natgillin/translations-raw huggingface dataset:
The interested parties should submit the requested information within a time period that is set by EFSA having considered, where relevant, the views of the interested parties.
Zainteresirane strani morajo zahtevane informacije predložiti v roku, ki ga določi EFSA ob upoštevanju stališč zainteresiranih strani, kadar je to primerno.
Regulation (EC) No 1333/2008 provides that the approval of food additives should also take into account environmental factors.
Uredba (ES) št. 1333/2008 določa, da mora odobritev aditivov za živila upoštevati tudi okoljske dejavnike.
Therefore, in the framework of the re-evaluation of a food additive the interested parties should inform the Commission and EFSA of any information relevant to any environmental risks from the production, use or waste of that additive.
Zato morajo zainteresirane strani v okviru ponovne ocene aditiva za živila Komisiji in Efsi sporočiti katere koli informacije v zvezi s katerimi koli okoljskimi tveganji zaradi proizvodnje, uporabe ali odlaganja navedenega aditiva.
Where the requested information necessary for the completion of the re-evaluation of a particular food additive is not provided, the food additive may be removed from the Union list of approved food additives.
Kadar zahtevane informacije, ki so potrebne za zaključitev ponovne ocene določenega aditiva za živila, niso predložene, se lahko aditiv za živila odstrani s seznama Unije o odobrenih aditivih za živila.
The re-evaluation procedure of food additives must fulfil transparency and public information requirements while guaranteeing the confidentiality of certain information.
Postopek ponovnega ocenjevanja aditivov za živila mora izpolnjevati zahteve glede preglednosti in javnosti informacij ter hkrati zagotavljati zaupnost nekaterih informacij.
By the date of entry into force of this Regulation, the Commission will make available to the public a list of approved food additives that are being re-evaluated with the date of their latest evaluation by the ‘SCF’ or EFSA.
Do datuma začetka veljavnosti te uredbe bo Komisija objavila seznam odobrenih aditivov za živila, ki se ponovno ocenjujejo, z datumom njihove zadnje ocene, ki sta jo opravila SCF ali EFSA.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council opposed them,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali, Evropski parlament in Svet pa mu nista nasprotovala –
This Regulation sets up a programme for the re-evaluation by the European Food Safety Authority (hereinafter referred to as ‘EFSA’) of approved food additives, as provided for in Article 32 of Regulation (EC) No 1333/2008.
Ta uredba določa program, ki ga bo Evropska agencija za varnost hrane (v nadaljnjem besedilu: EFSA) izvajala za ponovno oceno odobrenih aditivov za živila, kot je določeno v členu 32 Uredbe (ES) št. 1333/2008.
Approved food additives, for which the re-evaluation by EFSA is already completed at the time of the adoption of this Regulation, shall not be re-evaluated again.
Odobreni aditivi za živila, za katere je v času sprejetja te uredbe EFSA že zaključila ponovno oceno, ne bodo ponovno ocenjeni.
Those food additives are listed in Annex I.
Navedeni aditivi za živila so na seznamu v Prilogi I.
‘approved food additive’ means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs [6], Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs [7] or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners [8];
„odobren aditiv za živila“ pomeni aditiv za živila, odobren pred 20. januarjem 2009 in naveden v Direktivi 94/35/ES Evropskega parlamenta in Sveta z dne 30. junija 1994 o sladilih za uporabo v živilih [6], Direktivi 94/36/ES Evropskega parlamenta in Sveta z dne 30. junija 1994 o barvilih za uporabo v živilih [7] in Direktivi 95/2/ES Evropskega parlamenta in Sveta z dne 20. februarja 1995 o aditivih za živila razen barvil in sladil [8];
‘business operator’ means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control;
„nosilec dejavnosti“ pomeni fizično ali pravno osebo, odgovorno za zagotavljanje, da se znotraj živilske dejavnosti pod njenim nadzorom izpolnjujejo zahteve iz Uredbe (ES) št. 1333/2008;
‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives;
„zainteresirani nosilec dejavnosti“ pomeni nosilca dejavnosti, k je zainteresiran za nadaljevanje odobritve enega ali več odobrenih aditivov za živila;
‘original dossier’ means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009.
„prvotna dokumentacija“ pomeni dokumentacijo, na podlagi katere je bil ocenjen aditiv za živila in dovoljena njegova uporaba pred 20. januarjem 2009.
