natgillin/translations-raw huggingface dataset:
Ukrepi, namenjeni spreminjanju nebistvenih določb posameznega akta sektorske živilske zakonodaje z izjemo novih živil, se v zvezi s črtanjem snovi s seznama Unije sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(3).
The measures, designed to amend non-essential elements of each sectoral food law, with the exception of novel foods, relating to the removal of a substance from the Union list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Zaradi učinkovitosti se ukrepi za spreminjanje nebistvenih določb posameznega akta sektorske živilske zakonodaje z izjemo novih živil, med drugim z njegovim dopolnjevanjem, v zvezi z dodajanjem snovi na seznam Unije, ter za dodajanje, umikanje in spreminjanje pogojev, specifikacij ali omejitev, povezanih z vključenostjo zadevne snovi v seznam Unije, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(4).
On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, with the exception of novel foods, inter alia, by supplementing it, relating to the addition of a substance to the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the Union list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(4).
Z izjemo novih živil in na podlagi nujnosti živil lahko Komisija v nujnih primerih za črtanje snovi s seznama Unije ali za dodajanje, črtanje ali spreminjanje pogojev, specifikacij ali omejitev, povezanih z vključenostjo snovi v seznam Unije, uporabi nujni postopek iz člena 14(5).
With exception of novel foods and on imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(5) for the removal of a substance from the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Union list.
Ukrepi v zvezi s črtanjem katerega od proizvodov, ki jih ureja uredba o novih živilih oziroma, s seznama Unije ali njihovim dodajanjem na ta seznam in/ali dodajanjem, črtanjem ali spreminjanjem pogojev, specifikacij ali omejitev, povezanih z vključenostjo takšnega proizvoda v seznam Unije, se sprejmejo v skladu z regulativnim postopkom iz člena 14(2).".
The measures relating to the removal, the adding of a product covered by the Regulation on novel foods to the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of such product on the Union list shall be adopted in accordance with the regulatory procedure referred to in Article 14(2).".
Člen 29 – odstavek 3
Article 29 - Paragraph 3
Vendar se členi 26, 27 in 28 uporabljajo od…*.
However, Articles 26 , 27 and 28 shall apply from … ** .
Z odstopanjem od drugega odstavka tega člena in člena 16(2) Uredbe (ES) št. 1331/2008 se zahtevki lahko vložijo v skladu s to uredbo od …** za odobritev živil iz točke (iv) člena 3(2)(a) te uredbe, če so taka živila na ta dan že na trgu v Unije.
Furthermore, by way of derogation from the second paragraph of this Article and by way of derogation from the second paragraph of Article 16 of Regulation (EC) No 1331/2008, applications may be made in accordance with this Regulation as from …** for the authorisation of food referred to in point (iv) of Article 3(2)(a) of this Regulation, where such food is already on the market within the Union at that date.
Vendar se člen 26 uporablja od…*.
However, Article 26 shall apply from ... ** .
Uvodna izjava 20 iz dokumenta Komisije.
Article 20 from Commission document.
Kot del okvira za izboljšanje in uskladitev zakonodaje Skupnosti „od kmetije do mize“, je Komisija v Beli knjigi o varnosti živil najavila svoj namen, da prouči uporabo zakonodaje o novih živilih in obstoječo zakonodajo po potrebi prilagodi glede na sklepe v poročilu o izvajanju Uredbe (ES) št. 258/97 v zvezi z novimi živili in novimi živilskimi sestavinami ter v skladu z zakonodajnim okvirom Direktive 90/220/EGS.
As part of the framework to improve and bring coherence to Community legislation from "farm to fork" the Commission announced in the White Paper on Food Safety its intentions to examine the application of the novel food legislation and to make the necessary adaptations to the existing legislation in the light of the conclusions of the report on the implementation of the Regulation (EC) No 258/97 on novel foods and novel ingredients and pursuant to the regulatory framework of Directive 90/220/EEC.
