natgillin/translations-raw huggingface dataset:
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Pri sklicevanju na ta odstavek, se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.
Pri sklicevanju na ta odstavek se uporabljata člena 5a(1), (2), (4) in (6) ter člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Glossary of common ingredient names
Glosar skupnih imen sestavin
The Commission shall compile and update a glossary of common ingredient names.
Komisija sestavi in posodobi glosar skupnih imen sestavin.
To this end, the Commission shall take account of internationally recognised nomenclatures including the International Nomenclature of Cosmetic Ingredients (INCI).
V ta namen Komisija upošteva mednarodno priznane nomenklature, vključno z mednarodno nomenklaturo za kozmetične sestavine (INCI - International Nomenclature of Cosmetic Ingridients).
That glossary shall not constitute a list of the substances authorised for use in cosmetic products.
Snovi navedene v glosarju, ni nujno, da so dovoljene za uporabo v kozmetičnih izdlekih.
The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve months after publication of the glossary in the Official Journal of the European Union.
Za označevanje kozmetičnih izdelkov, danih na trg, se uporablja skupna imena sestavin najpozneje dvanajst mesecev po objavi glosarja v Uradnem listu Evropske unije.
Competent authorities, poison control centres or assimilated entities
Pristojni organi, centri za nadzor zastrupitev ali enakovredni subjekti
Member States shall designate their national competent authorities.
Države članice imenujejo svoje nacionalne pristojne organe.
Member States shall communicate the details of authorities referred to in paragraph 1 and of the poison centres and similar bodies referred to in Article 13(6) to the Commission.
Države članice sporočijo Komisiji podrobne podatke o pristojnih organih iz odstavka 1 in o centrih za zastrupitve in podobnih organih iz člena 13(6).
They shall communicate an update of these details as necessary.
Po potrebi sporočijo tudi spremembe teh podatkov.
The Commission shall compile and update a list of the authorities and bodies referred to in paragraph 2 and make it available to the public.
Komisija sestavi in posodobi seznam pristojnih organov in organov iz odstavka 2 ter ga da na voljo javnosti.
Annual report on animal testing
Letno poročilo o testih na živalih
Every year the Commission shall present a report to the European Parliament and the Council on:
Komisija vsako leto Evropskemu parlamentu in Svetu predloži poročilo o:
progress made in the development, validation and legal acceptance of alternative methods.
napredku pri razvoju, znanstvenem potrjevanju in pravni sprejemljivosti alternativnih metod.
The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals.
Poročilo vključuje natančne podatke o številu in vrsti testov na živalih v zvezi s kozmetičnimi izdelki.
The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC.
Države članice so dolžne zbirati navedene informacije poleg statističnih podatkov, kakor je določeno z Direktivo 86/609/EGS.
The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;
Komisija zlasti zagotovi razvoj, znanstveno potrjevanje in pravno sprejemljivost alternativnih testnih metod, pri katerih se ne uporabljajo žive živali;
progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;
napredku, ki ga je Komisija dosegla v svojih prizadevanjih, da bi OECD sprejela alternativne metode, znanstveno potrjene na ravni Skupnosti, in da bi tretje države priznale rezultate preskusov varnosti, ki jih je Skupnost izvedla z alternativnimi metodami, zlasti v okviru sporazumov o sodelovanju med Skupnostjo in temi državami;
the manner in which the specific needs of small and medium-sized enterprises have been taken into account.
načinu, kako so se upoštevale posebne potrebe malih in srednje velikih podjetij.
Formal objection against harmonised standards
Formalni ugovor proti usklajenim standardom
When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments.
Kadar država članica ali Komisija meni, da usklajeni standard ne izpolnjuje zahtev iz ustreznih določb te uredbe v celoti, Komisija ali zadevna država članica zadevo predloži odboru, ustanovljenem s členom 5 Direktive 98/34/ES, in jo utemelji.
The Committee shall deliver its opinion without delay.
Odbor nemudoma predloži svoje mnenje.
In the light of the Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.
Ob upoštevanju mnenja odbora se Komisija odloči, ali sklice na zadevne usklajene standarde v Uradnem listu Evropske Unije objavi, ne objavi, objavi z omejitvami, zadrži, zadrži z omejitvami ali jih umakne.
The Commission shall inform the Member States and the European standardisation body concerned.
Komisija obvesti države članice in zadevni evropski organ za standardizacijo.
It shall, if necessary, request the revision of the harmonised standards concerned.
Če je to potrebno, zahteva spremembo zadevnih usklajenih standardov.
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Države članice sprejmejo določbe o kaznih za kršitev določb te uredbe in sprejmejo vse ukrepe, potrebne za njihovo izvajanje.
