natgillin/translations-raw huggingface dataset:
Če so novi znanstveni dokazi in znanstveni podatki, ki so predmet lastninske pravice, zaščiteni s tem členom ter hkrati predmet predpisov o zaupnosti iz Uredbe (ES) št. .../... [o vzpostavitvi skupnega postopka odobritve za aditive za živila, živilske encime in arome za živila] 1 , Komisija sprejme obdobje zaupnosti sorazmerno s petletnim obdobjem za varstvo informacij.
Where new scientific evidence and proprietary scientific data that enjoy protection under this Article are at the same time subject to the rules on confidentiality under Regulation (EC) No …/... of the European Parliament and of the Council of ... [establishing a common authorisation procedure for food additives, food enzymes and food flavourings ] 1 , the Commission shall adapt the period of confidentiality proportionately to the five-year period for the protection of information.
Poročilo natančneje določa način soobstoja varstva osebnih podatkov s predpisi o zaupnosti (zasebnosti) tovrstnih informacij v skladu s členom 12 Uredbe Evropskega parlamenta in Sveta o vzpostavitvi skupnega postopka odobritve za aditive za živila, živilske encime in arome za živila.
The report specifies how the protection of personal data is to coexist with the rules on the confidentiality (privacy) of such information in accordance with Article 12 of the Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
Z odstopanjem od člena 7(4) Uredbe (ES) št. .../... [enotni postopek] se posodabljanje seznama Skupnosti z novim živilom, razen s tradicionalnim živilom iz tretje države, določi v skladu z regulativnim postopkom iz člena 14(2), kadar za nove znanstvene dokaze in podatke, ki so predmet lastninske pravice, velja varstvo v skladu s tem členom.
By way of derogation from Article 7(4) of Regulation (EC) No .../... [common procedure], the updating of the Community list with a novel food, other than a traditional food from a third country, shall be decided on in accordance with the regulatory procedure referred to in Article 14(2) in cases where newly developed scientific evidence and proprietary data are protected in accordance with this Article.
V takih primerih se odobritev izda za obdobje, določeno v prvem odstavku.
In such cases, the authorisation shall be granted for the period specified in the first paragraph.
(Ta predlog spremembe je nekdanji èlen 7(3)(1).)
(This amendment is former Article 7, paragraph 3, subparagraph 1)
Določba, ki jo je prvotno urejal člen 7, se podrobneje razloži.
The provision originally in Article 7 is spelt out in greater detail.
V primerih, navedenih v odstavku 1a, se pri vnosu novega živila na seznam Skupnosti poleg informacij iz člena 7(2) navede še:
In the cases referred to in paragraph 1a, the entry of a novel food in the Community list shall indicate, in addition to the information referred to in Article 7(2):
(b) dejstvo, da vnos temelji na novih znanstvenih dokazih in/ali znanstvenih podatkih, ki so predmet lastninske pravice, za katere velja varstvo v skladu s tem členom;
(b) the fact that the entry is based on newly developed scientific evidence and/or proprietary scientific data protected in accordance with this Article;
(c) ime in naslov vlagatelja;
(c) the name and address of the applicant;
(d) dejstvo, da je vložnik iz točke (c) omejen pri dajanju novega živila na trg, razen če poznejši vlagatelj pridobi odobritev za živilo brez sklica na podatke, ki so predmet lastninske pravice, iz točke (b).
(d) the fact that the novel food is restricted for placing on the market by the applicant specified in point (c), unless a subsequent applicant obtains authorisation for the food without reference to the proprietary data referred to in point (b).
(Ta predlog spremembe je nekdanji člen 7(3(2) razen točke (d).)
(This amendment is former Article 7, paragraph 3, subparagraph 2, except for point (d))
Tako se ponudijo dodatne informacije, ki jih je treba objaviti na seznamu Skupnosti.
This provides additional information which must be published in the Community list.
Člen 12 – odstavek 1 c (novo)
Article 12 – paragraph 1 c (new)
Pred potekom obdobja, določenega v odstavku 1, se seznam Skupnosti posodobi tako, da posebne navedbe iz odstavka 3 niso več vključene, če odobreno živilo še vedno izpolnjuje pogoje iz te uredbe.
