natgillin/translations-raw huggingface dataset:
Pri ocenjevanju varnosti novih živil mora agencija upoštevati tudi vidike, kot so sestava, alergenost in toksičnost novih živil.
When assessing the safety of novel foods, the authority should also consider such aspects as the composition, allergenicity and toxicity of novel foods.
V primeru etičnih zadržkov se poleg ocene varnosti pridobi mnenje evropske skupine za etiko v znanosti in novih tehnologijah.
In the event of ethical objections , an opinion shall be sought, over and above the safety assessment, from the European Group on Ethics in Science and New Technologies (EGE).
Komisija lahko zaradi varnosti živil in v skladu z mnenjem agencije zahteva spremljanje po dajanju na trg.
The Commission may impose for food safety reasons and following the opinion of the Authority, a requirement for post-market monitoring.
Nosilci živilske dejavnosti, ki dajejo živilo na trg Skupnosti, so odgovorni za izvajanje zahtev za spremljanje po dajanju na trg, določenih v vnosu zadevnega živila v seznam Skupnosti novih živil.
The food business operators placing the food in the Community market shall be responsible for the implementation of the post-marketing requirements specified in the entry of the food concerned in the Community list of novel foods.
Komisija zaradi varnosti živil in v skladu z mnenjem agencije zahteva spremljanje po dajanju na trg.
The Commission shall impose for food safety reasons and following the opinion of the Authority, a requirement for post-market monitoring.
Spremljanje se izvaja po petih letih in upošteva vidike varnosti živil, zdravja in dobrega počutja živali ter vplive na okolje.
This monitoring shall take place after five years and take into account food safety aspects as well as animal health and welfare aspects and the environmental impact.
Posebno pozornost je treba nameniti skupinam prebivalstva, ki zaužijejo največ hrane.
Special attention should be paid to the categories of the population with the highest dietary intakes.
Zahteve za spremljanje veljajo tudi za nova živila, ki so že na trgu, vključno z novimi živili, odobrenimi po poenostavljenem postopku (uradno obvestilo) iz 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 ('notification') of Regulation (EC) No 258/97.
Države članice imenujejo pristojne organe, odgovorne za spremljanje po dajanju na trg.
Member States shall appoint competent authorities that will be responsible for the post-marketing monitoring.
Proizvajalec takoj obvesti Komisijo o:
The producer shall forthwith inform the Commission of:
Proizvajalec in nosilec živilske dejavnosti takoj obvestita Komisijo o:
The producer and food business operator shall forthwith inform the Commission of:
(a) kakršnih koli znanstvenih ali tehničnih informacijah, ki bi lahko vplivale na oceno varnosti uporabe novega živila;
(a) any new scientific or technical information which might influence the evaluation of the safety in use of the novel food;
(b) kakršni koli prepovedi ali omejitvi, ki jo naloži pristojni organ ali katera koli tretja država, v kateri se novo živilo daje na trg.
(b) any prohibition or restriction imposed by the competent authority of any third country in which the novel food is placed on the market.
Vsak nosilec živilske dejavnosti obvesti Komisijo in pristojne organe države članice, v kateri deluje, o zdravstvenih težavah, s katerimi so ga seznanili potrošniki ali organizacije za varstvo potrošnikov.
All food business operators shall notify the Commission and the competent authorities of the Member State in which they operate of any health problem of which they have been informed by consumers or consumer protection organisations.
Pristojni organ države članice poroča Komisiji v treh mesecih po opravljenem inšpekcijskem pregledu.
The Member States’ competent authority shall report to the Commission within three months of the completion of an inspection.
Komisija predloži poročilo Evropskemu parlamentu in Svetu najkasneje eno leto po končanem petletnem obdobju iz odstavka 1.
The Commission shall submit a report to the European Parliament and the Council no later than a year after the expiry of the five-year period referred to in paragraph 1.
Zaradi preprečevanja poskusov na živalih se poskusi na vretenčarjih za namene te uredbe izvajajo samo kot skrajni ukrep.
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.
Spodbujajo se poskusi brez uporabe živali in inteligentne strategije poskusov, prepovejo pa se podvojeni poskusi na vretenčarjih.
The use of non-animal tests and intelligent testing strategies shall be promoted, and duplicate vertebrate animal testing shall be prohibited.
