natgillin/translations-raw huggingface dataset:
Namen te uredbe je zagotoviti visoko raven zaščite zdravja ljudi in okolja kot tudi prosti pretok snovi na notranjem trgu ob pospeševanju konkurenčnosti in inovacij.
The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
Namen te uredbe je zagotoviti visoko raven zaščite zdravja ljudi in okolja kot tudi prosti pretok snovi na notranjem trgu , večjo preglednost in spodbujanje testiranja brez uporabe živali, ob pospeševanju konkurenčnosti in inovacij v skladu z dolžnostjo skrbnega ravnanja ter ob upoštevanju obveznosti, ki so jih Evropska unija in države članice sprejele v okviru mednarodnih trgovinskih sporazumov, še zlasti STO .
The purpose of this Regulation is to ensure a high level of protection of human health and the environment, the free circulation of substances on the internal market , increased transparency and the promotion of non-animal testing, while enhancing competitiveness and innovation in accordance with the duty of care, and having due regard for the obligations entered into by the EU and its Member States in the framework of international trade agreements, in particular within the WTO .
(Predloga spremembe 59 in 419 – prva obravnava)
(Amendment 59 and 419 - first reading)
Glede na veliko število kemikalij in njihove uporabe, za katere ne bodo veljale določbe REACH, vključno s približno 70.000 snovmi, ki se proizvajajo v količini manj kot ena tona letno, je potrebno splošno načelo dolžnosti skrbnega ravnanja, ki opredeljuje odgovornost industrije za varno ravnanje z VSEMI kemikalijami in njihovo uporabo.
In view of the considerable number of chemicals and uses which will not be covered by REACH provisions -including an estimated 70,000 substances produced at less than 1 tonne per annum - a general principle of Duty of care is needed to define the responsibility of industry for the safe handling and use of ALL chemicals.
Predvideno je, da bo veljalo za vse snovi (ne glede na količino proizvodnje), kar pomeni, da se od industrije pričakuje, da izpolni posebne obveznosti v skladu z REACH ter tudi, da ravna v skladu z osnovnimi socialnimi, gospodarskimi in okoljskimi odgovornostmi podjetništva.
It is intended to apply to all substances (irrespective of production volume), implying that industry is expected not just to meet the specific obligations under REACH, but also to fulfil the basic social, economic and environmental responsibilities of entrepreneurship.
Te posebne določbe bodo podjetjem zagotavljale pravno varnost pri izpolnjevanju dolžnosti skrbnega ravnanja.
These specific provisions will also ensure legal certainty for companies to fulfil their duty of care.
Povezano s predlogom spremembe k uvodni izjavi 1.
Linked to Amendment of Recital 1.
Ta uredba temelji na načelu, da morajo proizvajalci, uvozniki in uporabniki na nižji stopnji zagotoviti, da proizvajajo, dajejo v promet ali uporabljajo takšne snovi, ki nimajo neugodnega učinka na zdravje ljudi ali okolje.
This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.
Njegove določbe temeljijo na previdnostnem načelu.
Its provisions are underpinned by the precautionary principle.
Ta uredba temelji na načelu, da morajo proizvajalci, uvozniki in uporabniki na nižji stopnji zagotoviti, da proizvajajo, dajejo v promet ali uporabljajo takšne snovi, ki nimajo neugodnega učinka na zdravje ljudi ali okolje pod običajnimi ali razumno predvidljivimi pogoji uporabe.
This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment, under normal or reasonably foreseeable conditions of use .
Ustreza predlogu spremembe 60, sprejetem v prvi obravnavi.
Corresponds to Amendment 60 First Reading.
Besedilo je skladno z opredelitvijo „varnega proizvoda” iz Direktive o splošni varnosti proizvodov (2001/95/ES) in je potrebno za opredelitev okvira in omejitev, znotraj katerih se vsebina te uredbe uporablja.
It is consistent with the definition of “safe product” as defined in the General Product Safety Directive (2001/95/EC) and is necessary to define the frame and the limits to which the subject of this Regulation applies.
