natgillin/translations-raw huggingface dataset:
This applies in particular if the main part of the design development, manufacturing, testing or another crucial process is located with the subcontractor or supplier.
To velja zlasti, če se glavni del načrtovanja, proizvodnje, preizkušanja ali drugega ključnega postopka izvaja pri podizvajalcu ali dobavitelju.
Within the context of such unannounced audits, the notified bodies should check a recently produced adequate sample, preferably a device taken from the ongoing manufacturing process, for its conformity with the technical documentation and with legal requirements.
V okviru takih nenapovedanih revizij bi morali priglašeni organi skladnost s tehnično dokumentacijo in zakonskimi zahtevami preveriti na nedavno proizvedenem ustreznem vzorcu, še najbolje pripomočku, pridobljenem neposredno iz proizvodnega postopka.
The check of the conformity of the device should include the verification of the traceability of all critical components and materials and of the manufacturer’s traceability system.
Preučevanje skladnosti pripomočka bi moralo vključevati preverjanje sledljivosti vseh ključnih sestavnih delov in materialov ter proizvajalčevega sistema sledljivosti.
The check should encompass a file review and, if necessary in order to establish the conformity, a test of the device.
To preverjanje bi moralo zajemati pregled dokumentacije in, če je to potrebno za ugotovitev skladnosti, preizkus pripomočka.
To prepare the test, notified bodies should request from the manufacturer all the relevant technical documentation including previous test protocols and results.
Za pripravo preizkusa bi morali priglašeni organi od proizvajalca zahtevati vso ustrezno tehnično dokumentacijo, vključno s protokoli in rezultati prejšnjih preizkusov.
The test should be undertaken in accordance with the testing procedure defined by the manufacturer in the technical documentation which has to be validated by the notified body.
Preizkus bi moral biti izveden v skladu s postopkom preizkušanja, ki ga je proizvajalec opredelil v tehnični dokumentaciji in ki ga mora potrditi priglašeni organ.
The test may also be performed by the manufacturer, its critical subcontractor or crucial supplier under observation of the notified body.
Preizkus lahko izvede proizvajalec, njegov ključni podizvajalec ali ključni dobavitelj pod nadzorom priglašenega organa.
Notified bodies in charge of product assessment [1] should, in addition to the steps foreseen in Sections 1, 2 and 3, sample devices belonging to at least three different device types and, where the manufacturer produces more than 99 device types, devices belonging to at least every hundredth type at the end of the production chain or in the manufacturer’s warehouse with a view of testing the conformity of the device types.
Priglašeni organi, odgovorni za ocenjevanje izdelkov [1], bi morali poleg ukrepov, predvidenih v oddelkih 1, 2 in 3, za preizkušanje skladnosti tipov pripomočkov vzeti vzorce vsaj treh tipov pripomočkov in, kadar proizvajalec proizvede več kot 99 tipov pripomočkov, vsaj vsak stoti tip, in sicer na koncu proizvodne verige ali v proizvajalčevem skladišču.
Variants containing a technical difference which might affect safety or performance of the device should be counted as a separate device type.
Različice, ki se tako tehnično razlikujejo, da to lahko vpliva na varnost ali delovanje pripomočka, bi se morale šteti za poseben tip pripomočka.
Dimensional size variants should not be regarded as different types unless specific risks are linked to the dimension.
Različice, ki odstopajo po velikosti, se ne bi smele obravnavati kot različni tipi, razen če so z velikostjo povezana posebna tveganja.
These samples should be tested by the notified bodies or by qualified personnel under their observation on their own premises, or on the manufacturer’s premises, or on the premises of the manufacturer’s critical subcontractor or crucial supplier or in external laboratories.
Te vzorce bi morali preizkušati priglašeni organi ali pod njihovim nadzorom usposobljeno osebje v prostorih organov, proizvajalčevih prostorih, prostorih proizvajalčevega ključnega podizvajalca oziroma ključnega dobavitelja ali v zunanjih laboratorijih.
Sampling criteria and testing procedures should be defined in advance.
