natgillin/translations-raw huggingface dataset:
Obvezno sporočanje informacij o snoveh v izdelkih
Duty to communicate information on substances contained in articles
Proizvajalec ali uvoznik snovi iz Priloge XIV ali pripravka ali izdelka, ki vsebuje tako snov, na zahtevo uporabnika na nižji stopnji, kolikor je to mogoče razumno zahtevati, priskrbi nujne informacije za oceno učinkov snovi na zdravje ljudi in okolje glede na delovanje in uporabo, navedenih v zahtevi.
Any manufacturer or importer of a substance listed in Annex XIV, or a preparation or article containing such a substance, shall at the request of the downstream user, in so far as this may reasonably be required, furnish the information necessary to assess the effects of the substance on human health or the environment with respect to the operations and uses indicated in that request.
Zahteve za informacije iz odstavka I veljajo s potrebnimi spremembami na višji stopnji v dobavni verigi.
The information requirements specified in paragraph 1 shall apply mutatis mutandis up the supply chain.
Uporabniki na nižji stopnji, ki v izdelek dodajo snov ali pripravek, za katerega je bil pripravljen varnostni list, in tisti, ki pozneje ravnajo s tem izdelkom ali ga nadalje predelujejo, predložijo varnostni list vsem prejemnikom tega izdelka ali njegovega izvedenega izdelka.
Downstream users who incorporate into an article a substance or preparation for which a safety data sheet was established, and those who subsequently handle or further process that article, shall pass on the safety data sheet to any recipient of the article or its derivative.
Potrošnik ni prejemnik.
Recipients shall not include consumers.
Potrošniki imajo pravico, da od proizvajalca ali uvoznika zahtevajo informacije o snoveh v izdelku, ki ga ta proizvaja ali uvaža.
Consumers shall have the right to ask the producer or importer for information on the substances present in an article produced or imported by him.
Proizvajalci ali uvozniki omogočijo kateremu koli posameznemu potrošniku, na zahtevo in v 15 delovnih dneh, brezplačen dostop do vseh podrobnosti o varnosti in informacij o uporabi za snovi v katerem koli izdelku, ki so ga proizvedli ali uvozili.
Producers or importers shall, on request and within 15 working days, enable any individual consumer to obtain, free of charge, full details of safety and use information concerning the substances present in any article they have produced or imported.
(Predloga sprememb 166 in 366 – prva obravnava)
(Amendments 166 and 366 - first reading)
Proizvajalcem, trgovcem na drobno in potrošnikom je treba omogočiti, da ugotovijo, ali končni izdelek vsebuje določene snovi in po potrebi poiščejo ter izberejo varnejše nadomestilo.
Manufacturers, retailers and consumers should be able to find out whether specific substances are contained in an end product and, if necessary, to seek out and choose a safer alternative.
Informacije o nevarnih (dovoljenih) snoveh kot takih, v pripravkih in izdelkih je treba posredovati po celotni dobavni verigi (navzgor in navzdol), da bi podjetja tako lahko sprejela ustrezne ukrepe in odločitve glede vsebine njihovih izdelkov na osnovi informacij.
Information on hazardous (authorised) substances on their own, in preparations, and in articles must be distributed through the supply chain (upwards and downwards) to enable the companies to take appropriate actions and to make informed decisions concerning the contents of their products.
(c) uporabnik na nižji stopnji snov ali pripravek uporablja v skupni količini manj kot 1 tono na leto;
(c) the downstream user uses the substance or preparation in a total quantity of less than 1 tonne per year;
(Nov predlog spremembe – člen 62(2)(c), povezan z uvodno izjavo 54)
(New amendment - Rule 62(2)(c)), linked to recital 54)
Zaradi praga ene tone, ki ga je uvedel Svet, bi morali uporabniki na nižji stopnji pripraviti poročilo o kemijski varnosti (CSR) samo za uporabe, večje od ene tone, če jih ne pokriva CSR proizvajalca.
As a result of the 1 tonne threshold introduced by Council, downstream users would only have to prepare a chemical safety report (CSR) for uses >1 tonne, if not covered by the CSR of the manufacturer.
Za CSR proizvajalcev ni predvidenega nobenega takšnega praga za uporabo.
No such use threshold is foreseen for the CSR by manufacturers.
Ta nova določba bi ustvarila slabo pobudo za proizvajalce, da bi izključili uporabe pod eno tono iz svojih CSR, ker ne bi bilo nobenih obveznosti za uporabnike na nižji stopnji.
This new clause would create a perverse incentive for manufacturers to exclude uses below 1 tonne from their CSR, as it would not result in any obligations for downstream users.
