natgillin/translations-raw huggingface dataset:
Za zmanjšanje njegovih stroškov in izboljšanje njegove mednarodne sprejemljivosti je treba evropski pristop čim bolj uskladiti z mednarodnimi pobudami, vključno s celovitim pristopom k mednarodnemu ravnanju s kemikalijami UNEP-a, Aktom o kemikalijah, ki se proizvajajo v velikih količinah (HPV) Sveta Organizacije za gospodarsko sodelovanje in razvoj, HPV Initiative Mednarodnega sveta kemičnih združenj in HPV Challenge Agencije za zaščito okolja ZDA.
In order to reduce its costs and improve its international acceptability, the European approach should be as closely aligned as possible with international initiatives including the UNEP "Strategic Approach to International Chemicals Management", the Organization for Economic Cooperation and Development's "Council Act on High Production Volume (HPV) Chemicals", the International Council of Chemical Associations HPV Initiative and the US Environmental Protection Agency's HPV Challenge.
Agencija zagotavlja infrastrukturo, ki jo podjetja potrebujejo za izpolnitev svojih obveznosti iz določb o izmenjavi podatkov.
The Agency should provide the infrastructure needed for enterprises to meet their obligations under the data-sharing provisions.
Treba je preprečiti, da bi se naloge Agencije zamenjevale z zadevnimi nalogami
It is important to avoid confusion between the mission of the Agency and the respective missions of the
Evropske agencije za vrednotenje zdravil, ustanovljene z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004
European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
Evropske agencije za vrednotenje zdravil
European Medicines Agency
agencije za varnost
European Food Safety
Sklepom Sveta z dne 22. julija 2003
the Council Decision of 22 July 2003
UL C 218, 13.9.2003, str.
OJ C 218, 13.9.2003, p.
Zato Agencija sprejme poslovnik, v skladu s katerim mora sodelovati z
Consequently, the Agency should establish rules of procedure where co-operation with the
Evropsko agencijo za varnost hrane
European Food Safety Authority
ali Svetovalnim odborom za varnost, higieno in varovanje zdravja pri delu.
or the Advisory Committee on Safety, Hygiene and Health Protection at Work is necessary.
Treba je določiti, da ta uredba drugače ne posega v pristojnosti, ki so bile z zakonodajo Skupnosti prenesene na
It is necessary to establish that this Regulation is otherwise without prejudice to the competence conferred on the
Evropsko agencijo za vrednotenje zdravil
European Medicines Agency
in Svetovalni odbor za varnost, higieno in varovanje zdravja pri delu.
and the Advisory Committee on Safety, Hygiene and Health Protection at Work by Community legislation.
Da se doseže delovanje notranjega trga za snovi kot take ali v pripravkih ter hkrati zagotovi visoka raven varovanja zdravja ljudi in okolja, je treba sprejeti pravila za popis razvrstitev in oznak.
In order to achieve the functioning of the internal market for substances on their own or in preparations, while at the time ensuring a high level of protection for human health and the environment, rules should be established for a classification and labelling inventory.
Razvrstitev in oznake posameznih snovi, ki jih je treba registrirati ali pa so zajete v člen 1 Direktive 67/548/EGS in se dajejo v promet, je zato treba sporočiti Agenciji.
The classification and labelling for any substance either subject to registration or covered by Article 1 of Directive 67/548/EEC and placed on the market should therefore be notified to the Agency.
Vire je treba usmeriti k snovem, ki najbolj vzbujajo skrb.
Resources should be focused on substances of the highest concern.
Sprejeti je treba določbe, ki bodo pristojnim organom omogočile predložitev predlogov Agenciji.
Provision should be made to enable competent authorities to submit proposals to the Agency.
Agencija mora predložiti svoje mnenje o predlogu, zadevnim stranem pa je treba omogočiti, da dajo pripombe.
The Agency should give its opinion on the proposal while parties concerned should have an opportunity to comment.
Nato Komisija sprejme odločitev.
The Commission should take a decision subsequently.
Redna poročila držav članic in Agencije o uporabi te uredbe bodo nepogrešljivo sredstvo za spremljanje izvajanja zakonodaje o kemikalijah in trendov na tem področju; sklepi, sprejeti na podlagi ugotovitev iz poročil, bodo koristno in praktično sredstvo za preverjanje uredbe in po potrebi za oblikovanje predlogov za njeno spremembo.
