natgillin/translations-raw huggingface dataset:
ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2007)0872 ),
having regard to the Commission proposal to European Parliament and the Council ( COM(2007)0872 ),
ob upoštevanju členov 251(2) in 95(1) Pogodbe ES, na podlagi katerih je Komisija podala predlog Parlamentu ( C6-0027/2008 ),
having regard to Article 251(2) and Article 95(1) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0027/2008 ),
ob upoštevanju svojega stališča v prvi obravnavi UL C 117 E, 6.5.2010, str.
having regard to its position at first reading OJ C 117 E, 6.5.2010, p.
ob upoštevanju členov 294(7) in 114(1) Pogodbe o delovanju Evropske unije,
having regard to Article 294(7) and Article 114(1) of the Treaty on the Functioning of the European Union,
ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora z dne 29. maja 2008 UL C 224, 30.8.2008, str.
having regard to the opinion of the European Economic and Social Committee of 29 May 2008 OJ C 224, 30.8.2008, p.
ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A7–0152/2010 ),
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A7-0152/2010 ),
sprejema v nadaljevanju navedeno stališče v drugi obravnavi;
Adopts the position at second reading hereinafter set out;
ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora UL C 224, 30.8.2008, str.
Having regard to the opinion of the European Economic and Social Committee OJ C 224, 30.8.2008, p.
v skladu z rednim zakonodajnim postopkom Stališče Evropskega parlamenta z dne 25. marca 2009 (UL C 117 E, 6.5.2010, str.
Acting in accordance with the ordinary legislative procedure Position of the European Parliament of 25 March 2009 (OJ C 117 E, 6.5.2010, p.
236), stališče Sveta v prvi obravnavi z dne 15. marca 2010 (UL C 122 E, 11.5.2010, str.
236) and Council Position at first reading of 15 March 2010 (OJ C 122 E, 11.5.2010, p.
38.) in stališče Evropskega parlamenta z dne 7. julija 2010.
38), position of the European Parliament of 7 July 2010.
Pri izvajanju politike Unije in ob upoštevanju Pogodbe o delovanju Evropske unije je treba zagotoviti visoko raven zaščite zdravja ljudi in varstva potrošnikov ter tudi visoko raven dobrega počutja živali in varstva okolja.
In implementing Union policy and having regard to the Treaty on the Functioning of the European Union (TFEU), a high level of protection of human health and consumer protection should be guaranteed and also a high level of animal welfare and environmental protection.
Poleg tega je treba nenehno upoštevati previdnostno načelo, kot je določeno v Uredbi (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
At all times, moreover, 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
Člen 13 Pogodbe o delovanju Evropske unije pojasnjuje, da Unija in države članice pri oblikovanju in izvajanju politik v celoti upoštevajo zahteve po dobrem počutju živali, saj so živali čuteča bitja.
Article 13 TFEU clarifies that the Union and the Member States are to pay full regard to the welfare requirements of animals when formulating and implementing policies, since animals are sentient beings.
Standardi, opredeljeni v zakonodaji Unije, morajo veljati za vsa živila, ki se dajo na trg Unije, tudi za živila, uvožena iz tretjih držav.
The standards laid down in Union legislation must be applied to all foods placed on the market within the Union, including foods imported from third countries.
Znanstveni odbor Komisije za nastajajoča in na novo ugotovljena zdravstvena tveganja (ZONNUZT) je v svojem mnenju z dne 28. in 29. septembra 2005 ugotovil, „da obstajajo precejšne vrzeli v znanju, ki je potrebno za oceno tveganja.
The Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted on 28–29 September 2005 an opinion which concluded that there were ‘major gaps in the knowledge necessary for risk assessment.
Pravila Unije 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 UL L 43, 14.2.1997, str.
The Union's 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 OJ L 43, 14.2.1997, p.
Priporočilo Komisije 97/618/ES z dne 29. julija 1997 o znanstvenih vidikih in predstavitvi informacij, potrebnih za podporo vlogam za dovoljenja za dajanje na trg novih živil in sestavin novih živil in pripravo poročil o začetni presoji v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta UL L 253, 16.9.1997, str.