Priorities for the re-evaluation of approved food additives
Prednostna ponovna ocena odobrenih aditivov za živila
Approved food additives shall be re-evaluated in the following order and within the following deadlines:
Odobreni aditivi za živila se ponovno ocenijo v naslednjem vrstnem redu in v naslednjih rokih:
the re-evaluation of all approved food colours listed in Directive 94/36/EC shall be completed by 31 December 2015;
ponovna ocena vseh odobrenih živilskih barvil iz Direktive 94/36/ES se zaključi do 31. decembra 2015;
the re-evaluation of all approved food additives other than colours and sweeteners listed in Directive 95/2/EC shall be completed by 31 December 2018;
ponovna ocena vseh odobrenih aditivov za živila, razen barvil in sladil, iz Direktive 95/2/ES se zaključi do 31. decembra 2018;
the re-evaluation of all approved sweeteners listed in Directive 94/35/EC shall be completed by 31 December 2020.
ponovna ocena vseh odobrenih sladil iz Direktive 94/35/ES se zaključi do 31. decembra 2020.
For certain food additives within the functional classes referred to in paragraph 1 more specific deadlines are set out in Annex II to this Regulation.
Za nekatere aditive za živila v funkcijskem razredu iz odstavka 1 so v Prilogi II k tej uredbi določeni posebni roki.
Those food additives shall be evaluated first among the other food additives of the same functional class.
Navedeni aditivi za živila se najprej ocenijo z drugimi aditivi za živila, ki sodijo v isti funkcijski razred.
By way of derogation from paragraphs 1 and 2, EFSA may at any moment start the re-evaluation of a food additive or a group of food additives with priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that
Z odstopanjem od odstavkov 1 in 2 lahko EFSA na zahtevo Komisije ali na lastno pobudo vsak trenutek prednostno začne ponovno oceno aditiva za živila ali skupine aditivov za živila, če se pojavijo novi znanstveni dokazi, ki:
indicates a possible risk for human health or
nakazujejo morebitno tveganje za zdravje ljudi ter
may in any way affect the safety assessment of that food additive or group of food additives.
lahko na kakršen koli način vplivajo na oceno varnosti navedenega aditiva za živila ali skupine aditivov za živila.
Re-evaluation procedure
Postopek ponovnega ocenjevanja
When re-evaluating an approved food additive, EFSA shall:
EFSA pri ponovni oceni odobrenega aditiva za živila:
examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA;
preuči prvotno mnenje Znanstvenega odbora za hrano (v nadaljnjem besedilu: SCF) ali Efse in njune delovne dokumente;
examine, where available, the original dossier;
preuči, kadar je to mogoče, prvotno dokumentacijo;
examine the data submitted by the interested business operator(s) and/or any other interested party;
preuči podatke, ki so jih predložili zainteresirani nosilci dejavnosti in/ali katera koli druga zainteresirana stran;
examine any data made available by the Commission and Member States;
preuči katere koli podatke, ki ji dajo na voljo Komisija in države članice;
identify any relevant literature published since the last evaluation of each food additive.
navede katero koli ustrezno literaturo, objavljeno po zadnji oceni vsakega aditiva za živila.
Call for data
Poziv za predložitev podatkov
In order to acquire the data from the interested business operators and/or other interested parties, EFSA shall make open call(s) for data for the food additives under re-evaluation.
EFSA za pridobitev podatkov od zainteresiranih nosilcev dejavnosti in/ali drugih zainteresiranih strani objavi javne pozive za predložitev podatkov za aditive za živila, ki se ponovno ocenjujejo.
In specifying the timetable for data submission, EFSA shall allow a reasonable time period after the entry into force of this Regulation, to allow the interested business operator and/or any other interested party to meet this duty.
EFSA pri določitvi časovnega razporeda za predložitev podatkov omogoči razumen rok po začetku veljavnosti te uredbe, da zainteresiranim nosilcem dejavnosti in/ali kateri koli drugi zainteresirani strani omogoči izpolnitev te obveznosti.
The data referred to in paragraph 1 may comprise among others:
Podatki iz odstavka 1 lahko med drugim zajemajo:
study reports from the original dossier as evaluated by the SCF or EFSA or the Joint FAO/WHO Expert Committee on Food Additives (JECFA),
poročila o študiji iz prvotne dokumentacije, kakor so jo ocenili SCF ali EFSA ali Skupni strokovni odbor FAO/WHO za aditive za živila (JECFA);
information on the data on the safety of the food additive concerned not previously reviewed by the SCF or the JECFA,
informacije o podatkih glede varnosti zadevnega aditiva za živila, ki jih SCF ali JECFA nista predhodno pregledala;
information on the specifications of the food additives presently in use, including information on particle size and relevant physicochemical characteristics and properties,
informacije o specifikacijah aditivov za živila, ki so trenutno v uporabi, vključno z informacijami o velikosti delcev in ustreznih fizikalno-kemijskih značilnostih in lastnostih;
information on the manufacturing process,
informacije o proizvodnem postopku;
information on analytical methods available for determination in food,
informacije o razpoložljivih analitskih metodah za določitev v hrani;
information on the human exposure to the food additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure),
informacije o izpostavljenosti ljudi aditivom za živila iz živil (npr. vzorci porabe in uporabe, dejanske ravni uporabe in najvišje ravni uporabe, pogostnost porabe in drugi dejavniki, ki vplivajo na izpostavljenost);
reaction and fate in food.
