natgillin/translations-raw huggingface dataset:
Projekt 3.8, ki je bil na začetku namenjen nadomestilu smernic za sektor potrošniškega blaga, ni dal uporabnih rezultatov.
Project 3.8 (initially supposed to replace the guidelines for the consumer goods sector) has not produced a workable result.
Vseeno je sektor odvisen od poklicne in izvedene pomoči – tako kot različni organi, udeleženi v uvoznih postopkih.
Nonetheless the sector depends on professional and knowledgeable help– just as the different authorities involved in the import procedures.
Smernice, ki jih je oblikovala Agencija, bi podjetjem in organom v vseh državah članicah EU omogočile enotno raven podpore, tako kot neevropskim podjetjem, ki morda ne razpolagajo s temeljitim poznavanjem zakonodaje REACH.
Guidelines drafted by the agency would provide a uniform level of support for companies and authorities in all EU Member States and likewise for non-European companies who may lack a thorough knowledge of the REACH legislation.
Evropska oznaka kakovosti
European quality mark
Komisija do .... * predloži Evropskemu parlamentu in Svetu poročilo in po potrebi zakonodajni predlog o oblikovanju evropske oznake kakovosti, namenjene določitvi in oglaševanju izdelkov, ki so bili na kateri koli stopnji proizvodnega procesa izdelani v skladu z zahtevami iz te uredbe.
By …. * the Commission shall present to the European Parliament and the Council a report and, if appropriate, a legislative proposal on the creation of 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.
* Dve leti po začetku veljavnost te uredbe.
* Two years after the entry into force of this Regulation.
(Predlog spremembe 90 – prva obravnava)
(Amendment 90 - first reading)
Proizvajalec ali uvoznik lahko predloži informacije iz člena 10(a)(iv), (vi), (vii) ali (ix) ločeno, če:
A manufacturer or importer may submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:
Proizvajalec ali uvoznik lahko brez poseganja v naslov III predloži informacije iz člena 10(a)(iv), (vi), (vii) ali (ix) ločeno, če:
A manufacturer or importer may , without prejudice to Title III, submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:
Za zmanjšanje podvajanja testiranja na živalih, so podjetja, ki ne sodelujejo pri skupni predložitvi podatkov, še vedno zavezana k izmenjavanju podatkov o testiranju na živalih.
To reduce duplication of animal testing companies opting out of joint submission of data must still be required to share data from animal testing.
Prednost imajo metode in vitro in uporaba odnosov (količinske) strukturne dejavnosti ((Q)SAR).
Priority shall be given to in vitro methods and the use of (quantitative) structure activity relationships ((Q)SARs).
V ta namen da Agencija podjetjem na voljo seznam testov, zbirk podatkov in odobrenih modelov.
To this end, the Agency shall make available to companies a list of tests, databases and approved models.
(Predlog spremembe 106 – prva obravnava)
(Amendment 106 - first reading)
V luči etičnih in znanstvenih prizadevanj, povezanih s testi na živalih, je treba dati prednost drugim strategijam.
In light of the ethical and scientific concerns linked to animal tests, priority should be given to alternative strategies.
Informacije o intrinzičnih lastnostih snovi se lahko pridobijo tudi na druge načine in ne samo s testi, zlasti z uporabo kvalitativnih in kvantitativnih modelov razmerja med strukturo in aktivnostjo snovi ali iz informacij o strukturno sorodnih snoveh (združevanje v skupine ali navzkrižno branje), če so izpolnjeni pogoji iz Priloge XI.
Information on intrinsic properties of substances may be generated by means other than tests, in particular through the use of qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across), provided that the conditions set out in Annex XI are met.
Testiranja v skladu z oddelkoma 8.6 in 8.7 Priloge VIII, Prilogo IX in Prilogo X se lahko izpustijo, kjer to utemeljujejo informacije o izpostavljenosti in ukrepi za obvladovanje tveganj, izvedeni, kot je določeno v oddelku 3 Priloge XI.
Testing in accordance with Annex VIII, section 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3.
Informacije o intrinzičnih lastnostih snovi , zlasti o toksičnosti za ljudi se pridobijo, kadarkoli je mogoče, tudi na druge načine in ne samo s testi na vretenčarjih , zlasti z uporabo kvalitativnih in kvantitativnih modelov razmerja med strukturo in aktivnostjo snovi ali iz informacij o strukturno sorodnih snoveh (združevanje v skupine ali navzkrižno branje), če so izpolnjeni pogoji iz Priloge XI, ali s toksikogenomiko .
