natgillin/translations-raw huggingface dataset:
‘If individual risk-based concentration limits for the fragrance allergens are subsequently established by the SCCNFP, the Commission shall propose the adoption of such limits to replace the limit of 0.01 % mentioned above.
„Če odbor SCCNFP glede na tveganje pozneje določi posamezne omejitve koncentracij dišavnih alergenov, Komisija predlaga sprejetje takšnih omejitev kot nadomestilo za zgoraj navedeno omejitev 0,01 %.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).’
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 12(3).“.
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
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
As regards Regulation (EC) No 726/2004, the Commission should be empowered to adapt certain provisions and annexes, to adopt new provisions, and to lay down specific conditions of application.
V zvezi z Uredbo (ES) št. 726/2004 bi bilo treba Komisiji podeliti pooblastila za prilagoditev nekaterih določb in prilog, za sprejetje novih določb ter za opredelitev posebnih pogojev za vloge.
Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 726/2004, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb Uredbe (ES) št. 726/2004, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Regulation (EC) No 726/2004 is hereby amended as follows:
Zato se Uredba (ES) št. 726/2004 spremeni:
Article 3(4) shall be replaced by the following:
v členu 3 se odstavek 4 nadomesti z naslednjim:
After the competent committee of the Agency has been consulted, the Commission may adapt the Annex to technical and scientific progress and may adopt any necessary amendments without extending the scope of the centralised procedure.
Po posvetovanju s pristojnim odborom agencije lahko Komisija prilagodi prilogo tehničnemu in znanstvenemu napredku in lahko sprejme vsakršne potrebne spremembe, ne da bi pri tem povečala obseg centraliziranega postopka.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 87(2a).“;
in Article 14(7), the third subparagraph shall be replaced by the following:
v členu 14(7) se tretji pododstavek nadomesti z naslednjim:
‘The Commission shall adopt a Regulation laying down provisions for granting such authorisation.
„Komisija sprejme uredbo, v kateri so navedene določbe za izdajo dovoljenja za promet.
That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;
Ta ukrep, namenjen spreminjanju nebistvenih določb te uredbe z njenim dopolnjevanjem, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 87(2a).“;
Article 16(4) shall be replaced by the following:
v členu 16 se odstavek 4 nadomesti z naslednjim:
The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation.
Komisija po posvetovanju z agencijo sprejme ustrezne določbe za pregled sprememb dovoljenja za promet v obliki uredbe.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 87(2a).“;
Article 24 is hereby amended as follows:
člen 24 se spremeni:
‘The holder of the marketing authorisation for a medicinal product for human use shall ensure that all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to Member States and the Agency, and no later than 15 days following receipt of the information.
„Imetnik dovoljenja za promet zdravila za humano uporabo zagotovi, da se vsi domnevni resni neželeni učinki in vsakršno domnevno prenašanje kakega povzročitelja okužbe prek zdravila na ozemlju tretje države nemudoma sporoči državam članicam in agenciji, in sicer najkasneje v 15 dneh po prejemu podatkov.
The Commission shall adopt provisions for the reporting of suspected unexpected adverse reactions which are not serious, whether occurring in the Community or in a third country.
Komisija sprejme določbe za poročanje o domnevnih nepričakovanih neželenih učinkih zdravila, ki niso resni, ne glede na to, ali se pojavijo v Skupnosti ali tretji državi.
Those measures, designed to amend non-essential elements of this regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 87(2a).“;
The Commission may lay down provisions to amend paragraph 3 in view of experience gained with its operation.
Komisija lahko predpiše določbe za spremembo odstavka 3 glede na izkušnje, pridobljene med njegovo uporabo.
Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 87(2a).“;
The Commission may adopt any amendment which may be necessary to update the provisions of this Chapter in order to take account of scientific and technical progress.
Komisija lahko sprejme vsakršno spremembo, ki je morda potrebna za posodobitev določb tega poglavja, da se upošteva znanstveni in tehnični napredek.
