natgillin/translations-raw huggingface dataset:
Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information.
Kjer teh sestavin iz praktičnih razlogov ni mogoče označiti na embalaži, bi bilo treba te informacije priložiti tako, da ima lahko potrošnik dostop do teh informacij.
A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients.
Komisija bi morala sestaviti glosar skupnih imen sestavin ter tako zagotoviti enotno označevanje in olajšati identifikacijo sestavin kozmetičnih izdelkov.
This glossary should not be intended to constitute a limitative list of substances used in cosmetic products.
Ta glosar ne bi smel biti namenjen omejevanju seznama snovi, uporabljenih v kozmetičnih izdelkih.
In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use.
Zaradi obveščanja potrošnikov bi bilo treba na kozmetičnih izdelkih natančno in jasno navesti rok trajanja.
Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product.
Ker bi morali biti potrošniki seznanjeni z datumom, do katerega kozmetični izdelek opravlja svojo prvotno nalogo in se ga lahko varno uporablja, je pomembno, da se ve, kateri je minimalni datum uporabe, to je datum, do katerega je najboljše, da se izdelek uporabi.
Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer.
Kadar je minimalni rok trajanja daljši od 30 mesecev, bi moral potrošnik biti obveščen o tem, koliko časa po odprtju kozmetičnega izdelka ga lahko brez škode še uporablja.
However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.
Vendar se ta zahteva ne bi smela uporabljati, kadar pojem trajnosti izdelka po odprtju ni pomemben, to je pri izdelkih za enkratno uporabo, izdelkih, ki se ne pokvarijo, ali izdelkih, ki se ne odpirajo.
A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them.
SCCS je za znatno število snovi ugotovil, da lahko povzročijo alergične reakcije, zato bo treba omejiti njihovo uporabo in/ali zanje določiti nekatere pogoje.
In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients.
Da se zagotovi ustrezno obveščanje potrošnikov, bi bilo treba prisotnost teh snovi navesti na seznamu sestavin ter pritegniti pozornost potrošnikov na prisotnost teh sestavin.
This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate.
Te informacije bi morale izboljšati postavljanje diagnoze za kontaktno alergijo pri potrošnikih in bi jim morale omogočiti, da se izogibajo uporabi kozmetičnih izdelkov, ki jih ne prenašajo.
For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.
Za snovi, ki lahko povzročijo alergije velikemu številu ljudi, bi bilo treba upoštevati možnost uporabe drugih omejevalnih ukrepov, kot sta prepoved ali zmanjšanje koncentracije.
In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas.
Pri oceni varnosti kozmetičnega izdelka bi morala obstajati možnost, da se upoštevajo rezultati ocen tveganja, opravljenih na drugih ustreznih področjih.
The use of such data should be duly substantiated and justified.
Uporaba takšnih podatkov bi morala biti primerno utemeljena in upravičena.
The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products.
Potrošnike bi bilo treba zaščititi pred zavajajočimi izjavami v zvezi z učinkovitostjo in drugimi značilnostmi kozmetičnih izdelkov.
In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market [11] is applicable.
Zlasti se uporabi Direktiva 2005/29/ES Evropskega parlamenta in Sveta z dne 11. maja 2005 o nepoštenih poslovnih praksah podjetij v razmerju do potrošnikov na notranjem trgu [11].
Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.
Poleg tega bi morala Komisija v sodelovanju z državami članicami določiti skupna merila o posebnih izjavah na kozmetičnih izdelkih.
It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development.
Na kozmetičnem izdelku bi bilo treba omogočiti izjavo, da se pri razvoju izdelka niso izvajala testiranja na živalih.
The Commission, in consultation with the Member States, has developed guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer.
Po posvetovanju z državami članicami je Komisija pripravila smernice, s katerimi je zagotovila, da se pri uporabi izjav uporabljajo skupna merila in da se doseže usklajen dogovor o pomenu teh izjav, ter zlasti, da take izjave ne zavajajo potrošnika.
In developing such guidelines, the Commission has also taken into account the views of the many small and medium-sized enterprises which make up the majority of the ‘non-animal testing’ producers, relevant non-governmental organisations, and the need for consumers to be able to make practical distinctions between products on the basis of animal testing criteria.
