natgillin/translations-raw huggingface dataset:
ker poznavanje porekla učinkovine zagotavlja potrošnikom večjo varnost,
whereas consumers are ensured higher safety standards if they know the origin of an active substance,
ker se določbe, namenjene proizvajalcem zdravil in učinkovin v členu 111 zgoraj navedene direktive, neposredno uporabljajo tudi za uvoznike,
whereas the provisions concerning manufacturers of medicines and active substances in Article 111 of the above-mentioned Directive are also directly applicable to importers,
poziva, naj proizvajalec in uvoznik učinkovin predložita potrdilo o dobri proizvodni praksi, ki ga izdajo evropski organi po obveznem inšpekcijskem pregledu proizvodih obratov;
Believes that both producers and importers of active substances should submit a GMP certificate delivered by the European authorities following mandatory inspection at the site of production;
naroči svojemu predsedniku, naj to izjavo skupaj z imeni podpisnikov posreduje Svetu, Komisiji in parlamentom držav članic.
Instructs its President to forward this Declaration, together with the names of the signatories, to the Council, the Commission and the Parliaments of the Member States.
Zakonodajna resolucija Evropskega parlamenta o Skupnem stališču Sveta z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o registraciji, ocenjevanju, dovoljevanju in omejevanju kemikalij (REACH), o ustanovitvi Evropske agencije za kemikalije in o spremembi Direktive 1999/45/ES Evropskega parlamenta in Sveta ter 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 (7524/8/2006 - C6-0267/2006 - 2003/0256(COD) )
European Parliament legislative resolution on the Council common position for adopting a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the European Parliament and of the Council 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 (7524/8/2006 – C6-0267/2006 – 2003/0256(COD) )
ob upoštevanju skupnega stališča Sveta (7524/8/2006 – C6-0267/2006 ) UL C 276 E, 14.11.2006, str.
having regard to the Council common position (7524/8/2006 – C6-0267/2006 ) OJ C 276 E, 14.11.2006, p.
ob upoštevanju svojega stališča iz prve obravnave UL C 280 E, 18.11.2006, str.
having regard to its position at first reading OJ C 280 E, 18.11.2006, p.
o predlogu Komisije Parlamentu in Svetu ( KOM(2003)0644 ) Še ni objavljeno v Uradnem listu.
on the Commission proposal to Parliament and the Council ( COM(2003)0644 ) Not yet published in the OJ.
ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A6-0352/2006 ),
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A6-0352/2006 ),
ob upoštevanju izjav Komisije, ki so priložene k tej zakonodajni resoluciji in ki bodo objavljene skupaj z zakonodajnim besedilom v Uradnem listu,
having regard to the Commission statements which are annexed to this legislative resolution and which will be published together with the legislative act in the Official Journal,
(Ker sta Parlament in Svet dosegla sporazum, stališče Parlamenta iz druge obravnave ustreza končnemu zakonodajnemu aktu Uredbi (ES) št. 1907/2006.)
(As an agreement was reached between Parliament and Council, Parliament's position at second reading corresponds to the final legislative act, Regulation (EC) No 1907/2006.)
Izjava Komisije o alternativnih metodah
Commission Statement on Alternative Methods
Kot del strategije Skupnosti za spodbujanje alternativnih preskusnih metod je razvoj metod, ki vključujejo računalniško podprte, in vitro ter druge metodologije, vključno z izboljšanjem sedanjih metod, že desetletja prednostna naloga.
As part of the Community's strategy to promote alternative test methods, the development of methods covering computer supported, in vitro and other methodologies, including refinement of current methods, has been a priority for decades.
V času od leta 1999 do 2002 (peti okvirni program) je EU podpirala 43 raziskovalnih projektov v vrednosti 65 milijonov EUR, mnogi od njih še vedno potekajo.
Between 1999 and 2002 (Fifth Framework Programme), the EU supported 43 research projects worth EUR 65 million, several of which are still ongoing.
V trenutnem okvirnem programu za raziskave (šesti okvirni program: 2003–2006) vlaga Evropska unija več kot 90 milijonov EUR v razvoj zanesljivih, učinkovitih metod, brez postopkov na živalih, ki bodo kos zahtevam mednarodne validacije.
In the current Research Framework Programme (Sixth Framework Programme: 2003-2006), the European Union is investing more than EUR 90 million to develop robust, effective, non-animal testing methods that will withstand the requirements of international validation.