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 OJ L 253, 16.9.1997, p.
bi moralo postati neuporabno v zvezi z novimi živili.
should therefore become obsolete as regards novel foods.
Za zagotovitev kontinuitete z Uredbo (ES) št. 258/97 bi bilo treba dejstvo, da živilo ni bilo v uporabi v pomembnem obsegu za prehrano ljudi v Uniji pred začetkom uporabe Uredbe (ES) št. 258/97, in sicer 15. majem 1997, ohraniti kot merilo, v skladu s katerim se živilo šteje za novo.
In order to ensure continuity with Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree within the Union before the date of application of Regulation (EC) No 258/97, namely 15 May 1997, should be kept as the criterion for a food to be considered as novel.
Uporaba v Uniji pomeni uporabo v državah članicah ne glede na datum njihovega pristopa k Evropski uniji.
A use within the Union refers to a use in the Member States irrespective of the date of their accession to the European Union.
▌Obstoječo opredelitev novega živila bi bilo treba pojasniti
▌The existing definition of novel food should be clarified,
z razlago meril za novost
with an explanation of the criteria for novelty,
in posodobiti ter nadomestiti obstoječe skupine in pri tem navesti sklic na splošno opredelitev živila iz ▌uredbe
and updated by replacing the existing categories with a reference to the general definition of food in ▌Regulation
V skladu z opredelitvijo te uredbe se za nova štejejo živila z novo ali namenoma spremenjeno prvotno molekulsko strukturo, živila, ki jih sestavljajo mikroorganizmi, glive ali alge ali so iz njih pridobljena, novi sevi mikroorganizmov brez preteklih izkušenj o varni uporabi, pa tudi koncentrati snovi, ki se naravno pojavijo v rastlinah.
Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use and concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation.
, ki se tržijo in uporabljajo
the production of foods to be marketed and consumed
Med nova živila bi morali zato šteti živila iz
Novel food should therefore include foods derived from
rastlin in
plants and
živali ▌, proizvedena z netradicionalnimi tehnikami gojenja in vzreje, in ▌živila,
animals, produced by non-traditional breeding techniques, and ▌foods
z novimi proizvodnimi postopki,
by new production processes,
kot sta nanotehnologija in nanoznanost,
such as nanotechnology and nanoscience,
ki bi lahko vplivali na živila ▌.
which might have an impact on food ▌.
Živila iz novih rastlinskih sort ali živalskih pasem, proizvedena s tradicionalnimi tehnikami gojenja ali vzreje, se ne bi smela šteti za nova živila. ▌
Foods derived from new plant varieties, or from animal breeds produced by traditional breeding techniques, should not be considered as novel foods. ▌
, ki določa, da metode ekstenzivne ali intenzivne reje, ki povzročajo ali lahko povzročijo trpljenje ali poškodbo katere koli zadevne živali, niso dovoljene.
, point 20 of the Annex of which states that natural or artificial breeding procedures which cause, or are likely to cause, suffering or injury to any of the animals concerned must not be practised.
za etiko v znanosti in novih tehnologijah, ustanovljena s Sklepom Komisije z dne 16. decembra 1997,
The European Group on Ethics in Science and New Technologies, established by Commission Decision of 16 December 1997,
v svojem mnenju št. 23 z dne 16. januarja 2008 o etičnih vidikih kloniranja živali za preskrbo s hrano navedla, da „ni prepričljivih dokazov, ki bi upravičili proizvodnjo hrane iz klonov in njihovih potomcev“
stated in its Opinion (No. 23) of 16 January 2008 on ethical aspects of animal cloning for food supply that it ‘does not see convincing arguments to justify the production of food from clones and their offspring’.
Glasilo Evropske agencije za varnost živil (2008) 767, str.
