natgillin/translations-raw huggingface dataset:
In order to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market.
Zaradi varovanja zdravja ljudi bi bilo treba varnost aditivov, encimov in arom, ki se uporabljajo v živilih za prehrano ljudi, oceniti, preden se dajo v promet v Skupnosti.
Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [3], Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes [4] and Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods [5] (hereinafter referred to as the sectoral food laws) lay down harmonised criteria and requirements concerning the assessment and authorisation of these substances.
Uredba (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [3], Uredba (ES) št. 1332/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o encimih za živila [4] in Uredba (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih [5] (v nadaljnjem besedilu „področna živilska zakonodaja“) določajo usklajena merila in zahteve za oceno in odobritev teh snovi.
It is envisaged, in particular, that food additives, food enzymes and food flavourings, to the extent that the safety of food flavourings must be assessed in accordance with Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods], must not be placed on the market or used in foodstuffs for human consumption, in accordance with the conditions laid down in each sectoral food law, unless they are included on a Community list of authorised substances.
Predvideva se zlasti, da se aditivi za živila, encimi za živila in arome za živila, če je treba varnost arom za živila oceniti v skladu z Uredbo (ES) št. 1334/2008, ne smejo dati v promet ali uporabiti v živilih za prehrano ljudi v skladu s pogoji iz posamezne področne živilske zakonodaje, razen če so vključeni v seznam odobrenih snovi Skupnosti.
Ensuring transparency in the production and handling of food is absolutely crucial in order to maintain consumer confidence.
Zagotavljanje preglednosti pri proizvodnji živil in ravnanju z njimi je ključnega pomena za ohranjanje zaupanja potrošnikov.
In this context, it appears appropriate to establish for these three categories of substances a common Community assessment and authorisation procedure that is effective, time-limited and transparent, so as to facilitate their free movement within the Community market.
Zato se zdi primerno, da se vzpostavi skupni postopek Skupnosti za oceno in odobritev teh treh kategorij snovi, ki je učinkovit, časovno omejen in pregleden, tako da olajšuje njihov prost pretok na trgu Skupnosti.
This common procedure must be founded on the principles of good administration and legal certainty and must be implemented in compliance with those principles.
Ta skupni postopek mora temeljiti na načelih dobrega upravljanja in pravne varnosti ter se mora izvajati v skladu s tema načeloma.
This Regulation will thus complete the regulatory framework concerning the authorisation of the substances by laying down the various stages of the procedure, the deadlines for those stages, the role of the parties involved and the principles that apply.
Ta uredba bo tako z določitvijo različnih faz postopka, rokov za te faze, vloge udeleženih strani in veljavnih načel dopolnila regulativni okvir za odobritev snovi.
Nevertheless, for some aspects of the procedure, it is necessary to take the specific characteristics of each sectoral food law into consideration.
Kljub temu je treba pri nekaterih vidikih postopka upoštevati posebne značilnosti posamezne področne živilske zakonodaje.
The deadlines laid down in the procedure take into account the time needed to consider the different criteria set in each sectoral food law, as well as allowing adequate time for consultation when preparing the draft measures.
Roki, določeni v postopku, upoštevajo potreben čas za pretehtanje različnih meril, ki jih postavlja posamezna področna živilska zakonodaja, ter dajejo dovolj časa za posvetovanja med pripravljanjem osnutkov ukrepov.
In particular, the nine-months deadline for the Commission to present a draft regulation updating the Community list should not preclude the possibility of this being done within a shorter period.
Devetmesečni rok, v katerem mora Komisija predložiti osnutek uredbe o posodobitvi seznama Skupnosti, zlasti ne bi smel izključiti možnosti, da tega ni mogoče narediti prej.
Upon receipt of an application the Commission should initiate the procedure and where necessary seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [6] as soon as possible after the validity and applicability of the application have been assessed.
Komisija bi morala po prejetju zahtevka začeti postopek in po potrebi Evropsko agencijo za varnost hrane (v nadaljnjem besedilu „Agencija“), ustanovljeno z Uredbo (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [6], prositi za mnenje čim prej po oceni veljavnosti in uporabnosti zahtevka.
In accordance with the framework for risk assessment in matters of food safety established by Regulation (EC) No 178/2002, the authorisation to place substances on the market must be preceded by an independent scientific assessment, of the highest possible standard, of the risks that they pose to human health.
V skladu z okvirom za oceno tveganja v zvezi z varnostjo živil, ki ga določa Uredba (ES) št. 178/2002, mora biti odobritev za dajanje snovi v promet podeljena šele po neodvisni znanstveni oceni tveganosti za zdravje ljudi, ki temelji na največji možni kakovosti.
