WORLD TRADE G/SPS/GEN/16*
17June1997
ORGANIZATION(97-2481)
Original: Spanish Committee onSanitary andPhytosanitary Measures
COMMUNICATION FROM PERU
Thefollowing communication hasbeenreceived from thePermanent Mission ofPeru.
________________
ThePermanent Mission ofPeru totheUnited Nations Office andOther International
Organizations atGeneva presents itscompliments totheSecretariat oftheWorld Trade Organization
(WTO), andwithreference toparagraph 1ofAnnex BoftheAgreement ontheApplication ofSanitary
andPhytosanitary Measures, hasthehonour totransmit herewith thetextofSupreme Decree
No.001-97-SA: Sanitary/Hygienic Regulations onFood andBeverages forHuman Consumption,
published intheOfficial Journal "ElPeruano" on17May1997.
*Thisdocument annuls andreplaces document G/SPS/GEN/15, distributed on17June1997 inSpanish only.G/SPS/GEN/16
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Supreme Decree No.001-97-SA
ThePresident oftheRepublic
Considering
Thatitistheresponsibility oftheStatetoenact provisions fortheregulation, supervision and
sanitary/hygienic control ofallstages inthefoodchain forthepurpose ofguaranteeing thesafety of
foodandbeverages forhuman consumption, soastoprotect consumer health andfacilitate security
oftrade inthose products.
Thatitisappropriate tolaydown health standards tofacilitate international trade infoodand
beverages, inaccordance withscientific andtechnological advances, market integration andeconomic
globalization.
Inaccordance withArticle 194ofLegislative Decree No.17505 -Sanitary Code; andwith
theapproval oftheCouncil ofMinisters;
Decrees
Article1.Theattached"SanitaryRegulationsonFoodandBeveragesforHumanConsumption",
consisting of13(thirteen) articles, arehereby approved.
Article2.TheSanitaryRegulationsonFoodstuffsapprovedbySupremeDecreeNo.112-63-DGS
andamended bySupreme Decree No.014-84-SA; the"Regulations oncontrol offactories producing
aerated water andsweetened aerated water", approved bySupreme Decree No.49-66-DGS and
amendments thereto, Ministerial Resolution No.077-95-PCM, setting uptheCommittee responsible
forimplementing standards relating tofoodmanufacture andtrade, andother lawsandregulations
inconsistent withtheRegulations approved bythisSupreme Decree arehereby repealed.
Article 3.ThisSupreme Decree shalltakeeffect from thedayfollowing itspublication.
Article 4.ThisSupreme Decree shallbeendorsed bytheChairman oftheCouncil ofMinisters
andbytheMinister ofHealth.
Government House, Lima, 14May1997.
Alberto Fujimori Fujimori
President oftheRepublic
Alberto Pandolfi Arbulu
Chairman oftheCouncil ofMinisters
Marino Costa Bauer
Minister ofHealthG/SPS/GEN/16
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Sanitary/Hygienic Regulations onFood andBeverages forHuman Consumption
Article 1.Food andbeverages forhuman consumption shallbesubject totherules, supervision
andhygienic andsanitary control established bythehealth authority atevery stage orphase ofthe
foodchain, withtheaimofprotecting thehealth ofconsumers andfacilitating security oftrade.
Article 2.Thefunction ofhealth authority shallbevested intheMinistry ofHealth through
theGeneral Directorate ofEnvironmental Health (DIGESA), withjurisdiction throughout thenational
territory andwithsanitary powers covering:
(a) Hygiene andhealth related aspects offoodandbeverages inthefoodchain, including
theoperations andprocesses carried outintheinstallations andmeans oftransport
usedinhandling andmarketing;
(b) knowledge ofissues andproblems relating tothehealth andoccupational safety of
persons working ineachofthestages ofthefoodchain, aswellasconsumer health;
(c) theauthoritytoenactstandardsandregulationsinrespectofsanitary/hygienicmonitoring
andcontrol;
(d) theuseofthepolice force andtheassistance ofanyjudicial, political oradministrative
authority forappropriate enforcement purposes intheexercise ofitsfunctions;
(e) thepower toauthorize -forreasons ofhealth andhygiene andtoprotect public health -
theconfiscation anddestruction offoodorbeverages ortheclosure ofinstallations
and/or theexclusion ofpersons from theoperations theycarry outatevery stage of
thefoodchain.
Article 3.Inorder toensure optimum compliance withtheregulations andsubject toprior
technical clearance, thehealth authority maydelegate functions totheregional orsubregional executive
directorates ofenvironmental health andtothehealth departments ofthemunicipalities, anditmay
alsoentrust technical operations toauthorized institutions orfirms inthepublic orprivate sector.
