natgillin/translations-raw huggingface dataset:
After consulting the SCCS or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation, taking into account the provisions of Directive 2005/29/EC.
Po posvetovanju s SCCS ali drugimi zadevnimi organi, Komisija sprejme seznam skupnih meril za navedbe, ki se lahko uporabljajo v zvezi s kozmetičnimi izdelki, v skladu z regulativnim postopkom s pregledom iz člena 32(3) te uredbe, ob upoštevanju določb Direktive 2005/29/ES.
By 11 July 2016, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria adopted under the second subparagraph.
Komisija do 11. julij 2016 Evropskemu parlamentu in Svetu predloži poročilo o uporabi navedb na podlagi sprejetih skupnih meril iz drugega pododstavka.
If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, the Commission shall take appropriate measures to ensure compliance in cooperation with the Member States.
Če je v poročilu ugotovljeno, da navedbe, ki se uporabljajo v zvezi s kozmetičnimi izdelki, niso skladne s skupnimi merili, Komisija ob sodelovanju z državami članicami sprejme ustrezne ukrepe za zagotovitev skladnosti.
The responsible person may refer, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the cosmetic product, to the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished cosmetic product, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products.
Odgovorna oseba lahko na embalaži izdelka ali katerem koli dokumentu, objavi, etiketi, obroču ali manšeti, priloženi izdelku ali nanašajoči se nanj, navede, da se testiranja kozmetičnega izdelka niso izvajala na živalih, samo če izvajalec ali njegov dobavitelj nista izvajala ali naročila nobenih testiranj končnega kozmetičnega izdelka ali njegovega prototipa ali katere koli od vsebovanih sestavin na živalih ali uporabila katere koli sestavine, ki jo je kdor koli testiral na živalih zaradi razvoja novih kozmetičnih izdelkov.
Access to information for the public
Dostop do informacij za javnost
Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are made easily accessible to the public by any appropriate means.
Brez poseganja v varovanje, zlasti poslovnih skrivnosti in pravic intelektualne lastnine, odgovorna oseba zagotovi, da so kvalitativna in kvantitativna sestava kozmetičnega izdelka, v primeru parfumov in aromatičnih sestavin pa tudi ime in številka šifre sestave in identiteta dobavitelja, kot tudi obstoječe informacije o neželenih učinkih in resnih neželenih učinkih zaradi uporabe kozmetičnega izdelka, lahko dostopni javnosti s kakršnimi koli ustreznimi sredstvi.
The quantitative information regarding composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with Article 3 of Regulation (EC) No 1272/2008.
Zahtevane kvantitativne informacije glede sestave kozmetičnega izdelka, ki morajo biti dostopni javnosti, se omejijo na nevarne snovi, v skladu s členom 3 Uredbe (ES) št. 1272/2008.
MARKET SURVEILLANCE
NADZOR TRGA
In-market control
Notranji nadzor trga
Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market.
Države članice skladnost s to uredbo preverjajo z notranjim nadzorom kozmetičnih izdelkov, ki so dostopni na trgu.
They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.
Izvajati morajo primerne preverbe kozmetičnih izdelkov in gospodarskih subjektov v primernem obsegu, preko dokumentacije z informacijami o izdelku in, kadar je primerno, fizične in laboratorijske preskuse na podlagi ustreznih vzorcev.
Member States shall also monitor compliance with the principles of good manufacturing practices.
Države članice nadzirajo tudi skladnost z načeli dobre proizvodne prakse.
Member States shall entrust to market surveillance authorities the necessary powers, resources and knowledge in order for those authorities to properly perform their tasks.
Države članice, organom za nadzor trga, dajo potrebna pooblastila, sredstva in znanje za pravilno izvajanje njihovih nalog.
Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means.
Takšni pregledi in ocene se izvajajo vsaj vsako četrto leto, rezultati pregledov in ocen pa se sporočijo ostalim državam članicam in Komisiji ter dajo na voljo javnosti prek elektronskih komunikacij ter, če je to ustrezno, prek drugih sredstev.
Communication of serious undesirable effects
Obveščanje o resnih neželenih učinkih
In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:
V primeru resnih nezaželenih učinkov, odgovorna oseba in distributerji nemudoma sporočijo pristojnim organom države članice, kjer se je pojavil resen nezaželen učinek, naslednje:
all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;
vse resne neželene učinke, ki so jim znani ali za katere bi bilo razumno pričakovati, da so jim znani,
the name of the cosmetic product concerned, enabling its specific identification;
ime zadevnega kozmetičnega izdelka, ki omogoča njegovo specifično identifikacijo,
the corrective measures taken by him, if any.
korektivne ukrepe, ki so jih morebiti sprejeli.
Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States.