The EFSA Journal (2008)767, p.
ugotavlja, da sta „zdravje in dobro počutje precejšnjega dela klonov ... zelo in pogosto življenjsko ogrožena“
that ‘the health and welfare of a significant proportion of clones … have been found to be adversely affected, often severely and with a fatal outcome’
Vendar bi morala biti živila, pridobljena iz kloniranih živali in njihovih potomcev, izvzeta iz področja uporabe te uredbe.
Foods derived from cloned animals and their descendants should, however, be excluded from the scope of this Regulation.
Obravnavati jih je treba v posebni uredbi, sprejeti po rednem zakonodajnem postopku, ne pa po enotnem postopku odobritve.
They should be dealt with in a specific regulation, adopted under the ordinary legislative procedure, and should not be subject to the common authorisation procedure.
Komisija bi morala pred datumom začetka uporabe te uredbe predložiti ustrezen zakonodajni predlog.
Before the date of application of this Regulation, the Commission should present a corresponding legislative proposal.
Dokler ne začne veljati uredba o kloniranih živalih, je treba uvesti moratorij za dajanje na trg živil, proizvedenih iz kloniranih živali ali 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 or their descendants.
Treba bi bilo sprejeti izvedbene ukrepe, da se določijo
Implementing measures should be adopted to provide for
Če se je živilo ▌uporabljalo izključno kot prehransko dopolnilo ali njegova sestavina, kot je opredeljeno v Direktivi 2002/46/ES
If ▌a food was used exclusively as, or in, a food supplement, as defined in Directive 2002/46/EC
to živilo po tem dnevu daje na trg v Uniji za isto uporabo in se ne šteje za novo živilo.
be placed on the market ▌after that date for the same use without being considered as a novel food.
treba v skladu s to uredbo odobriti tudi druge načine uporabe zadevnega živila
uses of the food concerned
kot prehransko dopolnilo ali njegova sestavina.
be authorised in accordance with this Regulation.
Uporaba namensko proizvedenih nanomaterialov v proizvodnji živil se lahko z nadaljnjim razvojem tehnologije poveča.
The use of engineered nanomaterials in food production might increase with the further development of technology.
Poskusne metode, ki so zdaj na voljo, ne zadoščajo za oceno tveganj
Test methods currently available are not adequate for assessing
Nujno je treba razviti poskusne metode za testiranje nanomaterialov, pri katerih se ne uporabljajo živali
Non-animal test methods for testing nanomaterials should be developed as a matter of urgency
Samo nanomateriali na seznamu odobrenih snovi so lahko prisotni v embalaži živila, skupaj z mejno količino teh snovi, ki lahko preide v ali na živilske proizvode v tovrstni embalaži.
Only nanomaterials entered in a list of approved substances should be present in food packaging, accompanied by a limit on migration into or onto the food products contained in such packaging.
živilski proizvodi, proizvedeni iz
food products produced from
sestavin živil,
food ingredients
ki so na voljo na trgu Unije
available on the market within the Union,
teh sestavin,
amounts of those food ingredients
se ne bi smeli šteti za nova živila. ▌
, should not be considered as novel food. ▌
Določbe Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini UL L 311, 28.11.2001, str.
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 OJ L 311, 28.11.2001, p.
bi se morale uporabljati, kadar bi lahko za proizvod ob upoštevanju vseh njegovih značilnosti veljali tako opredelitev „zdravilo“ kot opredelitev proizvoda iz druge zakonodaje Unije.
should apply where, taking into account all its characteristics, a product may fall both within the definition of ‘medicinal product’ and within the definition of a product covered by other Union legislation.
Državi članici bi moralo biti omogočeno, da omeji dajanje takega proizvoda na trg v skladu z zakonodajo Unije, če v skladu z Direktivo 2001/83/ES ugotovi, da je proizvod zdravilo.
In this respect, a Member State, if it establishes in accordance with Directive 2001/83/EC that a product is a medicinal product, should be able to restrict the placing on the market of such product in accordance with Union law.
Poleg navedenega so zdravila izključena iz opredelitve živila, kakor je opredeljeno v Uredbi (ES) št. 178/2002, in se ta uredba zanje ne bi smela uporabljati.
