Decision No. 118/2008/QD-BNN promulgating the Regulation on inspection and certification of food quality, hygiene and safety of fisheries goods

26 OF FICiAL GAZETTE Issue no121December2Q08 (GOng Bao nos 703-704JDecember 30, 2008) structure of the Agriculture and Rural Development Ministry; Pursuant to the November 26, 2003 Lawon Fisheries and the November 20 20071.nw on Quality ofProducts andGoods; Pursuant to the July 26, 2003 Ordinance on Foud Hygiene and Safety, and the Govemmeru's Decree No. J6312004/ND-CP of September 7, 2004, detailing the implementation ofa number ofarticles oftlu: Ordinunce on.Food Hygiene und Safety; Pursuant to the Government's Decree No. 79/ 20081ND-CP ofJuly 18, 2008, providingfor the system for management. inspection and testing offood hygiene and safety; DECISION No. 11812008/QD-BNN OF DECEMBER 11, 2008, PROMULGATING THE REGULATION ON INSPECTION AND CERTIFICATION OF FOOD QUALITY, HYGIENE AND SAFETY OF FlSHERIES GOODS THE MINISTER OFAGRICULTURE AND RURAL DEVELOPMENT Pursuant to the Government's Decree No. OJ/ 2008/ND-CP of January 3. 2008, defining the functions, tasks, powers and organizational Pursuant to Joint Circular No. 2412rxJ51ITLT BIT-BTS of December 8. 2005, of the Health Ministry and the Fisheries Ministry (now the Agriculture and Rural Development Ministry), guiding the task assignment and coordination in state management offood hygiene and safety of aquatic products; At theproposal ofthe director ofthe National Agro-Foresrry-Fisheries Product Quality Assurance Department, DECIDES: Article 1.- To promulgate together with this Decision the Regulation on inspection and certification of food quality, hygiene and safety of fisheries goods to supersede provisions on inspection and certification of food Quality, hygiene and safety offisheries goods used as foods e VIETNAU LAW & LEGAL FORUM Issue no 12JDecember 2008 OF fie I.t..L GAZEl l E (Cong Bao nos703-701/DGCQfllb6r 30, 2008) in the Regulation on state inspection and certification of quality of fisheries goods, promulgated together with Decision No. 6501 2000/QD-BTS ofAugust 4, 2000,of the Fisheries Minister (now the Agriculture and Rural Development Minister). Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO." Article 3.- The director of the Office of the Ministry, the director of the National Agro Forestry-Fisheries Product Quality Assurance Department, heads of units of the Ministry, and directors ofprovincial-level Agriculture and Rural Development Services shall implement this Decision. For the Ministerof Agriculture and Rural Development VICe Minister LUONG LE PHUONG REGULATION ON INSPECTION AND CERTIFICATION OF FOOD QUALITY, HYGIENE AND SAFETY OF FISHERIES GOODS (Promulgated together with the Agriculture and RuralDevelopmentMinistersDecision No. J181 2U08lQU-BNN ofDecember 11,2008) Chapterl GENERAL PROVISIONS Article 1.- Scope of regulation This Regulation specifies the order and procedures for and tasks of inspection and certification of food quality, hygiene and safety of fisheries goods, andresponsibumes and powers of parties involved in the inspection and certification. Article2.- Subjectsofapplication 1. This Regulation applies to fisheries goods tordomesticconsumption orexport,andimported fisheries goods (including those imported for processing, recalled or returned from abroad). 2. The Regulation is not compulsorily applicable to: aJ Aquatic products being foods carried along for personal consumption or presentation as gifts; sample goods for display at exhibitions or trade fairs or sent to customers for non-marketing purposes; diplomatic bags and consular bags under law; bl Fisheries goods temporarily i.mported for re-export; temporarily exported for re-import, transi ted or transported via the Vietnamese territory, or consigned to bonded warehouses: cI Fisheries goods not used as food. 3. For export fisheries goods subject to quarantine undercurrent regulations, fuod quality, hygiene and safety inspection agencies shall conduct the food quality, hygiene and safety inspection and quarantine concurrently. Article 3.- Interpretation of terms In this Regulation, the terms below are construed as follows: e VIETNAM LAW & LEGAL FORUM 28 OFFICIAL GA.ZETTE Issue no121December 2008 (CongRAI) nos703-7~cem/:l.:!r 30, ?flOe) 1.Aquatic products means all aquatic animal or plant or amphibian species, including their spawns and parts used as food, or food mixtures containing aquaticproducts. 2. Fresh aquatic product means an aquatic productincarcassor processed notbyanymethod other than freezing. 3. Live aquatic product means an aquatic animal or plant which is Iive or maintained in an anabiotic state. 4. Fisheries good means an aquatic product which is marketed or consumed through barter, sale and perchase, or marketing. 5. Inspected goods batch means a volume of aquaticproducts registeredby the owner for one rimeinspection. 6. Certified goods batch means a volume of aquatic products registered by the owner for certificationthatit is an inspectedfisheriesgoods batch with a foodhygiene and safety certificate. 7. Recalled goods batch means a fisheries goods batdt recovered by the owner at his/her/its own will 8. Returned goods batch means an export goods bi:tJd.l rt:-t:xVU1 Leu back to Vietnam by 1I1c importingcountry or a customer. 9. Mandatory inspection means activities of inspectingandcertifying the foodquality, hygiene and safety of fisheries goods according to state management requirements. lO. Requested inspection means activities of inspectingandcertifyingthefoodquality, hygiene and safety of fisheries goods at the request of product owners. 11. Designated inspection agency means a qualified inspection and certification organization designated by the Agriculture and Rural DevelopmentMinistrytojoin in the foodquality, hygiene and safety inspection and certification of fisheriesgoods. 12. Competent agencymeansanagencytasked to perform the state management of food quality, hygiene and safetyof aquaticproducts. Article 4.