Pri pripravi takih smernic je Komisija upoštevala tudi stališča številnih malih in srednje velikih podjetij, ki predstavljajo večino proizvajalcev, ki izdelkov ne testirajo na živalih, ustreznih nevladnih organizacij in potrebo potrošnikov, da lahko enostavno razlikujejo med izdelki na podlagi meril o testiranju na živalih.
In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make informed product choices.
Poleg označenih informacij bi bilo treba potrošnikom omogočiti, da od odgovornih oseb zahtevajo nekatere z izdelkom povezane informacije, da lahko ozaveščeno izbirajo izdelke.
Effective market surveillance is necessary in order to ensure that the provisions of this Regulation are respected.
Za zagotovitev spoštovanja določb te uredbe je potreben učinkovit nadzor trga.
To this end, serious undesirable effects should be notified and competent authorities should have a possibility to request from the responsible person a list of cosmetic products containing substances which have raised serious doubts in terms of safety.
Zaradi tega bi bilo potrebno obveščanje o resnih neželenih učinkih, pristojni organi pa bi morali imeti možnost od odgovornih oseb zahtevati seznam kozmetičnih izdelkov, ki vsebujejo snovi, ki povzročajo resne dvome glede varnosti.
This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the notification by health professionals or consumers of serious undesirable effects to the competent authorities of Member States.
Ta uredba ne posega v možnost, ki jo imajo države članice, da v skladu z zakonodajo Skupnosti dajo možnost, da zdravstveno osebje ali potrošniki pristojne organe držav članic obvestijo o resnih nezaželenih učinkih.
This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the establishment of economic operators in the area of cosmetic products.
Ta uredba ne posega v možnost, ki jo imajo države članice, da v skladu z zakonodajo Skupnosti uredijo ustanavljanje gospodarskih subjektov na področju kozmetičnih izdelkov.
In case of non-compliance with this Regulation, a clear and efficient procedure for the withdrawal and recall of products may be necessary.
V primeru neskladnosti s to uredbo, bo morda potreben jasen in učinkovit postopek za umik in odpoklic izdelkov.
This procedure should, where possible, build upon existing Community rules for unsafe goods.
Ta postopek bi moral po možnosti temeljiti na obstoječih pravilih Skupnosti za nevarno blago.
In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced.
Uvesti bi bilo treba zaščitni postopek za obravnavo kozmetičnih izdelkov, ki bi lahko ogrožali zdravje ljudi, četudi so v skladu z določbami te uredbe.
The Commission should provide indications for the uniform interpretation and application of the concept of serious risks in order to facilitate the consistent implementation of this Regulation.
Komisija bi morala zagotoviti navodila za enotno razlago in uporabo pojma o resnih tveganjih, da se olajša skladno izvajanje te uredbe.
In order to comply with principles of good administrative practices, any decision by a competent authority in the framework of market surveillance should be duly substantiated.
Za zagotovitev skladnosti z načeli dobre upravne prakse bi morala biti vsaka odločitev pristojnih organov v okviru nadzora trga ustrezno utemeljena.
In order to ensure effective in-market control, a high degree of administrative cooperation amongst the competent authorities is necessary.
Za zagotovitev učinkovitega notranjega nadzora trga bi bila potrebna visoka stopnja upravnega sodelovanja med pristojnimi organi.
This concerns in particular mutual assistance in the verification of product information files located in another Member State.
To zlasti zadeva medsebojno pomoč pri preverjanju dokumentacije z informacijami o izdelku, ki se nahajajo v drugi državi članici.
The Commission should be assisted by the SCCS, an independent risk assessment body.
Komisiji bi moral pomagati SCCS, neodvisni organ za ocenjevanje tveganja.
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [12].
Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [12].
In particular, power should be conferred on the Commission to adapt the Annexes to this Regulation to technical progress.
Zlasti bi bilo treba Komisiji podeliti pooblastila za prilagajanje prilog k tej uredbi tehničnemu napredku.
Since those measures are of general scope and are designed to amend non-essential elements of this Regulation they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te uredbe, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of certain measures relating to CMRs, nanomaterials and potential risks to human health.
