natgillin/translations-raw huggingface dataset:
‘frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation.
„okvirna formulacija“ pomeni formulacijo, ki navaja kategorijo ali funkcijo sestavin in njihovo maksimalno koncentracijo v kozmetičnem izdelku ali daje ustrezne kvantitativne in kvalitativne informacije, ko kozmetični izdelek delno ali v celoti ni zajet v taki formulaciji.
The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.
Komisija zagotovi navodila za oblikovanje okvirne formulacije, ter jih redno prilagaja glede na tehnični in znanstveni napredek.
For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.
Za namene točke (a) odstavka 1 se snov ali zmes za zaužitje, inhaliranje, injiciranje ali implantacijo v človeško telo ne štejejo za kozmetične izdelke.
In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level.
Glede na različne opredelitve nanomaterialov, ki so jih objavili različni organi, ter ob upoštevanju stalnega tehničnega in znanstvenega razvoja na področju nanotehnologij, Komisija popravi in prilagodi točko (k) odstavka 1 tehničnemu in znanstvenemu napredku ter opredelitvam, ki so bile posledično sprejete na mednarodni ravni.
That measure, 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).
Ta ukrep, namenjen spreminjanju nebistvenih določb te uredbe, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 32(3).
SAFETY, RESPONSIBILITY, FREE MOVEMENT
VARNOST, ODGOVORNOST, PROSTI PRETOK
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:
Kozmetični izdelek, ki je dostopen na trgu, je varen za zdravje ljudi, če je uporabljen pod normalnimi ali razumno predvidljivimi pogoji uporabe, zlasti ob upoštevanju:
presentation including conformity with Directive 87/357/EEC;
predstavitve, vključno s skladnostjo z Direktivo 87/357/EGS;
labelling;
označevanja,
instructions for use and disposal;
navodil za uporabo in odstranjevanje,
any other indication or information provided by the responsible person defined in Article 4.
kakršnih koli drugih navedb ali informacij, s katerimi ga je opremila odgovorna oseba iz člena 4.
The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.
Z navedbo opozoril se osebe iz členov 2 in 4 ne izvzamejo iz zahtev po skladnosti z drugimi zahtevami iz te uredbe.
Responsible person
Odgovorna oseba
Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.
Na trg se lahko dajo le kozmetični izdelki, za katere je v Skupnosti določena odgovorna pravna ali fizična oseba.
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.
Odgovorna oseba za vsak kozmetični izdelek, ki je dan na trg, zagotovi skladnost z ustreznimi obveznostmi, določenimi v tej uredbi.
For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.
Odgovorna oseba za kozmetični izdelek, ki je proizveden v Skupnosti in ni naknadno izvožen in uvožen nazaj v Skupnost, je proizvajalec, ki ima sedež v Skupnosti.
The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
Proizvajalec lahko za odgovorno osebo pisno imenuje osebo, ki ima sedež v Skupnosti in ki mora to pisno sprejeti.
Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
Kadar proizvajalec kozmetičnega izdelka, ki je proizveden v Skupnosti in ni naknadno izvožen in uvožen nazaj v Skupnost, nima sedeža v Skupnosti, kot odgovorno osebo pisno imenuje osebo, ki ima sedež v Skupnosti, ki mora to pisno sprejeti.
For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.
V primeru uvoženega kozmetičnega izdelka je odgovorna oseba vsak uvoznik, ki je ta kozmetični izdelek dal na trg.
The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.
Uvoznik lahko za odgovorno osebo pisno imenuje osebo, ki ima sedež v Skupnosti in ki mora to pisno sprejeti.
The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.
Distributer je odgovorna oseba, ko da na trg kozmetični izdelek s svojim imenom ali pod svojo blagovno znamko ali če izdelek, ki je že na trgu, spremeni tako, da to vpliva na skladnost z veljavnimi zahtevami.
The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.
Prevod informacij o kozmetičnem izdelku, ki je že na trgu, se ne šteje za tako spremembo izdelka, ki lahko vpliva na skladnost z veljavnimi zahtevami iz te uredbe.
