natgillin/translations-raw huggingface dataset:
On 20 October 2011 the European Food Safety Authority (‘EFSA’) adopted a Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli and other pathogenic bacteria in seeds and sprouted seeds [3].
(5) Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je 20. oktobra 2011 sprejela znanstveno mnenje o tveganju, ki ga predstavljajo bakterija Escherichia coli, ki proizvaja toksin Šiga, in druge patogene bakterije v semenih ter semenih, ki kalijo [3].
In its Opinion, EFSA recommends, inter alia, that microbiological criteria should be strengthened as one of the components of a food safety management system for the sprouted seeds production chain.
Agencija v svojem mnenju med drugim predlaga, da bi bilo treba poostriti mikrobiološka merila, saj so eden od sestavnih delov sistema zagotavljanja varnosti živil za proizvodno verigo semen, ki kalijo.
That recommendation concerns the existing microbiological criteria on Salmonella for sprouted seeds and the consideration of microbiological criteria on other pathogens.
Navedeno priporočilo zadeva obstoječa mikrobiološka merila za salmonelo za semena, ki kalijo, in mnenje o mikrobioloških merilih za druge patogene.
EFSA also states that available data indicates a higher risk for sprouts in comparison with other sprouted seeds.
Agencija navaja tudi, da razpoložljivi podatki kažejo na visoko tveganje za kalčke v primerjavi z drugimi semeni, ki kalijo.
In its Opinion, EFSA considers different options for microbiological criteria for pathogenic E. coli for seeds:
Agencija v svojem mnenju obravnava različne možnosti za mikrobiološka merila za patogene E. coli za semena:
before the start of the production process, during sprouting and in the final product.
pred začetkom proizvodnega postopka, med kaljenjem in v končnem proizvodu.
In that context, EFSA states that the detection and mitigation of a contamination problem earlier in the sprouted seed production chain may have advantages as it avoids contamination being amplified during the full sprouting process.
V zvezi s tem navaja, da bi lahko odkrivanje in zmanjšanje onesnaženja že v proizvodni verigi za semena, ki kalijo, pomenilo prednost, saj preprečuje, da bi se onesnaževanje med kaljenjem povečalo.
It also acknowledges that testing seeds alone does not allow for the detection of contamination which may come at a later stage in the production process.
Priznava tudi, da samo testiranje semen ne omogoča odkrivanja onesnaženja, do katerega lahko pride pozneje v proizvodnem postopku.
EFSA therefore concludes that microbiological criteria could be useful during the sprouting process and/or for the final product.
Zato Agencija ugotavlja, da bi lahko bila mikrobiološka merila koristna med kaljenjem in/ali za končni proizvod.
When considering a microbiological criterion for the final sprouted seeds, EFSA notes that the time required for the detection methods for pathogenic bacteria combined with the short shelf-life may not allow withdrawing the product in the event of non-compliance.
Glede mikrobiološkega merila za končna semena, ki kalijo, Agencija ugotavlja, da zaradi časa, potrebnega za metode za odkrivanje patogenih bakterij v kombinaciji s kratkim rokom trajanja, v primeru neskladnosti proizvoda morda ne bi bilo mogoče umakniti pravočasno.
In its opinion EFSA considers that it is currently not possible to evaluate the extent of public health protection provided by specific microbiological criteria for seeds and sprouted seeds.
V svojem mnenju je navedla, da trenutno ni mogoče ovrednotiti obsega varovanja javnega zdravja, ki ga zagotavljajo posebna mikrobiološka merila za semena in semena, ki kalijo.
This highlights the need for data collection to conduct quantitative risk assessment.
Zato je potrebno zbirati podatke, da se opravi kvantitativna ocena tveganja.
Therefore this criterion should be reviewed taking into account progress in science, technology and methodology, emerging pathogenic micro-organisms in foodstuffs and information from risk assessment.
To merilo bi bilo zato treba ponovno pregledati ob upoštevanju napredka v znanosti, tehnologiji in metodologiji, novih patogenih mikroorganizmov v živilih ter podatkov iz ocene tveganja.
