natgillin/translations-raw huggingface dataset:
The Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions.
Komisija redno pregleda določbe te uredbe, ki se nanašajo na nanomateriale glede na znanstveni napredek in po potrebi predlaga ustrezne spremembe teh določb.
The first review shall be undertaken by 11 July 2018.
Prvi pregled se opravi do 11. julij 2018.
Traces of prohibited substances
Sledi prepovedanih snovi
The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.
Nenamerna navzočnost majhne količine prepovedane snovi, ki izhaja iz nečistoč naravnih ali sintetičnih sestavin, proizvodnega postopka, shranjevanja, migracije iz embalaže, ki je tehnično neizogibna ob dobri proizvodni praksi, se dovoli, če je takšna navzočnost v skladu s členom 3.
ANIMAL TESTING
TESTIRANJE NA ŽIVALIH
Animal testing
Testiranja na živalih
Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited:
Brez poseganja v splošne obveznosti iz člena 3 se prepove naslednje:
the placing on the market of cosmetic products where the final formulation, in order to meet the requirements of this Regulation, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
dajanje na trg kozmetičnih izdelkov, pri katerih se je končna formulacija zaradi izpolnjevanja zahtev te uredbe testirala na živalih z metodo, ki ni alternativna metoda, potem ko je taka alternativna metoda že bila znanstveno potrjena in sprejeta na ravni Skupnosti in ob ustreznem upoštevanju razvoja znanstvenega potrjevanja znotraj OECD;
the placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
dajanje na trg kozmetičnih izdelkov, ki vsebujejo sestavine ali kombinacije sestavin, ki so se zaradi izpolnjevanja zahtev te uredbe testirale na živalih z metodo, ki ni alternativna metoda, potem ko je taka alternativna metoda že bila znanstveno potrjena in sprejeta na ravni Skupnosti in ob ustreznem upoštevanju razvoja znanstvenega potrjevanja znotraj OECD;
the performance within the Community of animal testing of finished cosmetic products in order to meet the requirements of this Regulation;
izvajanje testiranj končnih kozmetičnih izdelkov na živalih znotraj Skupnosti zaradi izpolnjevanja zahtev te uredbe;
the performance within the Community of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Regulation, after the date on which such tests are required to be replaced by one or more validated alternative methods listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [15] or in Annex VIII to this Regulation.
izvajanje testiranj sestavin ali kombinacij sestavin na živalih zaradi izpolnjevanja zahtev te uredbe znotraj Skupnosti, po datumu, ko se zahteva, da se taka testiranja nadomestijo z eno ali več znanstveno potrjenimi alternativnimi metodami, navedenimi v Uredbi Komisije (ES) št. 440/2008 z dne 30. maja 2008 o določitvi testnih metod v skladu z Uredbo (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) [15] ali v Prilogi VIII k tej uredbi.
The Commission, after consulting the SCCS and the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, has established timetables for the implementation of the provisions under points (a), (b) and (d) of paragraph 1, including deadlines for the phasing-out of the various tests.
Komisija je po posvetovanju s SCCS in Evropskim centrom za validacijo alternativnih metod (ECVAM) in ob ustreznem upoštevanju razvoja znanstvene validacije znotraj OECD določila časovne razporede za uresničevanje določb iz točk (a), (b) in (d) odstavka 1, vključno z roki za postopno opuščanje različnih testiranj.
The timetables were made available to the public on 1 October 2004 and sent to the European Parliament and the Council.
Časovni razporedi so bili dani na voljo javnosti 1. oktobra 2004 in poslani Evropskemu parlamentu in Svetu.
The period for implementation was limited to 11 March 2009 in relation to points (a), (b) and (d) of paragraph 1.
V zvezi s točkami (a), (b) in (d) odstavka 1 je bilo obdobje izvajanja omejeno do 11. marca 2009.
In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration, the period for implementation of paragraph 1(a) and (b) shall be limited to 11 March 2013.
V zvezi s testiranji glede strupenosti pri večkratnih odmerkih, strupenosti za razmnoževanje in toksikokinetike, za katere se alternativne možnosti še ne obravnavajo, se obdobje izvajanja odstavka 1(a) in (b) omeji na 11. marec 2013.
The Commission shall study possible technical difficulties in complying with the ban in relation to tests, in particular those concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration.
Komisija podrobno preuči možne tehnične težave pri izvajanju prepovedi v zvezi s testiranji, zlasti tistimi v zvezi s strupenostjo pri večkratnih odmerkih, strupenostjo za razmnoževanje in toksikokinetiko, za katere se alternativne možnosti še ne obravnavajo.