Evropska skupina za etiko in nove tehnologije
European Group on Ethics and new Technologies
Po potrebi se lahko Komisija o etičnih vprašanjih glede znanosti in novih tehnologij, ki so zelo pomembne z etičnega vidika, na lastno pobudo ali pobudo države članice po potrebi posvetuje z evropsko skupino za etiko in nove tehnologije, da bi pridobila njeno mnenje o teh vprašanjih.
Where appropriate, on ethical questions relating to science and new technologies of major ethical importance, the Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics and new Technologies, with a view to obtaining its opinion on ethical issues.
Komisija to mnenje javno objavi.
The Commission shall make this opinion available to the public.
Na zahtevo vložnika zahtevka, podprto z ustreznimi in preverljivimi informacijami, vključenimi v dokumentacijo zahtevka, se novih znanstvenih dokazov in znanstvenih podatkov, ki so predmet lastninske pravice, zagotovljenih za podporo zahtevkom, ne sme brez soglasja vložnika uporabiti v korist drugega zahtevka v obdobju petih let od datuma vnosa novega živila v seznam Skupnosti.
On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications, may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Community list without the agreement of the applicant.
Na zahtevo vložnika zahtevka, podprto z ustreznimi in preverljivimi informacijami, vključenimi v dokumentacijo zahtevka, se novih znanstvenih dokazov in znanstvenih podatkov, ki so predmet lastninske pravice, zagotovljenih za podporo zahtevkom, ne sme uporabiti v korist drugega zahtevka v obdobju petih let od datuma vnosa novega živila v seznam Skupnosti , razen če se je poznejši vložnik dogovoril s predhodnim vložnikom, da se lahko takšni podatki in informacije uporabijo, ob predpostavki, da :
On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Community list unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
(a) so bili znanstveni podatki in druge informacije s strani predhodnega vložnika v času vložitve predhodnega zahtevka označeni kot pravno zaščiteni;
(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
(c) novih živil ne bi bilo mogoče odobriti brez predložitve pravno zaščitenih podatkov s strani predhodnega vložnika.
(c) the novel food could not have been authori s ed without the submission of the proprietary data by the prior applicant.
Člen 21 uredbe 1942/2006/ES o prehranskih navedbah in zdravstvenih trditvah vsebuje jasnejšo opredelitev varstva podatkov.
Article 21 of Regulation 1924/2006/EC on nutrition and health claims includes a clearer definition of data protection.
Člen 12 je treba revidirati zaradi doslednosti določb o varstvu podatkov z uredbo 1942/2006/ES.
Article 12 should be revised for consistency of data protection provisions with Regulation 1924/2006/EC.
Podatki raziskovalnih projektov, ki jih deloma ali v celoti financirajo Evropska skupnost in/ali javne institucije, ter študije o tveganju ali s tem povezani podatki, kot so študije o krmi, bi morali biti objavljeni skupaj z zahtevkom in prosto na voljo drugim vložnikom.
Data from research projects partly or completely paid by the EC and/or public institutions and risk studies or data related to risk studies, like feeding studies should be published together with the application and shall be free ly available for use by other applicants.
Če se denar davkoplačevalcev uporablja za pridobivanje znanja, mora biti to znanje na voljo javnosti.
If public money is involved to generate knowledge, this knowledge should also be accessible to the public.
Člen 12 – odstavek 1 b (novo)
Article 12 – paragraph 1 b (new)
Prepovedano je ponavljanje študij, ki vključujejo vretenčarje.
T he r epetition of studies involving vertebrates shall be prohibited.
Za študije, ki vključujejo poskuse na vretenčarjih, in študije, s katerimi se lahko preprečujejo poskusi na živalih, ne bo veljalo varstvo podatkov.
In this context, studies involving tests on vertebrate animals and studies that may prevent animal testing will not be covered by data protection.
Zato je treba dovoliti dostop do študij na vretenčarjih in drugih študij, s katerimi se lahko preprečijo poskusi na živalih.
Thus access to studies on vertebrates and other studies that may prevent animal testing must be allowed.
Treba je navesti, da lastnik rezultatov poskusa ali študije ne more preprečiti, da njegove izsledke uporabi nekdo drug, če se tako preprečijo poskusi na živalih.
It should be included here that the owner of a test or study cannot prevent it being used by another person where this would avoid animal testing.
