natgillin/translations-raw huggingface dataset:
If the Commission does not object within eight working days of being informed by the Authority, the period referred to in Article 5(1) shall be automatically extended by the additional period.
Če Komisija ne ugovarja v osmih delovnih dneh od obvestila Agencije, se rok iz člena 5(1) avtomatično podaljša za dodatno obdobje.
The Commission shall inform the Member States of the extension.
Komisija o podaljšanju obvesti države članice.
If the additional information is not sent to the Authority within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided.
Če dodatne informacije Agenciji niso poslane v dodatnem roku iz odstavka 1, Agencija dokončno oblikuje mnenje na podlagi že posredovanih informacij.
Where applicants submit additional information on their own initiative, they shall send it to the Authority and to the Commission.
Če predlagatelj predloži dodatne informacije na lastno pobudo, jih pošlje Agenciji in Komisiji.
In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.
V takšnih primerih Agencija brez poseganja v člen 10 predloži mnenje v prvotnem roku.
The additional information shall be made available to the Member States and the Commission by the Authority.
Agencija da dodatne informacije na voljo državam članicam in Komisiji.
Updating the Community list
Posodobitev seznama Skupnosti
Within nine months of the Authority giving its opinion, the Commission shall submit to the Committee referred to in Article 14(1) a draft regulation updating the Community list, taking account of the opinion of the Authority, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration.
Komisija v devetih mesecih po tem, ko od Agencije dobi mnenje, odboru iz člena 14(1) predloži osnutek uredbe o posodobitvi seznama Skupnosti, pri čemer upošteva mnenje Agencije, vse ustrezne določbe zakonodaje Skupnosti in vse druge utemeljene dejavnike, ki se nanašajo na obravnavano zadevo.
In those cases where an opinion of the Authority has not been requested, the nine-month period shall start from the date the Commission receives a valid application.
Če Agencija ni zaprošena za mnenje, devetmesečni rok začne teči na dan, ko Komisija prejme veljavni zahtevek.
In the Regulation updating the Community list, the considerations on which it is based shall be explained.
V uredbi o posodobitvi seznama Skupnosti morajo biti pojasnjeni premisleki, na katerih uredba temelji.
Where the draft regulation is not in accordance with the opinion of the Authority, the Commission shall explain the reasons for its decision.
Če osnutek uredbe ni v skladu z mnenjem Agencije, Komisija pojasni razloge za svojo odločitev.
The measures, designed to amend non-essential elements of each sectoral food law, relating to the removal of a substance from the Community list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Ukrepi, ki so namenjeni spreminjanju nebistvenih določb posamezne področne živilske zakonodaje v zvezi s črtanjem snovi s seznama Skupnosti, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(3).
On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the addition of a substance to the Community list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the Community list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(4).
Zaradi učinkovitosti se ukrepi, ki so namenjeni spreminjanju nebistvenih določb posamezne področne živilske zakonodaje, med drugim z njenim dopolnjevanjem, za vključitev snovi na seznam Skupnosti ali dodajanje, črtanje ali spremembo pogojev, specifikacij ali omejitev, ki veljajo za vključenost snovi na seznam Skupnosti, sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(4).
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(5) for the removal of a substance from the Community list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community list.
V nujnih primerih lahko Komisija za črtanje snovi s seznama Skupnosti ali za dodajanje, črtanje ali spreminjanje pogojev, specifikacij ali omejitev, ki veljajo za vključenost snovi na seznam Skupnosti, uporabi nujni postopek iz člena 14(5).
Additional information concerning risk management
Dodatne informacije za obvladovanje tveganja
Where the Commission requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided.
Če Komisija od predlagatelja zahteva dodatne informacije za obvladovanje tveganja, skupaj s predlagateljem določi rok, v katerem se te informacije lahko zagotovijo.
In such cases, the period referred to in Article 7 may be extended accordingly.
V takšnih primerih se lahko rok iz člena 7 ustrezno podaljša.