Moreover, medicinal products are excluded from the definition of food as established by Regulation (EC) No 178/2002 and should not be subject to this Regulation.
Nova živila, odobrena na podlagi Uredbe (ES) št. 258/97, bi morala ohraniti status novih živil, vendar bi bila za kakršno koli novo uporabo teh živil potrebna odobritev.
Novel foods authorised under Regulation (EC) No 258/97 should maintain their novel food status but authorisation should be required for any new uses of such foods.
Živila, ki so namenjena tehnološki uporabi ali so gensko spremenjena, ne bi smela soditi v področje uporabe te uredbe.
Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation.
Zato ta uredba ne pokriva gensko spremenjenih živil iz Uredbe (ES) št. 1829/2003 Uredba (ES) št. 1829/2003 Evropskega Parlamenta In Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi(UL L 268, 18.10.2003, str.
Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p.
, živil, ki se uporabljajo izključno kot aditivi v okviru področja uporabe Uredbe (ES) št. 1333/2008 Uredba (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila (UL L 354, 31.12.2008, str.
, food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p.
, arom v okviru področja uporabe Uredbe (ES) št. 1334/2008 Uredba (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih (UL L 354, 31.12.2008, str.
, flavourings falling within the scope of Regulation (EC) No 1334/2008 Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (OJ L 354, 31.12.2008, p.
, encimov v okviru področja uporabe Uredbe (ES) št. 1332/2008 Uredba (ES) št. 1332/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o encimih za živila (UL L 354, 31.12.2008, str.
, enzymes falling within the scope of Regulation (EC) No 1332/2008 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (OJ L 354, 31.12.2008, p.
in ekstrakcijskih topil v okviru področja uporabe Direktive 2009/32/ES Direktiva 2009/32/ES Evropskega parlamenta in Sveta z dne 23. aprila 2009 o približevanju zakonodaj držav članic na področju ekstrakcijskih topil, ki se uporabljajo pri proizvodnji živil in njihovih sestavin (prenovitev) (UL L 141, 6.6.2009, str.
and extraction solvents falling within the scope of Directive 2009/32/EC Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (recast) (OJ L 141, 6.6.2009, p.
Uporaba vitaminov in mineralov je urejena s posebnimi sektorskimi živilskimi zakoni.
The use of vitamins and minerals is governed by specific sectoral food laws.
Zato bi bilo treba iz področja uporabe te uredbe izključiti vitamine in minerale, ki sodijo na področje uporabe Direktive 2002/46/ES, Uredbe (ES) št. 1925/2006 Evropskega parlamenta in Sveta z dne 20. decembra 2006 o dodajanju vitaminov, mineralov in nekaterih drugih snovi živilom UL L 404, 30.12.2006, str.
The vitamins and minerals falling within the scope of Directive 2002/46/EC, Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods OJ L 404, 30.12.2006, p.
in Direktive 2009/39/ES Evropskega parlamenta in Sveta z dne 6. maja 2009 o živilih za posebne prehranske namene (prenovitev) UL L 124, 20.5.2009, str.
and Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (recast) OJ L 124, 20.5.2009, p.
Vendar v teh posebnih predpisih niso obravnavani primeri, kjer se dovoljeni vitamini in minerali pridobivajo s proizvodnimi metodami ali z uporabo novih virov, ki se niso upoštevali v postopku odobritve.
However, those specific legal acts do not deal with cases where authorised vitamins and mineral substances are obtained by production methods or using new sources that were not taken into account when they were authorised.
Zato se do teh sprememb posebnih predpisov ti vitamini in minerali ne smejo izključiti iz področja uporabe te uredbe, če proizvodne metode ali novi viri povzročijo pomembne spremembe v sestavi ali strukturi vitaminov in mineralov, ki vpliva na hranilno vrednost, način njihove presnove ali stopnjo nezaželenih snovi.
Therefore, pending the amendment of those specific legal acts, such vitamins and mineral substances should not be excluded from the scope of this Regulation when the production methods or new sources give rise to significant changes in the composition or structure of the vitamins or minerals which affect their nutritional value, how they are metabolised or the level of undesirable substances.
