natgillin/translations-raw huggingface dataset:
Food business operators should decide themselves the necessary sampling and testing frequencies as part of their procedures based on HACCP principles and other hygiene control procedures.
Nosilci živilske dejavnosti morajo v okviru svojih postopkov, ki temeljijo na načelih HACCP, in drugih postopkov za nadzor higiene sami določiti potrebno pogostnost vzorčenja in preskušanja.
However, it may be necessary in certain cases to set harmonised sampling frequencies at Community level, particularly in order to ensure the same level of controls to be performed throughout the Community.
Vseeno pa je lahko v nekaterih primerih treba določiti usklajeno pogostnost vzorčenja na ravni Skupnosti, zlasti za zagotovitev enake ravni nadzorov, ki jih je treba opraviti v Skupnosti.
Test results are dependent on the analytical method used, and therefore a given reference method should be associated with each microbiological criterion.
Rezultati preskusov so odvisni od uporabljene analitične metode, zato je treba za vsako mikrobiološko merilo uporabiti določeno referenčno metodo.
However, food business operators should have the possibility to use analytical methods other than the reference methods, in particular more rapid methods, as long as the use of these alternative methods provides equivalent results.
Vseeno pa morajo imeti nosilci živilske dejavnosti možnost uporabiti analitične metode, ki se razlikujejo od referenčnih metod, zlasti hitrejše metode, če uporaba teh nadomestnih metod zagotavlja enakovredne rezultate.
Moreover, a sampling plan needs to be defined for each criterion in order to ensure harmonised implementation.
Poleg tega mora biti za vsako merilo določen načrt vzorčenja, da se zagotovi usklajeno izvajanje.
It is nevertheless necessary to allow the use of other sampling and testing schemes, including the use of alternative indicator organisms, on condition that these schemes provide equivalent guarantees of food safety.
Kljub temu je treba dovoliti uporabo drugih programov vzorčenja in preskušanja, vključno z uporabo nadomestnih indikatorskih organizmov, pod pogojem, da ti programi zagotavljajo enakovredna jamstva za varnost hrane.
Trends in test results should be analysed, as they are able to reveal unwanted developments in the manufacturing process enabling the food business operator to take corrective actions before the process is out of control.
Gibanja rezultatov preskusov je treba analizirati, ker lahko razkrijejo neželene razvoje v proizvodnih postopkih, kar nosilcem živilske dejavnosti omogoči, da sprejmejo korektivne ukrepe, preden postopek uide iz nadzora.
The microbiological criteria set in this Regulation should be open to review and revised or supplemented, if appropriate, in order to take into account developments in the field of food safety and food microbiology.
Mikrobiološka merila, določena v tej uredbi, je mogoče pregledati in spremeniti ali dopolniti, če je primerno, da se upoštevajo razvoj na področju varne hrane in živilske mikrobiologije.
This includes progress in science, technology and methodology, changes in prevalence and contamination levels, changes in the population of vulnerable consumers, as well as the possible outputs from risk assessments.
To vključuje napredek znanosti, tehnologije in metodologije, spremembe v stopnjah razširjenosti in kontaminacije, spremembe v populaciji občutljivih potrošnikov kot tudi možne rezultate ocen tveganja.
In particular, criteria for pathogenic viruses in live bivalve molluscs should be established when the analytical methods are developed sufficiently.
Ko so analitične metode dovolj razvite, je treba določiti zlasti merila za patogene viruse v živih školjkah.
There is a need for development of reliable methods for other microbial hazards too, e.g. Vibrio parahaemolyticus.
Zanesljive metode je treba razviti tudi za druga mikrobiološka tveganja, npr. Vibrio parahaemolyticus.
It has been demonstrated that the implementation of control programmes can markedly contribute to a reduction of the prevalence of salmonella in production animals and products thereof.
Dokazano je, da lahko izvajanje kontrolnih programov občutno prispeva k zmanjšanju razširjenosti salmonele v proizvodnih živalih in njihovih proizvodih.
The purpose of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents is to ensure that proper and effective measures are taken to control salmonella at relevant stages of the food chain.
Namen Uredbe Evropskega parlamenta in Sveta (ES) št. 2160/2003 z dne 17. novembra 2003 o nadzoru salmonele in drugih opredeljenih povzročiteljih zoonoz, ki se prenašajo z živili, je zagotoviti, da se sprejmejo ustrezni in učinkoviti ukrepi za nadzor salmonele na pomembnih stopnjah prehranjevalne verige.
