FDA行业指南：有关食品过敏原标签的问答（第 5 版）_中英文

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Contains Nonbinding Recommendations

Questions and Answers Regarding Food

Allergens, Including the Food Allergen

Labeling Requirements of the Federal

Food, Drug, and Cosmetic Act

(Edition 5): Guidance for Industry

You can comment on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit electronic

comments to https://www.regulations.gov. Submit written comments to the Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,

Rockville, MD 20852. All comments should be identified with the docket number FDA-

2022-D-0099.

For questions regarding this document, contact the Human Foods Program at

HFP-Policy@fda.hhs.gov.

Additional copies are available at https://www.fda.gov/FoodGuidances.

U.S. Department of Health and Human Services

Food and Drug Administration

Human Foods Program

January 2025

OMB Control No. 0910-0792

Current expiration date available at https://www.reginfo.gov/public/do/PRAMain

See additional PRA statement in Section III of this guidance.

包含无约束力的建议

关于食品过敏原的问题和答案，包括

《联邦食品、药品和化妆品法案》

（第5版）的食品过敏原标签要求：行

业指南

https://

www.regulations.gov

您可随时对任何指南提出意见（参见21 CFR 10.115(g)(5)），电子意见请提交至

，书面意见请提交至文件管理工作人员（HFA -305），美国食品

药品监督管理局，5630 Fishers Lane，Rm. 1061，Rockville，MD 20852。所有意见均应

注明案卷号FDA-2022-D-0099。

HFP-Policy@fda.hhs.gov如对本文件有疑问，请联系人类食品项目。

https://www.fda.gov/FoodGuidances

其他副本可在处获得。

美国卫生与公众服务部

美国食品药品监督管理局

人类食品计划

2025年1月

OMB控制编号0910-0792

https://www.reginfo.gov/public/do/PRAMain当前有效期可至，详见本指南第

三部分的 PRA 补充说明。

Contains Nonbinding Recommendations

Table of Contents

I. Introduction .................................................................................... 3

II. Questions and Answers .................................................................. 4

A. General Information……………………………………………………………………. 4

B. Types of Foods That Fall Under the Food Allergen Labeling Requirements of the

Federal Food, Drug, and Cosmetic Act……………………………………………………. 6

C. Food Sources…………………………………………………………………………... 13

D. The Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic

Act………………………………………………………………………………………… 16

E. Dietary Supplements…………………………………………………………………... 24

III. Paperwork Reduction Act of 1995 .............................................. 26

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标签： #指南 #FDA #中英文

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ContainsNonbindingRecommendations1QuestionsandAnswersRegardingFoodAllergens,IncludingtheFoodAllergenLabelingRequirementsoftheFederalFood,Drug,andCosmeticAct(Edition5):GuidanceforIndustryYoucancommentonanyguidanceatanytime(see21CFR10.115(g)(5)).Submitelectroniccommentstohttps://www.regulations.gov.Su...

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FDA行业指南：有关食品过敏原标签的问答（第 5 版）_中英文

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