natgillin/translations-raw huggingface dataset:
Kjer se člen 21 ne uporablja in se pristojni organ prepriča, da kozmetični izdelek, dan na trg, lahko predstavlja resno tveganje za zdravje ljudi, sprejme vse ustrezne začasne ukrepe, da se kozmetični izdelek umakne, odpokliče ali kako drugače omeji na trgu.
Where Article 21 does not apply, and a competent authority ascertains that a cosmetic product placed on the market is liable to present a serious risk for human health, it shall take all appropriate provisional measures in order to ensure that a cosmetic product is withdrawn, recalled or its availability otherwise restricted.
Kjer se člen 21 uporablja in se odgovorna oseba ne strinja z razlago pristojnega organa v zvezi s skladnostjo ali predlaganimi korektivnimi ukrepi, se pristojni organ in odgovorna oseba brez poseganja v določbe člena 21 strinjata, da je prišlo do spora.
Where Article 21 applies and the responsible person does not agree with the competent authority's interpretation regarding compliance or with the corrective actions proposed, the competent authority and the responsible person shall agree , without prejudice to Article 21, that a dispute has arisen.
Pristojni organ Komisijo in pristojne organe drugih držav članic nemudoma seznani s sprejetimi ukrepi in kakršnimi koli dodatnimi podatki.
The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States of the measures taken and any supporting data.
Pristojni organ Komisijo in pristojne organe drugih držav članic nemudoma seznani s sprejetimi ukrepi in kakršnimi koli dodatnimi podatki v primeru iz prvega pododstavka odstavka 1 ali s podrobnostmi, ki zadevajo spor, v primeru iz drugega pododstavka odstavka 1 .
The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States of the measures taken and any supporting data in cases covered by paragraph 1, first subparagraph, or, in cases covered by paragraph 1, second subparagraph, shall forward details of the dispute .
Za namene prvega pododstavka se uporablja sistem izmenjave informacij, določen v členu 12(1) Direktive 2001/95/ES.
For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.
Za namene prvega pododstavka tega odstavka se uporablja sistem izmenjave informacij, določen v členu 12(1) Direktive 2001/95/ES.
For the purposes of the first subparagraph of this paragraph , the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.
Uporablja se člen 12(2), (3) in (4) Direktive 2001/95/ES.
Article 12 (2), (3) and (4) of Directive 2001/95/EC shall apply.
Treba je predvideti možne spore med odgovorno osebo in pristojnim organom v zvezi z razlago uredbe.
Allowance needs to be made for disputes arising between the responsible person and the competent authority over the way in which the regulation is interpreted.
Potreben je postopek, s katerim se bo zagotovila usklajena uporaba uredbe v primeru spora.
A procedure needs to be laid down to ensure uniform application of the regulation where such disputes arise.
Člen 26 - odstavek 1 - pododstavek 1
Article 26 - paragraph 1 - subparagraph 1
Ob morebitnem tveganju za zdravje ljudi zaradi uporabe snovi v kozmetičnih izdelkih, ki ga je treba obravnavati na ravni celotne Skupnosti, lahko Komisija po posvetovanju z Znanstvenim odborom za potrošniške proizvode (ZOPP) ustrezno spremeni priloge II do VI.
Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consultation of the SCCP, amend Annexes II to VI accordingly.
Ob morebitnem tveganju za zdravje ljudi ali okolje zaradi uporabe snovi v kozmetičnih izdelkih, ki ga je treba obravnavati na ravni celotne Skupnosti, lahko Komisija po posvetovanju z Znanstvenim odborom za potrošniške proizvode (ZOPP) in po potrebi z Znanstvenim odborom za tveganja za zdravje in okolje ustrezno spremeni priloge II do VI.
Where there is a potential risk to human health or to the environment , arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consultation of the SCCP and if necessary the Scientific Committee on Health and Environmental Risks ( SCHER ) , amend Annexes II to VI accordingly.
Obstajajo številni primeri, v katerih je bilo ugotovljeno, da snovi, uporabljene v kozmetičnih izdelkih in izdelkih za higieno, predstavljajo tveganje za okolje.
There have been a number of examples where substances used in cosmetic and hygienic products have been identified as having environmental risks.
Če takšna tveganja niso ustrezno obravnavana v ostalih delih zakonodaje, bi morala obstajati možnost, da se te snovi vključi v Prilogo II k tej uredbi.