This assessment, which must be carried out under the responsibility of the Authority, must be followed by a risk management decision taken by the Commission under a regulatory procedure that ensures close cooperation between the Commission and the Member States.
Tej oceni, za katero je odgovorna Agencija, mora slediti odločitev o obvladovanju tveganja, ki jo sprejme Komisija po regulativnem postopku, ki zagotavlja tesno sodelovanje Komisije in držav članic.
The authorisation to place substances on the market should be granted pursuant to this Regulation provided that the criteria for authorisation laid down under the sectoral food laws are satisfied.
Odobritev za dajanje snovi v promet bi bilo treba podeliti v skladu s to uredbo, pod pogojem da so izpolnjena merila za odobritev, določena v področni živilski zakonodaji.
It is recognised that, in some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account, including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.
Priznava se, da v nekaterih primerih zgolj znanstvena ocena tveganja ne more zagotoviti vseh informacij, na katerih bi morala temeljiti odločitev o obvladovanju tveganja, in da se lahko upoštevajo drugi utemeljeni dejavniki, ki se nanašajo na obravnavano zadevo, vključno z družbenimi, gospodarskimi, etičnimi, okoljskimi dejavniki in dejavniki, povezanimi s tradicijami, ter izvedljivost nadzora.
In order to ensure that both business operators in the sectors concerned and the public are kept informed of the authorisations in force, the authorised substances should be included on a Community list created, maintained and published by the Commission.
Zaradi obveščanja nosilcev dejavnosti na zadevnih področjih in javnosti o veljavnih odobritvah bi bilo treba odobrene snovi vključiti v seznam Skupnosti, ki ga pripravi, vzdržuje in objavi Komisija.
Where appropriate and under certain circumstances, the specific sectoral food law may provide for protection of scientific data and other information submitted by the applicant for a certain period of time.
Kjer je primerno, lahko posebna področna živilska zakonodaja v določenih okoliščinah za določen čas predvideva zaščito znanstvenih podatkov in drugih informacij, ki jih predloži predlagatelj.
In this case, the sectoral food law should lay down the conditions under which these data may not be used for the benefit of another applicant.
V tem primeru bi morala področna živilska zakonodaja opredeliti pogoje, pod katerimi se ti podatki ne smejo uporabljati v korist drugega predlagatelja.
Networking between the Authority and the Member States’ organisations operating in the fields within the Authority’s mission is one of the basic principles of the Authority’s operation.
Mrežno povezovanje med Agencijo in organizacijami držav članic, ki delujejo na področjih dela Agencije, je eno od osnovnih načel delovanja Agencije.
In consequence, in preparing its opinion, the Authority may use the network made available to it by Article 36 of Regulation (EC) No 178/2002 and by Commission Regulation (EC) No 2230/2004 [7].
Zato lahko Agencija pri pripravi mnenja uporabi mrežo, ki ji jo daje na razpolago člen 36 Uredbe (ES) št. 178/2002 in Uredba Komisije (ES) št. 2230/2004 [7].
The common authorisation procedure for the substances must fulfil transparency and public information requirements while guaranteeing the right of applicants to preserve the confidentiality of certain information.
Skupni postopek odobritve snovi mora izpolnjevati zahteve po preglednosti in obveščanju javnosti ter hkrati predlagatelju zagotavljati pravico, da ohranja zaupnost nekaterih informacij.
Protecting the confidentiality of certain aspects of an application should be maintained as a consideration in order to protect the competitive position of an applicant.
Zaradi zavarovanja konkurenčnega položaja predlagatelja bi bilo treba še naprej upoštevati varstvo zaupnosti določenih vidikov zahtevka.
However, information relating to the safety of a substance, including, but not limited to, toxicological studies, other safety studies and raw data as such, should under no circumstances be confidential.
Vendar pa informacije o varnosti snovi, vključno, a ne zgolj s toksikološkimi raziskavami, drugimi študijami varnosti in neobdelanimi podatki, nikoli ne bi smele biti zaupne.
Pursuant to Regulation (EC) No 178/2002, 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.
V skladu z Uredbo (ES) št. 178/2002 se Uredba (ES) št. 1049/2001 Evropskega parlamenta in Sveta z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije [8] uporablja za dokumente, ki jih ima Agencija.
Regulation (EC) No 178/2002 establishes procedures for taking emergency measures in relation to foodstuffs of Community origin or imported from third countries.
Uredba (ES) št. 178/2002 vzpostavlja postopke za sprejetje nujnih ukrepov v zvezi z živili, ki imajo poreklo v Skupnosti ali so uvožena iz tretjih držav.
It authorises the Commission to adopt such measures in situations where foodstuffs are likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.
