natgillin/translations-raw huggingface dataset:
This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to the addition of vitamins and minerals and of certain other substances to foods, with the purpose of ensuring the effective functioning of the internal market, whilst providing a high level of consumer protection.
Ta uredba usklajuje določbe, ki jih v državah članicah predpisujejo zakoni in drugi predpisi, ki se nanašajo na dodajanje vitaminov, mineralov in nekaterih drugih snovi živilom, z namenom zagotavljanja učinkovitega delovanja notranjega trga, ob sočasnem zagotavljanju visoke ravni varstva potrošnikov.
The provisions of this Regulation regarding vitamins and minerals shall not apply to food supplements covered by Directive 2002/46/EC.
Določbe te uredbe v zvezi z vitamini in minerali se ne uporabljajo za prehranska dopolnila, ki jih zajema Direktiva 2002/46/ES.
This Regulation shall apply without prejudice to specific provisions laid down in Community legislation concerning:
Ta uredba se uporablja brez poseganja v posebne določbe zakonodaje Skupnosti, ki se nanašajo na:
foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended;
živila za posebne prehranske namene in, če ne obstajajo posebne določbe, na zahteve o sestavi tovrstnih izdelkov, potrebne zaradi posebnih prehranskih zahtev oseb, ki so jim ti proizvodi namenjeni;
novel foods and novel food ingredients;
nova živila in nove sestavine živil;
genetically modified food;
gensko spremenjena živila;
food additives and flavourings;
živilske dodatke in arome;
authorised oenological practices and processes.
dovoljene enološke postopke in obdelave.
‘Authority’ means the European Food Safety 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 [8];
„Agencija“ pomeni Evropsko agencijo za varnost hrane, 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 [8];
‘other substance’ means a substance other than a vitamin or a mineral that has a nutritional or physiological effect.
„Druga snov“ pomeni snov, ki ni vitamin ali mineral s hranilnim ali fiziološkim učinkom.
ADDITION OF VITAMINS AND MINERALS
DODAJANJE VITAMINOV IN MINERALOV
Requirements for the addition of vitamins and minerals
Zahteve za dodajanje vitaminov in mineralov
Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to the rules laid down in this Regulation.
Živilom se, v skladu s pravili iz te uredbe, lahko dodajo le vitamini in/ali minerali, ki so navedeni v Prilogi I, v oblikah, navedenih v Prilogi II.
Vitamins and minerals in a form that is bio-available to the human body may be added to foods, whether or not they are usually contained therein, in order to take into account, in particular:
Vitamini in minerali v takšni obliki, da jih človeško telo lahko absorbira, se lahko dodajo živilom ne glede na to, ali jih ta navadno vsebujejo ali ne, zlasti zaradi:
a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or
pomanjkanja enega ali več vitaminov in/ali mineralov v prebivalstvu ali v posebnih skupinah prebivalstva, kar je mogoče dokazati s kliničnimi ali subkliničnimi dokazi o pomanjkanju ali prikazati z ocenjeno nizko ravnjo vnosa hranil; ali
the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or
možnosti izboljšanja prehranskega stanja prebivalstva ali posebnih skupin prebivalstva in/ali odprave možnih pomanjkanj pri prehrambnih vnosih vitaminov ali mineralov zaradi sprememb prehranskih navad; ali
evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.
razvoja splošno sprejetih znanstvenih dognanj o vlogi vitaminov in mineralov v prehrani in posledičnih učinkih na zdravje.
Modifications to the lists referred to in paragraph 1 of this Article shall be adopted in accordance with the procedure referred to in Article 14(2), taking account of the opinion of the Authority.
Spremembe seznamov iz odstavka 1 tega člena, se sprejmejo v skladu s postopkom iz člena 14(2) ob upoštevanju mnenja Agencije.
Prior to making these modifications, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.
Preden Komisija naredi te spremembe, se posvetuje z zainteresiranimi stranmi, zlasti z nosilci živilske dejavnosti in skupinami potrošnikov.
