natgillin/translations-raw huggingface dataset:
Komisija skuša s predlogom poskrbeti za učinkovitejši in preglednejši postopek odobritve in izboljšati njegovo izvajanje.
The Commission proposal seeks to make the authorisation procedure more effective and transparent and to implement it better.
To bo prispevalo k boljšemu izvajanju uredbe in dalo potrošnikom večjo moč ter več možnosti, saj bodo imeli na voljo več informacij.
This will contribute to better implementation of the Regulation and give consumers greater power and more options because they will have more information at their disposal.
Tudi tukaj se je Komisija prehitela s sprejetjem stališča, da bi morala za uredbo o novih živilih med drugim veljati uredba o vzpostavitvi enotnega postopka odobritve za dodatke za živila, živilske encime in arome za živila.
Here too, the Commission has got ahead of itself by taking the view that the Regulation on novel foods should be governed, inter alia, by the Regulation establishing a common authorisation procedure for food additives, food enzymes and flavourings.
Evropski parlament in Svet še nista sprejela demokratične odločitve o enotnem postopku odobritve.
The European Parliament and the Council have not yet taken a democratic decision on the uniform authorisation procedure.
Poročevalka se je zato odločila predlagati postopek odobritve na podlagi postopka, določenega v Uredbi (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi
The rapporteur has therefore opted to propose an authorisation procedure based on the procedure laid down in Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
Za tradicionalna živila iz tretjih držav Komisija predlaga enostavnejši postopek odobritve, v katerem se varnost ocenjuje na podlagi preteklih izkušenj varne uporabe v državi porekla.
For traditional foods from third countries, the Commission proposes a simpler authorisation procedure, under which safety would be assessed in the light of the history of safe use in the country of origin.
Pomembno je natančno določiti, katero obdobje varne uporabe takšnih tradicionalnih živil iz tretjih držav je dovolj dolgo, da se zagotovi varnost proizvoda, pri čemer poročevalka predlaga obdobje 50 let namesto „ene generacije“, kot predlaga Komisija, saj je to težko določiti.
It is important that it should be precisely established what period of safe use of such traditional foods from third countries is long enough to guarantee the safety of the product, and the rapporteur proposes a period of 50 years for this, rather than the 'one generation' proposed by the Commission, which is difficult to define.
Predlog Komisije predvideva določeno raven varstva podatkov za obdobje petih let za zahtevke v skladu s to uredbo.
The Commission proposal aims to achieve a certain level of data protection for a five-year period for applications under this Regulation.
Poročevalko je nad tem presenečena, saj je Komisija med obravnavanjem enotnega postopka odobritve v Evropskem parlamentu navajala popolnoma drugačne argumente.
This surprises the rapporteur, as the Commission adduced a completely different line of argument during the consideration of the uniform authorisation procedure in the European Parliament.
Trdila je, da bi sistem varstva podatkov povzročil povečanje regulacije in bolj zapletene sisteme spremljanja in upravnih postopkov.
The Commission claimed there that a data protection system would result in an increase in regulation and would render monitoring systems and administrative procedures more complex.
Poleg tega bi sistem varstva podatkov oviral prost pretok blaga, ki je varno in ustreza merilom ustrezne zakonodaje, kar je v nasprotju z ukrepom, sprejetim v skladu s členom 95 Pogodbe o ES.
In addition, a data protection system would constitute an obstacle to free movement of goods which are safe and meet the criteria of the relevant legislation, which is contrary to the purposes of a measure adopted under Article 95 of the EC Treaty.
To neskladje zakonodajnih predlogov Komisije je izjemno nezadovoljivo.
This inconsistency in the Commission's legislative proposals is highly unsatisfactory.
Poročevalka zato predlaga ohranitev sistema zaupnosti proizvodnih podatkov, določenega v Uredbi Komisije (ES) št. 1852/2001 z dne 20. septembra 2001 o podrobnih pravilih o dostopnosti določenih informacij javnosti in varstvu podatkov, predloženih na podlagi Uredbe Evropskega parlamenta in Sveta (ES) št. 258/97
The rapporteur therefore proposes retaining the system of confidentiality of manufacturing data laid down in Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97
Poročevalka ostro poudarja, da je kazensko pravo vedno v rokah držav članic.
