natgillin/translations-raw huggingface dataset:
For consistency and coherence purposes, it is important to ensure a single definition of engineered nanomaterial in the area of food law.
Zato bi bilo treba opredelitev namensko proizvedenega nanomateriala, skupaj s prenosom pooblastil za sprejemanje delegiranih aktov na Komisijo, ki je s tem povezan, črtati iz Uredbe (EU) št. 1169/2011 in nadomestiti s sklicevanjem na opredelitev iz te uredbe.
The appropriate legislative framework for including such a definition is this Regulation.
Poleg tega bi bilo treba v tej uredbi določiti, da bi morala Komisija z delegiranimi akti prilagoditi opredelitev namensko proizvedenega nanomateriala iz te uredbe tehničnemu in znanstvenemu napredku ali opredelitvam, dogovorjenim na mednarodni ravni.
Accordingly, the definition of engineered nanomaterial, along with the related conferral of delegated powers to the Commission, should be deleted from Regulation (EU) No 1169/2011 and replaced by a reference to the definition set out in this Regulation.
Vitamine, minerale in druge snovi, namenjene uporabi v prehranskih dopolnilih v skladu z Direktivo 2002/46/ES Evropskega parlamenta in Sveta [12] ter Uredbo (ES) št. 1925/2006 Evropskega parlamenta in Sveta [13] ali v začetnih formulah za dojenčke in nadaljevalnih formulah za dojenčke in majhne otroke, žitnih kašicah in otroški hrani za dojenčke in majhne otroke, živilih za posebne zdravstvene namene in popolnih prehranskih nadomestkih za nadzor nad telesno težo v skladu z Uredbo (EU) št. 609/2013 Evropskega Parlamenta in Sveta [14], bi bilo prav tako treba oceniti v skladu s pravili iz te uredbe, če spadajo v opredelitev novih živil, določeno v njej.
Furthermore, this Regulation should provide that the Commission should, by means of delegated acts, adjust and adapt the definition of engineered nanomaterial set out in this Regulation to technical and scientific progress or to definitions agreed at international level.
Kadar so vitamini, minerali ali druge snovi, ki se uporabljajo v skladu z Direktivo 2002/46/ES, Uredbo (ES) št. 1925/2006 ali Uredbo (EU) št. 609/2013, nastali z uporabo postopka proizvodnje, ki se pred 15. majem 1997 ni uporabljal za proizvodnjo živil v Uniji in pri katerem se znatno spremeni sestava ali struktura živila, kar vpliva na njihovo hranilno vrednost, način njihove presnove ali raven neželenih snovi, ali kadar ti vitamini, minerali ali druge snovi vsebujejo namensko proizvedene nanomateriale ali so iz njih sestavljene, bi jih bilo prav tako treba šteti za nova živila v skladu s to uredbo in bi jih bilo treba ponovno oceniti, sprva v skladu s to uredbo, nato pa v skladu z ustrezno posebno zakonodajo.
Vitamins, minerals and other substances intended to be used in food supplements in accordance with Directive 2002/46/EC of the European Parliament and of the Council [12] and Regulation (EC) No 1925/2006 of the European Parliament and of the Council [13] or in infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children, food for special medical purposes, and total diet replacement for weight control in accordance with Regulation (EU) No 609/2013 of the European Parliament and of the Council [14], should also be assessed in accordance with the rules laid down in this Regulation when they fall within the definition of novel food set out therein.
Za živilo, ki se je pred 15. majem 1997 uporabljalo izključno kot prehransko dopolnilo ali v prehranskih dopolnilih, kakor so opredeljena v Direktivi 2002/46/ES, bi bilo treba dovoliti, da se po navedenem datumu daje na trg v Uniji za isto uporabo, saj se za namene te uredbe ne bi smelo šteti za novo živilo.
Where vitamins, minerals or other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013 result from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances, or where those vitamins, minerals or other substances contain or consist of engineered nanomaterials, they should also be considered novel foods under this Regulation and should be re-assessed first in accordance with this Regulation and subsequently in accordance with the relevant specific legislation.
Živila iz živalskih klonov ureja Uredba (ES) št. 258/97.
However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree within the Union before 15 May 1997.
