natgillin/translations-raw huggingface dataset:
Za ugotavljanje in oceno morebitnih tveganj, povezanih z njihovimi značilnostmi, bi bilo treba razviti posebne preizkusne metode.
Special testing method should be developed so that the potential risks relating to their specificities could be identified and evaluated.
(25c) Komisija bi morala na podlagi znanstvenega napredka redno pregledovati določbe o nanomaterialih, ne glede na njihovo obstojnost in topnost.
(25 c ) The Commission should regularly review the provisions on nanomaterials , regardless of their persistence and solubility , in the light of scientific progress.
(26a) Pri oceni varnosti snovi, zlasti tistih, ki so razvrščene kot CMR 1 ali 2, bi bilo treba upoštevati splošno izpostavljenost tem snovem iz vseh virov.
(26a) A safety assessment of substances, particularly those classified as CMR 1 or 2 substances , should consider the global exposure to such substances stemming from all sources.
Sočasno je za vse, ki so vključeni v pripravo ocen varnosti, ključnega pomena usklajen pristop k pripravi in uporabi takšnih ocen o splošni izpostavljenosti.
At the same time, for those involved in producing safety assessments, it is essential that there be a harmoni s ed approach to the development and use of such global exposure estimates.
Komisija bi zato morala v tesnem sodelovanju z ZOPP, Evropsko agencijo za kemikalije (ECHA), Evropsko agencijo za varnost hrane (EFSA) in drugimi zadevnimi zainteresiranimi stranmi nujno opraviti pregled in oblikovati smernice glede izdelave in uporabe ocen o splošni izpostavljenosti za te snovi.
In consequence, the Commission, in close cooperation with the SCCP, 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 global exposure estimates for these substances.
Zlasti pri snoveh CMR je treba oceno varnosti upoštevati v okviru splošne izpostavljenosti posameznikov tej snovi iz vseh virov.
For CMRs in particular, the safety assessment needs to be considered within the context of the global exposure of individuals to the substance from all sources.
Treba je pripraviti smernice za izdelavo ocen splošne izpostavljenosti in njihove uporabe pri ocenah varnosti posameznih proizvodov.
Guidance needs to be developed for the establishment of global exposure estimates and their use in individual product safety assessments.
(31) Varnost končnih kozmetičnih izdelkov se lahko zagotovi že na osnovi spoznanj o varnosti sestavin, ki jih vsebujejo.
(31) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain.
Zato bi bilo treba zagotoviti določbe, ki prepovedujejo preskušanje končnih kozmetičnih izdelkov na živalih.
Provisions prohibiting animal testing of finished cosmetic products should therefore be provided.
Smernice Komisije bi lahko zlasti malim in srednje velikim podjetjem olajšale uporabo metod, ki ne vključujejo uporabe živali za ocenjevanje varnosti končnih kozmetičnih izdelkov.
The application, in particular by small and medium-sized enterprises, of methods 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 poskusnih metod in postopkov ocenjevanja za ustrezne razpoložljive podatke, vključno s pristopoma navzkrižnega branja in zanesljivosti dokazov , ki ne vključujejo uporabe živali za ocenjevanje varnosti končnih kozmetičnih izdelkov.
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.
Pomembno se je zavedati, da bi bilo treba pri oceni varnosti končnih kozmetičnih izdelkov upoštevati vse ustrezne razpoložljive podatke, ne glede na to, ali izhajajo iz študij na živalih, ki so bile opravljene in vitro, in silico, na podlagi obstoječe dobre laboratorijske prakse ali brez nje, ali iz obstoječih podatkov za ljudi ali iz drugih virov.
It is important to recognize that all relevant available data, whether is stems from in-vitro, in-silico, GLP/non-GLP existing animal studies, existing human data, or other sources should be appropriately considered in the safety assessment of finished cosmetics products.
(39a) Pri oceni varnosti kozmetičnega izdelka bi morala obstajati možnost, da se upoštevajo rezultati ocen tveganja, opravljenih na drugih ustreznih področjih.
(39a) In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessment s that have been carried out in other relevant areas.