Criteria for meat and products thereof should take into account the expected improvement in the salmonella situation at the level of primary production.
Merila za meso in njegove izdelke morajo prav tako upoštevati pričakovano izboljšanje v zvezi z razširjenostjo salmonele na stopnji primarne proizvodnje.
For certain food safety criteria, it is appropriate to grant the Member States a transitional derogation, enabling them to comply with less stringent criteria but provided that the foodstuffs would only be marketed on the national market.
Pri nekaterih merilih za varnost hrane se državam članicam v primeru, da se živila tržijo le na nacionalnem trgu, odobri prehodno odstopanje, kar jim omogoča, da upoštevajo manj stroga merila.
The Member States should notify the Commission and other Member States where this transitional derogation is used.
Če države članice uporabljajo prehodno odstopanje, morajo o tem obvestiti Komisijo in ostale države članice.
Subject-matter and scope
Vsebina in področje uporabe
This Regulation lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Article 4 of Regulation (EC) No 852/2004.
Ta uredba določa mikrobiološka merila za nekatere mikroorganizme in izvedbena pravila, ki jih morajo upoštevati nosilci živilske dejavnosti pri izvajanju splošnih in posebnih higienskih ukrepov iz člena 4 Uredbe (ES) št. 852/2004.
The competent authority shall verify compliance with the rules and criteria laid down in this Regulation in accordance with Regulation (EC) No 882/2004, without prejudice to its right to undertake further sampling and analyses for the purpose of detecting and measuring other micro-organisms, their toxins or metabolites, either as a verification of processes, for food suspected of being unsafe, or in the context of a risk analysis.
Pristojni organ preverja skladnost s pravili in merili, določenimi v tej uredbi v skladu z Uredbo (ES) št. 882/2004. Ta uredba ne izključuje pravice do izvajanja dodatnega vzorčenja z namenom ugotavljanja drugih mikroorganizmov, njihovih toksinov ali metabolitov v primeru živil, za katere se sumi, da niso varna v sklopu analize tveganja.
This Regulation shall apply without prejudice to other specific rules for the control of micro-organisms laid down in Community legislation and in particular the health standards for foodstuffs laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council, the rules on parasites laid down under Regulation (EC) No 854/2004 of the European Parliament and of the Council and the microbiological criteria laid down under Council Directive 80/777/EEC.Article 2
Ta uredba se uporablja brez poseganja v druga posebna pravila glede nadzora nad mikroorganizmi, določena v zakonodaji Skupnosti, zlasti v zdravstvene standarde za živila, določene v Uredbi Evropskega parlamenta in Sveta (ES) št. 853/2004, pravila glede nadzora parazitov, določena na podlagi Uredbe Evropskega parlamenta in Sveta (ES) št. 854/2004, in mikrobiološka merila, določena na podlagi Direktive Sveta 80/777/EGS.Člen 2
The following definitions shall apply:
Uporabljajo se naslednje opredelitve pojmov:
‘micro-organisms’ means bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites;
„mikroorganizmi“ so bakterije, virusi, kvasovke, plesni, alge, parazitski protozoji, mikroskopski parazitski helminti ter njihovi toksini in metaboliti;
‘microbiological criterion’ means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch;
„mikrobiološko merilo“ je merilo, ki določa sprejemljivost živila, serije živil ali proizvodnega postopka na podlagi odsotnosti, prisotnosti ali števila mikroorganizmov in/ali količine njihovih toksinov/metabolitov na enoto mase, prostornine, površine ali serije;
‘food safety criterion’ means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market;
„merilo varnosti živila“ je merilo, ki opredeljuje sprejemljivost živila ali serije živil in se uporablja za živila, dana v promet;
‘process hygiene criterion’ a criterion indicating the acceptable functioning of the production process.
„proizvodno higiensko merilo“ je merilo, ki določa sprejemljivost higiene proizvodnega postopka.
Such a criterion is not applicable to products placed on the market.
Takšno merilo se ne uporablja za proizvode, dane v promet.