S tem nastane velika vrzel glede podatkov o varnosti za manjše uporabe.
This creates a serious loophole with regard to safety information for small uses.
Prag ene tone na leto bi ustvaril resno pravno luknjo za mnoge uporabe kemikalij.
Establishing a 1 tpa threshold would create a serious loophole for many uses of chemicals.
Izbris praga ene tone na leto zagotavlja, da imajo uporabniki na nižji stopnji pravico pridobiti podatke o varnosti od proizvajalcev, da bi lahko varno ravnali s snovjo in izboljšali svoje izdelke.
Deleting the threshold of 1 tpa ensures that the downstream users have the right to obtain the safety information from the manufacturers in order to handle the substance safely and improve their products.
ČLEN 39, ODSTAVEK 1 A (novo)
ARTICLE 39, PARAGRAPH 1 A (NEW)
Da se prepreči podvajanje testiranj na živalih, lahko zainteresirane stranke za vsak predlog za preskuse, ki vključujejo teste na vretenčarjih, v 90 dneh vložijo pripombe.
In order to prevent duplication of animal testing, any testing proposal involving tests on vertebrate animals shall be open for comment by interested parties for a period of 90 days.
Registracijski zavezanec ali uporabnik na nižji stopnji upošteva vse prejete pripombe in Agencijo obvesti, ali je kljub prejetim pripombam še vedno prepričan, da je treba izvesti predlagani poskus, in o svojih razlogih za to.
All comments received shall be taken into account by the registrant or the downstream user, who shall notify the Agency whether, in the light of the comments received, he nonetheless believes that it is necessary to carry out the proposed test and of his reasons therefor.
(Predlog spremembe 176 – prva obravnava)
(Amendment 176 - first reading)
Upoštevati je treba vse pripombe in informacije, ki bi lahko prispevale k zmanjšanju števila poskusov na živalih.
All relevant comments and information which could reduce animal testing should be taken into account.
ČLEN 39, ODSTAVEK 1 B (novo)
ARTICLE 39, PARAGRAPH 1 B (new)
Pred pripravo osnutka odločitve iz odstavka 2 o predlogu poskusa, ki vključuje poskuse na vretenčarjih, se je treba posvetovati z Evropskim centrom za validacijo alternativnih metod (ECVAM).
The European Centre for the Validation of Alternative Methods (ECVAM) shall be consulted before a decision as referred to in paragraph 2 on a testing proposal that includes vertebrate animal tests is drafted.
(Predlog spremembe 177 – prva obravnava)
(Amendment 177 - first reading)
Na podlagi preučitve v skladu z odstavkom 1 Agencija pripravi osnutek ene od naslednjih odločitev, ki se sprejme v skladu s postopkom iz členov 49 in 50:
On the basis of the examination under paragraph 1 , the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 49 and 50:
Na podlagi preučitve v skladu z odstavki 1, 1a in 1b Agencija pripravi osnutek ene od naslednjih odločitev, ki se sprejme v skladu s postopkom iz členov 49 in 50:
On the basis of the examination under paragraphs 1, 1a and 1b , the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 49 and 50:
(Spremenjena ponovna vložitev besedila Komisije)
(Modified reinstatement of the Commission text)
Za zagotovitev skladnosti.
To ensure coherence.
Registracijski zavezanec predloži Agenciji informacije v določenem roku.
The registrant shall submit the information required to the Agency by the deadline set.
Registracijski zavezanec predloži Agenciji informacije v razumnem roku , ki ga določi Agencija.
The registrant shall submit the information required to the Agency within a reasonable deadline to be set by the Agency.
Ta rok ne presega šestih mesecev.
This deadline shall not exceed six months.
Agencija prekliče registracijsko številko, če registracijski zavezanec v določenem roku ne predloži ustreznih informacij .
The Agency shall withdraw the registration number if the registrant fails to submit the relevant information within the deadline set .
Svetu ni uspelo določiti jasnega roka za predložitev informacij, kot je Parlament predlagal v predlogu spremembe 180.
Council has failed to provide a clear deadline for submission of information as the Parliament has proposed in Amendment 180.
Četudi je registracijski zavezanec je opravil pregled popolnosti iz člena 20, zahteve po informacijah morda vseeno niso izpolnjene.
A registrant might have passed the completeness check as stipulated in Article 20, but the information requirements might nevertheless not be fulfilled.
Neizpolnjevanje zahtev za informacije bi moralo imeti jasne posledice.
Non-compliance with the information requirements should have clear consequences.
Registracijski zavezanci morajo imeti le eno možnost, da v največ šestih mesecih popravijo pomanjkljive registracije.