The Commission shall inform the Member States of the extension and shall make the additional information available to the Member States once it has been provided.
Komisija države članice obvesti o podaljšanju roka in jim da na voljo dodatne informacije, ko jih dobi.
If the additional information is not sent within the additional period referred to in paragraph 1, the Commission shall act on the basis of the information already provided.
Če dodatne informacije niso poslane v dodatnem roku iz odstavka 1, Komisija ukrepa na podlagi že posredovanih informacij.
In accordance with the regulatory procedure referred to in Article 14(2), within a period of no longer than 24 months from the adoption of each sectoral food law, the implementing measures for this Regulation shall be adopted by the Commission, and shall concern in particular:
Komisija najpozneje 24 mesecev po sprejetju posamezne področne živilske zakonodaje v skladu z regulativnim postopkom iz člena 14(2) sprejme izvedbene ukrepe za to uredbo, ki zadevajo zlasti:
the content, drafting and presentation of the application referred to in Article 4(1);
vsebino, pripravo in predstavitev zahtevka iz člena 4(1);
the arrangements for checking the validity of applications;
ureditev preverjanja veljavnosti zahtevkov;
the type of information that must be included in the opinion of the Authority referred to in Article 5.
vrsto informacij, ki morajo biti vključene v mnenje Agencije iz člena 5.
With a view to the adoption of the implementing measures referred to in paragraph 1(a), the Commission shall consult the Authority, which, within six months of the date of entry into force of each sectoral food law, shall present it with a proposal concerning the data required for risk assessment of the substances concerned.
Komisija se glede sprejetja izvedbenih ukrepov iz odstavka 1(a) posvetuje z Agencijo, ki v šestih mesecih od začetka veljavnosti posamezne področne živilske zakonodaje Komisiji predloži predlog v zvezi s podatki, potrebnimi za oceno tveganja za zadevne snovi.
Extension of time periods
Podaljšanje rokov
In exceptional circumstances, the periods referred to in Article 5(1) and Article 7 may be extended by the Commission on its own initiative or, where applicable, at the Authority’s request, if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1).
Brez poseganja v člena 6(1) in 8(1) lahko Komisija v izjemnih primerih na lastno pobudo ali, če je primerno, na zahtevo Agencije podaljša roka iz člena 5(1) in člena 7, če to upravičuje narava obravnavane zadeve.
In such cases the Commission shall, where appropriate, inform the applicant and the Member States of the extension and the reasons for it.
V takšnih primerih Komisija, če je primerno, o podaljšanju in razlogih zanj obvesti predlagatelja in države članice.
The Authority shall ensure the transparency of its activities in accordance with Article 38 of Regulation (EC) No 178/2002.
Agencija zagotavlja preglednost svojih dejavnosti v skladu s členom 38 Uredbe (ES) št. 178/2002.
In particular, it shall make its opinions public without delay.
Predvsem brez odlašanja objavlja svoja mnenja.
It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1).
Objavi tudi vsako zaprosilo za mnenje in vsako podaljšanje roka v skladu s členom 6(1).
Among the information provided by applicants, confidential treatment may be given to information the disclosure of which might significantly harm their competitive position.
Med informacijami, ki jih zagotovijo predlagatelji, se kot zaupne lahko obravnavajo informacije, katerih razkritje bi lahko znatno škodovalo njihovemu konkurenčnemu položaju.
Information relating to the following shall not, in any circumstances, be regarded as confidential:
Kot zaupne se v nobenem primeru ne obravnavajo naslednje informacije:
the name and address of the applicant;
ime in naslov predlagatelja;
the name and a clear description of the substance;
ime in jasen opis snovi;
the justification for the use of the substance in or on specific foodstuffs or food categories;
utemeljitev, zakaj se snov uporablja v ali na določenem živilu ali kategoriji živil;
information that is relevant to the assessment of the safety of the substance;
informacije, ki so pomembne za oceno varnosti snovi;
where applicable, the analysis method(s).
