We provide prior consultation for applicants who submit application documentation for the designation of food additives and the revision of use standards.　　　　　

The contents of the Website are amended in necessity and the revisions are occurred in Japanese site first. You may refer latest information in Japanese site.

About documentation for request

●What kind of consultations do you offer?
　FADCC offers consultations on the documentation required for the designation request of food
　 additives and for revision request of the specifications/standards of food additives.
　 Please click here for more information.

●What contents are applicable to the consultation?
　 　・Inquiries FADCC can handle (followings are example of inquiries)
　　　　-　We would like to request for designation of food additive XX, which is widely used in
　 　　　　other countries, for use in Japan.
　　　　-　We would like to expand the target foods to which preservative XX can be applied,
　　　　 　 enabling preserved foods that do not deteriorate at room temperature.

　 　・Inquiries FADCC can not handle
　　　　-　Administrative decision regarding use/sale of food additives
　　　　　　　→Please contact your local health center first.
　　　　-　What would like to use XX as an enhancer for a supplement, what should we do?
　　　　　　　→Please contact your local health center first.
　　　　-　I heard that the food products are containing food additive XX. Is it safe to eat those
　　　　　 products?
　　　　　　　→Please ask the manufacturer or contact your local health center.
　　　　-　How can we import food XX which is sold overseas?
　　　　　　　→Please contact your local port quarantine.

●How can I apply for consultation?
　 　 ・If you wish to consult with FADCC, please fill out this inquiry form and send us by　e-mail.
　　　　We do not provide consultations on the phone.

　　　・We may ask you questions by e-mail if we are unclear about your inquiry or if we consider
　　　　 it necessary to know the details of your inquiry. For those determined to be applicable for
　　　　 our consultation, we will contact you regarding the meeting date.

●Do I need to submit documents for the consultation before the meeting?
　　　・ In addition to the inquiry form, we would like you to submit materials that will help us
　　　　 understand your inquiry. As the consultation progress, we would ask for confirmation
　　　　 using check sheet and submission of supporting documents.

●Regarding inquiries from other countries, do you offer consultations in
　languages other than Japanese?
　　 ・We conduct consultations only in Japanese. At the meeting, you may bring your interpreter
　　　　 if you need

●Could the contents of consultations be open to public?
　　・FADCC keeps strict confidentiality on the contents of the consultations.

About documentation for request

● What procedures are required for new designation or revision of 　　　　　 　specifications and standards of food additives?

・Any person who wishes to request for designation/revision of the item is required to
prepare and submit a set of application documents (an application document, an overview
document※ and related documents) to the Ministry of Health, Labour and Welfare 　　
(hereinafter referred to as ”MHLW”) in accordance with the ”Procedure for Preparing
Application Documents for Designation of Food Additives and Revision of Use Standards.
The minister for MHLW will request an assessment to the Food Safety commission of Japan (hereinafter referred to as ”FSCJ”) and experts to determine whether the request is acceptable or not, and take necessary procedures based on their opinions. (※ overview documents: Documents that summarize the overview, safety, and effectiveness of the substances) Please click here for more information.

●After the consultation, what will FADCC do for the requestors?
　　 ・If the contents of the consultation is regarding the requirements for new food additives or
　　　　revision of standards, and also if the requestors wish to make an application to MHLW,
　　　　FADCC can provide advice to help the requestor prepare the documents for application in a
　　　　reasonable manner. The requestor will use the advice as a reference and proceed with the
　　　　collection of supporting documents and the preparation of draft standards to be organized
　 　　 for preparation of the overview documents. It is necessary to prove by the set of application
　　　　documents that the contents of the request are legitimate and will promote the health and
　　　　welfare of the Japanese consumers. In particular, the purpose of organizing the overview
　　　　document is to present the specifications, effectiveness, and safety of the food additive with
　　　　 reasonable documents.

●Will the overview documents be prepared by FADCC?
　 　 ・No. The requestors who wish to designate for new food additives must prepare them on
　　　　 their own. We do not prepare them on the behalf.

●When requesting my item for designation as a new food additive, do I need to submit toxicity test results?
　 　・Basically, all the documents (overview, safety, and effectiveness of the substance) must be 　　　　submitted. If there already are materials publicly available, they can be used.

●How much does it cost to conduct tests required to prepare the overview documents?
　 　・Please contact the testing facilities for information on cost if you plan to outsource the tests.

●Can I consult you issues on food additives other than preparation for overview documents?
　 　・No. We only offer the consultation for the preparation of overview documents for the 　　　　　　　designation, the revision of usage, or the revision of standards for food additives in Japan.

●Can you refer us to an agency that can prepare the overview document on our behalf?
　 　・No, we can’t.