1. Historical background
In 1947, then Ministry of Health and Welfare enacted the Food Sanitation Law as the first comprehensive law for food safety/hygiene, and introduced a positive list system for food additives. Under the system, only additives designated as safe by the Ministry of Health, Labor and Welfare may be used in foods. Since 1947, all food additives have been regulated by this law. However, designation system had been applied only to chemically synthesized additives until 1995 when the Food Sanitation Law was amended. Currently, all types of additives are equally subject to the designation system, synthetic or non-synthetic, with minor exceptions.
2. Regulation of food additives under the Food Sanitation Law
|(1)|| Definition of''additive''|
The Food Sanitation Law, in the first Chapter, defines''additive''as
|(2)|| Designation of food additives|
Designation of a food additive is normally in accordance with the procedure given below, based on an application from a person who wishes to use it.
When an application for designation of an additive is submitted to the Minister of Health, Labour and Welfare, the Minister will ask the Food Safety Commission for opinions concerning health effects of the food additive. At the request for opinion, the necessary documents obtained are submitted to the commission. The Commission will make a scientific health risk assessment and establish the ADI. After the MHLW receives the Commission's report and recommendation, it will have the Pharmaceutical Affairs and Food Sanitation Council discuss the adequacy of draft standards. In discussion by the Council, international evaluations were taken into account. If the discussion proves that the additive is safe and effective, it will be designated as an additive approved for use.
Documents accompanying an application should comply with the directions given in the ''guidelines for designation of food additives and for revision of standards for use of food additives.'' The safety and effectiveness of an additive must be scientifically confirmed.
Currently, 345 additives are designated as approved by the Minister of Health, Labour, and Welfare under Article 10 of the Food Sanitation Law.
Separately from the designation process described above, the MHLW has decided to start to evaluate certain food additives with intent to authorize them even when there is no application from a person who wishes to use them. These food additives are those that meet the standards given below. This decision was made from the viewpoint of international harmonization for substances that are internationally proven safe and widely used in the world. This action underlies the following background. In recent years global food distribution has been increasing, and imported foods account for some 60 percent of the foods distributed in the Japanese market. Also, there is a growing possibility that imported foods contain food additives that are authorized in other countries but unauthorized in Japan.
Currently, 46 substances fall under these substances. Discussion is being conducted on substances for which the full documents on safety and usefulness are prepared.
> for which safety assessments have been finished by the JECFA (Joint FAO/WHO Expert Committee on Food Additives) and whose safety has been confirmed within a certain level, and > that are widely used in the U.S. and EU countries and whose need is considered to be high.
Exemption from the designation system
There are three substance categories that are exempted from the designation system.
|1)||Existing food additives (i.e., substances that were already marketed or used on the date of the amendment of the Food Sanitation Law and appear in the List of Existing Food Additives).|
|2)||Natural flavoring agents.|
|3)||Substances that are both generally provided for eating or drinking as foods and used as food additives have been excluded from the designation system.|
|(3)|| Establishment of specifications and standards|
Usually, people continue to consume food additives throughout their lifetime. Thus, food additives must be subjected to stringent regulations.
All designated chemicals, with a few exceptions, and some natural additives (existing food additives) are currently regulated by specifications and/or standards. These specifications and standards include specifications concerning chemical and physical characteristics, and standards for manufacturing, storage, and use. These standards, along with labeling and storage standards, are published in an official compilation of food additives, entitled ''Japan's Specifications and Standards for use of Food Additives.''
|(4)|| Official compilation of food additives|
In 1957, the Food Sanitation Law was amended, and a provision about an official compilation of food additives was newly established in order to collect the specifications and standards for food additives. Based on this provision, then Minister of Health and Welfare, on March 15, 1960, prepared the first edition of an official compilation of food additives.
Since the first edition was published, the publication has been updated constantly to keep pace with scientific advances and harmonize Japanese standards with international ones. The latest edition (seventh) was published in April 1999. Its English translation was published in September 2000.
|-||List of Designated Additives|
|-||List of Existing Food Additives|
|-||List of Plant or Animal Sources of Natural Flavorings|
|-||Standards for Use of Food Additives|
|-||Seventh Edition Japan's Specifications and Standards for Food Additives|
|Guidelines for designation of food additives and for revision of standards for use of food additives|
Standards and Evaluation Division|
Department of Food Safety
Ministry of Health, Labour and Welfare