natgillin/translations-raw huggingface dataset:
For the goods of CN code 02045039 and 02045079, the amount of a drawing request is determined by multiplying the net weight of the products by a coefficient of 1,67 (meat of kid) or 1,81 (meat of goat other than kid).
Za blago, uvrščeno pod oznako KN 02045039 in 02045079, se količina zahtevka za črpanje tarifne kvote določi z množenjem neto teže blaga s količnikom 1,67 (meso kozliča) ali 1,81 (kozje meso, razen mesa kozliča).
For the goods of CN code 02044310, the amount of a drawing request is determined by multiplying the net weight of the products by a coefficient of 1,67.
Za blago, uvrščeno pod oznako KN 02044310, se količina zahtevka za črpanje tarifne kvote določi z množenjem neto teže blaga s količnikom 1,67.
For the goods of CN code 02044390, the amount of a drawing request is determined by multiplying the net weight of the products by a coefficient of 1,81.
Za blago, uvrščeno pod oznako KN 02044390, se količina zahtevka za črpanje tarifne kvote določi z množenjem neto teže vlaga s količnikom 1,81.
Entry under this subheading is subject to the conditions laid down in the relevant Community provisions (see Articles 291 to 300 of Regulation (EEC) No 2454/93 (OJ L 253, 11.10.1993, p. 1)).’
Za vpis pod to podštevilko veljajo pogoji ustreznih določb Skupnosti (glej člene 291 do 300 Uredbe (EGS) št. 2454/93 (UL L 253, 11.10.1993, str. 1)).“
Protocol 3 to the Agreement between the European Economic Community and the Kingdom of Norway defining the concept of originating products and setting out the arrangements for administrative cooperation was amended by Decision No 1/2005 of the EC-Norway Joint Committee of 20 December 2005 [4].
Protokol 3 Sporazuma med Evropsko gospodarsko skupnostjo in Kraljevino Norveško, ki opredeljuje pojem proizvodov s poreklom in določa ureditve za upravno sodelovanje, je bil spremenjen z Odločbo št. 1/2005 Skupnega odbora ES-Norveška z dne 20. decembra 2005 [4].
Commission Implementing Regulation (EU) No 231/2011
Izvedbena uredba Komisije (EU) št. 231/2011
This Regulation shall enter into force on 10 March 2011.
Ta uredba začne veljati 10. marca 2011.
Commission Implementing Regulation (EU) No 232/2011
Izvedbena uredba Komisije (EU) št. 232/2011
These prices and duties have been last amended by Commission Regulation (EU) No 227/2011 [4].
Navedene cene in dolžnosti so bile nazadnje spremenjene z Uredbo Komisije (EU) št. 227/2011 [4].
OJ L 61, 8.3.2011, p. 7.
UL L 61, 8.3.2011, str. 7.
Amended representative prices and additional import duties applicable to white sugar, raw sugar and products covered by CN code 17029095 from 10 March 2011
Spremenjene reprezentativne cene in dodatne uvozne dajatve za beli in surovi sladkor ter proizvode z oznako KN 17029095, ki se uporabljajo od 10. marca 2011
Council Implementing Regulation (EU) No 233/2011
Izvedbena uredba Sveta (EU) št. 233/2011
implementing Article 16(2) of Regulation (EU) No 204/2011 concerning restrictive measures in view of the situation in Libya
o izvajanju člena 16(2) Uredbe (EU) št. 204/2011 o omejevalnih ukrepih glede na razmere v Libiji
Having regard to Council Regulation (EU) No 204/2011 of 2 March 2011 concerning restrictive measures in view of the situation in Libya [1], and in particular Article 16(2) thereof,
ob upoštevanju Uredbe Sveta (EU) št. 204/2011 z dne 2. marca 2011 o omejevalnih ukrepih glede na razmere v Libiji [1], zlasti člena 16(2) Uredbe,
On 2 March 2011, the Council adopted Regulation (EU) No 204/2011 concerning restrictive measures in view of the situation in Libya.
Svet je 2. marca 2011 sprejel Uredbo (EU) št. 204/2011 o omejevalnih ukrepih glede na razmere v Libiji.