če je primerno, analitska(-e) metoda(-e).
For the purposes of implementing paragraph 1, applicants shall indicate which of the information provided they wish to be treated as confidential.
Za namene izvajanja odstavka 1 predlagatelji pojasnijo, za katere posredovane informacije želijo, da se obravnavajo kot zaupne.
Verifiable justification must be given in such cases.
V takih primerih je treba navesti preverljivo utemeljitev.
The Commission shall decide after consulting with the applicants which information can remain confidential and shall notify applicants and the Member States accordingly.
Komisija po posvetu s predlagatelji odloči, katere informacije lahko ostanejo zaupne, in o tem obvesti predlagatelje in države članice.
After being made aware of the Commission’s position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided.
Potem ko so predlagatelji seznanjeni s stališčem Komisije, lahko v treh tednih umaknejo svoj zahtevek, da ohranijo zaupnost navedenih informacij.
Confidentiality shall be preserved until this period expires.
Zaupnost je zagotovljena, dokler ta rok ne poteče.
The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.
Komisija, Agencija in države članice v skladu z Uredbo (ES) št. 1049/2001 sprejmejo potrebne ukrepe za zagotovitev ustrezne zaupnosti informacij, ki jih prejmejo v skladu s to uredbo, razen informacij, ki morajo biti objavljene, če tako zahtevajo okoliščine, zaradi varovanja zdravja ljudi, zdravja živali ali okolja.
If an applicant withdraws, or has withdrawn, its application, the Commission, the Authority and the Member States shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the Commission and the applicant.
Če predlagatelj umakne ali je umaknil svoj zahtevek, Komisija, Agencija in države članice ne razkrijejo zaupnih informacij, tudi tistih, o zaupnosti katerih se mnenji Komisije in predlagatelja razhajata.
The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the Commission, the Authority and the Member States.
Izvajanje odstavkov 1 do 6 ne vpliva na izmenjavo informacij med Komisijo, Agencijo in državami članicami.
In the event of an emergency concerning a substance on the Community list, particularly in the light of an opinion of the Authority, measures shall be adopted in accordance with the procedures referred to in Articles 53 and 54 of Regulation (EC) No 178/2002.
V nujnih primerih v zvezi s snovjo na seznamu Skupnosti, zlasti glede na mnenje Agencije, se sprejmejo ukrepi v skladu s postopki iz členov 53 in 54 Uredbe (ES) št. 178/2002.
The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be two months, two months and four months respectively.
Roki iz člena 5a(3)(c) ter (4)(b) in (e) Sklepa 1999/468/ES so dva, dva oziroma štiri mesece.
Competent authorities of the Member States
Pristojni organi držav članic
Not later than six months after the entry into force of each sectoral food law, Member States shall forward to the Commission and to the Authority, in relation to each sectoral food law, the name and address of the national competent authority for the purposes of the common procedure, as well as a contact point therein.
Države članice v zvezi s posamezno področno živilsko zakonodajo Komisiji in Agenciji najpozneje v šestih mesecih od začetka veljavnosti posamezne področne živilske zakonodaje pošljejo ime in naslov nacionalnega pristojnega organa za namene skupnega postopka ter njegove kontaktne točke.
For each sectoral food law, it shall apply from the date of application of the measures referred to in Article 9(1).
Za posamezno področno živilsko zakonodajo se ta uredba uporablja od začetka uporabe ukrepov iz člena 9(1).
Article 9 shall apply from 20 January 2009.
Člen 9 se uporablja od 20. januarja 2009.
OJ C 168, 20.7.2007, p. 34.
UL C 168, 20.7.2007, str. 34.
Opinion of the European Parliament of 10 July 2007 (OJ C 175 E, 10.7.2008, p. 134), Council Common Position of 10 March 2008 (OJ C 111 E, 6.5.2008, p. 1), Position of the European Parliament of 8 July 2008 (not yet published in the Official Journal) and Council Decision of 18 November 2008.
