natgillin/translations-raw huggingface dataset:
Pred koncem roka iz člena 14(1) se seznam Unije posodobi v skladu z odstavkom 1 tega člena, če odobreno živilo še vedno izpolnjuje pogoje iz te uredbe, tako da posebne navedbe iz točke (h) odstavka 2 tega člena niso več vključene.
Before the expiry of the period referred to in Article 14(1), the Union list shall be updated in accordance with paragraph 1 of this Article so that, provided that the authorised food still meets the conditions laid down in this Regulation, the specific indications referred to in point (h) of paragraph 2 of this Article are no longer included.
Za namene posodobitve seznama Unije z vključitvijo novega živila, če novo živilo ni sestavljeno iz živila, za katerega veljajo določbe o varstvu podatkov iz člena 14, ali če takega živila ne vsebuje, ter:
For the purposes of updating the Union list through inclusion of a novel food, where the novel food does not consist of or contain food subject to data protection according to Article 14 and:
je novo živilo po sestavi, presnovi in ravni neželenih snovi enakovredno obstoječim živilom; ali
the novel food is equivalent to existing foods, in terms of composition, how it is metabolised and level of undesirable substances, or
novo živilo vsebuje živilo, predhodno odobreno za uporabo v Uniji, ali je iz njega sestavljeno, in kadar se pri novi predvideni uporabi lahko pričakuje, da se pri potrošnikih, tudi tistih iz ranljivih skupin, ne bo bistveno povečal vnos,
the novel food consists of, or contains, food previously approved for food use in the Union, and the new intended use can be expected not to significantly increase the intake of consumers, including consumers in vulnerable groups,
se postopek obveščanja iz člena 9 uporablja smiselno in ne glede na odstavek 1 tega člena.
then the notification procedure referred to in Article 9 shall apply mutatis mutandis, by way of derogation from paragraph 1 of this Article.
Nosilec živilske dejavnosti
traditional food from a third country
Komisija državam članicam in znanstvenemu odboru nemudoma posreduje
The Commission shall forward
in ga da na voljo javnosti na svojih spletnih straneh
and make it publicly available on its website
V štirih mesecih po tem, ko Komisija v skladu z odstavkom 2 posreduje uradno obvestilo iz odstavka 1, lahko država članica in znanstveni odbor obvestita Komisijo, da imata upravičene varnostne zadržke o dajanju zadevnega tradicionalnega živila na trg, ki temeljijo na znanstvenih dokazih
Within four months from the date on which the notification provided for in paragraph 1 is forwarded by the Commission according to paragraph 2, a Member State and the Authority may inform the Commission that they have justified safety objections, based on scientific evidence, to the placing on the market of the traditional food concerned
V tem primeru se živila ne dajo na trg Unije in se uporabijo členi 5 do 8.
In that case, the food shall not be placed on the market in the Union and Articles 5 - 8 shall apply.
Komisija ustrezno nemudoma in na dokazljiv način obvesti zadevnega nosilca živilske dejavnosti najkasneje v petih mesecih od datuma uradnega obvestila iz odstavka 1.
The Commission shall inform the food business operator concerned accordingly without undue delay and in a demonstrable manner not later than five months from the date of the notification provided for in paragraph 1.
Če niso bil predloženi zadržki glede varnosti na podlagi znanstvenih dokazov in zadevnemu nosilcu živilske dejavnosti v skladu z odstavkom 3 o tem ni bila sporočena nobena informacija, se lahko tradicionalno živilo daje na trg v Uniji po petih mesecih od datuma uradnega obvestila iz odstavka 1
If no justified safety objections based on scientific evidence have been raised and no such information has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Union after five months from the date of the notification provided for in paragraph 1
Komisija objavi seznam tradicionalnih živil iz tretjih držav, ki se lahko dajejo na trg v Uniji v skladu z odstavkom 4, na temu namenjeni spletni strani Komisije.
The Commission shall publish a list of traditional foods from third countries that may be placed on the market in the Union in accordance with paragraph 4 on a dedicated page of the Commission's website.
Ta stran je dostopna prek spletne strani s seznamom Unije iz člena 5 ter je z njo povezana
This page shall be accessible from and linked to the page on the Union list referred to in Article 5
Komisija za zagotovitev neoviranega delovanja postopka obveščanja iz tega člena najpozneje ...
In order to ensure the smooth functioning of the notification procedure provided for in this Article, the Commission shall, before ...
