natgillin/translations-raw huggingface dataset:
When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.
Ko je kozmetični izdelek dan na trg, odgovorna oseba Komisiji posreduje originalne podatke glede označb oziroma v primeru čitljivosti fotografijo le teh.
As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the Commission:
Od 11. julij 2013 er, ki omogoči dostopnost kozmetičnega izdelka na trgu v državi članici, ki se že prodaja v drugi državi članici, in na svojo pobudo prevede podatke na označbi na izdelku, da se uskladi z nacionalno zakonodajo, posreduje Komisiji v elektronski obliki naslednje informacije:
the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;
kategorijo kozmetičnega izdelka, njegovo ime v državi članici odkoder je kozmetični izdelek odposlan in njegovo ime v državi članici, kjer je dostopen na trgu kar omogoča njegovo natančno identifikacijo;
the Member State in which the cosmetic product is made available;
državo članico, v kateri je kozmetični izdelek dostopen;
the name and address of the responsible person where the product information file is made readily accessible..
ime in naslov odgovorne osebe, pri kateri je dokumentacija z informacijami o izdelku vselej na voljo.
Where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor shall communicate the following to the responsible person:
Kadar je bil kozmetični izdelek dan na trg pred 11. julij 2013 ampak se po navedem datumu ne daje več na trg, distributer, ki uvede ta izdelek v državo članico po tem datumu, odgovorni osebi sporoči naslednje:
his name and address.
svoje ime in naslov.
On the basis of that communication, the responsible person shall submit to the Commission, by electronic means, the information referred to in paragraph 1 of this Article, where notifications according to Article 7(3) and Article 7a (4) of Directive 76/768/EEC have not been carried out in the Member State in which the cosmetic product is made available.
Na osnovi navedenega sporočila, odgovorna oseba v elektronski obliki posreduje Komisiji informacije iz odstavka 1 tega člena, ko priglasitve iz člena 7(3) in člena 7a(4) Direktive 76/768/EGS niso bile opravljene v državi članici, kjer je kozmetični izdelek dostopen.
The Commission shall, without delay, make the information referred to in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities.
Komisija nemudoma omogoči dostopnost do informacij iz točk (a) do (g) odstavka 1 ter iz odstavkov 2 in 3 vsem pristojnim organom v elektronski obliki.
That information may be used by competent authorities only for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
Pristojni organi lahko uporabijo te informacije samo za namene nadzora trga, analizo trga, vrednotenje in obveščanje potrošnikov v okviru členov 25, 26 in 27.
The Commission shall, without delay, make the information referred to in paragraphs 1, 2 and 3 available electronically to poison centres or similar bodies, where such centres or bodies have been established by Member States.
Komisija nemudoma omogoči dostopnost do informacij iz odstavkov 1, 2 in 3 v elektronski obliki centrom za nadzor zastrupitev ali podobnim organom, kjer so takšne centre ali telesa države članice ustanovile v ta namen.
That information may be used by those bodies only for the purposes of medical treatment.
Navedeni organi lahko te informacije uporabljajo samo za namene zdravljenja.
Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.
Kadar se katere koli informacije iz odstavkov 1, 3 in 4 spremenijo, odgovorna oseba ali distributer nemudoma zagotovita njihovo posodobitev.
The Commission may, taking into account technical and scientific progress and specific needs related to market surveillance, amend paragraphs 1 to 7 by adding requirements.
Komisija lahko, ob upoštevanju tehničnega in znanstvenega napredka in posebnih potreb, ki zadevajo nadzor trga, spremeni odstavke od 1 do 7 z dodajanjem zahtev.
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
Navedeni ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 32(3).
