natgillin/translations-raw huggingface dataset:
In the control of the compliance of the materials and articles with this Regulation, it is appropriate to take into account the special needs of developing countries, and in particular of the least developed countries.
Pri nadzoru skladnosti materialov in izdelkov s to uredbo je treba upoštevati posebne potrebe držav v razvoju, in zlasti najmanj razvitih držav.
The Commission has been committed by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [7] to support developing countries with regard to food safety, including the safety of the materials and articles in contact with food.
Komisija se je z Uredbo Evropskega parlamenta in Sveta (ES) št. 882/2004 z dne 29. aprila 2004 o uradnih nadzorih za zagotavljanje preverjanja skladnosti z zakoni o krmi in živilih, zdravju živali in pravilih o dobrem počutju živali [7] zavezala podpreti države v razvoju glede varnosti živil, vključno z varnostjo materialov in izdelkov za stik z živili.
Special provisions have therefore been established in that Regulation which should be applicable also to the food contact materials and articles.
Zato navedena uredba vključuje posebne določbe, ki se morajo uporabljati tudi za materiale in izdelke za stik z živili.
It is necessary to establish procedures for the adoption of safeguard measures in situations where a material or article is likely to constitute a serious risk to human health.
Treba je določiti postopke sprejemanja zaščitnih ukrepov v primerih, ko bi material ali izdelek lahko predstavljal resno nevarnost za zdravje ljudi.
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents [8] applies to documents held by the Authority.
Za dokumente Agencije se uporablja Uredba Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije [8].
It is appropriate to protect the investment made by innovators in gathering the information and data supporting an application made under this Regulation.
V okviru te uredbe je treba zaščititi investicije inovatorjev pri zbiranju informacij in podatkov za podporo aplikacije.
In order to avoid unnecessary repetition of studies and in particular animal testing, however, sharing of data should be permitted provided there is agreement between the interested parties.
Da bi se izognili nepotrebnemu podvajanju študij in predvsem poskusov na živalih, bi bilo kljub temu treba dovoliti izmenjavo podatkov, če se zainteresirane stranke s tem strinjajo.
Community and national reference laboratories should be designated to contribute to a high quality and uniformity of analytical results.
Določiti je treba referenčne laboratorije na ravni Skupnosti in na nacionalni ravni, s čimer bi prispevali k visoki kakovosti in enotnosti analitičnih rezultatov.
This objective will be achieved within the framework of Regulation (EC) No 882/2004.
Ta cilj bo dosežen v okviru Uredbe (ES) št. 882/2004.
The use of recycled materials and articles should be favoured in the Community for environmental reasons, provided that strict requirements are established to ensure food safety and consumer protection.
Skupnost mora dajati prednost uporabi recikliranih materialov in izdelkov iz okolje-varstvenih razlogov, ob pogoju da so postavljene stroge zahteve, ki zagotavljajo varnost živil in varstvo potrošnikov.
Such requirements should be established taking also into account the technological characteristics of the different groups of materials and articles mentioned in Annex I. Priority should be given to the harmonisation of rules on recycled plastic material and articles as their use is increasing and national laws and provisions are lacking or are divergent.
Pri določevanju takih zahtev je treba upoštevati tudi tehnološke značilnosti različnih skupin materialov in izdelkov iz Priloge I. Pri tem mora imeti prednost usklajevanje pravil o recikliranih materialih in izdelkih iz plastične mase, saj njihova uporaba narašča, nacionalna zakonodaja pa ne obstaja ali je neskladna.
Therefore, a draft of a specific measure on recycled plastic materials and articles should be made available to the public as soon as possible in order to clarify the legal situation in the Community.
Zato mora biti osnutek posebnega ukrepa o recikliranju materialov in izdelkov iz plastične mase na voljo javnosti čim prej, da bi razjasnili pravni položaj v Skupnosti.
The measures necessary for the implementation of this Regulation and amendments to Annexes I and II hereto should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [9].
Ukrepi, potrebni za izvajanje te uredbe, in spremembe prilog I in II, se sprejmejo v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji dodeljenih izvedbenih pooblastil [9].
Member States should lay down rules on sanctions applicable to infringements of the provisions of this Regulation and ensure that they are implemented.
