natgillin/translations-raw huggingface dataset:
Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights [6] and Directive 2004/48/EC of the European parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights [7].
Države članice bi morale posebno pozornost nameniti izvajanju horizontalne zakonodaje Skupnosti in ukrepov, ki se nanašajo na ponarejene izdelke na področju kozmetičnih izdelkov, na primer Uredbi Sveta (ES) št. 1383/2003 z dne 22. julija 2003 o carinskem ukrepanju zoper blago, glede katerega obstaja sum, da krši določene pravice intelektualne lastnine, in o ukrepih, ki jih je treba sprejeti zoper blago, glede katerega je ugotovljeno, da je kršilo take pravice [6], in Direktivi 2004/48/ES Evropskega parlamenta in Sveta z dne 29. aprila 2004 o uveljavljanju pravic intelektualne lastnine [7].
In-market controls represent a powerful means of identifying products that do not comply with the requirements of this Regulation.
Notranji nadzor trga predstavlja učinkovito sredstvo za prepoznavanje izdelkov, ki niso skladni z zahtevami te uredbe.
To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice.
Za zagotovitev njihove varnosti, bi morali biti kozmetični izdelki, dani na trg, proizvedeni v skladu z dobro proizvodno prakso.
For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located.
Za učinkovito izvajanje nadzora trga bi morala biti dokumentacija z informacijami o izdelku pristojnim organom države članice, v kateri se dokumentacija nahaja, vselej dostopna na enem samem naslovu v Skupnosti.
In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation.
Za zagotovitev primerljivosti in visoke kakovosti bi morali biti rezultati nekliničnih varnostnih študij, izvedenih zaradi ocenjevanja varnosti kozmetičnih izdelkov, skladni z ustrezno zakonodajo Skupnosti.
It should be made clear which information is to be made available to the competent authorities.
Razjasniti bi bilo treba, katere informacije naj bodo dostopne pristojnim organom.
That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product.
Te informacije bi morale vsebovati vse potrebne podatke, povezana z istovetnostjo, kakovostjo, varnostjo za zdravje ljudi in učinki, ki naj bi jih imel kozmetični izdelek.
In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.
Te informacije o izdelku bi morale zlasti vključevati poročilo o varnosti kozmetičnega izdelka, ki dokumentira, da je bila izvedena ocena varnosti.
To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner.
Za zagotovitev enotne uporabe in nadzora nad omejitvami za snovi bi bilo treba vzorčenje in analize izvajati na ponovljiv in standardiziran način.
The term ‘mixture’ as defined in this Regulation should have the same meaning as the term ‘preparation’ previously used in Community legislation.
Izraz „zmes“, kakor je opredeljen v tej uredbi, bi moral imeti enak pomen kot izraz „pripravek“, ki se je pred tem uporabljal v zakonodaji Skupnosti.
For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market.
Zaradi učinkovitega nadzora trga bi bilo treba obveščati pristojne organe o nekaterih informacijah v zvezi s kozmetičnimi izdelki, danimi na trg.
In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centres and assimilated entities, where such centres have been established by Member States to that end.
Da bi se omogočilo hitro in ustrezno zdravljenje v primeru težav, bi bilo treba potrebne informacije o formulaciji izdelka sporočiti centrom za nadzor zastrupitev in enakovrednim subjektom, če so države članice takšne centre ustanovile v ta namen.
In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centres and assimilated entities should be submitted centrally for the Community by way of an electronic interface.
Za ohranitev najnižjih možnih upravnih obremenitev bi bilo treba informacije sporočene pristojnim organom, centrom za nadzor zastrupitev in enakovrednim subjektom predložiti na centralni ravni za Skupnost preko elektronskega vmesnika.
In order to ensure a smooth transition to the new electronic interface, economic operators should be allowed to notify the information required in accordance with this Regulation before its date of application.
Da se zagotovi gladek prehod na nov elektronski vmesnik, bi bilo treba gospodarskim subjektom omogočiti, da sporočijo informacije, zahtevane v skladu s to uredbo, pred datumom njene uporabe.
The general principle of the responsibility of the manufacturer or importer for the safety of the product should be supported by restrictions of some substances in Annexes II and III.
Splošno načelo odgovornosti proizvajalca ali uvoznika za varnost izdelka bi moralo biti podprto z omejitvami za snovi v prilogah II in III.
Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses.
Poleg tega, bi morale biti snovi, ki so namenjene za uporabo kot barvila, konzervansi in UV-filtri, navedene v Prilogah IV, V in VI, da se lahko dovoli taka uporaba.
To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction.
V izogib nejasnostim, bi bilo treba pojasniti, da seznam dovoljenih barvil iz Priloge IV vključuje zgolj snovi, ki obarvajo na osnovi absorpcije in odboja, in ne snovi, ki obarvajo na osnovi fotoluminiscence, interference ali kemične reakcije.
To address safety concerns raised, Annex IV, which is currently restricted to skin colorants, should also include hair colorants once the risk assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment [8] has been finalised.
Zaradi pomislekov v zvezi z varnostjo, bi morala Priloga IV, ki je trenutno omejena na barvila za kožo, vključevati tudi barvila za lase, potem ko Znanstveni odbor za varstvo potrošnikov (SCCS), ustanovljen s Sklepom Komisije 2008/721/ES z dne 5. septembra 2008 o vzpostavitvi svetovalne strukture znanstvenih odborov in strokovnjakov na področju varstva potrošnikov, javnega zdravja in okolja [8] izvede oceno tveganja za te snovi.
To this end, the Commission should have the possibility to include hair colorants in the scope of that Annex by the comitology procedure.
V ta namen bi morala Komisija imeti možnost, da barvila za lase vključi v področje uporabe te priloge s postopkom komitiologije.
The use of nanomaterials in cosmetic products may increase with the further development of technology.
Z nadaljnjim razvojem tehnologije lahko pride do povečanja uporabe nanomaterialov v kozmetičnih izdelkih.
In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level.
Za zagotovitev visoke ravni varstva potrošnikov, prostega pretoka blaga in pravne varnosti proizvajalcev je treba oblikovati enotno opredelitev nanomaterialov na mednarodni ravni.
The Community should endeavour to reach an agreement on a definition in appropriate international fora.
Skupnost bi si morala prizadevati, da se na ustreznih mednarodnih forumih doseže sporazum o opredelitvi.
Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.
Če bi bil ta sporazum dosežen, bi bilo treba opredelitev nanomaterialov v tej uredbi ustrezno prilagoditi.
At present, there is inadequate information on the risks associated with nanomaterials.
Trenutno so informacije o tveganjih, povezanih z nanomateriali, nezadostne.
In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.
Za boljšo oceno njihove varnosti bi moral SCCS v sodelovanju s pristojnimi organi določiti smernice za preizkusne metode, ki bi upoštevale posebne značilnosti nanomaterialov.
The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.
Komisija bi morala redno pregledovati določbe o nanomaterialih glede na znanstveni napredek.
Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [9], their use in cosmetic products should be prohibited.
Ob upoštevanju nevarnih lastnosti snovi, razvrščenih kot rakotvorne, mutagene ali strupene za razmnoževanje (CMR), kategorije 1A, 1B in 2, v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [9], bi bilo treba njihovo uporabo v kozmetičnih izdelkih prepovedati.
However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission in the Annexes to this Regulation.
Vendar pa ni nujno, da nevarne lastnosti snovi vedno predstavljajo tveganje, bi morala obstajati možnost, da se dovoli uporaba snovi, razvrščenih kot snovi CMR 2, če SCCS za njih ugotovi, da so glede na izpostavljenost in koncentracijo varne za uporabo v kozmetičnih izdelkih, in jih Komisija ureja v prilogah k tej uredbi.
With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substances in cosmetic products on the condition that such use has been found safe by the SCCS.
Za snovi, razvrščene kot CMR 1A ali 1B, bi morala, v izjemnem primeru, da so te snovi v skladu z zahtevami o varnosti hrane, med drugim zaradi njihove naravne prisotnosti v hrani, in ker zanje ni ustreznih alternativnih snovi, obstajati možnost da se jih uporabi v kozmetičnih izdelkih, pod pogojem, da je SCCS ugotovil, da je takšna uporaba varna.
Where such conditions are met, the Commission should amend the relevant Annexes to this Regulation within 15 months of classification of substances as CMR 1A or 1B substances under Regulation (EC) No 1272/2008.
