Q&A

FAQ about InquiryAbout us

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1-01. 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. FADCC doesn't provide phone consultations.
1-02. What kind of consultations do you offer?
	FADCC offers consultations on the documentation required for the designation of food additives and for revision of standards for use of food additives. Please click here for more information.
1-03. What contents are applicable to the consultation?
	・Inquiries FADCC can handle (followings are example of inquiries) 　-To request for the designation of food additive XX, 　　which is widely used in other countries, for use in Japan. 　-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 the nearest public health center in Japan first. 　 -What would like to use XX as an enhancer for a supplement, 　　　what should we do? 　　　 →Please contact the nearest public health center in Japan 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 the nearest 　　　　　public health center. 　-How can we import food XX which is sold overseas? 　　　 →Please contact the nearest Quarantine station in Japan.
1-04. What is the consultation process when I want to request the designation of food additive (or revision of standards for use of food additive)?
	・We provide consultation services through a stage-gate system starting in 2022. Please click here for details.
1-05. Do I need to submit documents for the consultation before the meeting?
	・ In addition to the inquiry form, we would like to ask you to submit materials that might help us understand your inquiry. As the consultation progress, we would ask for confirmation using check sheet and submission of supporting documents.
1-06. 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.
1-07. Could the contents of consultations be open to public?
	・FADCC keeps strict confidentiality on the contents of the consultations.

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2. About documentation for request

2-01. What procedures are required for new designation of food additives or revision of standards for use 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※ related documents, etc.) to the Prime Minister in accordance with the “The Procedure for Preparing Application Documents for Designation of Food Additives and Revision of Standards For Use of Food Additives.”(Japanese only) The Prime Minister 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 document: Document that summarizes the overview, 　　safety, and effectiveness of the substances. Please Click here for 　　more infomation.
2-02. What will FADCC do for the applicants?
	・If the contents of the consultation is regarding the requirements for new food additives or revision of standards, and also if the applicants wish to make an application to the Consumer Affairs Agency (hereinafter referred to as “CAA”), FADCC can provide advice to help the applicant prepare the document for application in a reasonable manner. The applicant 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 document. 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.
2-03. Will the overview document be prepared by FADCC?
	・No. The applicants who wish to designate for new food additives must prepare them on their own. We do not prepare them on the behalf.
2-04. 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.
2-05. How much does it cost to conduct tests required to prepare the overview document?
	・Please contact the testing facilities for information on cost if you plan to outsource the tests.
2-06. Can I consult you issues on food additives other than preparation for the overview document?
	・No. We only offer the consultation for the preparation of the overview document for the designation and revision of standards for use of food additives in Japan.
2-07. Can you refer us to an agency that can prepare the overview document on our behalf?
	・No, we can’t.

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3. Request, fee

3-01. How long does it take from request to the designation (or revision of standards for use)?
	As a standard processing period, after the application form is received by the CAA, it is generally required to be within one year for the evaluation of the Food Safety Commission of Japan (FSCJ) from the day the FSCJ receives an explanation of the request from the CAA to the date of notification of the results of the food health impact assessment for the request, and within one year from the date the Food Safety Commission notifies the results of the food health impact assessment to the date the CAA formulates standards for the item. However, the standard processing period shall not include the following periods: (i) The period required for the applicant to submit additional material(s) when the submitted materials are incomplete for the evaluation. (ii) The period required for the applicant to submit lacked material(s) for the assessment when the materials submitted do not fulfill the requirements.
3-02. Is there any additional requirement when the applicant is not a resident of Japan?
	If the applicant is not a resident of Japan, please specify "the contact information in Japan of a person who can responsibly manage matters related to the request in Japanese" on the application form.
3-03. Do you introduce an agent in Japan?
	FADCC does not introduce any agent or mediator.
3-04．Is there a fee for consultation with FADCC?
	There is no fee for consultation with FADCC.
3-05. Is there a fee for the request to the CAA?
	No fee for application shall be charged. However, the applicant is responsible for any testing costs, costs for literature searches, and other costs associated with the preparation of the application documents including the overview document.

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Disclaimer

The FAQ on this website describe on general issues in nature and may not be applicable to each individual case. The FAQ may be subject to change without prior notice due to reflect revisions of Guidelines for the Risk Assessment of Food Additives, The Procedure for Preparing Application Documents for Designation of Food Additives and Revision of Standards for Use of Food Additives, or deliberations by the Food Safety Commission of Japan or other authorities.

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

FAQ about InquiryAbout us

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