natgillin/translations-raw huggingface dataset:
available information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes;
razpoložljive informacije o komercialni in industrijski uporabi nove psihoaktivne snovi, razširjenosti take uporabe ter njeni uporabi za znanstvene raziskave in razvoj;
The Scientific Committee shall assess the risks posed by the new psychoactive substance or group of new psychoactive substances.
Znanstveni odbor oceni tveganja, ki jih predstavlja nova psihoaktivna snov ali skupina novih psihoaktivnih snovi.
The Scientific Committee may be extended as deemed necessary by the Director, acting on the advice of the chairperson of the Scientific Committee, by including experts representing the scientific fields relevant for ensuring a balanced assessment of the risks posed by the new psychoactive substance.
Direktor lahko na podlagi mnenja predsednika znanstvenega odbora ta odbor razširi s strokovnjaki z znanstvenih področij, ki so pomembna za pripravo uravnotežene ocene tveganj, ki jih predstavljajo nove psihoaktivne snovi, če se mu to zdi primerno.
The Director shall designate those experts from a list of experts.
Direktor te strokovnjake imenuje s seznama strokovnjakov.
The Management Board shall approve the list of experts every three years.
Upravni odbor odobri seznam strokovnjakov vsaka tri leta.
The Commission, the Centre, Europol and the European Medicines Agency shall each have the right to nominate two observers.
Komisija, Center, Europol in Evropska agencija za zdravila imajo pravico predlagati vsak po dva opazovalca.
The Scientific Committee shall carry out the risk assessment on the basis of the available information and of any other relevant scientific evidence.
Znanstveni odbor izvede oceno tveganja na podlagi razpoložljivih informacij in kakršnih koli drugih ustreznih znanstvenih dokazov.
It shall take into account all opinions held by its members.
Pri tem upošteva vsa mnenja svojih članov.
The Centre shall organise the risk assessment procedure, including identifying future information needs and relevant studies.
Center organizira postopek ocene tveganja, vključno z opredelitvijo prihodnjih potreb po informacijah in zadevnih študij.
The Centre shall submit the risk assessment report or the combined risk assessment report to the Commission and the Member States within six weeks of receipt of the request from the Commission to draw up a risk assessment report.
Center predloži poročilo o oceni tveganja ali skupno poročilo o oceni tveganja Komisiji in državam članicam v šestih tednih od prejema zahteve Komisije, da se pripravi poročilo o oceni tveganja.
Upon receipt of a duly reasoned request of the Centre, the Commission may extend the period for completion of the risk assessment or combined risk assessment to allow for additional research and data collection to take place.
Komisija lahko po prejemu ustrezno utemeljene zahteve Centra podaljša rok za dokončanje ocene tveganja ali skupne ocene tveganja, da bi omogočila dodatne raziskave in zbiranje podatkov.
That request shall contain information on the period of time needed to complete the risk assessment or combined risk assessment.
Ta zahteva vsebuje informacije o času, ki je potreben za dokončanje ocene tveganja ali skupne ocene tveganja.
Article 5d
Člen 5d
Exclusion from risk assessment
Izvzetje iz ocene tveganja
No risk assessment shall be carried out where the new psychoactive substance is at an advanced stage of assessment within the United Nations system, namely once the World Health Organisation Expert Committee on Drug Dependence has published its critical review together with a written recommendation, except where there are sufficient data and information available to suggest the need for a risk assessment report at Union level, the reasons for which shall be indicated in the initial report.
Ocena tveganja se ne izvede, kadar je nova psihoaktivna snov v zaključnih fazah ocenjevanja v okviru sistema Združenih narodov, tj. ko je strokovni odbor za odvisnost od drog Svetovne zdravstvene organizacije že objavil svoj kritični pregled s pisnim priporočilom, razen kadar je na voljo dovolj podatkov in informacij, ki kažejo, da je treba na ravni Unije pripraviti poročilo o oceni tveganja, razlogi za to pa se navedejo v začetnem poročilu.
No risk assessment shall be carried out where, following an assessment within the United Nations system, it has been decided not to schedule the new psychoactive substance under the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, or the 1971 Convention on Psychotropic Substances, except where there are sufficient data and information available to suggest the need for a risk assessment report at Union level, the reasons for which shall be indicated in the initial report.