Mnenje Evropskega parlamenta z dne 10. julija 2007 (UL C 175 E, 10.7.2008, str. 134), Skupno stališče Sveta z dne 10. marca 2008 (UL C 111 E, 6.5.2008, str. 1) in Stališče Evropskega parlamenta z dne 8. julija 2008 (še ni objavljeno v Uradnem listu). Sklep Sveta z dne 18. novembra 2008.
Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission (OJ L 379, 24.12.2004, p. 64).
Uredba (ES) št. 2230/2004 z dne 23. decembra 2004 o podrobnih pravilih za izvajanje Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta v zvezi z mrežo organizacij, ki delujejo na področjih dela Evropske agencije za varnost hrane (UL L 379, 24.12.2004, str. 64).
Regulation (EC) No 1332/2008 of the European Parliament and of the Council
Uredba (ES) št. 1332/2008 Evropskega parlamenta in Sveta
on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97
o encimih za živila in spremembi Direktive Sveta 83/417/EGS, Uredbe Sveta (ES) št. 1493/1999, Direktive 2000/13/ES, Direktive Sveta 2001/112/ES in Uredbe (ES) št. 258/97
The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.
Prosti pretok varnih in zdravstveno ustreznih živil je pomemben vidik notranjega trga in znatno prispeva k zdravju in dobremu počutju državljanov ter njihovim socialnim in gospodarskim interesom.
Food enzymes other than those used as food additives are not currently regulated or are regulated as processing aids under the legislation of the Member States.
Encimi za živila, razen tistih, ki se uporabljajo kot aditivi za živila, trenutno niso urejeni ali pa so v zakonodajah držav članic urejeni kot pomožna tehnološka sredstva.
Differences between national laws, regulations and administrative provisions concerning the assessment and authorisation of food enzymes may hinder their free movement, creating conditions for unequal and unfair competition.
Razlike med nacionalnimi zakoni in drugimi predpisi glede ocene in odobritve encimov za živila lahko ovirajo njihov prosti pretok in ustvarijo pogoje neenake in nepoštene konkurence.
It is therefore necessary to adopt Community rules harmonising national provisions relating to the use of enzymes in foods.
Zato je treba sprejeti pravila Skupnosti za uskladitev nacionalnih določb v zvezi z uporabo encimov v živilih.
This Regulation should only cover enzymes that are added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food, including enzymes used as processing aids (hereinafter referred to as food enzymes).
Ta uredba naj bi zajemala le encime, ki se dodajo živilom zaradi tehnoloških funkcij med proizvodnjo, predelavo, pripravo, obdelavo, pakiranjem, prevozom ali hrambo takšnih živil, vključno z encimi, ki se uporabljajo kot pomožna tehnološka sredstva (v nadaljnjem besedilu „encimi za živila“).
The scope of this Regulation should therefore not extend to enzymes that are not added to food to perform a technological function but are intended for human consumption, such as enzymes for nutritional or digestive purposes.
Področje uporabe te uredbe se zato ne bi smelo razširiti na encime, ki se ne dodajajo živilom zaradi tehnoloških funkcij, temveč so namenjeni za prehrano ljudi, kot so encimi za prehranske ali prebavne namene.
Microbial cultures traditionally used in the production of food such as cheese and wine, and which may incidentally produce enzymes but are not specifically used to produce them, should not be considered food enzymes.
Mikrobiološke kulture, ki se tradicionalno uporabljajo v proizvodnji živil, na primer sira in vina, in lahko proizvajajo tudi encime, vendar se ne uporabljajo izrecno za njihovo proizvodnjo, se ne bi smele obravnavati kot encimi za živila.
Food enzymes used exclusively in the production of food additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [3] should be excluded from the scope of this Regulation, since the safety of these foods is already assessed and regulated.
Encimi za živila, ki se uporabljajo izključno v proizvodnji aditivov za živila, ki spadajo na področje uporabe Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [3], bi morali biti izvzeti iz področja uporabe te uredbe, saj je varnost teh živil že ocenjena in urejena.
