Circular No. 19/2012/TT-BYT guiding the regulation conformity announcement and food safety regulation conformity announcement

Issue nos 08-09/November 2012 (Cong Bao,ws(J65.fX'lfv'Nr!veniher25, 2012) OFFICIAL GAZETTE 41 THE MINISTRY OF HEALTH Circular No. 19/2012/TT-BYT of November 9, 2012, guiding the regulation conformity announce­ ment and food safety regulation conformity announcement P11r1110111 lo the June ](), 20~.aw 011 Standards mu/ Teclmirnl Rcg11/a1iof!fs•und the (;//\'l'nl/lll'lll \ Decree No, I 27/2()(m7J.D-CP of 1\11g11s/ I. 2007, dcf(li/ing u ,rrfH1hcr of · arliclcs of the Lu\\' 011 SI01ul~/s and 'frch11icul Rcgulci1io11.1: P11rs1111111 to the l\/01·c111/>cr 21, =a17 L1n1 011 !1 rod11ct and Goods (21111/i1'311d 1/ic Go1·e1m11c111 '.I Decree No. 132/2()(;,fl,,JN/).CJ' of /)ccc111/1cr 31, 2008, dc1aili11u ;;,number . .~.,,,. of urticlcs of the La,, on Prud//ll 111'/"tJ Goods (211ali1,: l'urs1t<llll In the .!1111c 17. 2U Jrf1 <ill' on -Fond Sa/('f r Olli/ the (;1n·cm111c11,-./Jecree ' No. 3812012/N[).('p of 1\pril 1-t;. 201 :'., detoiling n 1u1mbcr of anicles of 1/fJ"taw on Food S({jc·tv: Pursuam to the Govem111e111 's Decree No. 63/2012/ND-CP 0/1\ugu.1I 31, 2012, d<Jini11R the fi111ctions, tasks, JJm\'Crs ond orguni;,u­ timwl structure o/ the Mi11is1n of 1/l'({lth: At the proposal of' the dircC/or of the Vietnam Food Ad111i11istrraio11; © VIETNAM LAW & LEGAL FORUM 42 OFFICIAL GAZETTE Issue nos 08-09/Nowmhe,· 2012 (Cong Ba.01101(/i "; NxlN01·c1 ihl.'I "-·'·".Of".) The Mi1 1istrv of' Health promulgates the Cfrcular guiding the regulation co11f'on11if\' a1111ou11ce11•c11t and food .rn,frt \· regulation confor111 ir ,· a111101111cc111c II r. Chapter I ,wENERAL PROVISIONS ArtidL'"I. Scope of regula,ticn fhis =!cular proviJes the order anJ Jossicrs for n.:gu~un conformity announcement anJ food t!ft:ty regulation conformity announ~1rnt (below rcferrcJ to as proJuct announc.:em,~111) for prepackaged processcJ ,,,e food, f~ 1JJitives, fooJ rlroccssing aids. ~ L packa~r1aterials anJ tools in Jirect contact with foe( below rcferreJ to as products): rcspons~litics of agencies receiving anJ registeriCegulation confom1i1.y c1n11ouncement and fo~ ~ afcty regulation conformity statemt,;.1~( ,clow referred to a:, rcgistration­ receivin~gcncies) anJ proJuct announcing organi2':8-ti.Qn', anJ inJiviJuals (below refcrrcJ to as orge§zations anJ inui\ iJuals): anJ post­ product .inJ;J( uncemcnt inspection. Art~. Interpretation of terms In this Circular, the terms below arc construcJ as I·ullows: product is conformable with fncd safety regulations. for products having no cum:-,punding technical regulations. :2. Major quality norms lllL'ans th,: k\L'ls or quantitic, ofsubsta11ccs ckcisi\L' to the nutritiuus value anc typical prnpntics of ;1 product.,, hich are used tu identify. classify :l!ld distinguish thL' proJuct from another fooJ nfthc sallll' typl·. .1. DcttikJ product ini'unnatiun sil,·L·t 11h':111s a docurn~nt on tcclrnic.'.1I rL'quire11w11t.\ lll a proJuct (containing the salllL' product 11a1m'. brand. major qua! ity norms anJ c 1em ical. physical mu microurganic sta11Jards) SL'I anJ announceJ by an orga11i1~1tio11 ur inJi I idual as conforn1.1ble \\'i th corrcspon Jing nat i una I technical regulations or with Vict11an1csL' fooJ safety regulations (in cas,: such produ:t has 110 technical n~gulations) or with rcgul;11i, ,11\ ul'tilL' CoJex Al1111entarious Commission (( ndn) in case Vietnamese regulations are not a, ailahil'. +. De,ig.natcJ tcstin!:'- laboratory illl':1I1s a testing laboratory which is dcsignalL'd h\ a competent agency in Vici 11am. 5. Acc1eJiteJ inJcpcndcnt lL'sting lahm:1t,Jry lllL'.ans :1 !L'sting. laboratory\\ hich is rcu1g11i1L'd by an accn·Jitation institution :rnd is i11d,·pL'lldL'ilt from prnJuct makers. 