Obligations of responsible persons
Obveznosti odgovornih oseb
Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24.
Odgovorne osebe zagotovijo skladnost s členi 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, členom 19(1), (2) in (5), ter členi 20, 21, 23 in 24.
Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.
Odgovorne osebe, ki menijo ali utemeljeno domnevajo, da kozmetični izdelek, ki so ga dali na trg, ni v skladu s to uredbo, nemudoma izvedejo potrebne korektivne ukrepe, da zagotovijo skladnost tega izdelka, ga umaknejo ali odpokličejo, kadar je to primerno.
Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.
Nadalje, v kolikor kozmetični izdelek predstavlja tveganje za zdravje ljudi, odgovorne osebe nemudoma obvestijo pristojne nacionalne organe držav članic, v katerih je njihov kozmetični izdelek dostopen na trgu, in državo članico, kjer je vselej dostopna dokumentacija z informacijami o izdelku, ter podrobno obrazložijo neskladje in sprejete korektivne ukrepe.
In the context of their activities, when making a cosmetic product available on the market, distributors shall act with due care in relation to applicable requirements.
Pri omogočanju dostopnosti kozmetičnega izdelka na trgu distributerji ravnajo s potrebno skrbnostjo v zvezi z veljavnimi zahtevami.
Before making a cosmetic product available on the market distributors shall verify that:
Preden omogočijo dostopnost kozmetičnega izdelka na trgu, distributerji preverijo, ali:
the labelling information provided for in Article 19(1)(a), (e) and (g) and Article 19(3) and (4) is present,
je izdelek označen z informacijami iz člena 19(1)(a), (e) in (g) in člena 19(3) in (4);
Where distributors consider or have reason to believe that:
Kadar distributerji menijo ali utemeljeno domnevajo, da:
a cosmetic product is not in conformity with the requirements laid down in this Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements,
kozmetični izdelek ni skladen z zahtevami iz te uredbe, lahko omogočijo dostopnost izdelka na trgu šele po tem, ko je ta usklajen z veljavnimi zahtevami;
a cosmetic product which they have made available on the market is not in conformity with this Regulation, they shall make sure that the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate, are taken.
kozmetični izdelek, katerega dostopnost na trgu so omogočili, ni skladen s to uredbo, zagotovijo izvajanje korektivnih ukrepov, da zagotovijo skladnosti tega izdelka, ga umaknejo ali odpokličejo, če je to primerno.
Furthermore, where the cosmetic product presents a risk to human health, distributors shall immediately inform the responsible person and the competent national authorities of the Member States in which they made the product available, giving details, in particular, of the non-compliance and of the corrective measures taken.
Nadalje, v kolikor kozmetični izdelek predstavlja tveganje za zdravje ljudi, distributerji takoj obvestijo odgovorno osebo in pristojne nacionalne organe držav članic, v katerih so omogočili dostopnost izdelka in jim predložijo podrobne informacije zlasti o neskladnosti in vseh sprejetih korektivnih ukrepih.
Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.
Distributerji zagotovijo, da v času, ko je izdelek v okviru njihove odgovornosti, pogoji skladiščenja ali prevoza ne ogrožajo njegove skladnosti z zahtevami iz te uredbe.
Distributors shall cooperate with competent authorities, at the request of the latter, on any action to eliminate the risks posed by products which they have made available on the market.
Distributerji, ki so omogočili dostopnost kozmetičnih izdelkov na trgu, sodelujejo s prisojnimi organi na njihovo zahtevo pri katerem koli ukrepu, katerega cilj je odpraviti tveganje, ki ga povzročajo ti kozmetični izdelki.
In particular, distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2, in a language which can be easily understood by that authority.
Distributerji na podlagi utemeljene zahteve pristojnega nacionalnega organa posredujejo vse potrebne informacije in dokumentacijo za dokazovanje skladnosti izdelka z zahtevami iz odstavka 2 v jeziku, ki ga pristojni organ brez težav razume.