Uporaba takšnih podatkov bi morala biti primerno utemeljena in upravičena.
The use of such data should be duly substantiated and justified.
Morala bi obstajati možnost za uporabo obstoječih podatkov iz ocen tveganja z drugih področij, vendar le v primerih, ko je to pomembno za oceno varnosti obravnavanega izdelka.
The use of existing data from risk assessments in other areas should be possible, but only when it is relevant for the safety assessment of the product in question.-
(40) Potrošnike bi bilo treba zaščititi pred zavajajočimi izjavami v zvezi z učinkovitostjo in drugimi značilnostmi kozmetičnih izdelkov.
(40) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products.
Za namen obravnave posebnih izjav v zvezi z značilnostmi kozmetičnih izdelkov , bi bilo treba omogočiti uporabo usklajenih standardov .
In order to address specific claims concerning the characteristics of cosmetic products, the possibility to make use of harmonised standards should be provided .
Za oceno veljavnosti posameznih izjav v zvezi z značilnostmi kozmetičnih izdelkov bi morala Komisija predložiti poročilo o uporabi izjav na izdelkih in o dokazih, predloženih zanje, ter po potrebi predlagati ustrezne ukrepe za reševanje morebitnih ugotovljenih težav .
In order to assess the validity of specific claims concerning the characteristics of cosmetic products , the Commission should present a report on the use of product claims and the proof given for them and , if appropriate , propose adequate measures to resolve any problems found.
Treba je zagotoviti, da se pri oglaševanju in označevanju lahko uporabljajo le izjave o tistih značilnosti, ki jih izdelek dejansko ima.
It is necessary to ensure that only claims on those characteristics that a product really has can be used in advertising and labelling.
Poročevalka sicer podpira usklajen pristop, vendar se ne strinja s predlagano rešitvijo.
While the rapporteur supports a harmonised approach, she does not agree with the proposed solution.
Namesto tega bi morala Komisija pregledati vse izjave na izdelkih in način, na katerega jih dokazuje odgovorna oseba, ter po potrebi predlagati ustrezne ukrepe za reševanje morebitnih ugotovljenih težav.
Instead, the Commission should review all product claims and the way they are proven by the responsible person and propose, if appropriate, adequate measures to resolve any problems found.
(44a) Države članice bi morale organom za nadzor trga zagotoviti potrebna pooblastila, sredstva in znanje za pravilno izvajanje njihovih nalog.
(44a) Member States should provide market surveillance authorities with the necessary powers, resources and knowledge to perform their tasks properly .
(b) „proizvajalec“ je vsaka fizična ali pravna oseba, ki načrtuje ali izdeluje kozmetični izdelek ali za katero se tak izdelek načrtuje ali izdeluje pod njegovim imenom ali blagovno znamko,
(b) ‘manufacturer’ means any natural or legal person who designs or manufactures a cosmetic product or who has such a product designed or manufactured, under his name or trademark;
b) „proizvajalec“ je vsaka fizična ali pravna oseba, ki načrtuje , izdeluje ali pakira kozmetični izdelek ali za katero se tak izdelek načrtuje , izdeluje ali pakira pod njegovim imenom ali blagovno znamko,
b) ‘manufacturer’ means any natural or legal person who designs , manufactures or packages a cosmetic product or who has such a product designed , manufactured or packaged , under his name or trademark;
Široka opredelitev „proizvajalca“ mora biti celovita in vključevati vse stopnje izdelave kozmetičnega izdelka.
The broad definition of 'manufacturer' should be exhaustive and cover all stages of the process of manufacturing cosmetic products.
(ba) „podizvajalec“ je vsaka fizična ali pravna oseba, ki načrtuje, izdeluje ali pakira izdelke za drugo fizično ali pravno osebo, ki je naročnik.
(ba) 'subcontractor' means any natural or legal person who designs, manufactures or packages products on behalf of another natural or legal person who is the main contractor.
Naročnika s podizvajalcem vežejo specifikacije in pogodba.
The main contractor is bound to the subcontractor by specifications and a contract.