6. Rcc,igni;cJ testing lahuraltln I1Ic;11h ;1 proJuct 111aker's testing l;1hur:1lm) ,, liicli is 1. FooJ safety reg.ulation conformity recognized by an accredit;1tio11 insti1u1i(i11 or a announcement means an organization's or testing laboratory which is Jcsignat:d h\ a individual's announcement th,1t its/his/her competent foreign ag.l'.ncy. © VIETNAM LAW & LEGAL FORUM Issue nos 08-09/Novcmhcr 2012 (Cong Bao nm (J65H/1(1/c1\•r11i/n25, 2!1 /2) OFFICIAL GAZETTE 43 Article 3. Contents of assessment uf urn.kr Clause l. Artick .1 uf tlii;, Circular and anrwunce<l pro<lucts' conformitv \\ith ha\e tl1L'ir products tes!c<l al a l.ksignated, corrcsronding 11.'.chnical regulations or v,ith food safety regulations l. Fur asscs\111ent uf co111"ur111i1y \\ ith co1-rcspu11ding technical rcgulatiun~ (belt\\\ rcfcrre<l to as regula1in11 conformity asses.\lllL'lll) for a1111ounccd pm<lucts ha\lng technical rL·gulations: As;,cssment contents applicahlc to c;tch s.pccific prn<luct arc pm, idnl 111 crnni;,pon<ling technical regulatiuns. 2. Fm asscs.sment or conforrnit\ with foml salcty reguL11ions I. helo,, referred to as !'odd s:tll'ly regulation cu11lm111ity assessment I for pru<lucts ha\·111g 110 tcclrnical rL:gulat1u11\: 1\-,:,cssmc1ll et intents applicahlc to each s1x'cilic product c1rc hasl:<l u11 food s:tl'cly llllllll\ prL·scrihL·<l hy thL' la\\ 011 food safety In LctsL: \'ict11amcsc rcgulatiuns arc not a,:.iilahk. ( \ilk\ rq1 uLttiuw, apply. ('hctpln ll ORUE!{ A:-,'!) DOSSIERS OF PROD!'( T t\NNOl ,Ne 'Ei\1Ei\T Article 4. Or<ln and <lossiers of regulation conformity :.innounccrnent accrc<litc<l in<lcp,:ndcnt or recogni1cd tL·~ting Lthoralory: l1r tl11ough :t rcgt1Lttio11 nrnformity LL'rlifiGttion institution dcsig1utd hv the :\llinistry of Health. h/ Step 7 Rcgistr:1tio11 ul' 1;..;.:.u.ilation ui111·onnity statements :\11 mga11i1atirn1 m 111di\ idu.1~Kes and ,uhmit.~ an a1111ou11cL'llle11t dt 1s~iLT u1tli•r Clause 2 of this Article tu a rqc:iqration-rL·,-:ci~agency prm idcd in 1\1·1iclc 7 nl thi, ( 'ircula,~ 2 Regubtion conlmmit\ :111n~ttncement dl)SSiLT ,1; The papers ,ind d!1ct1111c11h J~ided i11 -.-\rticlcs 5 and 7 ul the ( itJ\ n11me1~ I k'crL·l' :\t> 'iS/2012/r\D-CPot 1-\p1il 2~. '.:Ol~·t; uling J itllll1her or articles ol thL' L,t\\ Oil l~d Safrt~ ( hcl()\, rcknL'<l lu as Dc: TcL' :\ll c,stfj:1 l2/ND­ ·p): h/ ParticuL1rl:- fur prmlttct tc-;ting 2ults: The pr\\<luct testing result is~Lll'd h) a ~ignated, accrc<litcd indcpendrnt or 1\:c\lg11i~ testing lahoratorv \\ithin 12 llHllllhs ( the ffl'?'ttinal or .,, ' • t-:' nutarizl'.<l copy tugcth,:r \\ ith the l~inal for cump;rrisun. m consularly lcgaliSI copy), covering the norms required h) conL·spon<ling i . () r JC r Of r C .0 U I J ti O 11 CO 11 I'll 1· 111 ·1 t \' j • i j · "' - tee 1111ca regu at10ns. a1lI1ClllllCCll1eI1t a/ Step l: Regulation conformity assessment Organizations or individuals may con<luct rcgul:.ition conlmrnily assc~smcnt by thrnisclws Article 5. Or<lcr and dossiers of l()o<l sJfcty regulation conformity announcement I. Order of food safety regulation rnnfonnity © VIETNAM LAW & LEGAL FORUM 44 OFFICIAL GAZETTE Issue nos 08-09/Novernhcr 2012 (C6ngBao1101(165-fNJ/No1'<'1 ihcr2.', 20/2) announce,m:nt: a/ Step I Food safety regulation conformity assessment An organization or individual has its/his/her product tcqcd at a designated accredited