natgillin/translations-raw huggingface dataset:
For the purpose of implementing Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003, the applicant shall, together with the information required under Sections 1, 2 and 3 of this Annex, also provide samples of the food and feed and their control samples of a type and amount to be specified by the EURL for the specific application for authorisation.
Za izvajanje člena 5(3)(j) in člena 17(3)(j) Uredbe (ES) št. 1829/2003 vlagatelj skupaj z informacijami, ki se zahtevajo v oddelkih 1, 2 in 3 te priloge, predloži tudi vzorce živil in krme ter kontrolne vzorce živil in krme take vrste in v taki količini, kakor jih za posebno vlogo za odobritev podrobno navede EURL.
The information accompanying the control samples shall include information on the breeding of the plant which has been used for the production of the control samples and on the zygosity of the insert(s).
Informacije, priložene kontrolnim vzorcem, vključujejo informacije o pridelavi rastline, ki se uporablja za proizvodnjo kontrolnih vzorcev, in o zigotnosti vključkov.
The applicant may use the same raw material for the production of certified reference material and for the production of control samples.
Vlagatelj lahko uporabi enako surovino za proizvodnjo certificiranega referenčnega materiala in za proizvodnjo kontrolnih vzorcev.
CERTIFIED REFERENCE MATERIAL
CERTIFICIRANI REFERENČNI MATERIAL
The certified reference material shall be produced under ISO Guide 34 (General requirements for the competence of reference material producers) by a producer accredited to ISO Guide 34.
Certificirani referenčni material proizvede proizvajalec, akreditiran po Smernicah ISO 34, v skladu s Smernicami ISO 34 (Splošne zahteve za usposobljenost proizvajalcev referenčnega materiala).
The applicant shall provide information as regards the place where the certified reference material can be accessed.
Vlagatelj predloži informacije o kraju, kjer je na voljo certificirani referenčni material.
This shall be accompanied by adequate information demonstrating that the availability of the certified reference material will be maintained throughout the period of validity of the authorisation.
Temu se priložijo ustrezne informacije, ki dokazujejo, da se bo razpoložljivost certificiranega referenčnega materiala ohranjala ves čas veljavnosti dovoljenja.
For verification and value assignment, a method that has been properly validated (see ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories) shall be used.
Za preverjanje in določitev vrednosti se uporablja metoda, ki je bila ustrezno validirana (glej ISO/IEC 17025: Splošne zahteve za usposobljenost laboratorijev za testiranje in kalibracijo).
Uncertainties shall be estimated according to the ISO Guide to the Expression of Uncertainty in Measurement (GUM).
Negotovosti se ocenijo v skladu s Smernicami ISO o izražanju negotovosti pri merjenju (GUM).
The main characteristics of those internationally accepted technical provisions are the following:
Glavne značilnosti teh mednarodno sprejetih tehničnih predpisov so:
Genetically modified reference material containers:
1. posode za gensko spremenjeni referenčni material:
genetically modified reference material container (such as bottles, vials, ampoules) shall be tight and contain not less than the stated amount of material;
posode za gensko spremenjeni referenčni material (kot so steklenice, viale, ampule) tesnijo in vsebujejo najmanj navedeno količino materiala;
the commutability of the genetically modified reference material must be assured;
zagotovljena mora biti zamenljivost gensko spremenjenega referenčnega materiala;
packaging shall be appropriate to the purpose;
embalaža ustreza namenu;
labelling shall be of good aspect and quality.
označevanje je dobrega videza in kakovosti;
Homogeneity testing:
2. testiranje homogenosti:
samples shall have appropriate homogeneity;
vzorci imajo ustrezno homogenost;
between-bottle homogeneity shall be examined;
preveri se homogenost v sredini stekleničke;
any possible between-bottle heterogeneity shall be accounted for in the overall estimated reference material uncertainty.
kakršna koli heterogenost v sredini stekleničke se upošteva v skupni oceni negotovosti referenčnega materiala.