Člen 2 – odstavek 1 – točka e a (novo)
Article 2 – paragraph 1 – point e a (new)
(ea) „distributer“ je vsaka fizična ali pravna oseba, ki kupuje in naprej prodaja izdelke v nespremenjenem stanju ter nima nobenih lastninskih pravic pri blagovni znamki.
(ea) 'distributor' means any natural or legal person who purchases and resells a product unaltered and has no property rights in relation to the trademark.
Člen 2 – odstavek 1 – točka i a (novo)
Article 2 - paragraph 1 - point i a (new)
(ia) „nanomaterial“ je netopen ali biološko odporen in namenoma izdelan material z eno ali več zunanjimi dimenzijami ali notranjo strukturo v merilu od 1 do 100 nm,
ia) '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.
Člen 2 – odstavek 1 – točka k
Article 2 – paragraph 1 – point k
(k) „neželeni učinek“ je za zdravje ljudi nevarna reakcija, ki se lahko pripiše običajni ali razumno predvidljivi uporabi kozmetičnega izdelka,
(k) ‘undesirable effect’ means a harmful reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product;
(k) „neželeni učinek“ je za zdravje ljudi nevarna reakcija, ki se lahko pripiše običajni ali razumno predvidljivi uporabi specifičnega kozmetičnega izdelka,
(k) ‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a specific cosmetic product;
(Ne zadeva slovenske različice.)
‘Harmful’ has a specific meaning in other EU legislation (e.g. REACH and Classification/labelling legislation).
Člen 2 – odstavek 1 – točka l
Article 2 – paragraph 1 – point l
(l) „resni neželeni učinek“ je neželeni učinek, ki povzroči začasno ali stalno funkcionalno nezmožnost, invalidnost, hospitalizacijo, prirojene nepravilnosti ali neposredno bistveno tveganje ali smrt ,
(l) ’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 ;
(l) „resni neželeni učinek“ je neželeni učinek, ki povzroči smrt, ogrozi življenje bolnika, zahteva hospitalizacijo ali njeno podaljšanje, povzroči hudo ali trajno invalidnost ali nezmožnost ali prirojeno anomalijo ali malformacijo ,
(l) ’serious undesirable effect’ means an undesirable effect which results in death, threatens the patient's life, requires hospitalisation or prolonged hospitalisation , or results in serious or permanent invalidity or incapacity or in a congenital anomaly or malformation ;
Da bi se zagotovila skladnost in bi bilo zgodnje odkrivanje resnih in redkih stanj čim hitrejše, je treba opredelitev „resnega neželenega učinka“ uskladiti z veljavnimi opredelitvami Svetovne zdravstvene organizacije in Mednarodne konference o usklajevanju.
For the sake of consistency and to identify serious and rare situations as rapidly as possible, the definition of 'serious undesirable effect' should be brought into line with definitions currently used by the World Health Organisation (WHO) and the International Conference on Harmonisation (ICH).
Člen 2 – odstavek 1 – točka l a (novo)
Article 2 - paragraph 1 - point l a (new)
(la) „ranljive skupine prebivalstva“ so otroci, mlajši od treh let, starejši ljudje in osebe, ki kažejo znake zmanjšane odpornosti,
(la) 'vuln e rable population groups ' means children under three years of age, elderly people and persons showing compromised immune responses.
Člen 2 – odstavek 1 – točka n a (novo)
Article 2 – paragraph 1 – point n a (new)
(na) „ponarejeni kozmetični izdelek“ je vsak kozmetični izdelek, vključno z embalažo in oznakami, ki nosi blagovno znamko, trgovsko ime ali drugo obliko identifikacije blagovne znamke, odtis ali simbol ali vsak drug tovrstni znak proizvajalca kozmetičnih izdelkov, ki ni oseba, ki je resnično izdelala izdelek, ki je zato lažno predstavljen ali opisan kot izdelek drugega proizvajalca kozmetičnih izdelkov.