The rapporteur strongly emphasises that the criminal law is always a matter for Member States.
Zelo zaželeno bi bilo, da bi se države članice lahko prosto odločale, ali se kazen določi v skladu s kazenskim pravom ali pa bo upravne ali kake druge narave.
It is highly desirable that Member States should be able to decide freely whether a penalty is to be imposed under the criminal law or whether it should be administrative or of some other nature.
Dokler država članica zadostno ukrepa proti kršitvam uredbe o novih živilih, bo tudi izpolnjevala svoje obveznosti v skladu z zakonodajo Skupnosti.
So long as a Member State takes adequate action against violations of the Regulation on novel foods, it will be fulfilling its obligations under Community law.
Poročevalka podpira vse ukrepe za zmanjšanje upravne obremenitve ter izboljšanje preglednosti in učinkovitosti, vendar ti nikdar ne smejo odstopati od splošnega cilja uredbe o novih živilih, tj. varnosti hrane in varstva potrošnikov.
The rapporteur supports all measures to lessen administrative burdens and improve transparency and efficiency.
Odobritev in uporaba novih živil in živilskih sestavin je v Evropski uniji usklajena od leta 1997, ko je bila sprejeta Uredba (ES) št. 258/97.
Authorisation and use of novel foods and food ingredients is harmonised in the European Union since 1997 when Regulation EC No 258/97 was adopted.
V tej uredbi so opredeljena splošna načela za odobritev novih živil in živilskih sestavin.
This regulation lays down the general principles for authorisation of novel foods and food ingredients.
Novi predlog je namenjen racionalizaciji obstoječih predpisov za postopke odobritve, nadzora, označevanja in uporabe novih živil ter oblikovanju jasnejše opredelitve novih živil.
The new proposal aims to streamline the existing rules for authorisation procedures, supervision, labelling and use of novel foods, and to clarify the definition of novel food.
Pripravljavka mnenja podpira predlog, ampak predlaga naslednje izboljšave:
The rapporteur supports the proposal, but suggests improvements along the following lines:
· pripravljavka mnenja meni, da bi bilo treba pri obravnavanju odobritve novih živil upoštevati etièni vidik ter po potrebi zaprositi za mnenje odbor za etiko in nove tehnologije o etiènih vprašanjih v zvezi z znanostjo in novimi tehnologijami.
· The rapporteur suggests that ethical aspects should be taken into account when considering authorisation of a novel food, and also suggests that the Committee on ethics and new technologies should be consulted where appropriate on ethical issues regarding science and new technologies.
· Želi tudi zagotoviti, da bodo izvajalni ukrepi sprejeti pred začetkom veljavnosti uredbe.
· Furthermore the rapporteur wants to ensure that the implementing measures will be adopted before the Regulation enters into force.
To bo podjetjem zmanjšalo nejasnosti in zmedo pri vprašanju, katera pravila naj bi upoštevala.
This will reduce the uncertainties for businesses and confusion over what rules businesses should follow.
Če se izvedbeni ukrepi ne sprejmejo, se bodo še vedno pojavljale težave pri razlagi in možne razlike v upravljanju med državami članicami, kar bo imelo škodljiv vpliv na delovanje notranjega trga.
If the implementing measures are not adopted there will still be difficulties with the interpretation and possible differences in the administration among the Member States, which will have a negative effect on the functioning of the internal market.
Pripravljavka mnenja predlaga tudi, da se uredba začne uporabljati 12 in ne 6 mesecev po objavi.
The rapporteur furthermore suggests that the regulation should apply from 12 months after the date of publication instead of 6 months.
To bo omogočilo, da se izvajalni ukrepi sprejmejo pred začetkom veljavnosti uredbe.
This will make it possible to adopt the implementing measures before the application of the regulation.
· Pripravljavka mnenja želi v predlogu poenostaviti mejno podroèje pri zdravilih.
· There is a borderline affecting medicinal products, which the rapporteur wants to clarify in the proposal.