Article 41(6) shall be replaced by the following:
v členu 41 se odstavek 6 nadomesti z naslednjim:
Article 49 is hereby amended as follows:
člen 49 se spremeni:
in paragraph 2 the first subparagraph shall be replaced by the following:
v odstavku 2 se prvi pododstavek nadomesti z naslednjim:
‘The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious unexpected adverse reactions, and adverse human reactions, and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country are reported promptly to the Member States and the Agency, and no later than 15 days following receipt of the information.
„Imetnik dovoljenja za promet z veterinarskim zdravilom zagotovi, da se vsi domnevni resni neželeni učinki in neželeni učinki na ljudi in vsakršno domnevno prenašanje kakega povzročitelja okužbe prek zdravila na ozemlju tretje države nemudoma sporoči državam članicam in agenciji in sicer najkasneje v 15 dneh po prejemu podatkov.
Those measures, designed to amend non-essential elements of this regulation, shall be adopted in accordance with the procedure referred to in Article 87(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu s postopkom iz člena 87(2a).“;
Article 54 shall be replaced by the following:
člen 54 se nadomesti z naslednjim:
‘Article 54
„Člen 54
Article 70(2) shall be replaced by the following:
v členu 70 se odstavek 2 nadomesti z naslednjim:
However, the Commission shall adopt provisions establishing the circumstances in which small and medium-sized enterprises may pay reduced fees, defer payment of the fee, or receive administrative assistance.
Vseeno pa Komisija sprejme določbe, s katerimi zagotovi takšne okoliščine, v katerih majhna in srednje velika podjetja lahko plačujejo znižane pristojbine, odložijo plačilo pristojbine ali prejmejo upravno pomoč.
in Article 84(3), the first subparagraph shall be replaced by the following:
v členu 84(3) se prvi pododstavek nadomesti z naslednjim:
‘At the Agency's request, the Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe certain obligations laid down in connection with the authorisations.
„Na zahtevo agencije lahko Komisija naloži denarne kazni imetnikom dovoljenj za promet, ki so izdana po tej uredbi, če ne upoštevajo nekaterih obveznosti, predpisanih v zvezi z dovoljenji.
The maximum amounts as well as the conditions and methods for collection of these penalties shall be laid down by the Commission.
Najvišje zneske, pogoje in načine pobiranja teh kazni predpiše Komisija.
Article 87 is hereby amended as follows:
člen 87 se spremeni:
Council Directive 82/883/EEC of 3 December 1982 on procedures for the surveillance and monitoring of environments concerned by waste from the titanium dioxide industry
Direktiva Sveta 82/883/EGS z dne 3. decembra 1982 o postopkih za nadzor in spremljanje stanja prvin okolja, ki prihajajo v stik z odpadki iz industrije titanovega dioksida
As regards Directive 82/883/EEC, the Commission should be empowered to adapt to scientific and technical progress the contents of the Annexes as regards parameters listed in the ‘optional determination’ column and reference methods of measurement.
V zvezi z Direktivo 82/883/EGS bi bilo treba Komisiji podeliti pooblastila za prilagoditev vsebine prilog glede parametrov, navedenih v stolpcu z „neobvezno določitvijo“, in referenčnih merilnih metod tehničnemu in znanstvenemu napredku.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 82/883/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb Direktive 82/883/EGS, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 82/883/EEC is hereby amended as follows:
Zato se Direktiva 82/883/EGS spremeni:
The Commission shall adopt the requisite amendments to adapt to scientific and technical progress the contents of the Annexes as regards parameters listed in the “optional determination” column and reference methods of measurement.
Komisija sprejme spremembe, potrebne za prilagoditev znanstvenemu in tehničnemu napredku vsebin prilog o parametrih, navedenih v stolpcu z ‚neobvezno določitvijo‘ in o referenčnih merilnih metodah.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11(2).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 11(2).“;
The Commission shall be assisted by the committee.
Komisiji pomaga odbor.
Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture
Direktiva Sveta 86/278/EGS z dne 12. junija 1986 o varstvu okolja, zlasti tal, kadar se blato iz čistilnih naprav uporablja v kmetijstvu
As regards Directive 86/278/EEC, the Commission should be empowered to adapt to technical and scientific progress the provisions of the Annexes.