Restrictions on the addition of vitamins and minerals
Omejitve dodajanja vitaminov in mineralov
Vitamins and minerals may not be added to:
Vitamini in minerali se ne smejo dodajati:
unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish;
nepredelanim živilom, kar vključuje, a ni omejeno na, sadje, zelenjavo, meso, perutnino in ribe;
beverages containing more than 1,2 % by volume of alcohol, except and by way of derogation from Article 3(2), to products:
pijačam, ki vsebujejo več kot 1,2 vol. % alkohola, razen, z odstopanjem od člena 3(2), proizvodom:
referred to in Article 44(6) and (13) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine [9]; and
navedenim v členu 44(6) in (13) Uredbe Sveta (ES) št. 1493/1999 z dne 17. maja 1999 o skupni ureditvi trga za vino [9]; in
which were marketed prior to the adoption of this Regulation; and
ki so bili na trgu pred sprejetjem te uredbe; in
which have been notified to the Commission by a Member State in accordance with Article 11,
o katerih je država članica uradno obvestila Komisijo v skladu s členom 11,
and provided that no nutrition or health claim is made.
pod pogojem, da nimajo nikakršne prehranske ali zdravstvene trditve.
Additional foods or categories of foods to which particular vitamins and minerals may not be added may be determined in accordance with the procedure referred to in Article 14(2) in the light of scientific evidence and taking into account their nutritional value.
Dodatna živila ali kategorije živil, ki se jim ne sme dodajati določenih vitaminov in mineralov, se lahko določijo v skladu s postopkom iz člena 14(2) glede na znanstvene dokaze in ob upoštevanju njihove hranilne vrednosti.
Purity criteria
Merila čistosti
The purity criteria for vitamin formulations and mineral substances listed in Annex II shall be adopted in accordance with the procedure referred to in Article 14(2), except where they apply pursuant to paragraph 2 of this Article.
Merila čistosti za kemijske oblike vitaminov in mineralov, ki so navedene v Prilogi II, se sprejmejo v skladu s postopkom iz člena 14(2), razen kjer se uporabljajo v skladu z odstavkom 2 tega člena.
Purity criteria for vitamin formulations and mineral substances listed in Annex II, specified by Community legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this Regulation, shall apply.
Merila čistosti za kemijske oblike vitaminov in mineralov, navedene v Prilogi II, določena z zakonodajo Skupnosti, se uporabljajo v proizvodnji živil za namene, ki niso zajeti v tej uredbi.
For those vitamin formulations and mineral substances listed in Annex II for which purity criteria are not specified by Community legislation, and until such specifications are adopted, generally acceptable purity criteria recommended by international bodies shall be applicable and national rules setting stricter purity criteria may be maintained.
Za tiste kemijske oblike vitaminov in mineralov, navedene v Prilogi II, za katere merila čistosti niso določena z zakonodajo Skupnosti, in dokler te zahteve niso sprejete, veljajo splošno priznana merila čistosti, ki jih priporočajo mednarodni organi in lahko se ohranijo tudi nacionalni predpisi, ki določajo strožja merila čistosti.
Conditions for the addition of vitamins and minerals
Pogoji za dodajanje vitaminov in mineralov
When a vitamin or a mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts that shall be set in accordance with the procedure referred to in Article 14(2).
Ko se vitamini in minerali dodajo živilom, skupna količina vitamina ali minerala, ki je, ne glede na namen, prisotna v živilu ob času nakupa, ne presega največjih količin, ki jih je treba določiti v skladu s postopkom iz člena 14(2).
The Commission may, to this end, submit proposals for the maximum amounts by 19 January 2009 For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer's instructions.
Komisija lahko v ta namen predloži predloge za največje količine do 19. januarja 2009. Za koncentrirane ali dehidrirane izdelke se kot največje količine določijo tiste, ki jih živila vsebujejo takrat, ko so v skladu s proizvajalčevimi navodili pripravljena za uživanje.
Any conditions restricting or prohibiting the addition of a specific vitamin or mineral to a food or a category of foods shall be adopted in accordance with the procedure referred to in Article 14(2).