RESTRICTIONS FOR CERTAIN SUBSTANCES
OMEJITVE ZA NEKATERE SNOVI
Restrictions for substances listed in the Annexes
Omejitve za snovi, navedene v prilogah
Without prejudice to Article 3, cosmetic products shall not contain any of the following:
Brez poseganja v člen 3, kozmetični izdelki ne smejo vsebovati česar koli od navedenega:
prohibited substances
prepovedanih snovi
prohibited substances listed in Annex II;
prepovedanih snovi, naštetih v Prilogi II;
restricted substances
omejenih snovi,
restricted substances which are not used in accordance with the restrictions laid down in Annex III;
omejenih snovi, ki se ne uporabljajo v skladu z omejitvami iz Priloge III;
colorants
barvil
colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;
barvil, razen tistih, naštetih v Prilogi IV, in barvil, ki so tam našteta, vendar se ne uporabljajo v skladu s pogoji iz navedene priloge, razen za izdelke za barvanje las iz odstavka 2;
without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;
brez poseganja v točke (b), (d)(i) in (e)(i), snovi, ki so naštete v Prilogi IV, vendar niso namenjene uporabi kot barvila in se ne uporabljajo v skladu s pogoji iz navedene priloge;
preservatives
konzervansov
preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;
konzervansov, razen tistih, naštetih v Prilogi V in konzervansov, ki so našteti, vendar se ne uporabljajo v skladu s pogoji iz navedene priloge;
without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;
brez poseganja v točke (b), (c)(i) in (e)(i), snovi, ki so naštete v Prilogi V, vendar niso namenjene uporabi kot konzervansi in se ne uporabljajo v skladu s pogoji iz navedene priloge;
UV-filters
UV-filtrov
UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex;
UV-filtrov, razen tistih, naštetih v Prilogi VI in UV-filtrov, ki so našteti, vendar se ne uporabljajo v skladu s pogoji iz navedene priloge;
without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.
brez poseganja v točke (b), (c)(i) in (d)(i), snovi, ki so naštete v Prilogi VI, vendar niso namenjene uporabi kot UV-filtri in se ne uporabljajo v skladu s pogoji iz navedene priloge.
Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring products, such products shall not contain colorants intended to colour the hair, other than those listed in Annex IV and colorants intended to colour the hair which are listed there but not used in accordance with the conditions laid down in that Annex.
Razen, če se Komisija odloči, da bo razširila obseg Priloge IV na izdelke za barvanje las, takšni izdelki ne smejo vsebovati barvil, namenjenih za barvanje las, razen tistih, naštetih v Prilogi IV in barvil, namenjenih za barvanje las, ki so tam našteti vendar se ne uporabljajo v skladu s pogoji iz navedene priloge.
The decision of the Commission referred to in the first subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
Odločitev Komisije iz prvega pododstavka, namenjena spreminjanju nebistvenih določb te uredbe, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 32(3).
Substances classified as CMR substances
Snovi, ki so razvrščene kot CMR snovi
The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.
V kozmetičnih izdelkih je prepovedano uporabljati snovi, ki so razvrščene kot CMR, kategorije 2, v okviru dela 3 Priloge VI k Uredbi (ES) št. 1272/2008.
However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products.
Vendar pa se snov, razvrščena v kategorijo 2 lahko uporablja v kozmetičnih izdelkih, če jo je SCCS ocenil in ugotovil, da je varna za uporabo v kozmetičnih izdelkih.
To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.
V ta namen Komisija sprejme potrebne ukrepe v skladu z regulativnim postopkom s pregledom iz člena 32(3) te uredbe.
The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.
V kozmetičnih izdelkih je prepovedano uporabljati snovi, ki so razvrščene kot CMR snovi, kategorijo 1A ali 1B v okviru dela 3 Priloge VI k Uredbi (ES) št. 1272/2008.
However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:
Vendar pa se takšne snovi lahko izjemoma uporabljajo v kozmetičnih izdelkih, če so poleg njihove razvrstitve kot CMR snovi kategorijo 1A ali 1B v okviru dela 3 Priloge VI kUredbi (ES) št. 1272/2008, izpolnjeni vsi naslednji pogoji:
they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [14];
so skladne z zahtevami glede varnosti živil, kakor so opredeljene v Uredbi (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [14];
there are no suitable alternative substances available, as documented in an analysis of alternatives;
ni na voljo ustreznih alternativnih snovi, kakor izhaja iz analize alternativnih možnosti;
the application is made for a particular use of the product category with a known exposure; and
uporabljali se bodo le za posebno rabo kategorije izdelka, z znano izpostavljenostjo ter
they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.
SCCS jih je ocenil in ugotovil, da je njihova uporaba v kozmetičnih izdelkih varna, zlasti v smislu izpostavljenosti tem izdelkom in ob upoštevanju celotne izpostavljenosti iz drugih virov, ob upoštevanju občutljivih skupin prebivalstva.
Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.
V izogib napačni rabi kozmetičnega izdelka se v skladu s členom 3 te uredbe zagotovi posebno označevanje, ob upoštevanju možnih tveganj, povezanih s prisotnostjo nevarnih snovi in načini izpostavljenosti.