Pojasnitev, ali gre za novo živilo ali zdravilo, bo prehrambeni industriji omogoèila lažjo razlago predpisov in zmanjšala negotovosti o tem, katere predpise spoštovati na posameznih podroèjih.
A clarification of when it is a novel food and when it is a medicinal food will make it easier for the food industry to interpret the rules and reduce uncertainties over which rules are to be followed in which areas.
· Za tradicionalna živila iz tretjih držav je zahteva po vsaj 20-letni uporabi jasnejša kot zahteva po uporabi v vsaj „eni generaciji“, ker ta pravni izraz ni dovolj jasen.
· With traditional foods from third countries, the requirement of use for at least one generation is more clearly specified as 20 years, on the grounds that the wording ‘one generation’ is much too vague a legal term.
· Uporaba živil v Skupnosti se oceni ne glede na datum vstopa posamezne države članice v EU, kar bo omogočilo pojasnitev stanja zlasti za nove države članice.
· The use of foods in the Community is assessed irrespective of the entry of individual Member States to the EU, which will help clarify the situation particularly for the new Member States.
· Ponekod se je povečalo varstvo potrošnikov, na primer z izrecno prepovedjo dajanja na trg živil, ki niso vključena na seznam Skupnosti.
· In some places consumer protection has been tightened up – for instance by expressly prohibiting the placing on the market of foods that are not included on the Community’s list.
· Poročilo povečuje preglednost informacij za javnost, saj določa, da morajo biti na voljo na spletu.
· The report strengthens the transparency of information provided for the public, by making it compulsory for such information to be available on the Internet.
· Povečana je pravna varnost za podjetnike, ki vložijo veliko denarja v pripravo za dajanje na trg novih ali tradicionalnih živil ter morajo biti v primeru ovir med postopkom odobritve o tem nemudoma obveščeni, ovire pa utemeljene.
· Legal certainty is improved for businesspeople who invest large sums in preparation for placing on the market new or traditional foods by requiring them to be informed without undue delay and in a demonstrable manner, in the event of objections during the authorisation process.
· Obveznost Komisije, da vložnikom nudi tehnično podporo, se razširi in podrobneje razloži predvsem za mala in srednja podjetja, vključno z možnostjo vložitve enotnega elektronskega zahtevka.
· The Commission’s obligation to provide technical support for applicants is expanded and spelt out, especially for SMEs, including the option of submitting a uniform application by electronic means.
· Pripravljavka mnenja meni, da je treba spremljati nova živila na trgu po odobritvi, zato poziva Komisijo, naj vzpostavi ustrezno, natančno določeno obdobje za spremljanje, ki prepreči možnost pravne negotovosti v nedoločenem obdobju, kar bi vplivalo na ravnanje podjetnikov v konkurenčnem okolju.
· The requirement is more clearly specified for new foods on the market to be monitored after their approval, by requesting from the Commission the establishment of an adequate, precisely defined period for monitoring, which removes the potential of legal uncertainty for an unlimited period that would influence the attitudes of businesspeople in the competitive environment.
· Poročilo natančneje določa način soobstoja varstva osebnih podatkov z zaupnostjo (zasebnostjo) 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 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.
Ta kombinacija obdobja varstva podatkov in obdobja varovanja zaupnosti bi temeljila na načelu sorazmernosti, ki vključuje večjo izmenjavo znanstvenih spoznanj in preglednost informacij za potrošnike (na primer za tiste z alergijami itd.).
This combination of a period of protection of data and a period of protection of confidentiality would be guided by the principle of proportionality, which includes strengthening the sharing of scientific knowledge and the transparency of information for consumers (such as those with allergies, etc.).
· Pripravljavka mnenja meni, da morajo države članice v skladu z nacionalno zakonodajo objaviti kazni v 12 mesecih od objave uredbe v Uradnem listu EU ter da mora Komisija za ohranitev stalnosti predložiti poročilo o pregledu stanja do leta 2013, na podlagi katerega bo lahko Evropski parlament, izvoljen na volitvah junija 2009, ocenil učinkovitost uredbe.
