natgillin/translations-raw huggingface dataset:
If the Member State Committee fails to reach unanimous agreement, the Commission shall prepare a draft decision to be taken in accordance with the procedure referred to in Article 133(3).
Če Odbor držav članic soglasja ne doseže, Komisija pripravi osnutek odločitve, ki se sprejme v skladu s postopkom iz člena 133(3).
An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 3 and 6 of this Article.
Proti odločitvam Agencije iz odstavkov 3 in 6 tega člena se lahko vloži pritožba v skladu s členi 91, 92 in 93.
Adoption of decisions under substance evaluation
Sprejetje odločitev med evalvacijo snovi
The competent authority shall circulate its draft decision in accordance with Article 46, together with any comments by the registrant or downstream user, to the Agency and to the competent authorities of the other Member States.
Pristojni organ svoj osnutek odločitve, skupaj z vsemi pripombami registracijskega zavezanca ali nadaljnjega uporabnika, v skladu s členom 46 razpošlje Agenciji in pristojnim organom drugih držav članic.
The provisions of Article 51(2) to (8) shall apply mutatis mutandis.
Smiselno se uporabljajo določbe iz člena 51(2) do (8).
Cost sharing for tests without an agreement between registrants and/or downstream users
Delitev stroškov za teste brez sporazuma med registracijskimi zavezanci in/ali nadaljnjimi uporabniki
Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days.
Registracijski zavezanci ali nadaljnji uporabniki, ki so po odločitvi v skladu s tem naslovom zavezani opraviti test, si po svojih najboljših močeh prizadevajo, da bi se dogovorili o tem, kdo naj opravi test v imenu vseh drugih registracijskih zavezancev ali nadaljnjih uporabnikov, ter Agencijo o tem ustrezno obvestijo v 90 dneh.
If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them.
Če Agencija ne dobi obvestila o takšnem dogovoru v roku 90 dni, določi enega od registracijskih zavezancev ali nadaljnjih uporabnikov, da opravi test v imenu vseh drugih.
If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.
Če registracijski zavezanec ali nadaljnji uporabnik izvede test v imenu drugih, si stroške te študije vsi enakomerno porazdelijo.
In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the full study report.
V primeru iz odstavka 1 registracijski zavezanec ali nadaljnji uporabnik, ki izvede test, vsem zadevnim udeležencem priskrbi en izvod celovitega poročila o študiji.
The person performing and submitting the study shall have a claim against the others accordingly.
Udeleženec, ki izvede in predloži študijo, ima v skladu s tem terjatev do drugih.
Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed.
Vsak zadevni udeleženec lahko vloži zahtevek, da se drugemu udeležencu prepove proizvodnja, uvoz ali dajanje snovi v promet, če ta drugi udeleženec ne plača svojega deleža stroškov oziroma za ta znesek ne zagotovi jamstva ali ne izroči enega izvoda celovitega poročila o izvedeni študiji.
All claims shall be enforceable in the national courts.
Vsi zahtevki so izterljivi na nacionalnih sodiščih.
Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.
Vsak udeleženec se lahko odloči, da svoje zahtevke za povračilo stroškov predloži razsodišču in sprejme njegovo odredbo.
Publication of information on evaluation
Objava informacij o evalvaciji
By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation.
Agencija vsako leto do 28. februarja objavi na svoji spletni strani poročilo o napredku, doseženem v primerjavi s predhodnim koledarskim letom pri izvajanju obveznosti, ki so ji bile naložene v zvezi z evalvacijo.
This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations.
To poročilo vsebuje zlasti priporočila morebitnim registracijskim zavezancem, da bi tako izboljšali kakovost bodočih registracij.
AUTHORISATION
AVTORIZACIJA
Authorisation requirement
Zahteva za avtorizacijo
Aim of authorisation and considerations for substitution
Namen avtorizacije in obravnava nadomestitve
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 progressively replaced by suitable alternative substances or technologies where these are economically and technically viable.
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 postopno zamenjajo z ustreznimi alternativnimi snovmi ali tehnologijami, kjer so te ekonomsko in tehnično izvedljive.
To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
Vsi proizvajalci, uvozniki in nadaljnji uporabniki, ki prosijo za avtorizacijo, v ta namen preučijo, ali so na voljo druge alternative, ocenijo njihovo tveganje in ali je nadomestitev tehnično in ekonomsko izvedljiva.