V skladu s temi obveznostmi je cilj predloga Komisije o novih živilih z dne 14. januarja 2008 (KOM 2007(872)) zagotoviti varnost živil, varovati zdravje ljudi in zagotoviti delovanje notranjega trga z živili.
In accordance with these commitments, the proposal of the COM on Novel Food 14.01.2008 (COM 2007 (872)) aims to ensure food safety, protect human health and secure the functioning of the internal market for food.
Namen predloga je urediti dajanje novih živil in živil iz tretjih držav na trg.
The proposal aims to regulate the placing on the market of novel foods and foods from third countries.
Poleg tega določa pravila za odobritev, nadzor, označevanje in uporabo novih živil.
Furthermore, it lays down rules for authorisation, supervision, labelling and use of novel foods.
Prva obravnava v Evropskem parlamentu
First Reading in EP
Evropski parlament je 25. marca 2009 s 658 glasovi za, 15 glasovi proti in 11 vzdržanimi v prvi obravnavi po postopku soodločanja sprejel zakonodajno resolucijo o spremembi predloga uredbe o novih živilih .
On 25 March 2009, the European Parliament adopted by 658 votes to 15, with 11 abstentions, a legislative resolution amending, under the first reading of the co-decision procedure, the proposal for a regulation on novel food.
Glavne spremembe so:
The main amendments were as follows:
Namen: Ta uredba določa usklajena pravila za dajanje novih živil na trg v Skupnosti, da bi zagotovili visoko raven varovanja življenja in zdravja ljudi, zdravja in dobrega počutja živali, varstva okolja in interesov potrošnikov, in hkrati zagotovili preglednost in učinkovito delovanje notranjega trga ter spodbudili inovacije v kmetijsko-živilskem sektorju.
Purpose : This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of protection of human life and health, animal health and welfare, the environment and the interests of consumers whilst ensuring transparency and the effective functioning of the internal market and stimulating innovation within the agri-food industry.
Področje uporabe: Poslanci Evropskega parlamenta želijo iz področja uporabe te uredbe izvzeti živila, pridobljena iz kloniranih živali in njihovih potomcev.
Scope : MEPs intend to exclude foods derived from cloned animals and their offspring from the scope of this Regulation.
Ta uredba se uporablja za aditive za živila, živilske encime, arome ter nekatere sestavine živil z aromatičnimi lastnostmi, za katere se uporablja nov proizvodni postopek, ki se ni uporabljal pred 15. majem 1997 in je povzročil pomembne spremembe v sestavi ali strukturi živila (npr. namensko proizvedeni nanomateriali).
This Regulation shall apply to food additives, food enzymes, flavourings and certain food ingredients with flavouring properties to which is applied a new production process not used before 15 May 1997, which give rise to significant changes in the composition or structure of the food such as engineered nanomaterials.
Kadar lahko novo živilo na človeško telo učinkuje podobno kot zdravilo, Komisija za mnenje zaprosi Evropsko agencijo za zdravila (EMEA), ali živilo sodi pod Uredbo (ES) št. 726/2004.
Where a novel food can have an effect on the human body comparable to that of a medicinal product, the Commission shall seek an opinion of the European Medicines Agency (EMEA) whether it falls under Regulation (EC) No 726/2004.
Opredelitve: Poslanci Evropskega parlamenta so dodali opredelitve "kloniranih živali", "potomcev kloniranih živali" in " namensko proizvedenih nanomaterialov".
Definitions : MEPs have introduced the definition of “cloned animals”, “descendants of cloned animals” and “engineered nanomaterial”.
Komisija glede na številne opredelitve nanomaterialov, ki so jih objavili različni organi na mednarodni ravni, ter stalen tehnični in znanstveni razvoj na področju nanotehnologij spremeni in prilagodi te opredelitve glede na tehnični in znanstveni napredek ter opredelitve, ki bodo v prihodnje sprejete na mednarodni ravni.