independent or recognized testing lahoratnry: and assessestm-- product's conformity \\ ith food safety r~ 1tions hased on testing results and underC'~-~ 2. Article 3 of this Circular. bl Sff:e 2: Registration of food safety regulatic~< ,n formity statement); An organization or individual makes and submits~ rnounccment dossier under Clause 2 of this ~c le to a registration-rccci ving agency provided::MArticle 7 of this Circular. -2. Fe safety regulation conformity announc~nt dossier: a/ Tb0<1pers and documems provided in Articles (JJ11d 7 of Decree No. 38/20 I 2/ND­ CP; b/ Part@:itl arly for product tcsti ng results: The Product ~~ing result issued bv a designated. ,-.. L • L accreditc~dependent or recm:nized testin!l ......... L L laborat~ ithin I 2 months (the original or notariz~)py together with the original for comparison or consularly legalized copy). covering maj,ir4uality norms and safety nonns. c/The product use testing result.. for functional food with nnv uses or process~d from new substances or with new technology, which is marketed in Vietnam for the first time and has not been proved to he s; ifc and cfkctin: Article 6. Announcement for products ( other than functional food) imported Ii r USl' only within pr,Jduction estahli:,hnwnts. sup1:rrnarh'ts or four-star or higher-rank hotels I. A product a111rnuncc111cnt d1hsin comprise:;: a/ The product mani kst: For f,)()d materials.packaging mat,'ri:tls and tools i11 direct contact \\ ith food imporkd for production only within enterprises: Th, , product manifest complies with f~orm No 2 at :1clll'd tu this Circular (110! l!w11/arcc/J For food additi vcs and food pmce, sing aids imported 1mly for production within cn,erprisL's: The product manifest complies with Form No. 1 attached to this Circular (110! rmnslol'il!. For food products imported only for husiness \Vithin superm:1rkets or four-st:1r or higher-rank hotels: The product i-1anikst complies with Form :\lo -+ attached to this Circular (11or ru111.1!11Tcc/J. h/Thc business registration ccrtific IL' (L'OP) appended with the seal of the orga11i1atio11 or individual) c/Thc product testing result within I=· months or detailed product infonnation sl1L'1:t 11f thL· manufacturer: or the product IL'stin!-' ll's11lt 111' a designalld. accredited indepenu:111 11r recognized testing lahoratory. 2. Organizations or individuals shall 111;1ke and © VIETNAM LAW & LEGAL FO UM Issue nos 08-09/November 2012 (Cong Bao11m (ti5-fN/Novemher 25, 2012) OFFICIAL GAZETTE 45 submit an announcement dossier provided in Clause I of this Article to a registration-receiving agency provided in Article 7 of this Circular. Article 7. Competence to receive registra­ tion dossiers and grant receipts of regulation conformity st;,i.tements and certificates of food safety regulation conformity announcement 1. The Ministry of Health assigns the Yii:tnarn Fuod Administration to receive registration dossiers: grant receipts of regulation conformity statements (hclow referred to as receipts) and cl'.rtificatcs of food safety regulation conformity announcement ( hdow refcJTed to as certificates) for functiunal food. food additi,e~. foud prnccssi ng aids. ~111d imported prepac LtgL'd procl'.SSL'.d food, packaging materials and tuuls in direct contact with food: and make written certification of products (other than functional fnud) imported for use only within pruductiun est:.ihlishrnents. supermarkl'.ts and four-star ur higher-rank hotels. 