Registrants should have no more than one chance within a maximum of six months to correct flawed registrations.
S tem bi lahko zagotovili kakovost in preprečili stalne spore med organi in registracijskimi zavezanci.
This could ensure good quality and avoid never-ending disputes between the authorities and registrants.
Komisija se lahko po posvetovanju z Agencijo odloči, da bo spremenila odstotek izbrane dokumentacije ter dopolnila ali vključila nadaljnje kriterije v odstavku 5 v skladu s postopkom iz člena 132(3) .
The Commission may, after consulting with the Agency, take a decision to vary the percentage of dossiers selected and amend or include further criteria in paragraph 5 in accordance with the procedure referred to in Article 132(3) .
Komisija se lahko po posvetovanju z Agencijo odloči, da bo spremenila odstotek izbrane dokumentacije ter dopolnila ali vključila nadaljnje kriterije v odstavku 5 v skladu s postopkom iz člena 132(3a) .
The Commission may, after consulting with the Agency, take a decision to vary the percentage of dossiers selected and amend or include further criteria in paragraph 5 in accordance with the procedure referred to in Article 132(3a) .
Da se zagotovi usklajen pristop k zahtevanju dodatnih informacij, Agencija spremlja osnutke odločitev v skladu s členom 45 ter določi kriterije in prednostne naloge.
In order to ensure a harmonised approach to requests for further information, the Agency shall monitor draft decisions under Article 45 and shall develop criteria and priorities.
Kjer je ustrezno, se sprejmejo izvedbeni ukrepi v skladu s postopkom iz člena 132(3) .
Where appropriate, implementing measures shall be adopted in accordance with the procedure referred to in Article 132(3) .
Kjer je ustrezno, se sprejmejo izvedbeni ukrepi v skladu s postopkom iz člena 132(3a) .
Where appropriate, implementing measures shall be adopted in accordance with the procedure referred to in Article 132(3a) .
Agencija vse osnutke odločitev v skladu s členi 39, 40 ali 45 uradno sporoči zadevnemu(-im) registracijskemu(-im) zavezancu(-em) ali uporabniku(-om) na nižji stopnji in ga (jih) obvesti o njegovi (njihovi) pravici, da v 30 dneh po prejemu obvestila predloži(jo) svoje pripombe.
The Agency shall notify any draft decision under Articles 39, 40 or 45 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt.
Če zadevni registracijski zavezanec(-ci) ali uporabnik(-i) na nižji stopnji pripombe želijo predložiti, jih posredujejo Agenciji.
If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency.
Agencija pa nato o predložitvi pripomb takoj obvesti pristojni organ.
The Agency in turn shall inform the competent authority of the submission of the comments without delay.
Pristojni organ (za odločitve, sprejete v skladu s členom 45) in Agencija (za odločitve, sprejete v skladu s členoma 39 in 40) upoštevata vse prejete pripombe in lahko v skladu z njimi spremenita osnutek odločitve.
The competent authority (for decisions taken under Article 45) and the Agency (for decisions taken under Articles 39 and 40) shall take any comments received into account and may amend the draft decision accordingly.
Agencija vse osnutke odločitev v skladu s členi 39, 40 ali 45 , skupaj s pripombami zainteresiranih strani in Evropskega centra za validacijo alternativnih metod (ECVAM), uradno sporoči zadevnemu(-im) registracijskemu(-im) zavezancu(-em) ali uporabniku(-om) na nižji stopnji in ga (jih) obvesti o njegovi (njihovi) pravici, da v 30 dneh po prejemu obvestila predloži(jo) svoje pripombe.
The Agency shall notify any draft decision under Articles 39, 40 or 45, together with any comments by stakeholders and the European Centre for the Validation of Alternative Methods (ECVAM), to the registrant(s) or downstream user(s) concerned , informing them of their right to comment within 30 days of receipt.
(Predlog spremembe 206 – prva obravnava)
(Amendment 206 - first reading)
Zaradi preglednosti je treba objaviti tudi pripombe Evropskega centra za validacijo alternativnih metod in drugih zainteresiranih strani.
For reasons of transparency, the comments by ECVAM and other stakeholders should also be published.
Povezano s predlogi sprememb člena 39(1), (1a) in (2).
Linked to Amendments to Article 39(1), (1a) and (2).
Namen tega naslova je, da se zagotovi dobro delovanje notranjega trga ter hkrati, da se tveganja, izhajajoča iz snovi, ki so vzrok za veliko zaskrbljenost, ustrezno nadzirajo in da se te snovi sčasoma zamenjajo z ustreznimi alternativnimi snovmi ali tehnologijami, kjer so te ekonomsko in tehnično izvedljive.