In order to ensure the protection of public health in the Union and in view of that EFSA Opinion, Commission Regulation (EU) No 211/2013 of 11 March 2013 on certification requirements for imports into the Union of sprouts and seeds intended for the production of sprouts [4] and Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts [5] were adopted.
Da bi zagotovili varovanje javnega zdravja v Uniji ob upoštevanju navedenega mnenja Agencije, sta bili sprejeti Uredba Komisije (EU) št. 211/2013 z dne 11. marca 2013 o zahtevah za certificiranje za uvoz v Unijo kalčkov in semen, namenjenih za proizvodnjo kalčkov [4], ter Izvedbena uredba Komisije (EU) št. 208/2013 z dne 11. marca 2013 o zahtevah glede sledljivosti za kalčke in semena, namenjena za proizvodnjo kalčkov [5].
In addition to the measures laid down in those acts and considering the potential major health risk posed by the possible presence of pathogens in sprouts, provisions on additional microbiological criteria should be laid down following the EFSA recommendations, in particular on STEC serogroups which are considered of most important public health concern.
Poleg ukrepov iz navedenih aktov in ob upoštevanju potencialnega velikega zdravstvenega tveganja, ki ga predstavlja morebitna prisotnost patogenov v kalčkih, bi bilo treba v skladu s priporočili Agencije določiti dodatna mikrobiološka merila, zlasti za serološke skupine STEC, ki veljajo za najpomembnejše tveganje za javno zdravje.
Microbiological criteria are one of several control options in food safety and should be used by food business operators as a means to verify implementation of an effective food safety management system.
Mikrobiološka merila so ena od številnih možnosti nadzora na področju varnosti živil in bi jih morali nosilci živilske dejavnosti uporabljati kot sredstvo za preverjanje izvajanja učinkovitega sistema zagotavljanja varnosti živil.
However, due to the low prevalence and the heterogeneous distribution of some pathogens in seeds and sprouted seeds, the statistical limitations of sampling plans, and the lack of information about the application of good agricultural practices in the production of seeds, it is necessary to test all batches of seeds for the presence of the pathogens in cases where food business operators have not put in place food safety management systems including steps that reduce the microbiological risk.
Vendar je zaradi nizke in heterogene razširjenosti nekaterih patogenov v semenih in semenih, ki kalijo, statističnih omejitev načrtov vzorčenja ter pomanjkanja informacij o uporabi dobrih kmetijskih praks pri proizvodnji semen treba testirati vse serije semen v zvezi s prisotnostjo patogenov v primerih, ko nosilci živilske dejavnosti niso vzpostavili sistemov zagotavljanja varnosti živil, vključno s postopki za zmanjšanje mikrobioloških tveganj.
If food management systems are in place and if their effectiveness is confirmed by historical data, a reduction of sampling frequency may be considered.
Če so sistemi zagotavljanja varnosti živil vzpostavljeni in so njihovo učinkovitost potrdili pretekli podatki, je morda treba razmisliti o zmanjšanju pogostosti vzorčenja.
Such frequency should, however, never be less than once per month.
Vendar bi bilo treba vzorčenje opravljati vsaj enkrat mesečno.
When laying down microbiological criteria for sprouts, flexibility should be provided with regard to the stages of sampling and the type of samples which are to be taken, in order to take into account the diversity of production systems, while maintaining equivalent food safety standards.
Pri določanju mikrobioloških meril za kalčke bi bilo treba glede stopenj vzorčenja in vrste vzorcev, ki jih je treba odvzeti, zagotoviti prilagodljivost, da se upošteva raznovrstnost proizvodnih sistemov, obenem pa se ohranijo enakovredni standardi za varnost hrane.
In particular, it is appropriate to provide for alternatives to the sampling of sprouts in cases where the sampling is technically difficult.
Še zlasti je primerno, da se zagotovijo alternativne možnosti za vzorčenje kalčkov v primerih, kadar je vzorčenje tehnično zahtevno.