This requirement shall apply even when no statistically significant between-bottle variation is present.
Ta zahteva velja tudi, če ni statistično pomembnega spreminjanja v sredini stekleničke.
In this case, the method variation or the actual calculated between-bottle variation, whichever is larger, shall be included in the overall uncertainty.
V tem primeru se variabilnost metode ali dejansko izračunana variabilnost v sredini stekleničke, kar je več, vključi v skupno negotovost;
Stability testing:
3. testiranje stabilnosti:
samples shall have appropriate stability;
vzorci imajo ustrezno stabilnost;
stability shall be positively demonstrated by appropriate statistical extrapolation for the genetically modified reference material shelf-life to be within the stated uncertainty; the uncertainty related to this demonstration is part of the estimated reference material uncertainty.
stabilnost se pozitivno dokaže z ustrezno statistično ekstrapolacijo za gensko spremenjeni referenčni material z rokom uporabnosti znotraj navedene negotovosti; negotovost, povezana s tem dokazom, pa je del ocenjene negotovosti referenčnega materiala.
Assigned values are valid only for a limited time and shall be subject to a stability monitoring.
Dodeljene vrednosti veljajo samo omejen čas in njihova stabilnost se spremlja;
Batch characterisation:
4. opredelitev serije:
The methods used for verification and for certification shall:
1. metode, uporabljene za preverjanje in certificiranje:
be applied under metrologically valid conditions;
se uporabljajo po veljavnih meroslovnih pogojih;
have been properly technically validated before use;
se pred uporabo ustrezno tehnično validirajo;
have precision and trueness compatible with the target uncertainty.
so po natančnosti in točnosti združljive s ciljno negotovostjo;
Each set of measurements shall:
2. vsak sklop meritev:
be traceable to the stated references;
je sledljiv do navedenih sklicevanj;
be accompanied by an uncertainty statement whenever possible.
ima priloženo izjavo o negotovosti, kadar je to mogoče;
Participating laboratories shall:
3. sodelujoči laboratoriji:
have the required competence for the execution of the task;
imajo zahtevano pristojnost za izvajanje naloge;
be able to achieve traceability to the required stated references;
so sposobni doseči sledljivost do potrebnih navedenih referenc;
be able to estimate their measurement uncertainty;
so sposobni oceniti negotovost svojih meritev;
have in place a sufficient and appropriate quality assurance system.
imajo zadovoljiv in ustrezen sistem zagotavljanja kakovosti;
Final storage:
5. končno skladiščenje:
To avoid degradation after sample production, all samples shall be stored under conditions designated for the final storage of the genetically modified certified reference material before measurements are started.
1. da bi se izognili razgradnji po proizvodnji vzorcev, se vsi vzorci shranijo v pogojih, namenjenih končnemu skladiščenju gensko spremenjenega certificiranega referenčnega materiala, preden se začnejo meritve;
Otherwise, they shall be transported from door to door keeping them at all times under such storage conditions for which it has been demonstrated that there is no influence on the assigned values.
2. sicer pa se vedno prenašajo od vrat do vrat v pogojih shranjevanja, za katere je dokazano, da ne vplivajo na dodeljene vrednosti;
Establishment of a certificate for certified reference material:
6. uvedba potrdila za certificirani referenčni material:
A certificate complemented by a certification report shall be established, containing all information relevant to and needed by the user.
izda se potrdilo, dopolnjeno s poročilom o certificiranju, z vsemi pomembnimi informacijami, ki so za uporabnika pomembne in potrebne.
The certificate and report shall be made available when the genetically modified certified reference material is distributed.
Potrdilo in poročilo sta dana na voljo, ko se gensko spremenjeni certificirani referenčni material razdeli.
The information accompanying the certified reference material shall include information on the breeding of the plant which has been used for the production of the certified reference material and on the zygosity of the insert(s).