Ocena tveganja se ne izvede, kadar je bilo na podlagi ocene v okviru sistema Združenih narodov odločeno, da se nova psihoaktivna snov ne uvrsti na seznam iz Enotne konvencije o mamilih iz leta 1961, kakor je bila spremenjena s Protokolom iz leta 1972, ali Konvencije o psihotropnih substancah iz leta 1971, razen kadar je na voljo dovolj podatkov in informacij, ki kažejo, da je treba na ravni Unije pripraviti poročilo o oceni tveganja, razlogi za to pa se navedejo v začetnem poročilu.
No risk assessment shall be carried out where the new psychoactive substance is an active substance in:
Ocena tveganja se ne izvede, kadar je nova psihoaktivna snov zdravilna učinkovina v:
a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation;
zdravilu za uporabo v humani medicini ali zdravilu za uporabo v veterinarski medicini, za katero je bilo pridobljeno dovoljenje za promet;
an investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC.
zdravilu v preskušanju, kakor je opredeljeno v točki (d) člena 2 Direktive 2001/20/ES.
in Article 13(2), the fourth subparagraph is replaced by the following:
v členu 13(2) se četrti pododstavek nadomesti z naslednjim besedilom:
‘For the purpose of assessing the risks posed by the new psychoactive substance or group of new psychoactive substances, the Scientific Committee may be extended following the procedure laid down in Article 5c(4).’.
„Za oceno tveganj, ki jih nova psihoaktivna snov ali skupina novih psihoaktivnih snovi predstavlja, se lahko znanstveni odbor razširi v skladu s postopkom iz člena 5c(4).“
It shall apply from 23 November 2018.
Uporablja se od 23. novembra 2018.
Done at Strasbourg, 15 November 2017.
V Strasbourgu, 15. novembra 2017
OJ C 34, 2.2.2017, p. 182.
UL C 34, 2.2.2017, str. 182.
Position of the European Parliament of 24 October 2017 (not yet published in the Official Journal) and decision of the Council of 10 November 2017.
Stališče Evropskega parlamenta z dne 24. oktobra 2017 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 10. novembra 2017.
Joint Action 97/396/JHA of 16 June 1997 adopted by the Council on the basis of Article K.3 of the Treaty on European Union, concerning the information exchange, risk assessment and the control of new synthetic drugs (OJ L 167, 25.6.1997, p. 1).
Skupni ukrep 97/396/PNZ z dne 16. junija 1997 Sveta na podlagi člena K.3 Pogodbe o Evropski uniji o izmenjavi podatkov, oceni tveganja in nadzoru novih sintetičnih drog (UL L 167, 25.6.1997, str. 1).
Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances (OJ L 127, 20.5.2005, p. 32).
Sklep Sveta 2005/387/PNZ z dne 10. maja 2005 o izmenjavi podatkov, oceni tveganja in nadzoru nad novimi psihoaktivnimi snovmi (UL L 127, 20.5.2005, str. 32).
Directive (EU) 2017/2103 of the European Parliament and of the Council of 15 November 2017 amending Council Framework Decision 2004/757/JHA in order to include new psychoactive substances in the definition of ‘drug’ and repealing Council Decision 2005/387/JHA (see page 12 of this Official Journal).
Direktiva (EU) 2017/2103 Evropskega parlamenta in Sveta z dne 15. novembra 2017 o spremembi Okvirnega sklepa Sveta 2004/757/PNZ zaradi vključitve novih psihoaktivnih snovi v opredelitev pojma „prepovedana droga“ in razveljavitvi Sklepa Sveta 2005/387/PNZ (glej stran 12 tega Uradnega lista).
Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p. 1).
Uredba (ES) št. 1920/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o Evropskem centru za spremljanje drog in zasvojenosti z drogami (UL L 376, 27.12.2006, str. 1).
Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8).
Okvirni sklep Sveta 2004/757/PNZ z dne 25. oktobra 2004 o opredelitvi minimalnih določb glede elementov kaznivih dejanj in kazni na področju nedovoljenega prometa s prepovedanimi drogami (UL L 335, 11.11.2004, str. 8).
Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8).’;
Okvirni sklep Sveta 2004/757/PNZ z dne 25. oktobra 2004 o opredelitvi minimalnih določb glede elementov kaznivih dejanj in kazni na področju nedovoljenega prometa s prepovedanimi drogami (UL L 335, 11.11.2004, str. 8).“;
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. 67).
Direktiva 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. 67).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
Direktiva 2001/82/ES Evropskega parlamenta in sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str. 1).
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, 30.4.2004, str. 1).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).’;
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34).“;
Regulation (EU) 2017/2107 of the European Parliament and of the Council
Uredba (EU) 2017/2107 Evropskega parlamenta in Sveta
laying down management, conservation and control measures applicable in the Convention area of the International Commission for the Conservation of Atlantic Tunas (ICCAT), and amending Council Regulations (EC) No 1936/2001, (EC) No 1984/2003 and (EC) No 520/2007
o določitvi upravljalnih, ohranitvenih in nadzornih ukrepov, ki se uporabljajo na območju konvencije Mednarodne komisije za ohranitev tunov v Atlantiku (ICCAT), ter spremembi uredb Sveta (ES) št. 1936/2001, (ES) št. 1984/2003 in (ES) št. 520/2007
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 43(2) Pogodbe,
The objective of the common fisheries policy (CFP), as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council [3], is to ensure an exploitation of marine biological resources that provides long-term environmental, economic and social sustainability.
Cilj skupne ribiške politike, kot je določen v Uredbi (EU) št. 1380/2013 Evropskega parlamenta in Sveta [3], je zagotoviti izkoriščanje morskih bioloških virov, ki ustvarja dolgotrajno okoljsko, gospodarsko in socialno vzdržnost.
By Council Decision 98/392/EC [4] the Union approved the United Nations Convention on the Law of the Sea, which contains, inter alia, principles and rules with regard to the conservation and management of marine living resources.
Unija je s Sklepom Sveta 98/392/ES [4] odobrila Konvencijo Združenih narodov o pomorskem pravu, ki med drugim zajema načela in pravila v zvezi z ohranjanjem in upravljanjem živih morskih virov.
In the framework of its wider international obligations, the Union participates in efforts made in international waters to conserve fish stocks.
Unija v okviru svojih širših mednarodnih obveznosti sodeluje pri prizadevanjih za ohranitev staležev rib v mednarodnih vodah.
Pursuant to Council Decision 86/238/EEC [5], the Union has been a Contracting Party to the International Convention for the Conservation of Atlantic Tunas (‘the ICCAT Convention’) since 14 November 1997.
V skladu s Sklepom Sveta 86/238/EGS [5] je Unija od 14. novembra 1997 pogodbenica Mednarodne konvencije za ohranitev atlantskega tuna (v nadaljnjem besedilu: Konvencija ICCAT).
The ICCAT Convention provides a framework for regional cooperation on the conservation and management of tunas and tuna-like species in the Atlantic Ocean and the adjoining seas through the setting-up of an International Commission for the Conservation of Atlantic Tunas (ICCAT).
Konvencija ICCAT določa okvir za regionalno sodelovanje pri ohranjanju in upravljanju tunov in tunom podobnih vrst v Atlantskem oceanu in sosednjih morjih z ustanovitvijo Mednarodne komisije za ohranitev tunov v Atlantiku (ICCAT).
ICCAT has the authority to adopt compulsory decisions (recommendations) for the conservation and management of the fisheries under its purview, which are binding for the Contracting Parties.
ICCAT je pristojna za sprejetje obveznih odločitev (priporočil) o ohranjanju in upravljanju ribištva v okviru njenih pristojnosti, ki so za pogodbenice obvezujoče.
Those recommendations are essentially addressed to the Contracting Parties to the ICCAT Convention, but also contain obligations for private operators (e.g. vessel masters).
Ta priporočila so naslovljena predvsem na pogodbenice Konvencije ICCAT, vendar vsebujejo tudi obveznosti za zasebne subjekte (na primer poveljnike ribiških plovil).
The ICCAT recommendations enter into force six months following their adoption and, in respect of the Union, they must be implemented into Union law as soon as possible.
Priporočila ICCAT začnejo veljati šest mesecev po njihovem sprejetju in jih je, kar zadeva Unijo, treba čim hitreje prenesti v pravo Unije.