- Forms of inspection 1. Mandatoryinspection applies to: at Fisheries goods of aquatic product production and trading establishments managed by the Agriculture and Rural Development Ministry before they are marketed for domestic consumption; hi Fisheries goods exported to markets with requirementsfor foodquality,hygieneand safety inspection and certification by Vietnamese competentagencies; cIFisheriesgoods exportedto marketssubject to inspection and certification prescribed by the Agricultureand Rural Development Ministry to meet the line management requirements in each period; dJ Fisheries goods imported for use as raw materialsfor processing establishments; eI Recalledor returned fisheries goods. 2. Requested inspectionapplies to: aI Fisheries goods not subject to inspection under Clause 1 of thisArticle; bIFisheries goodsspecifiedinClause2,Article 2 of this Regulation,at customer request; © VIETNAM LAW & LEGAL FORUM Issue no121December2008 OF FieIAL GAZETTE (Crmg Rao nos 7fJJ-7()4H)ernmher 31), 20(8) 29 d Specific contents of objects specified in Clause 1 of this Article, which are not subject to inspection, at goods owner request. Article 5.- Inspectionagencies 1.Agencies and units assignedby provincial levelAgriculture andRural Development Services to performthe specializedmanagement of food quality, hygiene and safety of aquatic products shall inspectandcertifyfoodquality, hygieneand safetyof fisheriesgoods beforetheyaremarketed for domestic consumption. 2.Agenciesandunitsunderthe NationalAgro Forestry-Fisheries Product Quality Assurance Department shallinspectandcertifyfoodquality, hygiene and safetyof exported fisheriesgoods or fisheries goodswhichare imported forprocessing, recalled or returned (below collectively referred toas imported fisheriesgoods). 3. Designated inspection :'!8"p.nc:ip.s s[1f',ci fied by law and inspectionagencies specifiedin Clauses 1 and 2 of this Article shall inspect and certify food quality. hygiene and safety in the case of requested inspectionand certification. Article 6.- Bases for inspection and certification 1. Bases for inspection and certification of fisheries goods marketed for domestic consumptionarefoodquality, hygieneand safety regulations and technical regulations issued by theAgricultore and RuralDevelopmentMinistry and concerned ministries and branches; and production establishments' product quality notifications. 2. Bases for inspection and certification of fisheries goods specified at Points c, d and e, Clause 1, Article 4 of this Regulation are food quality, hygiene and safety regulations and technical regulations issuedby theAgriculture and RUT:'!I Development Ministry and concerned ministries. 3. Bases for inspection and certification of fisheries goods specified at Points b, Clause 1, Article 4 of this Regulation are food quality, hygiene and safety regulations issued by or recognized by importing markets, or treaties or international agreements which Vietnam has signed or acceded to. 4. For the case uf requested inspection and certification, inspectionand certification shallbe based onrequestsof goodsowners andcompl iant with regulations and technical regulations of VIetnam or importing markets. Article 7.- Certificatesand notices of failure 1. Certificates of food quality, hygiene and safetyof fisheries goods andcertificatesof results of inspection of fresh or live aquatic products (belowcollectively referredto as certificates) will beissuedbyinspection agenciesforgoodsbatches with satisfactory inspection results. Each goods batchregistered forinitialinspection willbe issued a certificate. Certificates will be valid only for goods batches under such transportation and preservation conditionsthatdo not affectthe food quality, hygiene and safety of the inspected fisheriesgoods. 2. For exported fisheries goods: Certificates willbeissued.onlyfor goodsbatches,eachhaving the maximum volume of 3 (three) 40-feet containers, for tra (Sutchi)catfish, or 1(one) 40, e VIETNAM LAW &LEGAL FORUM 30 OFFICIAL GAZETTE Issue nQ 12JDecem.ber2008 (CrmgRAn nns 7fl'J-7D4!DP.~mher .10, ?mJI) feet container, for other products. 3. Notices of failure to satisfy food quality, hygiene and safety standards of fisheries goods (below referred to as notices of failure) will be issued by inspection agencies to goods batches with unsatisfactory inspection results. 4. Certificates ornotices of failure wilJ be: aI Issued according to a set form provided in Appendix 2b (applicable to fresh or live aquatic products) or Appendix 2a (applicable to other aquatic products) or Appendix 2c to this Regulation applicable to fisheries goodsspecified at Point a, c, d and e, Clause 1, Article 4 of this Regulation. particularly for tishenes goods specified aI: Point b, Clause 1, Article 4 of this Regulation, certificates will havethecontentsand Iormat required by importing markets and bear the national emblem; hi Issued according to forms set by goods owners without bearing the national emblem, for cases specified at Point a, Clause 2, Article 4 of this Regulation, or may be issued according to a set fonn provided in Appendix 2a or Appendix. 2b to this Regulation at customer request but without bearing the national emblem; d Numbered accordingtoAppendix 3c to this Regulation; dI For 'a certificate or notice of failure, the original shall be handed to the goods owner while one copy shall be kept at the inspection agency. The number of copies of a certificate or notice may increase if the goods owner so requests. 5. If requested by goods owners or importing markets, inspection agencies may additionally issue other certificates not contrary to previously issued certificates. The serial numbers of arlrlitionally i!':!':lIfod ("t"rtific,Mp.!,: must contain identification signsidentical to theserialnumbers of previously issued certificates. 6. When goods owners apply for renewed certificates, inspection agencies shall withdraw previously issued certificates and consider issuing renewed certificates. A renewed certificate must be clearly printed with the words "Thiscertificate replaces certificate No ... dated..."In case goods owners fail to return previously issued certificates, they shaH clearly explain in writing the failure with proving documents and evidence. Theserial numbers of renewed certificates must contain identification signs identical to the serial numbers ofold certificates. Article 8.