natgillin/translations-raw huggingface dataset:
Ponavadi se da
Priority shall normally be given
imajo lastnosti PBT ali vPvB;
PBT or vPvB properties;
snovem s
substances with
v velikih količinah
high volumes
snovem, ki so sestavine, dodane tobačnim izdelkom v smislu člena 2(1) in (5) Direktive 2001/37/ES.
substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC.
Pri številu snovi, vključenih v Prilogo III, in datumih, določenih v skladu z odstavkom 1, je treba upoštevati tudi zmogljivosti Agencije za obravnavanje vlog v predvidenem roku.
The number of substances included in Annex XIII and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for.
Agencija vse zainteresirane strani pozove, da v treh mesecih po objavi predložijo pripombe, zlasti o:
The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on the following:
izpolnjevanju meril iz
fulfilment of the criteria in
uporabah, ki jih je treba izvzeti iz zahteve za pridobitev dovoljenja.
uses which should be exempt from the authorisation requirement.
Agencija svoje priporočilo dopolni ob upoštevanju prejetih pripomb.
The Agency shall update its recommendation, taking into account the comments received.
Po vključitvi snovi v Prilogo XIII se zanjo v skladu s postopkom iz naslova VIII ne smejo sprejeti nove omejitve za nadzorovanje nevarnosti za zdravje ljudi ali okolje, ki jih povzroča uporaba snovi zaradi notranjih lastnosti iz Priloge XIII
After inclusion of a substance in Annex XIII, this substance shall not be subject 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 arising from the intrinsic properties specified in Annex XIII
Snovi, za katere so bile prepovedane vse uporabe v skladu z naslovom VIII ali drugo zakonodajo Skupnosti, se ne vključijo v Prilogo XIII ali se iz nje odstranijo.
Substances for which all uses have been prohibited under Title VIII or by other Community legislation shall not be included in Annex XIII or shall be removed from it.
in vključitev
and inclusion in Annex XIII(a)
snovi iz
of substances referred to in
Snovi iz člena 63(a), (b) in (c) se vključijo v Prilogo XIII(a).
Substances referred to in Article 63(a), (b) and (c) shall be included in Annex XIII(a).
Za določitev snovi iz
To identify substances referred to in
člena 63(d)
Article 63(d)
, (e) in (f) se pred priporočili v skladu s
, (e) and (f) the procedure set out in
odstavkov 3 do 8
paragraphs 3 to 8
Komisija lahko Agencijo zaprosi, da pripravi dokumentacijo v skladu s Prilogo XIV za snovi, ki po njenem mnenju izpolnjujejo merila iz
The Commission may ask the Agency to prepare a dossier in accordance with Annex XIV for substances which in its opinion meet the criteria set out in
člena 63(d)
Article 63 (d)
Agencija to dokumentacijo razpošlje državam članicam.
The Agency shall circulate this dossier to the Member States.
Vsaka država članica lahko pripravi dokumentacijo v skladu s Prilogo XIV za snovi, ki po njenem mnenju izpolnjujejo merila iz
Any Member State may prepare a dossier in accordance with Annex XIV for substances which in its opinion meet the criteria set out in
, (e) in (f), in jo pošlje Agenciji.
, (e) and (f) and forward it to the Agency.
Agencija to dokumentacijo razpošlje drugim državam članicam.
The Agency shall circulate this dossier to the other Member States.
V 30 dneh po tem, ko je bila dokumentacija razposlana, lahko druge države članice ali Agencija predložijo pripombe v zvezi z določitvijo snovi v dokumentaciji.
Within 30 days of circulation, the other Member States or the Agency may comment on the identification of the substance in the dossier to the Agency.
Če Agencija ne prejme nobenih pripomb, lahko to snov vključi v svoja priporočila v skladu s
If the Agency does not receive any comments, it may include this substance in its recommendations under
členom 64(3)
Article 64(3)
Po prejemu pripomb drugih držav članic ali na svojo pobudo Agencija predloži dokumentacijo Odboru držav članic v 15 dneh po poteku 30-dnevnega roka iz
Upon receipt of comments from another Member State or on its own initiative, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 30-day period referred to in
Če Odbor držav članic v 30 dneh po prejemu dokumentacije doseže
If, within 30 days of the referral, the Member State Committee reaches a
dogovor s kvalificirano večino, da snov izpolnjuje merila za pridobitev dovoljenja in jo je treba vključiti v Prilogo XIII(b)
qualified majority agreement that the substance satisfies the criteria for authorisation and should be included in Annex XIII(b),
v 15 delovnih dneh priporoči Komisiji, da se snov vključi v Prilogo XIII(b), kot je določeno v
shall, within 15 working days, recommend to the Commission that the substance be included in Annex XIII(b), as provided for in
členu 64(3)
Article 64(3)
Če Odbor držav članic ne doseže
If the Member State Committee fails to reach a
dogovora s kvalificirano večino
qualified majority
, sprejme mnenje v 30 dneh po prejemu dokumentacije.
agreement, it shall adopt an opinion within 30 days of the referral.