It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law;
Določa okvirno stopnjo kontaminacije, pri kateri je potrebno izvesti korektivne ukrepe z namenom, da se zagotovi higiena proizvodnje v skladu z živilsko zakonodajo;
‘batch’ means a group or set of identifiable products obtained from a given process under practically identical circumstances and produced in a given place within one defined production period;
„serija“ je skupina ali vrsta živil, ki jo je mogoče opredeliti in ki je pridobljena po določenem proizvodnem postopku pod dejansko povsem enakimi pogoji na določenem mestu v določenem časovnem obdobju;
‘shelf-life’ means either the period corresponding to the period preceding the ‘use by’ or the minimum durability date, as defined respectively in Articles 9 and 10 of Directive 2000/13/EC;
„rok uporabnosti“ je obdobje pred „uporabno do“ ali najkrajši rok trajanja, kot je določen v členih 9 in 10 Direktive 2000/13/ES;
‘ready-to-eat food’ means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern;
„živila za neposredno uživanje“ so živila, ki jih proizvajalec nameni neposredni prehrani ljudi in jih pred uporabo ni treba kuhati ali kako drugače obdelati, da bi se izničila ali na sprejemljivo raven zmanjšala prisotnost določenih mikroorganizmov;
‘food intended for infants’ means food specifically intended for infants, as defined in Commission Directive 91/321/EEC;
„hrana, namenjena dojenčkom,“ je hrana, ki je posebej namenjena dojenčkom, kot je opredeljeno v Direktivi Komisije 91/321/EGS;
‘food intended for special medical purposes’ means dietary food for special medical purposes, as defined in Commission Directive 1999/21/EC;
„hrana, namenjena za posebne zdravstvene namene,“ je hrana za posebne zdravstvene namene, kot je opredeljena v Direktivi Komisije 1999/21/EGS;
‘sample’ means a set composed of one or several units or a portion of matter selected by different means in a population or in an important quantity of matter, which is intended to provide information on a given characteristic of the studied population or matter and to provide a basis for a decision concerning the population or matter in question or concerning the process which has produced it;
„vzorec“ je določena količina snovi, sestavljena iz ene ali več enot ali delov snovi, ki je iz celotne količine snovi izbrana na različne načine z namenom pridobiti podatke o določeni lastnosti te snovi in je podlaga za odločanje o omenjeni snovi ali postopku njene izdelave;
‘representative sample’ means a sample in which the characteristics of the batch from which it is drawn are maintained.
„reprezentativni vzorec“ je vzorec, ki ohranja značilnosti serije, iz katere je odvzet.
This is in particular the case of a simple random sample where each of the items or increments of the batch has been given the same probability of entering the sample;
To je zlasti pomembno pri naključnih vzorcih, kjer mora za vsak sestavni del serije obstajati enaka verjetnost, da bo vključen v vzorec;
‘compliance with microbiological criteria’ means obtaining satisfactory or acceptable results set in Annex I when testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective action, in accordance with food law and the instructions given by the competent authority.
„skladnost z mikrobiološkimi merili“ pomeni doseganje zadovoljivih ali sprejemljivih rezultatov v skladu s Prilogo I in vključuje odvzem vzorcev, opravljanje analiz in izvajanje korektivnih ukrepov v skladu z živilsko zakonodajo in navodili, ki jih je dal pristojni organ.
Food business operators shall ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I. To this end the food business operators at each stage of food production, processing and distribution, including retail, shall take measures, as part of their procedures based on HACCP principles together with the implementation of good hygiene practice, to ensure the following:
Nosilci živilske dejavnosti zagotavljajo, da živila izpolnjujejo mikrobiološka merila, določena v Prilogi I. V ta namen nosilci živilske dejavnosti v vseh stopnjah proizvodnje, predelave in distribucije živil, vključno s prodajo na drobno, v okviru postopkov, ki temeljijo na načelih HACCP, in z izvajanjem dobre higienske prakse sprejmejo ukrepe, da zagotovijo:
that the supply, handling and processing of raw materials and foodstuffs under their control are carried out in such a way that the process hygiene criteria are met,
da so pri oskrbi, ravnanju in predelavi surovin in živil pod njihovim nadzorom izpolnjena proizvodna higienska merila;
that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use.
da so izpolnjena merila varnosti živil med rokom uporabnosti živil ob upoštevanju pogojev distribucije, shranjevanja in uporabe.
As necessary, the food business operators responsible for the manufacture of the product shall conduct studies in accordance with Annex II in order to investigate compliance with the criteria throughout the shelf-life.