In view of the gravity of the situation in Libya, additional persons and entities should be included in the list of persons and entities subject to restrictive measures as set out in Annex III to that Regulation,
Glede na resnost razmer v Libiji bi bilo treba na seznam oseb in subjektov, za katere veljajo omejevalni ukrepi, iz Priloge III k navedeni uredbi dodati še druge osebe in subjekte –
The persons and entities listed in the Annex to this Regulation shall be included in Annex III to Regulation (EU) No 204/2011.
Osebe in subjekti, navedeni v Prilogi k tej uredbi, se dodajo na seznam iz Priloge III k Uredbi (EU) št. 204/2011.
OJ L 58, 3.3.2011, p. 1.
UL L 58, 3.3.2011, str. 1.
Commission Regulation (EU) No 234/2011
Uredba Komisije (EU) št. 234/2011
implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings
o izvajanju Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings [1], and in particular Article 9(1) thereof,
ob upoštevanju Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila [1] ter zlasti člena 9(1) Uredbe,
After consulting the European Food Safety Authority pursuant to Article 9(2) of Regulation (EC) No 1331/2008,
po posvetovanju z Evropsko agencijo za varnost hrane v skladu s členom 9(2) Uredbe (ES) št. 1331/2008,
Regulation (EC) No 1331/2008 lays down procedural arrangements for updating the lists of substances the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [2], Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes [3] and Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods [4] (hereinafter referred to as ‘the sectoral food laws’).
Uredba (ES) št. 1331/2008 določa postopke za posodobitev seznamov snovi, katerih trženje je odobreno v Uniji v skladu z Uredbo (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [2], Uredbo (ES) št. 1332/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o encimih za živila [3] in Uredbo (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih [4] (v nadaljnjem besedilu: področna živilska zakonodaja).
Pursuant to Article 9 of Regulation (EC) No 1331/2008 it is for the Commission to adopt the implementing measure as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, arrangements for checking the validity of applications and the type of information that should be included in the opinion of the European Food Safety Authority (hereinafter referred to as ‘the Authority’).
V skladu s členom 9 Uredbe (ES) št. 1331/2008 Komisija sprejme izvedbene ukrepe v zvezi z vsebino, pripravo in vložitvijo zahtevkov za posodobitev seznamov v Uniji po posamezni področni živilski zakonodaji, ureditvijo preverjanja veljavnosti zahtevkov ter vrsto informacij, ki morajo biti vključene v mnenje Evropske agencije za varnost hrane (v nadaljnjem besedilu: Agencija).
In order to update the lists it is necessary to verify that the use of the substance complies with the general and specific conditions of use as provided for in the respective sectoral food laws.
Za posodobitev seznamov se je treba prepričati, da je uporaba snovi skladna s splošnimi in posebnimi pogoji uporabe iz zadevne področne živilske zakonodaje.
The Authority adopted a scientific opinion on 9 July 2009 on data requirements for the evaluation of food additive applications [5].
Agencija je 9. julija 2009 sprejela znanstveno mnenje o zahtevah po podatkih za presojanje zahtevkov za aditive za živila [5].
This data should be provided when an application for the use of a new food additive is submitted.
Te podatke je treba sporočiti ob vložitvi zahtevka za uporabo novega aditiva za živila.
In case of an application for a modification of the conditions of use of an already authorised food additive or for a modification of the specifications of an already authorised food additive, the data required for risk assessment may not be required, as long as this is justified by the applicant.
Pri zahtevku za spremembo pogojev uporabe že odobrenega aditiva za živila ali za spremembo specifikacij že odobrenega aditiva za živila zahtevani podatki za oceno tveganja morda ne bodo potrebni, če predlagatelj utemelji spremembo.
The Authority adopted a scientific opinion on 23 July 2009 on data requirements for the evaluation of food enzyme applications [6].
Agencija je 23. julija 2009 sprejela znanstveno mnenje o zahtevah po podatkih za presojanje zahtevkov za encime za živila [6].
This data should be provided when an application for the use of a new food enzyme is submitted.
Te podatke je treba sporočiti ob vložitvi zahtevka za uporabo novega encima za živila.
In case of an application for a modification of the conditions of use of an already authorised food enzyme or for a modification of the specifications of an already authorised food enzyme, the data required for risk assessment may not be required, as long as this is justified by the applicant.
Pri zahtevku za spremembo pogojev uporabe že odobrenega encima za živila ali za spremembo specifikacij že odobrenega encima za živila zahtevani podatki za oceno tveganja morda ne bodo potrebni, če predlagatelj utemelji spremembo.