Države članice določijo pravila o sankcijah za kršitve določb te uredbe in zagotovijo njihovo izvajanje.
Such sanctions must be effective, proportionate and dissuasive.
Take sankcije morajo biti učinkovite, sorazmerne in odvračilne.
It is necessary for business operators to have sufficient time to adapt to some of the requirements established by this Regulation.
Potrebno je, da imajo nosilci dejavnosti dovolj časa za prilagoditev nekaterim zahtevam, ki jih določa ta uredba.
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States because of the differences between the national laws and provisions and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Ker države članice zaradi razlik med nacionalnimi zakoni in drugimi predpisi ne morejo zadovoljivo dosegati ciljev te uredbe, ki jih je mogoče bolje dosegati na ravni Skupnosti, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti, kakor je določeno v členu 5 Pogodbe.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
V skladu z načelom sorazmernosti, kakor je določeno v navedenem členu, ta uredba ne presega tega, kar je potrebno za dosego teh ciljev.
Directives 80/590/EEC and 89/109/EEC should therefore be repealed,
Zaradi tega je treba direktivi 80/590/EGS in 89/109/EGS razveljaviti –
Purpose and subject matter
Namen in predmet urejanja
The purpose of this Regulation is to ensure the effective functioning of the internal market in relation to the placing on the market in the Community of materials and articles intended to come into contact directly or indirectly with food, whilst providing the basis for securing a high level of protection of human health and the interests of consumers.
Namen te uredbe je zagotoviti učinkovito delovanje notranjega trga glede dajanja materialov in izdelkov za neposreden ali posreden stik z živili na trg Skupnosti, hkrati pa zagotoviti osnovo za zagotavljanje visoke stopnje zaščite zdravja ljudi in interesov potrošnikov.
This Regulation shall apply to materials and articles, including active and intelligent food contact materials and articles, (hereinafter referred to as materials and articles) which in their finished state:
Ta uredba se uporablja za materiale in izdelke, vključno z aktivnimi in inteligentnimi materiali in izdelki namenjenimi za stik z živili (v nadaljnjem besedilu „materiali in izdelki“):
are intended to be brought into contact with food;
ki so namenjeni stiku z živili;
are already in contact with food and were intended for that purpose;
ki so že prišli v stik z živili in so izdelani v ta namen;
can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.
za katere se lahko razumno pričakuje, da bodo prišli v stik z živili ali da bodo njihove sestavine prešle v živila ob normalnih ali predvidljivih pogojih uporabe.
materials and articles which are supplied as antiques;
materiale in izdelke, ki se dobavljajo kot starine;
covering or coating materials, such as the materials covering cheese rinds, prepared meat products or fruits, which form part of the food and may be consumed together with this food;
materiale za prekrivanje ali premaze, kakršni so materiali za prekrivanje sirove skorje, gotovih mesnih izdelkov ali sadja, ki so sestavni del živil in se lahko zaužijejo skupaj s temi živili;
fixed public or private water supply equipment.
stalno opremo javne ali zasebne oskrbe z vodo.
For the purposes of this Regulation, the relevant definitions laid down in Regulation (EC) No 178/2002 shall apply, with the exception of the definitions of ‘traceability’ and ‘placing on the market’, which shall have the following meanings:
Za namene te uredbe se uporabljajo ustrezne opredelitve pojmov, določene v Uredbi (ES) št. 178/2002, razen opredelitve pojmov „sledljivost“ in „dajanje v promet“ ki imajo naslednji pomen:
‘traceability’: the ability to trace and follow a material or article through all stages of manufacture, processing and distribution;
„sledljivost“ je možnost zasledovanja in sledenja materialu ali izdelku v vseh stopnjah proizvodnje, predelave in distribucije;
‘placing on the market’: the holding of materials and articles for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.
„dajanje v promet“ je imetje materialov in izdelkov za namene prodaje, vključno s ponujanjem za prodajo ali katerokoli drugo obliko prenosa, proti plačilu ali ne, ter za prodajo, distribucijo in druge oblike prenosa.
The following definitions shall also apply:
Uporabljajo se tudi naslednje opredelitve:
‘active food contact materials and articles’ (hereinafter referred to as active materials and articles) means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food.