In view of the various definitions of nanomaterials published by different bodies at international level and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt these definitions to technical and scientific progress and with definitions subsequently agreed at international level.
Drugi predlogi sprememb, sprejeti v prvi obravnavi, so obravnavali zbiranje informacij za razvrstitev novega živila, prepoved novih živil, ki niso v skladu z uredbo, pogoje za uvrstitev novih živil na seznam Skupnosti, informacije, spremljanje, označevanje, tradicionalna živila iz tretjih držav, uporabo poskusnih metod brez uporabe živali in inteligentnih strategij poskusov, varstvo podatkov ter inšpekcije in nadzorne ukrepe.
Other amendments adopted in first reading covered the collection of information regarding the classification of a novel food, the prohibition of non-compliant novel foods, the conditions for the entry of novel foods in the Community list, Information, Monitoring, Labelling, traditional food from a third country, use of non-animal tests and intelligent testing strategies, data protection as well as inspection and control measures.
Druga obravnava
Second Reading
Svet je svoje stališče v prvi obravnavi o novih živilih sprejel 15. marca 2010.
The position of the Council at first reading on novel food was adopted on 15 March 2010.
Svet je upošteval nekaj delov iz prve obravnave v Parlamentu, vendar ni ustrezno upošteval najpomembnejših predlogov sprememb iz prve obravnave, zlasti ne pri vprašanju kloniranih živali v hrani in krmi.
However, the most important amendments of the first reading have not been taken into consideration in an appropriate manner by the Council, particularly in view of the issue of cloned animals in food and feed.
Poročevalka v svojem poročilu za drugo obravnavo v čim večji meri spoštuje stališče Evropskega parlamenta v prvi obravnavi, saj je bilo to sprejeto z zelo veliko večino.
Your rapporteur respects the first reading position of the European Parliament as much as possible in her second reading report, as the first reading position was adopted by a very large majority.
Ponovno so uvedeni skoraj vsi predlogi sprememb iz prve obravnave.
Almost all of the amendments adopted in the first reading have been reinstated.
János Áder, Elena Oana Antonescu, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Esther de Lange, Bas Eickhout, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Julie Girling, Françoise Grossetête, Satu Hassi, Jolanta Emilia Hibner, Karin Kadenbach, Christa Klaß, Jo Leinen, Corinne Lepage, Peter Liese, Kartika Tamara Liotard, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panajotov (Vladko Todorov Panayotov), Gilles Pargneaux, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Frédérique Ries, Anna Rosbach, Oreste Rossi, Daciana Octavia Sârbu, Horst Schnellhardt, Richard Seeber, Teodoros Skilakakis (Theodoros Skylakakis), Catherine Soullie, Anja Weisgerber, Glenis Willmott, Sabine Wils
János Áder, Elena Oana Antonescu, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Esther de Lange, Bas Eickhout, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Julie Girling, Françoise Grossetête, Satu Hassi, Jolanta Emilia Hibner, Karin Kadenbach, Christa Klaß, Jo Leinen, Corinne Lepage, Peter Liese, Kartika Tamara Liotard, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panayotov, Gilles Pargneaux, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Frédérique Ries, Anna Rosbach, Oreste Rossi, Daciana Octavia Sârbu, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Catherine Soullie, Anja Weisgerber, Glenis Willmott, Sabine Wils
o predlogu uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila, kar zadeva farmakovigilanco zdravil za humano uporabo
on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
MNENJE Odbora za industrijo, raziskave in energetiko .............................32
OPINION of the Committee on Industry, Research and Energy ...............34
MNENJE Odbora za notranji trg in varstvo potrošnikov .........................49
OPINION of the Committee on the Internal Market and Consumer Protection 52
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0664 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0664 ),
– ob upoštevanju členov 251(2) in 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0515/2008 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0515/2008 ),
– ob upoštevanju členov 294(3), 114 in 168(4)(c) Pogodbe o delovanju Evropske unije,
– having regard to Article 294(3) and Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the European Union,
– ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora z dne 10. junija 2009
– having regard to the opinion of the European Economic and Social Committee of 10 June 2009
UL C 306, 16.12.2009, str.