Informacije, priložene certificiranemu referenčnemu materialu, vključujejo informacije o pridelavi rastline, ki se uporablja za proizvodnjo certificiranega referenčnega materiala, in o zigotnosti vključkov.
Certified values (such as quantity of genetically modified material expressed in mass fraction) shall be traceable to stated references and be accompanied by an expanded uncertainty statement valid for the entire shelf-life of the genetically modified certified reference material.
Certificirane vrednosti (na primer za gensko spremenjeni material, izražen v masnem deležu) so sledljive do navedenih sklicevanj in jih spremlja razširjena izjava o negotovosti, ki velja za celotno dobo razpoložljivosti gensko spremenjenega certificiranega referenčnega materiala.
The requirements regarding animal feeding trials in the context of GMO risk assessments should be reviewed in the light of the outcome of this project expected to be available by the end of 2015 at the latest.
Zahteve v zvezi s poskusi krmljenja živali v primeru ocene tveganja GSO bi bilo treba pregledati glede na rezultat tega projekta, ki naj bi bil na voljo najpozneje do konca leta 2015.
Other credible scientific knowledge which might be available at that time should also be taken into account.
Upoštevati bi bilo treba tudi druga znanstvena spoznanja, ki bodo takrat morda na voljo.
Where no appropriate conventional counterpart can be identified, a comparative safety assessment cannot be made and consequently a safety and nutritional assessment of the genetically modified food or feed shall be carried out as for novel foods falling within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Council [1] that do not have conventional counterparts (such as where the genetically modified food or feed is not closely related to a food or feed with a history of safe use or where a specific trait or specific traits are introduced with the intention of bringing complex changes in the composition of the genetically modified food or feed).1.3.1. Choice of the conventional counterpart and additional comparators
Kadar ni mogoče odkriti podobne konvencionalne vrste, se primerjalne ocene varnosti ne da narediti in zato se ocena varnosti in hranilne vrednosti gensko spremenjenih živil ali krme izvede kakor za nova živila, ki spadajo v področje uporabe Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta [1] in nimajo podobnega konvencionalnega proizvoda (na primer, kadar gensko spremenjena živila ali krma niso tesno povezani z živili ali krmo z zgodovino varne uporabe ali kadar se vnesejo posebna lastnost ali posebne lastnosti z namenom povzročitve zapletenih sprememb v sestavi gensko spremenjenih živil ali krme).1.3.1 Izbira podobne konvencionalne vrste in dodatnih primerjalnih vrst
More detailed guidance for the application of the requirements of this Section is available in the EFSA scientific opinion ‘Guidance on selection of comparators for the risk assessment of genetically modified plants and derived food and feed’ [2]. 1.3.2. Experimental design and statistical analysis of data from field trials for comparative analysis
Podrobnejše smernice za uporabo zahtev tega oddelka so na voljo v znanstvenem mnenju EFSA „Smernice za izbiro primerjalnih vrst za oceno tveganja za gensko spremenjene rastline in iz njih pridobljena živila in krmo“ [2].1.3.2 Načrt poskusa in statistična analiza podatkov iz poskusov na prostem za primerjalno analizo
Genotoxicity test protocols are provided for in Table 2 of Section 1.7 of this Annex.1.4.3. Information on altered levels of food and feed constituents
Protokoli za teste genotoksičnosti so podani v preglednici 2 v oddelku 1.7 te priloge.1.4.3 Informacije o spremenjenih ravneh sestavin živila in krme
ay feeding study in rodents with whole genetically modified food/feed
1.4.4.1 90-dnevna študija o krmljenju na glodavcih s celotnimi gensko spremenjenimi živili/krmo
More detailed guidance for performing this study is provided in the EFSA Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed [8]. 1.4.4.2. Animal studies with respect to reproductive and developmental toxicity testing
Podrobnejša navodila za izvedbo te študije so na voljo v Smernicah EFSA za 90-dnevno študijo oralne toksičnosti s ponavljajočimi se odmerki celotnih živil/krme na glodavcih [8].1.4.4.2 Študije na živalih v zvezi s testiranjem reproduktivne in razvojne toksičnosti
More detailed guidance for the application of the requirements of this Section is available in the EFSA scientific opinion on the assessment of allergenicity of GM plants and micro-organisms and derived food and feed adopted on 30 June 2010 [9]. 1.5.1. Assessment of allergenicity of the newly expressed protein
Podrobnejše smernice za uporabo zahtev iz tega oddelka so na voljo v znanstvenem mnenju EFSA o oceni alergenosti gensko spremenjenih rastlin in mikroorganizmov ter iz njih pridobljenih živil in krme, sprejetem 30. junija 2010 [9].1.5.1 Ocena alergenosti novoizražene beljakovine
EFSA, 2008 Report of the EFSA GMO Panel Working Group on Animal Feeding Trials, 2008.