Identification within the supply chain
Identifikacija v dobavni verigi
At the request of a competent authority:
Na zahtevo pristojnega organa:
responsible persons shall identify the distributors to whom they supply the cosmetic product,
odgovorne osebe identificirajo distributerje, katerim dobavljajo kozmetični izdelek;
the distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied.
distributer identificira distributerja ali odgovorno osebo, ki mu je dobavila kozmetični izdelek, in distributerje, katerim je dobavil kozmetični izdelek.
This obligation shall apply for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.
Ta obveznost se uporablja še 3 leta po datumu, ko je bila serija kozmetičnega izdelka dostopna distributerju.
The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
Proizvodnja kozmetičnih izdelkov je skladna z dobro proizvodno prakso z namenom zagotoviti cilje iz člena 1.
Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Proizvodnja je skladna z dobro proizvodno prakso, kadar je proizvodnja skladna z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije.
Member States shall not, for reasons related to the requirements laid down in this Regulation, refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.
Države članice ne smejo zaradi zahtev te uredbe zavrniti, prepovedati ali omejiti omogočanje dostopnosti na trgu kozmetičnim izdelkom, ki izpolnjujejo določbe te uredbe.
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION
OCENA VARNOSTI, DOKUMENTACIJA Z INFORMACIJAMI O IZDELKU, PRIGLASITEV
In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.
Za zagotavljanje skladnost kozmetičnega izdelka s členom 3, odgovorna oseba zagotovi, da je bila pri kozmetičnem izdelku, preden je bil dan na trg, opravljena ocena varnosti na podlagi ustreznih informacij in da je sestavljeno poročilo o varnosti kozmetičnega izdelka v skladu s Prilogo I.
The responsible person shall ensure that:
Odgovorna oseba zagotovi, da:
the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
se namen uporabe kozmetičnega izdelka ter pričakovana sistemska izpostavljenost posameznim sestavinam v končni formulaciji upoštevata pri oceni varnosti;
an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;
se pri oceni varnosti za obravnavanje ustreznih podatkov, pridobljenih iz vseh obstoječih virov, uporabi primerna analiza, ki temelji na pomembnosti dokazov;
the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
se poročilo o varnosti kozmetičnega izdelka posodablja glede na dodatne ustrezne informacije, ki so zbrane po tem, ko je bil izdelek dan na trg.
The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.
Prvi pododstavek se uporablja tudi za kozmetične izdelke, ki so bili priglašeni v skladu z Direktivo 76/768/EGS.
The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).
Komisija v tesnem sodelovanju z vsemi zainteresiranimi stranmi sprejme ustrezne smernice, da se podjetjem, zlasti malim in srednje velikim, omogoči izpolnjevanje zahtev iz Priloge I. Navedene smernice se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 32(3).
The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
Oceno o varnosti kozmetičnega izdelka, kakor je določena v delu B Priloge I, izvede oseba, ki ima diplomo ali druga dokazila o formalnih kvalifikacijah, pridobljenih ob končanju univerzitetnega teoretičnega in praktičnega študija farmacije, toksikologije, medicine ali podobne vede, ali študija, ki se v državi članici priznava kot enakovreden.
Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of assessing the safety of a cosmetic product shall comply with Community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognised as being equivalent by the Commission or the ECHA.
Neklinične študije varnosti navedene v oceni varnosti v skladu z odstavkom 1, ki so bile izvedene po 30. juniju 1988 z namenom oceniti varnost kozmetičnih izdelkov, so v skladu z zakonodajo Skupnosti o načelih dobre laboratorijske prakse, kakor se uporablja v času opravljanja študije, ali z drugimi mednarodnimi standardi, ki jih Komisija ali ECHA priznavata za enakovredne.
Product information file
Dokumentacija z informacijami o izdelku
When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.
Ko je kozmetični izdelek dan na trg, odgovorna oseba hrani dokumentacijo z informacijami o njem.