However, when these food enzymes are used as such in food, they are covered by this Regulation.
Če pa se ti encimi za živila kot taki uporabijo v živilih, spadajo na področje uporabe te uredbe.
Food enzymes should be approved and used only if they fulfil the criteria laid down in this Regulation.
Encimi za živila bi se lahko odobrili in uporabili le, če izpolnjujejo merila iz te uredbe.
Food enzymes must be safe when used, there must be a technological need for their use and their use must not mislead the consumer.
Uporaba encimov za živila mora biti varna, obstajati mora tehnološka potreba po njihovi uporabi in njihova uporaba ne sme zavajati potrošnika.
Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product.
Zavajanje potrošnika med drugim vključuje zadeve, povezane z vrsto, svežostjo, kakovostjo uporabljenih sestavin, naravnostjo izdelka oziroma proizvodnega postopka ali prehransko kakovostjo izdelka, vendar ni omejeno izključno nanje.
The approval of food enzymes should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls.
Pri odobritvi encimov za živila bi se morali upoštevati tudi drugi dejavniki v zvezi z obravnavanim primerom, med drugim družbeni, gospodarski, etični, okoljski dejavniki in dejavniki, povezani s tradicijami, ter previdnostno načelo in možnost izvajanja nadzora.
Some food enzymes are permitted for specific uses, such as in fruit juices and certain similar products and certain lactoproteins intended for human consumption, and for certain authorised oenological practices and processes.
Nekateri encimi za živila so dovoljeni za posebno uporabo, na primer v sadnih sokovih in nekaterih podobnih izdelkih ter nekaterih mlečnih beljakovinah, namenjenih za prehrano ljudi, in za nekatere dovoljene enološke postopke in obdelave.
The use of such food enzymes should comply with this Regulation and with the specific provisions laid down in the relevant Community legislation.
Ti encimi za živila bi se morali uporabljati v skladu s to uredbo in posebnimi določbami iz ustrezne zakonodaje Skupnosti.
Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption [4], Council Directive 83/417/EEC of 25 July 1983 on the approximation of the laws of the Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption [5] and Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine [6] should therefore be amended accordingly.
Direktivo Sveta 2001/112/ES z dne 20. decembra 2001 o sadnih sokovih in nekaterih podobnih proizvodih, namenjenih za prehrano ljudi [4], Direktivo Sveta 83/417/EGS z dne 25. julija 1983 o približevanju zakonov držav članic v zvezi z nekaterimi beljakovinami v mleku (kazeini in kazeinati) za prehrano ljudi [5] in Uredbo Sveta (ES) št. 1493/1999 z dne 17. maja 1999 o skupni ureditvi trga za vino [6] bi zato bilo treba ustrezno spremeniti.
Since all food enzymes should be covered by this Regulation, Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [7] should be amended accordingly.
Ker naj bi bili vsi encimi za živila zajeti v tej uredbi, bi bilo treba ustrezno spremeniti tudi Uredbo (ES) 258/97 Evropskega parlamenta in Sveta z dne 27. januarja 1997 v zvezi z novimi živili in novimi živilskimi sestavinami [7].
Food enzymes the use of which is permitted within the Community should appear in a Community list that should clearly describe the enzymes and specify any conditions governing their use, including where necessary information on their function in the final food.
Encimi za živila, katerih uporaba je v Skupnosti dovoljena, bi se morali vključiti na seznam Skupnosti, ki jasno opisuje encime, določa vse pogoje njihove uporabe in po potrebi vključuje tudi informacije o njihovi funkciji v končnem živilu.
This list should be supplemented by specifications, in particular on their origin, including where relevant information about allergenic properties, and purity criteria.
Ta seznam bi moral biti dopolnjen s specifikacijami, zlasti o poreklu, po potrebi pa tudi z informacijami o alergenih lastnostih in merilih čistosti.