Vsi pogoji, ki omejujejo ali prepovedujejo dodajanje določenega vitamina ali minerala živilu ali kategoriji živil, se sprejmejo v skladu s postopkom iz člena 14(2).
The maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 shall be set taking into account:
Največje količine iz odstavka 1 in pogoji iz odstavka 2 se določijo ob upoštevanju:
upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers; and
zgornjih varnih vrednosti vitaminov in mineralov, določenih z znanstveno oceno tveganja na podlagi splošno sprejetih znanstvenih dognanj, ob upoštevanju, kadar je primerno, različnih stopenj občutljivosti različnih skupin potrošnikov; in
intakes of vitamins and minerals from other dietary sources.
vnosa vitaminov in mineralov iz drugih prehrambnih virov.
When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set, due account shall also be taken of reference intakes of vitamins and minerals for the population.
Pri določanju najvišjih količin, navedenih v odstavku 1, in pogojev iz odstavka 2 se ustrezno upošteva tudi priporočen vnos vitaminov in mineralov za prebivalstvo.
When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set for vitamins and minerals whose reference intakes for the population are close to the upper safe levels, the following shall also be taken into account, as necessary:
Pri določanju najvišjih količin iz odstavka 1 in pogojev iz odstavka 2 za vitamine in minerale, katerih priporočen vnos za prebivalstvo je blizu zgornje varne vrednosti, se po potrebi upošteva tudi naslednje:
the contribution of individual products to the overall diet of the population in general or of sub-groups of the population;
delež posameznih proizvodov v celotni prehrani prebivalstva na splošno ali nekaterih podskupin prebivalstva;
the nutrient profile of the product established as provided for by Regulation (EC) No 1924/2006.
profil hranil izdelka, določen v skladu z Uredbo (ES) št. 1924/2006.
The addition of a vitamin or a mineral to a food shall result in the presence of that vitamin or mineral in the food in at least a significant amount where this is defined according to the Annex to Directive 90/496/EEC.
Živilu dodan vitamin ali mineral je prisoten v živilu vsaj v taki količini, če je ta določena, v skladu s Prilogo k Direktivi 90/496/EGS.
The minimum amounts, including any lower amounts, by derogation from the significant amounts mentioned above, for specific foods or categories of foods shall be adopted in accordance with the procedure referred to in Article 14(2).
Najmanjše količine, vključno z vsemi manjšimi količinami, se z odstopanjem od znatnih količin, navedenih zgoraj, za določena živila ali kategorije živil sprejmejo v skladu s postopkom iz člena 14(2).
Labelling, presentation and advertising
Označevanje, predstavljanje in oglaševanje
The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients.
Označevanje, predstavljanje in oglaševanje živil, ki so jim bili dodani vitamini in minerali, ne vsebuje nobene navedbe, ki trdi ali namiguje, da uravnotežena in raznolika prehrana ne more zagotoviti primernih količin hranil.
Where appropriate, a derogation concerning a specific nutrient may be adopted in accordance with the procedure referred to in Article 14(2).
Po potrebi se lahko določi odstopanje za določeno hranilo v skladu s postopkom iz člena 14(2).
The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients.
Označevanje, predstavljanje in oglaševanje živil, ki so jim bili dodani vitamini in minerali ne sme zavajati ali preslepiti potrošnika glede prehranske prednosti, ki jo ima živilo zaradi dodajanja teh hranil.
Nutrition labelling of products to which vitamins and minerals have been added and which are covered by this Regulation shall be compulsory.
Označevanje hranilne vrednosti izdelkov, ki so jim bili dodani vitamini in minerali, in ki jih zajema ta uredba, je obvezno.
The information to be provided shall consist of that specified in Article 4(1), Group 2 of Directive 90/496/EEC and of the total amounts present of the vitamins and minerals when added to the food.
Podatki, ki jih je treba navesti, zajemajo podatke, določene v skupini 2 člena 4(1) Direktive 90/496/EGS, in skupne količine vitaminov in mineralov, kadar so dodani živilom.
