natgillin/translations-raw huggingface dataset:
The Commission and the Member States shall immediately inform each other of the measures taken under this Regulation and share any other relevant information at their disposal in connection with this Regulation, in particular information in respect of:
Komisija in države članice takoj obvestijo druga drugo o ukrepih, sprejetih v skladu s to uredbo, in si izmenjajo vse druge pomembne informacije, ki so jim na voljo v zvezi s to uredbo, zlasti informacije o:
funds frozen pursuant to Article 2 and authorisations granted pursuant to Articles 5, 6 and 7;
sredstvih, zamrznjenih v skladu s členom 2, in odobritvah, izdanih v skladu s členi 5, 6 in 7;
matters relating to the violation and enforcement of the provisions of this Regulation and judgments handed down by national courts.
zadevah v zvezi s kršitvami in uveljavljenjem določb te uredbe ter sodbah, ki jih izrečejo nacionalna sodišča.
The Member States shall immediately inform each other and the Commission of any other relevant information at their disposal which might affect the implementation of this Regulation.
Države članice takoj obvestijo druga drugo in Komisijo o vseh drugih pomembnih razpoložljivih informacijah, ki bi lahko vplivale na izvajanje te uredbe.
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Države članice določijo pravila o sankcijah, ki se uporabljajo za kršitve določb te uredbe, in sprejmejo vse potrebne ukrepe, da se zagotovi njihovo izvajanje.
The penalties provided for must be effective, proportionate and dissuasive.
Te sankcije morajo biti učinkovite, sorazmerne in odvračilne.
Member States shall designate the competent authorities referred to in this Regulation and identify them on the websites listed in Annex II.
Države članice imenujejo pristojne organe iz te uredbe in jih opredelijo na spletnih mestih iz Priloge II.
Member States shall notify the Commission of any changes in the addresses of their websites listed in Annex II.
Države članice Komisijo uradno obvestijo o vseh spremembah naslovov svojih spletnih mest iz Priloge II.
Member States shall notify the Commission of their competent authorities, including the contact details of those competent authorities, without delay after the entry into force of this Regulation, and shall notify it of any subsequent amendment.
Države članice po začetku veljavnosti te uredbe Komisijo brez odlašanja uradno obvestijo o svojih pristojnih organih, vključno s kontaktnimi podatki teh pristojnih organov, in o vseh naknadnih spremembah.
to any legal person, entity or body, inside or outside the territory of the Union, which is incorporated or constituted under the law of a Member State;
za vse pravne osebe, subjekte ali organe na ozemlju Unije ali zunaj njega, ki so registrirani ali ustanovljeni po pravu države članice;
to any legal person, entity or body in respect of any business done in whole or in part within the Union.
za vse pravne osebe, subjekte ali organe v zvezi z vsakim poslom, ki se v celoti ali delno opravi v Uniji.
Council Common Position 2002/402/CFSP of 27 May 2002 concerning restrictive measures against members of the ISIL (Da'esh) and Al-Qaida organisations, and other individuals, groups, undertakings and entities associated with them (OJ L 139, 29.5.2002, p. 4).
Skupno stališče Sveta 2002/402/SZVP z dne 27. maja 2002 o omejevalnih ukrepih proti članom organizacij ISIL (Daiš) in Al-Kaida ter drugim osebam, skupinam, podjetjem in entitetam, povezanim z njimi (UL L 139, 29.5.2002, str. 4).
Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations (OJ L 139, 29.5.2002, p. 9).
Uredba Sveta (ES) št. 881/2002 z dne 27. maja 2002 o posebnih omejevalnih ukrepih za nekatere osebe in subjekte, povezane z organizacijama ISIL (Daiš) in Al-Kaida (UL L 139, 29.5.2002, str. 9).
Directive 95/46/EC will be replaced by Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Direktivo 95/46/ES bo nadomestila Uredba (EU) 2016/679 Evropskega parlamenta in Sveta z dne 27. aprila 2016 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov ter o razveljavitvi Direktive 95/46/ES (Splošna uredba o varstvu podatkov) (UL L 119, 4.5.2016, str. 1).
Latest version published in OJ C 122, 6.4.2016, p. 1.
Zadnja različica je objavljena v UL C 122, 6.4.2016, str. 1.