Information about the provisional and final results of these studies forms part of the yearly reports presented pursuant to Article 35.
Informacije o začasnih in končnih rezultatih teh preučevanj so sestavni del letnih poročil, predloženih na podlagi člena 35.
On the basis of these annual reports, the timetables established as referred to in the first subparagraph, could be adapted up to 11 March 2009 in relation to the first subparagraph and may be adapted up to 11 March 2013 in relation to the second subparagraph and after consultation of the entities referred to in the first subparagraph.
Na podlagi teh letnih poročil in po posvetovanju s subjekti, navedenimi v prvem pododstavku, se časovni razporedi iz prvega pododstavka, lahko prilagajajo vse do 11. marca 2009, v zvezi s prvim pododstavkom, oziroma vse do 11. marca 2013 v zvezi z drugim pododstavkom.
The Commission shall study progress and compliance with the deadlines as well as possible technical difficulties in complying with the ban.
Komisija preuči napredek in skladnost z roki kot tudi vse možne tehnične težave pri izpolnjevanju prepovedi.
Information about the provisional and final results of the Commission studies forms part of the yearly reports presented pursuant to Article 35.
Informacije o začasnih ali končnih rezultatih preučevanj Komisije so del letnih poročil, predloženih na podlagi člena 35.
If these studies conclude, at the latest two years prior to the end of the maximum period referred to in the second subparagraph, that for technical reasons one or more tests referred to in that subparagraph will not be developed and validated before the expiry of the period referred to therein it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.
Če zaključki teh preučevanj vsaj dve leti pred koncem najdaljšega časovnega obdobja, navedenega v drugem pododstavku, pokažejo, da se zaradi tehničnih razlogov eden ali več preskusov, navedenih v navedenem pododstavku, še ne bo razvil in ne bo znanstveno potrjen pred iztekom časovnega obdobja iz tega pododstavka, Komisija obvesti Evropski parlament in Svet ter predloži zakonodajni predlog v skladu s členom 251 Pogodbe.
In exceptional circumstances, where serious concerns arise as regards the safety of an existing cosmetic ingredient, a Member State may request the Commission to grant a derogation from paragraph 1.
V izjemnih okoliščinah, kadar se pojavijo resni pomisleki v zvezi z varnostjo obstoječe kozmetične sestavine, država članica od Komisije lahko zahteva, da odobri odstopanje od odstavka 1.
The request shall contain an evaluation of the situation and indicate the measures necessary.
V zahtevo se vključi ocena položaja in se navedejo potrebni ukrepi.
On this basis, the Commission may, after consulting the SCCS and by means of a reasoned decision, authorise the derogation.
Na tej podlagi lahko Komisija po posvetovanju z ZOPP in z utemeljeno odločitvijo odobri odstopanje.
That authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.
Ta odobritev določa pogoje, povezane s tem odstopanjem glede posebnih ciljev, trajanja in poročanja o rezultatih.
A derogation shall be granted only where:
Odstopanje se odobri, samo če:
the ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function;
je sestavina v široki uporabi in je ni mogoče nadomestiti z drugo sestavino, ki bi lahko imela podobno funkcijo;
the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.
če se dokazuje poseben problem zdravja ljudi in je opravljanje testiranj na živalih upravičeno, ter ga potrjuje podroben raziskovalni protokol, ki se predlaga kot osnova za oceno.
The decision on the authorisation, the conditions associated with it and the final result achieved shall be part of the annual report presented by the Commission in accordance with Article 35.
Sklep o odobritvi, pogoji povezani z njo in dobljeni končni rezultat so sestavni del letnega poročila, ki ga Komisija predloži v skladu s členom 35.
The measures referred to in the sixth 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).
Ukrepi iz šestega pododstavka, namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 32(3).
For the purposes of this Article and Article 20:
Za namene tega člena in člena 20:
‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype;
„končni kozmetični izdelek“ pomeni kozmetični izdelek v svoji končni formulaciji, kakor se daje na trg in je dostopen končnemu uporabniku, ali njegov prototip;
‘prototype’ means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.
„prototip“ pomeni prvi model ali osnutek, ki se še ni izdeloval v serijah in ki ga končni kozmetični izdelek posnema ali se iz njega dokončno razvije.
Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:
Brez poseganja v druge določbe tega člena so kozmetični izdelki dostopni na trgu samo, če so na primarni in skundarni embalaži kozmetičnih izdelkovnaslednje informacije v neizbrisni, čitljivi in vidni pisavi:
the name or registered name and the address of the responsible person.
ime ali registrirano ime in naslov odgovorne osebe.
Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address.
Te informacije so lahko skrajšane, če okrajšava še vedno omogoča prepoznavanje te osebe in njenega naslova.
If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted.
Če je navedenih več naslovov, se poudari tistega, na katerem je vselej na voljo dokumentacija z informacijami o izdelku.
The country of origin shall be specified for imported cosmetic products;
Za uvožene kozmetične izdelke se jasno navede država izvora;
the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging.
nominalna vsebina ob času pakiranja, navedena z maso ali prostornino, razen pri embalaži, ki vsebuje manj kot pet gramov ali pet mililitrov, brezplačnih vzorcih in pakiranjih za enkratno uporabo; za predpakirane izdelke, ki se običajno prodajajo kot komplet izdelkov, pri katerih podrobnosti o masi ali prostornini niso pomembne, ni treba navesti vsebine, če je na embalaži navedeno število kosov.
This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually;
Teh informacij ni treba navesti, če se število kosov zlahka vidi skozi embalažo ali če se izdelek običajno prodaja samo posamično;
the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3 (‘date of minimum durability’).
datum, do katerega kozmetični izdelek, shranjen pod ustreznimi pogoji, ohrani svojo prvotno funkcijo in zlasti ostane skladen s členom 3 („minimalni rok trajanja“).
The date itself or details of where it appears on the packaging shall be preceded by the symbol shown in point 3 of Annex VII or the words: ‘best used before the end of’.
Pred datumom ali podrobnostih o tem, kje na embalaži je datum naveden, je naveden simbol iz točke 3 Priloge VII ali napis: „uporabno najmanj do konca“.
The date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order.
Minimalni rok trajanja je izražen jasno in je sestavljen bodisi iz meseca in leta bodisi dneva, meseca in leta v tem vrstnem redu.
If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.
Če je potrebno, se ta informacija dopolni z navedbo pogojev, ki jih je treba izpolniti za jamstvo navedenega trajanja.
Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months.
Navedba minimalnega roka trajanja ni obvezna za kozmetične izdelke z minimalnim rokom trajanja več kot 30 mesecev.
For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer.
Za take izdelke je treba navesti časovno obdobje po odprtju izdelka, ko je njegova uporaba varna in ga uporabnik lahko brez škode uporablja.
This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years);
Te informacije se označi, razen kadar koncept trajanja po odprtju ni relevanten, z grafičnim simbolom, navedenim v točki 2 Priloge VII, ki mu sledi obdobje (v mesecih in/ali letih);
particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use;
podrobni varnostni ukrepi, ki jih je treba upoštevati pri uporabi, najmanj pa tisti, našteti v prilogah III do VI, in vse posebne previdnostne informacije na izdelkih za poklicno uporabo;
the batch number of manufacture or the reference for identifying the cosmetic product.
serijska številka proizvodnje ali referenčna številka za identifikacijo kozmetičnega izdelka.
Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;
Kadar je to iz praktičnih razlogov nemogoče, ker so kozmetični izdelki premajhni, morajo biti te informacije navedene samo na sekundarni embalaži;
the function of the cosmetic product, unless it is clear from its presentation;
namen kozmetičnega izdelka, razen če je razviden iz njegovega videza;
a list of ingredients.
seznam sestavin.
This information may be indicated on the packaging alone.
Ta podatek je lahko naveden samo na sekundarni embalaži.
The list shall be preceded by the term ‘ingredients’.
Pred seznamom je naveden izraz „sestavine“ ali „ingredients“.
For the purpose of this Article, an ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing.
Za namene tega člena „sestavina“ pomeni katero koli snov ali zmes, ki se namenoma uporablja za kozmetični izdelek med proizvodnim postopkom.
The following shall not, however, be regarded as ingredients:
Kot sestavine se ne štejejo:
impurities in the raw materials used;
nečistoče v uporabljenih surovinah;
subsidiary technical materials used in the mixture but not present in the final product.
pomožne tehnične snovi, ki se uporabljajo v zmesi, pa jih končni izdelek ne vsebuje.
Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’.
Parfumi in aromatične sestavine ter njihove surovine se navedejo z izrazom „parfum“ali „aroma“.
Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.
Poleg tega se na seznamu sestavin poleg izrazov parfum ali aroma navede prisotnost snovi, katerih navedba se zahteva v stolpcu „drugo“ v Prilogi III.
The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product.
Seznam sestavin se navede v padajočem vrstnem redu glede na njihovo maso v času dodajanja kozmetičnemu izdelku.
Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.
Sestavine v koncentracijah, nižjih od 1 %, se lahko navedejo v kakršnem koli vrstnem redu za sestavinami v koncentracijah, višjih od 1 %.
All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients.
Vse prisotne sestavine v obliki nanomaterialov morajo biti jasno označene na seznamu sestavin.
The names of such ingredients shall be followed by the word ‘nano’ in brackets.
Beseda „nano“ se postavi v oklepaju pred ime teh sestavin.
Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients.
Barvila, ki niso namenjena barvanju las se lahko navedejo v kakršnem koli vrstnem redu za drugimi kozmetičnimi sestavinami.
For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added.
Za dekorativne kozmetične izdelke, ki se tržijo v več barvnih odtenkih, se lahko navedejo vsa barvila v paleti, razen tistih, ki so namenjeni barvanju las, pod pogojem, da se dodata besedi „lahko vsebuje“ ali simbol „+/–“.
The CI (Colour Index) nomenclature shall be used, where applicable.
Kjer se zdi primerno se uporablja nomenklatura CI (Colour Index).
Where it is impossible for practical reasons to label the information mentioned in points (d) and (g) of paragraph 1 as provided, the following applies:
Kadar iz praktičnih razlogov ni mogoče navesti informacij iz točk (d) in (g) odstavka 1, kot je določeno, se uporablja naslednje:
the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card;
informacije se navedejo na priloženem ali pripetem listku, etiketi, traku, nalepki ali kartici;
unless impracticable, this information shall be referred to by abbreviated information or the symbol given in point 1 of Annex VII, which must appear on the container or packaging for the information referred in point (d) of paragraph 1 and on packaging for the information referred in point (g) of paragraph 1.
razen, če je to neizvedljivo, se te informacije navedejo v skrajšani obliki ali z grafičnim simbolom, navedenim v točki 1 Priloge VII, ki morajo biti za informacije iz točke (d) odstavka 1 navedeni na primarni ali sekundarni embalaži, za informacije iz točke (g) odstavka 1 pa na sekundarni embalaži.
In the case of soap, bath balls and other small products where it is impossible for practical reasons for the information referred to in point (g) of paragraph 1 to appear on a label, tag, tape or card or in an enclosed leaflet, this information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.
Pri milih, kopalnih kroglicah in drugih majhnih izdelkih, pri katerih iz praktičnih razlogov ni mogoče, da bi bile informacije navedene v točki (g) odstavka 1, na etiketi, nalepki, traku ali kartici ali na priloženem listku, se te informacije navedejo na obvestilu v neposredni bližini zbirnega mesta (posode, škatle, itd…), na katerem se kozmetični izdelek prodaja.
For cosmetic products that are not pre-packaged, are packaged at the point of sale at the purchaser's request, or are pre-packaged for immediate sale, Member States shall adopt detailed rules for indication of the information referred to in paragraph 1.
Za kozmetične izdelke, ki niso predpakirani, ki so pakirani na kraju prodaje na zahtevo kupca ali pa so predpakirani za takojšnjo prodajo, države članice sprejmejo predpise za navedbo informacij, predvidenih v odstavku 1.
The language of the information mentioned in points (b), (c), (d) and (f) of paragraph 1 and in paragraphs (2), (3) and (4) shall be determined by the law of the Member States in which the product is made available to the end user.
Jezik, v katerem so navedene informacije iz točk (b), (c), (d) in (f) odstavka 1 in iz odstavkov (2), (3) in (4), se določi z zakonodajo države članice, v kateri je izdelek dostopen končnemu uporabniku.
The information mentioned in point (g) of paragraph 1 shall be expressed by using the common ingredient name set out in the glossary provided for in Article 33.
Informacije iz točke (g) odstavka 1 se navedejo z uporabo skupnih imen sestavin iz glosarja, določenega v členu 33.
In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature shall be used.
Če skupno ime sestavine ne obstaja, se uporabi izraz iz splošno sprejete nomenklature.
Product claims
Navedbe na izdelkih
In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.
Kozmetičnim izdelkom se pri označevanju, dostopnosti na trgu in oglaševanju ne sme z uporabo besedil, imen, blagovnih znamk, slik ter simboličnih in drugih oznak pripisovati značilnosti ali funkcij, ki jih v resnici nimajo.
The Commission shall, in cooperation with Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of a claim.
Komisija, ob sodelovanju z državami članicami, pripravi akcijski načrt glede navedb, ki se uporabljajo, in določi prednostne naloge za določitev skupnih meril za utemeljitev uporabe navedbe.