Merila vzorčenja in postopki preizkušanja morajo biti opredeljeni vnaprej.
In particular if a sampling in the manufacturer’s premises is not possible, notified bodies should take samples from the market, if necessary with support by the competent authorities, or should perform testing on a device installed at a customer location.
Zlasti če vzorčenje v proizvajalčevih prostorih ni mogoče, bi morali priglašeni organi vzorce pridobiti na trgu, po potrebi s pomočjo pristojnih organov, ali pa bi morali preizkušanje izvesti na pripomočku, nameščenem pri stranki.
To prepare the test, notified bodies should request from the manufacturer relevant technical documentation including final batch testing reports, previous test protocols and results.
Za pripravo preizkusa bi morali priglašeni organi od proizvajalca zahtevati ustrezno tehnično dokumentacijo, vključno s poročili o preizkusih zadnje serije ter protokoli in rezultati prejšnjih preizkusov.
Notified bodies in charge of verifying the quality system of the manufacturer [2] should, in addition to the steps foreseen in Sections 1, 2 and 3, verify whether the manufacturing activity ongoing at the time of the unannounced audit is in line with the manufacturer’s documentation relevant for the manufacturing activity and that both are in conformity with legal requirements.
Priglašeni organi, odgovorni za preverjanje proizvajalčevega sistema kakovosti [2], bi morali poleg ukrepov, predvidenih v oddelkih 1, 2 in 3, preveriti, ali je proizvodna dejavnost, ki poteka v času nenapovedane revizije, v skladu s proizvajalčevo dokumentacijo v zvezi z zadevno proizvodno dejavnostjo in ali sta obe skladni z zakonskimi zahtevami.
In addition, these notified bodies should check in more detail at least two critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, sterilisation, batch-release, packaging, or product quality control.
Ti priglašeni organi bi morali poleg tega natančneje preveriti vsaj dva ključna postopka, kot so nadzor nad načrtovanjem, priprava specifikacij materialov, nakup zunanjih materialov in sestavnih delov ter nadzor nad njimi, sestavljanje, sterilizacija, izdaja serij, pakiranje oziroma nadzor nad kakovostjo izdelkov.
Amongst the suitable critical processes, notified bodies should select one which has a high likelihood of non-conformity and one which is particularly safety relevant.
Priglašeni organi bi morali izmed ustreznih ključnih postopkov izbrati enega, za katerega obstaja velika verjetnost neskladnosti, in enega, ki je še posebno pomemben za varnost.
General advice with regard to contractual arrangements between the notified body and the manufacturer for the organisation of unannounced audits
Splošni nasveti glede pogodbenih dogovorov med priglašenim organom in proizvajalcem za organizacijo nenapovedanih revizij
In order to ensure that notified bodies are in a position to perform unannounced audits, some modalities, such as the following ones, should be considered.
Da se priglašenim organom omogoči opravljanje nenapovedanih revizij, bi bilo treba upoštevati nekatera podrobna pravila, kot so opisana v nadaljevanju.
Unannounced audits in premises of the manufacturer or its critical subcontractors or crucial suppliers should be foreseen in the contractual arrangements between the notified bodies and the manufacturers.
Nenapovedane revizije v prostorih proizvajalca, njegovega ključnega podizvajalca ali ključnega dobavitelja bi bilo treba predvideti v pogodbenih dogovorih med priglašenimi organi in proizvajalci.
If a visa is needed to visit the country where the manufacturer is located, the contractual arrangements should contain, as an annex, an invitation to visit the manufacturer at any time and an invitation which leaves the date of signature and the date of visit open (to be filled-in by the notified body).
Če je za obisk države, v kateri proizvajalec opravlja dejavnost, potreben vizum, bi morali pogodbeni dogovori v prilogi vsebovati vabilo, na podlagi katerega lahko priglašeni organ kadar koli obišče proizvajalca, ter vabilo s praznima poljema za datum podpisa in datum obiska (oba vnese priglašeni organ).
The contractual arrangements should also contain, as an annex, similar invitations issued by the critical subcontractors or crucial suppliers.