The testing of spent irrigation water for pathogenic bacteria has been proposed as an alternative strategy, as it seems to be a good indicator of the types of micro-organisms in the sprouts themselves.
Testiranje izrabljene vode za namakanje glede patogenih bakterij je bilo predlagano kot alternativna strategija, saj se zdi, da je dober pokazatelj vrst mikroorganizmov v kalčkih.
Due to the uncertainties regarding the sensitivity of this strategy, it is needed that food businesses operators using this alternative establish a sampling plan, including sampling procedures and sampling points of the spent irrigation water.
Zaradi negotovosti v zvezi z občutljivostjo te strategije morajo nosilci živilske dejavnosti, ki uporabljajo to alternativno možnost, izdelati načrt vzorčenja, vključno s postopki vzorčenja in mesti vzorčenja izrabljene vode za namakanje.
Certain STEC serogroups (namely O157, O26, O103, O111, O145 and O104:H4) are recognised to be those causing the most of the Haemolytic Uremic Syndrome (HUS) cases occurring in the EU.
Za nekatere serološke skupine STEC (O157, O26, O103, O111, O145 in O104:H4) je znano, da povzročijo največ primerov hemolitično-uremičnega sindroma v EU.
Furthermore serotype O104:H4 caused the outbreak in May 2011 in the Union.
Poleg tega je serotip O104:H4 maja 2011 povzročil izbruh v Uniji.
Therefore microbiological criteria should be considered for these six serogroups.
Zato bi bilo treba upoštevati mikrobiološka merila za teh šest seroloških skupin.
It cannot be excluded that other STEC serogroups may be pathogenic to humans as well.
Ni namreč mogoče izključiti, da druge serološke skupine STEC niso patogene za ljudi.
In fact, such STEC may cause less severe forms of disease such as diarrhoea and or bloody diarrhoea or may also cause HUS and therefore represent a hazard for the consumer’s health.
Pravzaprav lahko taka STEC povzroči manj resne oblike bolezni, kot sta driska in/ali krvava driska, pa tudi hemolitično-uremični sindrom in torej predstavljajo nevarnost za zdravje potrošnikov.
Sprouts should be considered to be ready-to-eat food, as they can be consumed without the need for cooking or other processing, which would otherwise be effective in eliminating or reducing to an acceptable level pathogenic micro-organisms.
Kalčki bi se morali šteti za pripravljeno živilo, saj se lahko zaužijejo brez kuhanja ali druge predelave, kar bi bil sicer učinkovit način za odpravljanje patogenih mikroorganizmov ali njihovo zmanjšanje na sprejemljivo raven.
Food business operators producing sprouts should therefore comply with the food safety criteria for ready-to-eat food laid down in Union legislation, including the sampling of processing areas and equipment as part of their sampling scheme.
Nosilci živilske dejavnosti, ki proizvajajo kalčke, bi morali zato v okviru svojega programa vzorčenja izpolnjevati merila za varnost pripravljenih živil iz zakonodaje Unije, vključno z vzorčenjem predelovalnih prostorov in opreme.
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 [6] aims at ensuring that proper and effective measures are taken to detect and control Salmonella and other zoonotic agents at all relevant stages of production, processing and distribution in order to reduce their prevalence and the risk they pose to public health.
Cilj Uredbe (ES) št. 2160/2003 Evropskega parlamenta in Sveta z dne 17. novembra 2003 o nadzoru salmonele in drugih opredeljenih povzročiteljih zoonoz, ki se prenašajo z živili [6], je zagotoviti, da se sprejmejo ustrezni in učinkoviti ukrepi za odkrivanje in nadzor salmonele in drugih povzročiteljev zoonoz v vseh zadevnih fazah proizvodnje, predelave in distribucije zaradi zmanjševanja njihove razširjenosti in tveganja za javno zdravje.