EFSA, 2008. Poročilo delovne skupine sosveta GSO EFSA o poskusih krmljenja živali iz leta 2008.
More detailed guidance for the application of the requirements of this Section is available in the EFSA opinion on ‘Statistical considerations for the safety evaluation of GMOs’ [3]. 1.3.2.2. Statistical analysis
Podrobnejše smernice za uporabo zahtev iz tega oddelka so na voljo v mnenju EFSA o „Statističnih vidikih glede ocene varnosti GSO“ [3].1.3.2.2 Statistična analiza
Then the random factors for model 1 should be, but not necessarily be restricted to, those representing the variation: (i) between the test materials (a set that includes the GM plant, its conventional counterpart, each of the non-GM reference varieties and any additional comparators); (ii) in the interaction between the test materials and I; (iii) between sites; and (iv) between blocks within sites. Model 2 should be identical to model 1 except that the random factor representing the interaction between the test materials and I is omitted.
Nato naj se slučajni faktorji za model 1, vendar ne nujno, omejijo na dejavnike, ki predstavljajo variabilnost: (i) med testnim materialom (sklop, ki vključuje gensko spremenjeno rastlino, podobno konvencionalno vrsto, vsako od gensko nespremenjenih referenčnih sort in vse dodatne primerjalne vrste; (ii) v medsebojnem učinkovanju med testnim materialom in I; (iii) med lokacijami; in (iv) med bloki na lokacijah. Model 2 mora biti enak modelu 1, razen da se izpusti naključni dejavnik, ki predstavlja medsebojno učinkovanje med testnimi materiali in I.
More detailed guidance for the application of the requirements of this Section is available in the Report of the EFSA GMO Panel Working Group on Animal Feeding Trials [10]. 1.6.5. Conclusion of the nutritional assessment
Podrobnejša navodila za uporabo zahtev iz tega oddelka so na voljo v Poročilu delovne skupine sosveta GSO EFSA o poskusih krmljenja živali [10].1.6.5 Sklepna ugotovitev ocene hranilne vrednosti
The method shall also take into consideration the more detailed requirements set out in the common criteria set by the EURL, and the ENGL for minimum performance requirements for analytical methods for GMO testing. These criteria are part of the guidance provided by the EURL.
4. metoda upošteva tudi podrobnejše zahteve iz skupnih meril, ki jih je pripravil EURL, ter minimalne zahteve za izvajanje analiznih metod testiranja GSO mreže ENGL. Ta merila so del smernic, ki jih je pripravil EURL.
Commission Implementing Regulation (EU) No 504/2013
Izvedbena uredba Komisije (EU) št. 504/2013
amending Implementing Regulation (EU) No 1225/2011 as regards the communication of information for the purpose of relief from customs duty
o spremembi Izvedbene uredbe (EU) št. 1225/2011, kar zadeva sporočanje informacij za oprostitev carin
Pursuant to Article 17 of Commission Implementing Regulation (EU) No 1225/2011 of 28 November 2011 for the purposes of Articles 42 to 52, 57 and 58 of Council Regulation (EC) No 1186/2009 setting up a Community system of reliefs from customs duty [2], Member States have to communicate information to the Commission in respect of the admission free of customs duties of certain spare parts, components, accessories, tools and equipment exceeding a certain value or price.
