natgillin/translations-raw huggingface dataset:
The sampling procedure applied by the food business operator might deviate from the provisions of Regulation (EC) No 401/2006 but should be representative for the lot sampled.
Postopek vzorčenja, ki ga uporabi nosilec živilske dejavnosti, lahko odstopa od določb Uredbe (ES) št. 401/2006, vendar bi moral biti reprezentativen za vzorčeni lot.
The sampling and analysis for cereals and cereal products intended for feed and compound feed should be performed in accordance with the provisions provided for in Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed [3].
Vzorčenje in analiza žit in žitnih proizvodov, namenjenih za krmo in krmne mešanice, bi se morala izvajati v skladu z določbami Uredbe Komisije (ES) št. 152/2009 z dne 27. januarja 2009 o določitvi metod vzorčenja in analitskih metod za uradni nadzor krme [3].
The Limit of Quantification (LOQ) should preferably not be higher than 10 μg/kg for T-2 and HT-2 toxin individually.
Meja določanja (LOQ) po možnosti ne bi smela biti večja od 10 μg/kg za posamičen toksin T-2 ali HT-2.
The sampling procedure applied by the feed business operator might deviate from the provisions of Regulation (EC) No 152/2009 but should be representative for the lot sampled.
Postopek vzorčenja, ki ga uporabi nosilec dejavnosti poslovanja s krmo, lahko odstopa od določb Uredbe (ES) št. 152/2009, vendar bi moral biti reprezentativen za vzorčeni lot.
Member States, with the active involvement of the feed and food business operators, should perform investigations to identify the factors resulting in these levels above the indicative level and determine the measures to be taken to avoid or reduce such presence in future.
Države članice bi morale ob dejavnem sodelovanju nosilcev dejavnosti poslovanja s krmo in živilske dejavnosti izvajati preiskave za opredelitev dejavnikov, ki vodijo do teh vsebnosti nad okvirno vrednostjo, ter določiti ukrepe, ki bi jih bilo treba sprejeti za preprečitev ali zmanjšanje take prisotnosti v prihodnje.
These investigations should certainly be performed in case of repetitive findings within a certain period of time of levels above the indicative levels of T-2 and HT-2 toxin in cereals and cereal products mentioned in Annex to this Recommendation.
Te preiskave bi bilo treba v vsakem primeru opraviti, če se v žitih in žitnih proizvodih v nekem obdobju večkrat odkrijejo vsebnosti toksinov T-2 in HT-2, ki presegajo okvirne vrednosti iz Priloge k temu priporočilu.
The sampling and analysis with the objective to obtain more information on the different factors, including agronomic factors, which lead to relative high levels of T-2 and HT-2 toxin in cereals and cereal products, should be targeted on cereals and cereal products from primary processing.
Vzorčenje in analiza zaradi pridobivanja več informacij o različnih dejavnikih, tudi kmetijskih, ki vodijo do razmeroma velikih vsebnosti toksinov T-2 in HT-2 v žitih in žitnih proizvodih, bi morala biti usmerjena v žita in žitne proizvode iz prve predelave.
Member States, with the active involvement of the feed and food business operators, should perform investigations on the effects of feed and food processing on the presence of T-2 and HT-2 toxin.
Države članice bi morale ob dejavnem sodelovanju nosilcev dejavnosti poslovanja s krmo in živilske dejavnosti izvajati preiskave o vplivih predelave krme in živil na prisotnost toksinov T-2 in HT-2.
These investigations should certainly be performed in case of repetitive findings within a certain period of time of levels above the indicative level of T-2 and HT-2 toxin in cereal products.
Te preiskave bi bilo treba v vsakem primeru opraviti, če se v žitnih proizvodih v nekem obdobju večkrat odkrijejo vsebnosti toksinov T-2 in HT-2, ki presegajo okvirne vrednosti.