The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are eventually replaced by suitable alternative substances or technologies where these are economically and technically viable.
Namen tega naslova je, da se zagotovi, da se snovi, ki so vzrok za veliko zaskrbljenost, zamenjajo z varnejšimi nadomestnimi snovmi ali tehnologijami, kjer je to mogoče.
The aim of this Title is to ensure that substances of very high concern are replaced by safer alternative substances or technologies, where available.
Kjer takih nadomestnih snovi ni na voljo in kadar koristi za družbo prevladajo nad tveganji, povezanimi z uporabo take snovi, je namen tega naslova zagotoviti ustrezen nadzor uporabe snovi, ki so vzrok za veliko zaskrbljenost, in spodbujanje nadomestnih možnosti.
Where no such alternatives are available, and where the benefits to society outweigh the risks connected with the use of such substances, the aim of this Title is to ensure that the use of substances of very high concern is properly controlled and that alternatives are encouraged.
Njene določbe temeljijo na načelu previdnosti.
Its provisions are underpinned by the precautionary principle.
(Predlog spremembe 214 – prva obravnava)
(Amendment 214 - first reading)
Namen odobritve je zagotavljanje varovanja zdravja ljudi in okolja.
The aim of authorisation is to ensure the protection of human health and the environment.
Ponovno se vloži predlog spremembe 214 Evropskega parlamenta.
EP amendment 214 is re-tabled.
Črtati je treba poudarek na notranjem trgu.
The emphasis on the internal market needs to be deleted.
Ta poseben naslov ureja dovoljevanje uporabe kemikalij, ki so dokazano škodljive, pod posebnimi pogoji.
This specific title is about allowing chemicals that are known to be harmful to be used under specific conditions.
(da) uporabe rud in koncentratov kot naravno prisotnih surovin – ki sicer niso dane v promet za prodajo splošni javnosti – v napravah za predelavo, ki sodijo v področje uporabe Direktive 96/61/ES.
(da) uses of ores and concentrates, as naturally occurring raw materials, not otherwise on sale to the general public, in processing installations that fall within the scope of Directive 96/61/EC.
Večina jih vsebuje majhne količine rakotvornih, mutagenih ali strupenih (CMR) snovi in jih je zato treba odobriti.
Most contain small amounts of natural CMR substances and are therefore liable to Authorisation.
Tveganja, ki iz tega izhajajo, se ustrezno nadzorujejo: v okviru člena 57(2) se dovolijo izjeme.
Resulting risks are properly controlled: under article 57(2), exemptions will be granted.
Pri snoveh, za katere je treba pridobiti odobritev samo, ker izpolnjujejo kriterije iz člena 56(a), (b) ali (c) ali ker so opredeljene v skladu s členom 56(f) samo zaradi nevarnosti za zdravje ljudi, se odstavka 1 in 2 tega člena ne uporabljata za naslednje uporabe:
In the case of substances that are subject to authorisation only because they meet the criteria in Article 56(a), (b) or (c) or because they are identified in accordance with Article 56(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:
(a) uporabe v kozmetičnih proizvodih na področju uporabe Direktive 76/768/EGS;
(a) uses in cosmetic products within the scope of Directive 76/768/EEC;
(b) uporabe v materialih za stik z živili na področju uporabe Uredbe (ES) št 1935/2004.
(b) uses in food contact materials within the scope of Regulation (EC) No 1935/2004.
(Predlog spremembe 471/delno spremenjen – prva obravnava)
(Amendment 471/rev. partially - first reading)
Člen 55a
Article 55a
Seznam snovi, ki jih je treba odobriti
List of substances subject to authorisation
Snovi, za katere je znano, da izpolnjujejo kriterije iz člena 56, se do začetka postopka za odobritev uvrstijo na seznam v Prilogi XIV(a).
Substances that are known to fulfil the criteria of Article 56 shall be listed in Annex XIV(a) pending the procedure for authorisation.
Ko se postopek za odobritev začne, se snovi dodajo na seznam v Prilogi XIV(b), v skladu s postopkom iz člena 57(1).
Once the authorisation procedure has been initiated, the substances shall be listed in Annex XIV(b), in accordance with the procedure laid down in Article 57(1).
(Predlog spremembe 215 – prva obravnava)
(Amendment 215 - first reading)
Za povečanje preglednosti ter spodbujanje prostovoljnih ukrepov uporabnikov na nižji stopnji in inovacij v smeri varnejših nadomestnih možnosti, je treba vse snovi, ki izpolnjujejo merila za zelo veliko zaskrbljenost, takoj dodati na seznam snovi za odobritev (= Priloga XIVa).