šest mesecev
Six months
po dnevu začetka veljavnosti te uredbe.
after the entry into force of this Regulation.
z delegiranimi akti v skladu s členom 20 in pod pogoji iz členov 21 in 22 sprejme podrobna navodila o uporabi tega člena
, adopt detailed rules on the application of this Article by means of delegated acts in accordance with Article 20 and subject to the conditions of Articles 21 and 22
Brez poseganja v izvedbene ukrepe, sprejete na podlagi
Without prejudice to the
člena 9 (1)(a)
provisions of Article 9(1)(a)
Uredbe (ES) št. 1331/2008 in
of Regulation (EC) No 1331/2008 and
...* Komisija po potrebi in v tesnem sodelovanju z znanstvenim odborom
the Commission shall, where appropriate, in close cooperation with the Authority,
, nosilci živilske dejavnosti ter malimi in srednje velikimi podjetji poskrbijo
the food business operators and small and medium-sized enterprises
Predlagateljem zahtevkov je na voljo Priporočilo 97/618/ES dokler se ne nadomesti z revidiranimi tehničnimi smernicami v skladu s tem členom.
Recommendation 97/618/EC shall be available for use by applicants until replaced by revised technical guidance issued in accordance with this Article.
Tehnične smernice in orodja se objavijo najpozneje ...
The technical guidance and tools shall be published, not later than ...
na temu namenjeni javno dostopni strani na spletnih straneh Komisije.
, on a publicly accessible page intended for that purpose on the website of the Commission.
Mnenje znanstvenega odbora
Opinion of the Authority
Znanstveni odbor pri ocenjevanju varnosti novih živil, kjer je to potrebno, zlasti::
In assessing the safety of novel foods, where appropriate, the Authority shall, in particular:
živilo iz primerljive živilske kategorije, ki že obstaja na trgu
food ▌already existing on the market
Člen 12
Article 12 ▌Obligations on
To spremljanje se izvaja pet let po uvrstitvi novega živila na seznam Unije
This monitoring shall take place five years after the date of inclusion of a novel food in the Union list
Zahteve za spremljanje se uporabljajo tudi za nova živila, ki so že na trgu, vključno z novimi živili, odobrenimi po poenostavljenem postopku obveščanja iz člena 5 Uredbe (ES) št. 258/97.
The monitoring requirements shall also apply to novel foods already on the market, including those approved under the simplified procedure of notification laid down in Article 5 of Regulation (EC) No 258/97.
in nosilec živilske dejavnosti ali znanstveni odbor
and food business operator or the authority
takoj obvesti Komisijo o:
shall forthwith inform the Commission of:
vseh znanstvenih ali tehničnih informacijah, ki bi lahko vplivale na oceno varnosti pri uporabi novega živila;
any new scientific or technical information which might influence the evaluation of the safety in use of the novel food;
vsaki prepovedi ali omejitvi, ki jo naloži pristojni organ katere koli tretje države, v kateri se novo živilo da na trg.
any prohibition or restriction imposed by the competent authority of any third country in which the novel food is placed on the market.
Evropska skupina za etiko v znanosti
European Group on Ethics in Science and New Technologies
in nove tehnologije
Where appropriate,
Po potrebi
the Commission
Evropske skupine za etiko v znanosti in novih tehnologijah
of the European Group on Ethics in Science and new Technologies
petih let od datuma vključitve novega živila na seznam Unije ne smejo uporabiti v korist drugega zahtevka
a period of five years from the date of the inclusion of the novel food in the Union list
, razen če se je poznejši predlagatelj dogovoril s prvotnim predlagateljem, da se lahko taki podatki in informacije uporabijo, ob predpostavki, da
unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, and where
so bili novi znanstveni dokazi in/ali znanstveni podatki s strani predlagatelja v času vlaganja prvega zahtevka označeni kot pravno zaščiteni (pravno zaščiteni znanstveni podatki);
newly developed scientific evidence and/or scientific data was designated as proprietary by the applicant at the time the first application was made (proprietary scientific data);
prvotni predlagatelj je imel v času
the prior applicant had exclusive right of reference to the proprietary ▌data at the time the
zahtevka izključno pravico sklicevanja na pravno ▌podatke;
application was made;
novo živilo ne bi moglo biti odobreno brez predložitve pravno zaščitenih ▌podatkov s strani prvotnega predlagatelja; in
the novel food could not have been authorised without the submission of the proprietary ▌data by the prior applicant; and
so bili znanstveni podatki in druge informacije s strani predhodnega vložnika v času vložitve predhodnega zahtevka označeni kot pravno zaščiteni
the scientific data and other information was designated as proprietary by the prior applicant at the time the prior application was made
Vendar pa se lahko prvotni in poznejši predlagatelj, da se takšne informacije in podatki lahko uporabijo.