Raziskovalne dejavnosti se bodo nadaljevale v prihodnjem sedmem okvirnem programu (2007–2013) z usklajenimi dejavnostmi na alternativnih metodah in strategijah za preskušanje varnosti, predvsem farmacevtskih izdelkov (v okviru teme zdravje) in industrijskih kemikalij (v okviru teme okolje).
Research activities will continue in the forthcoming Seventh Framework Programme (2007-2013) through coordinated activities on alternative methods and strategies for safety testing focused on pharmaceuticals (under the Health theme) and industrial chemicals (under the Environment theme).
Preučuje se, katere metode lahko največ prispevajo k zmanjševanju preskusov na živalih v REACH ob upoštevanju časa, ki je potreben za razvoj preskusov in ustreznih rokov za registracijo v REACH.
Consideration has been given to which methods could make the most contribution to reducing animal testing within REACH, taking due account of the time needed to develop tests and the relevant registration deadlines in REACH.
Zato vključuje sedmi okvirni program razvoj metod, ki bi lahko neposredno podprle zmanjšanje števila živali, potrebnih pri preskušanju v okviru REACH.
As a result, the Seventh Framework Programme includes the development of methods that could directly support the reduction of the use of animals in testing within REACH.
Zainteresirane strani se poskuša vključiti s pobudami, kot so evropsko partnerstvo za alternativne možnosti preskušanja na živalih, ki sta ga 7. novembra 2005 uvedla komisarja Potočnik in Verheugen skupaj z industrijo.
Involvement of stakeholders is being sought through initiatives such as the European Partnership for Alternative Approaches to Animal Testing, launched on 7 November 2005 by Commissioners Potocnik and Verheugen together with industry.
Z učinkovitim združevanjem izkušenj Komisije ter industrije, izvedenskega mnenja in virov bo skupno usklajeno partnerstvo na ravni EU in v sektorjih bolj učinkovito kot dosedanje razdrobljene pobude na tem področju.
By effectively pooling Commission and industry experience, expertise and resources, a common coordinated Partnership at EU level and across sectors will be more effective than historically fragmented initiatives in this area.
Validacija alternativnih preskusnih metod je bila od leta 1991 prednostna naloga Komisije.
The validation of alternative testing methods has been a priority for the Commission since 1991.
Komisija bo nadaljevala z validacijo primernih metod in obravnavala uporabo validiranih metod v zakonodaji Skupnosti.
The Commission will continue to validate appropriate methods and will consider the application of validated methods in Community legislation.
Danes se primerne metode uporabljajo v okviru zakonodaje Skupnosti o kemikalijah za prilagoditev Priloge V Direktive 67/548/EGS.
Today, suitable methods are used in the context of the Community legislation on chemicals, to adapt Annex V of Directive 67/548/EEC.
Komisija priznava pomen čim hitrejšega zagotavljanja upravnega sprejetja za take metode in je sprejela mnoge validirane alternativne preskusne metode v Prilogo V 67/548/EGS še pred njihovim dokončnim mednarodnim sprejetjem.
The Commission recognises the importance of securing regulatory acceptance for such methods as rapidly as possible and has adopted several validated alternative test methods in Annex V of Directive 67/548/EEC ahead of their eventual international acceptance.
Zelo pomembna prednostna naloga Komisije je zagotoviti, da bo uredba REACH o preskusih sprejeta takoj po tem, ko bodo na voljo primerne validirane metode.
The Commission will give a high priority to ensuring that the REACH testing regulation is adapted as soon as possible after appropriate validated methods become available.
Komisija bo tudi nadalje dejavna v mednarodnih forumih, zlasti v OECD, kjer prispeva k razvoju novih standardov za teste s posebnim poudarkom na nedavno validiranih metodah, omenjenih zgoraj.
The Commission will continue to be active in international fora, particularly the OECD where it contributes to the development of new standards for tests and with especial focus on newly validated methods as mentioned above.
Ureditveni okvir, v katerem se uporabljajo preskusne metode, je enako pomemben kot posebne metode.
The regulatory framework in which test methods are used is as important as the specific methods.
Zmanjševanje preskušanja na živalih je od začetka ključni element pri oblikovanju REACH in Komisija se je dosledno trudila za izboljšanje tega vidika predloga.
Since its very beginning, the minimisation of animal testing has been a key element of the design of REACH and the Commission has consistently worked to improve this aspect of the proposal.
To je vidno pri pomembnih spremembah postopka, npr. uvedbi faze predhodne registracije kot rezultat pripomb na belo knjigo v letu 2001 in sprejetju skupnega datuma predhodne registracije na podlagi mnenja Parlamenta po prvi obravnavi in skupnega stališča Sveta.