In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
Za izvajanje tega odstavka, Komisija najpozneje v 15 mesecih po vključitvi zadevnih snovi v del 3 Priloge VI k Uredbi (ES) št. 1272/2008 spremeni priloge k tej uredbi v skladu z regulativnim postopkom s pregledom iz člena 32(3) te uredbe.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4) of this Regulation.
V nujnih primerih lahko Komisija uporabi nujni postopek iz člena 32(4) te uredbe.
The Commission shall mandate the SCCS to re-evaluate those substances as soon as safety concerns arise, and at the latest five years after their inclusion in Annexes III to VI to this Regulation, and at least every subsequent five years.
Komisija pooblasti SCCS, da ponovno oceni te snovi, takoj ko se pojavijo pomisleki v zvezi z varnostjo in najkasneje 5 let po njihovi vključitvi v priloge III do VI k tej uredbi ter nato vsaj vsakih pet let.
By 11 January 2012, the Commission shall ensure that appropriate guidance is developed with the aim of enabling a harmonised approach to the development and use of overall exposure estimates in assessing the safe use of CMR substances.
Do 11. januar 2012 izdelajo primerne smernice za omogočanje usklajenega pristopa k razvoju in uporabi ocen o celotni izpostavljenosti pri ocenjevanju varne uporabe CMR snovi.
This guidance shall be developed in consultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing, as appropriate, on relevant best practice.
Smernice se izdelajo s posvetovanjem s SCCS, ECHA in EFSA ter drugimi ustreznimi zainteresiranimi stranmi, po potrebi, z uporabo ustrezne najboljše prakse.
When Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties.
Ko so na voljo na ravni Skupnosti ali mednarodno dogovorjena merila za ugotavljanje snovi z lastnostmi endokrinih motilcev ali najkasneje do 11. januar 2015, Komisija pregleda to uredbo z vidika snovi z lastnostmi endokrinih motilcev.
Nanomaterials
Nanomateriali
For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured.
Za vsak kozmetični izdelek, ki vsebuje nanomateriale, se zagotovi visoka raven varovanja zdravja ljudi.
The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.
Določbe tega člena se ne nanašajo na nanometeriale, ki se uporabljajo kot barvila, UV-filtri ali konzervansi, ki jih ureja člen 14, razen če je to izrecno navedeno.
In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market, except where they have already been placed on the market by the same responsible person before 11 January 2013.
Poleg priglasitve iz člena 13 mora odgovorna oseba o kozmetičnih izdelkih, ki vsebujejo nanomateriale, v elektronski obliki obvestiti Komisijo šest mesecev preden se ti dajo na trg, razen če jih je ista odgovorna oseba dala na trg že pred 11. januar 2013.
In the latter case, cosmetic products containing nanomaterials placed on the market shall be notified to the Commission by the responsible person between 11 January 2013 and 11 July 2013 by electronic means, in addition to the notification in Article 13.
V slednjem primeru poleg priglasitve iz člena 13 odgovorna oseba v elektronski obliki obvesti Komisijo o kozmetičnih izdelkih, ki vsebujejo nanomateriale in so bili dani na trg, med 11. januar 2013 in 11. julij 2013.
The first and the second subparagraphs shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.
Prvi in drugi pododstavek se ne uporabljata za kozmetične izdelke, ki vsebujejo nanomateriale, ki so v skladu z zahtevami iz Priloge III.
The information notified to the Commission shall contain at least the following:
Med informacijami, ki se v priglasitvi pošljejo Komisiji so vsaj naslednje::
the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI;
identifikacija nanomateriala, vključno z njegovim kemijskim imenom (IUPAC) in drugimi deskriptorji, kot so navedeni v točki 2 preambule k prilogam II do VI;
the specification of the nanomaterial including size of particles, physical and chemical properties;
specifikacija nanomateriala, vključno z velikostjo delcev, fizikalne in kemijske lastnosti;
an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year;
ocena količin nanomateriala v kozmetičnih izdelkih, ki se nameravajo letno dati na trg;
the toxicological profile of the nanomaterial;
toksikološki profil nanomateriala;
the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;
varnostni podatki o nanomaterialu povezani s kategorijo kozmetičnih izdelkov, v katerih so uporabljeni;
the reasonably foreseeable exposure conditions.
razumno predvidljivi pogoje izpostavljenosti.