Before the expiry of the period referred to in paragraph 1, the Community list shall be updated so that, provided that the authorised food still meets the conditions set out in this Regulation, the specific indications referred to in paragraph 3 are no longer included.
Ta ukrep, namenjen spremembi nebistvenih določb te uredbe se sprejme v skladu z regulativnim postopkom s pregledom iz člena 14(3).
That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Ne glede na odobritev novega živila na podlagi členov 7 in 14 Uredbe (ES) št. .../... [enotni postopek] ali odobritev zdravstvene trditve na podlagi členov 17, 18 in 25 Uredbe (ES) št. 1924/2006 so podatki v zvezi z odobritvijo in/ali objavo odobritve v Uradnem listu enaki, obdobja varstva podatkov pa potekajo hkrati, če obstaja namen pridobitve odobritve novega živila in z njim povezane zdravstvene trditve ter če je varstvo podatkov na podlagi določb obeh uredb zagotovljeno in ga zahteva vložnik zahtevka.
Notwithstanding authorisation of a novel food pursuant to Articles 7 and 14 of Regulation (EC) No .../... [common procedure] or authorisation of a health claim pursuant to Articles 17, 18 and 25 of Regulation (EC) No 1924/2006, the data concerning the authorisation and the publication of the authorisation in the Official Journal shall be identical and the data protection periods shall run concurrently where it is intended to obtain authorisation for a novel food and for a health claim relating to that food, and where data protection pursuant to the provisions of both Regulations is warranted and requested by the applicant.
S postavitvijo jasnega roka za uradno obvestilo (12 mesecev), do katerega morajo države članice objaviti pravila o kaznih za kršenje te uredbe, se lahko poveča pravna varnost.
By setting a clear deadline for notification (12 months) by which the Member States must announce rules for imposing sanctions for infringement of this regulation we can increase legal certainty.
Poleg tega je predlog spremembe v skladu z daljšim obdobjem iz drugih členov, v katerem naj bi Evropska komisija sprejela izvedbene postopke.
In addition, the amendment is consistent with the longer period set out in other articles for the adoption of implementing arrangements by the European Commission.
Najpozneje [1. januarja 2015] in glede na pridobljene izkušnje Komisija pošlje Evropskemu parlamentu in Svetu poročilo o izvajanju te uredbe in zlasti člena 8 , po potrebi skupaj s kakršnimi koli predlogi.
No later than [1 January 2015] and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Article 8 , accompanied, where appropriate, by any proposals.
Najpozneje 31. decembra 2013 in glede na pridobljene izkušnje Komisija pošlje Evropskemu parlamentu in Svetu poročilo o izvajanju te uredbe in zlasti členov 8 in 12 , po potrebi skupaj s kakršnimi koli predlogi.
No later than 31 December 2013 and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Articles 8 and 12 , accompanied, where appropriate, by any proposals.
Za ohranitev stalnosti je primerneje, če pregled uredbe opravi Evropski parlament v naslednjem parlamentarnem obdobju.
For the sake of continuity it is more appropriate for the review of the regulation to be dealt with by the European Parliament in the next parliamentary term.
Komisija najpozneje šest mesecev po datumu začetka veljavnosti te uredbe [datum] vzpostavi seznam Skupnosti z vnosom živil, ki spadajo v področje uporabe te uredbe na podlagi členov 2 in 3 ter na podlagi Uredbe (ES) št. 258/97, v ta seznam Skupnosti, vključno s po potrebi vsemi obstoječimi pogoji odobritve.
By six months from the date of entry into force of this Regulation [date] at the latest the Commission shall establish the Community list by entering in this list novel foods which are authorised under Regulation (EC) No 258/97 and which fall within the scope of this Regulation pursuant to Articles 2 and 3 thereof , including any existing authorisation conditions, as appropriate.
Kakršna koli zahteva za dajanje na trg novega živila ki jo predloži država članica na podlagi člena 4 Uredbe (ES) št. 258/97 in za katero končen sklep ni bil sprejet pred datumom uporabe te uredbe se šteje za uporabo na podlagi te uredbe.
Any request for placing a novel food on the market submitted to a Member State under Article 4 of Regulation (EC) No 258/97 and for which a final decision has not been taken before the date of application of this Regulation shall be considered as an application under this Regulation.
