Handling of the unauthorized food additives

	The Japan Food Chemical Research Foundation
Handling of the unauthorized food additives
Last update：2006/11/30

The following documents on the unauthorized food additives were officially announced by Ministry of Health, Labour and Welfare (MHLW).

July 26, 2002

Handling of the unauthorized food additives, which are evaluated as safe
and are widely used internationally

<Background>
The international food trades are being increased and then the proportion of the imported foods among the total food of Japan is exceeding to 60%, while there can be found certain discrepancy between the food additive list of Japan and those of foreign countries to some extent.
This means that there may be some possibility for imported foods to include unauthorized food additives, which are recognized as safe internationally.
On the other hands, it is very difficult for us to find some discrepancy in the toxicity evaluation of food additive itself, ADI, between by Japanese experts and by other foreign experts so long as they judged the safety on the same scientific data.

<New policy>
1. Food additives except flavoring agents
So long as the food additives meet the following criteria, they are deemed safe and necessary as food additive, and then they are handled as candidates for new food additives and taken the safety and exposure assessment positively.
1) They are evaluated as safe by JECFA
2) They are widely used in foreign countries, including USA and EU countries and the necessary of them are recognized internationally

Procedure
1) Based on the information regarding the status quo of each food additives, MHLW will make up the draft list for candidates
2) The Pharmaceutical Affairs and Food Sanitation Council will review the draft list for candidates and authorize it
3) After the authorization of the list for candidates, each candidate will be reviewed the safety, quality and necessity based on the collected relevant data individually

2. Flavoring agents
The safety evaluation method performed by JECFA is completely different from those for other food additive and then completely new to the Japanese expert. Therefore the first step should be the review of this evaluation method itself prior to the above-mentioned procedure.

December 17, 2002

Handling of the unauthorized food additives, which are evaluated as safe
and are widely used internationally (Interim report)

The MHLW intends to newly designate certain additives that are not authorized in Japan based on an interim report titled, the handling of unauthorized food additives whose safety is globally confirmed and that are widely used outside Japan.

The following is an outline of the interim report.

(a) Target substances

Targets for designation are substances that meet the two criteria given below. These criteria are based on "concept for the designation of unauthorized food additives whose safety is globally confirmed and that are widely used outside Japan." The concept was accepted at the session of the Food Sanitation Committee under the Pharmaceutical Affairs and Food Sanitation Council on July 26, 2002.

Those whose safety assessment is finished by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and whose safety is confirmed within certain limitation, and

Those that are widely used in the U.S. and EU countries and whose necessity is considered to be high.

(b) On October 9, 2002 the MHLW requested related people, throughout Embassies in Tokyo and food-industrial organizations, to provide information on additives that were considered to satisfy the above criteria, including information on safety and necessity. The MHLW received information on 55 substances from 26 organizations including businesses in and outside Japan. These 55 substances exclude biotin, hydroxypropyl methylcellulose, Magnesium Stearate, and trimagnesium phosphate for which a request for opinion has already been made to the Pharmaceutical Affairs and Food Sanitation Council.

(c) Among the 55 substance, 38 met the criteria and 17 did not (see attachment 1

).
A breakdown of the 38 substances

Those that fall into the 26 items listed in the previous survey conducted by the MHLW: 17 items

Those that were not listed in the previous survey: 20 items

Item that is used as a food ingredient or others in the U.S. and EU countries because of regulatory difference, while it is categorized as a food additive in Japan: 1 item

No information was provided for 8 items out of the 26 items listed.

A breakdown of the 17 substances

Those that are not determined to be safe by JECFA but permitted in the US and the EU: 3 items

Those that were already determined to be safe by JECFA and permitted only in either of the U.S. and EU: 8 items

Those that are not determined to be safe by JECFA and permitted only in either of the U.S. and EU: 3 items

Item that is not determined to be safe by JECFA, not found to be used in the U.S, and permitted only in limited areas of the EU countries: 1 item

Those that could not be identified from the name because a general name was used: 2 items

(d) Future activities

The MHLW will start to review 46 substances‐38 items that meet the criteria and 8 listed items on which information was not provided (see section (c)).

Schedule

Those 46 substances are divided into four groups (see attachment 2

Review will be started at a related committee in about April 2003 after the collection and analysis of necessary data by experts. Review is first conducted for group 1, then sequentially done for other groups.

Flavoring agents are separately reviewed. They are under preliminary review by experts at the National Institute of Health Sciences about JECFA evaluation methods.