The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.
Države članice uradno obvestijo Komisijo o teh določbah do 11. julij 2013 in jo nemudoma uradno obvestijo o kakršnih koli naknadnih spremembah, ki vplivajo nanje.
Directive 76/768/EEC is repealed with effect from 11 July 2013, with the exception of Article 4b which is repealed with effect from 1 December 2010.
Direktiva 76/768/EGS se razveljavi z učinkom od 11. julij 2013, z izjemo člena 4b, ki se razveljavi z učinkom od 1. decembra 2010.
References to the repealed Directive shall be understood as references to this Regulation.
Sklicevanja na razveljavljeno direktivo se štejejo kot sklicevanja na to uredbo.
This Regulation shall be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.
Ta uredba ne sme posegati v obveznosti držav članic glede rokov za prenos direktiv v nacionalno zakonodajo, določenih v delu B Priloge IX.
However, the competent authorities shall continue to keep available the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC and responsible persons shall continue to keep readily accessible the information collected pursuant to Article 7a of that Directive until 11 July 2020.
Vendar pa morajo pristojni organi še naprej dajati na razpolago informacije, ki so jih prejeli v skladu s členom 7(3) in členom 7a(4) Direktive 76/768/EGS, in odgovorne osebe morajo še naprej imeti vselej dostopne informacije, ki so bile zbrane v skladu s členom 7a navedene direktive do 11. julij 2020.
By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.
Z odstopanjem od Direktive 76/768/EGS, se kozmetični izdelki, ki so skladni s to uredbo, lahko dajo na trg pred 11. julij 2013.
As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive.
Z odstopanjem od Direktive 76/768/EGS, se od 11. januar 2012 priglaitev, ki je bila opravljena v skladu s členom 13 te uredbe, šteje za skladno s členom 7(3) in členom 7a(4) navedene direktive.
This Regulation shall enter into force on the [twentieth day after its publication in the Official Journal of the European Union
Ta uredba začne veljati [dvajseti dan po objavi v Uradnem listu Evropske unije].
It shall apply from 11 July 2013, with the exception of:
Uporablja se od 11. julij 2013, razen:
Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and
člen 15(1) in (2), se uporablja od 1. decembra 2010, kakor tudi členi 14, 31 in 32, v kolikor so ti potrebni za uporabo člena 15(1) in (2); ter
Article 16(3) second subparagraph, which shall apply from 11 January 2013.
drugi pododstavek člena 16(3), ki se uporablja od 11. januar 2013.
OJ C 27, 3.2.2009, p. 34.
UL C 27, 3.2.2009, str. 34.
Opinion of the European Parliament of 24 March 2009 (not yet published in the Official Journal) and Council Decision of 20 November 2009.
Mnenje Evropskega parlamenta z dne 24. marca 2009 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 20. novembra 2009.
COSMETIC PRODUCT SAFETY REPORT
POROČILO O VARNOSTI KOZMETIČNEGA IZDELKA
The cosmetic product safety report shall, as a minimum, contain the following:
Poročilo o varnosti kozmetičnega izdelka vsebuje najmanj naslednje:
PART A – Cosmetic product safety information
DEL A – Informacije o varnosti kozmetičnega izdelka
Quantitative and qualitative composition of the cosmetic product
Kvantitativna in kvalitativna sestava kozmetičnega izdelka
The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function.
Kvalitativna in kvantitativna sestava kozmetičnega izdelka, vključno s kemijsko identiteto snovi (vključno s kemijskim imenom, INCI, CAS, EINECS/ELINCS, kjer je to mogoče) in njihova funkcija glede na predviden namen uporabe.
In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.
Pri parfumih in aromatičnih sestavah, opis imena in številka šifre sestave ter identiteta dobavitelja.
Physical/chemical characteristics and stability of the cosmetic product
Fizikalne/kemijske značilnosti in stabilnost kozmetičnega izdelka
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.
Fizikalne in kemijske značilnosti snovi, zmesi in kozmetičnih izdelkov.
The stability of the cosmetics product under reasonably foreseeable storage conditions.
Stabilnost kozmetičnega izdelka v razumno predvidljivih pogojih shranjevanja.
Microbiological quality
Mikrobiološka kakovost
The microbiological specifications of the substance or mixture and the cosmetic product.
Mikrobiološke specifikacije snovi ali zmesi in kozmetičnega izdelka.
Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.
Posebno pozornost je treba nameniti kozmetičnim izdelkom, ki se uporabljajo okoli oči, na sluznicah na splošno, na poškodovani koži, na otrocih, mlajših od treh let, na starejših ljudeh in osebah, ki kažejo znake zmanjšane odpornosti.