Kadar so ti pogoji izpolnjeni, bi morala Komisija spremeniti ustrezne priloge k tej uredbi v 15 mesecih po razvrstitvi snovi kot snovi CMR1A ali 1B v skladu z Uredbo (ES) št. 1272/2008.
Such substances should be continuously reviewed by the SCCS.
Takšne snovi bi moral ZOVP nenehno preverjati.
A safety assessment of substances, particularly those classified as CMR 1A or 1B substances, should consider the overall exposure to such substances stemming from all sources.
Pri oceni varnosti snovi, zlasti tistih, ki so razvrščene kot snovi CMR 1A ali 1B, bi bilo treba upoštevati celotno izpostavljenost tem snovem iz vseh virov.
At the same time, for those involved in producing safety assessments, it is essential that there be a harmonised approach to the development and use of such overall exposure estimates.
Istočasno je za tiste, ki so vključeni v pripravo ocen varnosti, ključnega pomena usklajen pristop k pripravi in uporabi takšnih ocen o celotni izpostavljenosti.
In consequence, the Commission, in close cooperation with the SCCS, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and other relevant stakeholders, should, as a matter of urgency, carry out a review and develop guidance regarding the production and use of overall exposure estimates for these substances.
Zato bi Komisija morala v tesnem sodelovanju s SCCS, Evropsko agencijo za kemikalije (ECHA), Evropsko agencijo za varnost hrane (EFSA) in drugimi zadevnimi zainteresiranimi stranmi nujno opraviti pregled in oblikovati smernice glede priprave in uporabe ocen o celotni izpostavljenosti za te snovi.
The assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses.
Ocena SCCS o uporabi snovi, razvrščenih kot CMR 1A ali 1B, v kozmetičnih izdelkih bi morala upoštevati tudi izpostavljenost tem snovem ranljivih skupin prebivalstva, kot so otroci, mlajši od 3 let, starejši ljudje, noseče in doječe ženske ter ljudje, ki imajo oslabljen imunski sistem.
The SCCS should give opinions where appropriate on the safety of use of nanomaterials in cosmetic products.
Po potrebi bi moral ZOVP dati mnenje o varnosti uporabe nanomaterialov v kozmetičnih izdelkih.
These opinions should be based on full information being made available by the responsible person.
To mnenje bi moralo temeljiti na popolnih informacijah, ki jih daje na voljo odgovorna oseba.
Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.
UkrepiKomisije in držav članic v zvezi v varstvom zdravja ljudi bi morali temeljiti na previdnostnem načelu.
In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.
Za zagotovitev varnosti izdelkov bi morale biti prepovedane snovi sprejemljive v sledeh samo, če so s pravilnimi proizvodnimi postopki tehnološko neizogibne in če je izdelek varen.
The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.
K Pogodbi je priložen Protokol o varstvu in dobrem počutju živali, po katerem morajo Skupnost in države članice v celoti upoštevati zahteve glede dobrega počutja živali pri izvajanju politik Skupnosti, zlasti v zvezi z notranjim trgom.
Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes [10] established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States.
Direktiva Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic v zvezi z varstvom živali, ki se uporabljajo v poskusne in druge znanstvene namene [10], je uvedla splošna pravila za uporabo živali v poskusne namene v Skupnosti in določila pogoje, pod katerimi se morajo taki poskusi izvajati na ozemlju držav članic.
In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, where such methods exist and are scientifically satisfactory.
Zlasti člen 7 navedene direktive določa, da se poskusi na živalih nadomestijo z alternativnimi metodami, če take metode obstajajo in so znanstveno zadovoljive.
The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients.
Varnost kozmetičnih izdelkov in njihovih sestavin se lahko zagotovi z uporabo alternativnih metod, ki pa niso nujno primerne za vse uporabe kemijskih sestavin.
Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers.
Zato bi bilo treba spodbujati, da bi vsa kozmetična industrija uporabljala take metode, ter zagotoviti njihovo sprejetje na ravni Skupnosti, če take metode nudijo enako raven varstva potrošnikov.
The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain.
Varnost končnih kozmetičnih izdelkov se lahko zagotovi že na osnovi spoznanj o varnosti sestavin, ki jih vsebujejo.
Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down.
Zato bi bilo treba zagotoviti določbe, ki prepovedujejo testiranje končnih kozmetičnih izdelkov na živalih.