ČLEN 1, ODSTAVKI 3 A, 3 B in 3 C (novo)
ARTICLE 1, PARAGRAPHS 3 A, 3 B and 3 C (new)
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, skupaj z njihovo proizvodnjo, uvozom in uporabo, ki ve ali lahko upravičeno predvideva, da ti postopki lahko škodljivo vplivajo na zdravje ljudi ali okolje, stori vse potrebno, kar se od njega lahko razumno pričakuje, da prepreči, omeji ali odpravi takšne vplive.
Any manufacturer, importer or downstream user performing or intending to perform operations involving a substance or 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, proizvajalcu, uvozniku ali uporabniku na nižji stopnji, mora v obsegu, kot se to lahko razumno zahteva, zagotoviti ustrezno obveščanje in izmenjavo informacij, skupaj s tehnično pomočjo, kjer je to primerno, ki je razumno potrebna za preprečevanje, omejevanje ali odpravljanje škodljivih vplivov na zdravje ljudi ali okolje.
Any manufacturer, importer or downstream user that supplies, 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.
To vključuje dolžnost na primeren in pregleden način opisati, zabeležiti in uradno obvestiti o tveganjih, ki izvirajo iz proizvodnje, uporabe in odstranjevanja vsake snovi.
This includes the duty to describe, document and notify in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance.
Proizvajalci in uporabniki na nižji stopnji 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.
(Predlog spremembe 364 – prva obravnava)
(Amendment 364 - first reading)
Uvaja načelo dolžnosti skrbnega ravnanja.
Introduces the principle of duty of care.
Izvajanje in delovanje določb te uredbe ne smeta pod nobenim pogojem vključevati povečanja birokratskih in administrativnih obremenitev za mala in srednja podjetja.
The implementation and operation of the provisions of this Regulation should not 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 srednjim podjetjem.
In implementing this Regulation, the European Union shall establish mechanisms for providing aid and support to small and medium-sized enterprises.
MSP so finančno in tehnično šibkejša od velikih podjetij in potrebujejo posebno pomoč.
SMEs are financially and technically weaker than big companies and require special support.
Enako predlogu spremembe 64 iz prve obravnave.
Identical to first reading amendment 64 .
Ta uredba se uporablja brez poseganja v zakonodajo Skupnosti v zvezi z zaposlitvijo in okoljem, vključno z Direktivo Sveta 89/391/EGS z dne 12. junija 1989 o uvajanju ukrepov za spodbujanje izboljšav varnosti in zdravja delavcev pri delu, Direktivo Sveta 96/61/ES z dne 24. septembra 1996 o celovitem preprečevanju in nadzorovanju onesnaževanja, Direktivo Sveta 98/24/ES, Direktivo 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti na področju vodne politike in Direktivo 2004/37/ES.
This Regulation shall apply without prejudice to Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work, Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control; Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy and Directive 2004/37/EC.
Ta uredba se uporablja brez poseganja v zakonodajo Skupnosti v zvezi z zaposlitvijo in okoljem, in v strožje nacionalne določbe za izvajanje omenjene zakonodaje, vključno z :
This Regulation shall apply without prejudice to Community workplace and environmental legislation, and to more stringent national provisions implementing such legislation, including :
(a) Direktivo Sveta 89/391/EGS ,
(a) Council Directive 89/391/EEC ,
(b) Direktivo Sveta 90/394/EGS,
(b) Council Directive 90/394/EEC,
(c) Direktivo Sveta 98/24/ES;
(c) Council Directive 98/24/EC,
(d) Direktivo Sveta 96/61/ES,
(d) Council Directive 96/61/EC,
(e) Direktivo Sveta 2000/60/ES ,
(e) Council Directive 2000/60/EC ,
(f) Direktivo Sveta 2004/37/ES.
(f) Directive 2004/37/EC.