List of natural and legal persons, entities and bodies referred to in Article 3
Seznam fizičnih in pravnih oseb, subjektov in organov iz člena 3
UNITED KINGDOM
Naslov za pošiljanje uradnih obvestil Evropski komisiji:
Address for notifications to the European Commission:
Elektronska pošta: relex-sanctions@ec.europa.eu
Council Implementing Regulation (EU) 2016/1687
Izvedbena uredba Sveta (EU) 2016/1687
Having regard to Council Regulation (EU) 2016/44 of 18 January 2016 concerning restrictive measures in view of the situation in Libya and repealing Regulation (EU) No 204/2011 [1], and in particular Article 21(2) thereof,
ob upoštevanju Uredbe Sveta (EU) 2016/44 z dne 18. januarja 2016 o omejevalnih ukrepih zaradi razmer v Libiji in razveljavitvi Uredbe (EU) št. 204/2011 [1] ter zlasti člena 21(2) Uredbe,
One person should be removed from the list of natural persons subject to restrictive measures as set out in Section A of Annex III to Regulation (EU) 2016/44.
S seznama fizičnih oseb, za katere veljajo omejevalni ukrepi iz dela A Priloge III k Uredbi (EU) 2016/44, bi bilo treba črtati eno osebo.
Annex III to Regulation (EU) 2016/44 should therefore be amended accordingly,
Prilogo III k Uredbi (EU) 2016/44 bi bilo zato treba ustrezno spremeniti –
Annex III to Regulation (EU) 2016/44 is hereby amended as set out in the Annex to this Regulation.
Priloga III k Uredbi (EU) 2016/44 se spremeni, kot je določeno v Prilogi k tej uredbi.
The name of the following person and the related entry are deleted from the list set out in Section A of Annex III to Regulation (EU) 2016/44:
S seznama iz dela A Priloge III k Uredbi (EU) 2016/44 se črtata naslednja oseba in vnos zanjo:
amending Annex VII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin sensitisation
o spremembi Priloge VII k Uredbi (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) glede preobčutljivosti kože
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [1], and in particular Articles 13(2) and 131 thereof,
ob upoštevanju Uredbe (ES) št. 1907/2006 Evropskega Parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) ter o ustanovitvi Evropske agencije za kemikalije in o spremembi Direktive 1999/45/ES ter o razveljavitvi Uredbe Sveta (EGS) št. 793/93 in Uredbe Komisije (ES) št. 1488/94 ter Direktive Sveta 76/769/EGS in direktiv Komisije 91/155/EGS, 93/67/EGS, 93/105/ES in 2000/21/ES [1], ter zlasti člena 13(2) in člena 131 Uredbe,
Regulation (EC) No 1907/2006 establishes requirements for the registration of substances manufactured or imported in the Union on their own, in mixtures or articles.
Uredba (ES) št. 1907/2006 določa zahteve za registracijo snovi, ki se proizvedejo ali uvozijo v Unijo kot take, v zmeseh ali izdelkih.
The registrants have to provide the information required by Regulation (EC) No 1907/2006, as appropriate, in order to fulfil the registration requirements.
Registracijski zavezanci morajo za izpolnitev registracijskih zahtev navesti podatke, ki se zahtevajo v skladu z Uredbo (ES) št. 1907/2006, kakor je ustrezno.
Article 13(2) of Regulation (EC) No 1907/2006 provides that test methods used to generate information on intrinsic properties of substances required by that Regulation are to be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.
Člen 13(2) Uredbe (ES) št. 1907/2006 določa, da se testne metode za pridobitev informacij o intrinzičnih lastnostih snovi, ki se zahtevajo v skladu z navedeno uredbo, redno pregledujejo in izboljšujejo, da se zmanjša število testiranj na vretenčarjih in število udeleženih živali.
When appropriate validated test methods become available, the Commission Regulation (EC) No 440/2008 [2] and the Annexes to Regulation (EC) No 1907/2006 should be amended, if relevant, so as to replace, reduce or refine animal testing.
Ko postanejo na voljo ustrezne potrjene testne metode, je treba, če je ustrezno, spremeniti Uredbo Komisije (ES) št. 440/2008 [2] in priloge k Uredbi (ES) št. 1907/2006, da se nadomestijo, omejijo ali izboljšajo testiranja na živalih.