· The requirement is more clearly specified for the Member States to announce sanctions under their national legislation within 12 months from publication of the regulation in the EU Official Journal, together with the requirement on the Commission, which in order to preserve continuity will be required to present a report reviewing the situation by the end of 2013, the aim being to enable the European Parliament elected in the June 2009 elections to assess the regulation’s effectiveness.
(3) Pravila Skupnosti za nova živila so določena z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta z dne 27. januarja 1997 v zvezi z novimi živili in novimi živilskimi sestavinami in Uredbo Komisije (ES) št. 1852/2001 z dne 20. septembra 2001 o podrobnih pravilih o dostopnosti določenih podatkov javnosti in varstvu podatkov, predloženih na podlagi Uredbe Evropskega parlamenta in Sveta (ES) št. 258/97.
(3) Community rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients and by Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97.
Zaradi jasnosti je treba razveljaviti Uredbo (ES) št. 258/97 in jo nadomestiti s to uredbo.
For the sake of clarity, Regulation (EC) no 258/97 should be repealed and replaced by this Regulation.
Sedanja uredba mora vključiti ukrepe, ki ji trenutno ureja Uredba (ES) št. 1852/2001.
The present Regulation should include measures currently governed by Regulation (EC) No 1852/2001.
Zaradi jasnosti je treba razveljaviti Uredbo (ES) št. 258/97 in Uredbo (ES) št. 1852/2001.
For the sake of clarity, Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 should be repealed .
Uredbo (ES) št. 258/97 je treba nadomestiti s to uredbo.
Regulation (EC) No 258/97 should be replaced by this Regulation.
Priporočilo Komisije 97/618/ES z dne 29. julija 1997 o znanstvenih vidikih in predstavitvi informacij, potrebnih za podporo aplikacij za dajanje na trg novih živil in novih živilskih sestavin, ter pripravi poročil o začetni presoji v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta 1 je treba nadomestiti z revidiranimi smernicami, prilagojenimi novim živilom.
Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council 1 should be replaced by revised guidance tailored to novel foods.
Vendar mora biti vložnikom zahtevkov še naprej omogočena uporaba priporočila Komisije 97/618/ES, dokler se ne nadomesti z revidiranimi smernicami.
However, applicants should continue to be able to avail themselves of Commission Recommendation 97/618/EC until it is replaced by revised guidance.
1 UL L 253, 16.09.97, str.
1 OJ L 253, 16.9.1997, p.
Določbe o postopku presoje iz Uredbe (ES) št. 1852/2001 so v predlagani uredbi zajete v določbah o enotnem postopku odobritve, zato Uredba Komisije (ES) št. 1852/2001 ni več potrebna.
The assessment procedure provisions of Regulation (EC) No 1852/2001 are covered by the provisions on a common authorisation procedure in the proposed regulation, and Commission Regulation (EC) No 1852/2001 is therefore no longer needed.
Predlagana nova uredba omogoča objavo novih smernic v pomoč vložnikom zahtevkov.
The proposed new regulation provides for publication of new guidance to assist applicants.
Sedanje smernice bi morale veljati, dokler se ne nadomestijo z revidiranimi smernicami.
The present guidance should remain in force until it has been replaced by a revised guidance.
Uporaba v Skupnosti se nanaša na uporabo v državah članicah ne glede na datum njihovega pristopa k Evropski uniji.
A use within the Community refers to a use in the Member States, independently of the date of their accession to the European Union.
(6a) Vendar je živila, pridobljena iz kloniranih živali in njihovih potomcev, treba izvzeti iz področja uporabe te uredbe.
(6a) However, foods derived from cloned animals and their offspring should be excluded from the scope of this Regulation.
Dokler ne začne veljati uredba o kloniranih živalih, je treba uvesti moratorij za dajanje na trg živil, proizvedenih iz kloniranih živali in njihovih potomcev.
Pending the entry into force of a regulation on cloned animals, a moratorium should be imposed on the placing on the market of foods manufactured from cloned animals and their offspring .
(8a) Določbe Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini 1 bi se morale uporabljati povsod, kjer bi se proizvod ob upoštevanju vseh svojih značilnosti lahko opredelil kot „zdravilo“ ali kot proizvod, katerega uporabo ureja druga zakonodaja Skupnosti.