The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
Dokumentacija z informacijami o izdelku se hrani še 10 let po datumu, ko je bila zadnja serija kozmetičnega izdelka dana na trg.
The product information file shall contain the following information and data which shall be updated as necessary:
Dokumentacija z informacijami o izdelku zajema naslednje informacije in podatke, ki se po potrebi posodabljajo:
a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
opis kozmetičnega izdelka, ki omogoča, da se dokumentacija z informacijami o izdelku jasno nanaša na kozmetični izdelek;
the cosmetic product safety report referred to in Article 10(1);
poročilo o varnosti kozmetičnega izdelka iz člena 10(1);
a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
opis metode proizvodnje in izjavo o skladnosti z dobro proizvodno prakso iz člena 8;
where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
kadar to upravičuje narava ali učinek kozmetičnega izdelka, dokazila o učinku, ki naj bi ga imel kozmetični izdelek,
data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
podatki o kakršnem koli testiranju na živalih, ki ga izvede proizvajalec, njegovi zastopniki ali dobavitelji v zvezi z razvojem ali oceno varnosti kozmetičnega izdelka ali njegovih sestavin, vključno z kakršnim koli testiranjem na živalih, izvedenim zaradi izpolnjevanja predpisov tretjih držav.
The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.
Odgovorna oseba pristojnemu organu države članice, v kateri se hrani dokumentacija z informacijami o izdelku, vedno zagotovi dostopnost te dokumentacije na naslovu, navedenem na embalaži izdelka in sicer v elektronski ali drugi obliki.
The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.
Informacije, ki jih vsebuje dokumentacija z informacijami o izdelku, so na voljo v jeziku, ki ga lahko brez težav razumejo pristojni organi države članice
The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.
Zahteve iz odstavkov od 1 do 3 tega člena veljajo tudi za kozmetične izdelke, ki so bili priglašeni v skladu z Direktivo 76/768/EGS.
Sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner.
Vzorčenje in analize kozmetičnih izdelkov se izvajajo na zanesljiv in ponovljiv način.
In the absence of any applicable Community legislation, reliability and reproducibility shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
V odsotnosti veljavne zakonodaje Skupnosti, se zanesljivost in ponovljivost predpostavljata, če je uporabljena metoda skladna z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije.
Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:
Preden je kozmetični izdelek dan na trg, odgovorna oseba v elektronski obliki Komisiji predloži naslednje informacije:
the category of cosmetic product and its name or names, enabling its specific identification;
kategorijo kozmetičnega izdelka in njegovo ime ali imena, ki omogočajo njegovo specifično identifikacijo;
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 dostopen;
the country of origin in the case of import;
državo izvora v primeru uvoza;
the Member State in which the cosmetic product is to be placed on the market;
državo članico, v kateri se bo kozmetični izdelek dal na trg;
the contact details of a physical person to contact in the case of necessity;
kontaktne podatke fizične osebe, s katero se po potrebi lahko stopi v stik;
the presence of substances in the form of nanomaterials and:
prisotnost snovi v obliki nanomaterialov in
their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation;
njihovo identifikacijo, vključno s kemijskim imenom (IUPAC) in drugimi deskriptorji, kot so navedeni v točki 2 preambule k prilogam II do VI k tej uredbi;
the reasonably foreseeable exposure conditions;
razumno predvidljive pogoje izpostavljenosti;
the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;
ime in številko CAS (Chemicals Abstracts Service) ali ES številko snovi, ki so razvrščene kot rakotvorne, mutagene ali strupene za razmnoževanje (CMR), kategorije 1A ali 1B, na podlagi dela 3 Priloge VI k Uredbi (ES) št. 1272/2008;
the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.
okvirno formulacijo, ki omogoča hitro in ustrezno zdravljenje v primeru težav.
The first subparagraph shall also apply to cosmetic products notified under Directive 76/768/EEC.
Prvi pododstavek velja tudi za kozmetične izdelke, ki so bili priglašeni v skladu z Direktivo 76/768/EGS.