However, a prior applicant may agree with a subsequent applicant that such data and information may be used.
Podatki raziskovalnih projektov, ki jih deloma ali v celoti financirajo Unija in/ali javne institucije, se objavijo skupaj z zahtevkom in so prosto na voljo drugim predlagateljem.
Data from research projects partly or completely paid by the Union and/or public institutions shall be published together with the application and shall be freely available for use by other applicants.
Komisija v posvetovanju s predlagateljem določi, katere podatke bi bilo treba zaščititi v skladu z odstavkom 1 in o odločitvi obvesti predlagatelja, znanstveni odbor in države članice.
The Commission shall determine, in consultation with the applicant, which information should be granted the protection referred to in paragraph 1, and shall inform the applicant, the Authority and the Member States of its decision.
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve določb te uredbe, in sprejmejo vse potrebne ukrepe, da se zagotovi njihovo izvajanje.
Member States shall lay down the rules on penalties applicable to infringements of the provision of this Regulation and shall take all measures necessary to ensure that they are implemented.
Države članice Komisijo uradno obvestijo o navedenih določbah do … * UL: prosimo, vstavite datum:
The Member States shall notify those provisions to the Commission by ... * OJ: please insert date:
mesecev po dnevu začetka veljavnosti te uredbe.
months after the entry into force of this Regulation.
O tem nemudoma obvesti druge države članice in Komisijo ter navede razloge za svojo odločitev.
It shall immediately inform the other Member States and the Commission thereof, giving grounds for its decision.
Komisija v tesnem sodelovanju z znanstvenim odborom čim prej preuči razloge iz odstavka 1 in sprejme ustrezne ukrepe.
The Commission, in close cooperation with the Authority, shall examine the grounds referred to in paragraph 1 as soon as possible and shall take the appropriate measures.
Za doseganje ciljev te uredbe, navedenih v členu 1, Komisija v skladu s členom 20 in pod pogoji iz členov 21 in 22 do … * UL: prosimo, vstavite datum: 24 mesecev po dnevu začetka veljavnosti te uredbe.
For the purposes of achieving the objectives of this Regulation as set out in Article 1, the Commission shall, no later than … * OJ: Please insert date: 24 months after the entry into force of this Regulation.
Komisiji se podeli pooblastilo za sprejemanje delegiranih aktov iz
The power to adopt the delegated acts referred to in
členov 2(3), 3(3), 4(3), 4(4), 8(1), 9(6) in
Articles 2(3), 3(3), 4(3), 4(4), 8(1), 9(6) and
19 za obdobje petih let po začetku veljavnosti te uredbe.
19 shall be conferred on the Commission for a period of five years following the entry into force of this Regulation.
Veljavnost prenesenega pooblastila se samodejno podaljša za enako obdobje, razen če ga Evropski parlament ali Svet prekliče v skladu s členom 21.
The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.
Za pooblastilo Komisiji za sprejemanje delegiranih aktov veljajo pogoji, določeni v členih 21 in 22.
The power to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 21 and 22.
Evropski parlament ali Svet lahko prekliče prenos pooblastila iz
The delegation of power referred to in
Institucija, ki je začela notranji postopek o morebitnem preklicu prenosa pooblastila,
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall
si prizadeva, da
endeavour to
o tem obvesti drugo institucijo in Komisijo
inform the other institution and the Commission
mesecih od datuma uradnega obvestila.
months from the date of notification.
Če do izteka tega roka niti Evropski parlament niti Svet ne ugovarja zoper delegirani akt
If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act
, se ta objavi v Uradnem listu Evropske unije in
it shall be published in the Official Journal of the European Union and
Komisija do … * UL: prosimo, vstavite datum: 5 let po dnevu začetka veljavnosti te uredbe.
By ... * OJ: please insert date: 5 years after the entry into force of this Regulation.
in ob upoštevanju pridobljenih izkušenj predloži Evropskemu parlamentu in Svetu poročilo o izvajanju te uredbe in zlasti členov 3, 9 in 14, po potrebi skupaj z morebitnimi zakonodajnimi predlogi.
and in the light of experience gained, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Articles 3, 9 and 14, accompanied, where appropriate, by any legislative proposals.
do … ** UL : prosimo, vstavite datum:
** OJ: Please insert date
tri leta in šest mesecev
: Three years and six months
* Evropskemu parlamentu in Svetu
* the Commission shall
poročilo o vseh vidikih živil, proizvedenih iz kloniranih živali in njihovih
to the European Parliament and to the Council a report on all aspects of food produced from animals obtained by using a cloning technique and from their
, temu pa po potrebi sledijo zakonodajni predlogi.
followed, where appropriate, by any legislative proposals.