In case such risks are not properly dealt with in other pieces of legislation, there should be a possibility to add such substances to Annex II of this Regulation.
Javnost pričakuje, da bodo kozmetični izdelki in izdelki za higieno varni tudi za okolje, zato bi morala uredba o kozmetičnih izdelkih vsebovati ta instrument, ki se ga uporabi v izjemnih primerih.
The general public expect cosmetic and hygienic products to be safe also for the environment, and the cosmetics regulation should therefore contain this instrument, to be used in exceptional case.
Znanstveni odbor za tveganja za zdravje in okolje je znanstveni odbor za ocenjevanje okoljskih vprašanj.
SCHER is the scientific committee for the assessment of environmental concerns.
Člen 26 – odstavek 1 – pododstavek 2 a (novo)
Article 26 – paragraph 1 – subparagraph 2 a (new)
Ob nesprejemljivem tveganju za okolje zaradi uporabe snovi v kozmetičnih izdelkih, ki je bilo ocenjeno v skladu z uredbo REACH in ga je treba obravnavati na ravni celotne Skupnosti, lahko Komisija po posvetovanju z Znanstvenim odborom za tveganja za zdravje in okolje ustrezno spremeni priloge II do VIa.
Where there is an unacceptable risk to the environment assessed under REACH, which aris es from the use of substances in cosmetic products, and which needs to be addressed on a Community-wide basis, the Commission may, after consultation of the (SCHER), amend Annexes II to VI accordingly .
Snovi, ki se uporabljajo v kozmetičnih izdelkih in izdelkih za higieno lahko pomenijo tveganje za okolje.
Substances used in cosmetic and hygienic products may present environmental risks.
Vpliv kozmetičnih izdelkov in njihovih sestavin na okolje ocenjuje Evropska agencija za kemikalije in je urejen z uredbo REACH.
The impact of cosmetic products and their ingredients on the environment is assessed by the EChA and regulated by the REACH Regulation.
V izjemnih primerih, ko tveganje za okolje še ni bilo ustrezno ocenjeno v skladu z obstoječo zakonodajo EU, bi moral obstajati mehanizem, s katerim bi Znanstveni odbor za tveganja za zdravje in okolje ocenil tveganje, Evropska komisija pa bi v skladu s prilogami II do VI k uredbi o kozmetičnih izdelkih zagotovila ustrezno obvladovanje tveganja.
In exceptional cases where the environmental risks have not already been properly assessed under existing EU legislation, a mechanism should exist for risk assessment by SCHER and for appropriate risk management by the European Commission under annexes II to VI of the Cosmetics Regulation.
Komisija sestavi in posodobi glosar skupnih imen sestavin.
The Commission shall compile and update a glossary of common ingredient names.
Glosar ni seznam dovoljenih snovi za uporabo v kozmetičnih izdelkih.
That glossary shall not constitute a list of the substances authorised for use in cosmetic products.
Komisija sestavi in posodobi glosar skupnih imen sestavin , ki temelji zlasti na na mednarodni nomenklaturi kozmetičnih sestavin .
The Commission shall compile and update a glossary of common ingredient names on the basis of, in particular, the International Nomenclature of Cosmetic Ingredients (INCI) .
Za označevanje kozmetičnih izdelkov, danih na trg, je treba skupna imena sestavin uporabljati najpozneje dvanajst mesecev po objavi glosarja v Uradnem listu Evropske unije.
The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve months after publication of the glossary in the Official Journal of the European Union .
Za označevanje kozmetičnih izdelkov, danih na trg, je treba skupna imena sestavin uporabljati najpozneje dve leti po objavi glosarja v Uradnem listu Evropske unije.
The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest two years after publication of the glossary in the Official Journal of the European Union .
Kadar država članica ali Komisija meni, da usklajeni standard ne izpolnjuje zahtev iz ustreznih določb te uredbe v celoti, Komisija ali država članica zadevo predloži odboru, ustanovljenem s členom 5 Direktive 98/34/ES, in jo utemelji.
When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments.
Odbor nemudoma predloži svoje mnenje.
The Committee shall deliver its opinion without delay.