Usklajeno varstvo podatkov
Harmonised data protection
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 objavo odobritve v Uradnem listu enaki, obdobja varstva podatkov pa tečejo hkrati, če se namerava pridobiti odobritev 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 authorisation is sought 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.
Glej obrazložitev v zvezi z uvodno izjavo 22.
See justification concerning recital 22.
Člen 12b
Article 12 b
Inšpekcijski in nadzorni ukrepi
Inspection and control measures
Da se zagotovi skladnost s to uredbo, se mora izvajati uradni nadzor v skladu z Uredbo (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali.
In order to enforce compliance with th is Regulation, official controls are to be carried out in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
V predlogu komisije inšpekcija in nadzorni ukrepi niso navedeni v členu.
In the Commission proposal, inspection and control measures are not referred to in an Article.
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve določb te uredbe, in sprejmejo vse potrebne ukrepe, da se zagotovi njihovo izvajanje.
The 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 najpozneje do [..] in jo nemudoma uradno obvestijo o kakršnih koli naknadnih spremembah.
The Member States shall notify those provisions to the Commission by [ ..] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Države članice Komisijo uradno obvestijo o navedenih določbah najpozneje v 12 mesecih in jo nemudoma uradno obvestijo o kakršnih koli naknadnih spremembah.
The Member States shall notify those provisions to the Commission within 12 months at the latest and shall notify it without delay of any subsequent amendment affecting them.
Z določitvijo 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 predpise.
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.
Posebne pravice držav članic
Privileges of Member States
Kadar ima država članica na podlagi novih informacij ali ponovne presoje obstoječih informacij izčrpne razloge za mnenje, da uporaba živila ali živilske sestavine, ki je v skladu s to uredbo, ogroža zdravje ljudi ali okolje, lahko ta država članica začasno omeji ali ustavi trgovanje in uporabo tega živila ali živilske sestavine na svojem ozemlju.
Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or a food ingredient complying with this Regulation endangers human health or the environment, that Member State may either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its territory.
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 the grounds for its decision.
Komisija v tesnem sodelovanju z Evropsko agencijo za varnost hrane čim prej preuči razloge iz odstavka 1 in sprejme ustrezne ukrepe.
The Commission, in close cooperation with EFSA, shall examine the grounds referred to in paragraph 1 as soon as possible and shall take the appropriate measures.
Država članica, ki je sprejela odločitev iz odstavka 1, jo lahko ohrani do začetka veljavnosti ukrepov.
The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.
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.
Poročilo in vsak predlog je dostopen javnosti.
The report and any proposal shall be made accessible to the public.
Najpozneje 31. decembra 2013 in glede na pridobljene izkušnje Komisija pošlje Evropskemu parlamentu in Svetu poročilo o izvajanju te uredbe , zlasti členov 8 in 12, glede na različne opredelitve nanomaterialov, ki jih objavijo različni organi, ter nenehni tehnični in znanstveni razvoj na področju nanotehnologij, po potrebi skupaj s kakršnimi koli predlogi.
Not 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 , particularly of Articles 8 and 12 , in view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, accompanied, where appropriate, by any proposals.
Zaradi 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.
Poleg tega bi bilo tudi primerno, da se Komisija v okviru tega pregleda osredotoči na izvajanje novega pravnega instrumenta za varstvo podatkov iz člena 12 v državah članicah.
Moreover as regards the new legal instrument for data protection under Article 12, it would seem appropriate for the Commission also to focus on implementation in the Member States in its review.
Komisija najpozneje šest mesecev po datumu začetku veljavnosti te uredbe [datum] vzpostavi seznam Skupnosti z vnosom novih živil, odobrenih 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 novel foods authorised under Regulation (EC) No 258/97 in this Community list , including any existing authorisation conditions, as appropriate.
Komisija najpozneje šest mesecev po datumu začetka veljavnosti te uredbe [datum] vzpostavi seznam Skupnosti z vnosom novih živil , ki sodijo na področje uporabe te uredbe v skladu s členi 2 in 3, na ta seznam , 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.
Glej predlog spremembe k členu 16.
See amendment to Article 16.
Namen predloga Komisije je sprememba Uredbe (ES) št. 258/97 o novih živilih, da bi poenostavili in centralizirali postopke odobritve novih živil in njihovega trženja.
The purpose of the Commission proposal is to amend Regulation (EC) No 258/97 on novel foods, with the aim of simplifying and centralising the procedures for authorising novel foods and placing them on the market.