Kadar odgovorna oseba poroča o resnih neželenih učinkih pristojnemu organu države članice, kjer se je učinek pojavil, ta pristojni organ nemudoma pošlje informacije iz odstavka 1 pristojnim organom drugih držav članic.
Where distributors report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States and to the responsible person.
Kadar distributerji poročajo o resnih neželenih učinkih pristojnemu organu države članice, kjer se je učinek pojavil, ta pristojni organ nemudoma pošlje informacije iz odstavka 1 pristojnim organom držav članic in odgovorni osebi.
Where end users or health professionals report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information on the cosmetic product concerned to the competent authorities of the other Member States and to the responsible person.
Kadar končni uporabniki ali zdravstveni delavci poročajo o resnih neželenih učinkih pristojnemu organu države članice, kjer se je učinek pojavil, ta pristojni organ nemudoma pošlje informacije o zadevnem kozmetičnem izdelku pristojnim organom držav članic in odgovorni osebi.
Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
Pristojni organi lahko uporabijo informacije iz tega člena za namen notranjega nadzora trga, analizo trga, oceno in obveščanje potrošnikov v okviru členov 25, 26 in 27.
Information on substances
Informacije o snoveh
In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance.
V primeru resnega dvoma glede varnosti katere koli snovi, ki jo vsebujejo kozmetični izdelki, lahko pristojni organ države članice, kjer je na trgu dostopen izdelek, ki vsebuje tako snov, z utemeljenim zahtevkom od odgovorne osebe zahteva predložitev seznama vseh kozmetičnih izdelkov, za katere je odgovorna in ki vsebujejo to snov.
The list shall indicate the concentration of this substance in the cosmetic products.
Seznam vsebuje navedbo koncentracij te snovi v kozmetičnih izdelkih.
NON-COMPLIANCE, SAFEGUARD CLAUSE
NEIZPOLNJEVANJE OBVEZNOSTI, ZAŠČITNA KLAVZULA
Non-compliance by the responsible person
Neizpolnjevanje obveznosti s strani odgovorne osebe
Without prejudice to paragraph 4, competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within an expressly mentioned time limit, commensurate with the nature of the risk, where there is non-compliance with any of the following:
Brez poseganja v odstavek 4, pristojni organi od odgovorne osebe zahtevajo, da sprejme vse ustrezne ukrepe, vključno s korektivnimi ukrepi za vzpostavitev skladnosti kozmetičnega izdelka, umik izdelka s trga, ali odpoklic v izrecno navedenem roku, sorazmerno z naravo tveganja, kadar ni izpolnjena katera koli izmed naslednjih zahtev:
the good manufacturing practice referred to in Article 8;
dobra proizvodna praksa iz člena 8;
the safety assessment referred to in Article 10;
ocena varnosti iz člena 10;
the requirements for the product information file referred to in Article 11;
zahteve za dokumentacijo z informacijami o izdelku iz člena 11;
the provisions on sampling and analysis referred to in Article 12;
določbe o vzorčenju in analizi iz člena 12;
the notification requirements referred to in Articles 13 and 16;
zahteve glede priglasitve iz členov 13 in 16;
the restrictions for substances referred to in Articles 14, 15 and 17;
omejitve za snovi iz členov 14, 15 in 17;
the animal testing requirements referred to in Article 18;
zahteve glede testiranj na živalih iz člena 18;
the labelling requirements referred to in Article 19(1), (2), (5) and (6);
zahteve glede označevanja iz člena 19(1), (2), (5) in (6);
the requirements related to product claims set out in Article 20;
zahteve v zvezi z navedbami na izdelkih iz člena 20;
the access to information for the public referred to in Article 21;
dostop do informacij za javnost iz člena 21;
the communication of serious undesirable effects referred to in Article 23;
obveščanje o resnih neželenih učinkih iz člena 23;
the information requirements on substances referred to in Article 24.
zahteve v zvezi z informacijami o snoveh iz člena 24.
Where applicable, a competent authority shall inform the competent authority of the Member State in which the responsible person is established of the measures which it has required the responsible person to take.
Po potrebi, pristojni organ obvesti pristojni organ države članice, kjer ima sedež odgovorna oseba, o ukrepih, ki jih je zahteval od odgovorne osebe.
The responsible person shall ensure that the measures referred to in paragraph 1 are taken in respect of all the products concerned which are made available on the market throughout the Community.
Odgovorna oseba zagotovi, da se ukrepi iz odstavka 1 sprejmejo za vse zadevne izdelke, ki so dostopni na trgu po vsej Skupnosti.
In the case of serious risks to human health, where the competent authority considers that the non-compliance is not limited to the territory of the Member State in which the cosmetic product is made available on the market, it shall inform the Commission and the competent authorities of the other Member States of the measures which it has required the responsible person to take.