V skladu s členom 17 Izvedbene uredbe Komisije (EU) št. 1225/2011 z dne 28. novembra 2011 za člene 42 do 52, 57 in 58 Uredbe Sveta (ES) št. 1186/2009 o sistemu oprostitev carin v Skupnosti [2] morajo države članice Komisiji sporočiti informacije v zvezi z uvozom brez uvoznih dajatev nekaterih rezervnih delov, sestavnih delov, dodatkov, orodij in naprav, ki presegajo določeno vrednost ali ceno.
The Commission has to forward the information to the Member States.
Komisija te informacije posreduje državam članicam.
Pursuant to Article 18 of the said Implementing Regulation that information is to be examined periodically by the Customs Code Committee.
V skladu s členom 18 navedene izvedbene uredbe te informacije periodično pregleduje Odbor za carinski zakonik.
Pursuant to Article 20 of Implementing Regulation (EU) No 1225/2011 certain information set out in applications for admission free of customs duty of goods imported by or on behalf of scientific establishments or organisations established inside the Union has to be communicated to the Commission by the Member States to which the application has been submitted.
V skladu s členom 20 Izvedbene uredbe (EU) št. 1225/2011 morajo države članice, ki so prejele vlogo, Komisiji sporočiti nekatere informacije iz vlog za uvoz brez uvoznih dajatev za blago, ki ga uvozijo znanstvene ustanove ali organizacije s sedežem v Uniji ali ki se uvozi v njihovem imenu.
Those obligations which date from 1983 are no longer necessary for the good management of imports with relief of customs duties.
Obveznosti, ki so bile določene leta 1983, niso več obvezne za dobro upravljanje uvoza, ki je oproščen carine.
Moreover they entail an unnecessary administrative burden, both for Member States and the Commission.
Poleg tega vsebujejo nepotrebno upravno breme za države članice in za Komisijo.
Thus, in the interest of regulatory simplification and rationality, the corresponding provisions should be deleted or simplified.
Zato bi bilo treba zaradi regulativne poenostavitve in racionalnosti zadevne določbe črtati ali poenostaviti.
Implementing Regulation (EU) No 1225/2011 should therefore be amended accordingly.
Izvedbeno uredbo (EU) št. 1225/2011 bi bilo zato treba ustrezno spremeniti.
Implementing Regulation (EU) No 1225/2011 is amended as follows:
Izvedbena uredba (EU) št. 1225/2011 se spremeni:
Chapter VII is deleted;
1. poglavje VII se črta;
Article 20 is replaced by the following:
2. člen 20 se nadomesti z naslednjim besedilom:
The competent authority of the Member State in which is situated the establishment or organisation to which the goods are consigned shall take a direct decision on applications under Article 19 in all cases.’.
Pristojni organ države članice, v kateri se nahaja ustanova ali organizacija, ki se ji blago dobavlja, v vseh primerih neposredno odloči o vlogah iz člena 19.“
OJ L 314, 29.11.2011, p. 20.
UL L 314, 29.11.2011, str. 20.
Commission Implementing Regulation (EU) No 505/2013
Izvedbena uredba Komisije (EU) št. 505/2013
laying down further exceptional measures as regards the release of out-of-quota sugar and isoglucose on the Union market at reduced surplus levy during the 2012/2013 marketing year
o nadaljnjih posebnih ukrepih glede dajanja izvenkvotnega sladkorja in izoglukoze na trg Unije z znižanimi presežnimi dajatvami v tržnem letu 2012/2013
The expected increase of this already high price level at the beginning of the 2012/2013 marketing year substantiated the risk of serious market disturbances which had to be prevented by the necessary measures.
