA, the term "food additive" refers to substances that are used by being added, mixed or infiltrated into food or by other methods in the process of producing food or 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, as well as those that do not remain, such as microorganism control agents and filtration aids.
In Japan, all substances used for the aforementioned purposes, regardless of their natural origin, are considered food additives.
It is important to note that the scope of food additives defined by the FSA differs from that defined by the Codex Alimentarius Commission (CAC). In Japan, the following substances, which are not classified as food additives by the CAC, are categorized as food additives:
Processing aids, including 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 (CAC, Procedural Manual, “Section I : Definitions for the purpose of the Codex Alimentarius”)
2. Competent Authorities
Food additives in Japan are primarily regulated by MHLW, Food Safety Commission (FSC) and Consumer Affairs Agency (CAA).
The MHLW, as a cabinet-level ministry, plays a crucial role in overseeing food additives. It is responsible for tasks such as setting standards, reviewing applications for new food additives, and ensuring their compliance with regulations. Additionally, the MHLW formulates the monitoring guidance plan of annual imported food, etc., to effectively supervise imported food and implement health and quarantine measures.
The FSC takes over the task with the task of evaluating the safety risks associated with food additives. Based on their evaluation results, they provide comments to the relevant ministers, urging them to take appropriate measures to address any identified risks.
The CAA, as an independent agency within Japan's cabinet, is dedicated to safeguarding consumer rights. It was established in response to various incidents, including food poisoning outbreaks and the discovery of substandard products. The CAA plays a vital role in ensuring the protection of consumer interests in relation to food additives and other consumer goods.
3. Regulation
3.1 Positive lists
Food additives that are permitted for use in food in Japan are limited to the below four positive lists:
3.1.1 Designation system
Designated additives are synthetic chemical additives that have been designated by the MHLW as substances unlikely to harm human health. Since 1995, natural products have been included in the target of the designation in addition to the previously designated synthetic food additives.
The concept of existing food additives was introduced in 1995 when the FSA was revised, as certain substances in Japan have been long permitted for use and distribution without going through the designation system. This exception is granted because these substances have a long history of consumption by humans and are widely used in Japan as natural substance. They are known as existing food additives and are listed on the List of Existing Food Additives.
Prior to this revision, only chemically synthesized substances were subject to the designation system. However, with the amendment, all additives, including those of natural origin, became subject to the designation system. The inclusion of existing food additives in the regulatory framework ensures their safe usage while acknowledging their established history of consumption.
3.1.2 Other additives
There are two substance categories that are exempted from the designation system: "natural flavoring agents" and "ordinary foods used as food additives."
These substances are derived from animals and plants, and used for enhancing the taste of food, but typically in very small quantities. Examples include vanilla flavoring and crab flavoring.
Substances commonly consumed as food are also employed as food additives. Examples include strawberry juice and agar. These substances serve both as food items in their own right and as additives for other food products.
3.2 Standards for Use of Food Additives
Food additives, including designated additives and some existing food additives, must comply with specific use standards. These standards outline the permissible usage of food additives, maximum use limits, and residue limits in different target foods. It is mandatory for these substances to adhere to these standards when they are employed in food products.
3.1 Japan's Specifications and Standards for Food Additives
The Food Sanitation Act requires the MHLW to prepare an official compilation of food additive specifications and standards, which 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 achieve international harmonization of standards.
4. Application for Designation of Food Additives and Revision of Standards
4.1 Application procedure
The designation of food additives and the revision of standards for food additives both require risk assessment by the Food Safety Commission of Japan (FSCJ) and review by the MHLW based on the risk assessment by the FSCJ.
Guidelines for the Designation of Food Additives and Revision of Standards for Use of Food Additives
Those wishing to apply for the designation of food additives or the revision of standards for food additives should collect documents required for the application, and submit them together with the application form to the MHLW. For details for application procedure, please refer to The Procedure for Preparing Application Documents for Designation of Food Additives and Revision of Use Standards for Food Additives and guidelines for FSCJ's risk assessment.
Notification for the standard period is available at The standard period required to designate food additives.
For consultation of the food additives designation application or the revision of standards, please contact Food Additive Designation Consultation Center (FADCC) of National Institute of Health Sciences.
Notice: If the applicant lives overseas, he or she should establish a contact person in Japan responsible for handling the application.
4.2 Documents required for application
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 | As necessary |
3 | Usage in other countries | Required | Required |
4 | Assessments by international organizations and other organizations | Required | As necessary |
5 | Physiochemical properties | Required | As necessary |
6 | Suggestions for usage standards | Required | Required |
7 | Others | ||
Findings regarding safety | |||
1 | Tests for disposition in organisms | Required | As necessary |
2 | Toxicity | ||
(1) Subchronic toxicity studies and chronic toxicity studies | Required | As necessary | |
(2) Carcinogenicity studies | Required | As necessary | |
(3) Toxicity/carcinogenicity combination studies with one-year repeated-dose administration | Required | As necessary | |
(4) Reproductive toxicity studies | Required | As necessary | |
(5) Prenatal developmental toxicity studies | Required | As necessary | |
(6) Genotoxicity studies | Required | As necessary | |
(7) Allergenic potential studies | Required | As necessary | |
(8) General pharmacological studies | Required | As necessary | |
(9) Other studies | As necessary | As necessary | |
3 | Findings in humans | Required | As necessary |
4 | Estimation of daily intake, etc. | Required | Required |
Notes:
When requesting a division of a food additive usage standard for which assessment of the food's effect on health has already been carried out by FSCJ, the materials required for "Revision of standard" should be submitted. When requesting a division of a food additive usage standard for which assessment of the food’s effect on health has not been carried out by FSCJ, documents required for designation should be submitted, in principle.
When a combination test for chronic toxicity and carcinogenicity is carried out by using one rodent species, a chronic toxicity test and carcinogenicity test on another rodent species can be omitted.
5. Labeling Requirements
5.1 Labeling Method
In principle, the ingredients in food are required to be listed on the label in descending order of quantity, with a few exceptions not required to be listed. Additionally, if a processed food is used as an ingredient, any additives present in it must also be listed. When it comes to the additives expression in the label, apart from directly stating the substance name of the additive itself, certain conditions allow the use of alias, combination names, or collective names. For more details, please refer to Appendix: Additives in the Food Labeling Standards.
5.1.1 Alias
Food additives are generally labeled with their substance names. However, the chemical names of additives can sometimes be unfamiliar and confusing. For example, it may be easier to understand "L-ascorbic acid" as "Vitamin C". Therefore, for certain additives, instead of the substance name, it is permissible to use the additive's trade name (name, alias), simplified name, and category name for labeling.
5.1.2 Combination
Additives used for the purposes of sweeteners, colorants, preservatives, thickening agents/stabilizers/gelling agents/starch adhesive, antioxidants, color fixatives, bleaching agents, and fungicides/fungicide are displayed together with their substance names as helpful information for consumer’s choices. For example, food preservative (Sorbic acid).
5.1.3 Collective
Additives used under the following 14 collective names may be labeled by the collective name instead of the substance name:
Yeast food, gum base, saltwater, bittering agent, enzyme, aroma chemical, brightening agent, acidifier, seasoning, coagulant for tofu, softening agent, emulsifying agent, acidity regulator, and expansive agent.
5.2 Exemption Label
Regarding food additives contained in food products, if they are used for nutrient fortification or as processing aids, or fall under the category of carryover, the labeling of additives is exempted. However, even if the labeling of additives is exempted, it is important to note that the allergen labeling for specific ingredients derived from those additives is still required.