The labelling of products to which vitamins and minerals have been added may bear a statement indicating such addition under the conditions laid down in Regulation (EC) No 1924/2006.
Označevanje izdelkov, ki so jim bili dodani vitamini in minerali, lahko vključuje izjavo, da so takšna dodajanja v skladu s pogoji, določenimi v Uredbi (ES) št. 1924/2006.
This Article shall apply without prejudice to other provisions of food law applicable to specified categories of foods.
Ta člen se uporablja brez poseganja v druge določbe živilske zakonodaje, ki se uporabljajo za določene kategorije živil.
Rules for implementing this Article may be specified in accordance with the procedure referred to in Article 14(2).
Pravila za izvajanje tega člena se lahko določijo v skladu s postopkom iz člena 14(2).
ADDITION OF CERTAIN OTHER SUBSTANCES
DODAJANJE NEKATERIH DRUGIH SNOVI
Substances prohibited, restricted or under Community scrutiny
Prepovedane, omejene snovi ali snovi pod strogim nadzorom Skupnosti
The procedure provided for in this Article shall be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
Postopek, predviden v tem členu, se uporabi, če se dodaja živilom druga snov, kot so vitamini in minerali, ali sestavina, ki vsebuje drugo snov kot so vitamini ali minerali, ali se uporablja pri proizvodnji živil v okoliščinah, ki lahko povzročijo zaužitje količin te snovi, ki so veliko večje od količin, ki naj bi se običajno zaužile pod normalnimi pogoji prehranjevanja z uravnoteženimi in raznolikimi živili in/ali bi kako drugače predstavljale potencialno tveganje za potrošnike.
On its own initiative or on the basis of information provided by Member States, the Commission may take a decision, following in each case an assessment of available information by the Authority and in accordance with the procedure referred to in Article 14(2), to include, if necessary, the substance or ingredient in Annex III.
Komisija lahko na lastno pobudo ali na podlagi informacij s strani držav članic sprejme odločitev, potem ko v vsakem posameznem primeru Agencija opravi oceno razpoložljivih informacij, in v skladu s postopkom iz člena 14(2), da se po potrebi snov ali sestavina doda v Prilogo III.
if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:
če se pokažejo škodljivi učinki na zdravje, se snov in/ali sestavino, ki to snov vsebuje:
be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
doda v del A Priloge III in prepove dodajanje te snovi živilom ali njeno uporabo v proizvodnji živil; ali
be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
doda v del B Priloge III in dovoli dodajanje te snovi živilom ali njeno uporabo v proizvodnji živil le pod tam navedenimi pogoji;
if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.
če se pokažejo možni škodljivi učinki na zdravje, vendar še vedno obstaja znanstvena negotovost, se snov doda na seznam v del C Priloge III.
Community provisions applicable to specified foods may provide for restrictions or prohibitions on the use of certain substances in addition to those laid down in this Regulation.
Predpisi Skupnosti, ki veljajo za določena živila, lahko predvidijo omejitve ali prepovedi uporabe nekaterih snovi poleg tistih, ki so določene v tej uredbi.
Food business operators, or any other interested parties, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use.
Nosilci živilske dejavnosti ali druge zainteresirane strani lahko Agenciji kadarkoli predložijo v oceno spis z znanstvenimi spoznanji, ki prikazujejo varnost snovi, navedene v delu C Priloge III, pod pogoji uporabe v živilu ali kategoriji živil, in pojasnjujejo namen te uporabe.
The Authority shall inform without delay the Member States and the Commission of the submission and shall make the file available to them.
Agencija o takem spisu nemudoma obvesti države članice in Komisijo ter jim nudi vpogled v zadeven spis.
Within four years from the date a substance has been listed in Annex III, Part C, a decision shall be taken, in accordance with the procedure referred to in Article 14(2) and taking into account the opinion of the Authority on any files submitted for evaluation as mentioned in paragraph 4 of this Article, to generally allow the use of a substance listed in Annex III, Part C, or to list it in Annex III, Part A or B, as appropriate.