EFSA Panel on Contaminants in the Food Chain (CONTAM);
Odbor EFSA za onesnaževalce v prehranjevalni verigi (CONTAM);
Scientific Opinion on risks for animal and public health related to the presence of T-2 and HT-2 toxin in food and feed.
Znanstveno mnenje o tveganjih za zdravje živali in javno zdravje, povezanih s prisotnostjo toksinov T-2 in HT-2 v živilih in krmi.
[187 pp.] doi:10.2903/j.efsa.2011.2481.
[187 str.] doi:10.2903/j.efsa.2011.2481.
Available online:
Na voljo na spletu:
Indicative levels for cereals and cereals products [1] [2]
Okvirne vrednosti za žita in žitne proizvode [1] [2]
Indicative levels for the sum of T-2 and HT-2 (μg/kg) from which onwards/above which investigations should be performed, certainly in case of repetitive findings [1]
Okvirne vrednosti za skupno količino toksinov T-2 in HT-2 (μg/kg), nad katerimi oziroma ob preseganju katerih bi bilo treba izvajati preiskave, vsekakor pa v primeru večkratnih odkritij [1]
Unprocessed cereals [3]
Nepredelana žita [3]
barley (including malting barley) and maize
ječmen (vključno s pivovarskim ječmenom) in koruza
oats (with husk)
oves (neoluščen)
wheat, rye and other cereals
pšenica, rž in druga žita
Cereal grains for direct human consumption [4]
Žitno zrnje za neposredno prehrano ljudi [4]
oats
oves
maize
koruza
Cereal products for human consumption
Žitni proizvodi za prehrano ljudi
oat bran and flaked oats
ovseni otrobi in kosmiči
cereal bran except oat bran, oat milling products other than oat bran and flaked oats, and maize milling products
žitni otrobi razen ovsenih otrobov, ovseni mlevski proizvodi razen ovsenih otrobov in kosmičev ter koruzni mlevski proizvodi
other cereal milling products
drugi žitni mlevski proizvodi
breakfast cereals including formed cereal flakes
žitni kosmiči, vključno z ekstrudiranimi
bread (including small bakery wares), pastries, biscuits, cereal snacks, pasta
kruh (vključno z majhnimi pekovskimi izdelki), pecivo, piškoti, prigrizki iz žita, testenine
cereal-based foods for infants and young children
žitne kašice za dojenčke in majhne otroke
Cereal products for feed and compound feed [5]
Žitni proizvodi za krmo in krmne mešanice [5]
oat milling products (husks)
ovseni mlevski proizvodi (luske)
other cereal products
drugi žitni proizvodi
compound feed, with the exception of feed for cats
krmne mešanice razen hrane za mačke
The levels referred to in this Annex are indicative levels above which, certainly in the case of repetitive findings, investigations should be performed on the factors leading to the presence of T-2 and HT-2 toxin or on the effects of feed and food processing.
Vrednosti v tej prilogi so okvirne vrednosti, ob preseganju katerih, zlasti pa v primeru večkratnih odkritij, bi bilo treba izvajati preiskave v zvezi z dejavniki, ki vodijo do prisotnosti toksinov T-2 in HT-2, ali vplivi predelave krme in živil.
The indicative levels are based on the occurrence data available in the EFSA database as presented in the EFSA opinion.
Okvirne vrednosti temeljijo na podatkih o prisotnosti, ki so na voljo v podatkovni zbirki agencije EFSA in predstavljeni v njenem mnenju.
The indicative levels are not feed and food safety levels.
Okvirne vrednosti niso vrednosti za varnost krme in živil.
Unprocessed cereals are cereals which have not undergone any physical or thermal treatment other than drying, cleaning and sorting.
Nepredelana žita so žita, ki niso bila mehansko ali toplotno obdelana, razen v postopkih sušenja, razvrščanja in čiščenja.
Cereal grains for direct human consumption are cereal grains which have undergone drying, cleaning, de-husking and sorting processes and on which no further cleaning and sorting processes will be performed before their further processing in the food chain.