The Authority adopted a scientific opinion on 19 May 2010 on data requirements for the risk assessment of flavourings to be used in or on foods [7].
Agencija je 19. maja 2010 sprejela znanstveno mnenje o zahtevah po podatkih za oceno tveganja arom za uporabo v živilih in na njih [7].
This data should be provided when an application for the use of a new flavouring is submitted.
Te podatke je treba sporočiti ob vložitvi zahtevka za uporabo nove arome za živila.
In case of an application for a modification of the conditions of use of an already authorised flavouring or for a modification of the specifications of an already authorised flavouring, the data required for risk assessment may not be required, as long as this is justified by the applicant.
Pri zahtevku za spremembo pogojev uporabe že odobrene arome ali za spremembo specifikacij že odobrene arome zahtevani podatki za oceno tveganja morda ne bodo potrebni, če predlagatelj utemelji spremembo.
It is important that toxicological tests are performed to a certain standard.
Pomembno je, da se toksikološki preskusi izvedejo po določenem standardu.
Therefore Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances [8] should be followed.
Zato je treba upoštevati Direktivo 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi [8].
Where such tests are carried out outside the territory of the Union, they should follow ‘the OECD Principles of Good Laboratory Practice’ (GLP) (OECD, 1998) [9].
Kadar se taki predpisi izvajajo zunaj ozemlja Unije, se morajo držati „Načel dobre laboratorijske prakse (DLP) OECD“ (OECD, 1998) [9].
The use of food additives and food enzymes should always be technologically justified.
Uporaba aditivov in encimov za živila mora biti vedno tehnološko utemeljena.
Applicants should also explain in case of a food additive why the technological effect cannot be achieved by any other economically and technologically practicable means.
Pri aditivu za živila morajo predlagatelji tudi pojasniti, zakaj tehnološkega učinka ni mogoče doseči z drugimi ekonomsko in tehnološko izvedljivimi sredstvi.
The use of a substance should be authorised if it does not mislead the consumer.
Uporabo snovi je treba odobriti, če ne zavaja potrošnika.
Applicants should explain that the requested uses do not mislead the consumer.
Predlagatelji morajo pojasniti, da zahtevane uporabe ne zavajajo potrošnika.
The advantages and benefits for the consumer should also be explained in case of a food additive.
Pri aditivu za živila je treba pojasniti tudi prednosti in koristi za potrošnika.
Without prejudice to Article 9 of Regulation (EC) No 1332/2008, Article 19 of Regulation (EC) No 1333/2008 and Article 13 of Regulation (EC) No 1334/2008, the Commission should verify the validity of the application and whether it falls within the scope of the respective sectoral food law.
Brez poseganja v člen 9 Uredbe (ES) št. 1332/2008, člen 19 Uredbe (ES) št. 1333/2008 in člen 13 Uredbe (ES) št. 1334/2008 mora Komisija preveriti, ali je zahtevek veljaven in ali spada v področje uporabe zadevne področne živilske zakonodaje.
An advice from the Authority should be taken into account, where appropriate, on the suitability of the submitted data for risk assessment.
Po potrebi je treba upoštevati nasvet Agencije o primernosti predloženih podatkov za oceno tveganja.
Such verification should not delay the assessment of an application.
Tako preverjanje pa ne sme odložiti ocene zahtevka.
The information provided in the opinion of the Authority should be sufficient to ascertain whether the authorisation of the proposed use of the substance is safe for consumers.
Informacije v mnenju Agencije morajo zadostovati za ugotovitev, ali je odobritev predlagane uporabe snovi varna za potrošnike.
This includes conclusions on the toxicity of the substance, where appropriate, and possible establishment of an acceptable daily intake (ADI) expressed in a numerical form with details of a dietary exposure assessment for all food categories, including exposure of vulnerable consumer groups.
To po potrebi vključuje sklepe o toksičnosti snovi in morebitno določitev sprejemljivega dnevnega vnosa, izraženega v številčni obliki, s podrobnostmi o oceni prehranske izpostavljenosti za vse kategorije živil, vključno z izpostavljenostjo ranljivejših skupin potrošnikov.
The applicant should also take into account detailed guidance concerning the data required for risk assessment established by the Authority (The EFSA Journal [10]).
Predlagatelj mora upoštevati tudi podrobne smernice za podatke, potrebne za oceno tveganja, ki jih je določila Agencija (EFSA Journal [10]).