Če se poročilo o začetni presoji, predvideno s členom 6(3) Uredbe (ES) št. 258/97, ni posredovalo Komisiji do ... + , se kakršna koli zahteva za dajanje na trg novega živila, ki jo predloži država članica na podlagi člena 4 te uredbe , šteje za uporabo na podlagi te uredbe.
Where the initial assessment report provided for by Article 6(3) of Regulation (EC) No 258/97 has not been forwarded to the Commission by ... + , any request for placing a novel food on the market submitted to a Member State under Article 4 of that Regulation shall be considered as an application under this Regulation.
Drugi zahtevki, predloženi na podlagi členov 3(4), 4 in 5 Uredbe (ES) št. 258/97 pred ... + , se obravnavajo v skladu z določbami navedene uredbe.
Other requests submitted under Article 3(4) and Articles 4 and 5 of Regulation (EC) No 258/97 before ... + shall be processed under the provisions of that Regulation.
+ Datum začetka uporabe te uredbe.
+ The date of application of this Regulation.
Predlagano besedilo Komisije lahko postavi v slabši položaj zahtevke, za katere se je poročilo o začetni presoji že posredovalo Komisiji, saj je na zahtevke, na katere niso bile dane pripombe, možno odobriti ne da bi jih posredovali Evropski agenciji za varnost hrane v oceno.
The Commission’s proposed text potentially disadvantages applications for which an initial assessment has already been forwarded to the Commission, since it may be possible to authorize such an application without redirection of the application to EFSA for evaluation if no objections are raised.
Vse zahtevke, za katere se je poročilo o začetni presoji že posredovalo Komisiji, je treba obravnavati na podlagi postopka iz Uredbe (ES) št. 258/97.
All applications for which an initial assessment report has already been forwarded to the Commission should continue according to the procedure defined in 258/97/ec.
Kakršni koli prehodni ukrepi za uporabo odstavka 1, ki so oblikovani za spremembo nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(3).
Any appropriate transitional measures for the application of paragraph 1, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Uporablja se po izteku šestih mesecev po objavi [datum].
It shall apply from six months after the date of publication of this Regulation [date].
Uporablja se po izteku 12 mesecev po objavi [datum].
It shall apply from 12 months after the date of publication of this Regulation [date].
Treba je podaljšati veljavnost uredbe s šest na 12 mesecev, zato da Komisija lahko sprejme izvedbene predpise za posamezne člene ter da imajo države članice in gospodarski subjekti v tem sektorju dovolj časa za izboljšanje priprav.
Extending the validity of the regulation from six to 12 months is needed to enable the Commission to adopt implementing rules for individual articles, and provides appropriate time for improving preparations by the Member States and operators in this sector.
Predlog Komisije spreminja Uredbo (ES) št. 258/97 o novih živilih, ker je potrebno poenostaviti in centralizirati postopek za odobritev novih živil in njihovo dajanje na trg.
The Commission proposal amends Regulation (EC) No 258/97 on novel foods with a view to simplifying and centralising the procedure for authorising novel foods and placing them on the market.
Komisija namerava natančneje opredeliti področje uporabe uredbe in izvzeti kategorije živil, ki jih že ureja posebna zakonodaja.
The Commission intends to define the scope of the Regulation more accurately by excluding categories of foods in respect of which specific legislation already exists.
Iz uredbe bodo tako izvzeti genetsko spremenjeni organizmi, aditivi za živila, arome, ekstrakcijska topila, encimi, vitamini in minerali.
Hence genetically modified organisms, food additives, flavourings, extraction solvents, enzymes, vitamins and minerals will be excluded from the Regulation.
Vse prošnje za odobritev bo treba predložiti Komisiji, nato pa bodo izročene pristojni Evropski agenciji za varnost hrane, ki bo izvedla oceno varnosti.
All applications for authorisation will have to be submitted to the Commission and then assigned to the European Food Safety Authority, which will have to carry out safety checks.
Novi živilski proizvodi ne smejo pomeniti tveganja za zdravje, niti zavajati potrošnika, v primeru zamenjave pa potrošniku ne smejo prehransko škoditi.