Results of preservation challenge test.
Rezultati izzivnega preskusa učinkovitosti konzerviranja.
Impurities, traces, information about the packaging material
Nečistote, sledi, podatki o embalažnem materialu
The purity of the substances and mixtures.
Čistost snovi in zmesi.
In the case of traces of prohibited substances, evidence for their technical unavoidability.
V primeru sledi prepovedanih snovi, dokaz o njihovi tehnični neizogibnosti.
The relevant characteristics of packaging material, in particular purity and stability.
Ustrezne značilnosti embalažnega materiala, zlasti čistosti in stabilnosti.
Normal and reasonably foreseeable use
Normalna in razumno predvidljiva uporaba
The normal and reasonably foreseeable use of the product.
Normalna in razumno predvidljiva uporaba izdelka.
The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.
Obrazložitev je treba utemeljiti zlasti glede na opozorila in druga pojasnila pri označevanju izdelka.
Exposure to the cosmetic product
Izpostavljenost kozmetičnemu izdelku
Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
Podatki o izpostavljenosti kozmetičnemu izdelku ob upoštevanju ugotovitev iz oddelka 5 v zvezi z naslednjim:
The site(s) of application;
mesto/a uporabe;
The surface area(s) of application;
površina/e uporabe;
The amount of product applied;
količina uporabljenega izdelka;
The duration and frequency of use;
trajanje in pogostnost uporabe;
The normal and reasonably foreseeable exposure route(s);
normalni in razumno predvidljivi načini izpostavljenosti;
The targeted (or exposed) population(s).
ciljne ali izpostavljene populacije.
Potential exposure of a specific population shall also be taken into account.
Treba je upoštevati tudi možno izpostavljenost določene populacije.
The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight).
Pri izračunu izpostavljenosti je treba upoštevati tudi toksikološke učinke, ki jih je treba preučiti (npr. izpostavljenost je morda treba izračunati glede na enoto površine kože ali na enoto telesne teže).
The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).
Upoštevati bi bilo treba tudi možnost sekundarne izpostavljenosti, do katere pride na načine, ki ne izhajajo iz neposredne uporabe (npr. nenamerno vdihovanje razpršilcev, nenamerno zaužitje izdelkov za nego ustnic itd.).
Particular consideration shall be given to any possible impacts on exposure due to particle sizes.
Posebno pozornost je treba nameniti kakršnim koli možnim vplivom na izpostavljenost zaradi velikosti delcev.
Exposure to the substances
Izpostavljenost snovem
Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.
Podatki o izpostavljenosti snovem, ki jih vsebuje kozmetični izdelek, za zadevne toksikološke parametre ob upoštevanju informacij iz oddelka 6.
Toxicological profile of the substances
Toksikološki profil snovi
Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints.
Brez poseganja v člen 18, mora toksikološki profil snovi, vsebovane v kozmetičnem izdelku, zajemati vse relevantne toksikološke učinke te snovi.
A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.
Posebna pozornost mora biti namenjena oceni lokalne toksičnosti (draženje kože in oči), oceni sposobnosti senzitizacije kože in v primeru UV absorbcije tudi oceni fototoksičnosti.
All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated.
Upoštevati je potrebno vse toksikološko pomembne načine absorbcije, kakor tudi sistemske učinke. Na podlagi NOAEL (No Observed Adverse Effect Level – odmerek brez opaznega škodljivega učinka) je potrebno izračunati MOS (Margin of Safety – meja varne uporabe).
The absence of these considerations shall be duly justified.
V primeru neupoštevanja navedenega je potrebno navesti utemeljitev.
Particular consideration shall be given to any possible impacts on the toxicological profile due to
Posebno pozornost je potrebno nameniti vsem možnim vplivom na toksikološki profil zaradi
particle sizes, including nanomaterials,
velikosti delcev, vključno nanomaterialov,
impurities of the substances and raw material used, and
nečistoče snovi in uporabljenih surovin, ter
interaction of substances.
medsebojnega delovanja snovi..
Any read-across shall be duly substantiated and justified.
Vsako navzkrižno uporabo podatkov iz različnih virov je treba dokazati in utemeljiti.
The source of information shall be clearly identified.
Vir informacij mora biti jasno opredeljen.
Undesirable effects and serious undesirable effects
Neželeni učinki in resni neželeni učinki
All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products.
Vsi razpoložljivi podatki o neželenih učinkih in resnih neželenih učinkih kozmetičnega izdelka ali, kjer je ustrezno, drugih kozmetičnih izdelkov.
This includes statistical data.
To vključuje statistične podatke.
Information on the cosmetic product
Informacije o kozmetičnem izdelku
Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.