Information on intrinsic properties of substances , in particular for human toxicity, shall be generated whenever possible by means other than vertebrate animal tests, in particular through the use of qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across), provided that the conditions set out in Annex XI are met , or toxicogenomics .
(Predlog spremembe 549 – prva obravnava)
(Amendment 549 - first reading)
Poleg etičnih vprašanj, povezanih s testi na vretenčarjih, je veliko znanstvenih vprašanj glede veljavnosti testov na živalih za ljudi.
In addition to the ethical questions linked to vertebrate animal testing, there are numerous scientific problems with the validity of such animal tests for humans.
Če se za pridobitev informacij o intrinzičnih lastnostih snovi zahtevajo testi, se ti izvedejo v skladu s testnimi metodami iz uredbe Komisije, sprejete v skladu s postopkom iz člena 132(3) , ki bodo po potrebi ustrezno spremenjene, predvsem zaradi izboljšanja, zmanjšanja ali nadomestitve testiranja na živalih, ali v skladu z drugimi mednarodnimi testnimi metodami, ki jih Komisija ali Agencija priznava kot enakovredne.
Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation adopted in accordance with the procedure referred to in Article 132(3) , which shall be revised as appropriate in particular to refine, reduce or replace animal testing, or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate.
Če se za pridobitev informacij o intrinzičnih lastnostih snovi zahtevajo testi, se ti izvedejo v skladu s testnimi metodami iz uredbe Komisije, sprejete v skladu s postopkom iz člena 132(3a) , ki bodo po potrebi ustrezno spremenjene, predvsem zaradi izboljšanja, zmanjšanja ali nadomestitve testiranja na živalih, ali v skladu z drugimi mednarodnimi testnimi metodami, ki jih Komisija ali Agencija priznava kot enakovredne.
Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation adopted in accordance with the procedure referred to in Article 132(3a) , which shall be revised as appropriate in particular to refine, reduce or replace animal testing, or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate.
Namen tega predloga spremembe je uskladiti besedilo z določbami novega sklepa o "komitologiji" in še zlasti nadomestiti običajni postopek "regulativnega odbora" z "regulativnim odborom z nadzorom", saj so zadevni ukrepi splošne narave, namenjeni spreminjanju nebistvenih delov osnutka zakonodaje.
The amendment is needed to align the text to the provisions of the new "commitology" Decision, and in particular to replace the ordinary "regulatory committee" procedure with the "regulatory committee with scrutiny", since the measures concerned are measures of general scope designed to amend non-essential elements of the draft legislation.
ČLEN 13, ODSTAVEK 2, PODODSTAVEK 1 A (novo)
ARTICLE 13, PARAGRAPH 2, SUBPARAGRAPH 1 A (new)
Te metode se redno pregledujejo in izboljšujejo, da bi zmanjšali poskuse na vretenčarjih in število udeleženih živali.
These methods shall be regularly reviewed and improved with a view to reducing experimentation on vertebrate animals and the number of animals involved.
Zlasti če Evropski center za validacijo alternativnih metod (ECVAM) razglasi nadomestno poskusno metodo za veljavno in pripravljeno za pravno priznanje,Agencija v skladu s postopkom iz člena 130 v 14 dneh predloži osnutek sklepa, ki spreminja ustrezno(e) prilogo(e) k tej uredbi, da se nadomesti poskusna metoda na živalih z nadomestno metodo.
In particular, if the European Centre for the Validation of Alternative Methods (ECVAM) declares an alternative test method valid and ready for regulatory acceptance, the Agency shall submit within 14 days a draft decision amending the relevant Annex(es) to this Regulation, in accordance with the procedure provided for in Article 130, with a view to replacing the animal test method with the alternative one.
(Predlog spremembe 108 – prva obravnava)
(Amendment 108 - first reading)
Brez vpliva na člen 4 Direktive 98/24/ES se izvede ocena kemijske varnosti in pripravi poročilo o kemijski varnosti za vse snovi, ki jih je treba registrirati v skladu s tem poglavjem , če registracijski zavezanec proizvaja ali uvaža takšno snov v količini, ki znaša deset ton ali več na leto .
Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter if the registrant manufactures or imports such a substance in quantities of 10 tonnes or more per year .
Brez vpliva na člen 4 Direktive 98/24/ES se izvede ocena kemijske varnosti in pripravi poročilo o kemijski varnosti za vse snovi, ki jih je treba registrirati v skladu s tem poglavjem.
Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter.
Namen predloga spremembe 110 iz prve obravnave je bil zagotoviti osnovne podatke o varnosti tudi za kemikalije v manjših količinah.
The intention of amendment 110 from the first reading was to secure basic safety data also for low volume chemicals.
To bi moralo veljati za vse kemikalije, ki jih je treba registrirati.
This should apply for all chemicals subject to registration.
Industrija in institucije vedno znova poudarjajo potrebo po "pristopu, ki temelji na tveganju" v zakonodaji REACH.
The industry and the institutions do not tire to stress the need for a "risk-based approach" of REACH.
Tveganje je kombinacija nevarnosti in izpostavljenosti.
Risk is the combination of hazard and exposure.
Vendar pa je ocena a) nevarnosti in b) izpostavljenosti zahtevana le v poročilu o kemijski varnosti.
However, an assessment of a) hazard and b) exposure is only required in the chemical safety report.
Omejitev ocen varnosti na snovi nad 10 ton bi dve tretjini snovi oprostilo obeh ocen.
To limit the safety assessments to substances above 10 tonnes would exclude two-thirds of the substances from both those assessments.
Zaradi tega bi bilo skoraj nemogoče določiti ustrezne ukrepe za obvladovanje tveganja za zaščito delavcev in potrošnikov pred nevarnimi snovmi.
As a consequence, it would be near impossible to identify the appropriate risk management measures to protect workers or consumers against hazardous substances.
Kopičenje neuporabnih podatkov ne koristi nikomur.
A data graveyard serves nobody.
Ocene kemijske varnosti in poročila o kemijski varnosti v skladu z odstavkom 1 ni treba pripraviti za snovi, razvrščene kot nevarne v skladu z Direktivo 67/548/EGS, ali snovi z lastnostmi PBT ali vBvP, ki so prisotne v trdnih pripravkih, izvzetih iz zahtev za označevanje v skladu s členom 12(2) Direktive 1999/45/ES in členom 9(3) Priloge VI k Direktivi 67/548/EGS.
A chemical safety assessment and chemical safety report in accordance with paragraph 1 need not be performed for substances classified as dangerous according to Directive 67/548/ECC, or PBT or vBvP substances, which are present in massive preparations exempted from labelling in accordance with Article 12(2) of Directive 1999/45/ECand point 9.3 of Annex VI to Directive 67/548/EEC.
Ponovna vložitev predlogov sprememb 422 in 960, sprejetih v prvi obravnavi.
Reinstates amendments 422 and 960 as adopted in first reading.
Snovi, ki so vezane v trdnih pripravkih, niso zelo tvegane za zdravje ljudi ali okolje, zato obstoječa zakonodaja ne predpisuje nobenega označevanja.
The risk for human health or the environment from substances bound in massive preparations is very limited and, accordingly, no labelling is required by existing legislation.
Zato lahko obveznosti priprave poročil in ocen kemijske varnosti odpravimo pod enakimi pogoji kot označevanje.
Therefore, the obligation to perform chemical safety assessments and reports can be dispensed with under the same conditions as the labelling.
ČLEN 14, ODSTAVKA 7 A IN 7 B (novo)
ARTICLE 14, PARAGRAPHS 7 A AND 7 B (new)
Proizvajalec ali uvoznik snovi ali pripravka, ki dobavlja takšno snov ali pripravek za uporabnike na nižji stopnji, na prošnjo uporabnika na nižji stopnji in kolikor je to mogoče razumno zahtevati, priskrbi podatke, ki so potrebni za oceno učinkov snovi ali pripravka na zdravje ljudi ali okolje v okviru postopkov ali uporabe, ki jih navede uporabnik na nižji stopnji v svoji prošnji.
The manufacturer or importer of a substance or preparation who supplies such a substance or preparation to a downstream user shall, at the request of the downstream user and in so far as this can reasonably be requested, supply the information needed to assess the effects of the substance or preparation on human health or the environment in the context of the operations or use indicated by the downstream user in his request.
Uporabnik na nižji stopnji na zahtevo dobavitelja in kolikor je to mogoče razumno zahtevati, priskrbi podatke, ki jih potrebuje dobavitelj za oceno učinkov snovi ali pripravka na zdravje ljudi ali okolje v okviru postopkov ali uporabe snovi ali pripravka z vidika uporabnika na nižji stopnji.