The principles of replacement, reduction and refinement, enshrined in Directive 2010/63/EU of the European Parliament and of the Council [3] should be taken into account.
Upoštevati bi bilo treba načela zamenjave, zmanjšanja in izboljšanja iz Direktive 2010/63/EU Evropskega parlamenta in Sveta [3].
Pursuant to Regulation (EC) No 1907/2006, in vivo studies are required for the generation of information on skin sensitisation in point 8.3 of Annex VII to Regulation (EC) No 1907/2006.
Na podlagi Uredbe (ES) št. 1907/2006 so za pridobitev informacij o preobčutljivosti kože iz točke 8.3 Priloge VII k Uredbi (ES) št. 1907/2006 potrebne študije in vivo.
In recent years, significant scientific progress has been made in the development of alternative test methods for skin sensitisation.
V zadnjih letih je bil dosežen precejšen znanstveni napredek pri razvoju alternativnih testnih metod za preobčutljivost kože.
Several in chemico/in vitro test methods have been validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and/or internationally agreed by the Organisation for Economic Cooperation and Development (OECD).
Številne testne metode in chemico/in vitro so bile potrjene s strani Referenčnega laboratorija Evropske unije za alternative testiranju na živalih (EURL ECVAM) in/ali mednarodno dogovorjene s strani Organizacije za gospodarsko sodelovanje in razvoj (OECD).
These test methods may allow the generation of adequate information to assess whether a substance causes skin sensitisation without the need to resort to in vivo testing, when applied in an appropriate combination in the framework of an integrated approach to testing and assessment (IATA).
S temi testnimi metodami se lahko pridobijo ustrezne informacije za oceno, ali snov povzroča preobčutljivost kože, pri tem pa testi in vivo niso potrebni, če se uporabi ustrezna kombinacija metod v okviru celostnega pristopa k testiranju in ocenjevanju (IATA).
To reduce animal testing, point 8.3 of Annex VII to Regulation (EC) No 1907/2006 should be amended to allow the use of these alternative methods, where adequate information can be obtained through this approach and where the available test methods are applicable for the substance to be tested.
Da bi zmanjšali število testiranj na živalih, bi bilo treba spremeniti točko 8.3 Priloge VII k Uredbi (ES) št. 1907/2006, da bi se omogočila uporaba teh alternativnih metod, kadar se ustrezne informacije lahko pridobijo s tem pristopom in kadar se razpoložljive testne metode uporabljajo za snov, ki jo je treba testirati.
The currently available alternative test methods agreed by OECD are based on an adverse outcome pathway (AOP) describing the mechanistic knowledge about the development of skin sensitisation.
Trenutno razpoložljive alternativne testne metode, ki jih je sprejela OECD, temeljijo na poteku neželenega izida, ki opisuje mehanicistično znanje o razvoju preobčutljivosti kože.
These methods are not intended to be used on their own, but to be applied in combination.
Te metode niso namenjene samostojni uporabi, ampak jih je treba uporabljati v kombinaciji.
For the comprehensive assessment of skin sensitisation, typically methods addressing the first three key events of the AOP should be used.
Za celovito oceno preobčutljivosti kože bi bilo običajno treba uporabiti metode, ki obravnavajo prve tri ključne dogodke poteka neželenega učinka.
However, under certain conditions, it may be possible to derive sufficient information without explicitly addressing all three key events by separate test methods.
Vendar je pod določenimi pogoji mogoče pridobiti dovolj informacij brez izrecne obravnave treh ključnih dogodkov z ločenimi testnimi metodami.
Therefore, the possibility should be given to registrants to scientifically justify the omission of tests addressing certain key events.
Zato bi morali registracijski zavezanci imeti možnost, da znanstveno upravičijo opustitev preskusov z obravnavo nekaterih ključnih dogodkov.
The test method indicated as the first choice for in vivo testing, the local lymph node assay (LLNA), provides information on the strength of the sensitisation potential of a substance.
Testna metoda, navedena kot prva izbira za testiranje in vivo, lokalna analiza bezgavk (LLNA), zagotavlja informacije o moči morebitne preobčutljivosti snovi.
The identification of strong skin sensitisers is important to allow appropriate classification and risk assessment of such substances.
Identifikacija povzročiteljev hude preobčutljivosti kože je pomembna, da se omogočita ustrezna razvrstitev in ocena tveganja takšnih snovi.