Druge zadevne informacije, npr. obstoječe študije na ljudeh prostovoljcih ali jasno potrjene in utemeljene ugotovitve ocen tveganj, ki so bile izdelane na drugih ustreznih področjih.
PART B – Cosmetic product safety assessment
DEL B – Ocena varnosti kozmetičnega izdelka
Assessment conclusion
Zaključek ocene
Statement on the safety of the cosmetic product in relation to Article 3.
Izjava o varnosti kozmetičnega izdelka v zvezi s členom 3.
Labelled warnings and instructions of use
Označena opozorila in navodila za uporabo
Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).
Izjava o nujnosti označevanja katerih koli posebnih opozoril in navodil za uporabo v skladu s členom 19(1)(d).
Reasoning
Obrazložitev
Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2.
Razlaga znanstvenega argumentiranja, na podlagi katerega je bil sprejet zaključek ocene v skladu z oddelkom 1, in izjave v skladu z oddelkom 2.
This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed.
Pojasnilo temelji na opisih iz dela A. Kjer je potrebno, je treba oceniti in obravnavati mejo varnostne uporabe (MOS).
There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.
Med drugim se pripravi posebna ocena kozmetičnih izdelkov, namenjenih za uporabo pri otrocih, mlajših od treh let, in kozmetičnih izdelkov, namenjenih izključno za zunanjo intimno higieno.
Possible interactions of the substances contained in the cosmetic product shall be assessed.
Ocenijo se možna medsebojna vplivanja snovi, ki jih vsebuje kozmetični izdelek.
The consideration and non-consideration of the different toxicological profiles shall be duly justified.
Preučitev in nepreučitev različnih toksikoloških profilov je treba natančno utemeljiti.
Impacts of the stability on the safety of the cosmetic product shall be duly considered.
Natančno je treba preučiti vplive stabilnosti na varnost kozmetičnih izdelkov.
Assessor's credentials and approval of part B
Verodostojnost ocenjevalca in odobritev dela B
Name and address of the safety assessor.
Ime in naslov ocenjevalca varnosti.
Proof of qualification of safety assessor.
Dokazilo o usposobljenosti ocenjevalca varnosti.
Date and signature of safety assessor.
Datum in podpis ocenjevalca varnosti.
Preamble to Annexes II to VI
Preambula k prilogam II do VI
For the purposes of the Annexes II to VI:
Za namene prilog II do VI:
‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes;
„izdelek, ki se izpere,“ je kozmetični izdelek, ki ga je treba po nanosu na kožo, lase ali sluznice odstraniti;
‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes;
„izdelek, ki se ne odstrani,“ je kozmetični izdelek, ki je namenjen daljšemu stiku s kožo, lasmi ali sluznicami;
‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eye lashes;
„izdelek za lase“ je kozmetični izdelek, namenjen nanašanju na lase oziroma dlake na glavi ali obrazu, razen trepalnic;
‘Skin product’ means a cosmetic product which is intended to be applied on the skin;
„izdelek za kožo“ je kozmetični izdelek, namenjen nanašanju na kožo;
‘Lip product’ means a cosmetic product which is intended to be applied on the lips;
„izdelek za ustnice“ je kozmetični izdelek, namenjen nanašanju na ustnice;
‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face;
„izdelek za obraz“ je kozmetični izdelek, namenjen nanašanju na kožo obraza;
‘Nail product’ means a cosmetic product which is intended to be applied on nails;
„izdelek za nohte“ je kozmetični izdelek, namenjen nanašanju na nohte;
‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity;
„izdelek za usta“ je kozmetični izdelek, namenjen nanašanju na zobe ali sluznice ustne votline;
‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous membranes
„izdelek, ki se nanaša na sluznice“ je kozmetični izdelek, namenjen nanašanju na sluznice
of the oral cavity,
ustne votline,
on the rim of the eyes,
ob robu oči
or of the external genital organs;
ali zunanjih spolnih organov;
‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes;
„izdelek za oči“ je kozmetični izdelek, namenjen za nanašanje v bližini oči;
‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their professional activity.
„poklicna uporaba“ pomeni, da kozmetične izdelke nanašajo in uporabljajo osebe pri izvajanju svoje poklicne dejavnosti.
In order to facilitate substance identification, the following descriptors are used:
Za lažjo identifikacijo snovi se uporabljajo naslednji deskriptorji:
The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975;
mednarodna nelastniška imena (INN - International Nonproprietary Names) za farmacevtske izdelke, WHO, Ženeva, avgust 1975;
The Chemical Abstracts Service numbers (CAS);
številke CAS (Chemical Abstract Service);