natgillin/translations-raw huggingface dataset:
Glede na to, da ni veljavne zakonodaje Skupnosti, se šteje, da je uporabljena metoda skladna z odstavkom 1, če je skladna z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije.
In absence of any applicable Community legislation, compliance with paragraph 1 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 .
Glede na to, da ni veljavne zakonodaje Skupnosti, se šteje, da je uporabljena metoda skladna z odstavkom 1, če je skladna z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije ali z drugimi mednarodno priznanimi standardi .
In absence of any applicable Community legislation, compliance with paragraph 1 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 , or with other internationally recognised standards .
Člen 10 – odstavek 1 – točka c
Article 10 - paragraph 1 - point c
(c) državo članico, v kateri je kozmetični izdelek dan na trg,
(c) the Member State where the cosmetic product is placed on the market;
(c) prvo državo članico, v kateri je kozmetični izdelek dan na trg,
(c) the first Member State where the cosmetic product is placed on the market;
Namen predloga spremembe je pojasniti, da bi moralo biti obvestilo predloženo le v prvi državi članici, v kateri je izdelek dan na trg.
This aims to clarify that the notification should only be done in the first Member State where the product is placed in the market.
Člen 10 - odstavek 1 - točka e
Article 10 - paragraph 1 - point e
(e) prisotnost snovi v obliki mikroniziranih delcev, razen tistih, ki so navedeni v prilogah III do VI te uredbe ,
(e) the presence of substances in the form of micronised particles other than substances listed in Annexe III to VI to this Regulation ;
(e) prisotnost snovi v obliki nanomaterialov, ne glede na njihovo obstojnost in topnost ,
(e) the presence of substances in the form of nanomaterials , regardless of their persistence and solubility ;
Člen 12 – odstavek 2 – pododstavek 2 – uvodni del in alinea 1
Article 12 – paragraph 2 – subparagraph 2 – introductory part and indent 1
Vendar pa se takšne snovi lahko uporabljajo v kozmetičnih izdelkih, če so poleg njihove razvrstitve med rakotvorne, mutagene ali strupene za razmnoževanje skupin 1 ali 2 na podlagi Direktive 67/548/EGS izpolnjeni vsi naslednji pogoji:
However, such substances may be used in cosmetic products if, subsequent to their classification as carcinogenic, mutagenic or toxic for reproduction of category 1 or 2 under Directive 67/548/EEC, all of the following conditions are fulfilled:
Vendar pa se takšne snovi izjemoma lahko uporabljajo v specifičnih kozmetičnih izdelkih, če so poleg njihove razvrstitve med rakotvorne, mutagene ali strupene za razmnoževanje skupin 1 ali 2 na podlagi Direktive 67/548/EGS po začetku veljavnosti te uredbe izpolnjeni vsi naslednji pogoji:
However, such substances may exceptionally be used in specific cosmetic products if, subsequent to their classification as carcinogenic, mutagenic or toxic for reproduction of category 1 or 2 under Directive 67/548/EEC after entry into force of this Regulation , all of the following conditions are fulfilled:
– ZOPP jih je ocenil in ugotovil, da je njihova uporaba v kozmetičnih izdelkih varna, zlasti v smislu izpostavljenosti,
- they have been evaluated and found safe for use by the SCCP in cosmetic products in particular in view of exposure;
– ZOPP jih je ocenil in ugotovil, da je njihova uporaba v specifičnih kozmetičnih izdelkih varna, zlasti v smislu splošne izpostavljenosti iz drugih pomembnih virov in zlasti ob upoštevanju ranljivih skupin prebivalstva ;
- they have been evaluated and found safe for use by the SCCP in specific cosmetic products in particular in view of the global exposure from other significant sources and taking particular account of vulnerable population groups;
V zvezi z obstoječo prepovedjo snovi CMR, ki so že razvrščene kot takšne, ni težav.
There has been no problem with regard to the current prohibition of CMR substances that are already classified as such.
Komisija je prihodnje odstopanje predlagala zgolj zato, da bi predividela prihodnje razvrščanje nekaterih snovi.
The future derogation was only proposed by the Commission to anticipate future classifications of certain substances.
Odstopanja bi se morala kot takšna uporabljati le za snovi, ki bodo v prihodnje razvrščena med snovi CMR.