This Regulation takes into account current scientific and technical knowledge.
Ta uredba upošteva najnovejše znanstveno in tehnično znanje.
The Commission may revise this Regulation in the light of any developments in this field and the publication of any revised or additional scientific guidance by the Authority.
Komisija lahko to uredbo pregleda zaradi razvoja dogodkov na tem področju in objave spremenjenih ali dodatnih znanstvenih smernic Agencije.
Practical arrangements related to an application for the authorisation of food additives, food enzymes and flavourings, such as addresses, persons to contact, transmission of documents, etc., should be made available in a separate communication of the Commission and/or the Authority.
Praktične pogoje za zahtevek za odobritev aditivov za živila, encimov za živila in arom za živila, kot so naslovi, kontaktne osebe, prenos dokumentov itd., je treba navesti v ločenem sporočilu Komisije in/ali Agencije.
It is necessary to provide for a time period in order to allow the applicants to comply with the provisions of this Regulation.
Treba je določiti rok, ki bo predlagateljem omogočil izpolnitev določb iz te uredbe.
This Regulation shall apply to applications as referred to in Article 3(1) of Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
Ta uredba se uporablja za zahtevke iz člena 3(1) Uredbe (ES) št. 1331/2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila.
CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION
VSEBINA, PRIPRAVA IN VLOŽITEV ZAHTEVKA
Content of an application
Vsebina zahtevka
The application referred to in Article 1 shall consist of the following:
Zahtevek iz člena 1 je sestavljen iz:
a letter;
dopisa;
a technical dossier;
tehnične dokumentacije;
a summary of the dossier.
povzetka dokumentacije.
The letter referred to in paragraph 1(a) shall be drafted in accordance with the model provided in the Annex.
Dopis iz odstavka 1(a) se sestavi v skladu z vzorcem iz Priloge.
The technical dossier referred to in paragraph 1(b) shall contain:
Tehnična dokumentacija iz odstavka 1(b) vsebuje:
the administrative data as provided for in Article 4;
upravne podatke iz člena 4;
the data required for risk assessment as provided for in Articles 5, 6, 8 and 10; and
podatke, potrebne za oceno tveganja iz členov 5, 6, 8 in 10, ter
the data required for risk management as provided for in Articles 7, 9 and 11.
podatke, potrebne za obvladovanje tveganja iz členov 7, 9 in 11.
In case of an application for a modification of the conditions of use of an already authorised food additive, food enzyme or flavouring all the data mentioned in Articles 5 to 11 may not be required.
Pri zahtevku za spremembo pogojev uporabe že odobrenega aditiva za živila, encima za živila ali arome morda ne bodo potrebni podatki iz členov 5 do 11.
The applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.
Predlagatelj predloži preverljivo utemeljitev, zakaj predlagane spremembe ne vplivajo na izsledke obstoječe ocene tveganja.
In case of an application for a modification of the specifications of an already authorised food additive, food enzyme or flavouring:
Pri zahtevku za spremembo specifikacij že odobrenega aditiva za živila, encima za živila ali arome:
the data may be limited to the justification of the request and the changes in the specification;
so lahko podatki omejeni na utemeljitev zahteve in sprememb v specifikaciji;
the applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.
predlagatelj predloži preverljivo utemeljitev, zakaj predlagane spremembe ne vplivajo na izsledke obstoječe ocene tveganja.
The summary of the dossier referred to in paragraph 1(c) shall include a reasoned statement that the use of the product complies with the conditions laid down in:
Povzetek dokumentacije iz odstavka 1(c) vključuje utemeljeno navedbo, da uporaba izdelka izpolnjuje pogoje iz:
Article 6 of Regulation (EC) No 1332/2008; or
člena 6 Uredbe (ES) št. 1332/2008 ali
Articles 6, 7 and 8 of Regulation (EC) No 1333/2008; or
členov 6, 7 in 8 Uredbe (ES) št. 1333/2008 ali
Article 4 of Regulation (EC) No 1334/2008.
člena 4 Uredbe (ES) št. 1334/2008.
Drafting and presentation
Priprava in vložitev
Applications shall be sent to the Commission.
Zahtevki se pošljejo Komisiji.
The applicant shall take into account the practical guidance on the submission of applications made available by the Commission (Directorate General for Health and Consumers’ [11] website).