reakcije in obnašanje v živilih.
The interested business operator(s) and any other interested party shall submit the data related to the re-evaluation of a food additive as referred to in Article 5(2), within the period set by EFSA in its call for data.
Zainteresirani nosilci dejavnosti in katera koli druga zainteresirana stran predložijo podatke, povezane s ponovno oceno aditiva za živila iz člena 5(2), v roku, ki ga v pozivu za predložitev podatkov določi EFSA.
In the submission the interested business operator and the other interested parties shall include the data requested by EFSA by following, to the extent possible, the applicable guidance on submissions for food additive evaluations [9].
Zainteresirani nosilec dejavnosti in druge zainteresirane strani pri predložitvi podatkov, ki jih zahteva EFSA, v največji možni meri upoštevajo veljavna navodila za predložitev informacij za ovrednotenje aditivov za živila [9].
Where there are several interested business operators they may, when possible, submit the data collectively.
Kjer je več zainteresiranih nosilcev dejavnosti, lahko, kadar je mogoče, podatke predložijo skupaj.
If during the re-evaluation additional information considered to be relevant for the re-evaluation of a particular food additive is needed, EFSA shall request from the interested business operators, and shall invite other interested parties, to submit this information by an open call for data.
Če se med ponovno oceno ugotovi, da so potrebne dodatne informacije, ki se štejejo za ustrezne pri ponovni oceni določenega aditiva za živila, EFSA od zainteresiranih nosilcev dejavnosti zahteva predložitev teh informacij z javnim pozivom za predložitev podatkov, ter k temu povabi tudi druge zainteresirane strani.
It shall set a deadline within which that information shall be submitted having considered, where relevant, the interested business operator's and/or other interested parties' view of the time required.
EFSA določi rok za predložitev navedenih informacij in pri tem upošteva, kadar je primerno, mnenje zainteresiranih nosilcev dejavnosti in/ali drugih zainteresiranih strani o času, ki ga potrebujejo.
In such cases, EFSA shall make the request for the additional information well in advance so that the overall deadlines for the re-evaluation as set out in Article 3(1) and in Annex II are not affected.
V takih primerih EFSA zahteva informacije dovolj zgodaj, da to ne vpliva na splošne roke za ponovno oceno iz člena 3(1) in Priloge II.
Information which has not been submitted within the deadline set by EFSA shall not be taken into account in the re-evaluation.
Informacije, ki niso predložene v roku, ki ga je določila EFSA, se v ponovni oceni ne upoštevajo.
However, in exceptional cases, EFSA may decide with the agreement of the Commission to take into account information submitted after the deadline, if that information is significant for the re-evaluation of a food additive.
Vendar se lahko EFSA v izjemnih primerih v soglasju s Komisijo odloči, da bo upoštevala informacije, predložene po preteku roka, če so navedene informacije pomembne za ponovno oceno aditiva za živila.
Where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008 [10].
Kadar zahtevane informacije Efsi niso predložene v določenem roku, se lahko aditiv za živilo odstrani s seznama Unije v skladu s postopkom iz člena 10(3) Uredbe (ES) št. 1333/2008 [10].
In the framework of the re-evaluation of a food additive, the interested business operator(s) or any other interested party shall inform EFSA and the Commission of any information available in relation to any environment risks from the production, use or waste of that food additive.
Zainteresirani nosilci dejavno ali katera koli druga zainteresirana stran v okviru ponovne ocene aditiva za živila obvestijo Efso in Komisijo o katerih koli razpoložljivih informacijah v zvezi s katerimi koli okoljskimi tveganji zaradi proizvodnje, uporabe ali odlaganja navedenega aditiva za živila.
Confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.