- 'Jesting laboratories involved in inspection and certification Testing laboratories involved in food quality, hygiene and safety inspection and certification include: a!Testing laboratories of inspection agencies and units specified in Clauses 1 and 2, Article 5 of this Regulation; hi Other testing laboratories satisfying the conditions specified by the Agriculnire and Rural Development Ministry and assessed and designated by the National Aaro-Porestrv FisheriesProductQualityAssurance Department or a competent inspection agency. Article 9.- information displayed on product packages and labels 1. Fisheries goods for domestic consumption or imported for processing must comply with © VIETNAM LAW & LEGAL FORUM Issue no121December2008 O!="~ICIAl GAZETTE (COng Baa nus703-704tDffl.vmbtlr 30, 2(08) 31 Vietnam's current regulations on labeling. 2. Packages and labels of export fisheries goods may contain information requested by customers but must neither cause misleading as to the nature of these goods nor violate laws of Vietnam and importingcountries.Particularly for exportfisheriesgoods specifiedat Pointsband c, Clause 1, Article 4 of this Regulation, their packages and labels must also contain the followinginformation: aJ Productof Vietnam; bl Manufacturercode; cI Product lot cede; dI Main ingredientsof product; eI Information required by export market (if any). Article 10.- Conditions on fisheries goods to be exported. imported or marketed for domestic consumption 1.Fisheriesgoodsspecified at Point a, Clause 1, Articlc 4 of this Regulation may be circulated when satisfyingany of the following conditions: aJ Being manufactured by establishments accreditedashavingsatisfiedallfood hygieneand safety assurance conditions or certified a.s conducting sustainable aquaculture (for aquaculuu e establlsluueuts), hi Havingpackages or labels bearingsignsof recognition of standardandregulationconformity; cl Having a food quality, hygiene and safety certificate issuedaccordingto a setformprovided inAppendix2aor 2b to thisRegulationaccording to the procedures specified in Article 12 of this Regulation; d/ Having an origin and food hygiene and safety control certificate issued according to the implementation results of national supervision programs by program-implementing agencies according to procedures specified in regulatory documents on the implementation of these programs. 2. Fisheries goods specifiedat Point b, Clause 1, Article 4 of this Regulation may go through customs procedures for export if theirmanufac turers are named on the list of manufacturers of exports to relevant markets announced by a competentVietnamese agencyin eachperiod 3. Customs proceduresshallbe completedfor fisheries goods specified at Points c, d and e, Clause 1,Article 4 of this Regulation when they are accompanied with either of the following documents: aJ Food quality,hygiene and safetycertificate issued according to a set form provided in Appendix2aor2bto thisRegulation(not printed herein); b/ Notice of exemption from food quality, hygiene and safety inspection ofaquatic products specifiedin Appendix 2d to this Regulation. 4.Forfisheries goodsspecifiedatPointa,Clause 2, Article 4 ofthis Regulation, certi ficates U1 uouces of inspection exemptionarenot required. Chaptcrll ORDER AND PROCEDURES FORAND TASKS OF INSPECTION AND CERTIFICATION e VIETNAM LAW & LEGAL FORUM 32 OF FieiAL GAZETTE l$Sue no12/December 2008 (Cong Sao nos 703-7041December 30, 2008) , Article 11.- Registration for inspection L A goods owner shall make a dossier of registration for inspection, which comprises a registration paper for food quality, hygiene and safety inspection, made according to a set fonn provided in Appendix la to this Regulation, the goodsbatch manifestand astatementofparticular requirementson food quality,hygieneand safety of fisheriesgoods (if any). 2. For imported fisheries goods, apart from thosespeGified in Clause 1of thisArticle, a dossier of registration for inspection must also contain the following: aJ Forfisheriesgoods importedforprocessing: a copy of the purchase and sale contract; a copy ofthecertificateof foodquality, hygiene andsafety of fisheriesgoods;and a copy of thecertificateof origin; bl For recalled or returned fisheries goods: a copyof thDcertificate of foodquality, hygieneand safety of the fisheries goods batch before exportation (if any); and a copy of the notice of recall orreturn,clearlystating thereasontherefor. 3. Goods owners shall send their dossiers of registration for inspection to inspection agencies directly orby postor viafacsimile (withtelephone confirmation) oremail,or make onlineregistration via the Internet then submit registration dossiers to inspectionagencies upon inspection. 4. Upon receiving dossiers of registration for inspection, inspectionagenciesshallconsiderand guide goods owners to supplement omitted or improper details and give certification in the papers of registration for inspection, then notify goodsownersof inspectionproceduresandreach agreement with the latter on places where inspection is to be conducted. Article 12.- Tasks of inspection of fisheries goods for domestic consumption 1. For fresh or live fisheriesgoods: a/ Examining the manufacture dossier and quality control dossier of the goods batch; bl Inspecting preservation conditions, packaging specifications, theouterappearance and features of products; c/When necessary, takingcontrolsamples for biologicaland chemicalverification. 2. For other fisheriesgoods: a/ Examining and inspecting the contents specifiedat Pointsa andb, Clause I of thi sArticle; b/ Inspecting the labelingof products; cl If the contents specifiedat Pointsa and b of this Clause are compliant with regulations, taking samplesformicrobiological andchemicalanalysis according to specific requirements on each type of product, at laboratories specified in Article 8 of this Regulation. Article 13.