It therefore should be clarified that the requirement for information allowing an assessment whether a substance should be presumed to be a strong sensitiser applies to all data, irrespective whether they are generated in vivo or in vitro.
Zato bi bilo treba pojasniti, da zahteva za informacije, ki omogočajo oceno, ali je za snov treba predpostavljati, da je povzročitelj hude preobčutljivosti, velja za vse podatke, ne glede na to, ali so pridobljeni in vivo ali in vitro.
However, in order to avoid animal testing and the repetition of already performed tests, existing in vivo skin sensitisation studies performed according to valid OECD test guidelines or EU test methods and in compliance to good laboratory practice [4] should be considered valid to fulfil the standard information requirement for skin sensitisation, even if the information derived from them is not sufficient for a conclusion whether a substance can be presumed to be a strong sensitiser.
Vendar bi se morale v izogib testiranju na živalih in ponavljanju že opravljenih testiranj obstoječe in vivo študije o preobčutljivosti kože, opravljene na podlagi veljavnih smernic OECD za testiranje ali testnih metod EU in v skladu z dobro laboratorijsko prakso [4], šteti kot veljavne za izpolnitev zahteve po standardnih informacijah za preobčutljivost kože, čeprav informacije, pridobljene iz njih, ne zadoščajo za sklep o tem, ali se za snov lahko predpostavlja, da je povzročitelj hude preobčutljivosti.
In addition, the standard information requirements and adaptation rules in 8.3 of Annex VII should be revised in order to remove redundancies with rules set by Annex VI and Annex XI and in the introductory parts of Annex VII as regards the review of available data, the waiving of studies for a toxicological endpoint if the available information indicates that the substance meets the criteria for classification for that toxicological endpoint, or to clarify the intended meaning as regards the waiving of studies for substances that are flammable under certain conditions.
Poleg tega bi bilo treba zahteve po standardnih informacijah in pravila za prilagoditev iz točke 8.3 Priloge VII pregledati, da se s pravili iz prilog VI in XI in iz uvodnih delov Priloge VII odpravijo odvečni elementi v zvezi s pregledom razpoložljivih podatkov in opustitve študij toksikoloških končnih točk, če je iz razpoložljivih informacij razvidno, da snov izpolnjuje merila za razvrstitev za zadevno toksikološko končno točko, ali da se pojasni želena razlaga v zvezi z opustitvijo študije za snovi, ki so vnetljive pod določenimi pogoji.
Where reference is made to the classification of substances, adaptation rules should be updated to reflect the terminology used in Regulation (EC) No 1272/2008 of the European Parliament and of the Council [5].
Pri sklicevanju na razvrstitev snovi bi bilo treba pravila za prilagoditev posodobiti, da bi odražala terminologijo iz Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [5].
ECHA, in cooperation with Member States and stakeholders, should further develop guidance documents for the application of the test methods and waiving possibilities for the standard information requirements provided by this Regulation for the purposes of Regulation (EC) No 1907/2006.
ECHA bi morala v sodelovanju z državami članicami in deležniki še naprej razvijati operativne smernice za uporabo testnih metod in možnosti za opustitev zahtev po standardnih informacijah iz te uredbe za namene Uredbe (ES) št. 1907/2006.
In doing so, ECHA should take full account of the work carried out in OECD, as well as in other relevant scientific and expert groups.
Pri tem bi morala ECHA v celoti upoštevati delo, opravljeno v OECD ter vseh drugih zadevnih znanstvenih in strokovnih skupinah.
Annex VII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Priloga VII k Uredbi (ES) št. 1907/2006 se spremeni v skladu s Prilogo k tej uredbi.
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
Direktiva 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi (UL L 50, 20.2.2004, str. 44).
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi, o spremembi in razveljavitvi direktiv 67/548/EGS in 1999/45/ES ter spremembi Uredbe (ES) št. 1907/2006 (UL L 353, 31.12.2008, str.
Point 8.3 of Annex VII of Regulation (EC) No 1907/2006 shall be replaced by the following:
PRILOGA
Skin sensitisation
V Prilogi VII k Uredbi (ES) št. 1907/2006 se točka 8.3 nadomesti z naslednjim:
Information allowing:
Preobčutljivost kože
a conclusion whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Cat.