Novel foods must not pose any risk to health, they must not mislead consumers and if they are used as a replacement food they must not compromise nutrition.
Po tem, ko bo Evropska agencija za varnost hrane podla mnenje, se bo Komisija s postopkom odbora odločila, ali naj novi proizvod uvrsti na seznam novih živil in ali bo potrebno posebno dodatno označevanje.
Once the EFSA has been consulted the Commission - by means of the committee procedure - will decide whether the new product is to be placed on the register of novel foods and whether special extra labelling will be required.
Komisija namerava poenostaviti postopek odobritve tradicionalnih živil iz tretjih držav in ocenjevati njihovo varnost na podlagi izkušenj varne uporabe v državi porekla.
In the case of traditional foods from third countries, the Commission intends to simplify the authorisation thereof and to assess their safety on the basis of the experience of safe use in the country of origin.
Poročevalec se strinja, da je postopek treba poenostaviti, zlasti zato, ker je Evropska agencija za varnost hrane ustrezen in pristojni organ za znanstveno ocenjevanje ravni varnosti živil.
The rapporteur agrees with the need to simplify the authorisation procedure, especially since the EFSA is the right body to assess the safety level of foods scientifically.
Čeprav lahko ta organ izda vsa znanstvena zagotovila o varnosti živil, pa gre pozdraviti ohranitev pravice Evropskega parlamenta do veta, kar bo omogočilo demokratično izvoljenim predstavnikom, da v najobčutljivejših in najspornejših primerih ohranijo zakonito pravico do nadzora (regulativni postopek s pregledom).
Although the EFSA is able to provide a full range of scientific guarantees concerning food safety, we should welcome the fact that the European Parliament will retain the power of veto, so as to ensure that in the most sensitive and controversial cases the democratically elected representatives will retain their legitimate power of oversight (regulation-with-oversight procedure).
Poleg tega poročevalec poziva k posvetovanju z evropsko skupino za etiko v znanosti in novih tehnologijah v vseh primerih, kjer se pojavi etični problem v zvezi z uporabo novih živilskih tehnologij in dajanjem novih živil na trg.
In addition, the rapporteur is calling for the European Group on Ethics in Science and New Technologies to be consulted in any case involving an ethical problem concerning the use of new food technologies and the placing of novel foods on the market.
Pri tradicionalnih živilih iz tretjih držav je treba natančno določiti dovolj dolgo obdobje varne uporabe, da bi se zagotovila popolnoma varna uporaba proizvoda, in prav zato poročevalec predlaga obdobje 50 let namesto splošnega izraza „ena generacija“.
As regards traditional foods from a third country, the period of safe use must be precisely defined in order to censure that the product is perfectly safe to use, for which reason the rapporteur is proposing a 50-year period instead of the general expression 'one generation'.
Nazadnje poročevalec meni, da morata imeti varnost hrane in zdravje potrošnikov, zlasti znanstveni podatki, ki dokazujejo varnost proizvoda, največjo prednost na vseh stopnjah postopka odobritve novih živil, saj sta pomembnejša od tržnih interesov in varstva pravic intelektualne lastnine.
Lastly, the rapporteur maintains that the absolute priority at all stages of the procedure for authorising novel foods must be food safety and the health of consumers, which take priority over commercial interests and the protection of intellectual-property rights, in particular scientific data demonstrating that a product is safe.
Ob popolnem upoštevanju previdnostnega načela bi morala Evropska unija dati svojim državljanom vsa zagotovila o zdravju, kakovosti in preglednosti svojih živil.
In full accordance with the precautionary principle, the EU should provide its citizens with a full range of safeguards concerning health and the quality and transparency of foods.
Predlog uredbe - akt o spremembi
Proposal for a regulation - amending act
(2a) Standarde, opredeljene v zakonodaji EU, je treba uporabljati za vsa živila, ki se dajo na trg Skupnosti, vključno z živili, uvoženimi iz tretjih držav.
(2a) The standards defined in EU legislation must be applied to all food placed on the Community market, including food imported from third countries.
Obstoječo opredelitev za novo živilo je treba pojasniti z razlago meril novosti , in posodobiti z zamenjavo obstoječih kategorij s sklicevanjem na splošno opredelitev za živilo iz Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane.