Informacije, katerih razkritje bi lahko znatno škodilo konkurenčnemu položaju nosilca dejavnosti ali drugih zainteresiranih strani, se lahko obravnavajo zaupno.
the name and address of the interested business operator;
ime in naslov zainteresiranega nosilca dejavnosti;
the chemical name and a clear description of the substance;
kemijsko ime in jasen opis snovi;
information for the use of the substance in or on specific foodstuffs or food categories;
informacije o uporabi snovi v določenih živilih ali kategorijah živil ali na njih;
the method(s) of analysis in food.
metode analize v hrani.
For the purposes of paragraph 1, the interested business operator(s) and the other interested parties shall indicate which of the information provided they wish to be treated as confidential.
Za namene odstavka 1 zainteresirani nosilci dejavnosti in druge zainteresirane strani navedejo, za katere od predloženih informacij želijo zaupno obravnavo.
Verifiable justification shall be given in such cases.
V takih primerih se poda preverljiva utemeljitev.
On a proposal from EFSA, the Commission shall decide after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify the EFSA and the Member States accordingly.
Na predlog Efse Komisija po posvetovanju z zainteresiranim nosilcem dejavnosti in/ali drugimi zainteresiranimi stranmi odloči, katere informacije lahko ostanejo zaupne ter o tem ustrezno obvesti Efso in države članice.
The Commission, EFSA and the Member States shall, in accordance with 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 [11], take the necessary measures to ensure appropriate confidentiality of the information received under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.
Komisija, EFSA in države članice v skladu z Uredbo Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije [11] sprejmejo potrebne ukrepe za zagotovitev primerne zaupnosti informacij, prejetih v skladu s to uredbo, razen za informacije, ki se morajo objaviti, če zaradi varovanja zdravja ljudi, zdravja živali ali okolja okoliščine tako določajo.
The implementation of paragraphs 1 to 5 shall not affect the circulation of information between the Commission, EFSA and the Member States.
Izvajanje odstavkov 1 do 5 ne vpliva na izmenjavo informacij med Komisijo, Efso in državami članicami.
Monitoring progress
Spremljanje napredka
Every year in December, EFSA shall inform the Commission and the Member States on the progress of the re-evaluation programme.
EFSA vsako leto decembra Komisijo in države članice obvesti o napredku programa za ponovno oceno.
COM(2007) 418 final.
COM(2007) 418 konč.
COM(2001) 542 final.
COM(2001) 542 konč.
Food Additives in Europe 2000, Status of safety assessments of food additives presently permitted in the EU, Nordic Council of Ministers, TemaNord 2002:560.
Aditivi za živila v Evropi 2000, stanje ocen varnosti aditivov za živila, dovoljenih v EU, Nordijski svet ministrov, TemaNord 2002:560.
Guidance on submissions for food additive evaluations by the Scientific Committee on Food.
Navodila Znanstvenega odbora za hrano za predložitev informacij za ovrednotenje aditivov za živila.
A list of approved food additives which were approved before 20 January 2009 and for which the re-evaluation by EFSA is completed at the time of adoption of this Regulation
Seznam odobrenih aditivov za živila, ki so bili odobreni pred 20. januarjem 2009 in za katere je EFSA v času sprejetja te uredbe že končala ponovno oceno
Substance
SNOV
Year of latest evaluation by SCF or EFSA
Datum zadnje ocene SCF ali Efse
Status of re-evaluation by EFSA
Status ponovne ocene Efse
Tartrazine
tartrazin
Re-evaluation completed on 23 September 2009
Ponovna ocena končana 23. septembra 2009
Quinoline Yellow
kinolin rumeno
Sunset yellow FCF, Orange Yellow S
sončno rumeno
Re-evaluation completed on 24 September 2009
Ponovna ocena končana 24. septembra 2009
Azorubine, Carmoisine
azorubin, karmoizin
Ponceau 4R, Cochineal Red A
ponso 4R, košenil rdeče A
Allura Red AC
alura rdeče AC
Lycopene
likopen
Re-evaluation completed on 30 January 2008
Ponovna ocena končana 30. januarja 2008
Re-evaluation completed on 26 January 2006