Regulation (EC) No 2160/2003, as amended by Commission Regulation (EU) No 1086/2011 [7], lays down detailed rules on a Salmonella food safety criterion for fresh poultry meat.
Uredba (ES) št. 2160/2003, kakor je bila spremenjena z Uredbo Komisije (EU) št. 1086/2011 [7], določa podrobna pravila za merila v zvezi z varnostjo hrane glede salmonele za sveže perutninsko meso.
As a consequence of the amendments made to Regulation (EC) No 2160/2003, Regulation (EC) No 2073/2005 was also amended by Regulation (EU) No 1086/2011.
Zaradi spremembe Uredbe (ES) št. 2160/2003 je bila z Uredbo (EU) št. 1086/2011 spremenjena tudi Uredba (ES) št. 2073/2005.
However, by that amendment, certain terminological ambiguities were introduced in the text of Regulation (EC) No 2073/2005.
Vendar so bile v besedilo Uredbe (ES) št. 2073/2005 zaradi navedene spremembe vključene tudi nekatere terminološke nejasnosti.
Those ambiguities should, in the interest of clarity and consistency of Union legislation, be clarified.
Zaradi jasnosti in doslednosti zakonodaje Unije bi bilo treba navedene nejasnosti razjasniti.
Regulation (EC) No 2073/2005 should therefore be amended accordingly.
Uredbo (ES) št. 2073/2005 bi bilo zato treba ustrezno spremeniti.
The measures provided for in this Regulation are in accordance with the opinion of the of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali, Evropski parlament in Svet pa jim nista nasprotovala –
Regulation (EC) No 2073/2005 is amended as follows:
Uredba (ES) št. 2073/2005 se spremeni:
In Article 2, the following point (m) is added:
v členu 2 se doda točka (m):
the definition of “sprouts” in Article 2(a) of Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts;
opredelitev pojma ‚kalčki‘ v členu 2(a) Izvedbene uredbe Komisije (EU) št. 208/2013 z dne 11. marca 2013 o zahtevah glede sledljivosti za kalčke in semena, namenjena za proizvodnjo kalčkov.
OJ L 281, 28.10.2011, p. 7.
UL L 281, 28.10.2011, str. 7.
See page 16 of this Official Journal.’;
Glej stran 16 tega Uradnega lista.“;
footnote 12 is deleted;
opomba 12 se črta;
in row 1.18 the reference to footnote 12 is replaced by the reference to footnote 23;
v vrstici 1.18 se sklicevanje na opombo 12 nadomesti s sklicevanjem na opombo 23;
the following row 1.29 and the corresponding footnotes 22 and 23 are added:
dodajo se naslednja vrstica 1.29 ter ustrezni opombi 22 in 23:
Sprouts [2]
Kalčki [2]
Shiga toxin producing E. coli (STEC) O157, O26, O111, O103, O145 and O104:H4
E. coli, ki proizvaja toksin Šiga (STEC) O157, O26, O111, O103, O145 in O104:H4
in 25 grams
v 25 g
Chapter 3 is amended as follows:
poglavje 3 se spremeni:
in Section 3.2, the part concerning ‘Sampling rules for poultry carcases and fresh poultry meat’ is amended as follows:
v oddelku 3.2 se del, ki se nanaša na „Pravila vzorčenja za klavne trupe perutnine in sveže perutninsko meso“ spremeni:
‘Slaughterhouses shall sample whole poultry carcases with neck skin for Salmonella analyses. Cutting and processing establishments other than those adjacent to a slaughterhouse cutting and processing meat received only from this slaughterhouse, shall also take samples for Salmonella analysis. When doing so, they shall give priority to whole poultry carcases with neck skin, if available, but ensuring that also poultry portions with skin and/or poultry portions without skin or with only a small amount of skin are covered, and that choice shall be risk-based.’;
„Klavnice izvajajo vzorčenje za preiskave na salmonelo pri celih klavnih trupih perutnine s kožo vratu. Razsekovalni in predelovalni obrati, razen tistih, ki so v bližini klavnice ter razsekujejo in predelujejo meso le iz te klavnice, prav tako odvzamejo vzorce za preiskave na salmonelo. Pri tem dajejo prednost celim klavnim trupom perutnine s kožo vratu, če je ta na voljo, vendar zagotovijo, da se zajamejo tudi deli piščancev s kožo in/ali deli piščancev brez kože ali z le malo kože ter da izbira temelji na tveganju.“;