„aktivni materiali in izdelki namenjeni za stik z živili“ (v nadaljnjem besedilu „aktivni materiali in izdelki“) pomenijo materiale in izdelke, ki so namenjeni podaljšanju roka uporabnosti ali vzdrževanju ali izboljšanju stanja pakiranih živil.
They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food;
Narejeni so z namenom, da vsebujejo sestavine, ki se sprostijo v pakirana živila ali absorbirajo snovi v pakiranih živilih iz njih ali okolja, ki živila obdaja;
‘intelligent food contact materials and articles’ (hereinafter referred to as intelligent materials and articles) means materials and articles which monitor the condition of packaged food or the environment surrounding the food;
„inteligentni materiali in izdelki za stik z živili“ (v nadaljnjem besedilu „inteligentni materiali in izdelki“) pomenijo materiale in izdelke, ki spremljajo stanje pakiranih živil ali okolja, ki živila obdaja;
‘business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing and distribution of materials and articles;
„podjetje“ pomeni katero koli podjetje, ki za dobiček ali ne, bodisi zasebno bodisi javno, izvaja katero koli dejavnost, povezano s katero koli stopnjo proizvodnje, predelave in distribucije materialov in izdelkov;
‘business operator’ means the natural or legal persons responsible for ensuring that the requirements of this Regulation are met within the business under their control.
„nosilec dejavnosti“ pomeni fizično ali pravno osebo, odgovorno za zagotavljanje, da se zahteve iz te uredbe izpolnjujejo v podjetju pod njegovim nadzorom.
Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
Materiali in izdelki, vključno z aktivnimi in inteligentnimi materiali in izdelki, se proizvajajo v skladu z dobro proizvodno prakso, tako da v normalnih ali predvidljivih pogojih uporabe njihove sestavine ne prehajajo v živila v količinah, ki bi lahko:
endanger human health;
ogrožale zdravje ljudi;
bring about an unacceptable change in the composition of the food;
povzročale nesprejemljivo spremembo v sestavi živil;
bring about a deterioration in the organoleptic characteristics thereof.
povzročale poslabšanje njihovih organoleptičnih lastnosti.
The labelling, advertising and presentation of a material or article shall not mislead the consumers.
Označevanje, oglaševanje in predstavitev materiala ali izdelka ne sme zavajati potrošnikov.
Special requirements for active and intelligent materials and articles
Posebne zahteve za aktivne in inteligentne materiale in izdelke
In the application of Article 3(1)(b) and 3(1)(c), active materials and articles may bring about changes in the composition or organoleptic characteristics of food on condition that the changes comply with the Community provisions applicable to food, such as the provisions of Directive 89/107/EEC on food additives and related implementing measures, or, if no Community provisions exist, with the national provisions applicable to food.
Pri uporabi člena 3(1)(b) in 3(1)(c) lahko aktivni materiali in izdelki povzročijo spremembe v sestavi ali organoleptičnih lastnostih živil, pod pogojem, da so te spremembe združljive s predpisi Skupnosti, ki se uporabljajo za živila, kakor so določbe Direktive 89/107/EGS o aditivih za živila in povezanih izvedbenih ukrepih, ali, če ne obstajajo predpisi Skupnosti, z nacionalnimi predpisi, ki se uporabljajo za živila.
Pending the adoption of additional rules in a specific measure on active and intelligent materials and articles, substances deliberately incorporated into active materials and articles to be released into the food or the environment surrounding the food shall be authorised and used in accordance with the relevant Community provisions applicable to food, and shall comply with the provisions of this Regulation and its implementing measures.
Do sprejetja dodatnih pravil v okviru posebnega ukrepa glede aktivnih in inteligentnih materialov in izdelkov se snovi, vključene v aktivne materiale in izdelke z namenom, da se sprostijo v živila ali okolje, ki živila obdaja, odobrijo in uporabljajo v skladu z ustreznimi predpisi Skupnosti, ki se uporabljajo za živila, in so skladne z določbami te uredbe in njenimi izvedbenimi ukrepi.
These substances shall be considered as ingredients within the meaning of Article 6(4)(a) of Directive 2000/13/EC [10].
Te snovi se štejejo kot sestavine v smislu člena 6(4)(a) Direktive 2000/13/ES [10].