This can be seen in terms of significant changes throughout the process such as adding the pre-registration phase as a result of feedback on the White Paper in 2001 and accepting a single pre-registration date as proposed in both Parliament's First Reading Opinion and the Council Common Position.
Zmanjševanje preskušanja na živalih je očitno tudi v podrobnem pravnem besedilu, vključno s spodbudo za razvrščanje snovi, vrednotenjem preskusnih predlogov in uporabo branja.
Minimisation of animal testing is also apparent in the detailed legislative text, including encouragement for grouping of substances, evaluation of testing proposals and use of read across.
Pomembno delo v zvezi z zmanjševanjem uporabe živali poteka v RIP (izvedbeni projekti REACH) z razvojem inteligentnih strategij preskušanja.
Important work related to reducing the use of animals is on-going in the RIPs (REACH Implementation Projects) with the development of intelligent testing strategies.
Komisija se zavezuje, da bo po sprejetju REACH nadaljevala s tem delom.
The Commission is committed to continuing this work after the adoption of REACH.
Razvoj ter ohranjanje smernic in postopkov agencije bosta npr. zagotavljala nadaljnje priložnosti za reševanje zadev v zvezi s preskušanjem na živalih.
For example the development and maintenance of guidelines and Agency procedures will offer further opportunities to address concerns over animal testing.
Komisija bo ustrezne vidike preučila tudi v pregledu Direktive 86/609/EGS, zlasti v zvezi z načini, ki lahko nadalje spodbujajo razvoj, validacijo in upravno sprejetje alternativnih metod skladno z načelom "tri Rs".
The Commission will also consider relevant aspects in the review of Directive 86/609/EEC, specifically in relation to the ways in which the development, validation and regulatory acceptance of alternative methods in accordance with the 'Three Rs' principle could be further promoted.
Izjava Komisije o dodatkih v tobaku v okviru pogajanj o REACH in obravnava sprememb EP o dodatkih v tobaku
Commission Statement on tobacco additives in the context of the negotiations on REACH and addressing the EP amendments on tobacco additives
Uredba REACH zajema kemijske sestavine tobačnih izdelkov kot tudi vse druge kemijske snovi.
The REACH Regulation covers chemical ingredients in tobacco products like any other chemical substance.
Te bo treba registrirati in opraviti vrednotenje, omejitev ali odobritev po sistemu REACH.
As such, they will need to be registered and be subject to evaluation, restriction or authorisation under the REACH system.
Nekateri njihovi učinki v zgoreli obliki bodo zajeti v vsaki zahtevani kemijski oceni varnosti.
Some of their effects in burnt form should be covered by any required chemical safety assessments.
Ko bo sistem REACH deloval, bo treba povzeti in upoštevati informacije, ki so na voljo v okviru REACH o sestavinah tobaka, da bi se bolje izkoristile sinergije s tekočim delom v okviru Direktive 2001/37/ES o približevanju zakonov in drugih predpisov držav članic o izdelavi, predstavitvi in prodaji tobačnih izdelkov.
Once the REACH system is in operation, it will be necessary to summarise and to take into account the information made available under REACH on tobacco ingredients in order to benefit better from the synergies with the ongoing work in the context of Directive 2001/37/EC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products.
V okviru Direktive 2001/37/ES se Komisija zavezuje, da bo spodbujala:
In the context of Directive 2001/37/EC, the Commission is committed to promote:
razvoj in uporabo usklajenega obrazca za poročanje o sestavinah tobaka, da bi oblikovala predpogoj za sistematično ocenjevanje sestavin tobaka.
the development and application of a harmonised reporting format for tobacco ingredients in order to create a precondition for systematic assessment of tobacco ingredients.
To bi se pozneje lahko razvilo v vzpostavitev evropske banke podatkov o sestavinah tobaka in njihovih učinkih;
This could evolve, at a later stage, into the setting up of a European data bank on tobacco ingredients and their effects;
oceno preskusov toksikoloških in zasvojevalnih učinkov z vidika javnega zdravja;
the assessment of tests for toxicological and addictive effects from a public health perspective;
sodelovanje neodvisnih tobačnih laboratorijev v EU, da bi države članice oblikovale osnovo za izvajanje skupnih analiz ter ocen sestavin tobaka in/ali emisij dima in poznejšo presojo o obliki morebitnega predloga za skupni seznam sestavin.
cooperation of independent tobacco laboratories within the EU in order to create the operational basis for a shared analysis and assessment of tobacco ingredients and/or smoke emissions by the Member States, and subsequent consideration on the form of a possible proposal for a common list of ingredients.