Če je potrebno, nosilci živilske dejavnosti, ki proizvajajo živila, opravijo študije v skladu s Prilogo II, da preučijo skladnost živil z merili med rokom uporabnosti.
In particular, this applies to ready-to-eat foods that are able to support the growth of Listeria monocytogenes and that may pose a Listeria monocytogenes risk for public health.
To zlasti velja za gotova živila za neposredno uživanje, ki omogočajo rast Listeria monocytogenes in lahko zaradi tega predstavljajo tveganje za zdravje ljudi.
Food businesses may collaborate in conducting those studies.
Pri izvajanju teh študij lahko sodelujejo druga živilska podjetja.
Guidelines for conducting those studies may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.
Smernice za izvajanje teh študij so lahko vključene v smernice za dobro prakso iz člena 7 Uredbe (ES) št. 852/2004.
Testing against criteria
Preskušanje meril
Food business operators shall perform testing as appropriate against the microbiological criteria set out in Annex I, when they are validating or verifying the correct functioning of their procedures based on HACCP principles and good hygiene practice.
Nosilci živilske dejavnosti z namenom potrjevanja in preverjanja pravilnosti postopkov, izvedenih na podlagi načel HACCP in dobre higienske prakse, izvajajo preskuse glede mikrobioloških meril, določenih v Prilogi I.
Food business operators shall decide the appropriate sampling frequencies, except where Annex I provides for specific sampling frequencies, in which case the sampling frequency shall be at least that provided for in Annex I. Food business operators shall make this decision in the context of their procedures based on HACCP principles and good hygiene practice, taking into account the instructions for use of the foodstuff.
Nosilci živilske dejavnosti določijo pogostnost vzorčenja v okviru postopkov, ki temeljijo na podlagi načel HACCP in dobre higienske prakse, ter ob upoštevanju navodil za pripravo živila, razen v primeru, ko je pogostnost vzorčenja določena v Prilogi I. V tem primeru mora biti pogostnost vzorčenja vsaj tolikšna, kot je določeno v Prilogi I.
The frequency of sampling may be adapted to the nature and size of the food businesses, provided that the safety of foodstuffs will not be endangered.
Pogostnost vzorčenja se lahko prilagodi naravi in velikosti živilske dejavnosti, če s tem ni ogrožena varnost živil.
Specific rules for testing and sampling
Posebna pravila za preskušanje in vzorčenje
The analytical methods and the sampling plans and methods in Annex I shall be applied as reference methods.
Kot referenčne metode se uporabljajo analitične metode in načrti vzorčenja ter metode iz Priloge I.
Samples shall be taken from processing areas and equipment used in food production, when such sampling is necessary for ensuring that the criteria are met.
Če je potrebno, se lahko zaradi zagotavljanja izpolnjevanja meril izvaja vzorčenje proizvodnih prostorov in opreme, ki se uporablja pri proizvodnji živil.
In that sampling the ISO standard 18593 shall be used as a reference method.
Pri tem vzorčenju se kot referenčna metoda uporabi standard ISO 18593.
Food business operators manufacturing ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health, shall sample the processing areas and equipment for Listeria monocytogenes as part of their sampling scheme.
Nosilci živilske dejavnosti, ki proizvajajo živila za neposredno uživanje, ki bi lahko zaradi vsebnosti Listeria monocytogenes pomenila tveganje za zdravje ljudi, morajo v okviru svojega programa vzorčenja zagotoviti odvzem vzorcev iz proizvodnih prostorov in opreme na prisotnost Listeria monocytogenes.
Food business operators manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose an Enterobacter sakazakii risk shall monitor the processing areas and equipment for Enterobacteriaceae as part of their sampling scheme.
Nosilci živilske dejavnosti, ki izdelujejo posušene formule za dojenčke ali živila za posebne zdravstvene namene, namenjena dojenčkom, mlajšim od šest mesecev, ki bi lahko zaradi vsebnosti Enterobacter sakazakii pomenila tveganje za njihovo zdravje, morajo v okviru svojega programa zagotoviti odvzem vzorcev iz proizvodnih prostorov in opreme na prisotnost enterobakterij.
The number of sample units of the sampling plans set out in Annex I may be reduced if the food business operator can demonstrate by historical documentation that he has effective HACCP-based procedures.