Agencija to mnenje sporoči Komisiji
The Agency shall transmit that opinion to the Commission
v 15 delovnih dneh,
within 15 working days
pri čemer jo obvesti o manjšinskih stališčih v Odboru
, including information on any minority view within the Committee
, da Komisija sprejme odločitev
, in order for the Commission to take a decision
Snovi, ki so na novo razvrščene, da izpolnjujejo merila iz člena 63(a), (b) in (c), in snovi, ki so opredeljene, da izpolnjujejo merila iz člena 63(d), (e) in (f), je treba v treh mesecih vključiti v Prilogo XIII(a).
Substances that are newly classified as fulfilling the criteria of Article 63(a), (b) and (c) and substances identified as fulfilling the criteria of Article 63(d), (e) and (f) shall be included in Annex XIII(a) within three months.
IZDAJANJE DOVOLJENJ
THE GRANTING OF AUTHORISATIONS
Izdajanje dovoljenj
The granting of authorisations
Komisija je v skladu s tem naslovom pristojna, da odloča o vlogah za pridobitev dovoljenja.
The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title.
Pri takšnem odločanju velja previdnostno načelo.
The precautionary principle shall apply when such decisions are taken.
Dovoljenje se izda
An authorisation shall be granted
ustrezne nadomestne snovi ali tehnologije ne obstajajo, zagotovljeni pa so ukrepi za zmanjšanje izpostavljenosti,
suitable alternative substances or technologies do not exist, and measures are in place to minimise exposure; and
ugotovljeno je, da socialno-ekonomske koristi presegajo tveganje za zdravje ljudi ali okolje zaradi uporabe snovi, in
it is demonstrated that the social and economic advantages outweigh the risks to human health or the environment which arise from the use of the substance; and
za človekovo zdravje
to human health
ali okolje
or the environment
, ki izhaja iz njenih notranjih lastnosti, določenih v Prilogi XIII(a), je ustrezno nadzorovano v skladu s Prilogo I, oddelek 6, in kot je dokumentirano v poročilu uporabnika o kemijski varnosti.
arising from the intrinsic properties specified in Annex XIII(a) is adequately controlled in accordance with section 6 of Annex I, and as documented in the applicant's chemical safety report.
se sprejme po proučitvi vseh naslednjih elementov:
shall be taken after consideration of all of the following elements:
nevarnosti, ki jih pomenijo uporabe snovi;
the risk posed by the uses of the substance;
socialno-ekonomskih koristi, ki izhajajo iz njene uporabe, in socialno-ekonomskih posledic v primeru zavrnitve izdaje dovoljenja, kot jih prikažejo vlagatelj ali druge zainteresirane strani;
the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
analize nadomestnih možnosti, ki jo predloži vlagatelj v skladu s
the analysis of the alternatives submitted by the applicant under
členom 68(4)(e), (f)
Article 68(4)(e) and (f)
in prispevkov tretje strani, predloženih v skladu s
and any third party contributions submitted under
členom 70(2)
Article 70(2)
razpoložljivih informacij o nevarnostih, ki jih pomenijo za zdravje ali okolje nadomestne snovi ali tehnologije.
available information on the health or environmental risks of any alternative substances or technologies.
Pri izdaji odobritve v skladu z odstavkom 2 Komisija ne bo upoštevala naslednjega:
In granting authorisation pursuant to paragraph 2 the Commission shall not consider the following:
tveganj za zdravje ljudi in okolje zaradi izpusta snovi iz objekta, za katerega je bilo izdano dovoljenje v skladu z Direktivo Sveta 96/61/ES
the risks to human health and the environment of emissions of the substance from an installation for which a permit was granted in accordance with Council Directive 96/61/EC
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 166/2006 Evropskega parlamenta in Sveta (UL L 33, 4.2.2006, str.
Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p.
tveganj za vodno okolje in tveganj, ki se prenašajo po vodnem okolju zaradi odvajanja snovi iz točkovnih virov v okviru zahteve po prejšnji uredbi, omenjeni v členu 11(3) Direktive 2000/60/ES Evropskega parlamenta in Sveta
the risks to and via the aquatic environment of discharges of the substance from a point source governed by the requirement for prior regulation referred to in Article 11(3) of Directive 2000/60/EC of the European Parliament and of the Council
in zakonodaji, sprejeti v skladu s členom 16 Direktive;
and legislation adopted under Article 16 thereof;
tveganj za zdravje ljudi zaradi uporabe snovi v medicinskem pripomočku, kot to urejajo direktive 90/385/EGS, 93/42/EGS in 98/79/ES.
the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.
Uporaba se ne dovoli, če bi to pomenilo sprostitev omejitve iz Priloge XVI.
A use shall not be authorised if this would constitute a relaxation of a restriction set out in Annex XVI.
Dovoljenje se izda samo, če je bila vloga predložena v skladu z zahtevami iz
An authorisation shall be granted only if the application is made in conformity with the requirements of
člena 68
Article 68
dovoljenja veljajo roki
be subject
predstavitev nadomestnih načrtov ter so lahko pogojena z drugimi pogoji, vključno s
and to the presentation of substitution plans, and may be subject to other conditions, including
časovno omejena
be subject to a time-limit
za obdobje največ 5 let
not exceeding 5 years
V dovoljenju morajo biti navedeni naslednji podatki:
The authorisation shall specify:
oseba(e), kateri(m) se izdaja dovoljenje;
the person(s) to whom the authorisation is granted;
podatki o snovi;
the identity of the substance(s);
uporaba(e), za katero(e) se izdaja dovoljenje;
the use(s) for which the authorisation is granted;
način spremljanja.
any monitoring arrangement.
Ne glede na pogoje iz dovoljenja imetnik zagotovi, da se raven izpostavljenosti zniža, če je to tehnično izvedljivo.
Notwithstanding any conditions of an authorisation, the holder shall ensure that the level of exposure is reduced to as low as is technically possible.
Preverjanje dovoljenj
Review of authorisations
Dovoljenja veljajo,
Authorisations shall
dokler se Komisija ne odloči, da je treba predložiti novo vlogo, če imetnik dovoljenja novo vlogo predloži vsaj 18 mesecev pred potekom roka.
be regarded as valid until the Commission decides on a new application, provided that the holder of the authorisation submits a new application at least 18 months before the expiry of the time-limit.
številko trenutno veljavnega
the number of the current
poročilo o kemijski varnosti.
update of the chemical safety report.
Če se spremenijo drugi sestavni deli prvotne vloge, predloži tudi te, ki jih prilagodi zadnjemu stanju.
If any other elements of the original application have changed, he shall also submit updates of these element(s).
koli preverijo, če se okoliščine iz prvotnega dovoljenja spremenijo tako, da pomenijo nevarnost za zdravje ljudi ali okolje ali da imajo socialno-ekonomske posledice.
be reviewed at any time if the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact.
V takšnih primerih Komisija določi ustrezen rok, do katerega imetnik(i) dovoljenja lahko predloži(jo) dodatne informacije, potrebne za preverjanje, ter pri tem navede, do kdaj bo sprejela odločitev v skladu s
In such cases, the Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with
členom 70
Article 70
V svoji odločitvi o preverjanju lahko Komisija ob upoštevanju sorazmernosti dovoljenje spremeni ali prekliče z datumom odločitve, če zaradi spremenjenih okoliščin ne bi bilo izdano.
In its review decision the Commission may, taking into account proportionality, amend the authorisation or withdraw the authorisation from the time of the decision, if under the changed circumstances it would not have been granted.
Pri nevarnosti
In cases where there is
se preverijo
be reviewed.
Če niso izpolnjeni okoljski cilji iz člena 4(1) Direktive 2000/60/ES, se lahko preverijo dovoljenja, izdana za uporabo zadevne snovi v ustreznem porečju.
If the environmental objectives as referred to in Article 4(1) of Directive 2000/60/EC are not met, the authorisations granted for the use of the substance concerned in the relevant river basin may be reviewed.
Če se uporaba snovi pozneje
If a use of a substance is subsequently
omeji ali
restricted or
, Komisija prekliče dovoljenje za to
, the Commission shall withdraw the authorisation for that
Vloge za izdajo dovoljenja
Applications for authorisations
Vloga za izdajo dovoljenja se predloži Agenciji.