Ponovna ocena končana 26. januarja 2006
Re-evaluation completed on 22 May 2008
Ponovna ocena končana 22. maja 2008
Ethyl p-hydroxybenzoate
etil p-hidroksibenzoat
Re-evaluation completed on 13 July 2004
Ponovna ocena končana 13. julija 2004
Sodium ethyl p-hydroxybenzoate
natrijev etil p-hidroksibenzoat
Sodium methyl p-hydroxybenzoate
natrijev metil p-hidroksibenzoat
Natamycin
natamicin
Re-evaluation completed on 26 November 2009
Ponovna ocena končana 26. novembra 2009
Sucrose esters of fatty acids
estri saharoze z maščobnimi kislinami
Re-evaluation completed on 23 November 2004; revised on 26 January 2006
Ponovna ocena končana 23. novembra 2004 in revidirana 26. januarja 2006
Sucroglycerides
saharogliceridi
Beeswax, white and yellow
čebelni vosek, bel in rumen
Re-evaluation completed on 27 November 2007
Ponovna ocena končana 27. novembra 2007
Specific priorities for certain food additives within the functional classes of food additives as referred to in Article 3(1) and (2)
Posebne prednosti za nekatere aditive za živila v funkcijskih razredih aditivov za živila iz člena 3(1) in (2)
PART I: FOOD COLOURS
DEL I: ŽIVILSKA BARVILA
Within the overall deadline of 31.12.2015 set for the re-evaluation of food colours in Article 3(1) the following specific deadlines are set for the following food colours:
V okviru splošnega roka dne 31. decembra 2015, določenega za ponovno oceno živilskih barvil v členu 3(1), so določeni posebni roki za naslednja živilska barvila:
The following food colours shall be evaluated by 15.4.2010
Naslednja živilska barvila bodo ocenjena do 15. aprila 2010
E 123 Amaranth,
E 123 amarant,
E 151 Brilliant Black BN, Black PN
E 151 briljantno črno BN, črno PN,
E 154 Brown FK,
E 154 rjavo FK,
E 155 Brown HT and
E 155 rjavo HT ter
E 180 Litholrubine BK
E 180 litolrubin BK.
The following food colours shall be evaluated by 31.12.2010
Naslednja živilska barvila bodo ocenjena do 31. decembra 2010
E 100 Curcumin,
E 100 kurkumin,
E 127 Erythrosine,
E 127 eritrozin,
E 131 Patent Blue V,
E 131 patentno modro V,
E 132 Indigotine, Indigo carmine
E 132 indigo, indigo karmin,
E 133 Brilliant Blue FCF,
E 133 briljant modro FCF,
E 142 Green S,
E 142 zeleno S,
E 150a Plain caramel,
E 150a karamel,
E 150b Caustic sulphite caramel,
E 150b alkalijski sulfitni karamel,
E 150c Ammonia caramel,
E 150c amonijev karamel,
E 150d Sulphite ammonia caramel,
E 150d amonijev sulfitni karamel,
E 161g Canthaxanthin,
E 161g kantaksantin,
E 170 Calcium carbonate,
E 170 kalcijev karbonat.
The following food colours shall be evaluated by 31.12.2015
Naslednja živilska barvila bodo ocenjena do 31. decembra 2015
E 101 (i) Riboflavin (ii) Riboflavin-5’-phosphate,
E 101 (i) riboflavin (ii) riboflavin-5′-fosfat
E 120 Cochineal, Carminic acid, Carmines
E 120 košenil, karminska kislina, karmini
E 140 Chlorophylls and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins,
E 140 klorofili in klorofilini: (i) klorofili (ii) klorofilini,
E 141 Copper complexes of Chlorophylls and Chlorophyllins: (i) Copper complexes of chlorophylls (ii) Copper complexes of chlorophyllins,
E 141 bakrovi kompleksi klorofilov in klorofilinov: (i) bakrovi kompleksi klorofilov (ii) bakrovi kompleksi klorofilinov,
E 153 Vegetable carbon,
E 153 rastlinsko oglje,
E 160b Annatto, bixin, norbixin
E 160b anato, biksin, norbiksin,
E 160a Carotenes: (i) mixed carotenes, (ii) beta-carotene,
E 160a karoteni: (i) mešanica karotenov, (ii) beta-karoten,
E 160c Paprika extract, capsanthin, capsorubin,
E 160c izvleček iz paprike, kapsantin, kapsorubin,
E 160e Beta-apo-8’-carotenal (C30),
E 160e beta-apo-8′-karotenal (C30),
E 160f Ethyl ester of beta-apo-8’, -carotenoic acid (C30),
E 160f etilni ester beta-apo-8′-karotenojske kisline (C30),
E 162 Beetroot red, betanin,
E 162 barvilo rdeče pese, betanin,
E 163 Anthocyanins,
E 163 antocianini,
E 171 Titanium dioxide,
E 171 titanov dioksid,
E 172 Iron oxides and hydroxides,
E 172 železovi oksidi in hidroksidi,
E 174 Silver,
E 174 srebro,
E 175 Gold
E 175 zlato.
PART II: FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERS
DEL II: ADITIVI ZA ŽIVILA RAZEN BARVIL IN SLADIL