Regular reports by the Member States and the Agency on the operation of this Regulation will be an indispensable means of monitoring the implementation of chemicals legislation as well as trends in this field; conclusions drawn from findings in the reports will be useful and practical tools for reviewing the Regulation and, where necessary, for formulating proposals for amendments.
V ta namen Komisija prevzame naknadno oceno učinka Uredbe po prvih petih letih njenega izvajanja za ocenitev, ali so prvotno določeni cilji uresničeni in ali sta bila zagotovljena delovanje in konkurenca na notranjem trgu.
To this end, the Commission should undertake an ex post impact assessment of the Regulation after the first five years of its implementation, to assess whether the targets initially set have been met and whether the functioning of, and competition within, the internal market have been preserved.
REACH mora državljane, delavce in potrošnike prepričati, da je vsak proizvod, dan v promet v Skupnosti, varen in da ni nevarnosti izpostavljanja kemikalijam v količinah ali mešanicah, ki so nevarne za njihovo zdravje ali okolje.
REACH should enable citizens, workers and consumers to trust that any product brought onto the market in the Community is safe and that there is no risk of being exposed to chemicals in quantities or mixtures that present a risk to their health or to the environment.
Državljani Skupnosti morajo imeti dostop do informacij o kemikalijah, ki so jim lahko izpostavljeni, zaradi česar lahko sprejemajo ozaveščene odločitve v zvezi z njihovo uporabo.
Community citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals.
To se pregledno lahko doseže tako, da se omogoči
A transparent means of achieving this is to grant them
, v njihovem jeziku (pod pogojem, da je to uradni jezik EU),
, in their own language (on condition that it is an official language of the European Union),
prost in enostaven dostop do osnovnih, nezaupnih podatkov, shranjenih v zbirki podatkov Agencije, ki vsebujejo kratek opis nevarnih lastnosti, zahtev za označevanje in ustrezne zakonodaje Skupnosti, vključno z dovoljenimi uporabami in ukrepi za obvladovanje tveganja.
free and easy access to basic non-confidential data held in the Agency's database, including brief profiles of hazardous properties, labelling requirements and relevant Community legislation including authorised uses and risk management measures.
Agencija in države članice morajo omogočiti dostop do informacij v skladu z Direktivo Evropskega parlamenta in Sveta 2003/4/ES z dne 28. januarja 2003 o dostopu javnosti do podatkov o okolju
The Agency and Member States should allow access to information in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information
, Uredbo Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije
, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents
ter Konvencijo UNECE o dostopu do informacij, sodelovanju javnosti pri odločanju in dostopu do pravnega varstva v okoljskih zadevah ("Århuška konvencija"), pri kateri je Evropska skupnost pogodbenica.
and with the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the "Aarhus Convention"), to which the European Community is a party.
Komisija mora presoditi smotrnost oblikovanja evropske oznake kakovosti, namenjene označevanju in oglaševanju izdelkov, ki so bili na kateri koli stopnji proizvodnega procesa izdelani v skladu z zahtevami, ki izvirajo iz te uredbe.
The Commission should consider the desirability of creating a European quality mark designed to identify and promote articles which, at each stage of the production process, have been produced in compliance with the requirements stemming from this Regulation.
Poleg sodelovanja pri izvajanju zakonodaje Skupnosti pristojni organi držav članic zaradi svoje bližine zainteresiranim stranem v državah članicah sodelujejo tudi pri izmenjavi informacij o nevarnostih snovi in obveznostih podjetij iz zakonodaje o kemikalijah; hkrati je tesno sodelovanje med Agencijo, Komisijo in pristojnimi organi držav članic potrebno tudi za zagotavljanje soodvisnosti in učinkovitosti celotnega postopka obveščanja.
Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of enterprises under chemicals legislation; at the same time, close co-operation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process.
Za učinkovito delovanje sistema, vzpostavljenega s to uredbo, je treba na področju izvajanja zagotoviti dobro sodelovanje in usklajevanje med
In order for the system established by this Regulation to operate effectively, there must be good co-operation and co-ordination between
, Agencijo in Komisijo.
the Member States, the Agency and the Commission regarding enforcement.
Agencija bo ne glede na to najbolj odgovorna za upravljanje te uredbe.