Predlagatelj upošteva praktična navodila za vložitev zahtevkov, ki jih objavi Komisija (na spletišču Generalnega direktorata za zdravje in varstvo potrošnikov [11].
For the establishment of the Union list of food enzymes as referred to in Article 17 of Regulation (EC) No 1332/2008, the deadline for submitting applications shall be 24 months after the date of application of the implementing measures established by this Regulation.
Za pripravo seznama encimov za živila v Uniji iz člena 17 Uredbe (ES) št. 1332/2008 je rok za vložitev zahtevkov 24 mesecev po datumu začetka uporabe izvedbenih ukrepov iz te uredbe.
Administrative data
Upravni podatki
The administrative data as referred to in Article 2(3)(a) shall include:
Upravni podatki iz člena 2(3)(a) vključujejo:
name of the applicant (company, organisation, etc.), address and contact details;
ime predlagatelja (podjetje, organizacija itd.), naslov in kontaktne podatke;
name of the manufacturer(s) of the substance, if different than the applicant’s, address and contact details;
ime proizvajalca ali proizvajalcev, če to ni sam predlagatelj, naslov in kontaktne podatke;
name of the person responsible for the dossier, address and contact details;
ime osebe, odgovorne za dokumentacijo, naslov in kontaktne podatke;
date of submission of the dossier;
datum predložitve dokumentacije;
type of the application, i.e. concerning a food additive, a food enzyme, or a flavouring;
vrsto zahtevka, tj. za aditive za živila, za encime za živila ali za aromo;
where applicable, chemical name according to IUPAC nomenclature;
po potrebi kemijsko ime po nomenklaturi IUPAC;
where applicable, E-number of the additive as defined in the Union legislation on food additives;
po potrebi E-številko aditiva, kot je opredeljeno v zakonodaji Unije o aditivih za živila;
where applicable, a reference to similar authorised food enzymes;
po potrebi sklic na podobne odobrene encime za živila;
where applicable, the FL-number of a flavouring substance as defined in the Union legislation on flavourings;
po potrebi FL-številko aromatične snovi, kot je opredeljeno v zakonodaji Unije o aromah;
where applicable, the information on authorisations falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [12];
po potrebi informacije o odobritvah, ki spadajo v področje uporabe Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi [12];
table of content of the dossier;
kazalo vsebine dokumentacije;
list of documents and other particulars; the applicant shall identify the number and titles of volumes of documentation submitted in support of the application; a detailed index with a reference to volumes and pages shall be included;
seznam dokumentov in drugih podrobnosti; predlagatelj navede število in naslove zvezkov dokumentacije, ki je priložena zahtevku; vključi se podrobno kazalo s sklicem na zvezke in strani;
list of the parts of the dossier to be treated as confidential; applicants shall indicate what they wish to be treated as confidential and give verifiable justification in accordance with Article 12 of Regulation (EC) No 1331/2008.
seznam delov dokumentacije, ki so zaupni; predlagatelji navedejo, kaj je treba po njihovih željah obravnavati kot zaupno, in predložijo preverljivo utemeljitev v skladu s členom 12 Uredbe (ES) št. 1331/2008.
General provisions on data required for risk assessment
Splošne določbe za podatke, potrebne za oceno tveganja
The dossier submitted in support of an application for the safety evaluation of a substance shall enable a comprehensive risk assessment of the substance and shall permit verification that the substance does not pose a safety concern to consumers within the meaning of Article 6(a) of Regulation (EC) No 1332/2008, Article 6(1)(a) of Regulation (EC) No 1333/2008 and Article 4(a) of Regulation (EC) No 1334/2008.
Dokumentacija, predložena poleg zahtevka za oceno varnosti snovi, omogoča celovito oceno tveganja snovi in preverjanje, da snov ne ogroža zdravja potrošnikov v smislu člena 6(a) Uredbe (ES) št. 1332/2008, člena 6(1)(a) Uredbe (ES) št. 1333/2008 in člena 4(a) Uredbe (ES) št. 1334/2008.
The application dossier shall include all the available data relevant for the purpose of the risk assessment (i.e. full published papers of all references cited or full copies of the original unpublished studies).
Dokumentacija zahtevka vključuje vse razpoložljive podatke, pomembne za oceno tveganja (tj. celotne objavljene dokumente vseh navedenih sklicev, vse kopije izvirnih neobjavljenih študij).