The downstream user shall supply, at the request of his supplier and in so far as this can reasonably be requested, the information needed by the supplier to assess the effects of the substance or preparation on human health or the environment in the context of the operations or use of the substance or preparation by the downstream user.
(Predlog spremembe 112 – prva obravnava)
(Amendment 112 - first reading)
Obveščanje med akterji proizvodne verige ne sme biti omejeno zgolj na izmenjavi informacij, da bi delovali v skladu z direktivo.
Communication between the players in the production chain must not be limited to a mere exchange of information intended simply to comply with the directive.
(c) z glavnim registracijskim zavezancem ne soglaša glede izbire teh informacij.
(c) he disagrees with the lead registrant on the selection of this information.
Agencija oceni obrazložitev in odloči, ali jo sprejme ali ne.
The Agency shall assess this explanation and take a decision on whether or not to accept it.
V primeru, da je ne sprejme, mora podjetje skupno predložiti podatke.
In the event of non-acceptance, the undertaking shall be required to submit the data jointly.
Kot so oblikovana sedaj, so merila glede informacij, ki jih morajo proizvajalci in uvozniki predložiti ločeno, dokaj nejasna in jih je težko utemeljiti in oceniti.
As currently formulated, the criteria which manufacturers and importers may submit concerning separate information are very vague and difficult to justify and assess.
Členi 5, 6, 7(1) in 21 se ne uporabljajo do …** za snovi v postopnem uvajanju, ki so bile vsaj enkrat po …* proizvedene v Skupnosti ali v Skupnost uvožene v količini, ki je znašala 100 ton ali več na leto na proizvajalca ali uvoznika.
Article 5, Article 6, Article 7(1) and Article 21 shall not apply until ...** to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after ...*.
Členi 5, 6, 7(1) in 21 se ne uporabljajo do …** za snovi v postopnem uvajanju, ki so v skladu z Direktivo 67/548/EGS razvrščene med zelo strupene za vodne organizme, ki imajo lahko dolgoročne škodljive posledice za vodno okolje (R50/53) ter so proizvedene v Skupnosti ali v Skupnost uvožene v količini, ki je znašala 1 tono ali več na leto na proizvajalca ali uvoznika; ali za snovi v postopnem uvajanju, ki so bile vsaj enkrat po …* proizvedene v Skupnosti ali v Skupnost uvožene v količini, ki je znašala 100 ton ali več na leto na proizvajalca ali uvoznika.
Article 5, Article 6, Article 7(1) and Article 21 shall not apply until ...** to phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC and manufactured in the Community or imported in quantities reaching 1 tonne or more per year per manufacturer or per importer; or to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after ...*.
(Predlog spremembe 374 – prva obravnava)
(Amendment 374 - first reading)
Dodatni prednostni seznam na podlagi tveganja: v drugo fazo registracije bi bilo potrebno dodati snovi – v količinah, manjših od 100 ton – ki so strupene za vodne organizme in imajo lahko dolgoročne škodljive posledice.
Additional risk-based prioritisation: substances - in quantities below 100 tonnes - that are toxic to aquatic organisms and that may cause long-term adverse effects should be added to the second phase of registration.
Drugače bi registracija teh nevarnih snovi trajala do 11 let.
Otherwise, it would take up to 11 years until these hazardous substances would be registered.
Obvestilo o nameri, da se ne registrira snovi
Notification of intention not to register a substance
Proizvajalci ali uvozniki snovi kot take ali v pripravku, ki ne nameravajo predložiti vloge za registracijo snovi, o tem ustrezno obvestijo Agencijo in uporabnike na nižji stopnji.
Manufacturers or importers of a substance, either on its own or in a preparation, who do not intend to submit an application for registration of the substance shall notify the Agency and downstream users of their intention.
Obvestilo iz odstavka 1 je obvezno:
The notification referred to in paragraph 1 shall be forwarded
(a) 12 mesecev pred iztekom roka iz člena 23(1) za snovi v postopnem uvajanju, ki so proizvedene ali uvožene v količinah 1.000 ton ali več na leto;
(a) 12 months before the deadline laid down in Article 23(1) for phase-in substances manufactured or imported in quantities reaching 1 000 tonnes or more per year;
(b) 24 mesecev pred iztekom roka iz člena 23(2) za snovi v postopnem uvajanju, ki so proizvedene ali uvožene v količinah 100 ton ali več na leto;
(b) 24 months before the deadline laid down in Article 23(2) for phase-in substances manufactured or imported in quantities reaching 100 tonnes or more per year;
(c) 36 mesecev pred iztekom roka iz člena 23(3) za snovi v postopnem uvajanju, ki so proizvedene ali uvožene v količinah 1 tone ali več na leto;
(c) 36 months before the deadline laid down in Article 23(3) for phase-in substances manufactured or imported in quantities reaching 1 tonne or more per year.