2. Provincial-level Health Departments assign provincial-level FoudAdministrations to recci\'l'. registration dossiers and grant receipt~ and certificates for domestic prepackaged proce\sed food (other than functional food). packaging materials and tools in direct contact with food produced or traded by organizations and individuals based in their localities. 3. For domestic products for export. their statements may be registered at the Vietnam Food Administration or provincial-level Food Administrations of the localities in which organizations or individuals are headquartered when so requested by importing countries. 4. For products of the same quality for which a single organization or indi\idual takes responsibility. which arc producl'.d in 2 ( two) or more pro\'inccs or cities, their statec:mnts may he rec;istcred at the Yil'.tnam Food Adrni'nistration ~ ,.,.. or the provincial-level Food Admini~rn of the locality in which such organization ol"il'fdividual is headquartered. S. The re~istration-r,:Leivinl~~ncies pm, idcd in ( '!:uses I and :2 llf this ¼-le shall recei\L' registration dussicr:-; and gr:c:mreceipts and ccrtificatl'.;, in accordance with ClWllses J, 4 and S, Article 4 of Decree :\lu 38/20:SNI )-( '!'. Within 2 (two) months art er rccei \'~l notice uf tlw reason for nut iss11i11~ a r~ipt and C • ..,, certi ficatl'. frnm a registratit·,n-rl.'ceivwii agency, ifan organization or individual fails tu SUf)plement -and completl'. the dossier as reqt~ted, the .., .. l'L'gistration-receiving agency shall ~eel such dossier. Ci. Registration-recl'.iving agencies.shall grant and manage serial numbers of rccripts and certificates. a/ Receipts and certificates granted by the Vietnam Food Administrati()n will bl'. respectively presented in the following order: serial number/year of grant/ ATTP-TNC B and serial number/year of grant/ ATTP-XNCB. b/ Receipts and certificates granted by @ VIETNAM LAW & LEGAL FORUM 46 OFFICIAL GAZETTE Issue nos 08-09/Novc i@cr]:0 1.2 (Cong Bao urn (fi,-fffi/11i()\ 1'11 ho - i,,) If ' 1} provincial-k\'cl Food Administrations will he respectin?ly writtcn in the followmg order: serial nurnhcr/yea • of grant/YT+:1hbrn iated name of province urL:ity-T\:Cl3. and SLTi,.tl 1rn111h,:rl)L':1r of gr:1111/YT+ahhre\iated ILllllL' of prU\ Incc ur city-XNCB. Ruk:;:1 ahhrn iatiun llf 11:1111:s Llf pn )\ ince, and citic~ receipts and cL·rli liL:atcs :1rL· prm ided in Forni :'.<.. 5 allacl1L·d to 1111, ( 'ircuL1r 11w1 1ransla1~. Arti~ . .: nouncement f()r food additi\es and fooctm< cessing c1ids 1. For i'4cd ;1ddi ti vcs and food processing aids on the ~i,try of I kalth-prornulgated list of substan~permitted for use. c11ganizatic,ns and ind iv i S ~- sh a II an no u 11 L: c products in acconL1~ with Articles -L 5. (1 and 7 of thi:; ( ,. I ~ 1rcu ar. C: 2. Fc~od additives and food rroccssi ng aids outside.~! 1am's list of substances permitted for use: ~uucts containing food additi\es and food p~,.,,ing aids outside \'ict11;1111's list of • • substancc::£:?rlllillL'd I'm use but L'll till' list undn Codex·~!, 11latiuns llr permitted fur usL· in countri~I rnanufacture. thL? \'iL:tnarn him! Adminlsfflt Llll shall consider penni,sion for product ann<iuncement. Nu. 311/:() 12/N D-( 'P h:, compL:ll'11I ,ta IL' agencies which ha\L' gr;1nted rec,:Ip1s c1ml ccrtificaks for the l'ir,t ti111L· fur thu,L' 1rud11Lls. .:'. ll'u1gani1:1ti()J1, I1r imli, 1du:tl, th,111,·q11,·,1 re-grant l r reCL'ipl\ ;llld ,.'l'rt i Ii l",lk, I ()I jll ( idu, h Lti I tL 1 !'111 I, and prnpL•J I\ 1rnpk111l' 111 t hl· 111·11udiL·;il ,h;1II in\ wet thL·ir prnd11cti1i11 Jllll h11-.1111·,, l'Stahlish 111cnts. lb.,ed Iin , i11lat1Llll h;1!lllli11c' result, and remcdi;il ,1L·tiu11s. l'L''..'