Pogodbeni dogovori bi morali v prilogi vsebovati tudi podobna vabila, ki jih izdajo ključni podizvajalci ali ključni dobavitelji.
The contractual arrangements should foresee that the manufacturers continuously inform the notified bodies on the periods when devices falling under the notified bodies’ certificates will not be manufactured.
V pogodbenih dogovorih bi bilo treba predvideti, da proizvajalci priglašene organe stalno obveščajo o obdobjih, ko se pripomočki, zajeti v certifikatih priglašenih organov, ne bodo proizvajali.
The contractual arrangements should authorise the notified bodies to end the contract as soon as their permanent unannounced access to the premises of the manufacturer or its critical subcontractors or crucial suppliers is no longer assured.
Na podlagi pogodbenih dogovorov bi morali biti priglašeni organi pooblaščeni, da prekinejo pogodbo takoj, ko jim njihov stalni nenapovedani dostop do prostorov proizvajalca, njegovega ključnega podizvajalca ali ključnega dobavitelja ni več omogočen.
The contractual arrangements should furthermore cover the measures to be taken by notified bodies to ensure the security of their auditors.
Pogodbeni dogovori bi morali poleg tega zajemati ukrepe, ki jih priglašeni organi sprejmejo za zagotovitev varnosti svojih revizorjev.
The contractual arrangements should provide for a financial compensation for the unannounced audits including, where applicable, the device acquisition, its testing and security arrangements.
V pogodbenih dogovorih bi bilo treba predvideti finančno nadomestilo za nenapovedane revizije, vključno z nadomestilom, kjer je ustrezno, za nakup pripomočka in njegovo preizkušanje ter za varnostno ureditev.
According to Section 2(a) and Annex I to this Recommendation.
V skladu z oddelkom 2(a) in Prilogo I k temu priporočilu.
According to Section 2(b) and Annex II to this Recommendation.
V skladu z oddelkom 2(b) in Prilogo II k temu priporočilu.
For medical devices other than in vitro diagnostic devices, notified bodies should review all relevant preclinical data, the clinical evaluation and the post-market clinical follow-up undertaken or planned by the manufacturer.
Za medicinske pripomočke, ki niso in vitro diagnostični medicinski pripomočki, bi morali priglašeni organi pregledati vse ustrezne predklinične podatke ter klinično vrednotenje in poprodajno klinično spremljanje, ki ju izvaja ali načrtuje proizvajalec.
They should verify that the clinical evaluation is up-to-date.
Preveriti bi morali tudi, ali je klinično vrednotenje ažurno.
of 4 November 2013
z dne 4. novembra 2013
amending Recommendation 2006/576/EC as regards T-2 and HT-2 toxin in compound feed for cats
o spremembi Priporočila 2006/576/ES glede toksinov T-2 in HT-2 v krmnih mešanicah za mačke
T-2 toxin and HT-2 toxin are mycotoxins produced by various Fusarium species.
Toksina T-2 in HT-2 sta mikotoksina, ki ju proizvajajo različne vrste glive Fusarium.
T-2 toxin is rapidly metabolised to a large number of products, HT-2 toxin being a major metabolite.
Toksin T-2 se hitro metabolizira v številne metabolite, od katerih je HT-2 eden od glavnih.
The Scientific Panel on Contaminants in the Food Chain (CONTAM panel) of the European Food Safety Authority (EFSA) adopted an opinion on a request from the Commission related to the risks for animal and public health related to the presence of T-2 and HT-2 toxin in food and feed [1].
Znanstveni odbor za onesnaževalce v prehranski verigi (odbor CONTAM) Evropske agencije za varnost hrane (EFSA) je na zahtevo Komisije sprejel mnenje glede tveganj za zdravje živali in javno zdravje, povezanih s prisotnostjo toksinov T-2 in HT-2 v živilih in krmi [1].
As regards the animal health risk, the CONTAM panel concluded that for ruminants, rabbits and fish, the current estimated exposure to T-2 and HT-2 toxin is considered unlikely to be a health concern.