An application for an authorisation shall be made to the Agency.
Vloge za izdajo dovoljenja lahko predložijo proizvajalec(ci), uvoznik(i) in/ali uporabnik(i) snovi na nižji stopnji.
Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance.
Vlogo lahko predloži ena ali več oseb.
Applications may be made by one or several persons.
Vloge se lahko predložijo za eno ali več snovi in za eno ali več uporab.
Applications may be made for one or several substances, and for one or several uses.
Vloge se lahko oddajo za lastno uporabo(e) vlagatelja(ev) in/ali uporabe, za katere ta namerava dajati snov v promet.
Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market.
Vloga za izdajo dovoljenja mora vsebovati naslednje informacije:
An application for authorisation shall include the following information:
ime in podatke za stike osebe ali oseb, ki oddajo vlogo;
the name and contact details of the person or persons making the application;
zahtevek za izdajo dovoljenja, v katerem se navede, za katero(e) uporabo(e) se skuša pridobiti dovoljenje, in zajame uporabo snovi v pripravkih in/ali vgraditev snovi v izdelke, če je ustrezno;
a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in preparations and/or the incorporation of the substance in articles, where this is relevant;
analizo nadomestnih možnosti, ob upoštevanju njihovih nevarnosti ter tehnične in ekonomske izvedljivosti nadomestitve, ki se ji, če je ustrezno, priloži načrt nadomestitve, ki vključuje raziskave in razvoj ter časovni razpored ukrepov, ki jih predlaga vlagatelj.
an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution, where appropriate accompanied by a substitution plan, including research and development and a timetable for proposed actions by the applicant.
Vloga ne vključuje:
The application shall not include any of the following:
nevarnosti za vodno okolje in prek njega, ki jih pomenijo izpusti snovi iz točkovnih virov, za katere veljata zahteva za predhodno ureditev iz člena 11(3)
the risks to and via the aquatic environment of discharges of the substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)
nevarnosti za zdravje ljudi, ki izhajajo iz uporabe snovi v medicinskem pripomočku, ki jih urejajo direktive 90/385/EGS, 93/42/EGS ali 98/79/ES.
the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.
Ob predložitvi vloge za registracijo se plača pristojbina, kot jo določi Agencija.
An application for an authorisation shall be accompanied by the fee as set by the Agency.
Naknadne vloge za izdajo dovoljenja
Subsequent applications for authorisation
Če je bila za uporabo snovi že oddana vloga, se lahko naknadni vlagatelj z izjavo o dostopnosti, ki mu jo izda predhodni vlagatelj, sklicuje na sestavne dele predhodne vloge, predložene v skladu s
If an application has been made for a use of a substance, a subsequent applicant may refer, by means of a letter of access granted by the previous applicant, to the parts of the previous application submitted in accordance with
členom 68(4)(d),(e) in (f)
Article 68(4)(d), (e) and (f)
Če je bilo za uporabo snovi že izdano dovoljenje, se naknadni vlagatelj lahko z izjavo o dostopnosti, ki mu jo izda imetnik dovoljenja, sklicuje na sestavne dele imetnikove vloge, predložene v skladu s
If an authorisation has been granted for a use of a substance, a subsequent applicant may refer, by means of a letter of access granted by the holder of the authorisation, to the parts of the holder's application submitted in accordance with
členom 68(4)(d), (e) in (f)
Article 68(4)(d), (e) and (f)
Postopek za sprejetje odločitev o dovoljenjih
Procedure for authorisation decisions
Agencija potrdi datum prejema vloge.
The Agency shall acknowledge the date of receipt of the application.
Odbor Agencije za oceno tveganja in
The Agency's Committees for Risk
Odbor Agencije za socialno-ekonomsko analizo pripravita osnutek svojega mnenja v desetih mesecih po datumu prejema vloge.
Socio-economic Analysis shall give their draft opinions within ten months of the date of receipt of the application.
Ob upoštevanju zaupnosti podatkov v skladu s
The Agency shall make available on its web-site broad information on uses, taking confidentiality into account in accordance with
členom 127
Article 127
da Agencija na razpolago na svoji spletni strani splošne informacije o uporabah, za katere je prejela vloge, pri čemer navede roke, do katerih zainteresirane tretje strani lahko predložijo informacije o nadomestnih snoveh ali tehnologijah.