The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof.
Odgovorna oseba lahko določi s pisnim pooblastilom drugo pravno ali fizično osebo za priglasitev o nanomaterialih in o tem obvesti Komisijo.
The Commission shall provide a reference number for the submission of the toxicological profile, which may substitute the information to be notified under point (d).
Komisija priskrbi referenčno številko za predložitev toksikološkega profila, ki lahko nadomesti informacije, ki se sporočajo v skladu s točko (d).
In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commission shall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions.
V primeru, da ima Komisija pomisleke v zvezi z varnostjo nanomateriala, nemudoma zahteva, naj SCCS predloži mnenje o varnosti takega nanomateriala za uporabo v ustreznih kategorijah kozmetičnih izdelkov in o razumno predvidljivih pogojih izpostavljenosti.
The Commission shall make this information public.
Komisija poskrbi, da so te informacije javno dostopne.
The SCCS shall deliver its opinion within six months of the Commission's request.
SCCS poda svoje mnenje v roku šestih mesecev od zahteve Komisije.
Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsible person to provide such data within an explicitly stated reasonable time, which shall not be extended.
V kolikor SCCS ugotovi, da določeni potrebni podatki manjkajo, Komisija od pristojne osebe zahteva, da take podatke zagotovi v jasno določenem razumnem času, ki se ga ne podaljša.
The SCCS shall deliver its final opinion within six months of submission of additional data.
SCCS poda svoje končno mnenje v roku šestih mesecev od predložitve dodatnih podatkov.
The opinion of the SCCS shall be made publicly available.
Mnenje SCCS je javno dostopno.
The Commission may, at any time, invoke the procedure in paragraph 4 where it has any safety concerns, for example due to new information supplied by a third party.
Komisija se lahko kadar koli sklicuje na postopek iz odstavka 4, če ima pomisleke v zvezi z varnostjo, na primer zaradi novih informacij, ki jih predloži tretja stran.
Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the Commission may amend Annexes II and III.
Ob upoštevanju mnenja SCCS in ob morebitnem tveganju za zdravje ljudi, vključno kadar je na voljo premalo podatkov, Komisija lahko spremeni prilogi II in III.
The Commission may, taking into account technical and scientific progress, amend paragraph 3 by adding requirements.
Komisija lahko, ob upoštevanju tehničnega in znanstvenega napredka, spremeni odstavek 3 z dodajanjem zahtev.
The measures, referred to in paragraphs 6 and 7, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
Ukrepi iz odstavkov 6 in 7, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 32(3).
On imperative grounds of urgency the Commission may use the procedure referred to in Article 32(4).
V nujnih primerih lahko Komisija uporabi postopek iz člena 32(4).
The following information shall be made available by the Commission:
Komisija da na razpolago naslednje informacije:
By 11 January 2014, the Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions.
Komisija do 11. januar 2014 poskrbi, da je na voljo katalog vseh nanomaterialov, ki se uporabljajo v kozmetičnih izdelkih, ki se dajo na trg, vključno s tistimi, ki se uporabljajo v barvilih, UV-filtrih in konzervansih v ločenem delu, pri čemer navede kategorije kozmetičnih izdelkov in razumno predvidljive pogoje izpostavljenost.
This catalogue shall be regularly updated thereafter and be made publicly available.
Ta katalog se redno posodablja in je javno dostopen.
The Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products within the Community, including those used as colorants, UV-filters and preservatives in a separate section.
Komisija Evropskemu parlamentu in Svetu predloži letno statusno poročilo s podatki o razvoju uporabe nanomaterialov v kozmetičnih izdelkih v Skupnosti, vključno s tistimi, ki se uporabljajo kot barvila, UV-filtri in konzervansi v ločenem delu.
The first report shall be presented by 11 July 2014 The report update shall summarise, in particular, the new nanomaterials in new categories of cosmetic products, the number of notifications, the progress made in developing nano-specific assessment methods and safety assessment guides, and information on international cooperation programmes.
Prvo poročilo se predloži do 11. julij 2014. Letna posodobitev povzema zlasti nove nanomateriale v novih kategorijah kozmetičnih izdelkov, število priglasitev, napredek razvoja metod vrednotenja, značilne za nanomateriale, in smernic za oceno varnosti ter informacije o programih mednarodnega sodelovanja.