Glede tveganj za zdravje živali je odbor CONTAM sklenil, da se trenutno ocenjena izpostavljenost prežvekovalcev, kuncev in rib toksinoma T-2 in HT-2 šteje za malo verjetno nevarnost zdravju.
For pigs, poultry, horses and dogs, the estimates of exposure to T-2 and HT-2 toxin indicate that the risk of adverse health effects is low.
Ocene izpostavljenosti prašičev, konj in psov toksinoma T-2 in HT-2 kažejo, da je tveganje škodljivih učinkov na zdravje majhno.
Due to the limited data and the severe adverse health effects at low dose levels, no No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect Level (LOAEL) could be established.
Zaradi omejenih podatkov in resnih škodljivih učinkov na zdravje pri majhnih odmerkih ni bilo mogoče določiti ravni NOAEL (raven brez opaženega škodljivega učinka) oziroma LOAEL (najnižja raven z opaženim škodljivim učinkom).
Taking into account the conclusions of the scientific opinion, investigations have to be undertaken in order to collect information on the factors resulting in relative high levels of T2 and HT-2 toxin in cereals and cereal products and on the effects of feed and food processing.
Ob upoštevanju sklepov znanstvenega mnenja je treba opraviti preiskave, da bi se zbrale informacije o dejavnikih, ki vodijo do razmeroma velikih vsebnosti toksinov T-2 in HT-2 v žitih in žitnih proizvodih, ter o vplivih predelave krme in živil.
Therefore, Commission Recommendation 2013/165/EU [2] was adopted to recommend carrying out these investigations.
Za priporočitev izvedbe teh preiskav je bilo sprejeto Priporočilo Komisije 2013/165/EU [2].
Given the toxicity of T-2 and HT-2 toxin for cats it is appropriate to establish in addition a guidance value for the sum of T-2 and HT-2 toxin in cat feed to be applied for judging the acceptability of cat feed as regards the presence of T-2 and HT-2 toxin.
Glede na toksičnost toksinov T-2 in HT-2 za mačke je poleg tega primerno uvesti orientacijsko vrednost za skupno vsebnost toksinov T-2 in HT-2 v krmi za mačke, ki se uporabi pri presojanju sprejemljivosti krme za mačke glede prisotnosti toksinov T-2 in HT-2.
Commission Recommendation 2006/576/EC [3] should therefore be amended,
Priporočilo Komisije 2006/576/ES [3] bi bilo zato treba ustrezno spremeniti –
In the Annex of Recommendation 2006/576/EC, the following entry is added after the entry on Fumonisin B1 + B2:
V Prilogi k Priporočilu 2006/576/ES se za vnosom za fumonizin B1 + B2 doda naslednji vnos:
‘Mycotoxin
„Mikotoksini
T-2 + HT-2 toxin
Toksina T-2 in HT-2
Compound feed for cats
Krmne mešanice za mačke
Done at Brussels, 4 November 2013.
V Bruslju, 4. novembra 2013
EFSA Panel on Contaminants in the Food Chain (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, EFSA Journal 2011; 9(12):2481.
Odbor EFSA za onesnaževalce v prehranski verigi (CONTAM); Znanstveno mnenje o tveganjih za zdravje živali in javno zdravje, povezanih s prisotnostjo toksinov T-2 in HT-2 v živilih in krmi. EFSA Journal (2011); 9(12):2481.
Commission Recommendation 2013/165/EU of 27 March 2013 on the presence of T-2 and HT-2 toxin in cereals and cereal products (OJ L 91, 3.4.2013, p. 12).
Priporočilo Komisije 2013/165/EU z dne 27. marca 2013 o prisotnosti toksinov T-2 in HT-2 v žitih in žitnih proizvodih (UL L 91, 3.4.2013, str. 12).
Commission Recommendation 2006/576/EC of 17 August 2006 on the presence of deoxynivalenol, zearalenone, ochratoxin A, T-2 and HT-2 and fumonisins in products intended for animal feeding (OJ L 229, 23.8.2006, p. 7).