V zvezi z Direktivo 86/278/EGS bi bilo treba Komisiji podeliti pooblastila za prilagoditev določb prilog znanstvenemu in tehničnemu napredku.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 86/278/EEC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb Direktive 86/278/EGS, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 86/278/EEC is hereby amended as follows:
Zato se Direktiva 86/278/EGS spremeni:
The Commission shall adapt to technical and scientific progress the provisions of the Annexes to the Directive, except for the parameters and values listed in Annexes I A, I B and I C, any factors likely to affect the evaluation of the values, and the parameters for analysis referred to in Annexes II A and II B.
Komisija določbe prilog k tej direktivi prilagodi tehničnemu in znanstvenemu napredku, razen parametrov in vrednosti iz prilog I A, I B in I C, vseh dejavnikov, ki lahko vplivajo na oceno vrednosti ter parametrov za analizo iz prilog II A in II B.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(2).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 15(2).“;
European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste
Direktiva 94/62/ES Evropskega Parlamenta in Sveta z dne 20. decembra 1994 o embalaži in odpadni embalaži
As regards Directive 94/62/EC, the Commission should be empowered to examine and, where necessary, review the illustrative examples for the definition of packaging and to determine the conditions under which concentration levels of heavy metals present in packaging or packaging components will not apply to some materials and product loops, the types of packaging exempted from the requirement regarding concentration levels and the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive.
V zvezi z Direktivo 94/62/ES bi bilo treba Komisiji podeliti pooblastila za preučitev in, kjer je potrebno, pregled ponazoritvenih primerov za opredelitev embalaže ter za določitev pogojev, pod katerimi koncentracije težkih kovin, prisotnih v embalaži ali sestavinah embalaže, ne velja za nekatere materiale in proizvodne verige, vrste embalaže, ki so izvzete iz zahteve glede koncentracij, ter tehnične ukrepe, ki so nujni za odpravo morebitnih težav, ki se pojavijo pri izvajanju določb te direktive.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 94/62/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb Direktive 94/62/ES, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 94/62/EC is hereby amended as follows:
Zato se Direktiva 94/62/ES spremeni:
in Article 3(1), the fourth subparagraph shall be replaced by the following:
v členu 3(1) se četrti pododstavek nadomesti z naslednjim:
‘The Commission shall, as appropriate, examine and, where necessary, review the illustrative examples for the definition of packaging given in Annex I. As a priority, the following items shall be addressed: CD and video cases, flower pots, tubes and cylinders around which flexible material is wound, release paper of self-adhesive labels and wrapping paper.
„Komisija, če je to primerno, preveri ter po potrebi popravi ponazoritvene primere za opredelitev pojma embalaža iz Priloge I. Prednostno se obravnavajo naslednji predmeti: škatle za zgoščenke in videokasete, cvetlični lončki, cevi in valji, okrog katerih je navit upogljiv material, podlaga samolepilnih etiket in ovojni papir.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 21(3).“;
Article 11(3) shall be replaced by the following:
v členu 11 se odstavek 3 nadomesti z naslednjim:
The Commission shall determine the conditions under which the concentration levels referred to in paragraph 1 will not apply to recycled materials and to product loops which are in a closed and controlled chain, as well as the types of packaging which are exempted from the requirement referred to in the third indent of paragraph 1.
Komisija določi pogoje, pod katerimi se koncentracije iz odstavka 1 ne uporabljajo za reciklirane materiale in za proizvode v zaprtih in nadzorovanih verigah ter za vrste embalaže, ki so izvzete iz zahteve iz tretje alinee odstavka 1.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 21(3).“;
In order to harmonise the characteristics and presentation of the data prod uced and to make the data of the Member States compatible, Member States shall provide the Commission with their available data in formats which shall be adopted on the basis of Annex I II, in accordance with the regulatory procedure referred to in Article 21(2).’;
Za uskladitev značilnosti in predstavitve dobljenih podatkov in za namene združljivosti podatkov držav članic te predložijo Komisiji svoje razpoložljive podatke v obliki, ki se sprejme na podlagi Priloge III, v skladu z regulativnim postopkom s pregledom iz člena 21(2).“;
The amendments necessary for adapting to scientific and technical progress the identification system (as referred to in Article 8(2) and Article 10, second paragraph, last indent) and the formats relating to the database system (as referred to in Article 12(3) and Annex III) shall be adopted in accordance with the regulatory procedure referred to in Article 21(2).