(na) 'counterfeit cosmetic product' means any cosmetic product, including the packaging and labelling thereof, bearing a trademark, a marketing name or any other form of trademark identification, a stamp or emblem or any marking of this type, belonging to a manufacturer of cosmetic products other than the person who actually manufactured the product and which thus falsely claims to be the product of another manufacturer of cosmetic products or is depicted as such.
Evropski sektor kozmetike spada med industrijske dejavnosti, ki so najbolj podvržene ponarejanju, kar ima vedno resnejše posledice za zdravje ljudi.
The European cosmetics sector is one of the main industrial activities to be affected by counterfeiting, with increasing risks for human health.
Zato je treba s to uredbo poskrbeti za primerno obravnavanje z ustrezno opredelitvijo kriminalne dejavnosti, nadzorom trga, informacijami v primeru neskladnosti ter kaznimi.
This calls for a concrete response in the regulation to deal adequately with the problem in terms of defining criminal activity, market control, information in the event of non-compliance and penalties.
Glede na različne opredelitve nanomaterialov, ki so jih objavili različni organi, ter ob upoštevanju stalnega tehničnega in znanstvenega razvoja na področju nanotehnologij, mora Komisija najpozneje 18 mesecev po začetku veljavnosti te uredbe prilagoditi opredelitev iz točke (ia) odstavka 1, da bi zagotovila skladnost z znanstvenim in tehničnim napredkom, pa tudi z opredelitvami, naknadno dogovorjenimi na mednarodni ravni.
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 adapt, no later than 18 months after the entry into force of this Regulation, the definition in paragraph 1(ia) to ensure that it is in keeping with scientific and technological progress and with definitions subsequently agreed at international level.
Navedeni ukrepi za spremembo nebistvenih določb te uredbe, med drugim z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 27(3).
Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(3) .
Obveznosti distributerjev, uvoznikov in trgovcev na drobno
Obligations of distributors, importers and retailers
Če distributer, uvoznik ali trgovec na drobno meni ali utemeljeno sumi, da je kozmetični izdelek ponarejen in zato ni v skladu s to uredbo, tega izdelka ne sme dajati na trg.
Where a distributor, importer or retailer considers , or has reason to believe , that a product is a counterfeit cosmetic product and therefore does not comply with the rules laid down in this R egulation, he shall not place the product on the market.
Če distributer, uvoznik ali trgovec na drobno daje ali je že dal kozmetični izdelek na trg in naknadno ugotovi, da je izdelek ponarejen in zato ni skladen s to uredbo, ga mora takoj umakniti s trga in odpoklicati že prodane izdelke.
Where a distributor, importer or retailer places , or has already placed , a product on the market and subsequently learns that the product is a counterfeit cosmetic product and therefore does not comply with this R egulation, he shall immediately withdraw it from the market and recall any products already sold.
Poleg tega mora distributer v primeru, ko je dal ponarejen kozmetični izdelek na trg, obvestiti pristojne nacionalne organe v državi članici, kjer je bil izdelek dan na trg.
Moreover, where a counterfeit cosmetic product has been placed on the market, the distributor shall duly warn the competent national authorities of the Member State where the product has been placed on the market.
Boj proti ponarejanju je nujen za ohranjanje javnega zdravja in konkurenčnosti.
Action to combat counterfeiting is essential for the sake of public health and competitiveness.
Proizvodnja je skladna z dobro proizvodno prakso, kadar je skladna z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije.
Compliance with good manufacturing practice shall be presumed where manufacturing 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 skladna z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije ali z drugimi mednarodno priznanimi standardi .
Compliance with good manufacturing practice shall be presumed where manufacturing is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union , or with other internationally recognised standards.
Za neovirano delovanje mednarodne trgovine.
To avoid hindering the operation of international trade.
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, 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 in accordance with Annex I is set up.
Posebno pozornost se nameni velikosti delcev, natančneje „nanomaterialom“, kakor so opredeljeni v členu 2.
Particular consideration shall be given to particle size and more specifically to 'nanomaterials' as defined in Art icle 2 .
Odgovorna oseba zagotovi, da 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 responsible person shall ensure that 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.