Priporočilo Komisije 2006/576/ES z dne 17. avgusta 2006 o prisotnosti deoksinivalenola, zearalenona, ohratoksina A, toksinov T-2 in HT-2 ter fumonizinov v proizvodih, namenjenih za krmo (UL L 229, 23.8.2006, str. 7).
on investigations into the levels of acrylamide in food
glede ugotavljanja ravni akrilamida v živilih
The food industry, the Member States and the Commission have undertaken extensive efforts since 2002 in order to investigate pathways of formation and to reduce the levels of acrylamide in processed foods.
Živilska industrija, države članice in Komisija si od leta 2002 močno prizadevajo ugotoviti načine nastajanja akrilamida in zmanjševati njegove ravni v predelanih živilih.
The organisation FoodDrinkEurope, which represents the European food and drink industry, developed a ‘toolbox’ [1] containing tools that can be used selectively by food producers in line with their particular needs to lower acrylamide levels in their products.
Organizacija FoodDrinkEurope, ki zastopa evropsko živilsko industrijo in industrijo pijač, je razvila „zbirko orodij [1]“, ki jih proizvajalci živil lahko uporabljajo selektivno glede na njihove posebne potrebe za zniževanje ravni akrilamida v njihovih izdelkih.
Acrylamide levels in some foodstuffs appeared to be significantly higher than the levels in comparable products of the same product category.
Ravni akrilamida so bile v nekaterih živilih bistveno višje od ravni v primerljivih proizvodih iz iste kategorije proizvodov.
Therefore the Commission considered it appropriate that Member States’ competent authorities carry out investigations by examining the production and processing methods used by food business operators.
Zato je Komisija menila, da je ustrezno, da pristojni organi držav članic pregledajo metode proizvodnje in predelave, ki jih uporabljajo nosilci živilske dejavnosti.
To that end, the Commission adopted on 10 January 2011 a Recommendation on investigations into the levels of acrylamide in food [2] (‘the 2011 Recommendation’).
V ta namen je Komisija 10. januarja 2011 sprejela priporočilo o raziskavi ravni akrilamida v živilih [2] („priporočilo iz leta 2011“).
Pursuant to the 2011 Recommendation, Member States are encouraged to carry out investigations if the acrylamide level found in a specific foodstuff exceeds the indicative values set out in the Annex to that Recommendation.
Na podlagi priporočila iz leta 2011 naj države članice ugotovijo, ali raven akrilamida v določenem živilu presega okvirne vrednosti iz Priloge k navedenemu priporočilu.
Acrylamide levels in food have been monitored by Member States from 2007 to 2009 pursuant to Commission Recommendation 2007/331/EC [3], and as from 2010 pursuant to Commission Recommendation 2010/307/EU [4].
Ravni akrilamida v živilih so države članice spremljale od leta 2007 do 2009 v skladu s Priporočilom Komisije 2007/331/ES [3] in od leta 2010 v skladu s Priporočilom Komisije 2010/307/EU [4].
That monitoring exercise is targeted to those foodstuffs that are known to contain high acrylamide levels and/or contribute significantly to the human dietary intake.
Program spremljanja je usmerjen na tista živila, za katere je znano, da vsebujejo visoke ravni akrilamida in/ali pomembno prispevajo k njegovem vnosu s prehrano pri ljudeh.
On the basis of the results of the investigations obtained during the years 2011 and 2012 and on the basis of the monitoring results obtained pursuant to Recommendations 2007/331/EC and 2010/307/EU, it is appropriate to modify certain indicative values provided for in the Annex to the 2011 Recommendation.
Na podlagi rezultatov, pridobljenih v letih 2011 in 2012, ter rezultatov spremljanja stanja, pridobljenih v skladu s priporočiloma 2007/331/ES in 2010/307/EU, je primerno ustrezno spremeniti nekatere okvirne vrednosti iz Priloge k priporočilu iz leta 2011.
The 2011 Recommendation should therefore be replaced by a new Recommendation.