In order to increase transparency, stimulate voluntary measures by downstream users and innovation towards safer alternatives, all substances that meet the criteria of very high concern should be added immediately to a candidate list for authorisation (=Annex XIVa).
Snovi, ki se vključijo v Prilogo XIV
Substances to be included in Annex XIV
Snovi, ki se vključijo v Prilogo XIV(a)
Substances to be included in Annex XIV(a)
V skladu s postopkom iz člena 57 se lahko v Prilogo XIV vključijo naslednje snovi:
The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 57 :
Brez poseganja v obstoječe ali prihodnje omejitve se v skladu s postopkom iz člena 58 v Prilogo XIV(a) vključijo naslednje snovi:
Without prejudice to existing or future restrictions the following substances shall be included in Annex XIV(a) in accordance with the procedure laid down in Article 58 :
(Predlog spremembe 216 – prva obravnava)
(Amendment 216 - first reading)
Delno povezano s predlogi sprememb člena 55a novo.
Partially linked to the amendments on Article 55a new.
Zaradi uvedbe seznama snovi za pridobitev dovoljenja je treba spremeniti postopek za vključitev na sezname.
Given the introduction of a candidate list, the procedure for inclusion on the lists needs to be modified.
(f) snovi - kot so snovi, ki so po svojih lastnostih endokrini motilci, ali snovi, ki so po svojih lastnostih obstojne, se kopičijo v organizmih in so strupene ali zelo obstojne in se zelo lahko kopičijo v organizmih, ne izpolnjujejo meril iz točk (d) ali (e) - in za katere je za vsak primer posebej v skladu s postopkom iz člena 58 znanstveno dokazano, da imajo lahko resne učinke na zdravje ljudi ali okolje, ki so enakovredni učinkom snovi iz točk (a) do (e) .
(f) substances - such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) - for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 58.
(f) snovi - kot so snovi, ki so po svojih lastnostih endokrini motilci, ali snovi, ki so po svojih lastnostih obstojne, se kopičijo v organizmih in so strupene ali zelo obstojne in se zelo lahko kopičijo v organizmih, ne izpolnjujejo meril iz točk (d) ali (e) - in za katere je za vsak primer posebej v skladu s postopkom iz člena 58 ugotovljeno, da povzročajo enako mero zaskrbljenosti kot snovi, navedene v točkah (a) do (e).
(f) substances - such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) - which are identified as giving rise to a similar level of concern as substances listed in points (a) to (e) on a case-by-case basis in accordance with the procedure set out in Article 58.
(Predlog spremembe 217 – prva obravnava)
(Amendment 217 - first reading)
Ta predlog spremembe znižuje raven zaskrbljenosti, ki je potrebna, da se snov lahko doda v Prilogo XIVa.
This amendment lowers the level of concern required for a substance before it is allowed to be added to Annex XIVa.
(Nov predlog spremembe, v skladu s členom 62(2)(d) Poslovnika, da se upošteva spremenjeno mnenje Znanstvenega odbora za nastajajoča in na novo ugotovljena zdravstvena tveganja (SCENIHR) z dne 10. marca 2006 ter poročila z naslovom „Možna strupenost snovi na nanoravni“ ["Toxic Potential of Materials at the Nanolevel"], objavljenega v reviji Science dne 3. februarja 2006.)
(New amendment - Rule 62(2)(d) to take account of the modified Opinion of SCENIHR of 10 March 2006, and of the Review "Toxic Potential of Materials as the Nanolevel" published in Science on 3 February 2006))
Zelo majhne dimenzije nanomaterialov lahko po navedbah revije „Science“ spremenijo fizikalno-kemijske lastnosti ter ustvarijo možnosti za povečanje vnosa in interakcij z biološkimi tkivi.
According to "Science", the very small size of nanomaterials can modify the physico-chemical properties and create the opportunity for increased uptake and interaction with biological tissues.
Ta kombinacija lahko povzroči škodljive biološke učinke v živih celicah, ki sicer z enakim materialom v večji obliki ne bi bili mogoči.
This combination can generate adverse biological effects in living cells that would not otherwise be possible with the same material in larger form.
Po mnenju SCENIHR je še vedno na voljo zelo malo informacij o biološki usodi nanodelcev (npr. porazdelitev, kopičenje, metabolizem in strupenosti glede na organe).
According to SCENIHR, information about the biological fate of nanoparticles (e.g. distribution, accumulation, metabolism and organ specific toxicity) is still minimal.