, for which applications have been received, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.
Pri pripravi svojega mnenja odbora iz odstavka 1 najprej preverita, ali vloga vključuje vse informacije iz
In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in
, ki jih potrebujeta za izvedbo svoje naloge.
that is relevant to its remit.
Po potrebi odbor vlagatelja zaprosi za dodatne informacije, da se vloga uskladi z zahtevami iz
If necessary, a Committee shall ask the applicant for additional information to bring the application into conformity with the requirements of
Oba odbora upoštevata tudi informacije, ki jih predložijo tretje strani
Each Committee shall also take into account any information submitted by third parties
Takšne preiskave se plača s pristojbino za registracijo, ki jo določi Agencija v skladu s členom 68(6).
Such investigations shall be funded by the authorisation fee set by the Agency pursuant to Article 68(6).
(ki jo izvaja prosilec odobritve)
(carried out by the applicant for authorisation)
tveganja za zdravje ljudi in/ali okolje zaradi uporabe/uporab snovi, kot je opisano v prošnji;
of the risk to health and/or the environment arising from the use(s) of the substance as described in the application;
Odbor za socialno-ekonomsko analizo:
Socio-economic Analysis Committee:
socialno-ekonomskih dejavnikov v povezavi z uporabo/uporabami snovi, kot je opisano v prošnji, kadar je prošnja vložena v skladu s
of the socio-economic factors associated with the use(s) of the substance as described in the application, when an application is made in accordance with
členom 68(4)(e) in (f)
Article 68(4)(e) and (f)
Agencija pošlje osnutka obeh mnenj vlagatelju do konca roka iz odstavka 1.
The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1.
V enem mesecu po prejemu osnutka mnenja lahko vlagatelj pisno izrazi željo po predložitvi pripomb.
Within 1 month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment.
Osnutek mnenja se šteje kot prejet sedem dni po tem, ko ga je Agencija poslala.
The draft opinion shall be deemed to have been received 7 days after the Agency has sent it.
Če vlagatelj ne želi predložiti pripomb, Agencija ti mnenji pošlje Komisiji, državam članicam in vlagatelju v 15 dneh po poteku roka, v katerem lahko vlagatelj predloži pripombe, ali v 15 dneh po prejemu obvestila vlagatelja, da ne namerava predložiti pripomb.
If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.
Če vlagatelj želi predložiti pripombe, jih pošlje Agenciji v pisni obliki v dveh mesecih po prejemu osnutka mnenja.
If the applicant wishes to comment, he shall send his written argumentation to the Agency within 2 months of the receipt of the draft opinion.
Odbora preučita pripombe in v dveh mesecih po njihovem prejemu v pisni obliki sprejmeta vsak svoje dokončno mnenje, pri čemer jih ustrezno upoštevata.
The Committees shall consider the comments and adopt their final opinions within 2 months of receipt of the written argumentation, taking this argumentation into account where appropriate.
V nadaljnjih 15 dneh Agencija pošlje mnenji s priloženimi pisnimi pripombami Komisiji, državam članicam in vlagatelju.
Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.
istočasno, ko sporoči to vlagatelju,
, at the same time as it communicates these to the applicant,
da nezaupne dele svojih mnenj in vse njihove priloge na razpolago javnosti na svoji spletni strani v skladu s
make the non-confidential parts of its opinions and any attachments thereto publicly available on its website, in accordance with
V primeru iz
In cases covered by
člena 69(1)
Article 69(1)
Agencija obravnava vloge skupaj, če se lahko izpolnijo roki za prvo vlogo.
, the Agency shall treat the applications together, provided the deadlines for the first application can be met.
Komisija pripravi osnutek odločitve o dovoljenju v treh mesecih po prejemu mnenj Agencije.
The Commission shall prepare a draft authorisation decision within 3 months of receipt of the opinions from the Agency.
Dokončna odločitev o izdaji ali zavrnitvi dovoljenja se sprejme v skladu s postopkom iz
A final decision granting or refusing the authorisation shall be taken in accordance with the procedure referred to in
člena 141(2)
Article 141(2)
člena 69(2)
Article 69(2)
se rok iz odstavka 1 tega člena skrajša na pet mesecev.
, the deadline set out in paragraph 1 of this Article shall be shortened to 5 months.
DOVOLJENJA V DOBAVNI VERIGI
AUTHORISATIONS IN THE SUPPLY CHAIN
obveščanja o snoveh, za katere je potrebno
information on substances subject to