Žitno zrnje za neposredno prehrano ljudi je žitno zrnje, ki je bilo predmet postopkov sušenja, čiščenja, luščenja in razvrščanja ter za katero pred nadaljnjo predelavo v živilski verigi ne bo uporabljen noben nadaljnji postopek čiščenja in razvrščanja.
The indicative levels for cereals and cereal products intended for feed and compound feed are relative to a feed with a moisture content of 12 %.
Okvirne vrednosti za žita in žitne proizvode, namenjene za krmo in krmne mešanice, se nanašajo na krmo z 12-odstotno vsebnostjo vlage.
Member States should ensure that the analytical results are provided on a regular basis to EFSA for compilation into a single database and that the outcome of the investigations is provided to the European Commission every year, the first time by December 2013.
Države članice bi morale zagotoviti, da se rezultati analiz redno pošiljajo agenciji EFSA za vključitev v enotno podatkovno zbirko in da se izsledki preiskav vsako leto predložijo Evropski komisiji, prvič do decembra 2013.
A guidance note will be elaborated to ensure uniform application of this Recommendation and to ensure comparable reporting of results of investigations.
Pripravljeno bo navodilo za zagotovitev enotne uporabe tega priporočila in primerljivega poročanja o izsledkih preiskav.
on a common framework for a unique device identification system of medical devices in the Union
o skupnem okviru za sistem enotne identifikacije pripomočka medicinskih pripomočkov v Uniji
Traceability of medical devices throughout the whole supply chain contributes to patient safety by facilitating vigilance, market surveillance and transparency in this sector.
Sledljivost medicinskih pripomočkih skozi celotno dobavno verigo prispeva k varnosti pacientov, tako da omogoča vigilanco, nadzor trga in preglednost v tem sektorju.
The current regulatory framework for medical devices does not include specific provisions on traceability.
Sedanji regulativni okvir za medicinske pripomočke ne vključuje posebnih določb o sledljivosti.
Therefore, a recommendation paving the way to a reinforced regulatory approach on traceability of medical devices is needed.
Zato je potrebno priporočilo, ki bo utrlo pot okrepljenemu regulativnemu pristopu k sledljivosti medicinskih pripomočkov.
The proposal from the European Commission for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 [1] adopted on 26 September 2012, and the proposal from the European Commission for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices [2] adopted on 26 September 2012, include provisions on traceability of medical devices and in vitro diagnostic medical devices, in order to improve patient health and safety.
Predlog Evropske komisije za uredbo Evropskega parlamenta in Sveta o medicinskih pripomočkih in spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 [1], sprejet 26. septembra 2012, ter predlog Evropske komisije za uredbo Evropskega parlamenta in Sveta o in vitro diagnostičnih medicinskih pripomočkih [2], sprejet 26. septembra 2012, vključujeta določbe o sledljivosti medicinskih pripomočkov ter in vitro diagnostičnih medicinskih pripomočkov, da bi se izboljšala zdravje in varnost pacientov.
The Council conclusions on innovation in the medical device sector [3] of 6 June 2011 invites the Commission and Member States to pay particular attention to interoperability and safety issues related to the integration of medical devices in e-Health systems, especially personal health systems.
V sklepih Sveta o inovacijah v sektorju medicinskih pripomočkov [3] z dne 6. junija 2011 so Komisija in države članice pozvane, naj posebno pozornost namenijo vprašanjema interoperabilnosti in varnosti pri vključevanju medicinskih pripomočkov v sisteme e-zdravja, zlasti osebne zdravstvene sisteme.
Significant efforts are being made at international level towards a globally harmonised approach on traceability and to establish a globally accepted unique device identification (UDI) system for medical devices.
Na mednarodni ravni je bilo vloženega že veliko truda, da bi globalno usklajeno pristopili k sledljivosti in vzpostavili splošno sprejet sistem enotne identifikacije pripomočka (EIP) za medicinske pripomočke.