A Regulation of the European Parliament and of the Council on the sustainable management of external fishing fleets [6] will provide that that Regulation is to apply without prejudice to the provisions in Union law implementing provisions adopted by the regional fisheries management organisations (RFMOs) to which the Union is a Contracting Party.
Uredba Evropskega parlamenta in Sveta o trajnostnem upravljanju zunanjih ribiških flot [6] bo določala, da se navedena uredba uporablja brez poseganja v določbe prava Unije, ki prenašajo določbe, sprejete s strani regionalnih organizacij za upravljanje ribištva, katerih pogodbenica je Unija.
The last implementation of the ICCAT conservation and enforcement recommendations was done through Council Regulations (EC) No 1936/2001 [7] and (EC) No 520/2007 [8].
Priporočila ICCAT za ohranjanje in izvrševanje so bila zadnjič prenesena z uredbama Sveta (ES) št. 1936/2001 [7] in (ES) št. 520/2007 [8].
The ICCAT recommendation concerning a multiannual recovery plan for Bluefin tuna in the eastern Atlantic and Mediterranean was implemented by Regulation (EU) 2016/1627 of the European Parliament and of the Council [9].
Priporočilo ICCAT o večletnem načrtu za obnovo staleža modroplavutega tuna v vzhodnem Atlantiku in Sredozemskem morju je bilo preneseno z Uredbo (EU) 2016/1627 Evropskega parlamenta in Sveta [9].
This Regulation does not cover such multiannual recovery plan.
Ta uredba ne zajema takega večletnega načrta za obnovo staleža.
When implementing those recommendations, the Union and Member States should endeavour to promote coastal fishing activities and the use of fishing gear and techniques which are selective and have a reduced environmental impact, including gear and techniques used in traditional and artisanal fisheries, thereby contributing to a fair standard of living for local economies.
Pri izvajanju teh priporočil bi si morale Unija in države članice prizadevati za spodbujanje dejavnosti priobalnega ribolova ter uporabe ribolovnega orodja in tehnik, ki so selektivni in imajo manjši vpliv na okolje, vključno z orodji in tehnikami, ki se uporabljajo pri tradicionalnem in obrtnem ribolovu, s čimer bi pripomogle k primernemu življenjskemu standardu lokalnih gospodarstev.
Union legislation should merely implement the ICCAT recommendations in order to place Union and third country fishermen on an equal footing and to ensure that the rules can be accepted by all.
Priporočila ICCAT bi se morala zgolj prenesti v zakonodajo Unije, da se izenačijo pogoji za ribiče iz Unije in tretjih držav ter da se zagotovi, da so pravila sprejemljiva za vse.
The delegated acts and implementing acts provided for in this Regulation should be without prejudice to the implementation of future ICCAT recommendations into Union law through the ordinary legislative procedure.
Delegirani in izvedbeni akti, določeni v tej uredbi, ne bi smeli posegati v prenos prihodnjih priporočil ICCAT v pravo Unije po rednem zakonodajnem postopku.
In order to swiftly implement into Union law future amendments to the ICCAT recommendations, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the Annexes to this Regulation.
Da bi prihodnje zavezujoče spremembe priporočil ICCAT hitro prenesli v pravo Unije, bi bilo treba na Komisijo prenesti pooblastilo, da v skladu s členom 290 Pogodbe o delovanju Evropske unije sprejme akte, s katerimi bo spremenila priloge k tej uredbi.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making [10].
Zlasti je pomembno, da se Komisija pri svojem pripravljalnem delu ustrezno posvetuje, vključno na ravni strokovnjakov, in da se ta posvetovanja izvedejo v skladu z načeli, določenimi v Medinstitucionalnem sporazumu z dne 13. aprila 2016 o boljši pripravi zakonodaje [10].
In order to ensure uniform conditions for the implementation of the provisions of this Regulation, implementing powers should be conferred on the Commission.
Za zagotovitev enotnih pogojev izvajanja določb te uredbe bi bilo treba na Komisijo prenesti izvedbena pooblastila.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council [11].
Ta pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta [11].
In particular, Council Regulation (EC) No 1224/2009 [12] establishes a Union system for control, inspection and enforcement with a global and integrated approach so as to ensure compliance with all the rules of the CFP.