Dokler ne začne veljati posebna zakonodaja o živilih iz živalskih klonov, bi morala biti ta živila uvrščena na področje uporabe te uredbe kot živilo iz živali, pridobljenih z netradicionalnimi načini vzreje, in bi morala biti v skladu z veljavno zakonodajo Unije ustrezno označena za končnega potrošnika.
Therefore, uses of the food concerned other than as, or in, a food supplement should be subject to this Regulation.
Dajanje tradicionalnih živil iz tretjih držav na trg v Uniji bi bilo treba olajšati, če je izkazana dolga tradicija varne uporabe živila v tretji državi.
Food from animal clones has been regulated under Regulation (EC) No 258/97.
Navedena živila bi morala biti v vsaj eni tretji državi vsaj 25 let del običajne prehrane znatnega števila ljudi.
It is crucial that no legal ambiguity should emerge as regards the placing on the market of food from animal clones during the transitional period after the end of the application of Regulation (EC) No 258/97.
Dolga tradicija varne uporabe živila ne bi smela vključevati neprehranske uporabe ali uporabe, ki ni povezana z običajno prehrano.
Therefore, until specific legislation on food from animal clones enters into force, food from animal clones should fall under the scope of this Regulation as food from animals obtained by non-traditional breeding practices and should be appropriately labelled for the final consumer in accordance with the Union legislation in force.
Živila iz tretjih držav, ki se v Uniji štejejo za nova živila, bi bilo treba šteti za tradicionalna živila iz tretjih držav le, če so proizvedena v primarni pridelavi, kot je opredeljena v Uredbi (ES) št. 178/2002, ne glede na to, ali gre za predelana ali nepredelana živila.
The placing on the market within the Union of traditional foods from third countries should be facilitated where the history of safe food use in a third country has been demonstrated.
Živila, proizvedena izključno iz živilskih sestavin, ki ne spadajo na področje uporabe te uredbe, zlasti zaradi spremembe sestavin ali njihove količine, se ne bi smela šteti za nova živila.
Those foods should have been consumed in at least one third country for at least 25 years as a part of the customary diet of a significant number of people.
Vendar bi morale sestavine živil, ki so bile spremenjene in se v Uniji še niso v večjem obsegu uporabljale za prehrano ljudi, še naprej spadati na področje uporabe te uredbe.
The history of safe food use should not include non-food uses or uses not related to normal diets.
Direktiva 2001/83/ES Evropskega parlamenta in Sveta [15] se uporablja v primerih, kadar se lahko proizvod ob upoštevanju vseh njegovih lastnosti uvršča tako v opredelitev pojma „zdravilo“, kot je določeno v navedeni direktivi, kakor tudi v opredelitev proizvoda v skladu s to uredbo.
Foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods.
Če država članica v skladu z Direktivo 2001/83/ES ugotovi, da je proizvod zdravilo, lahko v skladu z zakonodajo Unije omeji njegovo dajanje na trg.
Food produced exclusively from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food or their amount, should not be considered to be a novel food.
Poleg tega so zdravila izključena iz opredelitve živila iz Uredbe (ES) št. 178/2002, zato ne bi smela spadati na področje uporabe te uredbe.
However, modifications to a food ingredient that has not yet been used for human consumption to a significant degree within the Union, should fall within the scope of this Regulation.
Na podlagi informacij, ki jih predložijo nosilci živilske dejavnosti in ki jih po potrebi dopolnjujejo druge informacije, ki so na voljo v državah članicah, bi bilo treba ugotoviti, ali se je živilo v večjem obsegu uporabljalo za prehrano ljudi v Uniji pred 15. majem 1997.
Directive 2001/83/EC of the European Parliament and of the Council [15] applies in cases where a product, taking into account all its characteristics, may fall both within the definition of ‘medicinal product’ as laid down in that Directive and within the definition of a product covered by this Regulation.
Nosilci živilske dejavnosti bi se morali posvetovati z državami članicami, če slabo poznajo status živila, ki ga nameravajo dati na trg.
In that respect, where a Member State establishes in accordance with Directive 2001/83/EC that a product is a medicinal product, it may restrict the placing on the market of that product in accordance with Union law.