Ta uredba se uporablja brez poseganja v prepovedi in omejitve, določene v Direktivi Sveta 76/768/EGS z dne 27. julija 1976 o približevanju zakonodaj držav članico o kozmetičnih izdelkih (1) , v zvezi s:
This Regulation shall apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1) , concerning:
(i) prepovedjo testiranja na živalih za končne kozmetične proizvode in njihove sestavine ali kombinacije sestavin; in
(i) the prohibition of animal testing of finished cosmetic products and the ingredients or combinations of ingredients thereof; and
(ii) trženjem kozmetičnih proizvodov, pri katerih so bile nekatere ali vse sestavine ali končna sestava testirane na živalih.
(ii) the marketing of cosmetic products of which some or all of the ingredients, or the final formulation, have been tested on animals.
Če so snovi, ki se uporabljajo le kot kozmetične sestavine, zajete v to uredbo, ni dovoljena nobena oblika testiranja na živalih, ki je prepovedana na podlagi Direktive 76/768/EES, kakor je bila spremenjena, za namene ocene, ki jo zahteva ta uredba v zvezi s takšnimi snovmi;
To the extent that substances used only as cosmetic ingredients are covered by this Regulation, no animal testing that is prohibited pursuant to Directive 76/768/EEC as amended shall be permitted for the purposes of the same assessment required by this Regulation with regard to such substances.
(1) UL L 262, 27.7.1976, str.
(1) OJ L 262, 27.7.1976, p.
Direktiva, kakor je bila spremenjena z Direktivo 003/15/ES (UL L 66, 11.3.2003, str.
Directive as amended by Directive 2003/15/EC (OJ L 66, 11.3.2003, p.
26) in kot je bila nazadnje spremenjena z Direktivo Komisije 2006/65/ES (UL L 198, 20.7.2006)
26) and as last amended by Commission Directive 2006/65/EC (OJ L 198, 20.7.2006)
Delna ponovna vložitev predloga spremembe 65, sprejetega v prvi obravnavi.
Partly reinstates amendment 65 as adopted in first reading.
Namen sedmega predloga spremembe k direktivi o kozmetiki je postopna odprava testiranja na živalih iz kozmetičnega sektorja.
The 7 th amendment to the Cosmetic Directive aims at stepwise removing animal testing from the Cosmetic sector.
3) Izdelek: pomeni predmet, ki med proizvodnjo dobi posebno obliko ali površino, ki bolj določa njegovo funkcijo kot njegova kemična sestava.
3) Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
3) Izdelek: pomeni predmet , sestavljen iz homogenega materiala , ki med proizvodnjo dobi posebno obliko ali površino, ki bolj določa njegovo funkcijo kot njegova kemična sestava.
3) Article: means an object composed of homogeneous material which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
Ta predlog spremembe zagotavlja spoštovanje obstoječe zakonodaje EU (Dir.
This amendment ensures compliance with existing EU legislation (Dir.
76/769/EGS o omejitvah, Dir.
76/769/EEC on Restrictions, Dir.
2000/53/ES o izrabljenih vozilih in RoHS).
2000/53/EC on End of Life Vehicles, and RoHS).
25) Opredeljena uporaba: pomeni uporabo snovi kot take ali v pripravku ali uporabo pripravka, ki jo določi udeleženec dobavne verige, vključno z njegovo lastno uporabo, ali ki jo pisno sporoči neposredni uporabnik na nižji stopnji.
25) Identified use: means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user;
25) Opredeljena uporaba: pomeni uporabo snovi kot take ali v pripravku ali uporabo pripravka, ki jo določi udeleženec dobavne verige, vključno z njegovo lastno uporabo, ali ki jo pisno sporoči neposredni uporabnik na nižji stopnji in ki se jo sporoči zadevnemu uporabniku na nižji stopnji .
25) Identified use: means a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user , and that is co m municated to the dow n stream user concerned ;
29) Na leto: pomeni na koledarsko leto, če ni drugače navedeno;
29) Per year: means per calendar year unless stated otherwise;
29) Na leto: pomeni na koledarsko leto.
29) Per year: means per calendar year.
Razen v primeru novih snovi in če ni drugače navedeno , se letne količine izračunajo na podlagi povprečja obsega proizvodnje iz treh neposredno predhodnih koledarskih let, v katerih je proizvajalec snov dejansko proizvedel .