Če proizvajalec ali uvoznik ne obvesti Agencije ali uporabnikov na nižji stopnji o svoji nameri, da ne bo registriral snovi, predloži vlogo za registracijo te snovi.
Should the manufacturer or importer fail to notify the Agency or downstream users of his intention not to register the substance, he shall be required to submit a registration application for the substance.
(Predlog spremembe 121 – prva obravnava)
(Amendment 121 - first reading)
Uporabniki na nižji stopnji – in to morda celo veliko število uporabnikov – so zaskrbljeni, da snovi ne bodo registrirane zaradi gospodarskih razlogov, ki bi imeli škodljiv učinek na njihovo poslovanje.
Downstream users are concerned that some - and even, perhaps, a large number - substances will not be registered for economic reasons, which would have an adverse impact on their business.
Nezmožni so pripraviti ustrezne pripravke za takšno možnost, ker ne bi vedeli zanjo, dokler ne bi potekel rok za registracijo.
They are unable to make suitable preparations for such an eventuality because they would not know about it until the deadline for registration had passed.
Določba, ki zahteva, da proizvajalci in uvozniki to vnaprej sporočijo, bi jim omogočila pogajanje s proizvajalcem ali uvoznikom.
A provision requiring manufacturers and importers to give advance notice would enable them to negotiate with the manufacturer or importer.
Uporabniki na nižji stopnji bi lahko bili pripravljeni sprejeti višjo ceno, da bi preprečili še višje stroške, ki nastajajo pri spreminjanju sestave izdelkov, in se tako izognili umiku snovi.
Downstream users might be willing to pay a higher price in order to avoid even higher reformulation costs, thus avoiding withdrawal of the substance.
ČLEN 27, ODSTAVEK 6
ARTICLE 27, PARAGRAPH 6
Agencija v enem mesecu po prejemu informacij iz odstavka 5 potencialnemu registracijskemu zavezancu dovoli sklicevanje na informacije, ki jih je zahteval v svoji registracijski dokumentaciji.
Within one month from the receipt of the information referred to in paragraph 5 , the Agency shall give the potential registrant permission to refer to the information requested by him in his registration dossier.
Predhodni registracijski zavezanec(-ci) ima(jo) do potencialnega registracijskega zavezanca terjatev enakega deleža stroškov, ki jih je ta imel in ki je izterljiva na nacionalnih sodiščih, pod pogojem, da potencialnemu registracijskemu zavezancu da na razpolago celovito poročilo o študiji.
Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national courts.
Predhodni registracijski zavezanec(-ci) ima(jo) do potencialnega registracijskega zavezanca terjatev pravičnega deleža stroškov, ki jih je ta imel in ki je izterljiva na nacionalnih sodiščih, pod pogojem, da potencialnemu registracijskemu zavezancu da na razpolago celovito poročilo o študiji.
Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for a fair share of the cost incurred by him, which shall be enforceable in the national courts.
Delitev dejanskih stroškov prvotnega(-ih) registracijskega(-ih) zavezanca(-ev) za zadevne študije se izračuna sorazmerno z obsegom proizvodnje/uvoza vsake stranke.
The sharing of the actual costs incurred by the original registrant(s) for the study concerned shall be calculated in a way which is proportional to each party’s production/import volume.
Kjer so bili prvotni skupni stroški že razdeljeni med dva ali več registracijskih zavezancev, vsak (vsi) nadaljnji morebitni registracijski zavezanec(-ci) plača(-jo) vsakemu registracijskemu zavezancu pravičen delež njegovega prispevka k stroškom.
Where the original total cost has already been shared between two or more registrants, any subsequent potential registrant(s) shall pay each registrant a fair share of his contribution to costs.
(Predlog spremembe 134 (delno) – prva obravnava)
(Amendment 134 (partially) - first reading)
(da) kratek splošen opis opredeljenih oblik uporabe, kar so minimalne začetne informacije o skupinah uporabe in izpostavljenosti, kot so opredeljene v oddelku 6 Priloge VI;
(da) a brief general description of identified uses; as a minimum initial information on use and exposure categories as specified in section 6 of Annex VI;