Poročila in morebitni predlogi so dostopni javnosti.
The reports and any proposals shall be made accessible to the public.
**, razen za tiste zahtevke v postopku, za katere se uporablja člen 26 te uredbe.
**, except with respect to those pending requests governed by Article 26 of this Regulation.
Priprava seznama Unije
Establishment of the Union list
Komisija najpozneje …*** pripravi seznam Unije in nanj vnese nova živila, odobrena in/ali vnesena na seznam Unije v skladu s členi 4, 5 in 7 Uredbe (ES) št. 258/97, po potrebi vključno z vsemi obstoječimi pogoji za odobritev.
No later than …*** the Commission shall establish the Union list by entering novel foods authorised and/or notified under Articles 4, 5 and 7 of Regulation (EC) No 258/97 in the Union list, including any existing authorisation conditions, as appropriate.
Vsi zahtevki za dajanje novega živila na trg ▌, predloženi državi članici v skladu s členom 4 Uredbe (ES) št. 258/97
Any request for placing a novel food on the market ▌submitted to a Member State under Article 4 of Regulation (EC) No 258/97
v povezavi s katero poročilo o začetni presoji na podlagi člena 6(3) navedene uredbe ni bilo posredovano Komisiji
in relation to which the initial assessment report provided for under Article 6(3) of that Regulation is not forwarded to the Commission
pred … * UL: prosimo, vstavite datum: 24 mesecev po dnevu začetka veljavnosti te uredbe.
before ... * OJ: please insert date: 24 months after the entry into force of this Regulation.
kot zahtevki po tej uredbi ▌.
an application under this Regulation ▌.
Drugi zahtevki ▌, predloženi v skladu s
Other ▌requests submitted under
členi 3(4), 4 in 5
Articles 3(4), 4 and 5
Uredbe (ES) št. 258/97 pred …*, se obravnavajo v skladu z določbami ▌Uredbe
of Regulation (EC) No 258/97 before ...* shall be processed under the provisions of ▌Regulation
Spremembe Uredbe (ES) št. 1331/2008
Amendments to Regulation (EC) No 1331/2008
Uredba (ES) št. 1331/2008 se spremeni:
Regulation (EC) No 1331/2008 is hereby amended as follows:
Uredba (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi enotnega postopka odobritve za aditive za živila, živilske encime, arome za živila in nova živila
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, food flavourings and novel foods
V členu 1 se odstavka 1 in 2 nadomestita z naslednjim: 1.
In Article 1, paragraphs 1 and 2 are replaced by the following: 1.
Skupni postopek določa ureditev postopkov za posodobitev seznamov snovi in proizvodov, katerih trženje je odobreno v Uniji v skladu z Uredbo (ES) št. 1333/2008, Uredbo (ES) št. 1332/2008, Uredbo (ES) št. 1334/2008 ter Uredbo (EU) št. …/2009 Evropskega parlamenta in Sveta z dne … o novih živilih* + UL: prosimo, vstavite datum in številko te uredbe.
The common procedure shall lay down the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1332/2008, Regulation (EC) No 1334/2008 and Regulation (EU) No …/… of the European Parliament and of the Council of … on novel foods ...* + OJ: please insert the number and the date of this Regulation.
(v nadaljnjem besedilu ‚področna živilska zakonodaja‘).
(hereinafter the “sectoral food laws”).
* UL L… ++ UL: prosimo, vstavite sklic objave te uredbe.
* OJ L ... ++ OJ: please insert the publication reference of this Regulation.
Seznam Unije snovi ali proizvodov
Union list of substances or products
V členu 4 se doda naslednji odstavek: 3.
The following paragraph is added to Article 4: 3.
Za posodobitev različnih seznamov Unije, reguliranih pod različnimi sektorskimi živilskimi zakonodajami, se lahko predloži en sam zahtevek v zvezi s snovjo ali proizvodom, če je zahtevek v skladu z zahtevami vsake sektorske živilske zakonodaje.
A single application relating to a substance or product may be made to update the different Union lists regulated under the different sectoral food laws in so far as the application complies with the requirements of each of the sectoral food laws.