.1,tr;1ti1111 recL'i\'ing agencies shall LkciLk un l'L' c'r,II1I Lll re-an rn )l!llCClllCn l. Ch,1ptn Ill RESPONSIBIIXr!ES ()1-1<1:CilSTI,'. \Tl<)\'­ RECEl\'l\:C, .-\(iF\'CIES \1\1) ORC,\~<IZATIO'.\'S Ar,D INl)I\ I I )I .-\LS .-\ rq,istr,1tiu11-rL'Cei\ ing ;I uenc·, II.1, till· IL 1ll1m ing righh and re,p1 iIhI hi Ii l iL's I. Tll l'lTei,L'. rL·gul:1till11 CL111!11r11111, ann11unc.·rnent llr i'Li1id -',ill·t, il'.'11l,1ti1111 cunformil) <1nn1.1uI1c,:IIll'lll d1i,, 1,·1, ,ii organizat11111s and imli, 1d11:1k ~, To grant and rL' .. :..'.rant IL'.Cc':I1[', a1HI certificates accmding tu tire ti Ille' limits fllll\ 1ckd Article 9. Re-grant ol receipts and in Clause, 1.-+ and 5. ,\rt1ck-+ 11f D,:CJL'L' N11 certificates 311/20 l :Y~~D-CP. 1. Receipts and certificates mav be re- 3. Wi1hin 7 (sc,enl w11rkin u LL,, :iltn granted in ,iccor<lancc with Article 8 of· Decree granting a receipt m certif1catc. tL1 nut if:, pruJucts © VIET AM LAW & LEGAL FORUM Issue nos 08-09/November 2012 (Cong Baonos(J65-fti:vNove111ber 25, 2012) OFFICIAL GAZETTE 47 obtaining such receipt or certificate on its website. 4. To append its seal on every two adjoining pages of detailed product information sheets and on product labels to certi(y compulsory labeling contents in accordance with law. Such seal appending is not valid for certification of industrial property. To return organizations and individuals a product dossier set and file dossiers under regulations. 5. To manage and use collected fees and charges for the grant of receipts and certificates under the Ministry of Finance's guidance. Article 11. Responsi bi I ities of organizations and individuals Organizations or individuals have the follm, ing rights and responsibilities: I. To announce and re-announce produc'lS at registration-receiving agencies prn\ ided in Article 7 of this Circular: lo fully pay fees and charges in accordance with law. 2. To control quality and food safety of their own products, To implement the periodical inspection and testing regime under regulations and take full responsibility for conformity of announced products. 3. To clearly announce product names which properly reflect product nature (ingredient.,, uses, processing technology). A product name which does not clearly reflect the product nature must be accompanied by the name of the product group and compulsory labeling contents. 4. To submit official labeh one (I) month after obtaining a receipt or certificate, if they have only submitted the draft labeling contents upon announcement. 5. When detecting a product whi~violates ~ ........ the law on product quality and food ... ty or is untruthfully labeled, advertised or arW.mced: a/ To promptly report on thc ~duct's unconformity to competent state 111.l!M'(lgement agencies and the rcgistration-rCL'L•ivi'ffl!1gency; h/ Tll remniy such uncunrormity cl When necessary or su reqt!,5sted h\ cumpL·tcnt state management age,cics. tu su~pcml production and rolling llllt urlr1d rcc;ill uncunformahle prnducts currently clti,:u lated in the market: d/ To report to compLt,.:11t state rn~gement agencies and lhL 1Tgistra1iun-rcccivD agency on results of remedying »uch inconfm~y before resurnmg the prnduction and trad~ of that product (L To keep product announccmeJJJ.,.dossicrs according to prescrihed time limits a~asis for examination and inspection or for pro,·ing confom1ity of their products with announced and committed contents of the dossiers, 7, In case of changing label appearance, packing method, quality