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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-06-09-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AF07</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200410</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0910</CODE>
            <NAME>Food and Drug Administration</NAME>
            <ACRONYM>FDA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Food Labeling: Food Allergen Ingredient Labeling</RULE_TITLE>
        <ABSTRACT><![CDATA[FDA initially intended to issue a proposed rule to establish requirements for labeling foods that contain common food allergens.  The purpose of this rulemaking was to reduce mortality and morbidity by making it easier for persons who have a food allergy to identify when packaged foods contain certain allergenic ingredients.  Subsequently, on August 2, 2004, the President signed into law the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP Act) (Pub. L. 108-282), which amended sections 201 and 403 of the Federal, Food, Drug and Cosmetic Act (FFD&C Act).  FDA is now in the process of determining the approach it intends to take in light of the new statutory requirements.

The FALCP Act amended section 201 of the FFD&C Act to define a major food allergen as: 1) milk, egg, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, pecans, walnuts), wheat, peanuts, and soybeans and 2) any ingredient that contains a protein derived from these foods.  Excluded from this definition are:  1) highly refined oils derived from the food source of a major food allergen and ingredients derived from such oils and 2) a food ingredient that is exempt under the petition or notification process specified in the law.  The FALCP Act also amended section 403 of the FFD&C Act to require that the labels of packaged foods use plain English terms to identify the food source of each of the major food allergens it contains as an ingredient. This requirement is applicable to all ingredients, including flavors, non-certified colors, and incidental additives.  The law provides a choice between two methods for declaring the food sources of any major food allergens contained in the ingredients of packaged foods:  either within the ingredient list or in a separate summary statement immediately following or adjacent to the ingredient list.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Long-Term Actions</RULE_STAGE>
        <MAJOR>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 101</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 331</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 343</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>To Be Determined</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Yes</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>Undetermined</FEDERALISM>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Rhonda</FIRST_NAME>
                <LAST_NAME>Kane</LAST_NAME>
                <MIDDLE_NAME>Rhoda</MIDDLE_NAME>
                <TITLE>Consumer Safety Officer</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>240 402-1803</PHONE>
                <FAX>301 436-2636</FAX>
                <EMAIL>rhonda.kane@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Room 4D008, HFS-820,</STREET_ADDRESS>
                    <CITY>College Park</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20740</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