- Tasks of inspection of fisheries goods for export 1. For fresh or live fisheriesgoods: aI Examining the manutacture dOSSIer and quality control dossierof the goods batch; bl Inspe cting pre serv ation condi tions, packaging and labeling specifications, the outer appearance and featuresof products; dWhen necessary, takingcontrol samples for biologicaland chemical verification. e VIETNAM LAW &LEGAL FORUM Issue no121December200B OF~ICIAL GAZETTE (Cong Dao nos 703-704lDecember JO, 2(08) 33 2. For other fisheries goods: at Examining and inspecting the contents specifiedatPointsa and b,Clause1of thisArticle; bl If the contents specified at Point a of this Clause are compliant with regulations, taking samples formicrobiological andchemical analysis according to specific requirements on each type of product, at laboratories specified in Article 8 of this Regulation. Article 14.- Tasks of inspection of imported fisheriesgoods 1.Forfisheries goodsimportedforprocessing: a/ Certifying the written registration for carryingout customs procedures; bl Examining the dossier, and inspecting preservation conditions, packaging and labeling specifications, the outer appearanceand features of products at the place where products are gathered as indicated in the written registration; cl If the contents specified at Point a of this Clause are compliant with regulations, taking samplesformicrobiological andchemicalanalysis according to specific regulations applicable toeach type ofproduct,at laboratories specifiedinArticle 8 of this Regulation. 2. For recalled or returned fisheries goods: a/ Certifying the written registration for carryingout customs procedures; bl Inspecting preservation conditions, packaging and labeling specifications, the outer appearanceand features of productsat the place whereproducts are gathered; cl Taking samples for microbiological and chemicalanalysis(onthebasisof riskassessment) accouliug tu specific regulations applicable to each type of product,at laboratories specifiedinArticle 8 of this Regulation. 3. Post-importationcontrol: a/ Goods ownersshallreport to the inspection agencyon measuresalreadytaken withrespect to their imported goods batches, and sale markets; bl The inspection agency shall verify goods owners' reportsthroughinspectingthesafetyand hygiene assurance conditions of Imlnt'tfacturing establishmentsor upon inspectingandcertifying that the goods batchhas been manufacturedfrom an importedmaterialslot,or on an irregularbasis (ifnecessary). Arlif.;U: 15.- I&:;LuUllX uf ceni Iicates 1.After concluding theon-site inspection,the inspection agency shall issue a certificate for the goods batch with satisfactory inspection results within the following timelimit: at1(one)working dayforfreshorlivefisheries goods for export or domesticconsumption; bl 10 (ten) workingdays for canned products; cl 7 (seven) working days for oth<u" types of product; d/ In caseofnecessity tosend productsamples for analysis at a laboratory, the inspection agency shall issue a certificate of food quality, hygiene and safety for fisheriesgoods to the goods owner within 1 (one) day aftei I ecel ving analysis results, 2. Contentsofcertificationmust be consistent withcontentsofinspection. Certificationwillnot begiven to uninspectedcontentsorproducts with e VIETNAM LAW & LEGAL FORUM 34 OFFICIAL GAZETTE Issue no12/December 2OQ8 (Cong Bllo nos 7Q3-7Q4A)eccmber 30, 2008)-------- .. -- . . ------~ unsatisfactoryinspection results. 3. Particularly for export fisheriesgoods: Un the basis of mutual recognition of inspection capability, the inspection agency may issue transitional certificates based oncernncates ISsued by another inspection agency. A transitional certificatemustbeissuedonthesame date of issue of the previously issued certlticate and not be contrary to the latter. Articl« 16.- Handling of aoods with unsatisfactory inspection results 1. Upon obtaining unsatisfactory inspection results of a goods batch, the inspection agency shall: aI Send analysis results to the goods owner within 1 (one) day after obtaining these results by directdelivery, facsimileore-mail, then send the originalrecord of theseresults by post; bI If the goods owner makes no complaint about these analysis results within 3 (three) workingdaysafterreceiving them,the inspection agency shall send a notice of failure, made according to a set form (not printed herein), to thegoodsownerandrequestin wriringfunctional agenciesfor coordinatedhandling. 2. The inspection agency shall send unsatisfactory verification results to the goods owner via facsimileor e-mail within I (one) day afterobtainingthem, thensendtheoriginalrecord of verificationresultsby post. 3. After receiving a notice of failure or unsatisfactory verification results from the inspection agency, the goodsownershallorganize investigation of thecauses ofcontamination; lake measures to redress these causes and handle the goods batch: appraise the effectiveness of these measures and report thereon to a relevant competentagency. 4. The competent agency shall verify enterprises' reports. When necessary, it may conduct on-site verification at manufacturing establishments. Chapter III EXEMPTIONFROM INSPECTION. REDUCEDINSPECTIONAND INTF.NSTFJRD INSPECTION Article 17.- Cases of application 1. Fisheries goods specified at Points a and e, Clause I, Article 4 of this Regulation may be consideredfor exemptionfrom inspectionif they satisfy the conditions specified in Article }8 of this Regulation. 2. Fisheries goodsspecifiedat Points bandd, Clause 1, Article 4 of this Regulation may be consideredfor reduced inspection if they satisfy the conditions specified in Article 20 of this Regulation. 3.Fisheriesgoods specifiedat Pointsa, b and d, Clause 1, Article 4 of this Regulation may be consideredformtensified inspection if theyviolate the provisionsofArticle23 of this Regulation. 4.Fisheriesgoods specifiedat Pointc, Clause 1, Article 4 of this Regulation will be inspected withinthe scopeandunderthe regimeprescribed in specific regulations of theAgriculture andRural Development Ministry applicable to specific e VIETNAM LAW & LEGAL FORUM Issue no121December2008 OFFICIAL GAZETTE (Gong BaDnos 703-7041December JO, 7()()R) ,- ." 35 cases. Article 18.- Conditions on exemption from inspection 1. Fisheries goods are manufactured at establishments on the list of manufacturing establishments exempt from inspection announced by the National Agro-Forestry FisheriesProductQualityAssuranceDepartment in each period, or 2.Fisheriesgoodshavebeensubjectedto food quality, hygiene and safety inspection and certificationbeforetheirexportation. Article 19.