Odločeno je bilo torej, da je nova uredba potrebna.
Thus it has been decided that new regulation is necessary.
Poročevalka meni, da mora biti, če se že sprejme odločitev o novih uredbah, njihov namen zelo jasen.
The rapporteur considers that if it is decided to adopt regulations, it must be very clear what their purpose is.
Po mnenju poročevalke naj bi bili cilji nove uredbe o novih živilih doseči visoko raven varnosti hrane ter varstva potrošnikov, okolja in zdravja živali, pri čemer je treba ves čas upoštevati previdnostno načelo, kot ga določa Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o splošnih načelih in zahtevah živilske zakonodaje, o ustanovitvi Evropske agencije za varnost hrane in o postopkih, ki zadevajo varnost hrane
In the rapporteur's view, the objectives of the new regulation on novel foods are to attain a high level of food safety, consumer protection, environmental protection and protection of animal health while at all times the precautionary principle as laid down 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
Nova živila ravno tako ne smejo ogrožati ali zavajati potrošnikov.
Novel foods must not endanger or mislead consumers, either.
Če nova živila nadomeščajo druga živila, za potrošnika ne smejo biti prehransko slabša.
Where novel foods serve to replace another food, the novel foods must not be nutritionally inferior from the consumer's point of view.
Predlog Komisije skuša razjasniti opredelitev novih živil in povezanih opredelitev.
The Commission proposal seeks to clarify the definition of novel foods and the associated definitions.
Poročevalka to podpira, vendar meni, da Komisiji zaradi nepazljivosti ni uspelo doseči cilja.
The rapporteur endorses this aim, but considers that the Commission has negligently fallen short in achieving it.
Poročevalka meni, da je zelo pomembno, da se živila, pridobljena iz kloniranih živali in njihovih potomcev, izključijo iz področja uporabe uredbe o novih živilih.
The rapporteur considers it very important that foods derived from cloned animals should be excluded from the scope of the Regulation on novel foods.
Ker še ni bila dosežena demokratična odločitev o zaželenosti živil, pridobljenih iz kloniranih živali in njihovih potomcev, zlasti z vidika zdravja in dobrega počutja živali, odločitve o dajanju na trg ne bi smeli prepustiti postopku komitologije.
As no democratic agreement has yet been reached on the desirability of these foods, particularly from the point of view of animal health and welfare, the decision as to whether or not to place on the market foods derived from cloned animals and their descendants cannot be left to the commitology procedure.
To vprašanje je treba rešiti s posebno uredbo Evropskega parlamenta in Sveta po postopku soodločanja.
It must be resolved by means of a specific regulation of the European Parliament and of the Council under the codecision procedure.
Nazadnje je treba upoštevati tudi, ali družba novo živilo morda obravnava kot neustrezno iz etičnih razlogov.
Lastly, account must also be taken of whether a society regards a novel food as inedible on ethical grounds.
Vsi zahtevki za odobritev novih živil bodo predloženi Komisiji in morajo izpolnjevati merila, določena v tej uredbi.
All applications for authorisation of novel foods will be submitted to the Commission and must comply with the criteria laid down in this Regulation; they will then be forwarded for consideration to the European Food Safety Authority (EFSA), which will assess the foods' safety.
Komisija jih bo posredovala Evropski agenciji za varnost hrane (EFSA), ki bo ocenila varnost živil.
This assessment must also take account of ethical and environmental aspects.
Pri oceni je treba upoštevati etične in okoljske vidike, torej je treba vključiti tudi mnenji evropske skupine za etiko v znanosti in novih tehnologijah in Evropske agencije za okolje.
Consequently the opinions of the European Group on Ethics in Science and New Technologies and the European Environment Agency must be involved in the safety assessment.
Sedaj Komisija obljublja potrošnikom in državljanom, da bo prevzela odgovornost za okoljske vidike in dobro počutje živali, med drugim glede na problem podnebnih sprememba in dobro počutje živali, zato mora biti evropska politika celovita in brezhibna na vseh pomembnih področjih zakonodaje, torej tudi v zvezi z uredbo o novih živilih.
At present, the Commission is promising consumers and citizens that it will take responsibility for environmental and animal welfare aspects, inter alia in view of the problems of climate change and animal welfare, and European policy must therefore be comprehensive and sound with reference to all relevant fields of legislation and therefore also to the Regulation on novel foods.