Active materials and articles shall not bring about changes in the composition or organoleptic characteristics of food, for instance by masking the spoilage of food, which could mislead consumers.
Aktivni materiali in izdelki ne smejo povzročati sprememb v sestavi ali organoleptičnih lastnostih živil, na primer tako, da prikrijejo pokvarjenost živil, kar lahko zavede potrošnike.
Intelligent materials and articles shall not give information about the condition of the food which could mislead consumers.
Inteligentni materiali in izdelki ne smejo dajati informacij o stanju živil, ki bi lahko zavedle potrošnike.
Active and intelligent materials and articles already brought into contact with food shall be adequately labelled to allow identification by the consumer of non-edible parts.
Aktivni in inteligentni materiali in izdelki, ki so že prišli v stik z živili, se ustrezno označijo, da lahko potrošnik prepozna neužitne dele.
Active and intelligent materials and articles shall be adequately labelled to indicate that the materials or articles are active and/or intelligent.
Aktivni in inteligentni materiali in izdelki se ustrezno označijo, tako da je navedeno, da so materiali ali izdelki aktivni in/ali inteligentni.
Specific measures for groups of materials and articles
Posebni ukrepi za skupine materialov in izdelkov
For the groups of materials and articles listed in Annex I and, where appropriate, combinations of those materials and articles or recycled materials and articles used in the manufacture of those materials and articles, specific measures may be adopted or amended in accordance with the procedure referred to in Article 23(2).
Za skupine materialov in izdelkov, naštetih v Prilogi I, in, kjer je to primerno, kombinacije teh materialov in izdelkov ali recikliranih materialov in izdelkov, uporabljenih v proizvodnji teh materialov in izdelkov, se lahko sprejmejo ali spremenijo posebni ukrepi v skladu s postopkom iz člena 23(2).
Those specific measures may include:
Ti posebni ukrepi lahko vsebujejo:
a list of substances authorised for use in the manufacturing of materials and articles;
seznam snovi, odobrenih za uporabo v proizvodnji materialov in izdelkov;
list(s) of authorised substances incorporated in active or intelligent food contact materials and articles, or list(s) of active or intelligent materials and articles and, when necessary, special conditions of use for these substances and/or the materials and articles in which they are incorporated;
seznam(-e) odobrenih snovi, vključenih v aktivne ali inteligentne materiale in izdelke za stik z živili, ali seznam(-e) aktivnih ali inteligentnih materialov in izdelkov in, če je to potrebno, posebne pogoje uporabe teh snovi in/ali materialov in izdelkov, v katere so vključene;
purity standards for substances referred to in (a);
standarde za čistost snovi iz točke (a);
special conditions of use for substances referred to in (a) and/or the materials and articles in which they are used;
posebne pogoje uporabe snovi iz točke (a) in/ali materialov in izdelkov, v katerih se uporabljajo;
specific limits on the migration of certain constituents or groups of constituents into or on to food, taking due account of other possible sources of exposure to those constituents;
mejne vrednosti specifičnih migracij posameznih sestavin ali skupin sestavin v ali na živila, ob ustreznem upoštevanju drugih možnih virov izpostavljenosti tem sestavinam;
an overall limit on the migration of constituents into or on to food;
mejne vrednosti celotne migracije sestavin v ali na živila;
provisions aimed at protecting human health against hazards arising from oral contact with materials and articles;
določbe za varovanje zdravja ljudi pred najrazličnejšim tveganjem, ki lahko izhaja iz oralnega stika z materiali in izdelki;
other rules to ensure compliance with Articles 3 and 4;
druga pravila za zagotovitev skladnosti s členoma 3 in 4;
basic rules for checking compliance with points (a) to (h);
osnovna pravila za preverjanje skladnosti s točkami od (a) do (h);
rules concerning the collection of samples and the methods of analysis to check compliance with points (a) to (h);
pravila glede zbiranja vzorcev in metod analize za preverjanje skladnosti s točkami od (a) do (h);
specific provisions for ensuring the traceability of materials and articles including provisions regarding the duration for retention of records or provisions to allow, if necessary, for derogations from the requirements of Article 17;
posebne določbe za zagotavljanje sledljivosti materialov in izdelkov, vključno z določbami o trajanju hrambe evidenc ali določbami, ki, če je to potrebno, dovoljujejo odstopanje od zahtev iz člena 17;
additional provisions of labelling for active and intelligent materials and articles;
dodatne določbe o označevanju aktivnih in inteligentnih materialov in izdelkov;
provisions requiring the Commission to establish and maintain a publicly available Community Register (Register) of authorised substances, processes, or materials or articles;
določbe, ki zahtevajo, da Komisija ustanovi in vzdržuje javno dostopen register Skupnosti („Register“) odobrenih snovi, postopkov ali materialov ali izdelkov;
specific procedural rules adapting, as necessary, the procedure referred to in Articles 8 to 12, or making it appropriate for the authorisation of certain types of materials and articles and/or processes used in their manufacture, including, where necessary, a procedure for an individual authorisation of a substance, process, or material or article through a decision addressed to an applicant.