Komisija bo tudi:
The Commission will also:
sodelovala v postopku razvoja smernic o preskušanju in merjenju vsebine in emisij tobačnih izdelkov v smislu Okvirne konvencije o nadzoru tobaka (FCTC) in
participate in the process of developing guidelines on testing and measuring of the contents and emissions of tobacco products in the context of the Framework Convention on Tobacco Control (FCTC), and
preučila možnosti sofinanciranja raziskave o toksičnosti in zlasti zasvojevalnem učinku tobačnih sestavin in/ali emisij dima v smislu okvirnega programa za raziskave.
consider co-financing research on toxicity and in particular addictiveness of tobacco ingredients and/or smoke emissions in the context of the Research Framework Programme.
Komisija bo do naslednjega pregleda Direktive 2001/37/ES, ki bo temeljil na poročilu o izvajanju, predloženem konec leta 2007, preučila nadaljnji razvoj okvira za oceno sestavin tobaka glede na pridobljene izkušnje in oceno učinka različnih možnosti.
By the next review of Directive 2001/37/EC, which will be based on the report on its implementation due at the end of 2007, the Commission will consider further development of the framework for the assessment of tobacco ingredients in the light of the experience gathered and impact assessments on different options.
Dokazno breme o učinkih vsebine in emisij tobačnih izdelkov na zdravje mora biti v pristojnosti industrije, ki je odgovorna za financiranje razvoja, validacije in izvajanja primernih preskusov toksičnosti in zasvojevalnega učinka.
The burden of proof on the health effects of the contents and emissions of tobacco products should lie fully with the industry, which should be responsible for the financing of the development, validation and carrying out of the appropriate toxicological and addictiveness tests.
Ta postopek morajo voditi organi javnega zdravja, da se zagotovi, da vse izdelane metodolgije ustrezno upoštevajo zadeve javnega zdravja.
This process must be led by the public health authorities to ensure that all the methodologies developed properly address public health concerns.
Na osnovi načela iz prejšnjega odstavka glede vloge industrije pri financiranju preskusov bo Komisija preučila konkretne možnosti za zagotavljanje ustreznih človeških in finančnih virov, da bi podprli vsak bistveni delovni program o vrednotenju sestavin in emisij dima in s tem primerno ocenili rezultate z vidika zdravja.
On the basis of the principle established in the previous paragraph concerning the role of the industry in financing the tests, the Commission will examine the concrete options for raising adequate human and financial resources in order to fund any substantial work programme on evaluating ingredients and smoke emissions in order to assess properly the results from a health perspective.
Komisija se zaveda, da so razvoj ter validacija metodologij in ocenjevanje snovi zahtevna naloga, ki bo trajala več let.
The Commission is aware that the development and validation of methodologies and the evaluation of substances is a demanding task that will take several years.
Zakonodajna resolucija Evropskega parlamenta o skupnem stališču Sveta z namenom sprejetja Direktive Evropskega parlamenta in Sveta o spremembi Direktive Sveta 67/548/EGS o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi z namenom prilagoditve Uredbi (ES) št. .../2006 o registraciji, ocenjevanju, dovoljevanju in omejevanju kemikalij (REACH) ter o ustanovitvi Evropske agencije za kemikalije (7525/3/2006 – C6-0268/2006 – 2003/0257(COD) )
European Parliament legislative resolution on the Council common position for adopting a directive of the European Parliament and of the Council amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No .../2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (7525/3/2006 – C6-0268/2006 – 2003/0257(COD) )
ob upoštevanju skupnega stališča Sveta (7525/3/2006 – C6-0268/2006 ) UL C 276 E, 14.11.2006, str.
having regard to the Council common position (7525/3/2006 – C6-0268/2006 ) OJ C 276 E, 14.11.2006, p.
o predlogu Komisije Parlamentu in Svetu ( KOM(2003)0644 ) Še ni objavljeno v Uradnem listu.
on the Commission proposal to Parliament and the Council ( COM(2003)0644 ) Not yet published in OJ.
ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A6-0345/2006 ),
having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A6-0345/2006 ),
naroči svojemu generalnemu sekretarju, naj potem, ko je bilo preverjeno, da so bili vsi postopki pravilno zaključeni, podpiše pravni akt in ga v soglasju z generalnim sekretarjem Sveta objavi v Uradnem listu Evropske unije;
Instructs its Secretary-General to sign the act, once it has been verified that all the procedures have been duly completed, and, in agreement with the Secretary-General of the Council, to have it published in the Official Journal of the European Union;
Zakonodajna resolucija Evropskega parlamenta o osnutku Sklepa Sveta o spremembi jezikovne ureditve poslovnika Sodišča Evropskih Skupnosti, da bi se bolgarski in romunski jezik vključila med jezike postopkov, določenih s poslovnikom (15712/2006 – C6-0434/2006 – 2006/0813(CNS) )
European Parliament legislative resolution on the draft Council Decision amending the Rules of Procedure of the Court of Justice of the European Communities as regards the language arrangements, in order to include Bulgarian and Romanian among the languages of cases as laid down in the Rules of Procedure (15712/2006 – C6-0434/2006 – 2006/0813(CNS) )
ob upoštevanju osnutka Sveta (15712/2006),
having regard to the Council draft (15712/2006),
ob upoštevanju člena 245(2) Pogodbe ES in člena 160(2) Pogodbe ESAE, v skladu s katerimi se je Svet posvetoval s Parlamentom ( C6-0434/2006 ),
having regard to Article 245 (2) of the EC Treaty and Article 160(2) of the EAEC Treaty, pursuant to which the Council consulted Parliament ( C6-0434/2006 ),
ob upoštevanju poročila Odbora za pravne zadeve ( A6–0463/2006 ),
having regard to the report of the Committee on Legal Affairs ( A6-0463/2006 ),
odobri osnutek sklepa Sveta;
Approves the draft Council decision;
poziva Svet, naj se ponovno posvetuje s Parlamentom, če namerava bistveno spremeniti besedilo, predloženo za posvetovanje;
Asks the Council to consult Parliament again if it intends to amend the text submitted for consultation substantially;
Zakonodajna resolucija Evropskega parlamenta o osnutku Sklepa Sveta o spremembi jezikovne ureditve poslovnika Sodišča prve stopnje Evropskih skupnosti za vključitev bolgarščine in romunščine med jezike postopka, določene s poslovnikom (15715/2006 – C6-0435/2006 – 2006/0814(CNS) )
European Parliament legislative resolution on the draft Council Decision amending the Rules of Procedure of the Court of First Instance of the European Communities with regard to languages, in order to include Bulgarian and Romanian among the languages of cases as laid down in the Rules of Procedure (15715/2006 – C6-0435/2006 – 2006/0814(CNS) )
ob upoštevanju osnutka Sveta (15715/2006),
having regard to the Council draft (15715/2006),
ob upoštevanju člena 245(2) Pogodbe ES in člena 160(2) Pogodbe ESAE, v skladu s katerima se je Svet posvetoval s Parlamentom ( C6-0435/2006 ),
having regard to Article 245(2) of the EC Treaty and Article 160(2) of the EAEC Treaty, pursuant to which the Council consulted Parliament ( C6-0435/2006 ),
ob upoštevanju poročila Odbora za pravne zadeve ( A6-0462/2006 ),
having regard to the report of the Committee on Legal Affairs ( A6-0462/2006 ),
poziva Svet, naj se posvetuje s Parlamentom, če namerava odstopati od besedila, ki ga je Parlament odobril;
Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;
Zakonodajna resolucija Evropskega parlamenta o Skupnem stališču Sveta z namenom sprejetja Odločbe Evropskega parlamenta in Sveta o Evropskem letu medkulturnega dialoga (2008) (14153/2/2006 – C6-0422/2006 – 2005/0203(COD) )
European Parliament legislative resolution on the Council common position for adopting a decision of the European Parliament and of the Council on the European Year of Intercultural Dialogue (2008) (14153/2/2006 – C6-0422/2006 – 2005/0203(COD) )
ob upoštevanju skupnega stališča Sveta (14153/2/2006 – C6-0422/2006 ),
having regard to the Council common position (14153/2/2006 – C6-0422/2006 ),
o predlogu Komisije Parlamentu in Svetu ( KOM(2005)0467 ) Še ni objavljeno v Uradnem listu.
on the Commission proposal to Parliament and the Council ( COM(2005)0467 ) Not yet published in OJ.
ob upoštevanju spremenjenega predloga Komisije ( KOM(2006)0492 ) Še ni objavljeno v Uradnem listu.
having regard to the amended Commission proposal ( COM(2006)0492 ) Not yet published in OJ.
ob upoštevanju priporočila za drugo obravnavo Odbora za kulturo in izobraževanje ( A6-0435/2006 )
having regard to the recommendation for second reading of the Committee on Culture and Education ( A6-0435/2006 ),