~ Order of and procedures for exemption from inspection 1. Goods owners shall make written requests for exemption from inspectionaccording to a set fonn (not printed herein). 2. Within 1 (one) workingday after receiving a request for exemption from inspection, the inspection agency shall consider and verify relevant contents, and: a/ Issuea noticeofexemptionfrom inspection, madeaccordingtoa setform (notprinted herein), in case the conditions specified in Article 18 of this Regulationare fully satisfied; bIClearlystatethereason(s)forrefusalto issue a notice of exemption from inspection in the writtenrequestand send itbackto thegood owner in case the conditions specified in Article 18 of this Regulationare not fully satisfied. Article20.- Conditionson reduced inspection 1. For export fisheries goods: a/ Within 12 (twelve)months before the date of requestfor reduced inspection, the safety and hygiene assurance conditions of enterprises' manufacturing establishments are graded HAlO, and; b/ Enterprises shall thenisel vcs inspect safety and hygiene assurance conditions of their manufacturing establishments and send reports thereon to the inspection agency underregulations on theNationalAgro-Forestry-FisheriesProduct QualityAssurance Department, and; Cf Within 12 months beforethe dateof request for reduced inspection: No goods batch is warned by a competent agencyof theimportingcountryspecifiedat Point b, Clause 1, Article 4 of this Regulation as violating regulationson foodquality, hygieneand safety, and; No violationof regulations on impurities or abuse of chemical growth stimulants and ice glazing ratio for the purpose of trade fraud is detected, through inspection or examination, by a functionalagency, and; No goods batch or product sold on the domestic market is detected as having failed to assurefood hygiene and safety criteriaregarding banned chemical and antibiotic residues (particularly, instant foods must also satisfy the microorganismgenn criteria), and; d/ There are testing laboratories capable of analyzing microorganism and indusnialsanitation criteria andsupervising themanufacturing process as indicated in the quality control programs of enterprises underregulations of theNationaiAgro Forestry-Fisheries Product Quality Assurance Department. For other criteria specified in the © VIETNAM LAW & L.EGAL FORUM 36 OFFICiA.L GAZETTE Issue no 121Decembef' 2008 (Cong Bao nos 703-7041December 30, 2008! quality control programs of enterprises which testing laboratories are incapable of analyzing. enterprises shall send goods samples to testing laboratories designatedundercurrentregulations by the Agriculture and Rural Development Ministryfor analysis; eIForenterprises whichhave been subjected to reduced-inspection: They have. committed not more than two violations in conducting self inspectionof theirmanufacturingdossiers, quality conrml dossiers, preservation conditions, outer appearance and features of goods and labeling information; or obtain results of analysis of microorganism orchemicalcriteriaconductedby themselves different from results of ordinary inspection of goods batches conducted by the inspectionagency. 2.Forfisheries goods importedforprocessing: a/Imparted goodsbatcheshavebeencertified as satisfying food quality, hygiene and safety requirements on fisheries goods by competent agencies of countries which have signed with Vletuaru agllXlIlt:lIU; Ull uiutual recognition of inspection and certification of food quality, hygiene and safety of fisheries goods, or for the last 6 (si:'t) monthsv S (five) consecutive goods batches of the same type and origin have been inspectedand certifiedas satisfying food quality, hygiene and safety requirements on fisheries goods,and; bl These goods originate from countries without seriousproblemsrelated LV food quality, hygiene and safety of fisheries goods as announced by the Agriculture and Rural Development Ministry in each period. 3. During the application of reduced inspection. enterprises which fail to satisfy the conditions specified in Clauses 1 and 2 of this Article will no longer enjoy reduced inspection until theysatisfy thefollowingconditions: a1They makereportsexplainingthereason(s) for the failure and apply effective remedies certified by the inspection agency: bIParticularly forexportgoods,theymustalso have at least 10 (ten) goods batches eligible for customs clearance on markets specified at Point b, Clause 1,Article4 of this Regulation. Article 21.- Reduced inspection of export fisheries goods I. Procedures forconsidering the application of reducedinspection at Enterprises shall send written requests for reducedinspection, madeaccording to a setform (not orinted herein), to the inspection agency underArticle5 of thisRegulation; bl Within 20 (twenty) working days after receiving written requests of entt'.rpri~el:, the inspection agency shall organizetheconsideration andexamination ofrelevantdossiersandconduct verification at enterprises; cl Within 7 (seven) working days after concluding the verification at enterprises, the inspection agency shall: Send noticesof reduced inspection of food quality, hygiene and safety of fisheries goods, made according to a set form (notprinted herein), if results of examination of dossiers and verification are satisfactory. Send notices of ineligibility for reduced e VIETNAM LAW &LEGAL FORUM Issue no 121December2008 0 FFIC IAL GAZETTE (O'ina Ran n(l~ 7llH(J4A)P.fflmhe,3O, 2008) 37 inspectionof food quality, hygiene and safetyof fisheries goods, made according to a set form (not printed herein), if results of examination of dossiers and verificationare unsatisfactory. 