Kadar država članica ali Komisija meni, da usklajeni standard ne izpolnjuje zahtev iz ustreznih določb te uredbe v celoti ali da bi upoštevanje inovacije omogočilo boljše izpolnjevanje zahtev iz ustreznih določb te uredbe ter doseganje višje ravni zaščite zdravja ljudi, Komisija ali država članica zadevo predloži odboru, ustanovljenem s členom 5 Direktive 98/34/ES, in jo utemelji.
When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation or that an innovation would better satisfy the requirements set out in the relevant provisions of this Regulation and would enable a higher level of protection of human health to be achieved , the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments.
Cilj 3 v obrazložitvi prenovitve določa, da so kozmetični izdelki, ki so dani na trg v EU, varni glede na inovacije v tem sektorju.
Objective 3, as set out in the Explanatory Memorandum, is to ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector.
Zdi se, da je utemeljeno pustiti možnost državi članici ali Komisiji, da zadevo predloži odboru, ustanovljenem s členom 5 Direktive 98/34/ES, da bi revidiral usklajeni standard, če meni, da bi inovacija omogočila učinkovitejše izpolnjevanje ustreznih določb te direktive, zlasti v zvezi z zaščito zdravja ljudi.
A Member State or the Commission should be entitled to approach the committee set up by Article 5 of Directive 98/34/EC, with a view to the revision of a harmonised standard where it considers that an innovation would ensure more effective compliance with the relevant provisions of the regulation, in particular those on human health protection.
Priloga I – del A – točka 1
Annex I – part A – point 1
Opis kvalitativne in kvantitativne sestave izdelka, vključno s kemijsko identiteto snovi (vključno s kemijskim imenom, INCI, CAS, EINESS/ELINCS) in njihovo nameravano funkcijo.
Description of the qualitative and quantitative composition of the product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS) and their intended function.
Pri eteričnih oljih, parfumskih sestavah in parfumih opis imena in kodna številka sestave ter identiteta dobavitelja.
In the case of essential oils, perfume compositions and perfumes, description of the name and code number of the composition and the identity of the supplier.
Kvalitativna in kvantitativna sestava izdelka, vključno s kemijsko identiteto snovi (vključno s kemijskim imenom, INCI, CAS, EINESS/ELINCS) in njihovo nameravano funkcijo.
The qualitative and quantitative composition of the product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS) and their intended function.
Izraz „opis“ je nov in zelo nejasen.
The term ‘description’ is new and very unclear.
V trenutno veljavni direktivi v tem kontekstu ne obstaja.
It does not exist in this context in the current directive.
Potrebne so dejanske informacije, ne pa njihov „opis“.
What is needed is the actual information, not a ‘description’ of it.
Priloga I – del A – točka 2 – pododstavek 1 in 2
Annex I – part A – point 2 – subparagraph 1 and 2
Opis fizikalnih in kemijskih značilnosti snovi, surovin in kozmetičnih izdelkov.
Description of the physical and chemical characteristics of the substances, the raw-material as well as the cosmetic product.
Fizikalne in kemijske značilnosti snovi, surovin in kozmetičnih izdelkov.
The physical and chemical characteristics of the substances, the raw-material as well as the cosmetic product.
Opis stabilnosti kozmetičnega izdelka v razumno predvidljivih pogojih shranjevanja.
Description of the stability of the cosmetics product under reasonably foreseeable storage conditions.
Stabilnost kozmetičnega izdelka v razumno predvidljivih pogojih shranjevanja.
The stability of the cosmetics product under reasonably foreseeable storage conditions.
Priloga I – del A – točka 3 – pododstavek 1
Annex I – part A – point 3 – subparagraph 1
Opis mikrobioloških specifikacij surovine in kozmetičnega izdelka.
Description of the microbiological specifications of the raw material and the cosmetic product.
Posebno pozornost je treba nameniti kozmetičnim izdelkom, ki se uporabljajo okoli oči, na sluznicah na splošno, na poškodovani koži, na otrocih, mlajših od treh let, na starejših ljudeh in osebah, ki kažejo znake zmanjšane odpornosti.
Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.
Mikrobiološke specifikacije surovine in kozmetičnega izdelka.
The microbiological specifications of the raw material and the cosmetic product.
Priloga I – del A – točka 4 – pododstavek 1
Annex I – part A – point 4 – subparagraph 1
Opis čistosti snovi in surovin.
Description of purity of the substances and raw material.
Čistost snovi in surovin.
The purity of the substances and raw material.