Save in the case of new substances, and unless stated otherwise , quantities per year shall be calculated on the basis of the average production volumes for the three immediately preceding calendar years during which the substance has actually been produced by the manufacturer;
Nihanja na trgu je treba upoštevati zato, da se jim prepreči vpliv na pogoje za registracijo, evalvacijo in odobritev (za obstoječe snovi).
Market fluctuations should be taken into account to prevent them from affecting the terms of registration, evaluation and authorisation (existing substances).
Enako predlogu spremembe 78 iz prve obravnave.
Identical to first reading amendment 78 .
30a) Ranljive populacije: pomeni občutljive ljudi vključno z novorojenčki, dojenčki, otroki, nosečnicami, doječimi materami, bolnimi in imunsko oslabelimi, starejšimi osebami, ljudmi z individualno genetsko občutljivostjo in drugimi opredeljenimi ogroženimi skupinami.
30a) Vulnerable populations: means susceptible humans including neonates, infants, children, pregnant women, nursing mothers, the infirm and immuno-compromised, elderly persons, those with individual genetic susceptibilities and other identified groups of concern;
(Predlog spremembe 80 – prva obravnava)
(Amendment 80 - first reading)
Besedilo člena 3 Sveta ne vsebuje opredelitve izraza ranljive populacije, čeprav je uporabljen v besedilu.
The Council wording of Article 3 has no definition of the term vulnerable populations although is used in the text.
Odstavek 1(a) se ne uporablja za snovi, ki so sestavine, dodane tobačnim izdelkom v smislu člena 2(1) in člena 2(5) Direktive Evropskega parlamenta in Sveta 2001/37ES z dne 5. junija 2001 o približevanju zakonov, predpisov in upravnih določb držav članic o proizvodnji, predstavitvi in prodaji tobačnih izdelkov.
Paragraph 1(a) shall not apply to substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products 1 .
1 UL L 194, 18.7.2001, str.
1 OJ L 194, 18.7.2001, p.
Ustreza predlogu spremembe 88, sprejetem v prvi obravnavi.
Corresponds to Amendment 88 adopted in First Reading
Izdelovalec ali uvoznik izdelkov prijavi pri Agenciji v skladu z odstavkom 4 tega člena, če snov izpolnjuje kriterije iz člena 56 in je opredeljena v skladu s členom 58(1), če sta izpolnjena naslednja pogoja :
Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 56 and is identified in accordance with Article 58(1) , if both the following conditions are met :
Izdelovalec ali uvoznik izdelkov prijavi pri Agenciji v skladu z odstavkom 4 tega člena, če snov izpolnjuje kriterije iz člena 56 in je opredeljena v skladu s členom 58(1), če:
Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 56 and is identified in accordance with Article 58(1) where :
(a) ti izdelki vsebujejo snov v količini, ki znaša skupaj več kot eno tono na leto na proizvajalca ali uvoznika;
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year;
(b) ti izdelki vsebujejo snov v količini, ki je višja od koncentracije 0,1 % mas. m/m.
(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).
(b) ti izdelki vsebujejo snov v količini, ki je višja od koncentracije 0,1 % mas. m/m v homogeni snovi v izdelku;
(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w) in a homogenous material of an article;
(ba) omejitve koncentracije za posamezno snov pod 0,1 % se lahko sprejmejo v skladu s postopkom iz člena 132(3);
(ba) substance specific concentration limits below the 0.1% limit may be adopted in accordance with the procedure referred to in Article 132(3);
(bb) proizvajalec ali uvoznik ne more izključiti izpostavljenosti ljudi in okolja tej snovi v celotnem življenjskem ciklu izdelka.
(bb) the producer or importer cannot exclude any exposure of the public or the environment to the substance during the full life-cycle of the article.
Odstavek 2 se ne uporablja, kjer proizvajalec ali uvoznik lahko izključi možnost izpostavljenosti ljudi ali okolja pod normalnimi ali razumno predvidljivimi pogoji uporabe, vključno pri odstranjevanju.
Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal.
V takih primerih proizvajalec ali uvoznik priskrbi prejemniku izdelka ustrezna navodila v skladu s členom 32(4).