Kadar pristojni organ, v primeru resnih tveganj za zdravje ljudi, meni, da neskladnost ni omejena le na ozemlje države članice, kjer je kozmetični izdelek dostopen na trgu, obvesti Komisijo in pristojne organe drugih držav članic o ukrepih, ki jih je zahteval od odgovorne osebe.
The competent authority shall take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it in the following cases:
Pristojni organ sprejme vse ustrezne ukrepe, da se prepove ali omeji dostopnost kozmetičnega izdelka na trgu ali da se izdelek umakne ali odpokliče s trga v naslednjih primerih:
where an immediate action is necessary in the event of serious risk to human health; or
kadar je potrebno takojšnje ukrepanje v primeru resnega tveganja za zdravje ljudi; ali
where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1.
kadar odgovorna oseba ne sprejme vseh ustreznih ukrepov v roku iz odstavka 1.
In the event of serious risks to human health, that competent authority shall inform the Commission and the competent authorities of the other Member States, without delay, of the measures taken.
V primeru resnega tveganja za zdravje ljudi, mora ta pristojni organ Komisijo in pristojne organe drugih držav članic nemudoma obvestiti o sprejetih ukrepih.
In the absence of a serious risk to human health, in the event that the responsible person does not take all appropriate measures, the competent authority shall without delay inform the competent authority of the Member State in which the responsible person is established of the measures taken.
Če resno tveganje za zdravje ljudi ni prisotno, v primeru, da odgovorna oseba ne sprejme vseh ustreznih ukrepov, pristojni organ nemudoma obvesti pristojni organ države članice, kjer ima odgovorna oseba sedež, o sprejetih ukrepih.
For the purposes of paragraphs 4 and 5 of this Article, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety [16] shall be used.Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products [17] shall also apply.
Za namene odstavkov 4 in 5 tega člena, se uporablja sistem izmenjave informacij, določen v členu 12(1) Direktive 2001/95/ES Evropskega parlamenta in Sveta z dne 3. decembra 2001 o splošni varnosti proizvodov [16].Uporabljata se tudi člen 12(2), (3) in (4) Direktive 2001/95/ES in člen 23 Uredbe (ES) št. 765/2008 Evropskega parlamenta in Sveta z dne 9. julija 2008 o določitvi zahtev za akreditacijo in nadzor trga v zvezi s trženjem proizvodov [17].
Non-compliance by distributors
Neizpolnjevanje obveznosti s strani distributerjev
Competent authorities shall require distributors to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within a given reasonable time limit, commensurate with the nature of the risk, where there is non-compliance with obligations laid down in Article 6.
Pristojni organi od distributerjev zahtevajo, da sprejmejo vse ustrezne ukrepe, vključno s korektivnimi ukrepi za vzpostavitev skladnosti kozmetičnega izdelka, umik izdelka s trga, ali odpoklic v razumnem roku, sorazmerno z naravo tveganja, kadar niso izpolnjene zahteve iz člena 6.
In the case of products meeting the requirements listed in Article 25(1), where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.
V primeru, da izdelek izpolnjuje zahteve iz člena 25(1), kjer se pristojni organ prepriča, oziroma ima razumen razlog za zaskrbljenost, da kozmetični izdelek ali izdelki, ki so dostopni na trgu, predstavljajo ali lahko predstavljajo resno tveganje za zdravje ljudi, sprejme vse ustrezne začasne ukrepe, da se kozmetični izdelek ali izdelki umaknejo, odpokličejo ali kako drugače omejijo na trgu.
The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States the measures taken and any supporting data.
Pristojni organ Komisijo in pristojne organe drugih držav članic nemudoma seznani s sprejetimi ukrepi in kakršnimi koli dodatnimi podatki.
For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.
Za namene prvega pododstavka se uporablja sistem izmenjave informacij, določen v členu 12(1) Direktive 2001/95/ES.
Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.
Uporablja se člen 12(2), (3) in (4) Direktive 2001/95/ES.
The Commission shall determine, as soon as possible, whether the provisional measures referred to in paragraph 1 are justified or not.
Komisija čim prej določi, ali so začasni ukrepi iz odstavka 1 utemeljeni ali ne.
For that purpose it shall, whenever possible, consult the interested parties, the Member States and the SCCS.
V ta namen se po možnosti posvetuje z zainteresiranimi strankami, državami članicami in SCCS.
Where the provisional measures are justified, Article 31(1) shall apply.
Če so začasni ukrepi utemeljeni, se uporablja člen 31(1).
Where the provisional measures are not justified the Commission shall inform the Member States thereof and the competent authority concerned shall repeal the provisional measures in question.