(8a) The provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use 1 should apply where, taking into account all its characteristics, a product may fall within the definition of “medicinal product” and within the definition of a product covered by other Community legislation.
Če država članica v skladu z direktivo 2001/83/ES ugotovi, da je proizvod zdravilo, lahko skladno z zakonodajo Skupnosti omeji dajanje tovrstnega proizvoda na trg.
In this respect, a Member State may, if it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such a product in accordance with Community law.
1 UL L 311, 28.11.01, str.
1 OJ L 311, 28.11.2001, p.
Opredelitev živila v skladu z Uredbo 178/2002 določa, da proizvod, ki je zdravilo, ne more biti živilo.
The definition of food according to Regulation 178/2002 implies that a product which is a medicine cannot be a food.
Ker razvrščanje proizvodov kot zdravil na podlagi Direktive 2001/83 ni popolnoma usklajeno med državami članicami, obstajajo nekatere razlike pri razvrščanju proizvodov kot zdravil.
As the categorisation of a product as a medicine according to Directive 2001/83 is not totally harmonised among Member States, some differences in categorisation of a product as a medicine exist.
Ta uvodna izjava industriji in potrošnikom podrobneje razlaga delovanje trga v zvezi z mejnimi proizvodi.
This recital provides more clarity for industry and consumers about the functioning of the market in relation to borderline products.
Če Komisija nima informacij o prehrani ljudi pred 15. majem 1997, je treba uvesti enostaven in pregleden postopek za zbiranje navedenih informacij, ki vključuje države članice in vse zainteresirane strani.
Where the Commission does not have information on human consumption before 15 May 1997, a simple and transparent procedure for collecting that information should be established involving the Member States and any interested parties.
Če Komisija nima informacij o prehrani ljudi pred 15. majem 1997, je treba uvesti postopek za zbiranje navedenih informacij, ki vključuje države članice in vse zainteresirane strani.
Where the Commission does not have information on human consumption before 15 May 1997, a procedure for collecting that information should be established involving the Member States and any interested parties.
Ta postopek mora biti enostaven in pregleden ter ne sme neupravičeno ovirati trga, sprejeti pa ga je treba najpozneje šest mesecev po začetku veljavnosti te uredbe.
This procedure should be simple and transparent, whilst avoiding any unjustified disruption to the market, and should be adopted no later than six months after the entry into force of this Regulation .
Postopek zbiranja informacij lahko vključuje vprašanja, ki se pojavljajo v zvezi s proizvodi, za katere se ugotovi, da niso nova živila.
The information collection procedure may involve raising questions about products that are ultimately found not to be novel foods.
Nepravilni sklepi v zvezi s statusom novega živila pri procesu preglednega zbiranja podatkov ne bi smeli škodljivo vplivati na konkurenčni položaj teh proizvodov.
In the process of a transparent collection of data, these products’ competitive position should not be negatively affected by incorrect inferences of novel status.
Postopek Komisije bi zato moral biti pozoren na take težave ter ne bi smel neupravičeno ovirati trga.
The Commission procedure should therefore be sensitive to such problems and avoid any unjustified disruption of the market.
Pri odobritvi novih živil bi bilo treba upoštevati tudi druge dejavnike v zvezi z obravnavanim primerom, vključno s etičnimi dejavniki.
The approval of novel foods should also take into account other factors relevant to the matter under consideration, including ethical factors.
Pri postopku odobritve novih živil (ker ta zajemajo tudi nova živila iz nanotehnologij ali postopkov kloniranja) je treba upoštevati vse dejavnike, ki so pomembni za končno odločitev, vključno z etičnimi vprašanji.
It is essential that in the process of approving new foods (since this also covers new foods gained from nanotechnologies or cloning processes) all the relevant factors essential for the final decision are taken into account, including the ethical issues.
(20) V posebnih okoliščinah, da bi se spodbujale raziskave in razvoj v kmetijsko-živilskem sektorju in s tem inovacije , je treba zaščititi naložbe inovatorjev v zbiranje informacij in podatkov, ki se predložijo pri vložitvi zahtevka po tej uredbi .
(20) Under specific circumstances in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application under this Regulation.