Naslednji stavek se vstavi na začetku člena 6(1):
The following sentence is inserted at the beginning of Article 6(1):
Če obstajajo znanstveni razlogi za pomisleke glede varnosti, predlagatelj predloži dodatne informacije glede ocene tveganja.
In the case of scientific grounds for safety concerns, additional information concerning risk assessment shall be identified and requested from the applicant.
Beseda „Skupnost“ se nadomesti z besedo „Unija“ v celotnem besedilu.
The term ‘Community’ shall be replaced by ‘Union’ throughout the text.
Uporablja se od ... * UL: prosimo, vstavite datum: 24 mesecev po dnevu začetka veljavnosti te uredbe.
It shall apply from … * OJ: please insert date: 24 months after the entry into force of this Regulation.
Zakonodajna resolucija Evropskega parlamenta z dne 7. julija 2010 o stališču Sveta iz prve obravnave z namenom sprejetja Direktive Evropskega parlamenta in Sveta o industrijskih emisijah (celovito preprečevanje in nadzorovanje onesnaževanja) (prenovitev) (11962/2/2009 – C7-0034/2010 – 2007/0286(COD) )
European Parliament legislative resolution of 7 July 2010 on the Council position at first reading for adopting a directive of the European Parliament and of the Council on industrial emissions (integrated pollution prevention and control) (recast) (11962/2/2009 – C7-0034/2010 – 2007/0286(COD) )
ob upoštevanju stališča Sveta iz prve obravnave (11962/2/2009 – C7-0034/2010 ),
having regard to the Council position at first reading (11962/2/2009 – C7-0034/2010 ),
ob upoštevanju predloga Komisije Parlamentu in Svetu ( KOM(2007)0844 ),
having regard to the Commission proposal to Parliament and the Council ( COM(2007)0844 ),
ob upoštevanju sporočila Komisije Parlamentu in Svetu z naslovom Posledice začetka veljavnosti Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja ( KOM(2009)0665 ),
having regard to the Commission Communication to Parliament and the Council entitled ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ ( COM(2009)0665 ),
ob upoštevanju členov 294(7) in 192(1) Pogodbe o delovanju Evropske unije,
having regard to Article 294(7) and Article 192(1) of the Treaty on the Functioning of the European Union,
ob upoštevanju svojega stališča iz prve obravnave UL C 87 E, 1.4.2010, str.
having regard to its position at first reading OJ C 87 E, 1.4.2010, p.
ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora z dne 14. januarja 2009 UL C 182, 4.8.2009, str.
having regard to the opinion of the European Economic and Social Committee of 14 January 2009 OJ C 182, 4.8.2009, p.
ob upoštevanju mnenja Odbora regij z dne 9. oktobra 2008 UL C 325, 19.12.2008, p.
having regard to the opinion of the Committee of the Regions of 9 October 2008 OJ C 325, 19.12.2008, p.
ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A7-0145/2010 ),
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A7-0145/2010 ),
v drugi obravnavi sprejme stališče, kot je navedeno v nadaljevanju;
Adopts its position at second reading hereinafter set out;
(Ker je bil dosežen sporazum med Parlamentom in Svetom, je stališče Parlamenta enako končnemu zakonodajnemu aktu, Direktivi 2010/75/EU.)
(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2010/75/EU)
Zakonodajna resolucija Evropskega parlamenta z dne 7. julija 2010 o skupnem stališču Sveta z namenom sprejetja uredbe Evropskega parlamenta in Sveta o določitvi obveznosti gospodarskih subjektov, ki dajejo na trg les in lesne proizvode (05885/4/2010 – C7-0053/2010 – 2008/0198(COD) )
European Parliament legislative resolution of 7 July 2010 on the Council position at first reading for adopting a regulation of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (05885/4/2010 – C7-0053/2010 – 2008/0198(COD) )
ob upoštevanju stališča Sveta v prvi obravnavi (05885/4/2010 – C7-0053/2010 ),
having regard to the Council position at first reading (05885/4/2010 – C7-0053/2010 ),
ob upoštevanju predloga Komisije Parlamentu in Svetu ( KOM(2008)0644 ),
having regard to the Commission proposal to Parliament and the Council ( COM(2008)0644 ),
ob upoštevanju členov 251(2) in 175(1) Pogodbe ES, v skladu s katerima je Komisija poslala predlog Parlamentu ( C6-0373/2008 ),
having regard to Article 251(2) and Article 175(1) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0373/2008 ),