V štirih letih po datumu, ko je bila snov dodana v del C Priloge III, se v skladu s postopkom iz člena 14(2) in ob upoštevanju mnenja Agencije o spisih, ki so bili v skladu z odstavkom 4 tega člena predloženi v ocenjevanje, sprejme odločitev o tem, ali se brez omejitev dovoli uporaba snovi, navedenih v delu C Priloge III, ali pa se jih po potrebi vključi na seznam v del A ali B Priloge III.
The Commission shall establish, in accordance with the procedure referred to in Article 14(2), implementing rules for the application of this Article, including rules concerning the submission referred to in paragraph 4 of this Article.
Komisija v skladu s postopkom iz člena 14(2) določi izvedbena pravila za uporabo tega člena, vključno s pravili za predložitev spisa iz odstavka 4 tega člena.
The Commission shall establish and maintain a Community Register on the addition of vitamins and minerals and of certain other substances to foods, hereinafter referred to as ‘the Register’.
Komisija vzpostavi in vodi register Skupnosti o dodajanju vitaminov, mineralov in nekaterih drugih snovi živilom, v nadaljnjem besedilu „register“.
the vitamins and minerals which may be added to foods as listed in Annex I;
vitamine in minerale, ki se lahko dodajo živilom in so navedeni v Prilogi I;
the vitamin formulations and mineral substances which may be added to foods as listed in Annex II;
kemijske oblike vitaminov in mineralov, ki se lahko dodajo živilom in so navedeni v Prilogi II;
the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6;
največje in najmanjše količine vitaminov in mineralov, ki se lahko dodajajo živilom, in vse pogoje, ki se navezujejo nanje, določene v skladu s členom 6;
the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11;
informacije glede nacionalnih predpisov o obveznem dodajanju vitaminov in mineralov, iz člena 11;
any restrictions on the addition of vitamins and minerals as set out in Article 4;
vse omejitve dodajanja vitaminov in mineralov, kakor so določene v členu 4;
the substances for which dossiers have been submitted as provided for in Article 17(1)(b);
snovi, za katere je bila predložena dokumentacija v skladu s členom 17(1)(b);
information about the substances referred to in Annex III and the reasons for their inclusion therein;
informacije o snoveh iz Priloge III in razloge za njihovo vključitev v navedeno prilogo;
information about the substances listed in Annex III, Part C, whose use is generally allowed as referred to in Article 8(5).
podatke o snoveh iz dela C Priloge III, ki se jih na splošno sme uporabljati v skladu s členom 8(5).
Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in foods which comply with this Regulation and Community acts adopted for its implementation by the application of non-harmonised national provisions governing the addition of vitamins and minerals to foods.
Brez poseganja v Pogodbo, zlasti v člena 28 in 30 Pogodbe, države članice ne smejo omejiti ali prepovedati trgovine z živili, ki so v skladu s to uredbo in predpisi Skupnosti, ki so bili sprejeti za njeno izvajanje, z uporabo neusklajenih nacionalnih predpisov, ki urejajo dodajanje vitaminov in mineralov živilom.
By 19 July 2007, Member States shall inform the Commission of existing national provisions on the mandatory addition of vitamins and minerals and of products covered by the derogation provided for in Article 4(b).
Države članice do 19. julija 2007 obvestijo Komisijo o obstoječih nacionalnih predpisih o obveznem dodajanju vitaminov in mineralov ter o izdelkih, za katere velja odstopanje iz člena 4(b).
If a Member State, in the absence of Community provisions, considers it necessary to adopt new legislation:
Če država članica meni, da je treba, zato ker ne obstajajo predpisi Skupnosti, sprejeti novo zakonodajo:
on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or
o obveznem dodajanju vitaminov in mineralov določenim živilom ali kategorijam živil; ali
on the prohibition or restriction on the use of certain other substances in the manufacture of specified foods,
o prepovedi ali omejitvi uporabe določenih drugih snovi v proizvodnji določenih živil,