posebna postopkovna pravila, ki prilagajajo, kakor je to potrebno, postopek iz členov 8 do 12 ali ga naredijo ustreznega za odobritev določenih vrst materialov in izdelkov in/ali postopkov, uporabljenih v njihovi proizvodnji, vključno, če je to potrebno, s postopkom za posamezno odobritev snovi, materiala ali izdelka ali postopka na podlagi odločbe, naslovljene na vlagatelja.
Existing specific directives on materials and articles shall be amended in accordance with the procedure laid down in Article 23(2).
Obstoječe posebne direktive o materialih in izdelkih se spremenijo v skladu s postopkom iz člena 23(2).
National specific measures
Nacionalni posebni ukrepi
In the absence of specific measures referred to in Article 5, this Regulation shall not prevent Member States from maintaining or adopting national provisions provided they comply with the rules of the Treaty.
Če posebni ukrepi iz člena 5 ne obstajajo, ta uredba državam članicam ne preprečuje ohraniti ali sprejeti nacionalnih predpisov, pod pogojem, da so skladne z določbami Pogodbe.
Role of the European Food Safety Authority
Vloga Evropske agencije za varnost hrane
Provisions liable to affect public health shall be adopted after consulting the European Food Safety Authority, hereinafter referred to as ‘the Authority’.
Določbe, ki bi lahko vplivale na zdravje ljudi, se sprejmejo po posvetovanju z Evropsko agencijo za varnost hrane, v nadaljevanju „Agencija“.
General requirements for the authorisation of substances
Splošne zahteve za odobritev snovi
When a list of substances as referred to in points (a) and (b) of the second subparagraph of Article 5(1) is adopted, anyone seeking an authorisation for a substance not yet included in that list shall submit an application in accordance with Article 9(1).
Ko je sprejet seznam snovi iz točk (a) in (b) drugega pododstavka člena 5(1), vsakdo, ki prosi za odobritev snovi, ki še ni vključena na ta seznam, predloži vlogo v skladu s členom 9(1).
No substance shall be authorised unless it has been adequately and sufficiently demonstrated that, when used under the conditions to be set in the specific measures, the final material or article satisfies the requirements of Article 3 and, where they apply, Article 4.
Nobena snov se ne odobri, če se ne dokaže kot ustrezna in zadostna, da ob njeni uporabi v skladu s pogoji, ki jih je treba določiti v posebnih ukrepih, končni material ali izdelek izpolnjuje zahteve iz člena 3 in, kjer se uporablja, 4.
Application for authorisation of a new substance
Vloga za odobritev nove snovi
To obtain the authorisation referred to in Article 8(1), the following procedure shall apply:
Za pridobitev odobritve iz člena 8(1) se uporablja naslednji postopek:
an application shall be submitted to the competent authority of a Member State accompanied by the following:
vloga se predloži pristojnemu organu države članice skupaj z:
the name and address of the applicant;
imenom in naslovom vlagatelja,
a technical dossier containing the information specified in the guidelines for the safety assessment of a substance to be published by the Authority;
tehnično dokumentacijo, ki vsebuje podatke, opredeljene v smernicah za oceno varnosti snovi, ki jih objavi Agencija,
a summary of the technical dossier;
povzetek tehnične dokumentacije;
the competent authority referred to in (a) shall:
pristojni organ iz točke (a):