Pričakovano povečanje te že tako visoke cene na začetku tržnega leta 2012/2013 je povečalo tveganje za resne motnje na trgu, ki jih je bilo treba s potrebnimi ukrepi preprečiti.
On 18 January, 15 February and 22 March 2013 the Commission adopted Implementing Regulations (EU) No 36/2013 [2], (EU) No 131/2013 [3] and (EU) No 281/2013 [4] providing exceptional measures intended to address the market disturbance.
Komisija je 18. januarja, 15. februarja in 22. marca 2013 sprejela izvedbene uredbe (EU) št. 36/2013 [2], (EU) št. 131/2013 [3] in (EU) št. 281/2013 [4], ki določajo posebne ukrepe za odpravljanje motenj na trgu.
Notwithstanding the measures taken, the current prices registered on the market show that it is necessary to adopt further measures to address the persisting market disturbance.
Kljub sprejetim ukrepom pa tekoče cene, registrirane na trgu, kažejo, da je treba sprejeti nadaljnje ukrepe za odpravljanje trajnih motenj na trgu.
On the other hand, the expectations of a good harvest lead to estimate the production of nearly 4600000 tonnes in excess of the sugar quota set out in Article 56 of Regulation (EC) No 1234/2007.
Po drugi strani pa je zaradi pričakovane dobre žetve ocenjena proizvodnja sladkorja za skoraj 4600000 ton presegla kvoto za sladkor iz člena 56 Uredbe (ES) št. 1234/2007.
Taking account of the foreseeable contractual commitments of sugar producers in respect of certain industrial uses provided for in Article 62 of that Regulation and of the 2012/2013 export commitments for out-of-quota sugar, substantial quantities of out-of-quota sugar of at least 1200000 tonnes would still be available.
Ob upoštevanju predvidljivih pogodbenih obveznosti proizvajalcev sladkorja glede nekaterih vrst industrijske uporabe iz člena 62 navedene uredbe in izvoznih obveznosti za izvenkvotni sladkor za leto 2012/2013 bi bile še vedno na voljo znatne količine izvenkvotnega sladkorja v obsegu najmanj 1200000 ton.
Article 3(1) of Commission Regulation (EC) No 967/2006 of 29 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 318/2006 as regards sugar production in excess of the quota [5] has fixed that levy at EUR 500 per tonne.
Uredba Komisije (ES) št. 967/2006 z dne 29. junija 2006 o podrobnih izvedbenih pravilih za Uredbo Sveta (ES) št. 318/2006 glede proizvodnje izvenkvotnega sladkorja [5] v členu 3(1) dajatev določa na 500 EUR na tono.
For the purpose of establishing average prices for quota and out-of-quota sugar on the Union market in accordance with Article 13(1) of Commission Regulation (EC) No 952/2006 of 29 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 318/2006 as regards the management of the Community market in sugar and the quota system [6], sugar covered by a certificate issued pursuant to this Regulation should be considered as quota sugar.
Za vzpostavitev povprečnih cen za sladkor iz kvote in izvenkvotni sladkor na trgu Unije v skladu s členom 13(1) Uredbe Komisije (ES) št. 952/2006 z dne 29. junija 2006 o podrobnih pravilih za izvajanje Uredbe Sveta (ES) št. 318/2006, kar zadeva upravljanje notranjega trga za sladkor in sistem kvot [6], se mora sladkor iz dovoljenja, izdanega na podlagi te uredbe, obravnavati kot sladkor iz kvote.
In accordance with Article 2(1)(a) of Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities’ own resources [7] contributions and other duties provided for within the framework of the common organisation of the markets in the sugar sector are to constitute own resources.
V skladu s členom 2(1)(a) Sklepa Sveta 2007/436/ES, Euratom z dne 7. junija 2007 o sistemu virov lastnih sredstev Evropskih skupnosti [7] morajo prispevki in druge dajatve, določeni v okviru skupne organizacije trgov v sektorju sladkorja, sestavljati vire lastnih sredstev.