Nova živila, razen vitaminov in mineralov, namenjena za posebne prehranske namene, za obogatitev živil ali uporabljena kot prehranska dopolnila, bi bilo treba oceniti v skladu s to uredbo.
Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with this Regulation.
Hkrati bi se morala zanje še naprej uporabljati pravila, določena v Direktivi 2002/46/ES in Uredbi (ES) št. 1925/2006 in Direktivi 2009/39/ES ter v posebnih direktivah, ki so navedene v Direktivi 2009/39/ES in Prilogi I Direktive 2009/39/ES.
They should also remain subject to the rules provided for in Directive 2002/46/EC, in Regulation (EC) No 1925/2006, in Directive 2009/39/EC, and in the specific Directives referred to in Directive 2009/39/EC and in Annex I thereto.
Postopek se sprejme najpozneje do ...
The procedure should be adopted no later than ...
UL: prosimo, vstavite datum: šest mesecev po začetku veljavnosti te uredbe.
OJ: Please insert date: Six months after the entry into force of this Regulation.
Nova živila bi se smela dajati na trg v Unije le, če so varna in ne zavajajo potrošnika.
Novel foods should be placed on the market within the Union only if they are safe and do not mislead the consumer.
Poleg tega se ▌ne bi
should not differ from
živil, ki jih nadomestijo,
that they are to replace
način, ki bi bil hranilno manj ugoden za potrošnika.
way that would be nutritionally disadvantageous for the consumer.
Za oceno varnosti in odobritev bi bilo treba uporabiti usklajen in centraliziran postopek, ki je učinkovit, časovno omejen in pregleden.
It is necessary to apply a harmonised centralised procedure for safety assessment and authorisation that is efficient, time-limited and transparent.
Za nadaljnje usklajevanje različnih postopkov za odobritev živil bi bilo treba izvesti oceno varnosti novih živil in ta živila vključiti na seznam Unije v skladu s postopkom iz Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila UL L 354, 31.12.2008, str.
With a view to further harmonising different procedures for the authorisation of food, the safety assessment of novel foods and their inclusion in the Union list should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings OJ L 354, 31.12.2008, p.
, ki bi se moral uporabljati vedno, kadar v tej uredbi ni predvidenega posebnega odstopanja.
, which should be applicable whenever it is not specifically derogated from by this Regulation.
Komisija bi morala po prejetju zahtevka za odobritev proizvoda kot novega živila oceniti veljavnost in uporabnost zahtevka.
Upon receipt of an application for authorisation of a product as a novel food, the Commission should assess the validity and applicability of the application.
Pri odobritvi novih živil bi se morali upoštevati tudi drugi dejavniki, pomembni za obravnavani primer, vključno z etičnimi in okoljskimi dejavniki ter dejavniki v zvezi z dobrim počutjem živali in previdnostno načelo.
The authorisation of a novel food should also take into account other factors relevant to the matter under consideration, including ethical, environmental, animal welfare factors and the precautionary principle.
Določiti bi bilo treba tudi merila za oceno možnih tveganj v povezavi z novimi živili.
Criteria for the evaluation of the potential risks arising from novel foods should also be laid down.
Da bi zagotovili usklajeno znanstveno ocenjevanje novih živil, bi morala tako oceno izvesti Evropska agencija za varnost hrane („agencija“).
In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the Authority.
V postopku odobritve je treba kot del ocene tveganja upoštevati etične in okoljske vidike.
Ethical and environmental aspects must be considered as part of the risk assessment during the authorisation procedure.
Te vidike bi morala oceniti evropska skupina za etiko v znanosti in novih tehnologijah oziroma znanstveni odbor.
Those aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respectively.
Zaradi poenostavitve postopkov bi bilo treba predlagateljem dovoliti, da predložijo en sam zahtevek za živila, ki jih urejajo različni sektorski živilski zakoni.
In order to simplify procedures, applicants should be allowed to present a single application for foods regulated under different sectoral food laws.