Kadar ni na voljo informacij o njegovi uporabi za prehrano ljudi pred 15. majem 1997 ali so te informacije nezadostne, bi bilo treba uvesti preprost in pregleden postopek za pridobitev teh informacij, ki bi vključeval Komisijo, države članice in nosilce živilske dejavnosti.
Moreover, medicinal products are excluded from the definition of food as laid down in Regulation (EC) No 178/2002 and should therefore not fall within the scope of this Regulation.
Nova živila bi bilo treba odobriti in uporabljati le, če izpolnjujejo merila iz te uredbe.
The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in Member States.
Morala bi biti varna, če pa njihove varnosti ni mogoče oceniti in če obstaja znanstvena negotovost, se lahko uporabi previdnostno načelo.
Food business operators should consult Member States if they are unsure of the status of the food which they intend to place on the market.
Njihova uporaba ne bi smela zavajati potrošnika.
Where there is no information on human consumption before 15 May 1997 or the information available is insufficient, a simple and transparent procedure, involving the Commission, the Member States and food business operators, should be established for collecting such information.
Zato se novo živilo, ki naj bi nadomestilo drugo živilo, ne bi smelo razlikovati od navedenega živila tako, da bi bilo za potrošnika prehransko manj ugodno.
Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation.
Nova živila se ne bi smela dati na trg ali uporabljati v živilih za prehrano ljudi, razen če so vključena na seznam Unije z novimi živili, odobrenimi za dajanje na trg v Uniji (v nadaljnjem besedilu: seznam Unije).
Novel foods should be safe and if their safety cannot be assessed and scientific uncertainty persists, the precautionary principle may be applied.
Zato je primerno z izvedbenim aktom vzpostaviti seznam Unije in nanj vključiti nova živila, ki so že odobrena ali priglašena v skladu z Uredbo (ES) št. 258/97, vključno z morebitnimi pogoji odobritve.
Their use should not mislead the consumer.
Ta seznam bi moral biti pregleden in lahko dostopen.
Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer.
Novo živilo bi bilo primerno odobriti s posodobitvijo seznama Unije v skladu z merili in postopki iz te uredbe.
Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’).
Uvesti bi bilo treba učinkovit, časovno omejen in pregleden postopek.
Therefore, it is appropriate to establish, by means of an implementing act, the Union list by including in that list the novel foods already authorised or notified in accordance with Regulation (EC) No 258/97, including any existing authorisation conditions.
Vložniki bi morali imeti možnost, da za tradicionalna živila iz tretjih držav z dolgo tradicijo varne uporabe živil izberejo hitrejši in poenostavljen postopek za posodobitev seznama Unije, če ni ustrezno utemeljenih pripomb glede varnosti.
That list should be transparent and easily accessible.
Določiti in jasno opredeliti bi bilo treba tudi merila za ocenjevanje varnostnih tveganj, ki izhajajo iz novih živil.
It is appropriate to authorise a novel food by updating the Union list subject to the criteria and procedures laid down in this Regulation.
Da bi zagotovili harmonizirano znanstveno ocenjevanje novih živil, bi morala takšna ocenjevanja izvajati Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija).
A procedure that is efficient, time-limited and transparent should be put in place.
Če bi lahko posodobitev vplivala na zdravje ljudi, bi bilo treba v okviru postopka za odobritev novega živila in posodobitev seznama Unije Agencijo zaprositi, da poda mnenje.
As regards traditional foods from third countries having a history of safe food use, the applicants should be able to opt for a faster and simplified procedure to update the Union list if no duly reasoned safety objections are expressed.
Agencija bi morala v svojem mnenju med drugim oceniti vse značilnosti novega živila, ki bi lahko ogrožale zdravje ljudi, in preučiti morebitne posledice za ranljive skupine prebivalstva.
Criteria for the assessment of the safety risks arising from novel foods should also be clearly defined and laid down.
Če je novo živilo sestavljeno iz namensko proizvedenih nanomaterialov, bi morala Agencija predvsem preveriti, ali so bile za oceno njihove varnosti uporabljene najsodobnejše metode preskušanja.
In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘the Authority’).
Za Komisijo in Agencijo bi morali veljati roki, ki bi zagotovili nemoteno obravnavo vlog.