As such, the derogations should only apply to substances that will be classified CMR in the future.
Odstopanja bi se morala uporabljati le za specifične uporabe, ne pa za kozmetične izdelke na splošno.
Derogations should also be only for specific uses, and not for cosmetic products in general.
Člen 12 – odstavek 2 a (novo)
Article 12 - paragraph 2 a (new)
Komisija do [dve leti po datumu objave te uredbe v uradnem listu] zagotovi, da se postopki za izdelavo in uporabo ocen splošne izpostavljenosti za snovi CMR pregledajo in da se oblikujejo ustrezne smernice, ki bodo omogočile usklajen pristop k izdelavi in uporabi takšnih ocen splošne izpostavljenosti pri ocenjevanju varne uporabe kozmetičnih izdelkov, ki vsebujejo te snovi.
By [ two years after the date of publication of this Regulation in the Official Journal ] , the Commission shall ensure that procedures for the development and use of global exposure estimates for CMR substances are reviewed and that appropriate guidelines are developed with the aim of enabling a harmoni s ed approach to the development and use of such overall exposure estimates in assessing the safe use of cosmetic products containing these substances .
Pregled se opravi v posvetovanju z ZOPP, Evropsko agencijo za kemikalije (ECHA), Evropsko agencijo za varnost hrane (EFSA) ter drugimi ustreznimi zainteresiranimi stranmi, po potrebi z uporabo ustrezne najboljše prakse.
This review shall be carried out in consultation with the SCCP, the ECHA, the EFSA and other relevant stakeholders, drawing as appropriate on relevant best practi c e.
Pri določenih snoveh, zlasti snoveh CMR, je treba oceno varnosti upoštevati v okviru splošne izpostavljenosti posameznikov tej snovi iz vseh virov.
For certain substances, 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.
Člen 12 – odstavek 2 b (novo)
Article 12 – paragraph 2 b (new)
Ko so na voljo na ravni Skupnosti ali mednarodno dogovorjena merila za ugotavljanje snovi z lastnostmi motilcev hormonov ali najpozneje 5 let po začetku veljavnosti te uredbe, Komisija pregleda uredbo z vidika snovi z lastnostmi motilcev hormonov.
When Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest 5 years after this Regulation has entered into force, the Commission shall review the Regulation with regard to substances with endocrine-disrupting properties.
Člen 12 a
Article 12 a
Za vsak proizvod, ki vsebuje nanomateriale, kakor so opredeljeni v členu 2, se zagotovi visoka raven varstva potrošnikov in varovanja zdravja ljudi.
For every product that contains nanomaterials as defined in Article 2, a high level of consumer protection and the protection of human health shall be ensured.
Najpozneje 12 mesecev pred datumom začetka uporabe te uredbe odgovorna oseba Komisijo uradno obvesti o vseh obstoječih kozmetičnih izdelkih, ki vsebujejo nanomateriale, in opredeli kategorijo vsakega izdelka, specifično naravo nanomaterialov, uporabljenih v njem, ter specifične pogoje izpostavljenosti.
At the latest 12 months before the date of application of this Regulation , the responsible person shall notify the Commission of all existing cosmetic products that contain nanomaterials, identifying the category of each product and the specific nature of the nanomaterials as used in it, as well as the specific exposure conditions.
Najpozneje šest mesecev pred datumom začetka uporabe te uredbe Komisija objavi začetno statusno poročilo o vseh nanomaterialih, ki so se že uporabili v kozmetičnih izdelkih, in o pogojih izpostavljenosti, povezanih s temi kozmetičnimi proizvodi.
At the latest six months before the date of application of this Regulation, the Commission shall publish an initial Status Report on all nanomaterials already used in cosmetic products as well as on the exposure conditions linked to these cosmetic products.
Če ima Komisija pomisleke v zvezi z varnostjo nanomaterialov glede na njihovo uporabo, zahteva, naj ZOPP predloži mnenje o varnosti teh nanomaterialov za zadevne kategorije izdelkov in specifične pogoje izpostavljenosti.
In the event that the Commission has concerns regarding the safety of the nanomaterials as used, the Commission shall request the SCCP to give its opinion on the safety of these nanomaterials for these categories of products and the specific exposure conditions.