A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:
Proizvajalec, uvoznik ali nadaljnji uporabnik snovi ne sme dati v promet za uporabo, niti je ne sme sam uporabljati, če je ta snov vključena v Prilogo XIV, razen če:
the use(s) of that substance on its own or in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or
je bilo za uporabo(-e) te snovi kot take ali v pripravku ali vgrajene v izdelek, za katero(-e) se snov daje v promet ali za katero(-e) jo sam uporablja, izdano dovoljenje v skladu s členi 60 do 64; ali
the use(s) of that substance on its own or in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or
je (so) bila(-e) uporaba(-e) te snovi kot take ali v pripravku ali vgrajene v izdelek, za katero(-e) je bila snov dana v promet ali za katero(-e) jo sam uporablja, izvzeta iz zahteve za pridobitev avtorizacije iz Priloge XIV v skladu s členom 58(2); ali
the date referred to in Article 58(1)(c)(i) has not been reached; or
če datum iz člena 58(1)(c)(i) še ni bil dosežen; ali
the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or
če je bil datum iz člena 58(1)(c)(i) že dosežen in je 18 mesecev pred tem datumom oddal vlogo, odločitev glede izdaje avtorizacije v skladu s to vlogo pa še ni bila sprejeta; ali
in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.
je bila za snovi, dane v promet, avtorizacija za to uporabo izdana njegovemu neposrednemu nadaljnjemu uporabniku te snovi.
A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use.
Nadaljnji uporabnik lahko uporablja snov, ki izpolnjuje kriterije iz odstavka 1, če je uporaba v skladu s pogoji iz avtorizacije za to uporabo udeležencu, ki je v dobavni verigi na višji stopnji.
Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development.
Odstavka 1 in 2 se ne uporabljata za snovi, ki se uporabljajo za znanstvene raziskave in razvoj.
Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted.
V Prilogi XIV je natančno navedeno, če se odstavka 1 in 2 uporabljata za v izdelke in postopke usmerjene raziskave in razvoj, kakor tudi največja količina, ki je izvzeta.
Paragraphs 1 and 2 shall not apply to the following uses of substances:
Odstavka 1 in 2 se ne uporabljata za naslednje uporabe snovi:
uses in plant protection products within the scope of Directive 91/414/EEC;
uporabe v fitofarmacevtskih sredstvih na področju uporabe Direktive 91/414/EGS;
uses in biocidal products within the scope of Directive 98/8/EC;
uporabe v biocidnih proizvodih na področju uporabe Direktive 98/8/ES;
use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels [47];
uporabo kot motorno gorivo, zajeto v Direktivo 98/70/ES Evropskega parlamenta in Sveta z dne 13. oktobra 1998 o kakovosti motornega bencina in dizelskega goriva [47];
uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.
uporabe izdelkov iz mineralnih olj kot gorivo za premične ali stacionarne kurilne naprave in uporabo kot gorivo v zaprtih sistemih.
In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:
Pri snoveh, za katere je treba pridobiti avtorizacijo samo, ker izpolnjujejo kriterije iz člena 57(a), (b) ali (c) ali ker so opredeljene v skladu s členom 57(f) samo zaradi nevarnosti za zdravje ljudi, se odstavka 1 in 2 tega člena ne uporabljata za naslednje uporabe:
uses in cosmetic products within the scope of Directive 76/768/EEC;
uporabe v kozmetičnih proizvodih na področju uporabe Direktive 76/768/EGS;
uses in food contact materials within the scope of Regulation (EC) No 1935/2004.
uporabe v materialih za stik z živili na področju uporabe Uredbe (ES) št. 1935/2004.
Paragraphs 1 and 2 shall not apply to the use of substances when they are present in preparations:
Odstavka 1 in 2 se ne uporabljata za uporabo snovi v pripravkih, in sicer za:
for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w);
snovi iz člena 57(d), (e) in (f), katerih koncentracija ne presega mejne vrednosti 0,1 % mas. m/m;
for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Annex I to Directive 67/548/EEC which result in the classification of the preparation as dangerous.
vse druge snovi, katerih koncentracija ne presega najnižje mejne vrednosti iz Direktive 1999/45/ES ali Priloge I k Direktivi 67/548/EGS in se zato pripravki iz njih razvrstijo kot nevarni.