OJ C 306, 16.12.2009, p.
– ob upoštevanju mnenja Odbora regij z dne 7. oktobra 2009
– having regard to the opinion of the Committee of the Regions of 7 October 2009
UL C 79, 27.3.2010, str.
OJ C 79, 27.3.2010, p.
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za notranji trg in varstvo potrošnikov ( A7-0153/2010 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection ( A7‑0153/2010 ),
– ob upoštevanju mnenja evropskega nadzornika za varstvo podatkov z dne 22. aprila 2009
- having regard to the opinion of the European Data Protection Supervisor of 22 April 2009
UL C 229, 23.9.2009, str.
OJ C 229, 23.9.2009, p.
(2a) Onesnaževanje voda in tal s farmacevtskimi ostanki je vse večji okoljski problem in vedno večji problem javnega zdravja.
(2a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and an emerging public health concern.
Treba je sprejeti ukrepe za spremljanje in ocenjevanje škodljivih vplivov zdravil na okolje, tudi tistih, ki vplivajo na javno zdravje.
Measures should be taken to monitor and evaluate adverse environmental effects of medicinal products, including those which impact on public health.
Komisija mora na podlagi podatkov, prejetih od Agencije, Agencije za okolje in držav članic, pripraviti poročilo o razsežnosti problema, obenem pa oceniti, ali so potrebne spremembe zakonodaje EU o zdravilih ali druge zadevne zakonodaje.
The Commission should, based on data received from the Agency, the Environment Agency, and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to EU legislation on medicinal products or other relevant EU legislation are required.
(4) Glavne naloge Agencije v zvezi s farmakovigilanco, določene v Uredbi (ES) št. 726/2004, je treba ohraniti in dodatno razviti, zlasti kar zadeva vodenje podatkovne baze Skupnosti o farmakovigilanci in mreže za obdelavo podatkov (v nadaljnjem besedilu „podatkovna baza Eudravigilance“) ter usklajevanje varnostnih sporočil držav članic.
(4) The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Community pharmacovigilance database and data-processing network (hereinafter referred to as 'the Eudravigilance database') and the coordination of safety announcements by the Member States.
(4) Glavne naloge Agencije v zvezi s farmakovigilanco, določene v Uredbi (ES) št. 726/2004, je treba ohraniti in dodatno razviti, zlasti kar zadeva vodenje podatkovne baze Skupnosti o farmakovigilanci in mreže za obdelavo podatkov (v nadaljnjem besedilu „podatkovna baza Eudravigilance“) , usklajevanje varnostnih sporočil držav članic ter obveščanje javnosti o vprašanjih varnosti .
(4) The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Community pharmacovigilance database and data-processing network (hereinafter referred to as 'the Eudravigilance database') , the coordination of safety announcements by the Member States and the provision of information regarding safety issues to the public .
Potrošniki imajo pravico do več informacij o farmakovigilanci ter o razmerju med koristmi in tveganji, ki so povezani z njihovimi zdravili.
Consumers have the right to have more information regarding pharmacovigilance concerns and about the risk-benefit balance of their medicines.
Agencija ima pomembno vlogo kot zanesljiv neodvisen vir informacij.
The Agency has an important role to play as a reliable independent source of information.
(5) Da se vsem pristojnim organom zagotovi, da lahko hkrati prejemajo informacije o farmakovigilanci zdravil za humano uporabo, odobrenih v Skupnosti, dostopajo do njih in jih skupaj uporabljajo, je treba voditi podatkovno bazo Eudravigilance in jo okrepiti kot enotno točko prejema takih informacij.
(5) In order to allow all competent authorities to receive and access, at the same time, pharmacovigilance information for medicinal products for human use authorised in the Community, and share it, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information.