Navedene uredbe že prenašajo številne določbe iz priporočil ICCAT.
Those Regulations already implement a number of the provisions laid down in the ICCAT recommendations.
Vendar bi morala Unija to vprašanje celostno in redno obravnavati v okviru regionalnih organizacij za upravljanje ribištva, da bi se prepoved Unije o pretovarjanju na morju v vodah Unije razširila na vse vode.
It is therefore not necessary to include those provisions in this Regulation.
S členom 15(1) Uredbe (EU) št. 1380/2013 je bila uvedena obveznost iztovarjanja, ki se uporablja od 1. januarja 2015 za ribolov malih in velikih pelagičnih vrst, ribolov za industrijske namene ter ribolov lososa v Baltskem morju.
The ICCAT recommendations, read together with applicable rules laid down in Regulation (EC) No 1224/2009, allow for large-scale pelagic longline vessels to tranship at sea in non-Union waters within the ICCAT zone.
Vendar v skladu s členom 15(2) navedene uredbe obveznost iztovarjanja ne posega v mednarodne obveznosti Unije, kot so obveznosti, ki izhajajo iz priporočil ICCAT.
However, the Union should comprehensively and systematically address that issue within the framework of the RFMOs with a view to extending the Union prohibition on transhipment at sea in Union waters to all waters.
V skladu z isto določbo je Komisija pooblaščena za sprejemanje delegiranih aktov, s katerimi se takšne mednarodne obveznosti prenesejo v pravo Unije, kar zlasti vključuje odstopanje od obveznosti iztovarjanja.
Article 15(1) of Regulation (EU) No 1380/2013 introduced a landing obligation which applies from 1 January 2015 to small and large-scale pelagic fisheries, fisheries for industrial purposes and fisheries for salmon in the Baltic sea.
Zato so v nekaterih primerih, določenih v Delegirani uredbi Komisije (EU) 2015/98 [15], zavržki za nekatere vrste ribolova malih in velikih pelagičnih vrst ter ribolova za industrijske namene dovoljeni.
However, under Article 15(2) of that Regulation, the landing obligation is without prejudice to the Union's international obligations, such as those resulting from ICCAT recommendations.
Uredba Sveta (ES) št. 1984/2003 [16] vzpostavlja programe statističnih dokumentov za mečarico in veleokega tuna v skladu z zadevnimi določbami ICCAT.
Under that same provision the Commission is empowered to adopt delegated acts, for the purpose of implementing such international obligations into Union law, including, in particular, derogations from the landing obligation.
Ker je ICCAT v zvezi s pretovarjanjem na morju sprejela nove določbe o statističnih programih, je primerno spremeniti Uredbo (ES) št. 1984/2003, da se navedene določbe prenesejo v pravo Unije.
Accordingly, the discard in some fisheries for small and large-scale pelagic fisheries and fisheries for industrial purposes is allowed in certain situations laid down in Commission Delegated Regulation (EU) 2015/98 [15].
Številna priporočila ICCAT so bila v zadnjih letih spremenjena ali razveljavljena.
Council Regulation (EC) No 1984/2003 [16] establishes statistical document programmes for swordfish and bigeye tuna in accordance with the relevant ICCAT provisions.
Zato je zaradi jasnosti, poenostavitve in pravne varnosti primerno spremeniti uredbi (ES) št. 1936/2001 in (ES) št. 520/2007 –
As new provisions on statistical programmes have been adopted by ICCAT in relation to transhipment at sea, it is appropriate to amend Regulation (EC) No 1984/2003 to implement those provisions into Union law.
SPREJELA NASLEDNJO UREDBO:
Many ICCAT recommendations have changed or have been repealed in recent years.
NASLOV I
Therefore, for reasons of clarity, simplification and legal certainty, it is appropriate to amend Regulations (EC) No 1936/2001 and (EC) No 520/2007,
SPLOŠNE DOLOČBE
TITLE I
Predmet urejanja
GENERAL PROVISIONS
Ta uredba vsebuje določbe o upravljanju, ohranjanju in nadzoru v zvezi z ribolovom izrazito selivskih vrst rib, ki jih upravlja Mednarodna komisija za ohranitev tunov v Atlantiku (ICCAT).