indicators, optional labeling contents, office addresses of © VIETNAM LAW & LEGAL FORUM 48 OFFICIAL GAZETTE Issue nos 08-0WNovembcr 2012 (Cong Ba.01101fJ65.fxx:vNm 'Cl ·1her2', 2012) organizations or individuals or places of production. names of organizations or individuals (in case of changing business registration certificate) to submit a written request for supplemenUtion together with the certification of changeu and supplemented contents of organizatio·1s or individuals responsible for productJ;;order to retain the serial numbers of granted t'lfi·,>granted receipts or certificates. Chapter IV POS~RODUCT ANNOUCEMENT INSPECTION ArticJe•l 2. Post-announcement inspection .,,.. Regi~ation-receiving agencies and provincM+-k·✓el Food Administrations of localities in which ii,duction and business establishments arc bas~ arc competent to inspect the implemtG.tion of the law on food safety and periodi~ testing regime with respect to annOUTl€MolJlroducts of these establishments. Artu:)Jf13. Sampling for periodical testing 1. ·o;,eriodical testing n~g1m.: is provided as folio~ a/ CJ~ year, for products of establishments possessing a ccrti ficate of one of the following advancedquillitycontrol systems: GMP. HACCP, ISO 22000 o • equivalent. b/ Twice a year, for products of estahl ishments without a certificate of the above systems. 2. Sampling for periodical testing shall he conducted by organizations or individuals or by compe tc n t a gen c 1c s as rcq UL' s tcd b\ organizations or individuals. 3. Indicators to be periodically tested arc major qu:.1lity norms announced in th,: deti.lilcd product information sheet or on the label of the marketed product: and a number of chemical. physical and microorganic indicator~ a 1nou11ccd in the detailed production i11forrnatio11 sheet ur prescribed by law. 4. Organizations and individuals may use testing results of irregular and p1:riodical inspection and examination teams or ·csults of' state exi.lmination of imported food safety as results or' pcrriodical ksting if 111c1:ti11.l-', the requirements provided in Clausv .\ ul' this Article. Chilptcr V IMPLEMENTATION PROVIS!< )NS Article 14. Transitional prmision Product standard certificates grant:d under the Health Ministry"s Decision No .. ,r~;~:)05/()1)­ BYT ofDi:cembcr 8. ~005. issuing tlw n'..l-',t1latio11 on announcement of food product sta11d:1rds. n.'.mi.lin val id ti II the cnd of their, alidi t v Juration. Article 15. Effect I. This Circular takes effect 011 D:ccrnbcr 25.2012. ©VIET AM LAW & LEGAL F RUM Issue nos 08-09/Novemhcr 2012 (Cong Bao11os(x55Ht:J/Nove111her25, 20 I 2) OFFICIAL GAZETTE 49 2. The Health Ministry's Decision No. 42/ Departments and the Vietnam food 2005/QD-BYT of December 8, 2005, issuing the Administration. regulation on announcement of food product standards. ceases to he effective on the effective date of this Circular. Article 16. Organization of implementation I. The Ministry of Health assigns the Vietnam Food Administration to organize and examine the implementation of this Circular nationwide. lfoumually. the Vietnam Food Administration shall report on the grant uf receipts and certificates to the Minister of Health. 2. Provincial-level Health Departments assign provincial-kvel Food Administrations to organize and ,,:xaminc thl'. implementation of this ( 'ircular within their localities. Provincial-level Food Administrations shall monthly report on the grant of receipts and certificates to provincial-level Health For the A1inistcr of llcolth Deputy Minister NGUYEN THANH LONG © VIETNAM LAW & LEGAL FORUM