The application, in particular by small and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines.
Smernice Komisije bi lahko zlasti malim in srednje velikim podjetjem olajšale uporabo testnih metod in postopkov ocenjevanja ustreznih razpoložljivih podatkov, vključno s pristopoma uporabe dokazov iz različnih virov in vrednotenje le teh, ki ne vključujejo uporabe živali za ocenjevanje varnosti končnih kozmetičnih izdelkov.
It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD).
Postopoma bo mogoče zagotoviti varnost sestavin, uporabljenih v kozmetičnih izdelkih, zuporabo alternativnih metod brez živali, znanstveno potrjenih na ravni Skupnosti ali odobrenih kot znanstveno potrjene s strani Evropskega centra za validacijo alternativnih metod (ECVAM) ob ustreznem upoštevanju razvoja znanstvenega potrjevanja v Organizaciji za gospodarsko sodelovanje in razvoj (OECD).
After consulting the SCCS as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients.
Po posvetovanju s SCCS o uporabnosti znanstveno potrjenih alternativnih metod na področju kozmetičnih izdelkov, bi morala Komisija takoj objaviti znanstveno potrjene ali odobrene metode, ki so priznane kot uporabne za take sestavine.
In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition.
Da se doseže najvišja možna stopnja varstva živali, bi bilo treba določiti rok za uvedbo dokončne prepovedi.
The Commission established timetables of deadlines up to 11 March 2009 for prohibiting the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for prohibiting each test currently carried out using animals.
Komisija je pripravila časovne razporede rokov do 11. marca 2009 za prepoved prometa s kozmetičnimi izdelki, končnimi formulacijami, sestavinami ali kombinacijami sestavin, ki so se testirale na živalih, ter za prepoved vseh testiranj, ki se sedaj izvajajo na živalih.
In view, however, of tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the final deadline for prohibiting the marketing of cosmetic products for which those tests are used to be 11 March 2013.
Glede na teste strupenosti pri ponavljajočih se odmerkih, strupenosti za razmnoževanje in toksikokinetike je primeren skrajni rok za prepoved prometa s kozmetičnimi izdelki, za katere se uporabljajo navedeni testi, 11. marec 2013.
On the basis of annual reports, the Commission should be authorised to adapt the timetables within the abovementioned maximum time limit.
Komisija bi morala imeti pooblastilo, da na osnovi letnih poročil prilagodi časovne razporede v okviru zgoraj navedenega skrajnega časovnega roka.
Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods.
Boljša koordinacija sredstev na ravni Skupnosti bo prispevala k povečanju znanstvenih spoznanj, ki so nujno potrebna za razvoj alternativnih metod.
It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Framework Programmes for research.
Zato je pomembno, da Skupnost še naprej povečuje svoja prizadevanja in sprejema potrebne ukrepe za pospeševanje in spodbujanje raziskav in razvoja novih alternativnih metod, pri katerih se živali ne uporabljajo, zlasti v okviru svojih okvirnih programov za raziskave.
The recognition by third countries of alternative methods developed in the Community should be encouraged.
Spodbujati bi bilo treba priznanje alternativnih metod, razvitih v Skupnosti, v tretjih državah.
In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD.
Za doseganje tega cilja bi morale Komisija in države članice storiti vse potrebno, da bi olajšale sprejetje takih metod v OECD.
The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid third countries requiring the repetition of such tests using animals.
Komisija bi si morala v okviru sporazumov o sodelovanju Evropske skupnosti tudi prizadevati pridobiti priznanje rezultatov preskusov varnosti, izvedenih v Skupnosti s pomočjo alternativnih metod, tako da se zagotovi neoviran izvoz kozmetičnih izdelkov, za katere so se uporabljale take metode, in prepreči ali izogne zahtevam, da tretje države zahtevajo ponovitev takih testov na živalih.
Transparency is needed regarding the ingredients used in cosmetic products.
V zvezi s sestavinami, uporabljenimi v kozmetičnih izdelkih, je potrebna preglednost.
Such transparency should be achieved by indication of the ingredients used in a cosmetic product on its packaging.
Takšno preglednost bi bilo treba doseči z označitvijo uporabljenih sestavin na embalaži kozmetičnega izdelka.