Zato bi bilo treba priporočilo iz leta 2011 nadomestiti z novim priporočilom.
Investigations should continue to include the food business operator’s Hazard Analysis and Critical Control Points (HACCP) or a similar system [6] with a view to exploring with the food business operator whether relevant processing steps susceptible for the formation of acrylamide have been identified and whether appropriate measures have been taken to control them.
Preiskave bi morale še naprej vključevati analizo tveganj in kritičnih nadzornih točk (HACCP) ali podoben sistem nosilca živilske dejavnosti [6], da se skupaj z nosilcem živilske dejavnosti razišče, ali so bile ugotovljene ustrezne stopnje predelave, pri katerih lahko nastaja akrilamid, ter ali so bili sprejeti ustrezni ukrepi za njihov nadzor.
In doing so, the competent authorities should assess the extent to which currently known options for the minimisation of acrylamide levels, e.g. those proposed in the Code of Practice for acrylamide adopted by the Codex Alimentarius Commission and in the acrylamide ‘toolbox’ developed by FoodDrinkEurope, have been implemented by the food business operator.
Pri tem bi morali pristojni organi oceniti, v kolikšni meri je nosilec živilske dejavnosti uporabil trenutno znane možnosti za minimiziranje ravni akrilamida, npr. možnosti, predlagane v kodeksu ravnanja za akrilamid, ki ga je sprejela Komisija za Codex Alimentarius, in v „zbirki orodij“ za akrilamid, ki jo je pripravila organizacija FoodDrinkEurope.
Indicative values set by this Recommendation are only intended to indicate the need for an investigation.
Namen okvirnih vrednosti, navedenih v tem priporočilu, je samo pokazati na nujnost preiskave.
They are not safety thresholds.
To niso varnostne mejne vrednosti.
Therefore, enforcement action and/or the issuing of a Rapid Alert should only be undertaken on the basis of a sound risk assessment carried out on a case by case basis, but not merely because an indicative value is exceeded.
Zato bi bilo treba sprejeti izvršilni ukrep in/ali sprožiti hitro obveščanje samo na podlagi razumne ocene tveganja za vsak posamezni primer, ne pa zgolj zaradi presežene okvirne vrednosti.
On the basis of the results of the investigations obtained during the years 2013 and 2014 pursuant to this Recommendation and on the basis of the monitoring results obtained pursuant to Recommendation 2010/307/EU and the outcome of the updated risk assessment performed by the EFSA on the presence of acrylamide in food, the Commission will assess the situation after an EFSA risk assessment becomes available and decide about the need for other appropriate measures,
Na podlagi rezultatov preiskav, ki bodo leta 2013 in 2014 pridobljeni v skladu s tem priporočilom, in na podlagi rezultatov spremljanja stanja, pridobljenih v skladu s Priporočilom 2010/307/EU, ter rezultata posodobljene ocene tveganja o vsebnosti akrilamida v hrani, ki jo opravi EFSA, bo Komisija ocenila razmere po oceni tveganja Evropske agencije za varnost hrane ter se odločila, ali so potrebni drugi ustrezni ukrepi –
Member States should, with the active involvement of food business operators, carry out further investigations into the production and processing methods used by food producers in cases where the level of acrylamide in a foodstuff, tested in the monitoring exercise carried out pursuant to Recommendation 2010/307/EU, exceeds the acrylamide indicative value set for the respective food category in the Annex to this Recommendation.
Države članice naj z aktivnim sodelovanjem nosilcev živilske dejavnosti nadalje preučijo metode proizvodnje in predelave, ki so jih uporabili proizvajalci živil, ko raven akrilamida v živilu, preskušenem v okviru programa spremljanja v skladu s Priporočilom 2010/307/EU, presega okvirno vrednost akrilamida, določeno za zadevno kategorijo živila v Prilogi k temu priporočilu.
For the purposes of point 1, the level of acrylamide should be assessed without considering the analytical measurement uncertainty.
Za namene točke 1 bi bilo treba raven akrilamida oceniti brez upoštevanja analitske merilne negotovosti.