Article 4.Thesanitary/hygienic monitoring andcontrol offoodandbeverages intended for
human consumption shallbebased onthefollowing principles:
(a) Prevention ofdiseases transmitted byfoodandbeverages through action toensure the
safety offoodandbeverages;
(b) satisfactory sanitary conditions ininstallations andmeans oftransport usedateachstage
inthefoodchain;
(c) sound hygienic practices inalloperations andprocesses carried outateachstage in
thefoodchain;
(d) development ofindependent hazard analysis andcritical control points ateachstage
inthefoodchain.
Article 5.Thefollowing systems shallbesetuptoachieve theobjectives ofthese Regulations
through decentralized anddeconcentrated functions andtasks andpursuant totheprinciples ofG/SPS/GEN/16
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sanitary/hygienic monitoring andcontrol offoodandbeverages forhuman consumption; theyshall
beregulated bytheMinistry ofHealth byministerial resolution.
(a) Thesystemofepidemiologicalmonitoringofdiseasestransmittedbyfoodandbeverages,
toprevent theoccurrence ofdiseases andcontrol thefactors which trigger them;
(b) thesystem ofsanitary authorization toregulate thedomestic orforeign marketing of
foodandbeverages ingeneral.
Article 6.Thesystem ofepidemiological monitoring ofdiseases transmitted byfoodand
beverages shallconsist of:
(a) Compulsorynotificationbyanypublicorprivatehealthestablishmentofdiseasescaused
bytheintake ofanyfoodorbeverage tothedepartment appointed bythehealth authority
atnational level;
(b) periodical sampling toassess thesanitary quality offood andbeverages of
epidemiological significance;
(c) epidemiological information forconsumers.
Article 7.Thesystem ofsanitary authorization shallconsist of:
(a) Sanitarycertificationofinstallationsusedforthedevelopmentofoperationsorprocesses
concerning foodandbeverages;
(b) approval ofthehygiene programme based onhazard analysis andcritical control points
foreachprocess, depending onthetypeoffoodorbeverage;
(c) sanitary certification based onsampling andbatch analysis offoodandbeverages of
epidemiological significance.
Article 8.Allfoodandbeverages forhuman consumption intended forexport shallbesubject
toofficial sanitary certification.
Article 9.Provisions ofspecific relevance tothisSupreme Decree shallbeissued byministerial
resolution oftheMinistry ofHealth, ontheproposal oftheDIGESA, particularly withregard to:
(a) Theprocedures forobtaining sanitary authorization;
(b) theprocedures fortheofficial sanitary certification ofexports;
(c) definitions andgeneral principles ofhygiene;
(d) theprinciples andcontent ofhazard analysis andcritical control points (HACCP);
(e) codes ofhygienic practice foreachcategory offoodstuffs.
Article10.TheDIGESAshallpresideovertheNationalCommitteeoftheCodexAlimentarius.
Fortherevision andharmonization ofsanitary regulations, technical committees shallbeestablished
withtheparticipationoftheprivatesector,organizationsrepresentingproducersandtraders,professionals
ofrecognized repute andthePeruvian University. Account shallbetaken, intherevision process,G/SPS/GEN/16
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oftheinternational standards applicable tothesubject, particularly those oftheCodex Alimentarius
andtheWorld Trade Organization (WTO).
- TheDIGESA shallissue regulations governing theorganization andfunctioning of
theNational Committee oftheCodex Alimentarius, which shall beapproved by
ministerial resolution oftheMinistry ofHealth.
Article11.Fortheprotectionofpublichealth,thehealthauthoritymaypromulgatethefollowing
preventive measures:
(a) Confiscation: i.e.thewithdrawal, forpurposes ofdestruction, offoodandbeverages
thatdonotmeetsafety standards, withnopossibility ofcompensation ordamages.
(b) Partial ortotalsuspension ofbusiness: i.e.theinterruption ofactivities andoperations
carried outinafood plant which does notconform tosanitary andhygienic
requirements.
Thesuspension ofbusiness shallbelifted ifandwhen thegrounds orfactswhich led
toitsimposition areremedied.
Ifthesuspension ofbusiness isnotlifted within one(1)yearofitsbeing imposed,
anysanitary authorization previously granted shallberevoked.
(c) Exclusion ofworkers: i.e.thewithdrawal orremoval ofaworker fromtheactivities
heperforms when hisstateofhealth constitutes apublic health hazard, foraslong
astheproblem persists.
Article12.InfringementsoftheseRegulationsandofthespecificsanitaryrulesarisingtherefrom
shallbesubject tothefollowing penalties:
(A) Warning and/or reprimand: applicable toinfringements defined asminor, which do
notjeopardize public health andwhere thecauses thereof arecorrected within ashort
period oftime.
(B) Fine: apecuniary sanction imposed inaccordance withtheseriousness oftheoffence
anddetermined onthebasis ofthefiscal unitsubject totaxation (Unidad Impositiva
Tributaria -UIT).
(C) Publication ofpenalties: tosetanexample, andprovided thatthere issome element
ofrisktohealth andrepetition ofsimilar offences, thehealth authority mayorder
publication ofthepenalties imposed.
Article 13.Theapplication ofadministrative penalties shallbenobartocriminal procedures.