(5) The existing definition of novel food should be clarified, with an explanation of the criteria for novelty, and updated by replacing the existing categories, with a reference to the general definition of food in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
(6) Treba je tudi pojasniti, da je treba živilo šteti za novo, če se proizvaja s tehnologijo, ki prej še ni bila uporabljena.
(6) It should also be clarified that a food should be considered as novel when it is applied a production technology, which was not previously used.
Uredba mora zajemati zlasti nastajajoče tehnologije pri postopkih gojenja in proizvodnje živil, ki vplivajo na živila in zato na njihovo varnost.
In particular, emerging technologies in breeding and food production processes, which have an impact on food and thus might have an impact on food safety, should be covered by this Regulation.
Nova živila morajo zato vsebovati živila iz rastlin in živali, proizvedenih z netradicionalnimi tehnikami gojenja in živila, spremenjenih z novimi proizvodnimi postopki, ko sta nanotehnologija in nanoznanost, ki lahko vplivata na živila .
Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience which might have an impact on food.
Živila iz novih rastlinskih sort ali živalskih pasem, proizvedena s tradicionalnimi tehnikami gojenja, se ne smejo šteti za nova živila.
Food derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods.
(6) Področje uporabe te uredbe bi moralo zajemati vsa živila, ki se pred 15. majem 1997 v Skupnosti niso uporabljala v pomembnem obsegu za prehrano ljudi.
(6) The scope of this Regulation should encompass all food which was not used for human consumption to a significant degree within the Community before 15 May 1997.
Merila novosti v zvezi z živili morajo vključevati uporabo novih vrst organizmov, kot so rastline, živali, mikroorganizmi, glive ali alge, ter novih delov obstoječih organizmov in snovi z novo molekulsko strukturo.
The criteria for novelty in relation to food should include use of new species of organisms such as plants, animals, micro-organisms, fungi or algae, and use of new parts of existing organisms and substances with a new molecular structure .
Obstoječe živilo je treba šteti za novo, če je bilo spremenjeno tako, da so njegova kemijska sestava, molekulska struktura, velikost delcev ali druge sestavine spremenjene tako, da bi to utegnilo imeti posledice za varnost hrane.
Existing food should be considered novel if it has been modified in a way that changes its chemical composition, molecular structure, particle size or other elements in a way that is likely to have an impact on food safety.
Treba je tudi pojasniti, da je treba živilo šteti za novo, če se proizvaja s tehnologijo, ki prej še ni bila uporabljena.
It should also be clarified that a food should be considered as novel when it is applied a production technology, which was not previously used.
Nova živila morajo zato vsebovati živila iz rastlin in živali, proizvedenih z netradicionalnimi tehnikami gojenja in živila, spremenjenih z novimi proizvodnimi postopki, ko sta nanotehnologija in nanoznanost, ki lahko vplivata na varnost živil .
Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience which might have an impact on food safety .
Živila iz novih rastlinskih sort ali živalskih pasem, proizvedena s tradicionalnimi tehnikami gojenja, se ne smejo šteti za nova živila.
Food derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods
Da bi bila zakonodaja jasna, je treba razložiti merila novosti živila, po možnosti v besedilu in uvodnih izjavah.
In order to make the legislation clear, there should be some explanation of the criteria for novelty of a food preferably in the text itself or in the recitals.
Namen predlaganega besedila je opisati sedanje delovanje zakonodaje o novih živilih.
The proposed text aims at describing the way the novel food legislation is working at present.
V predzadnjem stavku manjka beseda „varnost“.
The word “safety” is missing in the second last sentence.
(6a) Živila, proizvedena iz kloniranih živali in njihovih mladičev, so izvzeta iz področja uporabe te uredbe.
(6a) Food produced from cloned animals and their offspring should, however, be excluded from the scope of this Regulation.
Njihovo področje bi bilo treba urediti s posebno uredbo, sprejeto s postopkom soodločanja namesto z „enotnim postopkom”.
It should be governed by a specific regulation to be enacted through the co-decision procedure instead of through the "common procedure".
V zvezi s tem mora Komisija predstaviti zakonodajni predlog pred začetkom veljavnosti te uredbe.
The Commission should present a legislative proposal to this effect before the date of application of this Regulation.