Število vzorčnih enot v načrtih vzorčenja, določenih v Prilogi I, se lahko zmanjša, če nosilec živilske dejavnosti z ustrezno dokumentacijo dokaže, da uporablja učinkovite postopke, ki temeljijo na načelih HACCP.
If the aim of the testing is to specifically assess the acceptability of a certain batch of foodstuffs or a process, the sampling plans set out in Annex I shall be respected as a minimum.
V primeru ciljnega vzorčenja z namenom oceniti sprejemljivost določene serije živila ali postopka, se načrti vzorčenja, določeni v Prilogi I, upoštevajo kot minimalni.
Food business operators may use other sampling and testing procedures, if they can demonstrate to the satisfaction of the competent authority that these procedures provide at least equivalent guarantees.
Nosilci živilske dejavnosti lahko uporabijo druge postopke vzorčenja in preskušanja, če pristojnemu organu dokažejo, da ti postopki zagotavljajo najmanj enaka jamstva.
Those procedures may include use of alternative sampling sites and use of trend analyses.
Ti postopki lahko vključujejo uporabo drugih mest vzorčenja in novih analiznih metod.
Testing against alternative micro-organisms and related microbiological limits as well as testing of analytes other than microbiological ones shall be allowed only for process hygiene criteria.
Preskušanje na prisotnost drugih mikroorganizmov in povezanih mikrobioloških mej ter preizkušanje na prisotnost drugih analitov, razen mikrobioloških, se lahko izvaja le z namenom ugotavljanja proizvodnih higienskih meril.
The use of alternative analytical methods is acceptable when the methods are validated against the reference method in Annex I and if a proprietary method, certified by a third party in accordance with the protocol set out in EN/ISO standard 16140 or other internationally accepted similar protocols, is used.
Uporaba alternativnih analitičnih metod je sprejemljiva, če so validirane glede na referenčno metodo iz Priloge I in jih potrdi tretja stran v skladu s protokolom, določenim v standardu EN/ISO 16140, ali podobnimi mednarodno sprejetimi protokoli.
If the food business operator wishes to use analytical methods other than those validated and certified as described in paragraph 3 the methods shall be validated according to internationally accepted protocols and their use authorised by the competent authority.
Če želi nosilec živilske dejavnosti uporabiti analitične metode, ki niso bile validirane in potrjene, kot je opisano v prejšnjem pododstavku, morajo biti te metode validirane v skladu z drugimi mednarodno sprejetimi protokoli in je njihovo uporabo odobril pristojni organ.
Labelling requirements
Zahteve za označevanje
When the requirements for Salmonella in minced meat, meat preparations and meat products intended to be eaten cooked of all species set down in Annex I are fulfilled, the batches of those products placed on the market must be clearly labelled by the manufacturer in order to inform the consumer of the need for thorough cooking prior to consumption.
Proizvajalec mora na deklaraciji za mleto meso, mesne pripravke in mesne proizvode, proizvedene iz vseh vrst mesa, ki naj bi se zaužili kuhani in izpolnjujejo merila za salmonele, določene v Prilogi I, jasno označiti, da je potrebno ta živila pred uporabo temeljito prekuhati (termično obdelati).
As from 1 January 2010 labelling as referred to in paragraph 1 in respect of minced meat, meat preparations and meat products made from poultrymeat will no longer be required.
Od 1. januarja 2010 označevanje iz odstavka 1 ne bo več potrebno za mleto meso, mesne pripravke in mesne proizvode, proizvedene iz perutninskega mesa.
Unsatisfactory results
Nezadovoljivi rezultati
When the results of testing against the criteria set out in Annex I are unsatisfactory, the food business operators shall take the measures laid down in paragraphs 2 to 4 of this Article together with other corrective actions defined in their HACCP-based procedures and other actions necessary to protect the health of consumers.
Če so rezultati preskušanja glede meril, določenih v Prilogi I, nezadovoljivi, nosilci živilske dejavnosti sprejmejo ukrepe, določene v odstavku 2, 3 in 4 tega člena skupaj z drugimi korektivnimi ukrepi, določenimi v postopkih, ki temeljijo na načelih HACCP, ter druge ukrepe, potrebne za varovanje zdravja potrošnikov.
In addition, they shall take measures to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination.
Razen tega nosilci živilske dejavnosti sprejmejo ukrepe za ugotavljanje vzroka nezadovoljivih rezultatov z namenom, da se prepreči ponoven pojav nesprejemljive mikrobiološke kontaminacije.