UDI mechanisms, based on different national and/or regional traceability requirements, have already been developed and there is a risk that further diverging UDI mechanisms may be developed at these levels.
Mehanizmi EIP, ki temeljijo na različnih nacionalnih in/ali regionalnih zahtevah po sledljivosti, so že razviti in obstaja nevarnost, da bi na teh ravneh razvili še več različnih mehanizmov EIP.
In future certain information contained in the UDI code could feed the Electronic Health Record according to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare [4] and the Digital Agenda for Europe [5],
V prihodnje bi določene informacije z oznako EIP lahko uporabili za vnos v elektronski zdravstveni zapis v skladu z Direktivo 2011/24/EU Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu [4] in Evropsko digitalno agendo [5] –
Purpose of the Recommendation
Namen Priporočila
Traceability is currently not regulated by the medical device directives [6] while it is addressed in some cases at national and/or regional level.
Sledljivosti trenutno ne urejajo direktive o medicinskih pripomočkih [6], v nekaterih primerih pa jo obravnava nacionalna in/ali regionalna zakonodaja.
The differences and incompatibility between the traceability mechanisms may weaken and compromise the efficiency of the systems put in place.
Razlike med mehanizmi za sledljivost in njihova nezdružljivost bi lahko omajale sedanje sisteme in ogrozile njihovo učinkovitost.
In addition, the development of different national and/or regional unique device identification mechanisms would oblige manufacturers to adapt their products to each mechanism in order to fulfil traceability obligations.
Poleg tega bi razvoj različnih nacionalnih in/ali regionalnih mehanizmov za enotno identifikacijo pripomočka od proizvajalcev zahteval, da za izpolnjevanje obveznosti glede sledljivosti svoje proizvode prilagodijo vsakemu od teh mehanizmov.
The best way to ensure effective traceability of medical devices in the Union is to develop a UDI system harmonised at European level.
Najboljši način za zagotovitev učinkovite sledljivosti medicinskih pripomočkov v Uniji je razvoj sistema EIP, usklajenega na evropski ravni.
The ongoing revision process of the current Directives on medical devices should empower the Commission to adopt detailed traceability requirements.
V postopku revizije veljavnih direktiv o medicinskih pripomočkih, ki trenutno poteka, bi bilo treba Komisijo pooblastiti, da sprejme podrobne zahteve po sledljivosti.
This Recommendation does not aim to define all the aspects of the UDI system.
Cilj tega priporočila ni določiti vse vidike sistema EIP.
It should be taken as a tool to facilitate the compatibility of the traceability mechanisms established at national and/or regional level and to pave the way to the mandatory implementation of an internationally compatible UDI system of the Union.
Razumeti bi ga bilo treba kot orodje, ki bo olajšalo združljivost mehanizmov za sledljivost, vzpostavljenih na nacionalni in/ali regionalni ravni, in utrlo pot obvezni uvedbi mednarodno združljivega sistema EIP Unije.
Scope of the Recommendation
Področje uporabe priporočila
This Recommendation applies to medical devices, active implantable medical devices (other than devices which are custom-made or intended for clinical investigations) and in vitro diagnostic medical devices (other than those manufactured in health institutions and for performance evaluation), including their accessories.
To priporočilo se nanaša na medicinske pripomočke, aktivne medicinske pripomočke za vsaditev (razen pripomočkov, izdelanih za posameznega uporabnika ali namenjenih za klinične preiskave) ter in vitro diagnostične medicinske pripomočke (razen tistih, ki so proizvedeni v zdravstvenih ustanovah in ki so namenjeni ocenjevanju učinkovitosti), vključno z njihovimi dodatki.
International activity on UDI
Mednarodna dejavnost na področju EIP
At international level, in 2008 the Global Harmonization Task Force (GHTF) [7] set up an ad hoc working group with the purpose of developing an internationally coordinated approach on UDI.