Under the procedure for authorising a novel food and updating the Union list, the Authority should be requested to give its opinion if the update is liable to have an effect on human health.
Vendar bi morali Komisija in Agencija v nekaterih primerih imeti pravico, da te roke podaljšata.
In its opinion, the Authority should assess, inter alia, all the characteristics of the novel food that may pose a safety risk to human health and consider possible effects on vulnerable groups of the population.
Agencija ali Komisija lahko za oceno ali obvladovanje tveganja od vložnika zahteva dodatne informacije.
In particular, the Authority should verify that, where a novel food consists of engineered nanomaterials, the most up-to-date test methods are used to assess their safety.
Če ta dodatnih informacij, kot so bile zahtevane, ne zagotovi v roku, ki ga po posvetovanju z njim določi Agencija oziroma Komisija, lahko to vpliva na mnenje Agencije ali na morebitno odobritev in posodobitev seznama Unije.
The Commission and the Authority should be subject to deadlines to guarantee a smooth processing of applications.
Agencija je v svojem mnenju z dne 6. aprila 2011 o smernicah za oceno tveganja pri uporabi nanoznanosti in nanotehnologij v prehranski in krmni verigi ugotovila, da glede morebitne uporabe nanomaterialov v živilih ni na voljo dovolj informacij v zvezi z vidiki nanotoksikokinetike in toksikologije namensko proizvedenih nanomaterialov in bi bilo morda treba obstoječe metode preskušanja toksičnosti metodološko spremeniti.
However, in certain cases, the Commission and the Authority should have the right to extend those deadlines.
Svet Organizacije za gospodarsko sodelovanje in razvoj je v priporočilu z dne 19. septembra 2013 o testiranju varnosti in ocenjevanju proizvedenih nanomaterialov ugotovil, da so pristopi za preskušanje in ocenjevanje tradicionalnih kemikalij na splošno ustrezni za oceno varnosti nanomaterialov, a da bi jih morda bilo treba prilagoditi njihovim posebnostim.
The applicant may be requested by the Authority or by the Commission to provide additional information for the purposes of risk assessment or risk management respectively.
Da bi lahko bolje ocenili varnost nanomaterialov, ki se uporabljajo v živilih, in obravnavali vrzeli v toksikološkem znanju in merilnih metodologijah, bi bile morda potrebne metode preskušanja, tudi tiste, ki se ne izvajajo na živalih, ki bi upoštevale posebne značilnosti namensko proizvedenih nanomaterialov.
In case the applicant fails to provide the additional information, as required, within the period set by the Authority or by the Commission after consulting the applicant, lack of such information may have consequences for the opinion of the Authority or for a possible authorisation and update of the Union list.
Kadar se metode preskušanja uporabljajo za nanomateriale, bi moral vložnik obrazložiti njihovo znanstveno ustreznost za nanomateriale, po potrebi pa tudi tehnične prilagoditve, izvedene zaradi posebnih značilnosti teh materialov.
As regards the possible use of nanomaterials for food use, the Authority considered in its opinion of 6 April 2011 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain that limited information is available in relation to aspects of nanotoxicokinetics and toxicology of engineered nanomaterials and that existing toxicity testing methods may need methodological modifications.
Kadar se novo živilo odobri in vključi na seznam Unije, bi bilo treba na Komisijo prenesti pooblastilo za določitev zahtev za spremljanje odobrenega novega živila po dajanju na trg, da bi se zagotovilo, da njegova uporaba poteka v varnih okvirih, določenih v oceni tveganja, ki jo opravi Agencija.
The Organisation for Economic Cooperation and Development Council Recommendation of 19 September 2013 on the Safety Testing and Assessment of Manufactured Nanomaterials concluded that the approaches for the testing and assessment of traditional chemicals are, in general, appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials.
Zahteve za spremljanje po dajanju na trg so torej lahko upravičene, če je treba pridobiti informacije o dejanskem trženju živila.
In order to better assess the safety of nanomaterials for food use and in order to address the current gaps in toxicological knowledge and measurement methodologies, test methods, including non-animal tests, which take into account specific characteristics of engineered nanomaterials may be needed.
Nosilci živilske dejavnosti bi morali v vsakem primeru obvestiti Komisijo o vseh relevantnih informacijah o živilih, ki jih dajejo na trg.
