STC Number - 147

Regulation on food additives

Maintained by: Japan
Raised by: European Union
Supported by: United States of America
First date raised: November 2002 G/SPS/R/28 paras. 35-37
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: Raised orally; RD/SPS/114
Products covered: 21 Miscellaneous edible preparations; 2106 Food preparations not elsewhere specified or included.
Primary subject keyword: Food safety
Keywords: Food safety; Human health; International Standards / Harmonization; Food additives
Status: Partially resolved
Solution: In November 2020, information was received from the European Union on the partial resolution of this STC (RD/SPS/114, 29 October 2020).
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In November 2002, the representative of the European Communities indicated that his authorities had compiled a list of substances, including food additives, aromas, food ingredients and extract solvents which were not formally authorized by Japanese law, but which could constitute barriers to food products to Japan. He requested Japan to approve the list of substances that had been evaluated by the European Communities on scientific grounds, and indicated that the use of some of the additives had already been authorized by Japan for other purposes. Furthermore, all of the substances had been evaluated at the international level by the scientific committee of the Codex Alimentarius Commission. The representative of the European Communities acknowledged Japan's interest in addressing the problem and reported that a number of bilateral meetings had already taken place.

The representative of the United States shared the concerns expressed by the European Communities and urged Japan to consider expedited approval for these food additives that were commonly used and considered safe. He suggested that better guidance ought to be provided by Japan regarding the data they required for the approval of food additives that were commonly used around the world. The United States encouraged Japan to rely on the reviews already conducted by Codex and other countries in order to minimize trade disruptions.

The representative of Japan stated that a new policy for evaluating the safety and the necessity of the use of food additives and for authorizing their use had been recently enacted in Japan. His authorities were putting together a list of food additives that were considered safe and necessary to use for certain foods. The use of food additives varied from country to country depending upon customs and habits, and a number of food additives authorized by the European Communities were not authorized in Japan and vice versa. He suggested that the European Communities consult directly with the Standard Division of the Department of Food Safety in the Ministry of Health, Labour and Welfare in Tokyo for further details regarding this issue.

In January 2005, Japan reported that food additives, including flavouring agents were permitted to be used only when designated by the Minister of Health, Labour and Welfare under the Food Sanitation Law as substances that were unlikely to cause a health hazard. With regards to the use of unauthorized food additives, an application must be filed with the Minister.

Furthermore, since 2002, Japan had given priority to certain food additives for authorization, including those proposed by the European Communities and that were also proven safe by the FAO/WHO Joint Expert Committee on Food Additives. The Minister had taken the necessary procedures to hear the opinions of the Food Safety Commission (FSC) on 29 additives, including 9 flavouring agents, for which full documentation had been prepared. Of the 29 substances, 4 additives (including 3 flavouring agents) were designated as authorized food additives in December 2004. This information was provided to the European Communities at the Japan-EU Regulatory Reform Dialogue and at other opportunities. In order to expedite and facilitate Japanese evaluations of the substances, the European Communities were requested to provide the documentation and literature supporting EC scientific evaluation of the substances.

In November 2020, the Secretariat informed that in September 2020 it had contacted all Members who had raised specific trade concerns (STCs) that had not been discussed in the previous year, to request an update on their status. In furtherance of this request, information was received from the European Union on the partial resolution of this STC. The Secretariat indicated that the information received had been circulated in document RD/SPS/114 of 29 October 2020, and that the SPS IMS would be updated on this basis, using the date of the November 2020 SPS Committee meeting as the date of resolution of the relevant STCs.