‘For the Salmonella analyses for fresh poultry meat other than poultry carcases, five samples of at least 25 g of the same batch shall be collected. The sample taken from poultry portions with skin shall contain skin and a thin surface muscle slice in case the amount of skin is not sufficient to form a sample unit. The sample taken from poultry portions without skin or with only a small amount of skin shall contain a thin surface muscle slice or slices added to any skin present to make a sufficient sample unit. The slices of meat shall be taken in a way that includes as much as possible of the surface of the meat.’;
„Za preiskave na salmonelo pri svežem perutninskem mesu, pri katerem ne gre za klavne trupe perutnine, se iz ene serije odvzame pet vzorcev po najmanj 25 g. Vzorec iz delov perutnine s kožo vsebuje kožo in tanek površinski mišični reženj, če količina kože ne zadošča za vzorčno enoto. Vzorec iz delov perutnine brez kože ali z le malo kože vsebuje tanek površinski mišični reženj ali režnje, ki se dodajo, da skupaj z morebitno kožo tvorijo ustrezno vzorčno enoto. Režnji mesa se odvzamejo tako, da vključujejo čim več površine mesa.“;
the following Section 3.3 is added:
doda se naslednji oddelek 3.3:
Sampling rules for sprouts
Pravila vzorčenja za kalčke
For the purposes of this Section, the definition of batch in Article 2(b) of Implementing Regulation (EU) No 208/2013 will apply.
V tem oddelku se uporablja opredelitev pojma ‚serija‘ iz člena 2(b) Izvedbene uredbe (EU) št. 208/2013.
A. General rules for sampling and testing
A. Splošna pravila za vzorčenje in testiranje
Preliminary testing of the batch of seeds
Predhodno testiranje serije semen
Food business operators producing sprouts shall carry out a preliminary testing of a representative sample of all batches of seeds.
Nosilci živilske dejavnosti, ki proizvajajo kalčke, opravijo predhodno testiranje reprezentativnega vzorca vseh serij semen.
A representative sample shall include at least 0,5 % of the weight of the batch of seeds in sub samples of 50 g or be selected based on a structured statistically equivalent sampling strategy verified by the competent authority.
Reprezentativni vzorec vključuje vsaj 0,5 % teže serije semen v delnih vzorcih po 50 g ali je izbran na podlagi strukturirane strategije vzorčenja, ki je statistično enakovredna in jo preveri pristojni organ.
For the purposes of performing the preliminary testing, the food business operator must sprout the seeds in the representative sample under the same conditions as the rest of the batch of seeds to be sprouted.
Za izvajanje predhodnega testiranja mora nosilec živilske dejavnosti semena kaliti v reprezentativnem vzorcu pod enakimi pogoji, kot bo kaljen preostanek serije semen.
Sampling and testing of the sprouts and the spent irrigation water
Vzorčenje in testiranje kalčkov in izrabljene vode za namakanje
Food business operators producing sprouts shall take samples for microbiological testing at the stage where the probability of finding Shiga toxin producing E. coli (STEC) and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process.
Nosilci živilske dejavnosti, ki proizvajajo kalčke, odvzamejo vzorce za mikrobiološke preiskave v fazi, v kateri je verjetnost za odkritje E. coli, ki proizvaja toksin Šiga (STEC), in Salmonelle spp. najvišja, vsekakor pa ne prej kot 48 ur po začetku kaljenja.
Samples of sprouts shall be analysed according to the requirements in rows 1.18 and 1.29 of Chapter 1.
Vzorci kalčkov se analizirajo v skladu z zahtevami iz vrstic 1.18 in 1.29 poglavja 1.