Spremembe, potrebne za prilagoditev sistema prepoznavanja znanstvenemu in tehničnemu napredku (iz člena 8(2) in zadnje alinee drugega odstavka člena 10), in oblik, ki se nanašajo na sistem zbirke podatkov (iz člena 12(3) in Priloge III), se sprejmejo v skladu z regulativnim postopkom iz člena 21(2).
The Commission shall adopt the amendments necessary for adapting to scientific and technical progress the illustrative examples on the definition of packaging (as referred to in Annex I).
Komisija sprejme spremembe, ki so potrebne za prilagoditev znanstvenemu in tehničnemu napredku ponazoritvenih primerov za opredelitev embalaže (iz Priloge I).
Article 20(1) shall be replaced by the following:
v členu 20 se odstavek 1 nadomesti z naslednjim:
The Commission shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Community, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging.
Komisija določi tehnične ukrepe, potrebne za reševanje vseh težav pri uporabi določb te direktive, zlasti v povezavi z inertnimi embalažnimi materiali, danimi v promet v Skupnosti v zelo majhnih količinah (približno 0,1 masnega odstotka), primarno embalažo za medicinske pripomočke in farmacevtske proizvode, manjšo embalažo in razkošno embalažo.
Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels
Direktiva Sveta 1999/32/ES z dne 26. aprila 1999 o zmanjšanju deleža žvepla v nekaterih vrstah tekočega goriva
As regards Directive 1999/32/EC, the Commission should be empowered to establish criteria for the use of emission abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community and to adopt amendments necessary to make technical adaptations to some provisions in the light of scientific and technical progress.
V zvezi z Direktivo 1999/32/ES bi bilo treba Komisiji podeliti pooblastila za določitev meril za uporabo tehnologij za zmanjševanje emisij z ladij ne glede na zastavo v zaprtih pristaniščih, lukah in estuarijih Skupnosti in za sprejetje sprememb, potrebnih za tehnično prilagoditev nekaterih določb zaradi upoštevanja znanstvenega in tehničnega napredka.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 1999/32/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb Direktive 1999/32/ES, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 1999/32/EC is hereby amended as follows:
Zato se Direktiva 1999/32/ES spremeni:
Article 4c(3) shall be replaced by the following:
v členu 4c se odstavek 3 nadomesti z naslednjim:
Criteria shall be established by the Commission for the use of emission abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community.
Komisija določi merila za uporabo tehnologij za zmanjševanje emisij z ladij ne glede na zastavo v zaprtih pristaniščih, lukah in estuarijih Skupnosti.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 9(2).
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 9(2).
The Commission shall communicate these criteria to the IMO.’;
Komisija sporoči ta merila MPO.“;
Article 7(4) shall be replaced by the following:
v členu 7 se odstavek 4 nadomesti z naslednjim:
Any amendments necessary to make technical adaptations to Article 2, points 1, 2, 3, 3a, 3b and 4, or Article 6(2) in the light of scientific and technical progress shall be adopted by the Commission.
Vse spremembe, potrebne za tehnično prilagoditev točk 1, 2, 3, 3a, 3b in 4 člena 2 ali člena 6(2) zaradi znanstvenega in tehničnega napredka, sprejme Komisija.
Such adaptations shall not result in any direct changes to the scope of this Directive or to limits on sulphur in fuel specified in this Directive.’;
Take prilagoditve ne vplivajo neposredno na spremembo področja uporabe te direktive ali mejne vrednosti žvepla v gorivu, določene v tej direktivi.“;
Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants
Direktiva 2001/81/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2001 o nacionalnih zgornjih mejah emisij za nekatera onesnaževala zraka
As regards Directive 2001/81/EC, the Commission should be empowered to update the methodologies to be used in accordance with Annex III.
V zvezi z Direktivo 2001/81/ES bi bilo treba Komisiji podeliti pooblastila za posodobitev metodologije, ki se uporablja v skladu s Prilogo III.