Na mednarodni ravni je delovna skupina za svetovno usklajevanje (Global Harmonization Task Force) [7] leta 2008 ustanovila začasno delovno skupino z namenom razvoja mednarodno usklajenega pristopa k EIP.
This group, gathering industry and regulators, was chaired by the European Commission and ceased its activity in September 2011, when the GHTF adopted a guidance [8] document on a ‘Unique Device Identification (UDI) System for Medical Devices’.
V slednji so se zbrali predstavniki industrije in zakonodajalcev, predsedovala pa ji je Evropska komisija; skupina je z dejavnostmi prenehala septembra 2011, ko je delovna skupina za svetovno usklajevanje sprejela smernice [8] o „sistemu enotne identifikacije pripomočka (EIP) za medicinske pripomočke“.
The work of the GHTF towards a further harmonisation of the medical device regulatory framework is being carried out under the auspice of the International Medical Device Regulators Forum (IMDRF) [9].
Delovna skupina za svetovno usklajevanje si še naprej prizadeva za usklajevanje regulativnega okvira medicinskih pripomočkov, njeno delo pa poteka pod okriljem mednarodnega foruma regulativnih organov na področju medicinskih pripomočkov [9].
This Recommendation is aligned to the approach developed at international level.
To priporočilo je usklajeno s pristopom, razvitim na mednarodni ravni.
European activity on UDI
Evropska dejavnost na področju EIP
In 2010, the European Commission set up a European UDI ad hoc Working Group, within the regulatory framework established by the directives on medical devices, in order to develop a coordinated approach, taking into account the progress made at both national and international level.
11. Evropska komisija je leta 2010 ustanovila evropsko posebno delovno skupino za EIP v regulativnem okviru, ki je bil določen v direktivah o medicinskih pripomočkih, da bi razvili usklajen pristop ob upoštevanju napredka, doseženega na nacionalni in mednarodni ravni.
The aim of the group is threefold:
Skupina ima tri cilje:
first, it is intended to encourage contributions and monitor the reaction of Competent Authorities to the work carried out at international level;
spodbujati prispevke k delu na mednarodni ravni in spremljati, kako se nanj odzivajo pristojni organi;
second, it encourages the sharing of views and information on national initiatives developed by Member States and search for common solutions;
spodbujati izmenjavo mnenj in informacij o nacionalnih pobudah, ki so jih razvile države članice, in iskanje skupnih rešitev;
thirdly, it facilitates the convergence with the future Union legislation of national initiatives developed by Member States.
pospeševati zbliževanje nacionalnih pobud, ki so jih razvile države članice, s prihodnjo zakonodajo Unije.
RATIONALE
UTEMELJITEV
The primary objectives of a UDI system are patient safety [10] enhancement and patient care optimisation.
Glavna cilja sistema EIP sta povečanje varnosti pacientov [10] in optimizacija oskrbe pacientov.
facilitating efficient recalls and other field safety corrective actions (FSCA);
omogoča učinkovit odpoklic in druge varnostne popravljalne ukrepe;
facilitating efficient post market actions by national competent authorities;
omogoča učinkovite ukrepe pristojnih nacionalnih organov po dajanju na trg;
enabling queries in numerous data systems;
omogoča poizvedbe v številnih podatkovnih sistemih;
reducing the likelihood of medical errors linked to misuse of the device.
zmanjšuje verjetnost zdravstvenih napak, povezanih z nepravilno uporabo pripomočka.
The establishment of a UDI system could also support the achievement of other objectives such as the fight against counterfeiting, better distribution control, stock management and reimbursement issues.
Vzpostavitev sistema EIP bi lahko podprla tudi doseganje drugih ciljev, kot so boj proti ponarejanju, boljši nadzor nad distribucijo, upravljanje zalog in povračilo stroškov.
However, the objectives referred to in paragraph 14 should be seen as possible positive consequences of the UDI system.