The Agency will nevertheless bear central responsibility for managing this Regulation.
Da se zagotovi skladnost s to uredbo, države članice sprejmejo učinkovite ukrepe za spremljanje in nadzorovanje.
In order to ensure compliance with this Regulation, Member States should put in place effective monitoring and control measures.
Da se zagotovi preglednost, nepristranskost in doslednost izvedbenih dejavnosti v državah članicah, se vzpostavi ustrezen sistem kaznovanja, v okviru katerega se naložijo učinkovite, sorazmerne in odvračilne kazni za kršitve, ki imajo lahko škodljive posledice za zdravje ljudi in okolje.
In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary to set up an appropriate framework for sanctions with a view to imposing effective, proportionate and dissuasive sanctions for non-compliance, as non-compliance can result in damage to human health and the environment.
Treba je načrtovati in izvajati potrebne inšpekcijske preglede ter poročati o njihovih ugotovitvah.
The necessary inspections should be planned, carried out and their results should be reported.
Ukrepe, potrebne za izvajanje te uredbe, in nekatere njene spremembe je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje izvedbenih pooblastil, podeljenih Komisiji UL L 184, 17.7.1999, str.
The measures necessary for the implementation of this Regulation and certain amendments to it should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission OJ L 184, 17.7.1999, p.
Zelo pomembno je, da se kemikalije med prehodom k celotni uporabi določb iz te uredbe in zlasti v začetnem obdobju delovanja Agencije učinkovito in pravočasno pravno uredijo; zato je treba sprejeti določbe, ki bodo Komisiji po potrebi omogočile izvajanje nalog Agencije vsaj v začetnem obdobju; Komisiji je treba omogočiti, da po potrebi lahko imenuje začasnega izvršnega direktorja, dokler ga ne more imenovati upravni odbor Agencije.
It is essential that chemicals be regulated in an effective and timely manner during the transition to full applicability of the provisions of this Regulation and, in particular, during the start-up period of the Agency; provision should therefore be made for the Commission to fulfil the functions of the Agency at least in the start-up period; if necessary, the Commission should be able to appoint an Executive Director ad interim until the Agency's Management Board can appoint an Executive Director itself.
Da se v celoti izkoristi delo, opravljeno v skladu z Uredbo (EGS) št. 793/93 in Direktivo 76/769/EGS, ter prepreči, da bi takšno delo propadlo, je treba Komisijo v začetnem obdobju pooblastiti za uvedbo omejitev, sprejetih na podlagi tega dela, ne da bi ji bilo treba v celoti upoštevati postopek za določitev omejitev iz te uredbe.
To take full advantage of the work performed under Regulation (EEC) No 793/93 as well as under Directive 76/769/EEC and to avoid such work going to waste, the Commission should be empowered during the start-up period to initiate restrictions based on that work without following the full restrictions procedure laid down in this Regulation.
Za določbe iz te uredbe je ustrezno, da začnejo veljati postopno, da se tako zagotovi nemoten prehod v nov sistem; poleg tega mora postopen začetek veljavnosti določb vsem vpletenim stranem, organom, podjetjem in interesnim skupinam omogočiti, da svoje vire pravočasno usmerijo k pripravi na nove naloge
It is appropriate for the provisions of this Regulation to enter into force in a staggered way to smooth the transition to the new system; moreover, a gradual entry into force of the provisions should allow all parties involved, authorities, enterprises as well as stakeholders, to focus resources in the preparation for new duties at the right times
, vključno s sklenitvijo prostovoljnih sporazumov, usklajenih s strani Komisije med industrijo in drugimi zainteresiranimi stranmi
, including through the conclusion of voluntary agreements, coordinated by the Commission, between industry and other interested parties
Ta uredba nadomešča Direktivo 76/769/EGS, Direktivo Sveta 91/157/EGS z dne 18. marca 1991 o baterijah in akumulatorjih, ki vsebujejo nekatere nevarne snovi UL L 78, 26.3.1991, str.
This Regulation replaces Directive 76/769/EEC, Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances OJ L 78, 26.3.1991, p.
Direktiva, kakor je bila spremenjena z Direktivo Komisije 98/101/ES (UL L 1, 5.1.1999, str.
Directive as amended by Commission Directive 98/101/EC (OJ L 1, 5.1.1999, p.