However, if a food business operator producing sprouts has a sampling plan, including sampling procedures and sampling points of the spent irrigation water, they may replace the sampling requirement under the sampling plans set out in rows 1.18 and 1.29 of Chapter 1 with the analysis of 5 samples of 200 ml of the water that was used for the irrigation of the sprouts.
Če pa ima nosilec živilske dejavnosti, ki proizvaja kalčke, načrt vzorčenja, vključno s postopki vzorčenja in mesti vzorčenja izrabljene vode za namakanje, lahko zahteve za vzorčenje v skladu z načrti vzorčenja iz vrstic 1.18 in 1.29 poglavja 1 nadomesti z analizo 5 vzorcev po 200 ml vode, ki je bila uporabljena za namakanje kalčkov.
In that case requirements set out in rows 1.18 and 1.29 of Chapter 1 shall apply to the analysis of the water that was used for the irrigation of the sprouts, with the limit of absence in 200 ml.
V tem primeru se zahteve iz vrstice 1.18 in 1.29 poglavja 1 uporabljajo za analizo vode, ki je bila uporabljena za namakanje kalčkov, z mejo zaznavnosti pri 200 ml.
When testing a batch of seeds for the first time, food business operators may only place sprouts on the market if the results of the microbiological analysis comply with rows 1.18 and 1.29 of Chapter 1, or the limit of absence in 200 ml if they analyse spent irrigation water.
Pri prvem testiranju serije semen lahko nosilci živilske dejavnosti dajo kalčke na trg le, če so rezultati mikrobiološke analize skladni z vrsticama 1.18 in 1.29 poglavja 1 ali z mejo zaznavnosti pri 200 ml, če se analizira izrabljena voda za namakanje.
Food business operators producing sprouts shall take samples for microbiological analysis at least once a month at the stage where the probability of finding Shiga toxin producing E. coli (STEC) and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process.
Nosilci živilske dejavnosti, ki proizvajajo kalčke, odvzamejo vzorce za mikrobiološke preiskave vsaj enkrat na mesec v fazi, kjer je verjetnost za odkritje E. coli, ki proizvaja toksin Šiga (STEC), in Salmonelle spp. najvišja, vsekakor pa ne prej kot 48 ur po začetku kaljenja.
B. Derogation from the preliminary testing of all batches of seeds set out in point A.1 of this Section
B. Odstopanje od predhodnega testiranja vseh serij semen iz točke A.1 tega oddelka
When justified on the basis of the following conditions and authorised by the competent authority, food business operators producing sprouts may be exempted from the sampling set out in point A.1 of this Section:
Nosilci živilske dejavnosti, ki proizvajajo kalčke, so lahko izvzeti iz vzorčenja iz točke A.1 tega oddelka, kadar je to upravičeno na podlagi naslednjih pogojev in to odobri pristojni organ:
historical data confirms that during at least 6 consecutive months prior to granting the authorisation, all batches of the different types of sprouts produced in the establishment comply with the food safety criteria set out in rows 1.18 and 1.29 of Chapter 1.’
pretekli podatki potrjujejo, da so bile v zadnjih 6 zaporednih mesecih pred izdajo dovoljenja vse serije različnih vrst kalčkov proizvedene v obratu, ki izpolnjuje merila za varnost živil iz vrstic 1.18 in 1.29 poglavja 1.“
Taking into account the most recent adaptation by the European Union reference laboratory for Escherichia coli, including Verotoxigenic E. coli (VTEC), for the detection of STEC O104:H4.
Ob upoštevanju najnovejših prilagoditev, ki jih je referenčni laboratorij Evropske unije za odkrivanje STEC O104:H4 opravil za Escherichia coli, vključno z verotoksično E. coli (VTEC).
Excluding sprouts that have received a treatment effective to eliminate Salmonella spp. and STEC.’;
Razen kalčkov, ki so bili učinkovito obdelani za preprečevanje Salmonelle spp. in STEC.“;