Substances to be included in Annex XIV
Snovi, ki se vključijo v Prilogo XIV
The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
V skladu s postopkom iz člena 58 se lahko v Prilogo XIV vključijo naslednje snovi:
substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC;
snovi, ki izpolnjujejo kriterije za razvrstitev kot rakotvorne iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;
snovi, ki izpolnjujejo kriterije za razvrstitev kot mutagene iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
snovi, ki izpolnjujejo kriterije za razvrstitev kot strupene za razmnoževanje iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;
snovi, ki so v skladu s kriteriji iz Priloge XIII te uredbe obstojne, strupene in se lahko kopičijo v organizmih;
substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
snovi, ki so v skladu s kriteriji iz Priloge XIII te uredbe zelo obstojne in se zelo lahko kopičijo v organizmih;
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 59.
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 kriterijev iz točke (d) ali (e) – in za katere je za vsak primer posebej v skladu s postopkom iz člena 59 znanstveno dokazano, da imajo lahko resne učinke na zdravje ljudi ali okolje, ki so enakovredni učinkom snovi iz točk (a) do (e).
Inclusion of substances in Annex XIV
Vključitev snovi v Prilogo XIV
Whenever a decision is taken to include in Annex XIV substances referred to in Article 57, such a decision shall be taken in accordance with the procedure referred to in Article 133(4).
Odločitev o vključitvi snovi iz člena 57 v Prilogo XIV se sprejme v skladu s postopkom iz člena 133(4).
It shall specify for each substance:
Takšna odločitev mora za vsako snov vsebovati naslednje podatke:
the identity of the substance as specified in Section 2 of Annex VI;
podatke o snovi, kakor je določeno v oddelku 2 Priloge VI;
the intrinsic property (properties) of the substance referred to in Article 57;
intrinzično(-e) lastnost(-i) snovi iz člena 57;
transitional arrangements:
prehodne ureditve:
the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as the sunset date) which should take into account, where appropriate, the production cycle specified for that use;
datum(-e), s katerim(-i) se prepove dajanje v promet in uporaba snovi, če se ne pridobi avtorizacija (v nadaljevanju „datum poteka“), ki morajo po potrebi upoštevati poseben proizvodni ciklus za to uporabo;
a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;
datum ali datume vsaj 18 mesecev pred datumom(-i) poteka, do katerega(-ih) morajo prispeti vloge, če želi vlagatelj nadaljevati uporabo ali dajanje snovi v promet za določene uporabe po datumu(-ih) poteka; te nadaljnje uporabe se dovolijo po datumu poteka do sprejetja odločitve glede predložene avtorizacije;
review periods for certain uses, if appropriate;
roke za preverjanje določenih uporab, če je ustrezno;
uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.
uporabe ali kategorije uporab, ki so izvzete iz zahtev avtorizacije, če obstajajo, in pogoje za takšne izjeme, če obstajajo.
Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled.
Uporabe ali kategorije uporab so lahko izvzete iz zahtev avtorizacije pod pogojem, da je na podlagi veljavne posebne zakonodaje Skupnosti, ki določa za uporabo snovi v zvezi z varovanjem zdravja ljudi ali okolja minimalne zahteve, tveganje pod primernim nadzorom.
In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form.
Pri določitvi takšnih izjem se upošteva zlasti sorazmernost tveganja za zdravje ljudi in okolje v zvezi z naravo snovi, kot na primer, ko se tveganje spreminja glede na fizično obliko.
Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1.
Pred odločitvijo o vključitvi snovi v Prilogo XIV Agencija ob upoštevanju mnenja Odbora držav članic priporoči prednostne snovi, ki jih je treba vključiti, in pri tem za vsako snov navede podatke iz odstavka 1.
Priority shall normally be given to substances with:
Običajno se da prednost snovem, ki:
PBT or vPvB properties; or
imajo lastnosti PBT ali vPvB; ali
wide dispersive use; or
široko razširjeno uporabo; ali
high volumes.
so v velikih količinah.
The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for.
Pri številu snovi, vključenih v Prilogo XIV, in datumih, določenih v skladu z odstavkom 1, je treba upoštevati tudi zmogljivosti Agencije za obravnavanje vlog v predvidenem roku.