In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article in accordance with Article 32(4).
Sporočene informacije morajo vsebovati:
The information to be notified shall include the following:
(a) podatke o proizvajalcu ali uvozniku ter podatke za vzpostavitev stika z njim, kakor je določeno v oddelku 1 Priloge VI, razen njihovih mest uporabe;
(a) the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;
(b) številko(-e) registracije (registracij) iz člena 20(1), če je(so) na voljo;
(b) the registration number(s) referred to in Article 20(1), if available;
(c) identiteto(-e) o snovi(-eh) v skladu z oddelki 2.1 do 2.3.4 Priloge VI;
(c) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;
(d) razvrstitev snovi, kakor je določeno v oddelkih 4.1 in 4.2 Priloge VI;
(d) the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;
(e) kratek opis uporabe (uporab) snovi, vsebovane v izdelku, kakor je določeno v oddelku 3.5 Priloge VI ter uporab izdelka (-ov);
(e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);
(f) količinski razpon snovi, kot na primer od 1 do 10 ton, od 10 do 100 ton itd.
(f) the tonnage range of the substance(s), such as 1-10 tonnes, 10-100 tonnes and so on.
Agencija lahko sprejme odločitev, da od izdelovalcev ali uvoznikov izdelkov zahteva, da v skladu s tem naslovom predložijo registracijo za vse snovi v teh izdelkih, če so izpolnjeni vsi naslednji pogoji:
The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:
(b) Agencija lahko utemeljeno domneva, da:
(b) the Agency has grounds for suspecting that:
(i) se snov sprošča iz izdelkov in
(i) the substance is released from the articles, and
(ii) sprostitev snovi iz izdelkov predstavlja tveganje za zdravje ljudi ali za okolje;
(ii) the release of the substance from the articles presents a risk to human health or the environment;
(ii) sprostitev snovi iz izdelkov predstavlja tveganje za zdravje ljudi ali za okolje;
(ii) the release of the substance from the articles the substance presents a risk to human health or the environment;
(c) za snov ne velja odstavek 1.
(c) the substance is not subject to paragraph 1.
Ob predložitvi registracije se plača pristojbina v skladu z naslovom IX.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
Ta predlog spremembe, ki sta ga EP in Svet oblikovala sporazumno, je v skladu z sporazumnim paketom o snoveh v izdelkih, ki ga je podprla večina političnih skupin (predlog spremembe 357 iz prve obravnave).
This amendment is a compromise between EP and Council and is in line with the compromise package on substances in articles agreed by a majority of political groups (first reading amendment 357).
Proizvajalcem in uvoznikom lajša delo in pomaga pri zaščiti konkurenčnosti proizvajalcev izdelkov iz EU z zagotavljanjem enakih konkurenčnih pogojev v okviru sporazumov STO.
It simplifies the work for producers and importers, helps to protect the competitiveness of EU producers of articles by providing the same level playing field within the framework of the WTO agreements.
Tudi potrošnikom zagotavlja visoko raven zaščite.
It will also provide a high level protection for consumer.
ČLEN 7, ODSTAVEK 7 A (novo)
ARTICLE 7, PARAGRAPH 7 A (new)
Agencija zagotovi smernice za pomoč proizvajalcem in uvoznikom izdelkov ter pristojnim organom.
The Agency shall provide guidelines to help the producers and importers of articles as well as the competent authorities.
(Predlog spremembe 88 (delno) – prva obravnava)
(Amendment 88 (partially) - first reading )
Za uvoznike izdelkov predstavlja REACH ogromen organizacijski zalogaj.
REACH represents a huge organisational challenge for importers of articles.
Predlog Sveta predvideva nekaj smernic za specifične sektorje, vendar pa smernic za specifične sektorje, namenjenih proizvajalcem in uvoznikom izdelkov, o katerih se je EP dogovoril v prvi plenarni obravnavi, ni več.
The Council proposal foresees several sector specific guidelines; however, the sector specific guidelines for producers and importers of articles, on which the EP agreed in 1 st plenary reading, are no longer mentioned.