Komisijo pooblašča, da sprejme takšne ukrepe, kadar je verjetno, da živila predstavljajo resno tveganje za zdravje ljudi, zdravje živali ali okolje, in kadar takšnega tveganja ni mogoče zadovoljivo obvladati z ukrepi, ki jih sprejme(-jo) zadevna(-e) država(-e) članica(-e).
In the interests of efficiency and legislative simplification, there should be a medium-term examination of the question whether to extend the scope of the common procedure to other legislation in the area of food.
Zaradi učinkovitosti in poenostavitve zakonodaje bi bilo treba srednjeročno preveriti, ali je treba področje uporabe skupnega postopka razširiti na ostalo zakonodajo na področju živil.
Since the objectives of this Regulation cannot be sufficiently achieved by the Member States on account of differences between 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 ciljev te uredbe države članice zaradi razlik v nacionalnih zakonodajah in določbah ne morejo zadovoljivo doseči in ker te cilje lažje doseže Skupnost, Skupnost lahko sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
In particular the Commission should be empowered to update the Community lists.
Komisiji bi bilo zlasti treba podeliti pooblastila za posodabljanje seznamov Skupnosti.
Since those measures are of general scope and are designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb posamezne področne živilske zakonodaje, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the addition of substances to the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists.
Zaradi večje učinkovitosti bi bilo treba skrajšati običajne roke za regulativni postopek s pregledom za vključevanje snovi na seznam Skupnosti in za dodajanje, črtanje ali spreminjanje pogojev, specifikacij ali omejitev, ki veljajo za vključenost snovi na seznam Skupnosti.
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the removal of a substance from the Community lists and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community lists,
Kadar v nujnih primerih ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, bi bilo treba Komisiji omogočiti uporabo nujnega postopka iz člena 5a(6) Sklepa 1999/468/ES za črtanje snovi s seznama Skupnosti in za dodajanje, črtanje ali spreminjanje pogojev, specifikacij ali omejitev, ki veljajo za vključenost snovi na seznam Skupnosti –
This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the common procedure) of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs (hereinafter referred to as the substances), which contributes to the free movement of food within the Community and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer interests.
Ta uredba določa skupni postopek za oceno in odobritev (v nadaljnjem besedilu „skupni postopek“) aditivov za živila, encimov za živila, arom za živila in izvornih snovi za arome za živila ter sestavin živil z aromatičnimi lastnostmi, ki se uporabljajo ali so namenjeni za uporabo v ali na živilih (v nadaljnjem besedilu „snovi“), ki prispeva k prostemu pretoku živil v Skupnosti ter k visoki ravni varovanja zdravja ljudi in visoki ravni varstva potrošnikov, vključno z zaščito interesov potrošnikov.
This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods [10].
Ta uredba se ne uporablja za arome dima, ki spadajo na področje uporabe Uredbe (ES) št. 2065/2003 Evropskega parlamenta in Sveta z dne 10. novembra 2003 o aromah dima, ki se uporabljajo ali so namenjene uporabi v ali na živilih [10].
The common procedure shall lay down the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community pursuant to Regulation (EC) No 1333/2008 [on food additives], Regulation (EC) No 1332/2008 [on food enzymes] and Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods] (hereinafter referred to as the sectoral food laws).
Skupni postopek določa ureditev postopkov za posodobitev seznamov snovi, katerih trženje je odobreno v Skupnosti v skladu z Uredbo (ES) št. 1333/2008, Uredbo (ES) št. 1332/2008 in Uredbo (ES) št. 1334/2008 (v nadaljnjem besedilu „področna živilska zakonodaja“).
The criteria according to which substances can be included on the Community list provided for in Article 2, the content of the regulation referred to in Article 7 and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law.
Merila, v skladu s katerimi se lahko snovi vključijo na seznam Skupnosti iz člena 2, vsebina uredbe iz člena 7 in, če je primerno, prehodne določbe v zvezi s postopki v teku so določene v posamezni področni živilski zakonodaji.
Community list of substances
Seznam snovi Skupnosti
Under each sectoral food law, substances that have been authorised to be placed on the Community market shall be included on a list the content of which is determined by the said law (hereinafter referred to as the Community list).
V skladu s posamezno področno živilsko zakonodajo se snovi, ki so bile odobrene za dajanje v promet v Skupnosti, vključijo na seznam, katerega vsebina je določena s to zakonodajo (v nadaljnjem besedilu „seznam Skupnosti“).
The Community list shall be updated by the Commission.
Seznam Skupnosti posodablja Komisija.