Informacije, ki omogočajo
1A), and
sklep, ali je snov povzročitelj preobčutljivosti kože in ali se lahko predpostavlja, da ima potencial, da povzroči precejšnjo preobčutljivost pri ljudeh (kat.
risk assessment, where required.
1A) in
The study(ies) under point 8.3.1 and 8.3.2 do not need to be conducted if:
oceno tveganja, kadar je to potrebno.
the substance is classified as skin corrosion (Category 1), or
Študij iz točke 8.3.1 in 8.3.2 ni treba izvesti, če:
the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or
je snov razvrščena kot jedka za kožo (kategorija 1) ali
the substance is spontaneously flammable in air or in contact with water or moisture at room temperature.
je snov močna kislina (pH ≤ 2,0) ali baza (pH ≥ 11,5) ali
Skin sensitisation, in vitro/in chemico
je snov samovnetljiva na zraku oziroma v stiku z vodo ali vlago pri sobni temperaturi.
Information from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation:
Preobčutljivost kože, in vitro/in chemico
molecular interaction with skin proteins;
Podatki iz testnih metod in vitro/in chemico, priznani v skladu s členom 13(3), ki obravnavajo vsakega od naslednjih ključnih dogodkov preobčutljivosti kože:
inflammatory response in keratinocytes;
molekularno interakcijo s proteini v koži
activation of dendritic cells.
vnetjem v keratinocitih
The(se) test(s) do not need to be conducted if
aktivacijo dendritičnih celic
an in vivo study according to point 8.3.2 is available, or
Testov ni treba izvesti, če:
the available in vitro/in chemico test methods are not applicable for the substance or are not adequate for classification and risk assessment according to point 8.3.
je na voljo študija in vivo v skladu s točko 8.3.2 ali
If information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted.
se razpoložljive testne metode in vitro/in chemico ne uporabljajo za snov ali niso zadostne za razvrstitev in oceno tveganja v skladu s točko 8.3.
Skin sensitisation, in vivo
Če informacije na podlagi testnih metod, ki obravnavajo enega ali dva ključna dogodka v stolpcu 1, že omogočajo razvrstitev in oceno tveganja v skladu s točko 8.3, študij, ki obravnavajo druge ključne dogodke, ni treba izvesti.
An in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3.
Preobčutljivost kože, in vivo.
The murine local lymph node assay (LLNA) is the first-choice method for in vivo testing.
Študija in vivo se izvede le, če se testni metodi in vitro/in chemico, opisani v točki 8.3.1., ne uporabljata ali rezultati teh študij niso zadostni za razvrstitev in oceno tveganja v skladu s točko 8.3.
Only in exceptional circumstances should another test be used.
Testiranje in vivo se najprej izvede z lokalno analizo bezgavk pri glodavcih (LLNA).
Justification for the use of another in vivo test shall be provided.
Drug test naj bo uporabljen le v izjemnih okoliščinah.
Commission Implementing Regulation (EU) 2016/1689
Izvedbena uredba Komisije (EU) 2016/1689
Commission Implementing Regulation (EU) 2016/1690
Izvedbena uredba Komisije (EU) 2016/1690
determining the quantities to be added to the quantity fixed for the subperiod 1 January to 31 March 2017 under the tariff quotas opened by Regulation (EC) No 442/2009 in the pigmeat sector
o določitvi količin, ki jih je treba dodati količini, določeni za podobdobje od 1. januarja do 31. marca 2017 v okviru tarifnih kvot, ki so z Uredbo (ES) št. 442/2009 odprte v sektorju prašičjega mesa
The quantities covered by import licence applications lodged from 1 to 7 September 2016 for the subperiod 1 October to 31 December 2016 are smaller than those available.
Količine v zahtevkih za uvozna dovoljenja, vloženih od 1. do 7. septembra 2016 za podobdobje od 1. oktobra do 31. decembra 2016, so nižje od razpoložljivih količin.
The quantities for which import licence applications have not been lodged under Regulation (EC) No 442/2009, to be added to the subperiod 1 January to 31 March 2017, are set out in the Annex to this Regulation.
Količine, za katere zahtevki za uvozna dovoljenja niso bili vloženi v skladu z Uredbo (ES) št. 442/2009 in ki jih je treba dodati količinam za podobdobje od 1. januarja do 31. marca 2017, so navedene v Prilogi k tej uredbi.