2. Reduced inspection aJ Testing laboratories of enterprises shall conduct inspection and keep by themselves all inspectionresultsunderapproved quality control programs; bI Enterprisesshall registerfor inspectionand certification of food quality, hygiene and safety offisheries goodsbatchesunderArticle 11 of this Regulation at least 5 (five) working days before the expected date ot issuance of certificates. Enclosed with a registration dossier must be analysis results relatedto thegoodsbatch specified at Point a, Clause 2 of this Article and a detailed statement of information on the issuance of the certificate; d After examining registration dossiers of enterprises, the inspection agency shall give a certification in the registration papers and send them back to goods owners, clearly stating whethergoods batches willbe subject to reduced inspectionor ordinaryinspection.The inspection agency shallconduct ordinaryinspection of only 1 (one) random goods batch out of 5 (five) consecutive goods batches registered by an enterprise for inspection under Point b, Clause 2 of this Article. Inspection and certification of goodsbatchessubjectto ordinaryinspectionshall be conducted under Chapter II ofthis Regulation: dJ For goods batches eligible for reduced inspection: Within 1 (one) working day after receivingcompleteregistrationdossiersof goods owners, based on results of self-inspection by enterprises, the inspection agency shall verify information in thesedossiersandissuecertificates made according to forms set by importing countries Article 22.- Reduced inspection of imported fisheriesgoods 1.Enterprisesshall registerfor inspectionand certification of food quality, hygiene and safety of their fisheries goods batches underArticle 11 of thisRegulation at least 5 (five) working days beforethe expected dateofissuance ofcertificates. Enclosed with a registration dossier is a detailed statement of information on the issuance of the certificates. 2. Inspectiontasks: aJ Examining registration dossiers, giving certificationinregistrationpapers, clearlystating the inspection regime, if dossiers are valid, and sending them back to goods owners; bl Inspecting preservation conditions, packaging and Labeling specifications dud the outerappearanceof productsatgatheringplaces, for all goods batches registeredfor inspection; d COnducting inspectiononly byobservanon and taking samples for microorganism and chemical analysis from 1 (one) random goods batch out of 5 (five) consecutive goods batches registered by an enterprise for inspection under Clause 1of thisArticle. d! For goods batches eligible for reduced inspection: Within 1 (one) working day after conducting the on-site inspection, the inspection agency shall ISSue certiticates according to a set © VIETNAM LAW & LEGAL FORUM 38 OFFiCIAL GAZETTE Issue no 121December 2008 (Gong Baonos 703-704/December YJ, 2(08) ,-------,-~~'. ,----, form (not printed herein). Article 23.~ Cases ot intensifiedinspection 1. Export fisheries goods are subject to intensified inspection when their owners: aJ Are subject to intensified inspection under the Regulation on inspection and recognition of fisherie s goods-manufac turi ng or - trading establishments which satisfy food hygiene and safety assurance conditions specified by the Agriculture and Rural DevelopmentMinistry. bl Are warned by competent agencies of importingcountriesas specified at Pointb, Clause 1> Artic Ie4 of this Regulationas having violated regulationson foodquality, hygieneand safetyof fisheriesgoods in 2 (two) or more goods batches mayear. 2. Fisheries goods for domesticconsumption are subject to intensified inspection when their owners: aIAre subject to intensified inspection under the Regulation on inspectionandrecognition of Iisheries goods-mauuf'acturlug 01 -trading establishments which satisfy food hygiene and safety assurance conditions specified by the Agriculture and Rural Development Ministry. bIArewarnedbydomestic competentagencies as havingfailed toassurefoodhygieneand safety regardingbannedchemicalandantibiotic residues and microorganism germ criteria (for instant foods). 3. Goods imported for processing are subject to intensified inspection when: aJ They originate from exporting countries subjectto seriouswarnings aboutbannedchemical or antibioticresidues, or; hi Lots of materials of the same species or the same originare detected asfailing to assure food quality, hygieneand safety of fisheries goods. Article 24.~ Tasks and order of intensified inspection 1. The inspection agency shall send to enterprises written notices of intensified inspection, clearly stating the reason(s) for intensifiedinspection. 2. Inspection tasks: Apart from ordinary inspection tasksasspecified, intensified inspection of fisheriesgoods involves the following tasks: aI For export fisheries goods: taking samples for analysis of criteria warned by competent agencies of importing countries or relevant criteria, in a number doubling that of samples taken for ordinaryinspection. bI For fisheries goods imported forprocessing: conducting additional analysis of criteria about which there are warnings or taking a number of samples doubling that of samples taken foe ordinaryinspectionbeforeconductinganalysisof criteria detectedas failing to assure food quality, hygiene and safety. cl For fisheries goods for domestic consumption: taking samples for analysis of criteriawarnedbydomestic competent agencies, in a number doubling that of samples taken for ordinaryinspection. 3.Fisheriesgoods wiII no longer be subjectto intensified inspection when the following requirementsare met: aJ Enterprises report on the application of tel VIETNAM LAW & LEGAL FORUM 39Issue no 121December2008 OFFICIAL GAZETTE (GOng Biw nee 703-704!December 3D, 2(08) remedies and appraisal of che effectiveness of applied remedies as certified and notified in writing by the inspection agency, and; hi Forexport goods: These goods donot violate Point it., Clause 1, Article 22 of 1I1b Rc:guialiull and at least 5 (five) consecutive lots of the same goods exported to markets specified at Point b, Clause 1, Article 4 of this Regulation have satisfactory inspection results; dFor goods for domestic consumption: These goods do not violate Point a, Clause '2, Article '2'2 of this Regulation and at least 5 (five) consecutive lots of these goods have satisfactory inspection results; d/For imported goods batches: At least 5 (five) imported lots of the same goods of the same origin have satisfactory inspection results. Chapter IV RESPONSIBILITIES AND POWERS Article 25.