, Direktivo Komisije 93/67/EGS z dne 20. julija 1993 o določitvi načel za oceno tveganja, ki ga pomenijo za ljudi in okolje snovi, priglašene v skladu z Direktivo Sveta 67/548/EGS UL L 227, 8.9.1993, str.
, Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC OJ L 227, 8.9.1993, p.
, Direktivo Komisije 93/105/
, Commission Directive 93/105/
z dne 25. novembra 1993 o določitvi Priloge VII D, ki vsebuje informacije, potrebne za tehnično dokumentacijo iz člena 12 sedme spremembe Direktive Sveta 67/548/EGS UL L 294, 30.11.1993, str.
of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC OJ L 294, 30.11.1993, p.
, Direktivo Komisije 2000/21/ES z dne 25. aprila 2000 o seznamu zakonodaje Skupnosti iz pete alinee člena 13(1) Direktive Sveta 67/548/EGS UL L 103, 28.4.2000, str.
, Commission Directive 2000/21/EC of 25 April 2000 concerning the list of Community legislation referred to in the fifth indent of Article 13(1) of Council Directive 67/548/EEC OJ L 103, 28.4.2000, p.
, Uredbo (EGS) št. 793/93 in Uredbo Komisije (ES) št. 1488/94 z dne 28. junija 1994 o določitvi načel za oceno tveganja, ki ga obstoječe snovi pomenijo za ljudi in okolje v skladu z Uredbo Sveta (EGS) št. 793/93 UL L 161, 29.6.1994, str.
, Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 OJ L 161, 29.6.1994, p.
Ta Uredba velja brez poseganja v Direktivo Sveta 92/85/EGS z dne 19. oktobra 1992 o uvedbi ukrepov za spodbujanje izboljšav na področju varnosti in zdravja pri delu nosečih delavk in delavk, ki so pred kratkim rodile ali dojijo (deseta posamezna direktiva v skladu s členom 16(1) Direktive 89/391/EGS)
This Regulation applies without prejudice to general Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
in Direktive Sveta 98/24/ES z dne 7. aprila 1998 o varovanju zdravja in zagotavljanju varnosti delavcev pred tveganji zaradi izpostavljenosti kemičnim dejavnikom pri delu (štirinajsta posebna direktiva v smislu člena 16(1) Direktive 89/391/EGS)
and specific Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
UL L 131, 5.5.1998, str.
OJ L 131, 5.5.1998, p.
Direktiva 98/24/ES ostaja ključni pravni instrument varovanja zdravja in zagotavljanja varnosti delavcev pred tveganji zaradi izpostavljenosti kemičnim dejavnikom pri delu.
Directive 98/24/EC continues to be the key legal instrument concerning the protection of the health and safety of workers from the risks related to chemical agents at work.
Države članice in socialni partnerji so pozvani, da zagotovijo najučinkovitejše izvajanje in uveljavljanje Direktive 98/24/ES.
Member States and the social partners are urged to ensure the most effective implementation and enforcement of Directive 98/24/EC.
Zaradi doslednosti je treba spremeniti
For the sake of consistency,
Direktivo 1999/45/ES
Directive 1999/45/EC,
V skladu z načelom sorazmernosti je za dosego osnovnega cilja te uredbe treba in ustrezno določiti pravila za kemikalije in ustanoviti Evropsko agencijo za kemikalije.
In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of this Regulation to lay down rules for chemical substances and to establish a European Chemicals Agency.
Ta uredba ne presega tistega, kar je potrebno za dosego zastavljenih ciljev v skladu s tretjim odstavkom člena 5 Pogodbe.
This Regulation does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty.
Uredba upošteva temeljne pravice in načela, ki jih zlasti priznava Listina Evropske unije o temeljnih pravicah UL C 364, 18.12.2000, str.
The Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of Fundamental Rights of the European Union OJ C 364, 18.12.2000, p.
NASLOV I SPLOŠNA VPRAŠANJA
TITLE I GENERAL ISSUES
VSEBINA IN PODROČJE UPORABE Člen 1 Vsebina
SUBJECT-MATTER AND SCOPE Article 1 Subject-matter
Ta uredba vsebuje določbe o snoveh v smislu člena 3(1).
This Regulation lays down provisions on substances within the meaning of Article 3(1).