ZOPP predloži svoje mnenje Komisiji v roku 12 mesecev od pridobitve vseh razpoložljivih varnostnih podatkov.
The SCCP shall give its opinion within 12 months of the submission of all relevant safety data and transmit it to the Commission.
Komisija nemudoma sprejme sklep o odobritvi izdelkov, ki povzročajo zaskrbljenost, v skladu z regulativnim postopkom iz člena 27(2).
The Commission shall urgently adopt a decision on the authorisation of the products of concern in accordance with the regulatory procedure referred to in Article 27(2).
18 mesecev pred datumom začetka uporabe te uredbe velja, da odgovorna oseba v skladu s členom 10(1)(e) Komisijo šest mesecev pred njegovim dajanjem na trg uradno obvesti o vsakem novem izdelku, ki vsebuje nanomateriale, ki niso vključeni v statusno poročilo ali so bili dani na trg pred objavo začetnega statusnega poročila iz odstavka 2 ali so uporabljeni v novi kategoriji izdelkov ali zanje veljajo novi pogoji izpostavljenosti.
18 months before the date of application of this Regulation, every new product that contains nanomaterials not included in the Status Report or placed on the market before the publication of the initial Status Report referred to in paragraph 2 , or nanomaterials used in a new product category or under new exposure conditions, shall be notified by the responsible person to the Commission in accordance with Article 10 (1) (e) six months prior to the placing on the market.
Odgovorna oseba na zahtevo Komisije predloži tudi oceno varnosti izdelka, ki upošteva specifično naravo nanomaterialov, kot so uporabljeni v kategoriji izdelka, in pogoje izpostavljenosti.
The responsible person shall also submit , upon the Commission's request , the safety assessment of the product related to the specific nature of the nanomaterials as used in the product category and the exposure conditions.
Komisija lahko od ZOOP zahteva, naj predloži svoje mnenje o varnosti teh nanomaterialov za zadevne kategorije izdelkov in specifične pogoje izpostavljenosti.
The Commission may request the SCCP to give its opinion on the safety of these nanomaterials for these categories of products and the specific exposure conditions.
ZOPP predloži svoje mnenje Komisiji v šestih mesecih od pridobitve vseh razpoložljivih varnostnih podatkov.
The SCCP shall give its opinion within six months of the submission of all relevant safety data and transmit it to the Commission.
Če ocena ZOPP ne pokaže, da uporaba nanomaterialov v tej kategoriji izdelkov ni varna, se izdelek lahko da na trg.
If the SCCP assessment does not conclude that the use of nanomaterials in the relevant product category is unsafe, the product may be made available on the market.
Če ocena ZOPP pokaže, da uporaba nanomaterialov v tej kategoriji izdelkov ni varna, Komisija sprejme sklep o odobritvi v skladu z regulativnim postopkom iz člena 27(2).
If the SCCP assessment concludes that the use of nanomaterials in the relevant product category is unsafe, the Commission shall adopt a decision on the authorisation in accordance with the regulatory procedure referred to in Article 27(2).
Komisija Svetu in Evropskemu parlamentu predloži letno posodobljeno statusno poročilo s podatki o razvoju uporabe nanomaterialov v kozmetičnih izdelkih v Evropski skupnosti.
The Commission shall submit to the European Parliament and the Council an annual update of the Status R eport, which will give information on developments in the use of nanomaterials in cosmetic products within the Community.
Letna posodobitev povzema zlasti priglašene nove nanomateriale in nove kategorije izdelkov, število uradnih obvestil, napredek pri razvoju metod določanja značilnosti za nanomateriale in smernic za oceno varnosti ter informacije o programih mednarodnega sodelovanja.
The report update shall summarise, in particular, the new nanomaterials and the new product categories notified, the number of notifications, the progress made in developing nano-specific assessment methods and safety assessment guides, and information on international cooperation programmes.
Komisija pregleda določbe te uredbe, ki se nanašajo na nanomateriale, najmanj vsakih 5 let glede na znanstveni napredek in po potrebi predlaga ustrezne spremembe določb.
The Commission shall review the provisions of this Regulation concerning nanomaterials at least every five years in the light of scientific progress and, where necessary , shall propose suitable amendments to those provisions.