When test methods are applied to nanomaterials, an explanation should be provided by the applicant of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations and adjustments that have been made in order to respond to the specific characteristics of those materials.
Spodbujati bi bilo treba nove tehnologije in inovacije na področju proizvodnje hrane, saj bi te lahko zmanjšale vpliv proizvodnje hrane na okolje, povečalo prehransko varnost in koristilo potrošnikom, pod pogojem, da se zagotovi visoka raven varstva potrošnikov.
When a novel food is authorised and included in the Union list, the Commission should have the power to introduce post-market monitoring requirements to monitor the use of the authorised novel food to ensure that the use is within safe limits as established in the risk assessment by the Authority.
Da bi se spodbujale raziskave in razvoj v kmetijsko-živilskem sektorju, in s tem inovacije, je v posebnih okoliščinah primerno zaščititi naložbe vložnikov v zbiranje informacij in podatkov, predloženih v podporo vlogi za novo živilo v skladu s to uredbo.
Post-market monitoring requirements may therefore be justified by the necessity to gather information on the actual marketing of the food.
Novi znanstveni dokazi in pravno zaščiteni podatki, predloženi skupaj z vlogo za vključitev novega živila na seznam Unije, bi morali biti varovani.
In any event, food business operators should inform the Commission of any new relevant information regarding the safety of the food they have placed on the market.
Ti podatki in informacije se omejeno časovno obdobje ne bi smeli uporabljati v korist poznejšega vložnika brez privolitve prvotnega vložnika.
New technologies and innovations in food production should be encouraged as they could reduce the environmental impact of food production, enhance food security and bring benefits to consumers as long as the high level of consumer protection is ensured.
Varstvo znanstvenih podatkov, ki jih je predložil vložnik, ne bi smelo preprečevati drugim vložnikom, da zahtevajo vključitev novih živil na seznam Unije na podlagi lastnih znanstvenih podatkov ali s sklicevanjem na varovane podatke ob privolitvi prvotnega vložnika.
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 the applicants in gathering the information and data provided in support of an application for a novel food made in accordance with this Regulation.
Vendar se skupno petletno obdobje varstva podatkov, ki je bilo odobreno prvotnemu vložniku, ne bi smelo podaljšati zaradi odobritve varstva podatkov poznejšim vložnikom.
The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should be protected.
Kadar vložnik zaprosi za varstvo znanstvenih podatkov v zvezi z istim živilom v skladu s to uredbo in Uredbo (ES) št. 1924/2006 Evropskega parlamenta in Sveta [16], bi moralo biti omogočeno, da bi obe obdobji za varstvo podatkov potekali sočasno.
Those data and information should, for a limited period of time, not be used to the benefit of a subsequent applicant, without the agreement of the initial applicant.
Zato bi bilo treba omogočiti, da bi smel vložnik zaprositi za prekinitev postopka odobritve novega živila.
The protection of scientific data provided by an applicant should not prevent other applicants from seeking the inclusion of a novel food in the Union list on the basis of their own scientific data or by referring to the protected data with the agreement of the initial applicant.
V skladu z Direktivo 2010/63/EU Evropskega parlamenta in Sveta [17] bi bilo treba preskuse na živalih nadomestiti, zmanjšati ali izboljšati.
However, the overall five-year period of data protection which has been granted to the initial applicant should not be extended due to the granting of data protection to subsequent applicants.
Zato bi se bilo treba v okviru področja uporabe te uredbe, kadar je to mogoče, izogibati podvajanju preskusov na živalih.
In cases where an applicant requests the protection of scientific data relating to the same food in accordance with this Regulation and with Regulation (EC) No 1924/2006 of the European Parliament and of the Council [16], it should be possible for the respective data protection periods to run concurrently.
Tovrstno prizadevanje bi lahko zmanjšalo pomisleke glede dobrobiti živali in etičnih vprašanj v zvezi z uporabo novih živil.
Therefore, provision should be made for staying, on request by the applicant, the authorisation procedure for a novel food.
Za nova živila veljajo splošne zahteve za označevanje iz Uredbe (EU) št. 1169/2011 ter druge ustrezne zahteve za označevanje v živilskem pravu Unije.