- Responsibilities and powers of goods owners: 1. Responsibilities: aJ To Tt>,ei>;tp;r for inspection and l'1".rtifir:ltion of food quality, hygiene and safety of fisheries goods with an inspection agency under Article 5 of this Regulation: bl To create conditions for staffs of the inspection agency to perform inspection tasks and take samples, and supply sufficient relevant dossiers and documents; c/ To refrain from changing product characteristics ur labeling iufonuauon already registered and subjected to food quality, hygiene and safely inspection and certification; d/ To take responsibility for results of analysis of food quality, hygiene and safety criteria of fisheries goods carried OUI by themselves with regard to export goods batcheseligible for reduced inspection; e/ To take appropriate measures to handle goods batches which fail to satisfy food quality, hygiene and safety requirements, returned or recalled goods batches at the request of the inspection agency and competent ageacies: f/ To pay inspection charges and certification fees under Chapter V, even in case they refuse to receive certificates or their goods batches fail to satisfy food quality, hygiene and safety requirements. 2. Powers: al To seleer an insper-rion ::l2pnc.y and ::l resting laboratory to conduct the analysis for cases specified in Clause 2,Article 4 ofthis Regulation; hI To be eligible for reduced. inspection ifthcy satisfy all the requirements specified in this Regulation; cl Th request the inspection agencj-to supply information, regulations and fOnTIS relesant to the inspection and certification of food quality, lIygiene and safety of fisheries goods muler this Regulation; d/ To disagree with inspection results; to request re-mspection with chemical analysis of stored samples; to seek expert assessment; to lodge complaints and denunciations about any improper acts of inspectors, the inspection agency and e VIETNAM LAW & LEGAL FORUM ()F~!ClAL GAZETTE Issue no 12JDecember2008 (Cong Bao nos703-7D4/Dscember 30, 2008) testinglaboratoriesunder law. Article 26.· Responsibilities and powers of inspectors 1.Responsibilities: aJ To conduct theinspectionand certification of food quality, hygiene and safety under n;gu1atioD3 within their assigned scope; blTo strictlycomplywiththeinspection order and procedures: to ensure the accuracy, trutnrulness and objecnvtry of me tnspecuon uf goodsbatches; ct 1'0 keep confidential information on production and business activities of inspected establishments; dJ To be answerable to the head of the inspectionagencyandheldresponsible beforelaw for their inspection results. 2.Powers: at To-request concerned establishments to supplyrelevantdossiersand samplesto servethe inspection: to photograph, copy or take notes of information necessary for inspection; bIToenter places whereaquaticproducts are manufactured, stored, preserved or transported for product inspection; cI Tc make written records of and seal up samples for a givenperiod of timenecessary for sending or reporting them to competent state agencies when having evidence to believe that concerned establisnmerus violate food quality, hygieneand safetyregulations; dI To refuse to conduct inspection in cases goods owners fail to comply with the provisions of Points a and b. Clause 1, Article 25 of this Regulation; eI To propose measures of handling food quality, hygieneandsafetyviolations. Article27.-Responsibilities andpowersof the inspection agency 1. Responsibilities: atToconductthe inspection and certification of food quality, hygiene and safety of fisheries goods underregulations and within me scope uf its assigned tasks and powers; to ensure the accuracy, truthfulness andobjectivity of inspection and certificarion; hiTosupplyformsandguide goodsownersin making dossiersof registrationfor inspection(if any) underregulations; cl To receive dossiers of registration for inspection, organize the inspection, sampling, testing andissueofcertificates or notices offailure according to theprescribedorderandprocedures and provisions of thisRegulation; dlTokeepinspectionandcertification dossiers for at least 2 (two) years and supply them to competentagenciesuponrequest; eJToreceiveandsettlein a promptandproper manner goods owners' complaints about its inspr:ction ami c.p.rtificarion of food quality. hygieneand safetyof fisheries goods; fl To take responsibility for its inspection TC:5ult3; contents of certificates and notices of failure; gI To pay damages to goods owners for consequences causedby i ts faults or errorsmade VIETNAM LAW & LEGAL FORUM Issue no 121December 2008 OFF ICIAL GAZETTE (Cong Bao nos 703-7041rJsc9mb6r 30, 2008) 41 during the inspection and certification under current law; hi TocomplywiththeNationalAgro-Forestry Fisheries Product Quality Assurance Deparuneru's uniformprofessionaldirection and guidanceand submitto itsperiodical examination and supervisionof theinspectionandcertification of food quality, liygieuc aud safety uf fisheries goods; ifTo sendquarter!y and annual reports on the mspectiou and certification of food quality, hygiene and safety of fisheries goods to the NationalAgro-Forestry-FisheriesProductQuality AssuranceDepartment ; j1Tocoordinate withotherinspectionagencies in supplying information upon request; kI To collect inspectionand certificationfees and chargesspecifiedin Chapter V. 2. Powers: at To request goods owners to supply documentsrelated to the originand food quality, hygiene and safety of goods batches registered for inspection; b/Totakesamples ofandinspectgoodsbatches under (his Regulation; d To refuse to conduct the inspection and certificationof food quality, hygiene and safety in case goodsowners fail to strictlycomply with the provisions of Clause 1, Article 25 of this Regulation; dI Torequestgoodsownerstodisposeofgoods batcheswhichfail to satisfyfood quality, hygiene and safety requirements under regulations; to monitorthedisposal and disposalresults; to report such to the National Agro-Forestry-Fisheries Product Quality Assurance Department; eI To propose concerned agencies to handle goodsownersthat fail to comply withregulations on food quality, hygieneandsafetyinspecuon and certification. Article 28.