WORLD TRADE G/SPS/N/USA/116
20March 1998
ORGANIZATION
(98-1153)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: U.S.Food andDrug Administration
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Food additives
4. Title andnumber ofpages ofthenotified document: Direct Food Substances Affirmed
asGenerally Recognized asSafe; EggWhite Lysozyme.
5. Description ofcontent: TheFood andDrug Administration (FDA) isissuing atentative
finalruletoamend itsregulations toaffirm thateggwhite lysozyme enzyme
preparation, when labelled bythecommon orusual name "eggwhite lysozyme" to
identify itssource, isgenerally recognized assafe(GRAS) foruseinpreventing late
blowing ofcheese caused bythebacterium Clostridum tyrobutyricum during cheese
production. FDA hastentatively concluded thatthisuseoftheeggwhite lysozyme
enzyme preparation isGRAS onlywhen theingredient statement forbothbulkand
packaged foodthatcontains cheese manufactured using eggwhite lysozyme included
thecommon orusual name "eggwhite lysozyme" toidentify thesource oftheprotein.
Eggwhites areknown tobeanallergenic foodsource, particularly inchildren. There
isaliterature report indicating thatlysozyme mayinfacthavebeenanallergen for
some individuals whobecame sensitive toeggwhites. Although thereported invitro
study doesnotestablish thatingestion ofeggwhite lysozyme incheese willactually
cause aclinically significant allergic reaction insuchsensitive individuals, FDA isnot
aware ofanydataorinformation thatwould refute thestudy'sinference thateggwhite
lysozyme maybeallergenic. Therefore, FDA concludes thatthere isinsufficient
information inthecurrent record todetermine whether theingestion ofeggwhite
lysozyme elicits anallergic response when consumed byindividuals whoaresensitive
toeggwhites. Accordingly, FDA isproposing labelling toalertsuchindividuals tothe
presence ofeggwhite lysozyme incheese. Such labelling alsowould alertthesensitive
population tothepossible presence ofsource-derived proteins other thanlysozyme in
theenzyme preparation. Togiveinterested persons anopportunity tocomment onthis
condition ofuserequired forGRAS status, FDA isissuing thistentative finalrule.
6. Objective andrationale: Human health
./.G/SPS/N/USA/116
Page2
7. Aninternational standard, guideline orrecommendation does notexist [X].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents andlanguage(s) inwhich these areavailable: 63FR12421,
13March 1998 (Available inEnglish -6pages); 21CFR Part184.
9. Proposed date ofadoption: Tobedetermined.
10. Proposed date ofentry intoforce: Thedateofentry intoforce willbeannounced when
thefinalruleispublished intheFederal Register.
11. Final date forcomments: Submit written comments by27May1998
Agency orauthority designated tohandle comments: Food andDrug Administration
12. Texts available from: National enquiry point []oraddress, telefax number andE-mail
address (ifavailable) ofother body:
USDA/FAS/FSTSD
Attn: Carolyn F.Wilson
Room 5545 South Agriculture Building
Stop1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone (202) 720-2239
Fax(202) 690-0677
E-mail ofsts@fas.usda.gov