Člen 15 – odstavek 1 – točka a a (novo)
Article 15 – paragraph 1 – point a a (new)
(aa) država izvora, če je bil kozmetični izdelek proizveden zunaj Skupnosti;
(aa) the country of origin, if the cosmetic product was manufactured outside the Community;
Člen 15 – odstavek 1 – točka g – pododstavek 3 a (novo)
Article 15 – paragraph 1 – point g – subparagraph 3 a (new)
Vsaka vsebovana sestavina v obliki nanomateriala mora biti jasno označena na seznamu sestavin.
All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients.
Beseda „nano“ se postavi pred ime sestavine.
The names of such ingredients shall be preceded by the word 'nano'.
Nanotehnologije so predmet posebnih določb v okviru revizije zakonodaje o kozmetičnih izdelkih, zato se morajo sestavine v obliki nanomateriala pojaviti na seznamu sestavin, uporabljenih v zadevnem kozmetičnem izdelku.
Given that nanotechnologies are covered by specific provisions in the revised cosmetic product legislation, where a cosmetic product contains nanomaterials, this should be specified in the list of that product's ingredients.
To bo zagotovilo minimalno preglednost in informacije, do katerih so upravičeni vsi akterji na trgu (potrošniki, organi nadzora itd.).
This will ensure a basic level of information and transparency for all stakeholders (consumers, supervisory authorities, etc.).
Člen 15 – odstavek 1 – točka g – pododstavek 5
Article 15 – paragraph 1 – point g – subparagraph 5
Barvila, ki niso namenjena barvanju las se lahko navedejo v kakršnem koli vrstnem redu za drugimi kozmetičnimisestavinami.
Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients.
Za dekorativne kozmetične izdelke, ki se tržijo v več barvnih odtenkih, se lahko navedejo vsa barvila v paleti, ki niso namenjena barvanju laspod pogojem, da se dodata besedi „lahko vsebuje“ ali simbol „+/–“.
For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added.
Barvila, ki niso namenjena barvanju las se lahko navedejo v kakršnem koli vrstnem redu za drugimi kozmetičnimi sestavinami.
Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients.
Za dekorativne kozmetične izdelke, ki se tržijo v več barvnih odtenkih, se lahko navedejo vsa barvila v paleti, ki niso namenjena barvanju las pod pogojem, da se dodata besedi „lahko vsebuje“ ali simbol „+/–“.
For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added.
Uporablja se nomenklatura CI (Colour Index).
The CI (Colour Index) nomenclature shall be used.
Člen 16 - odstavek 1- pododstavek 2
Article 16 - paragraph 1 - subparagraph 2
Šteje se, da so zahteve iz prvega pododstavka izpolnjene, če so kozmetični izdelki v skladu z ustreznimi usklajenimi standardi, katerih sklicevanja so objavljena v Uradnem listu Evropske unije.
Compliance with the first subparagraph shall be presumed if the cosmetic products are in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Člen 16 – odstavek 1a (novo)
Article 16 – paragraph 1a (new)
Komisija ob sodelovanju držav članic pripravi akcijski načrt glede izjav, ki se uporabljajo na kozmetičnih izdelkih, in določi prednostne naloge za določitev skupnih meril za uporabo izjave.
The Commission shall establish, in cooperation with Member States, an action plan regarding claims used in cosmetic products and fix priorities for determining common criteria for the use of a claim.
Po posvetovanju z ZOPP ali drugimi zadevnimi organi Komisija sprejme seznam skupnih meril za izjave, ki se lahko uporabljajo v zvezi s kozmetičnimi izdelki, v skladu z regulativnim postopkom s pregledom iz člena 27(3) ob upoštevanju določb Direktive 2005/29/ES.
After consultation of the SCCP or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, in accordance with the regulatory procedure with scrutiny referred to in Article 27(3), taking into account provisions of Directive 2005/29/EC.
Tri leta po začetku veljavnosti te uredbe Komisija Evropskemu parlamentu in Svetu predloži poročilo o uporabi izjav na podlagi sprejetih skupnih meril iz prejšnjega pododstavka.
Three years after the date of application of this Regulation, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria adopted under the previous subparagraph.
Če poročilo ugotovi, da izjave, ki se uporabljajo v zvezi s kozmetičnimi izdelki, niso skladne s skupnimi merili, Komisija sprejme ustrezne ukrepe za zagotovitev skladnosti.
If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, it shall take appropriate measures to ensure compliance.
Brez poseganja v varovanje zlasti poslovne skrivnosti in pravic intelektualne lastnine odgovorna oseba zagotovi, da so kvalitativna in kvantitativna sestava kozmetičnega izdelka, pri parfumskih sestavah in parfumih pa tudi ime in številka šifre sestave in identiteta dobavitelja, kot tudi obstoječe informacije o neželenih stranskih učinkih in resnih neželenih stranskih učinkih zaradi uporabe kozmetičnega izdelka, javno dostopni s kakršnimi koli ustreznimi sredstvi.
Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product is made publicly accessible by any appropriate means.
Brez poseganja v varovanje zlasti poslovne skrivnosti in pravic intelektualne lastnine odgovorna oseba zagotovi, da so kvalitativna in kvantitativna sestava kozmetičnega izdelka, pri parfumskih sestavah in parfumih pa tudi ime in številka šifre sestave in identiteta dobavitelja, kot tudi obstoječe informacije o neželenih stranskih učinkih in resnih neželenih stranskih učinkih zaradi uporabe kozmetičnega izdelka, lahko dostopni javnosti s kakršnimi koli ustreznimi sredstvi.
Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product is made eas i ly accessible to the public by any appropriate means.
Države članice skladnost s to uredbo preverjajo z notranjim nadzorom kozmetičnih izdelkov, ki so na voljo na trgu.
Member States shall survey compliance with this Regulation via in-market controls of the cosmetic products made available on the market.
Države članice izvajajo nadzor v ustreznem obsegu z ocenjevanjem razpoložljive dokumentacije in po potrebi s pomočjo fizičnih in laboratorijskih preizkusov na podlagi ustreznih vzorcev.
Member States shall perform controls of adequate scale by assessing the documentation available and, where appropriate, by means of physical and laboratory tests, based on a dequate samples.
Države članice Komisiji letno poročajo o nadzoru, opravljenem zaradi preverjanja skladnosti s to uredbo, in o glavnih ugotovitvah v zvezi z neskladnostjo.
Member States shall report to the Commission annually on the controls performed for surveying compliance with this Regulation and on the main findings relating to non-compliance .
Za zagotovitev varnosti potrošnikov in skladnost proizvajalcev z zahtevami za poročilo o varnosti iz člena 7 in Priloge I je treba uvesti jasne nadzorne instrumente.
To ensure the safety for the consumers as well as the compliance of the producers with the requirements for the safety report set up in Article 7 as well as Annex I, clear control instruments have to be introduced.
Poročevalka zato poziva države članice, da izvajajo ustrezen nadzor in v primeru neskladnosti poročajo Komisiji.
The rapporteur therefore asks the Member States to perform adequate controls and in case of non-compliance to report back to the Commission.
Člen 18 – odstavek 1 a (novo)
Article 18 – paragraph 1 a (new)
Ta nadzor trga mora državam članicam omogočati tudi prepoznavanje ponarejenih kozmetičnih izdelkov, ki zato niso skladni z zahtevami iz člena 21.
Member States shall also use in-market controls as a means of identifying cosmetic products that are counterfeit and therefore do not comply with the requirements set out in Article 21.
Člen 21 - odstavek 1 - uvodni del
Article 21 - paragraph 1 - introductory part
Pristojni organi od pristojne osebe zahtevajo, da sprejme vse ustrezne ukrepe, vključno s korektivnimi ukrepi za vzpostavitev skladnosti izdelka, umik izdelka s trga, ali odpoklic v razumnem roku, sorazmerno z naravo tveganja , kadar niso izpolnjene naslednje zahteve:
Competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the product into compliance, the withdrawal of the product from the market or its recall within a given reasonable time limit , commensurate with the nature of the risk, where there is non compliance with any of the following:
Pristojni organi od pristojne osebe zahtevajo, da sprejme vse ustrezne ukrepe, vključno s korektivnimi ukrepi za vzpostavitev skladnosti izdelka, umik izdelka s trga, ali takojšen odpoklic, kadar niso izpolnjene naslednje zahteve:
Competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the product into compliance, the withdrawal of the product from the market or its recall without delay , where there is non compliance with any of the following:
Člen 22 - odstavek 1 in 2
Article 22 - paragraphs 1 and 2