Priloga I – del A – točka 4 – pododstavek 3
Annex I – part A – point 4 – subparagraph 3
Opis ustreznih značilnosti embalažnega materiala, zlasti čistosti in stabilnosti.
Description of the relevant characteristics of packaging material, in particular purity and stability.
Ustrezne značilnosti embalažnega materiala, zlasti čistosti in stabilnosti.
The relevant characteristics of packaging material, in particular purity and stability.
Priloga I – del A – točka 5
Annex I – part A – point 5
Opis normalne in razumno predvidljive uporabe izdelka.
Description of the normal and reasonably foreseeable use of the product.
Obrazložitev je treba utemeljiti zlasti glede na opozorila in druga pojasnila pri označevanju izdelka.
The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.
Normalna in razumno predvidljiva uporaba izdelka.
The normal and reasonably foreseeable use of the product.
Priloga I – del A – točka 6 - uvod
Annex I – part A – point 6 – introduction
Opis izpostavljenosti kozmetičnemu izdelku ob upoštevanju ugotovitev iz oddelka 5 v zvezi z naslednjim:
Description of exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
Podatki o izpostavljenosti in ocena izpostavljenosti kozmetičnemu izdelku ob upoštevanju ugotovitev iz oddelka 5 v zvezi z naslednjim:
Data on and assessment of the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to
Potrebni so podatki in ocena informacije, ne pa njen „opis“.
What is needed is the data and an assessment of the information, not a ‘description’ of it.
Priloga I – del A – točka 7
Annex I – part A – point 7
Opis izpostavljenosti snovem, ki jih vsebuje kozmetični izdelek, za zadevne toksikološke parametre ob upoštevanju informacij iz oddelka 6.
Description of the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.
Podatki o izpostavljenosti in ocena izpostavljenosti snovem, ki jih vsebuje kozmetični izdelek, za zadevne toksikološke parametre ob upoštevanju informacij iz oddelka 6.
Data on and assessment of the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.
Priloga I – del A – točka 8 – pododstavek 1
Annex I – part A – point 8 – subparagraph 1
Brez poseganja v člen 14, opis toksikološkega profila vseh zadevnih toksikoloških parametrov.
Without prejudice to Article 14, description of the toxicological profile of all relevant toxicological endpoints.
Posebno pozornost pri oceni lokalne toksičnosti (draženje kože in oči) je treba nameniti senzibilizaciji kože; pri vpijanju žarkov UV pa toksičnosti, ki jo povzroča sončna svetloba.
A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.
Brez poseganja v člen 14, ocena toksikološkega profila vseh zadevnih toksikoloških parametrov.
Without prejudice to Article 14, an assessment of the toxicological profile of all relevant toxicological endpoints.
Potrebna je ocena informacije, ne pa njen „opis“.
What is needed is an assessment of the information, not a ‘description’ of it.
Priloga I – del A – točka 9
Annex I – part A – point 9
Opis neželenih stranskih učinkov in resnih neželenih stranskih učinkov kozmetičnega izdelka ali, kjer je ustrezno, drugih kozmetičnih izdelkov .
Description of the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products.
To vključuje statistične podatke.
This includes statistical data.
Popolni podatki o neželenih stranskih učinkih in resnih neželenih stranskih učinkih kozmetičnega izdelka ali, kjer je ustrezno, drugih kozmetičnih izdelkih .
Complete data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products.
Potrebni so popolni podatki za te informacije, ne pa njihov „opis“.
What is needed is complete data for this information, not a ‘description’ of it.
Priloga I – del A – točka 10
Annex I – part A – point 10
Druge zadevne informacije, npr. opis obstoječih študij na podlagi ljudi prostovoljcev.
Other relevant information, e.g. description of existing studies from human volunteers.
Druge zadevne informacije, npr. obstoječe študije na podlagi človeških prostovoljcev.
Other relevant information, e.g. existing studies from human volunteers.
Potrebne so informacije kot takšne, ne pa njihov „opis“.
What is needed is the information as such, not a ‘description’ of it.
Druge zadevne informacije, npr. opis obstoječih študij na podlagi človeških prostovoljcev ali upoštevanje izidov, utemeljenih s poskusi in podprtih z ocenami tveganja, ki so bile izvedene na drugih ustreznih področjih .
Other relevant information, e.g. description of existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas .
Treba je omogočiti uporabo obstoječih podatkov iz ocen tveganja, ki so bile izvedene na drugih področjih, če so ti podatki pomembni za oceno varnosti zadevnega kozmetičnega izdelka.
It should be possible to use existing data from risk assessments carried out in other areas, where such data are of relevance in assessing the safety of the product in question.
Priloga I – del B – točka 3 – podtočka 3
Annex I – part B – point 3 – subpoint 3
Ocenijo se možna medsebojna vplivanja snovi, ki jih vsebuje kozmetični izdelek.
Possible interactions of the substances contained in the cosmetic product shall be assessed.
Če se takšno medsebojno vplivanje ne pričakuje, je to treba ustrezno utemeljiti.
If such interaction is not expected, this shall be duly justified .
Neobstoječega učinka ni mogoče preveriti in ustrezno utemeljiti!
It is impossible to verify and duly justify a non-existent effect !
V okviru svoje strategije za poenostavitev zakonodajnega okolja se je Komisija odločila za prenovitev Direktive Sveta 76/768/EGS o približevanju zakonodaje v zvezi s kozmetičnimi izdelki.
As a part of its strategy for simplifying the regulatory environment, the Commission has decided to recast the Council Directive 76/768/EEC on the approximation of the laws relating to cosmetic products.
Direktiva, ki je od svojega sprejetja leta 1976 doživela 55 sprememb, je postala okorna in zastarela in ne zagotavlja več potrebne pravne gotovosti na področju, ki se hitro razvija.
The directive, which has been subject to 55 amendments since its adoption in 1976, has become cumbersome and outdated, and does no longer provide the necessary legal certainty in a rapidly developing field.
Komisija si s prenovitvijo prizadeva za odpravo pravne negotovosti in nedoslednosti, in sicer z uvedbo opredelitev in izvedbenih ukrepov.
With the recast, the Commission aims remove legal uncertainties and inconsistencies by introducing a set of definitions and implementation measures.
Komisija je, da bi preprečila razlike pri prenosu v nacionalno zakonodajo, spremenila pravno obliko akta iz direktive v uredbo.
To avoid divergences in national transposition, the Commission has changed the legal form of the act from a directive into a regulation.
Drug pomemben cilj je povečati varnost kozmetičnih izdelkov.
Another main objective is to increase the safety of cosmetic products.
Sedanja direktiva o kozmetičnih izdelkih ne vsebuje jasnih zahtev za oceno varnosti, zato Komisija sedaj zanjo uvaja „minimalne standarde“.
Since the current Cosmetics Directive does not contain clear requirements for a safety assessment, the Commission now introduces "minimum standards" for it.
Poročevalka odločno podpira ta cilj in želi poleg tega okrepiti varnostni vidik za zagotavljanje varstva in zdravja vseh potrošnikov.
The rapporteur strongly supports this goal and further wants to strengthen the safety aspect to ensure the protection and health of all consumers.
Poročilo je osredotočeno na štiri vidike:
In total the report focuses on four aspects:
Ocena varnosti kozmetičnih izdelkov
Safety assessment of cosmetic products
V skladu s členom 7 mora odgovorna oseba predložiti oceno varnosti z vsemi ustreznimi informacijami preden je kozmetični izdelek dan na trg.
According to Article 7, the responsible person has to produce a safety assessment with all the relevant information prior to placing a cosmetic product on the market.
V Prilogi I k uredbi so opisane ustrezne informacije, ki jih mora vključevati ocena varnosti.
Annex I of the Regulation describes the relevant information that has to be included in the safety assessment.
Vse odgovorne osebe se morajo jasno zavedati vseh obveznosti in zahtev, ki izhajajo iz te priloge.
It is important that all responsible persons have a clear understanding of the full obligations and requirements stemming from this Annex.
Poročevalka zato poziva Komisijo, naj v tesnem sodelovanju z vsemi zainteresiranimi stranmi sprejme smernice, ki bodo odgovornim osebam v pomoč pri pripravi ocen varnosti in poročila o varnosti izdelka za njihove izdelke.
Therefore, the rapporteur asks the Commission in close cooperation with all stakeholders to adopt guidance that helps the responsible persons to produce the safety assessments and the product safety report of their products.
Uporaba nanomaterialov v kozmetičnih izdelkih
The use of nanomaterials in cosmetic products
Nanomateriali so že danes sestavni del številnih izdelkov na trgu.
Already today nanomaterials are part of many products on the market.