Te določbe se uporabljajo za proizvodnjo, uvoz, dajanje v promet ali uporabo takšnih snovi kot takih, v pripravkih ali izdelkih, če je tako navedeno.
These provisions shall apply to the manufacture, import, placing on the market or use of such substances on their own, in preparations or in articles, if so stated.
Namen te uredbe je zagotoviti prost promet s takšnimi snovmi na notranjem trgu
The purpose of this Regulation is to ensure the free circulation of such substances on the internal market
v skladu z dolžnostjo skrbnega ravnanja in ob upoštevanju obveznosti, ki so jih Evropska unija in države članice sprejele v okviru mednarodnih trgovinskih sporazumov, še zlasti STO
in accordance with the duty of care, and having due regard for the obligations entered into by the European Union and its Member States in the framework of international trade agreements, in particular within the WTO
Ta uredba temelji na načelu, da morajo proizvajalci, uvozniki in uporabniki na nižji stopnji zagotoviti, da proizvajajo, dajejo v promet, uvažajo ali uporabljajo takšne snovi, ki ne vplivajo škodljivo na zdravje ljudi ali okolje
This Regulation is based on the principle that it is up to manufacturers, importers and downstream users to ensure that they manufacture, place on the market, import or use such substances that do not adversely affect human health or the environment
pod normalnimi ali razumno predvidljivimi pogoji uporabe
under normal or reasonably foreseeable conditions of use.
Vsak proizvajalec, uvoznik ali uporabnik na nižji stopnji, ki izvaja ali namerava izvajati postopke, ki vključujejo snov, pripravek ali izdelek, ki vsebuje takšno snov ali pripravek, vključno z njihovim proizvajanjem, uvažanjem in uporabo, ki ve ali lahko upravičeno predvideva, da ti postopki lahko škodljivo vplivajo na zdravje ljudi ali okolje, si prizadeva, da se od njega lahko upravičeno pričakuje, da prepreči, omeji ali odpravi takšne vplive.
Any manufacturer, importer or downstream user performing or intending to perform operations involving a substance or a preparation, or an article containing such a substance or preparation, including the manufacturing, importation and application thereof, who knows or could reasonably have foreseen that these operations could adversely affect human health or the environment, shall make every effort that may reasonably be required of him to prevent, limit or remedy such effects.
Vsak proizvajalec, uvoznik ali uporabnik na nižji stopnji, ki pri izvajanju poklica ali dejavnosti dobavlja snov ali pripravek ali izdelek, ki vsebuje takšno snov ali pripravek, mora proizvajalcu, uvozniku ali uporabniku na nižji stopnji, v takšni meri, da se to lahko upravičeno pričakuje, zagotoviti ustrezno obveščanje in izmenjavo informacij, vključno, kjer je primerno, s tehnično pomočjo, upravičeno potrebno za preprečevanje, omejevanje ali odpravljanje škodljivih vplivov na zdravje ljudi ali okolje.
Any manufacturer, importer or downstream user that provides, in the pursuit of his profession or business, a substance or preparation, or an article containing such a substance or preparation, to a manufacturer, importer or downstream user shall, to the extent this may reasonably be required, ensure adequate communication and information exchange, including where appropriate technical assistance, reasonably necessary to prevent, limit or remedy adverse effects on human health or the environment.
Proizvajalci in uporabniki na nižjih stopnjah bodo izbrali snov za proizvodnjo in uporabo na podlagi najbolj varnih snovi, ki so na razpolago.
Producers and downstream users shall select a substance for production and use on the basis of the safest substances available.
Izvajanje in delovanje določb te uredbe ne smeta pod nobenim pogojem vključevati povečanja upravnih obremenitev za mala in srednje velika podjetja.
The implementation and operation of the provisions of this Regulation may under no circumstances involve an increase in the bureaucratic and administrative burden on small and medium-sized enterprises.
Pri izvajanju te uredbe Evropska unija vzpostavi mehanizme za zagotavljanje pomoči ter podpore malim in srednje velikim podjetjem.
In implementing this Regulation, the European Union shall establish mechanisms for providing aid and support to small and medium-sized enterprises.
radioaktivne snovi s področja uporabe Direktive Sveta 96/29/Euratom UL L 159, 29.6.1996, str.
radioactive substances within the scope of Council Directive 96/29/Euratom OJ L 159, 29.6.1996, p.