Če začasni ukrepi niso utemeljeni, Komisija o tem obvesti države članice, zadevni pristojni organ pa zadevne začasne ukrepe razveljavi.
Good administrative practices
Dobra upravna praksa
Any decision taken pursuant to Articles 25 and 27 shall state the exact grounds on which it is based.
Za vsako odločitev v skladu s členoma 25 in 27 je potrebna natančna utemeljitev.
It shall be notified by the competent authority without delay to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject.
Pristojni organ o njej brez odlašanja uradno obvesti odgovorno osebo in jo istočasno seznani tudi s pravnimi sredstvi, ki so ji na voljo v skladu z zakonodajo zadevne države članice, ter z roki, ki se za ta pravna sredstva uporabljajo.
Except in the case where immediate action is necessary for reasons of serious risk to human health, the responsible person shall have the opportunity to put forward his viewpoint before any decision is taken.
Razen v primerih, ko je zaradi resnega tveganja za zdravje ljudi nujno takojšnje ukrepanje, ima odgovorna oseba možnost predložiti svoje stališče, preden je sprejeta kakršna koli odločitev.
Where applicable, the provisions mentioned in paragraphs 1 and 2 shall apply with regard to the distributor for any decisions taken pursuant to Articles 26 and 27.
Kjer se zdi primerno, se določbe iz odstavkov 1 in 2 uporabljajo za distributerja za vse sklepe, ki se sprejmejo v skladu s členoma 26 in 27.
The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure the proper application and due enforcement of this Regulation and shall transmit to each other all information necessary with a view to applying this Regulation uniformly.
Pristojni organi držav članic sodelujejo med seboj in s Komisijo, da zagotovijo pravilno uporabo in primerno izvajanje te uredbe ter si posredujejo vse informacije, ki so potrebne za enotno uporabo te uredbe.
The Commission shall provide for the organisation of an exchange of experience between the competent authorities in order to coordinate the uniform application of this Regulation.
Komisija zagotovi izmenjavo izkušenj med pristojnimi organi z namenom usklajevanja enotne uporabe te uredbe.
Cooperation may be part of initiatives developed at international level.
Sodelovanje je lahko del pobud, oblikovanih na mednarodni ravni.
Cooperation regarding verification of product information files
Sodelovanje pri preverjanju dokumentacije z informacijami o izdelku
The competent authority of any Member State where the cosmetic product is made available may request the competent authority of the Member State where the product information file is made readily accessible to verify whether the product information file satisfies the requirements referred to in Article 11(2) and whether the information set out therein provides evidence of the safety of the cosmetic product.
Pristojni organ katere koli države članice, kjer je kozmetični izdelek dostopen, lahko od pristojnega organa države članice, kjer je vselej dostopna dokumentacija z informacijami o izdelku, zahteva, da preveri, ali dokumentacija z informacijami o izdelku izpolnjuje zahteve iz člena 11(2) in ali informacije v njem dokazujejo varnost kozmetičnega izdelka.
The requesting competent authority shall provide a motivation for the request.
Pristojni organ, ki zaprosi za informacije navede razloge za svojo zahtevo.
Upon that request, the competent authority requested shall, without undue delay and taking into account the degree of urgency, carry out the verification and shall inform the requesting competent authority of its findings.
Na podlagi te zahteve pristojni organ brez nepotrebnega odlašanja in ob upoštevanju stopnje nujnosti preveri informacije in o svojih ugotovitvah obvesti pristojni organ, ki e za te informacije zaprosil.
IMPLEMENTING MEASURES, FINAL PROVISIONS
IZVEDBENI UKREPI, KONČNE DOLOČBE
Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly.
Ob morebitnem tveganju za zdravje ljudi zaradi uporabe snovi v kozmetičnih izdelkih, ki ga je treba obravnavati na ravni celotne Skupnosti, lahko Komisija po posvetovanju s SCCS ustrezno spremeni priloge II do VI.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4).
V nujnih primerih lahko Komisija uporabi nujni postopek iz člena 32(4).
The Commission may, after consulting the SCCS, amend Annexes III to VI and VIII for the purposes of adapting them to technical and scientific progress.
Komisija lahko po posvetovanju s SCCS spremeni priloge III do VI in VIII, z namenom prilagoditve prilog tehničnemu in znanstvenemu napredku.
Where it appears necessary, in order to ensure the safety of cosmetic products placed on the market, the Commission may, after consulting the SCCS, amend Annex I.
Komisija lahko po posvetovanju s SCCS spremeni Prilogo I, kadar je to potrebno za zagotavljanje varnosti kozmetičnih izdelkov, ki so dani na trg.
The Commission shall be assisted by the Standing Committee on Cosmetic Products.
Komisiji pomaga Stalni odbor za kozmetične izdelke.