Odgovorna oseba zagotovi, da:
The responsible person shall ensure that:
(a) se predvidena uporaba kozmetičnega izdelka ter pričakovana sistemska izpostavljenost posameznim sestavinam v končni formulaciji upoštevata pri oceni varnosti;
(a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation is taken into account in the safety assessment;
(b) se pri oceni varnosti uporabi primerna analiza, ki temelji na zanesljivosti dokazov, za pregled ustreznih podatkov, pridobljenih iz več virov, vključno s podatki iz študij in vitro, in silico, študij dobre laboratorijske prakse in vivo ter obstoječih študij na ljudeh;
(b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing relevant data from several sources, including data from in-vitro, in-silico, existing GLP (Good Laboratory Practice) or non-GLP in-vivo and human studies;
(c) se poročilo o varnosti kozmetičnega izdelka posodablja glede na dodatne ustrezne informacije, ki so zbrane po tem, ko je bil izdelek dan na trg.
c) 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.
V Prilogi I so razčlenjene informacije o varnosti kozmetičnega izdelka, ki na koncu tvorijo poročilo o varnosti kozmetičnega izdelka.
Annex 1 collates the cosmetic product safety information and leads to cosmetic safety report.
Treba je priznati, da je treba vse ustrezne razpoložljive podatke, ki se pridobijo iz študij in vitro, in silico, obstoječih študij dobre laboratorijske prakse na živalih, obstoječih študij na ljudeh ali iz drugih virov, ustrezno upoštevati pri oceni varnosti končnih kozmetičnih izdelkov.
It is important to recognise that all available relevant data, whether from in vitro, in silico, existing animal GLP (good laboratory practice), human studies or other studies, should be taken into account appropriately in assessing the safety of finished cosmetic products.
Odgovorna oseba hrani dokument z informacijami o izdelku za kozmetični izdelek, za katerega je odgovorna oseba.
The responsible person shall keep a product information file for the cosmetic product for which he is the responsible person.
V primeru, da dejavnosti razvoja in/ali proizvodnje opravljajo podizvajalci, se odgovornost za hranjenje dokumenta z informacijami o izdelku lahko s pisno pogodbo deli med osebo, ki je odgovorna za dajanje na trg, in njenimi podizvajalci.
Should the development and/or manufacturing activities be subcontracted , responsibilities relating to preservation of the product information file may be shared , by written contract, between the person responsible for placing the product on the market and the subcontractors.
V tej uredbi je treba upoštevati pogoste primere, ko osebe, ki so odgovorne za dajanje na trg, uporabijo podizvajalce za razvoj in/ali proizvodnjo svojih kozmetičnih izdelkov.
Account should be taken in this regulation of the frequent cases in which the persons responsible for placing a product on the market resort to subcontracting for the development and/or production of their cosmetic products.
Dokument z informacijami o izdelku se v tem primeru deli med naročnikom in podizvajalci zaradi različnih razlogov (posodabljanje informacij, zaupnost, označevanje naslova).
In such cases, the information file is shared between the main contractor and his subcontractor for various reasons (updating of details, confidentiality, labelling of address).
Člen 8 - odstavek 2 - točka d
Article 8 - paragraph 2 - point d
(d) kadar to upravičuje narava ali učinek kozmetičnega izdelka, dokazila o učinkih, ki naj bi jih imel kozmetični izdelek,
(d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
(d) dokazila o učinkih, ki naj bi jih imel kozmetični izdelek,
(d) proof of the effect claimed for the cosmetic product;
Odgovorna oseba daje na voljo dokument z informacijami o izdelku najmanj deset let po zadnji dostavi tega kozmetičnega izdelka.
The responsible person shall keep the product information file accessible for a period of at least ten years after the last delivery of the cosmetic product.
Treba je določiti dobo za hranjenje dokumenta z informacijami, ko kozmetičnega izdelka ni več na trgu.
A period of time should be laid down during which the product information file must be preserved once the cosmetic product is no longer on the market.
Doba 10 let je skladna z obdobjem hranjenja informacij v drugih predpisih.
Ten years is consistent with the information preservation period laid down in other regulations.