· Responsibilities and powers of testinglaboratories 1.Responsibilities: af To strrctly comply with the 1esting procedures, ensurecapability of testingequipment and keepconfidentialgoods owners' intbrmation under law; b/ To ensure that testing results are accurate and objective; to promptly notify and take responsibility for testing results; d Toparticipate in testingskill improvement programs at the request of the National Agro Forestry-Fisheries Product Quality Assurance Department; dI To store and preserve under regulations testing samples for at least 7 (seven) days after obtaining testing results for samples subject to inspectionof chemical criteria; eI To keep dossiers and documents related to testingactivities for 2 (two) years; fI To pay damages under current law to goods ownersforconsequences causedbyfaults or errors made during tests they have conducted. 2. Powers: at To refuse to receive samples not up to requirements; to refuse to test samples or criteria beyond the scope of accreditation; e VIETNAM LAW & LEGAL FORUM 42 OF Fie iAL GAZE"7"TE Issue no121December 2008 (Gdng Baa nos 703-704/December 3G, 2OOR) bl To be provided with information and training ('(lJ'lrlitinm: in nrcl~t to mise their te"'ting capability; cJ Tocollect testingfeesand chargesspecified bylaw. Article 29.- Responsibilities of the National Agro-Forestry-Fisheries Product Quality AssuranceDepartment 1. To provide uniformprofessional guidance for and periodically inspect and supervise the inspectioaagencies' inspection andcertification of foodquality, hygieneand safety offisheries goods. 2. To perform the unified management of professionaloperations of, and train, retrain and issuecertificates to, staffconducting theinspection and certification of food quality, hygiene and safetyof fisheriesgoods nationwide. 3. To receive dossiers for registration, evaluation and accreditation oftesting laboratories that have sufficient conditions for analyzing chemicaland micro-biological criteriaof aquatic products for fisheries goods inspection and certification. 4. To update informationon requirements of importing markets before notifying them to establishmentsand inspectionagencies. 5.Tosend biannualreports to theAgriculture andRural Development Mtnistry andconcerned agencies on theinspection andcertification offood quality, hygiene and safety of fisheries goods throughout the counuy, 6.Tosumupandnotifyonaregularorirregular basis the following lists: at A list of criteria subject to inspection and permissible limits applicable to each fisheries g()Clrl<dfi"h",ri",,, ennrl." ernllp on relevant markers; hi A listof testingmethodsand required trace limits of microbiological and chemical criteria related to food quality, hygiene and safety of fisheriesgoods. c/ A listof marketsreferred to at Points b and c, Clause 1, Article 4 of thisRegulation. dI A list of testing laboratories accredited by the National Agro-Forestry-Fisheries Product Quality AssuranceDepartment as qualified for analyzing foodquality, hygieneandsafetycriteria of fisheries goods. 7. To provide guidance on the forms and methods of management of certificates for uniformapplicationnationwide. 8.Toguideinspectionagenciesin conducting reducedinspectionunder this Regulation. Article30.- Responsibilities uflJruviucial-level Agricultureand Rural DevelopmentServices 1. To direct, guide and inspect the implementation of this Regulationby inspection agenciesunder theirmanagement. 2. To guide, disseminate and inspect the observanceof regulations of the Agriculture and RuralDevelopmentMinistryand theprofessional guidanceoftheNationalAgro-Forestry-Fisheries ProductQualityAssuranceDepartment. 3. To build the physical foundations and organizational apparatus of inspection agencies under their management in order to enable them toconducttheinspection andcertificationof food quality, hygiene and safety of fisheries goods under this Regulation within the ambit of their '0 VrETNAM LAW &LEGAL FORUM Issue no12/Deeember 2008 0 Fnc IAl GAZETiE (Cong Bao nos 7D3.7D4~mber'J{), 2OOB) 43 assignedpowers. 4. To coordinate wilh concerned agencies in their localities in organizing the guidance and public infonnation on, and education about food quality, hygiene and safety knowledge under their management. Chapter F INSPECTION AND CERTIFICATION FEES AND CHARGES Article 31.- Fees and charges 1. Inspection agencies may collect fees and chargesfortheinspection andcertificationoffood quality, hygiene and safety of fisheries goods under theFinance Ministry's current regulations. 2. Fees and charges for the inspection and certification of food quality, hygiene and safety of fisheries goods shall be managed and used underthe FinanceMinistry's current regulations. Chapter VI COMPLAINTS, SETTI..EMENT OF COMPLAINTS AND HANDUNGOF VIOLATIONS Article 32.- Complaints and settlement of complaints 1.Within3 (three)days after the inspection is concluded or receiving analysis results, goods owners may lodge complaints about .inspection results or requestinspection agenciesorconcerned testing laboratories to review inspection and testingresults. 2. Inspectionagencies shall receiveand settle complaints and denunciations of goods owners in accordance with the Law on Complaints and Denunciations. 3. Goodsowners shallbear all charges for re iJ ispcctiou uf stored samples ill case re-tnspection results are not different from initial inspection results. 4. In case inspection results of inspection agencies or testing laboratories are inaccurate, causing damage to goods owners, goods owners may claim damages under law. Article33.- Handling of violations I Acts violating this Regulation shall be handled under the Government's current regulations on handling of administrative violations in the fisheries domain and other relevantprovisionsof law. 2. Acts of obstructing or opposing operations of inspection agencies, and acts violating this Regulation andcausingserious consequences may be examined for penal liabilityunder law. Article 34.- The National Agro-Forestry FisheriesProductQualityAssuranceDepartment and provincial- level Agriculture and Rural Development Services shall sum up opinions of all organizations and individuals on problems arising in the course of implementation of this Regulation and submit them to the Agriculture and Rural Development Ministry for considerationand appropriaterevision. For the Minister of Agricultureand Rural Development VICe Minister LUONG LE PHUONG e VIETNAM LAW & LEGAL FORUM