The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009.
Agencija svoje prvo priporočilo prednostnih snovi, ki jih je treba vključiti v Prilogo XIV, izda do 1. junija 2009.
The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.
Nadaljnja priporočila za vključitev dodatnih snovi v Prilogo XIV Agencija izda vsaj vsako drugo leto.
Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information.
Preden Agencija pošlje svoje priporočilo Komisiji, ga da najprej na razpolago javnosti na svoji spletni strani, pri čemer jasno navede datum objave, ob upoštevanju členov 118 in 119 o dostopu do informacij.
The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement.
Agencija vse zainteresirane strani pozove, da v treh mesecih po objavi predložijo pripombe, zlasti o uporabah, ki jih je treba izvzeti iz zahtev avtorizacije.
The Agency shall update its recommendation, taking into account the comments received.
Agencija svoje priporočilo dopolni ob upoštevanju prejetih pripomb.
Subject to paragraph 6, after inclusion of a substance in Annex XIV, this substance shall not be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the use of the substance on its own, in a preparation or incorporation of a substance in an article arising from the intrinsic properties specified in Annex XIV.
Po vključitvi snovi v Prilogo XIV se ob upoštevanju odstavka 6 zanjo v skladu s postopkom iz naslova VIII ne smejo sprejeti nove omejitve za nadzorovanje tveganj za zdravje ljudi ali okolje, ki jih povzroča uporaba snovi kot take, v pripravku ali njena vgraditev v izdelek, zaradi intrinzičnih lastnosti iz Priloge XIV.
A substance listed in Annex XIV may be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the presence of the substance in (an) article(s).
Za snov iz Priloge XIV se lahko sprejmejo nove omejitve v skladu s postopkom iz naslova VIII za nadzorovanje tveganj za zdravje ljudi ali okolja zaradi prisotnosti snovi v izdelku(-ih).
Substances for which all uses have been prohibited under Title VIII or by other Community legislation shall not be included in Annex XIV or shall be removed from it.
Snovi, za katere so bile prepovedane vse uporabe v skladu z naslovom VIII ali drugo zakonodajo Skupnosti, se ne vključijo v Prilogo XIV ali se iz nje odstranijo.
Substances which as a result of new information no longer meet the criteria of Article 57 shall be removed from Annex XIV in accordance with the procedure referred to in Article 133(4).
Snovi, ki na podlagi novih informacij ne izpolnjujejo več kriterijev iz člena 57, se odstranijo iz Priloge XIV v skladu s postopkom iz člena 133(4).
Identification of substances referred to in Article 57
Identifikacija snovi iz člena 57
The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV.
Postopek, naveden v odstavkih 2 do 10 tega člena, se uporablja za opredelitev snovi, ki izpolnjujejo kriterije iz člena 57, in določitev seznama tistih snovi, ki bodo morda vključene v Prilogo XIV.
The Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e).
Agencija v tem seznamu navede snovi, ki so na njenem delovnem programu v skladu s členom 83(3)(e).
The Commission may ask the Agency to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57.
Komisija lahko Agencijo zaprosi, da pripravi dokumentacijo v skladu z ustreznimi oddelki Priloge XV za snovi, ki po njenem mnenju izpolnjujejo kriterije iz člena 57.
The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC.
Dokumentacija je lahko omejena na sklicevanje na vnos v Prilogi I k Direktivi 67/548/EGS, če je primerno.
The Agency shall make this dossier available to the Member States.
Agencija da to dokumentacijo na razpolago državam članicam.
Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 and forward it to the Agency.
Vsaka država članica lahko pripravi dokumentacijo v skladu s Prilogo XV za snovi, ki po njenem mnenju izpolnjujejo kriterije iz člena 57, in jo pošlje Agenciji.
The Agency shall make this dossier available within 30 days of receipt to the other Member States.
Agencija to dokumentacijo v 30 dneh po prejemu da na razpolago drugim državam članicam.
The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance.
Agencija na svoji spletni strani objavi obvestilo, da je bila za snov pripravljena dokumentacija iz Priloge XV.
The Agency shall invite all interested parties to submit comments within a specified deadline to the Agency.
Agencija vse zainteresirane strani povabi, naj ji v določenem roku predložijo pripombe.