Kadar v nujnih primerih ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, bi bilo treba Komisiji omogočiti uporabo nujnega postopka iz člena 5a(6) Sklepa 1999/468/ES za sprejetje nekaterih ukrepov v zvezi s snovmi CMR, nanomateriali in morebitnimi tveganji za zdravje ljudi.
Member States should lay down provisions on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented.
Države članice bi morale določiti določbe o kaznih za kršitve določb te uredbe in zagotoviti njihovo izvajanje.
Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation.
Gospodarski subjekti, države članice in Komisija potrebujejo dovolj časa za prilagoditev spremembam, ki jih uvaja ta uredba.
Therefore it is appropriate to provide for a sufficient transitional period for that adaptation.
Zato je treba določiti dovolj dolgo prehodno obdobje za to prilagoditev.
However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period.
Vendar bi bilo za zagotavljanje gladkega prehoda gospodarskim subjektom treba dovoliti, da dajo na trg kozmetične izdelke v skladu s to uredbo pred koncem tega prehodnega obdobja.
In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC.
Za povečanje varnosti kozmetičnih izdelkov in okrepitev nadzora nad trgom bi morali biti kozmetični izdelki, ki bodo dani na trg po začetku datuma uporabe te uredbe, v skladu z njenimi zahtevami glede ocene o varnosti, dokumentacije z informacijami o izdelku in priglasitve, četudi so podobne zahteve že izpolnjene v skladu z Direktivo 76/768/EGS.
Directive 76/768/EEC should be repealed.
Direktivo 76/768/EGS bi bilo treba razveljaviti.
However, in order to ensure appropriate medical treatment in the event of difficulties and to ensure market surveillance, the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC concerning cosmetic products should be kept by the competent authorities for a certain period of time and the information kept by the responsible person should remain available for the same period of time.
Vendar pa bi morali, z namenom zagotavljanja ustreznega medicinskega zdravljenja v primeru težav in z namenom zagotavljanja nadzora nad trgom, pristojni organi za določeno časovno obdobje hraniti informacije o kozmetičnih izdelkih, pridobljene v skladu s členom 7(3) in členom 7a(4) Direktive 76/768/EGS, in tudi informacije, ki jih hrani odgovorna oseba, bi morale ostati na voljo v istem časovnem obdobju.
This Regulation should 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 bi smela posegati v obveznosti držav članic glede rokov za prenos direktiv v nacionalno zakonodajo, določenih v delu B Priloge IX.
Since the objective of this Regulation, namely the achievement of the internal market and a high level of protection of human health through the compliance of cosmetic products with the requirements laid down in this Regulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty.
Ker ciljev te uredbe, in sicer zagotovitve notranjega trga in visoke ravni varovanja zdravja ljudi preko skladnosti kozmetičnih izdelkov z zahtevami te uredbe, države članice ne morejo zadovoljivo doseči in ker te cilje zaradi obsega in učinkov te uredbe lažje doseže Skupnost, Skupnost lahko sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne prekoračuje okvirov, ki so potrebni za doseganje navedenega cilja –
SCOPE, DEFINITIONS
PODROČJE UPORABE, OPREDELITVE POJMOV
Scope and objective
Področje uporabe in cilji
This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.
Ta uredba uvaja pravila, s katerimi morajo biti skladni vsi kozmetični izdelki, dostopni na trgu, da se zagotovi delovanje notranjega trga in visoka raven varovanja zdravja ljudi.
‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
„kozmetični izdelek“ pomeni katero koli snov ali zmes, namenjeno stiku z zunanjimi deli človeškega telesa (povrhnjico, lasiščem, nohti, ustnicami in zunanjimi spolnimi organi) ali z zobmi in sluznico ustne votline zaradi izključno ali predvsem njihovega čiščenja, odišavljenja, spreminjanja njihovega videza, njihovega varovanja, ohranjanja v dobrem stanju ali korekcije telesnega vonja;
‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
„snov“ pomeni kemijski element in njegove spojine v naravnem stanju ali pridobljene s kakršnim koli proizvodnim postopkom, vključno z vsemi dodatki, potrebnimi za ohranitev njene obstojnosti, in vsemi nečistočami, ki nastanejo pri uporabljenem postopku, ne vključuje pa topil, ki se lahko izločijo, ne da bi to vplivalo na obstojnost snovi ali spremenilo njeno sestavo;
‘mixture’ means a mixture or solution composed of two or more substances;
„zmes“ pomeni zmes ali raztopino, sestavljeno iz dveh ali več snovi;
‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;
„proizvajalec“ pomeni vsako fizično ali pravno osebo, ki proizvaja kozmetični izdelek ali za katero se tak izdelek načrtuje ali proizvaja in ki trži ta kozmetični izdelek pod svojim imenom ali blagovno znamko;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;
„distributer“ pomeni vsako fizično ali pravno osebo v dobavni verigi, ki ni proizvajalec ali uvoznik in ki omogoči dostopnost kozmetičnega izdelka na trgu Skupnosti;
‘end user’ means either a consumer or professional using the cosmetic product;
„končni uporabnik“ pomeni potrošnika ali osebo, ki poklicno uporablja kozmetični izdelek;
‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;
„dostopnost na trgu“ pomeni vsako dobavo kozmetičnega izdelka za distribucijo, porabo ali uporabo na trgu Skupnosti v okviru gospodarske dejavnosti, bodisi odplačno ali neodplačno;
‘placing on the market’ means the first making available of a cosmetic product on the Community market;
„dajanje na trg“ pomeni, da je kozmetični izdelek prvič dostopen na trgu Skupnosti;
‘importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;
„uvoznik“ pomeni vsako fizično ali pravno osebo, ustanovljeno v Skupnosti, ki da kozmetični izdelek iz tretje države na trg Skupnosti;
‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services [13] on the basis of a request made by the Commission in accordance with Article 6 of that Directive;
„harmonizirani standard“ pomeni standard, ki ga je sprejel eden izmed evropskih organov za standardizacijo iz Priloge I k Direktivi 98/34/ES Evropskega parlamenta in Sveta z dne 22. junija 1998 o določitvi postopka za zbiranje informacij na področju tehničnih standardov in tehničnih predpisov o storitvah informacijske družbe [13] na podlagi predloga, ki ga je pripravila Komisija v skladu s členom 6 navedene direktive;
‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;
„nanomaterial“ pomeni netopen ali biološko obstojen in namenoma proizveden material z eno ali več zunanjimi dimenzijami ali notranjo strukturo v merilu od 1 do 100 nm;
‘preservatives’ means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;
„konzervansi“ pomeni snovi, ki so izključno ali v glavnem namenjene zaviranju razvoja mikroorganizmov v kozmetičnem izdelku;
‘colorants’ means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants;
„barvila“ pomeni snovi, ki so izključno ali v glavnem namenjena barvanju kozmetičnega izdelka, celotnega telesa ali določenih delov telesa, in sicer na osnovi absorpcije ali odboja vidne svetlobe; za barvila se štejejo tudi predhodne sestavine (prekurzorji) za oksidativna barvila za lase;
‘UV-filters’ means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation;
„UV-filtri“ pomeni snovi, ki so izključno ali v glavnem namenjene zaščiti kože pred določenimi ultravijoličnimi žarki z absorpcijo, odbijanjem ali razprševanjem ultravijoličnih žarkov;
‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product;
„neželeni učinek“ pomeni za zdravje ljudi nevarno reakcijo, ki se lahko pripiše običajni ali razumno predvidljivi uporabi kozmetičnega izdelka;
‘serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death;
„resni neželeni učinek“ pomeni neželeni učinek, ki povzroči začasno ali stalno funkcionalno nezmožnost, invalidnost, hospitalizacijo, prirojene nepravilnosti ali neposredno bistveno tveganje ali smrt;
‘withdrawal’ means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain;
„umik“ pomeni vsak ukrep za preprečitev omogočanja dostopnosti kozmetičnega izdelka iz dobavne verige na trgu;
‘recall’ means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user;
„odpoklic“ pomeni vsak ukrep za vrnitev kozmetičnega izdelka, ki je že bil dostopen končnemu uporabniku;