Vendar bi bilo cilje iz odstavka 14 treba obravnavati le kot morebitne pozitivne posledice sistema EIP.
Improvement of incident reporting
Izboljšanje poročanja o zapletih
The use of a UDI is expected to improve incident reporting and offers the opportunity to gather all the incidents related to one medical device at Union level and, in case of an internationally accepted and compatible UDI, at international level.
Pričakuje se, da bo uporaba EIP izboljšala poročanje o zapletih in ponudila priložnost za zbiranje informacij o vseh zapletih v zvezi z enim medicinskim pripomočkom na ravni Unije ter, v primeru mednarodno sprejete in združljive EIP, na mednarodni ravni.
This will increase the potential for comparing results associated with each specific medical device.
S tem se bo povečala možnost primerjave rezultatov, povezanih z vsakim posameznim medicinskim pripomočkom.
Efficient recalls and other field safety corrective actions
Učinkovit odpoklic in drugi varnostni popravljalni ukrepi
The attribution of a unique identifier to a specific device and its use along the distribution chain (global use) will allow the unambiguous identification of the device itself.
Dodelitev enotnega identifikatorja posameznemu pripomočku in njegova uporaba v distribucijski verigi (svetovna uporaba) bo omogočala nedvoumno identifikacijo pripomočka.
For traceability to be ensured, it is not sufficient that every manufacturer has developed its own traceability mechanism.
Za zagotavljanje sledljivosti ne zadostuje, da vsak proizvajalec razvije lasten mehanizem za sledljivost.
The lack of a Union system used all along the supply chain could lead to negative outcomes inasmuch as each actor of the distribution chain might modify the coding developed by the manufacturer.
Pomanjkanje sistema Unije, ki bi se uporabljal na vseh točkah dobavne verige, bi lahko privedlo do negativnih rezultatov, saj bi lahko vsak udeleženec v distribucijski verigi spremenil kodiranje, ki ga je razvil proizvajalec.
This might give rise to errors in the encoding of medical devices which would in turn endanger the traceability of devices in case of FSCA.
To bi lahko povzročilo napake v kodiranju medicinskih pripomočkov, kar bi ogrozilo sledljivost pripomočkov v primeru varnostnih popravljalnih ukrepov.
The use of the same coding language improves the tracking and tracing of medical devices.
Uporaba istega jezika kodiranja izboljšuje sledenje in spremljanje medicinskih pripomočkov.
Efficient post market actions by national competent authorities
Učinkoviti ukrepi pristojnih nacionalnih organov po dajanju na trg
A UDI system helps specifically to target identified products.
Sistem EIP omogoča ukrepe za točno določene proizvode.
In addition, it will provide an opportunity to ensure coordinated reactions by Member States.
Poleg tega bo ponudil priložnost za zagotovitev usklajenega odziva držav članic.
Queries in numerous data systems
Poizvedbe v številnih podatkovnih sistemih
By using the same UDI in different data systems (both at regulatory and health institutions level) queries will become more efficient and it will be easier to perform searches in order to aggregate information.
Z uporabo iste EIP v različnih podatkovnih sistemih (tako na regulativni ravni kot tudi na ravni zdravstvenih ustanov) bodo poizvedbe postale učinkovitejše, iskanje in zbiranje informacij pa lažje.
At the moment, this approach is not possible because each data system has its own identification tool.
Trenutno ta pristop ni mogoč, ker ima vsak podatkovni sistem lastno identifikacijsko orodje.
Reduction of medical errors
Zmanjšanje zdravstvenih napak
It might be expected that, by using identification mechanisms, the number of cases where medical devices have been incorrectly selected will be reduced.
Pričakuje se, da bi se z uporabo mehanizmov za identifikacijo število primerov nepravilno izbranih medicinskih pripomočkov lahko znižalo.
For the purposes of this Recommendation the following definitions apply:
V tem priporočilu se uporabljajo naslednje opredelitve pojmov: