natgillin/translations-raw huggingface dataset:
Expenditure incurred, in respect of projects referred to in Annex II, on the purchase and fitting on board of fishing vessels of automatic localisation devices enabling vessels to be monitored at a distance by a fisheries monitoring centre through a vessel monitoring system (VMS) shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits established in that Annex.
Finančni prispevek za izdatke za projekte iz Priloge II za nakup naprav za samodejno določanje položaja in njihovo namestitev na ribiških plovilih, da lahko center za spremljanje ribištva na daljavo spremlja plovila s satelitskim sistemom za spremljanje plovil (VMS), znaša 90 % upravičenih izdatkov v okviru omejitev iz navedene priloge.
In order to qualify for the financial contribution referred to in paragraph 1, automatic localisation devices shall satisfy the requirements laid down in Commission Regulation (EC) No 2244/2003 [5].
Za upravičenost do finančnega prispevka iz odstavka 1 naprave za samodejno določanje položaja izpolnjujejo zahteve iz Uredbe Komisije (ES) št. 2244/2003 [5].
Expenditure incurred, in respect of projects referred to in Annex III, on the development, purchase, and installation of, as well as technical assistance for, the components necessary for electronic recording and reporting systems (ERS), in order to allow efficient and secure data exchange related to monitoring, control and surveillance of fisheries activities, shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits established in that Annex.
Finančni prispevek za izdatke v zvezi s projekti iz Priloge III za razvoj, nakup in namestitev sestavnih delov, potrebnih za sisteme elektronskega zapisovanja in poročanja (ERS), ter tehnično pomoč v zvezi z njimi, da se omogoči učinkovita in varna izmenjava podatkov v zvezi s spremljanjem, nadzorom in pregledom ribolovnih dejavnosti, znaša 90 % upravičenih izdatkov v okviru omejitev iz navedene priloge.
Expenditure incurred, in respect of projects referred to in Annex IV, on the purchase and fitting on board of fishing vessels of ERS devices enabling vessels to record and report electronically to a Fisheries Monitoring Centre data on fisheries activities, shall qualify for a financial contribution of 90 % of the eligible expenditure, within the limits established in that Annex.
Finančni prispevek za izdatke za projekte iz Priloge IV za nakup naprav za elektronsko zapisovanje in poročanje ter njihovo namestitev na ribiških plovilih, da lahko plovila elektronsko zapisujejo podatke o ribolovnih dejavnostih in jih sporočajo centru za spremljanje ribištva, znaša 90 % upravičenih izdatkov v okviru omejitev iz navedene priloge.
The financial contribution referred to in paragraph 1 shall be calculated on the basis of a price capped at EUR 3000 per vessel.
Finančni prispevek iz odstavka 1 se izračuna na podlagi cene, ki je omejena na 3000 EUR na plovilo.
Total maximum Union contribution for Croatia
Skupni najvišji prispevek Unije za Hrvaško
The planned expenditure, the eligible share thereof, and the maximum Union contribution to Croatia is as follows:
Načrtovani izdatki, njihovi upravičeni deleži in najvišji prispevek Unije Hrvaški so naslednji:
This Decision is addressed to the Republic of Croatia.
Ta sklep je naslovljen na Republiko Hrvaško.
Project code
Šifra projekta
All payments in respect of which a reimbursement is claimed shall be made by Croatia by 30 June 2017.
Hrvaška do 30. junija 2017 opravi vsa plačila, za katera se zahteva povračilo.
Payments made after that deadline shall not be eligible for reimbursement.
Plačila, ki se opravijo po tem roku, niso upravičena do povračila.
of 25 November 2013
z dne 25. novembra 2013
on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
o Smernicah v zvezi s Prilogo I k Uredbi (ES) št. 1223/2009 Evropskega parlamenta in Sveta o kozmetičnih izdelkih
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products [1], and in particular the third subparagraph of Article 10(1) thereof,
ob upoštevanju Uredbe (ES) št. 1223/2009 Evropskega parlamenta in Sveta z dne 30. novembra 2009 o kozmetičnih izdelkih [1] in zlasti tretjega pododstavka člena 10(1) Uredbe,
It is essential that cosmetic products made available on the Union market be safe for human health when used under normal and reasonably foreseeable conditions of use.
Bistveno je, da so kozmetični izdelki, ki so dostopni na trgu Unije, varni za zdravje ljudi, če so uporabljeni pod normalnimi in razumno predvidljivimi pogoji uporabe.
To that end, Regulation (EC) No 1223/2009 requires that, in order to establish that a cosmetic product is safe under those conditions, cosmetic products undergo a safety assessment.
V ta namen se z Uredbo (ES) št. 1223/2009 zahteva izvedba ocene varnosti kozmetičnih izdelkov, s katero se zagotovi, da so ti izdelki pod navedenimi pogoji varni.
The operator designated as the responsible person in accordance with Regulation (EC) No 1223/2009 is to ensure that, for each cosmetic product which is to be placed on the Union market, a cosmetic product safety report is drawn up on the basis of the relevant information and in accordance with the requirements laid down in Annex I to Regulation (EC) No 1223/2009.
Subjekt, imenovan za odgovorno osebo v skladu z Uredbo (ES) št. 1223/2009, mora zagotoviti, da se za vsak kozmetični izdelek, ki bo dan na trg Unije, pripravi poročilo o varnosti kozmetičnega izdelka na podlagi ustreznih informacij in v skladu z zahtevami, določenimi v Prilogi I k Uredbi (ES) št. 1223/2009.
In order to facilitate the understanding of the requirements of Annex I to Regulation (EC) No 1223/2009 by all undertakings, and especially small and medium-size enterprises, the Regulation requires that the Commission adopts appropriate guidelines.
Da bi vsa podjetja, zlasti pa mala in srednje velika, lažje razumela zahteve iz Priloge I k Uredbi (ES) št. 1223/2009, je v njej določeno, naj Komisija sprejme ustrezne smernice.
This Decision sets out appropriate guidelines on Annex I to Regulation (EC) No 1223/2009.
Ta sklep določa ustrezne smernice v zvezi s Prilogo I k Uredbi (ES) št. 1223/2009.
They were developed with the contribution of the relevant stakeholders, including representatives of small and medium-sized enterprises.
K njihovi pripravi so prispevale ustrezne zainteresirane strani, vključno s predstavniki malih in srednje velikih podjetij.
The guidelines should assist responsible persons in complying with their regulatory obligations.
Te smernice bi odgovornim osebam morale pomagati pri izpolnjevanju regulativnih obveznosti.
However, they are not meant to replace the knowledge and expertise of the qualified safety assessor, as required by Article 10(2) of Regulation (EC) No 1223/2009, who should remain the only professional allowed to carry out the cosmetic product safety assessment as described in Part B of Annex I.
Vendar njihov namen ni nadomestiti znanja in izkušenj usposobljenega ocenjevalca varnosti, zahtevanih s členom 10(2) Uredbe (ES) št. 1223/2009, ki bi moral ostati edini strokovnjak, ki lahko izvede oceno varnosti kozmetičnega izdelka, opisano v delu B Priloge I.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Cosmetic Products,
Ukrepi, ki jih določa ta sklep, so v skladu z mnenjem Stalnega odbora za kozmetične izdelke –
The guidelines to enable undertakings to comply with the requirements laid down in Annex I to Regulation (EC) No 1223/2009 on cosmetic products are set out in the Annex to this Decision.
Smernice, s katerimi se podjetjem omogoča izpolnjevanje zahtev iz Priloge I k Uredbi (ES) št. 1223/2009 o kozmetičnih izdelkih, so določene v Prilogi k temu sklepu.
Done at Brussels, 25 November 2013.
V Bruslju, 25. novembra 2013
GUIDELINES ON ANNEX I TO REGULATION (EC) No 1223/2009 ON THE COSMETIC PRODUCT SAFETY REPORT
SMERNICE V ZVEZI S PRILOGO I K UREDBI (ES) št. 1223/2009 O POROČILU O VARNOSTI KOZMETIČNEGA IZDELKA
Article 11 of Regulation (EC) No 1223/2009 requires that a product information file is drawn up for each product before it is placed on the market.
Člen 11 Uredbe (ES) št. 1223/2009 določa, da se za vsak izdelek, preden se da na trg, pripravi dokumentacija z informacijami o izdelku.
The other elements are a clear description of the cosmetic product, a description of the method of manufacturing and a statement on compliance with good manufacturing practice, the proof of the effects claimed, and data on animal testing [1].
Drugi deli so jasen opis kozmetičnega izdelka, opis metode proizvodnje in izjava o skladnosti z dobro proizvodno prakso, dokazila o učinkih, ki naj bi jih imel kozmetični izdelek, ter podatki o testiranju na živalih [1].
Where the responsible person drawing up the cosmetic product safety report is not the manufacturer of the product, they should ensure they have access to all the technical and scientific skills necessary to obtain reliable cosmetic product safety information and an appropriate safety assessment to demonstrate that the product they are responsible for is safe, in accordance with Article 3 of Regulation (EC) No 1223/2009.
Kadar odgovorna oseba, ki pripravlja poročilo o varnosti kozmetičnega izdelka, ni njegov proizvajalec, si mora priskrbeti dostop do vseh tehničnih in znanstvenih znanj in spretnosti, ki so potrebni za pridobitev zanesljivih informacij o varnosti kozmetičnega izdelka in ustrezne ocene varnosti za dokazovanje, da je izdelek, za katerega je ta oseba odgovorna, varen, kot določa člen 3 Uredbe (ES) št. 1223/2009.
They may therefore need to involve not only the safety assessor, but also the manufacturer, the suppliers of raw materials, and other technical experts.
Za to je lahko potrebna vključitev ne le ocenjevalca varnosti, ampak tudi proizvajalca, dobaviteljev surovin in drugih tehničnih strokovnjakov.
In any case, the responsible person is to ensure that the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment; an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; 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 [2].
Vsekakor mora odgovorna oseba zagotoviti, da se pri oceni varnosti upoštevata namen uporabe kozmetičnega izdelka in pričakovana sistemska izpostavljenost posameznim sestavinam v končni formulaciji, da se pri oceni varnosti za obravnavanje ustreznih podatkov, pridobljenih iz vseh obstoječih virov, uporabi primerna analiza, ki temelji na pomembnosti dokazov, in 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 [2].
The cosmetic product safety assessment, as set out in Part B of Annex I to Regulation (EC) No 1223/2009, is to be carried out by a qualified safety assessor.
Oceno varnosti kozmetičnega izdelka, kot je določena v delu B Priloge I k Uredbi (ES) št. 1223/2009, mora izvesti usposobljen ocenjevalec varnosti.
The responsible person and the safety assessor should work closely together to ensure that the safety of the product is properly assessed and documented and that the assessment is kept up to date.
Odgovorna oseba in ocenjevalec varnosti morata tesno sodelovati in tako zagotoviti, da se izdelek pravilno oceni in dokumentira ter da se ocena posodablja.
The responsible person and the safety assessor should gather all the necessary information as required by Part A of Annex I to Regulation (EC) No 1223/2009.
Zbrati morata vse potrebne informacije, zahtevane v delu A Priloge I k Uredbi (ES) št. 1223/2009.
The cosmetic product safety report should be drawn up in a transparent way and should be well-argued and easily understood.
Poročilo o varnosti kozmetičnega izdelka mora biti pregledno ter dobro utemeljeno in lahko razumljivo.
The Cosmetic Product Safety Report is an expert piece of work made up of different modules and where the information required under Part A may be stored in different databases.
Poročilo o varnosti kozmetičnega izdelka je strokovno delo, ki je sestavljeno iz različnih modulov in katerega informacije, določene v delu A, so lahko shranjene v različnih zbirkah podatkov.
The report, which should contain, as a minimum, all the information indicated in Annex I to Regulation (EC) No 1223/2009, should appear under the same or similar headings for ease of reference of the competent authorities.
Poročilo, ki mora vsebovati najmanj vse informacije, navedene v Prilogi I k Uredbi (ES) št. 1223/2009, mora biti sestavljeno iz istih ali podobnih oddelkov kot navedena priloga, da se pristojnim organom zagotovi boljša preglednost.
However, it may be sufficient to provide under each heading a clear reference to a document containing the information and readily available in electronic or printed format.
Lahko pa zadošča tudi, da se v vsakem oddelku navede jasno sklicevanje na dokument, ki vsebuje informacije in je takoj na voljo v elektronski ali tiskani obliki.
ANNEX I TO REGULATION (EC) No 1223/2009 — COSMETIC PRODUCT SAFETY REPORT
PRILOGA I K UREDBI (ES) št. 1223/2009 – POROČILO O VARNOSTI KOZMETIČNEGA IZDELKA
In accordance with Annex I to Regulation (EC) No 1223/2009, the Cosmetic Product Safety Report is to contain, ‘as a minimum’, the information required under each of the headings of Part A and Part B.
V skladu s Prilogo I k Uredbi (ES) št. 1223/2009 mora poročilo o varnosti kozmetičnega izdelka vsebovati „najmanj“ informacije, zahtevane v okviru vsakega izmed oddelkov dela A in dela B.
Part A aims to gather all the data necessary for the safety assessment of the product, while Part B sets out the reasoning, starting from the data, for drawing conclusions as to the safety of the product.
Del A je namenjen zbiranju vseh podatkov, potrebnih za oceno varnosti izdelka, del B pa določa obrazložitev, s katero se na podlagi teh podatkov oblikujejo ugotovitve glede varnosti izdelka.
The structure and content of the safety report should reflect the requirements of Annex I to Regulation (EC) No 1223/2009.
Struktura in vsebina poročila o varnosti morata izražati zahteve iz Priloge I k Uredbi (ES) št. 1223/2009.
However, if the report does not directly contain the required information, it should provide a reference to another readily available source.
Če se zahtevane informacije ne vključijo neposredno v poročilo, pa je treba v njem navesti sklicevanje na drug takoj dostopen vir.
The responsible person is to ensure that the Cosmetic Product Safety Report is kept up to date in the light of additional relevant information emerging after the product has been placed on the market [3].
Odgovorna oseba mora zagotoviti, da se poročilo o varnosti kozmetičnega izdelka posodablja glede na dodatne ustrezne informacije, ki se pojavijo po tem, ko je bil izdelek dan na trg [3].
PART A — COSMETIC PRODUCT SAFETY INFORMATION
DEL A – INFORMACIJE O VARNOSTI KOZMETIČNEGA IZDELKA
Part A of the cosmetic product safety report is intended to gather the data necessary to prove that the cosmetic product is safe.
Del A poročila o varnosti kozmetičnega izdelka je namenjen zbiranju podatkov, potrebnih za dokazovanje, da je kozmetični izdelek varen.
The information should enable the safety assessor to clearly identify and quantify, based on the identified hazards, the risks a cosmetic product may present to human health.
Te informacije morajo ocenjevalcu varnosti omogočiti, da na podlagi opredeljenih nevarnosti jasno določi tveganja za zdravje ljudi, ki bi jih lahko vključeval kozmetični izdelek, in oceni obseg teh tveganj.
A hazard may arise, for example, from the raw materials, the manufacturing process, the packaging, the conditions of use of the product, the microbiological specifications, the quantities used, the toxicological profile of the substances, etc.
Nevarnost lahko izhaja na primer iz surovin, proizvodnega postopka, embalaže, pogojev uporabe izdelka, mikrobioloških specifikacij, uporabljenih količin, toksikološkega profila snovi itd.
As Part A of Annex I to Regulation (EC) No 1223/2009 requires that the data listed under its headings are provided as a minimum, any discrepancy with regards to the requirements of Part A should be justified.
Ker se v delu A Priloge I k Uredbi (ES) št. 1223/2009 zahteva, da se zagotovijo najmanj podatki, navedeni v oddelkih tega dela, je treba vsako odstopanje od zahtev iz dela A utemeljiti.
Part A of Annex I to Regulation (EC) No 1223/2009 lists the data that is to be available, ‘as a minimum’, for the safety assessor to be able to carry out the safety assessment.
V delu A Priloge I k Uredbi (ES) št. 1223/2009 je določen minimalni obseg podatkov, ki morajo biti na voljo, da lahko ocenjevalec varnosti izvede oceno varnosti.
In addition to the minimum data listed in Part A of Annex I to Regulation (EC) No 1223/2009, the safety assessor can use any additional data, where relevant.
Poleg minimalnega obsega podatkov, določenega v delu A Priloge I k Uredbi (ES) št. 1223/2009, lahko ocenjevalec varnosti uporabi tudi katere koli dodatne podatke, kjer je to ustrezno.
On the other hand, they, or the responsible person, may consider that, depending on the type of product, some of the required data are not relevant or necessary to assess the safety of the product (e.g. preservation challenge test).
Po drugi strani lahko ocenjevalec ali odgovorna oseba glede na vrsto izdelka meni, da nekateri zahtevani podatki niso pomembni ali potrebni za oceno varnosti izdelka (npr. izzivni preskus učinkovitosti konzerviranja).
In this case, the absence of specific data is to be clearly justified in Part A and the justification is to be repeated and validated by the safety assessor in their reasoning in Part B. The responsible person should check the presence of the required data or the justification for their absence.
V tem primeru je treba izpust določenih podatkov v delu A jasno utemeljiti, utemeljitev pa mora ponoviti in potrditi ocenjevalec varnosti v svoji obrazložitvi v delu B. Odgovorna oseba mora preveriti prisotnost zahtevanih podatkov ali utemeljitev za njihov izpust.
The data required by Part A can be drawn from any reliable source.
Podatki, zahtevani v delu A, se lahko pridobijo iz katerega koli zanesljivega vira.
Examples include: data from suppliers, scientific literature, experience gained with similar or other product categories, results of studies on the product itself or on the substances it contains, available data on similar formulations, or computer models.
Primeri vključujejo podatke dobaviteljev, znanstveno literaturo, izkušnje, pridobljene s podobnimi ali drugimi kategorijami izdelkov, rezultate študij o izdelku samem ali o snoveh, ki jih vsebuje, razpoložljive podatke o podobnih formulacijah ali računalniške modele.
The safety report should highlight the relevance of the data in relation to the product.
V poročilu o varnosti je treba poudariti pomembnost podatkov glede na izdelek.
The guidance published by the EU scientific committees concerned with risk assessment [4], as well as the recommendations of national competent authorities or professional organisations, may provide further helpful support.3.1.
Koristna dodatna podpora so lahko navodila v zvezi z ocenjevanjem tveganj [4], ki jih objavijo znanstveni odbori EU, in priporočila nacionalnih pristojnih organov ali strokovnih združenj.
The aim of that section of the cosmetic product safety report is to provide the exact quantitative and qualitative composition of the finished product, starting from the raw materials.
Namen tega oddelka poročila o varnosti kozmetičnega izdelka je zagotoviti natančno kvantitativno in kvalitativno sestavo končnega izdelka, kakršna izhaja iz surovin.
Raw materials are substances or mixtures used in the manufacturing of the cosmetic product.
Surovine so snovi ali zmesi, ki se uporabijo za proizvodnjo kozmetičnega izdelka.
The intended function of each substance is to be indicated.
Navesti je treba predvideno funkcijo vsake snovi.
The complete product composition is to be specified, stating the name and identity (qualitative) of each raw material (including chemical name, INCI, CAS, Einecs/ELINCS, where possible), and the amount of each raw material, stating the weight percentage (quantitative).
Opredeliti je treba celotno sestavo izdelka z navedbo imena in identitete (kvalitativna sestava) vsake surovine (vključno s kemijskim imenom, INCI, CAS, EINECS/ELINCS, kjer je to mogoče) ter količino vsake surovine z navedbo masnega deleža (kvantitativna sestava).
Ranges should not be used, unless this can be justified (e.g. viscosity or pH adjusters).
Razponi se ne smejo uporabljati, razen če je to mogoče utemeljiti (npr. pri sredstvih za uravnavanje viskoznosti ali pH-vrednosti).
If concentration ranges are unavoidable, toxicological considerations and calculations should be based on the highest concentration figure.
Če se ni mogoče izogniti koncentracijskim območjem, morajo toksikološki premisleki in izračuni temeljiti na najvišji koncentraciji.
It may also be useful to indicate the supplier(s) of the raw materials.
Koristna je lahko tudi navedba dobaviteljev surovin.
All substances entering into the composition of commercial mixtures supplied as raw materials (including directly added preservatives, antioxidants, chelators, buffering agents, solvents, other additives, etc.) are to be identified and quantified in the formula of the finished product.
Vse snovi, ki sestavljajo na trgu dostopne zmesi, dobavljene kot surovine (vključno z neposredno dodanimi konzervansi, antioksidanti, kelatorji, pufri, topili, drugimi aditivi itd.), je treba identificirati in količinsko opredeliti v formuli končnega izdelka.
This also applies to all substances indirectly added to the product, such as preservatives used for preserving raw materials.
To velja tudi za vse snovi, ki se izdelku dodajo posredno, kot so konzervansi za konzerviranje surovin.
When chemically well-defined substances are present, their quantity and molecular formula should be given together with their analytical specifications (degree of purity, identification of major impurities, criteria and test methods used).
Kadar so prisotne kemijsko natančno opredeljene snovi, je treba navesti njihovo količino in molekulsko formulo skupaj z njihovimi analitičnimi specifikacijami (stopnjo čistosti, identifikacijo pomembnejših nečistot ter uporabljenimi merili in preskusnimi metodami).
When complex ingredients are present, their nature and quantity together with a clear definition of the mixture and the material(s) used should be given in order to identify the substances with regard to their composition and effects (manufacturing and purification processes, including physical, chemical, enzymatic, biotechnological and microbiological steps).
Kadar so prisotne kompleksne sestavine, je treba navesti njihove lastnosti in količino skupaj z jasno opredelitvijo uporabljenih zmesi in materialov, da se snovi identificirajo glede na njihovo sestavo in učinke (proizvodni postopki in postopki prečiščevanja, vključno s fizikalnimi, kemijskimi, encimskimi, biotehnološkimi in mikrobiološkimi fazami).
The purity criteria and test methods used should be provided.
Navesti je treba merila in preskusne metode za čistost.
Examples of complex ingredients include those of mineral, botanical, animal or biotechnological origin.
Primeri kompleksnih sestavin vključujejo snovi rudninskega, botaničnega, živalskega ali biotehnološkega izvora.
The scope of the information needed on complex ingredients, depending on their nature and origin, is explicitly listed in the Scientific Committee for Consumer Safety (SCCS) Note of Guidance [5].
Obseg potrebnih informacij o kompleksnih sestavinah glede na njihove lastnosti in izvor je izrecno naveden v navodilih Znanstvenega odbora za varstvo potrošnikov (ZOVP) [5].