‘Updating the Community list’ means:
„Posodobitev seznama Skupnosti“pomeni:
adding a substance to the Community list;
vključitev snovi na seznam Skupnosti;
removing a substance from the Community list;
črtanje snovi s seznama Skupnosti;
adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community list.
dodajanje, črtanje ali spreminjanje pogojev, specifikacij ali omejitev, ki veljajo za vključenost snovi na seznam Skupnosti.
COMMON PROCEDURE
SKUPNI POSTOPEK
Main stages of the common procedure
Glavne faze skupnega postopka
The common procedure for updating the Community list may be started either on the initiative of the Commission or following an application.
Skupni postopek za posodobitev seznama Skupnosti se lahko začne na pobudo Komisije ali z zahtevkom.
Applications may be made by a Member State or by an interested party, who may represent several interested parties, in accordance with the conditions provided for by the implementing measures referred to in Article 9(1)(a) (hereinafter referred to as the applicant).
Zahtevek lahko vloži država članica ali zainteresirana stran, ki lahko zastopa več zainteresiranih strani, v skladu s pogoji, ki jih določajo izvedbeni ukrepi iz člena 9(1)(a) (v nadaljnjem besedilu „predlagatelj“).
Applications shall be sent to the Commission.
Zahtevek se pošlje Komisiji.
The Commission shall seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority), to be given in accordance with Article 5.
Komisija zaprosi za mnenje Evropsko agencijo za varnost hrane (v nadaljnjem besedilu „Agencija“), ki se poda v skladu s členom 5.
However, for the updates referred to in Article 2(2)(b) and (c), the Commission shall not be required to seek the opinion of the Authority if the updates in question are not liable to have an effect on human health.
Vendar pa Komisiji ni treba zaprositi za mnenje Agencije za posodobitve iz člena 2(2)(b) in (c), če te posodobitve ne bodo imele učinka za zdravje ljudi.
The common procedure shall end with the adoption by the Commission of a regulation implementing the update, in accordance with Article 7.
Skupni postopek se konča tako, da Komisija v skladu s členom 7 sprejme uredbo o izvedbi posodobitve.
By way of derogation from paragraph 3, the Commission may end the common procedure and decide not to proceed with a planned update, at any stage of the procedure, if it judges that such an update is not justified.
Z odstopanjem od odstavka 3 lahko Komisija v kateri koli fazi postopka konča skupni postopek in ne nadaljuje z načrtovano posodobitvijo, če oceni, da takšna posodobitev ni upravičena.
Where applicable, it shall take account of the opinion of the Authority, the views of Member States, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration.
Če je primerno, upošteva mnenje Agencije in stališča držav članic, vse ustrezne določbe zakonodaje Skupnosti in vse druge utemeljene dejavnike, ki se nanašajo na obravnavano zadevo.
In such cases, where applicable, the Commission shall inform the applicant and the Member States directly, indicating in its letter the reasons for not considering the update justified.
V takšnih primerih Komisija, če je primerno, neposredno obvesti predlagatelja in države članice ter v pismu navede razloge, zaradi katerih meni, da posodobitev ni upravičena.
Initiating the procedure
Začetek postopka
On receipt of an application to update the Community list, the Commission:
Komisija ob prejemu zahtevka za posodobitev seznama Skupnosti:
shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;
predlagatelju v pisni obliki potrdi prejem zahtevka v roku 14 delovnih dni od prejema;
where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).
če je primerno, čim prej uradno obvesti Agencijo o zahtevku in jo v skladu s členom 3(2) prosi za mnenje.
The application shall be made available to the Member States by the Commission.
Komisija da zahtevek na voljo državam članicam.
Where it starts the procedure on its own initiative, the Commission shall inform the Member States and, where applicable, request the opinion of the Authority.
Kadar Komisija začne postopek na lastno pobudo, o tem obvesti države članice in, če je primerno, prosi za mnenje Agencijo.
The Authority shall give its opinion within nine months of receipt of a valid application.
Agencija poda mnenje v devetih mesecih po prejemu veljavnega zahtevka.
The Authority shall forward its opinion to the Commission, the Member States and, where applicable, the applicant.
Agencija pošlje mnenje Komisiji, državam članicam in, če je primerno, predlagatelju.
Additional information concerning risk assessment
Dodatne informacije za oceno tveganja
In duly justified cases where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended.
V ustrezno utemeljenih primerih, v katerih Agencija od predlagateljev zahteva dodatne informacije, se lahko rok iz člena 5(1) podaljša.
After consulting the applicant, the Authority shall lay down a period within which this information can be provided and shall inform the Commission of the additional period needed.
Po posvetovanju s predlagateljem Agencija določi rok, v katerem se te informacije lahko zagotovijo, in obvesti Komisijo o potrebnem dodatnem roku.