Države članice zato imetnikom dovoljenj za promet ne bi smele nalagati dodatnih zahtev za poročanje.
Member States should therefore not impose on marketing authorisation holders any additional reporting requirements.
Namesto tega mora podatkovna baza Eudravigilance sočasno obvestiti zadevne države članice o poročilih, ki jih vložijo imetniki dovoljenj za promet.
Instead, the Eudravigilance database should simultaneously notify the relevant Member States of reports submitted by market authorisation holders .
Da bi zagotovili visoko raven kakovosti informacij, morajo države članice podpirati razvoj strokovnih mnenj nacionalnih in regionalnih centrov farmakovigilance.
In order to ensure high-quality information, Member States should support the development of national and regional pharmacovigilance centres' expertise.
Pristojni nacionalni organi bi morali zbirati poročila teh centrov in podatke vnašati v podatkovno bazo Eudravigilance.
The national competent authorities should collect the reports from those centres and transfer the data to the Eudravigilance database.
Podatkovna baza mora biti v celoti dostopna državam članicam, Agenciji in Komisiji, v ustreznem obsegu pa tudi imetnikom dovoljenj za promet in javnosti.
The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public.
Podatkovna baza mora biti v celoti dostopna državam članicam, Agenciji in Komisiji, v ustreznem obsegu pa tudi imetnikom dovoljenj za promet in javnosti , v vseh uradnih jezikih Unije .
The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public :. in all the official languages of the Union .
Države članice bi morale biti elektronsko obveščene, kadar bi imetniki dovoljenja za promet vložili poročila Eudravigilance o hudih domnevnih neželenih učinkih na svojem ozemlju, in sicer kot dodaten varnostni vzvod, s katerim bi zagotovili, da nacionalni pristojni organi te informacije ne bi spregledali.
Member States should be alerted electronically when Market Authorisation Holders submit reports to Eudravigilance about serious suspected adverse reactions which happen on their territory, as an extra check to ensure that national competent authorities do not miss or overlook this information.
(6) Za večjo preglednost v zvezi z vprašanji farmakovigilance mora Agencija postaviti in voditi evropski spletni portal za varnost zdravil.
(6) In order to increase transparency as regards pharmacovigilance issues, a European medicines safety web-portal should be created and maintained by the Agency.
(6) Za večjo preglednost v zvezi z vprašanji farmakovigilance mora Agencija vzpostaviti in voditi evropski spletni portal za varnost zdravil v vseh uradnih jezikih Unije .
(6) In order to increase transparency as regards pharmacovigilance issues, a European medicines safety web-portal should be created and maintained by the Agency in all the official languages of the Union .
(9) Da se v vsej Skupnosti zagotovi usklajen odziv na pomisleke glede varnosti zdravil za humano uporabo, mora Svetovalni odbor za oceno tveganja na področju farmakovigilance podpirati Odbor za zdravila za uporabo v humani medicini in koordinacijsko skupino , ustanovljeno z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini pri vseh vprašanj , povezanih s farmakovigilanco zdravil za humano uporabo.
(9) In order to ensure harmonised responses across the Community to safety concerns regarding medicinal products for human use, the Pharmacovigilance Risk Assessment Advisory Committee should support the Committee for Medicinal Products for Human Use and the coordination group established by 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 on any question relating to the pharmacovigilance of medicinal products for human use.
Zaradi doslednosti in stalnosti ocen pa morajo biti za oceno tveganja in koristi zdravil za humano uporabo, odobrenih v skladu s to uredbo, še vedno pristojni Odbor za zdravila za humano uporabo v okviru Agencije in organi, pristojni za izdajanje dovoljenj za promet.
However, for the sake of consistency and continuity of the assessments, the final responsibility for the risk-benefit assessment of medicinal products for human use authorised in accordance with this Regulation should remain with the Committee for Medicinal Products for Human Use of the Agency and with the authorities competent for the granting of marketing authorisations.